Posted - Oct 01, 2024
Job Description An opportunity has arisen for an External Manufacturing O...
Job Description An opportunity has arisen for an External Manufacturing Operations Associate Director. Our Manufacturing & Supply Division is d...
Posted - Oct 01, 2024
Job Description An opportunity has arisen for an External Manufacturing O...
Job Description An opportunity has arisen for an External Manufacturing Operations Associate Director. Our Manufacturing & Supply Division is d...
Posted - Oct 01, 2024
Job Description The candidate selected for this hybrid position will have...
Job Description The candidate selected for this hybrid position will have responsibilities as both an Institutional Account Lead (IAL) and Payer Acco...
Posted - Oct 01, 2024
Job Description The candidate selected for this hybrid position will have...
Job Description The candidate selected for this hybrid position will have responsibilities as both an Institutional Account Lead (IAL) and Payer Acco...
Posted - Oct 01, 2024
Job Description An opportunity has arisen for an External Manufacturing O...
Job Description An opportunity has arisen for an External Manufacturing Operations Associate Director. Our Manufacturing & Supply Division is d...
Posted - Oct 01, 2024
Job Description An opportunity has arisen for an External Manufacturing O...
Job Description An opportunity has arisen for an External Manufacturing Operations Associate Director. Our Manufacturing & Supply Division is d...
Posted - Oct 01, 2024
Job Description An opportunity has arisen for an External Manufacturing O...
Job Description An opportunity has arisen for an External Manufacturing Operations Associate Director. Our Manufacturing & Supply Division is d...
Posted - Oct 01, 2024
Job Description An opportunity has arisen for an External Manufacturing O...
Job Description An opportunity has arisen for an External Manufacturing Operations Associate Director. Our Manufacturing & Supply Division is d...
Posted - Oct 01, 2024
Job Description An opportunity has arisen for an External Manufacturing O...
Job Description An opportunity has arisen for an External Manufacturing Operations Associate Director. Our Manufacturing & Supply Division is d...
Posted - Oct 01, 2024
Job Description An opportunity has arisen for an External Manufacturing O...
Job Description An opportunity has arisen for an External Manufacturing Operations Associate Director. Our Manufacturing & Supply Division is d...
Posted - Oct 01, 2024
Job Description An opportunity has arisen for an External Manufacturing O...
Job Description An opportunity has arisen for an External Manufacturing Operations Associate Director. Our Manufacturing & Supply Division is d...
Posted - Oct 01, 2024
Job Description An opportunity has arisen for an External Manufacturing O...
Job Description An opportunity has arisen for an External Manufacturing Operations Associate Director. Our Manufacturing & Supply Division is d...
Posted - Oct 01, 2024
Job Description An opportunity has arisen for an External Manufacturing O...
Job Description An opportunity has arisen for an External Manufacturing Operations Associate Director. Our Manufacturing & Supply Division is d...
Posted - Oct 01, 2024
Job Description An opportunity has arisen for an External Manufacturing O...
Job Description An opportunity has arisen for an External Manufacturing Operations Associate Director. Our Manufacturing & Supply Division is d...
Posted - Oct 01, 2024
Job Description We are seeking an Associate Principal Scientist to join ou...
Job Description We are seeking an Associate Principal Scientist to join our Data-Rich Experimentation (DRE) organization, within Process Research &am...
Posted - Oct 01, 2024
Job Description We are seeking an Associate Principal Scientist to join ou...
Job Description We are seeking an Associate Principal Scientist to join our Data-Rich Experimentation (DRE) organization, within Process Research &am...
Posted - Oct 01, 2024
Job Description IPT Quality Lead M2 The Associate Director within Quali...
Job Description IPT Quality Lead M2 The Associate Director within Quality is responsible for providing Quality direction and oversight to one of...
Posted - Oct 01, 2024
Job Description IPT Quality Lead M2 The Associate Director within Quali...
Job Description IPT Quality Lead M2 The Associate Director within Quality is responsible for providing Quality direction and oversight to one of...
Posted - Oct 01, 2024
Job Description An opportunity has arisen for an External Manufacturing O...
Job Description An opportunity has arisen for an External Manufacturing Operations Associate Director. Our Manufacturing & Supply Division is d...
Posted - Oct 01, 2024
Job Description An opportunity has arisen for an External Manufacturing O...
Job Description An opportunity has arisen for an External Manufacturing Operations Associate Director. Our Manufacturing & Supply Division is d...
Posted - Oct 01, 2024
Job Description The Quantitative Pharmacology and Pharmacometrics (QP2) De...
Job Description The Quantitative Pharmacology and Pharmacometrics (QP2) Department of our Company's Research Laboratories is seeking a curious and co...
Posted - Oct 01, 2024
Job Description The Quantitative Pharmacology and Pharmacometrics (QP2) De...
Job Description The Quantitative Pharmacology and Pharmacometrics (QP2) Department of our Company's Research Laboratories is seeking a curious and co...
Posted - Oct 01, 2024
Job Description An opportunity has arisen for an External Manufacturing O...
Job Description An opportunity has arisen for an External Manufacturing Operations Associate Director. Our Manufacturing & Supply Division is d...
Posted - Oct 01, 2024
Job Description An opportunity has arisen for an External Manufacturing O...
Job Description An opportunity has arisen for an External Manufacturing Operations Associate Director. Our Manufacturing & Supply Division is d...
Posted - Oct 01, 2024
Job Description We are seeking a Senior Scientist to join our Data-Rich Ex...
Job Description We are seeking a Senior Scientist to join our Data-Rich Experimentation (DRE) organization, within Process Research & Developing...
Posted - Oct 01, 2024
Job Description We are seeking a Senior Scientist to join our Data-Rich Ex...
Job Description We are seeking a Senior Scientist to join our Data-Rich Experimentation (DRE) organization, within Process Research & Developing...
Posted - Oct 01, 2024
Job Description An opportunity has arisen for an External Manufacturing O...
Job Description An opportunity has arisen for an External Manufacturing Operations Associate Director. Our Manufacturing & Supply Division is d...
Posted - Oct 01, 2024
Job Description An opportunity has arisen for an External Manufacturing O...
Job Description An opportunity has arisen for an External Manufacturing Operations Associate Director. Our Manufacturing & Supply Division is d...
Posted - Oct 01, 2024
Job Description An opportunity has arisen for an External Manufacturing O...
Job Description An opportunity has arisen for an External Manufacturing Operations Associate Director. Our Manufacturing & Supply Division is d...
Posted - Oct 01, 2024
Job Description An opportunity has arisen for an External Manufacturing O...
Job Description An opportunity has arisen for an External Manufacturing Operations Associate Director. Our Manufacturing & Supply Division is d...
Posted - Oct 01, 2024
Job Description The Associate Director, Technical Operations, is responsib...
Job Description The Associate Director, Technical Operations, is responsible for the management and oversight of a team providing technical support f...
Posted - Oct 01, 2024
Job Description The Associate Director, Technical Operations, is responsib...
Job Description The Associate Director, Technical Operations, is responsible for the management and oversight of a team providing technical support f...
Posted - Oct 01, 2024
Job Description The candidate selected for this hybrid position will have...
Job Description The candidate selected for this hybrid position will have responsibilities as both an Institutional Account Lead (IAL) and Payer Acco...
Posted - Oct 01, 2024
Job Description The candidate selected for this hybrid position will have...
Job Description The candidate selected for this hybrid position will have responsibilities as both an Institutional Account Lead (IAL) and Payer Acco...
Posted - Oct 01, 2024
Job Description The candidate selected for this hybrid position will have...
Job Description The candidate selected for this hybrid position will have responsibilities as both an Institutional Account Lead (IAL) and Payer Acco...
Posted - Oct 01, 2024
Job Description The candidate selected for this hybrid position will have...
Job Description The candidate selected for this hybrid position will have responsibilities as both an Institutional Account Lead (IAL) and Payer Acco...
Posted - Oct 01, 2024
Job Description Position Description: Quality Assurance (QA) Senior Spe...
Job Description Position Description: Quality Assurance (QA) Senior Specialist - Large Molecule Analytical We are seeking a quality leader for th...
Posted - Oct 01, 2024
Job Description Position Description: Quality Assurance (QA) Senior Spe...
Job Description Position Description: Quality Assurance (QA) Senior Specialist - Large Molecule Analytical We are seeking a quality leader for th...
Posted - Oct 01, 2024
Job Description Our Quality Assurance group ensures every single material...
Job Description Our Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored an...
Posted - Oct 01, 2024
Job Description Our Quality Assurance group ensures every single material...
Job Description Our Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored an...
Posted - Oct 01, 2024
Job Description Our IT team operates as a business partner proposing ideas...
Job Description Our IT team operates as a business partner proposing ideas and innovative solutions that enable new organizational capabilities. We c...
Posted - Oct 01, 2024
Job Description Our IT team operates as a business partner proposing ideas...
Job Description Our IT team operates as a business partner proposing ideas and innovative solutions that enable new organizational capabilities. We c...
Posted - Oct 01, 2024
Job Description Our IT team operates as a business partner proposing ideas...
Job Description Our IT team operates as a business partner proposing ideas and innovative solutions that enable new organizational capabilities. We c...
Posted - Oct 01, 2024
Job Description Our IT team operates as a business partner proposing ideas...
Job Description Our IT team operates as a business partner proposing ideas and innovative solutions that enable new organizational capabilities. We c...
Posted - Oct 01, 2024
Job Description Our IT team operates as a business partner proposing ideas...
Job Description Our IT team operates as a business partner proposing ideas and innovative solutions that enable new organizational capabilities. We c...
Posted - Oct 01, 2024
Job Description Our IT team operates as a business partner proposing ideas...
Job Description Our IT team operates as a business partner proposing ideas and innovative solutions that enable new organizational capabilities. We c...
Posted - Oct 01, 2024
Job Description Our IT team operates as a business partner proposing ideas...
Job Description Our IT team operates as a business partner proposing ideas and innovative solutions that enable new organizational capabilities. We c...
Posted - Oct 01, 2024
Job Description Our IT team operates as a business partner proposing ideas...
Job Description Our IT team operates as a business partner proposing ideas and innovative solutions that enable new organizational capabilities. We c...
Job Description
An opportunity has arisen for an External Manufacturing Operations Associate Director. Our Manufacturing & Supply Division is dedicated to being the most trusted supplier of biopharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create a reliable global manufacturing network that's devoted to delivering a high quality, reliable supply to customers and patients on time, every time.
Based out of the United States, the ExM Operations Associate Director is accountable for meeting customer demand at the Contract Manufacturing Organizations (CMOs) they manage by achieving excellence in Compliance, Supply, Continuous Improvement & Cost. This is achieved through their direction as a key contributor within Focus Factory, and in partnership with those CMOs while leveraging lean manufacturing principles and the E2E supply chain.
You will be accountable for potentially new project support as well as commercial oversight between our Manufacturing Division and the CMO, by establishing strong business partnership as well as boundaries and ground rules of engagement.
You will steer a cross-functional team (Supply Chain, Quality, Technical Ops, Procurement...) who are accountable for delivering daily/weekly/monthly/annual requirements at their external partner(s).
Bring energy, knowledge, innovation to carry out the following:
Ensure compliance (Quality Risk management, Deviation Management, Product Release, Change Control); Meeting Demand; Dispute resolution (w/ appropriate escalation); Production Planning; Materials Management & Logistics; Technology issues; Oversight of shop floor production (determining when an ExM functional rep should be deployed to the External Party's (EP) facility); Lean Manufacturing and Continuous Improvement activities; Linking E2E (upstream and downstream) and with Supply Chain Management ensure and optimize flow of materials
Maintain a virtual presence at external partners site on the production floor either virtually or physically; builds a strong co-dependent relationship with the sites leadership team and can assess (-read a site-) & diagnose the current condition. Assess risks at a partners site and formulate in partnership with the external partner and our Company cross-functional team action orientated and time bound improvement plans. This may be executed virtually as well through use of innovative technologies that allow for remote sharing of information
Partner with internal ExM team members including Procurement, Quality, Project management and Technology on commercial aspects of relationship, including Identify, Select, Negotiate and Re-negotiate/terminate, as required. The External Manufacturing Operations Associate Director may not be involved in all transactional interactions if they can be managed/delegated to a functional area but will be kept apprised of status/resolutions, etc
Participate in and represents External Manufacturing on the cross-functional teams with Supply Chain Management/Product Source Management/ Procurement/ Integrated Development and Supply Team for due diligence ahead of siting approval & post siting approval to support Source of Supply (SOS)/New Product Introduction (NPI) changes at an external party and assume primary ownership of the new relationship.
Ensure there is a plan with clear actions and timelines in place to deliver SOS or NPI
Work with the external partner to comprehend CMO capacity (e.g., stated capacity, firm capacity, future capacity plans, time horizon / lead times required, etc.) and future capacity based on established improvements.
Accountable for maintaining the integrity of the Master Supply Agreement ensuring alignment with the Supply and Quality agreements and appropriate document revision and distribution control and for ensuring contract terms established upon by our Manufacturing Division and the External Party are executed including purchase orders, forecasts, deliveries, and approving invoice payments.
Accountable for inventory control. Based on the location of goods (at External Party or at our Company), External Manufacturing Operations Associate Director ensures adequate documentation of material disposition. In some markets, External Manufacturing Operations may need to witness the destruction of goods (to prevent counterfeiting) or have the External Party certify the destruction, per destruction procedures.
Act as our Company operational excellence leader & coach for own team and works with external partner and lean manufacturing resources, as needed, to identify External Party OpEx / continuous improvement opportunities and supports implementation once approved.
Lead with the Virtual external partner periodic Business and Operations Review Meetings (Joint Steering Committee). Based on our Company and External Manufacturing strategy the External Manufacturing Operations Associate Director develops with their cross functional team and their external partner the annual plan for the relationship with clear goals and targets
Participate in the creation and maintenance of an External Manufacturing Organization Handbook containing Global External Manufacturing policies, procedures, templates, etc
Minimum education required:
Required experience and skills:
Minimum 8 years' experience in commercial / business and manufacturing (sterile operations, quality, technology, planning)
Role requires a portion in management/leadership positions or project management.
At least two (2) years of experience in management/leadership positions which may include Employee Business Resource Group (EBRG) management experience such as Women's Network, LEAD or mentoring.
Ability to achieve compliance goals, through a risk-based approach has a deep comprehension of GMP and EHS compliance and compliance risk in Sterile Operations.
Proven Lean Six Sigma skills (operational excellence) to deliver compliant supply and achieve highest quality, lowest cost and shortest lead-time.
Skills to comprehend and intelligently apply economic, financial and industry data to make business decisions that drive value for our Company and our customers.
Can Visualize the way forward, identifying opportunities that add value to the work and proactively mitigate risk across the value chain.
Possess excellent interactive, communication, partnership and negotiation skills to work outside boundaries as a norm.
Ability to use deep knowledge and expertise in production operations to drive results and business outcomes.
Ability to apply comprehension of end-to-end supply chain within external and internal network and stakeholders across the network to achieve results and contribute to supply chain optimization.
Direct Health Authority Audit experience is desirable.
NOTICE FOR INTERNAL APPLICANTS
In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.
If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.
Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.
Current Employees apply HERE (https://wd5.myworkday.com/msd/d/task/1422$6687.htmld)
Current Contingent Workers apply HERE (https://wd5.myworkday.com/msd/d/task/1422$4020.htmld)
US and Puerto Rico Residents Only:
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here (https://survey.sogosurvey.com/r/aCdfqL) if you need an accommodation during the application or hiring process.
We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
EEOC Know Your Rights (https://www.eeoc.gov/sites/default/files/2022-10/22-088_EEOC_KnowYourRights_10_20.pdf)
EEOC GINA Supplement
Pay Transparency Nondiscrimination (https://www.dol.gov/sites/dolgov/files/OFCCP/pdf/pay-transp_%20English_formattedESQA508c.pdf)
We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.
Learn more about your rights, including under California, Colorado and other US State Acts (https://www.msdprivacy.com/us/en/CCPA-notice/)
U.S. Hybrid Work Model
Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as -remote-.
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status:
Regular
Relocation:
No relocation
VISA Sponsorship:
No
Travel Requirements:
25%
Flexible Work Arrangements:
Remote
Shift:
Not Indicated
Valid Driving License:
No
Hazardous Material(s):
n/a
Job Posting End Date:
10/7/2024
*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Job Posting End Date: 10/07/2024
A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Requisition ID: R315369
Job Description
The candidate selected for this hybrid position will have responsibilities as both an Institutional Account Lead (IAL) and Payer Account Executive within the assigned geography and for assigned accounts. The Primary Territory for this position covers Minnesota, South Dakota, and North Dakota, therefore, the percentage of travel required may be less, or more, depending on where a candidate resides in or near the geography.
Primary Activities & Responsibilities include but are not limited to the following:
The IAL Hybrid Institutional Account Lead / Payer Account Executive will manage the business relationship between our Company and assigned customer accounts with the following goals:
Establishing profitable product access within our Company's product strategy
Optimizing Net Sales and Contract Performance across a portfolio of our Company products
Ensuring proper oversight and compliance with our Company policies and exercising appropriate financial stewardship
IAL Primary Activities:
The IAL is responsible for appropriately addressing customer educational needs, interacting with multiple stakeholders within the assigned account to enhance our Company's business relationship with its customers. Each IAL is responsible for the following designated customers as assigned by the HCS Regional Director:
Integrated Delivery Network (IDN, including hospital outpatient and home-infusion if IDN owned)
Federal accounts (including Veterans' Affairs and Military Treatment Facilities)
Corrections
The IAL engages senior Institutional Leadership and is responsible for building trust and credibility with their assigned customers through strong interpersonal relationships, in depth knowledge of the customer's organization, objectives, and business and environmental issues impacting the customer, and in-depth knowledge of the same for our Company. The IAL engages senior Institutional Leadership in the following roles using approved messages and resources:
Pharmacy Service Line, and will serve as lead for the assigned customers across our Company's account teams with overlapping contacts with the customer
Information Technology Departments and will serve as lead for assigned customers across our Company's account teams with overlapping contacts with the customer
Veterans Integrated Service Network (VISN) & VISN Pharmacy Executive within the Veterans'' Affairs system
C-Suite in top assigned accounts
Develops strategic and tactical account plans for assigned accounts. The responsibilities could include the following:
Economic:
Persuasively presenting Group Purchasing Organization (GPO) brand pricing programs to pharmacy leadership
Negotiate direct contracts, where appropriate
Communicating approved financial, health care economic and budget impact models
Operational:
Communicating product access with overlay Field Based Employees (FBE) for assigned IDN accounts
Confirming customer contracts are properly loaded to provide the appropriate contract pricing to the eligible sites of care
Communicating approved information to customer Information Technology departments
Leads account planning for assigned IDN Accounts with other IAM colleagues and FBE's
Manages on going communications to extended Team
Account coordination and access facilitation to overlapping contacts with FBE's
Promote assigned our Company products along entire continuum of care (transition of care) using approved messages and resources
Conducts appropriate business review of account performance to optimize net sales for our Company
Clinical:
Communicate to customers the clinical value proposition for assigned products using approved messages and resources
Appropriately use approved our Company resources to meet customer educational needs
Payer Account Executive Primary Activities
The Payer Account Executive leads the development and implementation of long-term Customer Account Plans. The AE collaborates with the customer team to identify and pursue areas of mutual opportunity (Payers and HCP's) based on better health outcomes for patients. Negotiates contract terms and conditions with the customer. Responsible for P&L (revenue/expenses) for the Payer business.
Customer Account Planning and Management
Accountable for payer customer/portfolio P&L (revenue and expenses); works with other stakeholders (Customer Manager, Directors, Planners) to provide input on resource allocation decisions across customer targets within the larger geography.
Serves as the primary interface and owner for the customer (payer) account and is responsible for the overall (payer) customer experience.
Establishes relationships and maintains a pervasive communication network with the (payer) customer at many levels, including corporate personnel, medical directors in charge of provider networks, quality directors, pharmacy directors, financial directors, COO, CEO.
Conducts business strategy discussions and performance reviews with key customers on a regular basis (plays a significant role in ensuring that the Director of Commercial Operations, Customer Team Leader(s), and understand the (payer) customer's business strategy and support it at the local HCP level)
Proactively meet with (payer) customers to solicit feedback and adjust plans on a regular basis
Develop Customer Account plans aligned with Managed Care and brand strategies over a 3-5-year time horizon. Solicits input from Director of Commercial Operations, Customer Team Leader(s), and other relevant stakeholders to develop the long-term customer plan. Assesses competitor position as part of account plan development.
Identifies, understands and can articulate the key drivers affecting the customers' business including the customer's long-term plan and objectives.
Utilizes customer account strategy to define the objectives of the customer relationship
Identifies potential customer issues and needs (clinical, financial, business)
Collaborates with the customer to identify and pursue areas of mutual opportunity, focused on better health outcomes for patients
Develop innovative contracting to support better health outcomes
Leverages programs and services designed to improve treatment and better outcomes for patients
Represents the voice of the customer and advocates on behalf of the customer
Coordinates and manages the communication process between customers and identified internal or external expert(s) and ensures customer needs are accurately identified and addressed
Proactively identifies the internal and external experts needed to communicate complex clinical and scientific information to customers
Based on customer needs, provide appropriate clinical support and knowledge related to our Company products.
Communicates our Company activities that would be relevant to the Customer including promotional positioning (support of appropriate utilization) and/or provider quality and outcomes-based activities.
Provides feedback to and gains feedback from, the Solutions Consultant to ensure solution meets customer need.
Business Operations:
Interface with Contract Management and serve as the primary negotiator with the customer for product price discounts
Develops negotiation strategy in collaboration with Financial-Contracting Manager/Director
Develops innovative contracting to support better health outcomes
Communicates actively with Customer Team Leader and customer team members regarding customer priorities, issues, and initiatives
Coordinates with Customer Team Leader counterparts on a very frequent basis to ensure understanding of the customer's business issues and appropriately leverage opportunities to improve alignment between the HCP and Payer customers (identify issues, opportunities and interdependencies between Payers and Providers)
Understands of the interplay of key MC customers and regional stakeholders (provider networks, state and local government, clients (employer and member)) to establish relationships with influencers that will impact the customer relationship and maximize customer value
Qualifications:
Minimum Qualifications:
Bachelor's degree candidates: 3+ years of recent Sales or Account Management experience
Demonstrated leadership skills
Strong business and financial acumen of the external healthcare environment.
Strong interpersonal and communication skills.
Data Analytics capability
Valid Driver's License
Ability to travel and cover the assigned geography to meet with customers in-person
Preferred Qualifications:
Advanced degree candidates (MBA, PharmD, MSN): 3+ years of relevant external health care experience
Negotiation skills
Experience working in cross-functional teams
NOTICE FOR INTERNAL APPLICANTS
In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.
If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.
Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.
Current Employees apply HERE (https://wd5.myworkday.com/msd/d/task/1422$6687.htmld)
Current Contingent Workers apply HERE (https://wd5.myworkday.com/msd/d/task/1422$4020.htmld)
US and Puerto Rico Residents Only:
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here (https://survey.sogosurvey.com/r/aCdfqL) if you need an accommodation during the application or hiring process.
We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
EEOC Know Your Rights (https://www.eeoc.gov/sites/default/files/2022-10/22-088_EEOC_KnowYourRights_10_20.pdf)
EEOC GINA Supplement
Pay Transparency Nondiscrimination (https://www.dol.gov/sites/dolgov/files/OFCCP/pdf/pay-transp_%20English_formattedESQA508c.pdf)
We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.
Learn more about your rights, including under California, Colorado and other US State Acts (https://www.msdprivacy.com/us/en/CCPA-notice/)
U.S. Hybrid Work Model
Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as -remote-.
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status:
Regular
Relocation:
No relocation
VISA Sponsorship:
No
Travel Requirements:
50%
Flexible Work Arrangements:
Remote
Shift:
Not Indicated
Valid Driving License:
Yes
Hazardous Material(s):
n/a
Job Posting End Date:
10/7/2024
*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Job Posting End Date: 10/07/2024
A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Requisition ID: R314626
Job Description
An opportunity has arisen for an External Manufacturing Operations Associate Director. Our Manufacturing & Supply Division is dedicated to being the most trusted supplier of biopharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create a reliable global manufacturing network that's devoted to delivering a high quality, reliable supply to customers and patients on time, every time.
Based out of the United States, the ExM Operations Associate Director is accountable for meeting customer demand at the Contract Manufacturing Organizations (CMOs) they manage by achieving excellence in Compliance, Supply, Continuous Improvement & Cost. This is achieved through their direction as a key contributor within Focus Factory, and in partnership with those CMOs while leveraging lean manufacturing principles and the E2E supply chain.
You will be accountable for potentially new project support as well as commercial oversight between our Manufacturing Division and the CMO, by establishing strong business partnership as well as boundaries and ground rules of engagement.
You will steer a cross-functional team (Supply Chain, Quality, Technical Ops, Procurement...) who are accountable for delivering daily/weekly/monthly/annual requirements at their external partner(s).
Bring energy, knowledge, innovation to carry out the following:
Ensure compliance (Quality Risk management, Deviation Management, Product Release, Change Control); Meeting Demand; Dispute resolution (w/ appropriate escalation); Production Planning; Materials Management & Logistics; Technology issues; Oversight of shop floor production (determining when an ExM functional rep should be deployed to the External Party's (EP) facility); Lean Manufacturing and Continuous Improvement activities; Linking E2E (upstream and downstream) and with Supply Chain Management ensure and optimize flow of materials
Maintain a virtual presence at external partners site on the production floor either virtually or physically; builds a strong co-dependent relationship with the sites leadership team and can assess (-read a site-) & diagnose the current condition. Assess risks at a partners site and formulate in partnership with the external partner and our Company cross-functional team action orientated and time bound improvement plans. This may be executed virtually as well through use of innovative technologies that allow for remote sharing of information
Partner with internal ExM team members including Procurement, Quality, Project management and Technology on commercial aspects of relationship, including Identify, Select, Negotiate and Re-negotiate/terminate, as required. The External Manufacturing Operations Associate Director may not be involved in all transactional interactions if they can be managed/delegated to a functional area but will be kept apprised of status/resolutions, etc
Participate in and represents External Manufacturing on the cross-functional teams with Supply Chain Management/Product Source Management/ Procurement/ Integrated Development and Supply Team for due diligence ahead of siting approval & post siting approval to support Source of Supply (SOS)/New Product Introduction (NPI) changes at an external party and assume primary ownership of the new relationship.
Ensure there is a plan with clear actions and timelines in place to deliver SOS or NPI
Work with the external partner to comprehend CMO capacity (e.g., stated capacity, firm capacity, future capacity plans, time horizon / lead times required, etc.) and future capacity based on established improvements.
Accountable for maintaining the integrity of the Master Supply Agreement ensuring alignment with the Supply and Quality agreements and appropriate document revision and distribution control and for ensuring contract terms established upon by our Manufacturing Division and the External Party are executed including purchase orders, forecasts, deliveries, and approving invoice payments.
Accountable for inventory control. Based on the location of goods (at External Party or at our Company), External Manufacturing Operations Associate Director ensures adequate documentation of material disposition. In some markets, External Manufacturing Operations may need to witness the destruction of goods (to prevent counterfeiting) or have the External Party certify the destruction, per destruction procedures.
Act as our Company operational excellence leader & coach for own team and works with external partner and lean manufacturing resources, as needed, to identify External Party OpEx / continuous improvement opportunities and supports implementation once approved.
Lead with the Virtual external partner periodic Business and Operations Review Meetings (Joint Steering Committee). Based on our Company and External Manufacturing strategy the External Manufacturing Operations Associate Director develops with their cross functional team and their external partner the annual plan for the relationship with clear goals and targets
Participate in the creation and maintenance of an External Manufacturing Organization Handbook containing Global External Manufacturing policies, procedures, templates, etc
Minimum education required:
Required experience and skills:
Minimum 8 years' experience in commercial / business and manufacturing (sterile operations, quality, technology, planning)
Role requires a portion in management/leadership positions or project management.
At least two (2) years of experience in management/leadership positions which may include Employee Business Resource Group (EBRG) management experience such as Women's Network, LEAD or mentoring.
Ability to achieve compliance goals, through a risk-based approach has a deep comprehension of GMP and EHS compliance and compliance risk in Sterile Operations.
Proven Lean Six Sigma skills (operational excellence) to deliver compliant supply and achieve highest quality, lowest cost and shortest lead-time.
Skills to comprehend and intelligently apply economic, financial and industry data to make business decisions that drive value for our Company and our customers.
Can Visualize the way forward, identifying opportunities that add value to the work and proactively mitigate risk across the value chain.
Possess excellent interactive, communication, partnership and negotiation skills to work outside boundaries as a norm.
Ability to use deep knowledge and expertise in production operations to drive results and business outcomes.
Ability to apply comprehension of end-to-end supply chain within external and internal network and stakeholders across the network to achieve results and contribute to supply chain optimization.
Direct Health Authority Audit experience is desirable.
NOTICE FOR INTERNAL APPLICANTS
In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.
If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.
Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.
Current Employees apply HERE (https://wd5.myworkday.com/msd/d/task/1422$6687.htmld)
Current Contingent Workers apply HERE (https://wd5.myworkday.com/msd/d/task/1422$4020.htmld)
US and Puerto Rico Residents Only:
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here (https://survey.sogosurvey.com/r/aCdfqL) if you need an accommodation during the application or hiring process.
We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
EEOC Know Your Rights (https://www.eeoc.gov/sites/default/files/2022-10/22-088_EEOC_KnowYourRights_10_20.pdf)
EEOC GINA Supplement
Pay Transparency Nondiscrimination (https://www.dol.gov/sites/dolgov/files/OFCCP/pdf/pay-transp_%20English_formattedESQA508c.pdf)
We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.
Learn more about your rights, including under California, Colorado and other US State Acts (https://www.msdprivacy.com/us/en/CCPA-notice/)
U.S. Hybrid Work Model
Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as -remote-.
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status:
Regular
Relocation:
No relocation
VISA Sponsorship:
No
Travel Requirements:
25%
Flexible Work Arrangements:
Remote
Shift:
Not Indicated
Valid Driving License:
No
Hazardous Material(s):
n/a
Job Posting End Date:
10/7/2024
*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Job Posting End Date: 10/07/2024
A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Requisition ID: R315369
Job Description
An opportunity has arisen for an External Manufacturing Operations Associate Director. Our Manufacturing & Supply Division is dedicated to being the most trusted supplier of biopharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create a reliable global manufacturing network that's devoted to delivering a high quality, reliable supply to customers and patients on time, every time.
Based out of the United States, the ExM Operations Associate Director is accountable for meeting customer demand at the Contract Manufacturing Organizations (CMOs) they manage by achieving excellence in Compliance, Supply, Continuous Improvement & Cost. This is achieved through their direction as a key contributor within Focus Factory, and in partnership with those CMOs while leveraging lean manufacturing principles and the E2E supply chain.
You will be accountable for potentially new project support as well as commercial oversight between our Manufacturing Division and the CMO, by establishing strong business partnership as well as boundaries and ground rules of engagement.
You will steer a cross-functional team (Supply Chain, Quality, Technical Ops, Procurement...) who are accountable for delivering daily/weekly/monthly/annual requirements at their external partner(s).
Bring energy, knowledge, innovation to carry out the following:
Ensure compliance (Quality Risk management, Deviation Management, Product Release, Change Control); Meeting Demand; Dispute resolution (w/ appropriate escalation); Production Planning; Materials Management & Logistics; Technology issues; Oversight of shop floor production (determining when an ExM functional rep should be deployed to the External Party's (EP) facility); Lean Manufacturing and Continuous Improvement activities; Linking E2E (upstream and downstream) and with Supply Chain Management ensure and optimize flow of materials
Maintain a virtual presence at external partners site on the production floor either virtually or physically; builds a strong co-dependent relationship with the sites leadership team and can assess (-read a site-) & diagnose the current condition. Assess risks at a partners site and formulate in partnership with the external partner and our Company cross-functional team action orientated and time bound improvement plans. This may be executed virtually as well through use of innovative technologies that allow for remote sharing of information
Partner with internal ExM team members including Procurement, Quality, Project management and Technology on commercial aspects of relationship, including Identify, Select, Negotiate and Re-negotiate/terminate, as required. The External Manufacturing Operations Associate Director may not be involved in all transactional interactions if they can be managed/delegated to a functional area but will be kept apprised of status/resolutions, etc
Participate in and represents External Manufacturing on the cross-functional teams with Supply Chain Management/Product Source Management/ Procurement/ Integrated Development and Supply Team for due diligence ahead of siting approval & post siting approval to support Source of Supply (SOS)/New Product Introduction (NPI) changes at an external party and assume primary ownership of the new relationship.
Ensure there is a plan with clear actions and timelines in place to deliver SOS or NPI
Work with the external partner to comprehend CMO capacity (e.g., stated capacity, firm capacity, future capacity plans, time horizon / lead times required, etc.) and future capacity based on established improvements.
Accountable for maintaining the integrity of the Master Supply Agreement ensuring alignment with the Supply and Quality agreements and appropriate document revision and distribution control and for ensuring contract terms established upon by our Manufacturing Division and the External Party are executed including purchase orders, forecasts, deliveries, and approving invoice payments.
Accountable for inventory control. Based on the location of goods (at External Party or at our Company), External Manufacturing Operations Associate Director ensures adequate documentation of material disposition. In some markets, External Manufacturing Operations may need to witness the destruction of goods (to prevent counterfeiting) or have the External Party certify the destruction, per destruction procedures.
Act as our Company operational excellence leader & coach for own team and works with external partner and lean manufacturing resources, as needed, to identify External Party OpEx / continuous improvement opportunities and supports implementation once approved.
Lead with the Virtual external partner periodic Business and Operations Review Meetings (Joint Steering Committee). Based on our Company and External Manufacturing strategy the External Manufacturing Operations Associate Director develops with their cross functional team and their external partner the annual plan for the relationship with clear goals and targets
Participate in the creation and maintenance of an External Manufacturing Organization Handbook containing Global External Manufacturing policies, procedures, templates, etc
Minimum education required:
Required experience and skills:
Minimum 8 years' experience in commercial / business and manufacturing (sterile operations, quality, technology, planning)
Role requires a portion in management/leadership positions or project management.
At least two (2) years of experience in management/leadership positions which may include Employee Business Resource Group (EBRG) management experience such as Women's Network, LEAD or mentoring.
Ability to achieve compliance goals, through a risk-based approach has a deep comprehension of GMP and EHS compliance and compliance risk in Sterile Operations.
Proven Lean Six Sigma skills (operational excellence) to deliver compliant supply and achieve highest quality, lowest cost and shortest lead-time.
Skills to comprehend and intelligently apply economic, financial and industry data to make business decisions that drive value for our Company and our customers.
Can Visualize the way forward, identifying opportunities that add value to the work and proactively mitigate risk across the value chain.
Possess excellent interactive, communication, partnership and negotiation skills to work outside boundaries as a norm.
Ability to use deep knowledge and expertise in production operations to drive results and business outcomes.
Ability to apply comprehension of end-to-end supply chain within external and internal network and stakeholders across the network to achieve results and contribute to supply chain optimization.
Direct Health Authority Audit experience is desirable.
NOTICE FOR INTERNAL APPLICANTS
In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.
If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.
Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.
Current Employees apply HERE (https://wd5.myworkday.com/msd/d/task/1422$6687.htmld)
Current Contingent Workers apply HERE (https://wd5.myworkday.com/msd/d/task/1422$4020.htmld)
US and Puerto Rico Residents Only:
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here (https://survey.sogosurvey.com/r/aCdfqL) if you need an accommodation during the application or hiring process.
We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
EEOC Know Your Rights (https://www.eeoc.gov/sites/default/files/2022-10/22-088_EEOC_KnowYourRights_10_20.pdf)
EEOC GINA Supplement
Pay Transparency Nondiscrimination (https://www.dol.gov/sites/dolgov/files/OFCCP/pdf/pay-transp_%20English_formattedESQA508c.pdf)
We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.
Learn more about your rights, including under California, Colorado and other US State Acts (https://www.msdprivacy.com/us/en/CCPA-notice/)
U.S. Hybrid Work Model
Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as -remote-.
The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate's relevant skills, experience, and education.
Expected US salary range:
$122,800.00 - $193,300.00
Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. A summary of benefits is listed here (https://www.benefitsatmerck.com/) .
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status:
Regular
Relocation:
No relocation
VISA Sponsorship:
No
Travel Requirements:
25%
Flexible Work Arrangements:
Remote
Shift:
Not Indicated
Valid Driving License:
No
Hazardous Material(s):
n/a
Job Posting End Date:
10/7/2024
*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Job Posting End Date: 10/07/2024
A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Requisition ID: R315367
Job Description
An opportunity has arisen for an External Manufacturing Operations Associate Director. Our Manufacturing & Supply Division is dedicated to being the most trusted supplier of biopharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create a reliable global manufacturing network that's devoted to delivering a high quality, reliable supply to customers and patients on time, every time.
Based out of the United States, the ExM Operations Associate Director is accountable for meeting customer demand at the Contract Manufacturing Organizations (CMOs) they manage by achieving excellence in Compliance, Supply, Continuous Improvement & Cost. This is achieved through their direction as a key contributor within Focus Factory, and in partnership with those CMOs while leveraging lean manufacturing principles and the E2E supply chain.
You will be accountable for potentially new project support as well as commercial oversight between our Manufacturing Division and the CMO, by establishing strong business partnership as well as boundaries and ground rules of engagement.
You will steer a cross-functional team (Supply Chain, Quality, Technical Ops, Procurement...) who are accountable for delivering daily/weekly/monthly/annual requirements at their external partner(s).
Bring energy, knowledge, innovation to carry out the following:
Ensure compliance (Quality Risk management, Deviation Management, Product Release, Change Control); Meeting Demand; Dispute resolution (w/ appropriate escalation); Production Planning; Materials Management & Logistics; Technology issues; Oversight of shop floor production (determining when an ExM functional rep should be deployed to the External Party's (EP) facility); Lean Manufacturing and Continuous Improvement activities; Linking E2E (upstream and downstream) and with Supply Chain Management ensure and optimize flow of materials
Maintain a virtual presence at external partners site on the production floor either virtually or physically; builds a strong co-dependent relationship with the sites leadership team and can assess (-read a site-) & diagnose the current condition. Assess risks at a partners site and formulate in partnership with the external partner and our Company cross-functional team action orientated and time bound improvement plans. This may be executed virtually as well through use of innovative technologies that allow for remote sharing of information
Partner with internal ExM team members including Procurement, Quality, Project management and Technology on commercial aspects of relationship, including Identify, Select, Negotiate and Re-negotiate/terminate, as required. The External Manufacturing Operations Associate Director may not be involved in all transactional interactions if they can be managed/delegated to a functional area but will be kept apprised of status/resolutions, etc
Participate in and represents External Manufacturing on the cross-functional teams with Supply Chain Management/Product Source Management/ Procurement/ Integrated Development and Supply Team for due diligence ahead of siting approval & post siting approval to support Source of Supply (SOS)/New Product Introduction (NPI) changes at an external party and assume primary ownership of the new relationship.
Ensure there is a plan with clear actions and timelines in place to deliver SOS or NPI
Work with the external partner to comprehend CMO capacity (e.g., stated capacity, firm capacity, future capacity plans, time horizon / lead times required, etc.) and future capacity based on established improvements.
Accountable for maintaining the integrity of the Master Supply Agreement ensuring alignment with the Supply and Quality agreements and appropriate document revision and distribution control and for ensuring contract terms established upon by our Manufacturing Division and the External Party are executed including purchase orders, forecasts, deliveries, and approving invoice payments.
Accountable for inventory control. Based on the location of goods (at External Party or at our Company), External Manufacturing Operations Associate Director ensures adequate documentation of material disposition. In some markets, External Manufacturing Operations may need to witness the destruction of goods (to prevent counterfeiting) or have the External Party certify the destruction, per destruction procedures.
Act as our Company operational excellence leader & coach for own team and works with external partner and lean manufacturing resources, as needed, to identify External Party OpEx / continuous improvement opportunities and supports implementation once approved.
Lead with the Virtual external partner periodic Business and Operations Review Meetings (Joint Steering Committee). Based on our Company and External Manufacturing strategy the External Manufacturing Operations Associate Director develops with their cross functional team and their external partner the annual plan for the relationship with clear goals and targets
Participate in the creation and maintenance of an External Manufacturing Organization Handbook containing Global External Manufacturing policies, procedures, templates, etc
Minimum education required:
Required experience and skills:
Minimum 8 years' experience in commercial / business and manufacturing (sterile operations, quality, technology, planning)
Role requires a portion in management/leadership positions or project management.
At least two (2) years of experience in management/leadership positions which may include Employee Business Resource Group (EBRG) management experience such as Women's Network, LEAD or mentoring.
Ability to achieve compliance goals, through a risk-based approach has a deep comprehension of GMP and EHS compliance and compliance risk in Sterile Operations.
Proven Lean Six Sigma skills (operational excellence) to deliver compliant supply and achieve highest quality, lowest cost and shortest lead-time.
Skills to comprehend and intelligently apply economic, financial and industry data to make business decisions that drive value for our Company and our customers.
Can Visualize the way forward, identifying opportunities that add value to the work and proactively mitigate risk across the value chain.
Possess excellent interactive, communication, partnership and negotiation skills to work outside boundaries as a norm.
Ability to use deep knowledge and expertise in production operations to drive results and business outcomes.
Ability to apply comprehension of end-to-end supply chain within external and internal network and stakeholders across the network to achieve results and contribute to supply chain optimization.
Direct Health Authority Audit experience is desirable.
NOTICE FOR INTERNAL APPLICANTS
In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.
If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.
Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.
Current Employees apply HERE (https://wd5.myworkday.com/msd/d/task/1422$6687.htmld)
Current Contingent Workers apply HERE (https://wd5.myworkday.com/msd/d/task/1422$4020.htmld)
US and Puerto Rico Residents Only:
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here (https://survey.sogosurvey.com/r/aCdfqL) if you need an accommodation during the application or hiring process.
We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
EEOC Know Your Rights (https://www.eeoc.gov/sites/default/files/2022-10/22-088_EEOC_KnowYourRights_10_20.pdf)
EEOC GINA Supplement
Pay Transparency Nondiscrimination (https://www.dol.gov/sites/dolgov/files/OFCCP/pdf/pay-transp_%20English_formattedESQA508c.pdf)
We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.
Learn more about your rights, including under California, Colorado and other US State Acts (https://www.msdprivacy.com/us/en/CCPA-notice/)
U.S. Hybrid Work Model
Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as -remote-.
The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate's relevant skills, experience, and education.
Expected US salary range:
$122,800.00 - $193,300.00
Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. A summary of benefits is listed here (https://www.benefitsatmerck.com/) .
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status:
Regular
Relocation:
No relocation
VISA Sponsorship:
No
Travel Requirements:
25%
Flexible Work Arrangements:
Remote
Shift:
Not Indicated
Valid Driving License:
No
Hazardous Material(s):
n/a
Job Posting End Date:
10/7/2024
*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Job Posting End Date: 10/07/2024
A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Requisition ID: R315367
Job Description
An opportunity has arisen for an External Manufacturing Operations Associate Director. Our Manufacturing & Supply Division is dedicated to being the most trusted supplier of biopharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create a reliable global manufacturing network that's devoted to delivering a high quality, reliable supply to customers and patients on time, every time.
Based out of the United States, the ExM Operations Associate Director is accountable for meeting customer demand at the Contract Manufacturing Organizations (CMOs) they manage by achieving excellence in Compliance, Supply, Continuous Improvement & Cost. This is achieved through their direction as a key contributor within Focus Factory, and in partnership with those CMOs while leveraging lean manufacturing principles and the E2E supply chain.
You will be accountable for potentially new project support as well as commercial oversight between our Manufacturing Division and the CMO, by establishing strong business partnership as well as boundaries and ground rules of engagement.
You will steer a cross-functional team (Supply Chain, Quality, Technical Ops, Procurement...) who are accountable for delivering daily/weekly/monthly/annual requirements at their external partner(s).
Bring energy, knowledge, innovation to carry out the following:
Ensure compliance (Quality Risk management, Deviation Management, Product Release, Change Control); Meeting Demand; Dispute resolution (w/ appropriate escalation); Production Planning; Materials Management & Logistics; Technology issues; Oversight of shop floor production (determining when an ExM functional rep should be deployed to the External Party's (EP) facility); Lean Manufacturing and Continuous Improvement activities; Linking E2E (upstream and downstream) and with Supply Chain Management ensure and optimize flow of materials
Maintain a virtual presence at external partners site on the production floor either virtually or physically; builds a strong co-dependent relationship with the sites leadership team and can assess (-read a site-) & diagnose the current condition. Assess risks at a partners site and formulate in partnership with the external partner and our Company cross-functional team action orientated and time bound improvement plans. This may be executed virtually as well through use of innovative technologies that allow for remote sharing of information
Partner with internal ExM team members including Procurement, Quality, Project management and Technology on commercial aspects of relationship, including Identify, Select, Negotiate and Re-negotiate/terminate, as required. The External Manufacturing Operations Associate Director may not be involved in all transactional interactions if they can be managed/delegated to a functional area but will be kept apprised of status/resolutions, etc
Participate in and represents External Manufacturing on the cross-functional teams with Supply Chain Management/Product Source Management/ Procurement/ Integrated Development and Supply Team for due diligence ahead of siting approval & post siting approval to support Source of Supply (SOS)/New Product Introduction (NPI) changes at an external party and assume primary ownership of the new relationship.
Ensure there is a plan with clear actions and timelines in place to deliver SOS or NPI
Work with the external partner to comprehend CMO capacity (e.g., stated capacity, firm capacity, future capacity plans, time horizon / lead times required, etc.) and future capacity based on established improvements.
Accountable for maintaining the integrity of the Master Supply Agreement ensuring alignment with the Supply and Quality agreements and appropriate document revision and distribution control and for ensuring contract terms established upon by our Manufacturing Division and the External Party are executed including purchase orders, forecasts, deliveries, and approving invoice payments.
Accountable for inventory control. Based on the location of goods (at External Party or at our Company), External Manufacturing Operations Associate Director ensures adequate documentation of material disposition. In some markets, External Manufacturing Operations may need to witness the destruction of goods (to prevent counterfeiting) or have the External Party certify the destruction, per destruction procedures.
Act as our Company operational excellence leader & coach for own team and works with external partner and lean manufacturing resources, as needed, to identify External Party OpEx / continuous improvement opportunities and supports implementation once approved.
Lead with the Virtual external partner periodic Business and Operations Review Meetings (Joint Steering Committee). Based on our Company and External Manufacturing strategy the External Manufacturing Operations Associate Director develops with their cross functional team and their external partner the annual plan for the relationship with clear goals and targets
Participate in the creation and maintenance of an External Manufacturing Organization Handbook containing Global External Manufacturing policies, procedures, templates, etc
Minimum education required:
Required experience and skills:
Minimum 8 years' experience in commercial / business and manufacturing (sterile operations, quality, technology, planning)
Role requires a portion in management/leadership positions or project management.
At least two (2) years of experience in management/leadership positions which may include Employee Business Resource Group (EBRG) management experience such as Women's Network, LEAD or mentoring.
Ability to achieve compliance goals, through a risk-based approach has a deep comprehension of GMP and EHS compliance and compliance risk in Sterile Operations.
Proven Lean Six Sigma skills (operational excellence) to deliver compliant supply and achieve highest quality, lowest cost and shortest lead-time.
Skills to comprehend and intelligently apply economic, financial and industry data to make business decisions that drive value for our Company and our customers.
Can Visualize the way forward, identifying opportunities that add value to the work and proactively mitigate risk across the value chain.
Possess excellent interactive, communication, partnership and negotiation skills to work outside boundaries as a norm.
Ability to use deep knowledge and expertise in production operations to drive results and business outcomes.
Ability to apply comprehension of end-to-end supply chain within external and internal network and stakeholders across the network to achieve results and contribute to supply chain optimization.
Direct Health Authority Audit experience is desirable.
NOTICE FOR INTERNAL APPLICANTS
In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.
If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.
Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.
Current Employees apply HERE (https://wd5.myworkday.com/msd/d/task/1422$6687.htmld)
Current Contingent Workers apply HERE (https://wd5.myworkday.com/msd/d/task/1422$4020.htmld)
US and Puerto Rico Residents Only:
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here (https://survey.sogosurvey.com/r/aCdfqL) if you need an accommodation during the application or hiring process.
We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
EEOC Know Your Rights (https://www.eeoc.gov/sites/default/files/2022-10/22-088_EEOC_KnowYourRights_10_20.pdf)
EEOC GINA Supplement
Pay Transparency Nondiscrimination (https://www.dol.gov/sites/dolgov/files/OFCCP/pdf/pay-transp_%20English_formattedESQA508c.pdf)
We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.
Learn more about your rights, including under California, Colorado and other US State Acts (https://www.msdprivacy.com/us/en/CCPA-notice/)
U.S. Hybrid Work Model
Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as -remote-.
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status:
Regular
Relocation:
No relocation
VISA Sponsorship:
No
Travel Requirements:
25%
Flexible Work Arrangements:
Remote
Shift:
Not Indicated
Valid Driving License:
No
Hazardous Material(s):
n/a
Job Posting End Date:
10/7/2024
*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Job Posting End Date: 10/07/2024
A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Requisition ID: R315369
Job Description
An opportunity has arisen for an External Manufacturing Operations Associate Director. Our Manufacturing & Supply Division is dedicated to being the most trusted supplier of biopharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create a reliable global manufacturing network that's devoted to delivering a high quality, reliable supply to customers and patients on time, every time.
Based out of the United States, the ExM Operations Associate Director is accountable for meeting customer demand at the Contract Manufacturing Organizations (CMOs) they manage by achieving excellence in Compliance, Supply, Continuous Improvement & Cost. This is achieved through their direction as a key contributor within Focus Factory, and in partnership with those CMOs while leveraging lean manufacturing principles and the E2E supply chain.
You will be accountable for potentially new project support as well as commercial oversight between our Manufacturing Division and the CMO, by establishing strong business partnership as well as boundaries and ground rules of engagement.
You will steer a cross-functional team (Supply Chain, Quality, Technical Ops, Procurement...) who are accountable for delivering daily/weekly/monthly/annual requirements at their external partner(s).
Bring energy, knowledge, innovation to carry out the following:
Ensure compliance (Quality Risk management, Deviation Management, Product Release, Change Control); Meeting Demand; Dispute resolution (w/ appropriate escalation); Production Planning; Materials Management & Logistics; Technology issues; Oversight of shop floor production (determining when an ExM functional rep should be deployed to the External Party's (EP) facility); Lean Manufacturing and Continuous Improvement activities; Linking E2E (upstream and downstream) and with Supply Chain Management ensure and optimize flow of materials
Maintain a virtual presence at external partners site on the production floor either virtually or physically; builds a strong co-dependent relationship with the sites leadership team and can assess (-read a site-) & diagnose the current condition. Assess risks at a partners site and formulate in partnership with the external partner and our Company cross-functional team action orientated and time bound improvement plans. This may be executed virtually as well through use of innovative technologies that allow for remote sharing of information
Partner with internal ExM team members including Procurement, Quality, Project management and Technology on commercial aspects of relationship, including Identify, Select, Negotiate and Re-negotiate/terminate, as required. The External Manufacturing Operations Associate Director may not be involved in all transactional interactions if they can be managed/delegated to a functional area but will be kept apprised of status/resolutions, etc
Participate in and represents External Manufacturing on the cross-functional teams with Supply Chain Management/Product Source Management/ Procurement/ Integrated Development and Supply Team for due diligence ahead of siting approval & post siting approval to support Source of Supply (SOS)/New Product Introduction (NPI) changes at an external party and assume primary ownership of the new relationship.
Ensure there is a plan with clear actions and timelines in place to deliver SOS or NPI
Work with the external partner to comprehend CMO capacity (e.g., stated capacity, firm capacity, future capacity plans, time horizon / lead times required, etc.) and future capacity based on established improvements.
Accountable for maintaining the integrity of the Master Supply Agreement ensuring alignment with the Supply and Quality agreements and appropriate document revision and distribution control and for ensuring contract terms established upon by our Manufacturing Division and the External Party are executed including purchase orders, forecasts, deliveries, and approving invoice payments.
Accountable for inventory control. Based on the location of goods (at External Party or at our Company), External Manufacturing Operations Associate Director ensures adequate documentation of material disposition. In some markets, External Manufacturing Operations may need to witness the destruction of goods (to prevent counterfeiting) or have the External Party certify the destruction, per destruction procedures.
Act as our Company operational excellence leader & coach for own team and works with external partner and lean manufacturing resources, as needed, to identify External Party OpEx / continuous improvement opportunities and supports implementation once approved.
Lead with the Virtual external partner periodic Business and Operations Review Meetings (Joint Steering Committee). Based on our Company and External Manufacturing strategy the External Manufacturing Operations Associate Director develops with their cross functional team and their external partner the annual plan for the relationship with clear goals and targets
Participate in the creation and maintenance of an External Manufacturing Organization Handbook containing Global External Manufacturing policies, procedures, templates, etc
Minimum education required:
Required experience and skills:
Minimum 8 years' experience in commercial / business and manufacturing (sterile operations, quality, technology, planning)
Role requires a portion in management/leadership positions or project management.
At least two (2) years of experience in management/leadership positions which may include Employee Business Resource Group (EBRG) management experience such as Women's Network, LEAD or mentoring.
Ability to achieve compliance goals, through a risk-based approach has a deep comprehension of GMP and EHS compliance and compliance risk in Sterile Operations.
Proven Lean Six Sigma skills (operational excellence) to deliver compliant supply and achieve highest quality, lowest cost and shortest lead-time.
Skills to comprehend and intelligently apply economic, financial and industry data to make business decisions that drive value for our Company and our customers.
Can Visualize the way forward, identifying opportunities that add value to the work and proactively mitigate risk across the value chain.
Possess excellent interactive, communication, partnership and negotiation skills to work outside boundaries as a norm.
Ability to use deep knowledge and expertise in production operations to drive results and business outcomes.
Ability to apply comprehension of end-to-end supply chain within external and internal network and stakeholders across the network to achieve results and contribute to supply chain optimization.
Direct Health Authority Audit experience is desirable.
NOTICE FOR INTERNAL APPLICANTS
In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.
If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.
Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.
Current Employees apply HERE (https://wd5.myworkday.com/msd/d/task/1422$6687.htmld)
Current Contingent Workers apply HERE (https://wd5.myworkday.com/msd/d/task/1422$4020.htmld)
US and Puerto Rico Residents Only:
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here (https://survey.sogosurvey.com/r/aCdfqL) if you need an accommodation during the application or hiring process.
We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
EEOC Know Your Rights (https://www.eeoc.gov/sites/default/files/2022-10/22-088_EEOC_KnowYourRights_10_20.pdf)
EEOC GINA Supplement
Pay Transparency Nondiscrimination (https://www.dol.gov/sites/dolgov/files/OFCCP/pdf/pay-transp_%20English_formattedESQA508c.pdf)
We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.
Learn more about your rights, including under California, Colorado and other US State Acts (https://www.msdprivacy.com/us/en/CCPA-notice/)
U.S. Hybrid Work Model
Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as -remote-.
The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate's relevant skills, experience, and education.
Expected US salary range:
$122,800.00 - $193,300.00
Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. A summary of benefits is listed here (https://www.benefitsatmerck.com/) .
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status:
Regular
Relocation:
No relocation
VISA Sponsorship:
No
Travel Requirements:
25%
Flexible Work Arrangements:
Remote
Shift:
Not Indicated
Valid Driving License:
No
Hazardous Material(s):
n/a
Job Posting End Date:
10/7/2024
*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Job Posting End Date: 10/07/2024
A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Requisition ID: R315367
Job Description
We are seeking an Associate Principal Scientist to join our Data-Rich Experimentation (DRE) organization, within Process Research & Developing Enabling Technologies (PR&D ET), located in West Point, PA.
Primary Responsibilities:
In this role, the chosen candidate will work with a team of scientists tasked with identifying, developing, and deploying data-rich technologies aimed at improving the manner in which process understanding is gathered. The tools that we develop are as diverse as the team developing them, and in this Associate Principal Scientist role, the chosen candidate will leverage high-throughput experimentation and data science technologies to enable our process research and development efforts across our Company's small molecule, biologics, and vaccines portfolio.
Our Data-Rich Experimentation (DRE) organization is responsible for the invention and application of new data-rich tools to support the scientists across process research and development at our Company. We aspire to embed data-intense technologies into the fabric of our Company's process development culture. This Associate Principal Scientist role is a scientific position tasked with solving complex process research and development challenges in an interdisciplinary, collaborative environment via invention, development, and application of innovative high-throughput experimentation tools. Ultimately, using cutting-edge automation and data science capabilities, we aim to elucidate a deeper understanding of our processes across diverse medicines and vaccines.
In this Associate Principal Scientist role, the chosen candidate will leverage high-throughput experimentation and data science capabilities to help advance process-focused scientific research.
This includes, but is not limited to,:
delivering high throughput process development (HTPD) solutions to process teams and conducting microscale screening experiments as required to drive large molecule development,
identifying opportunities to utilize HTPD and developing novel HTPD workflows to enhance process understanding,
efficient programming, implementing and maintaining robotic systems with liquid-handling hardware,
leveraging digital tools to enable automated data pipeline such as algorithm-assisted experimental planning and automated data aggregation, analysis and visualization.
In addition to a passion for high-throughput experimentation and data science, the chosen candidate should have excellent interpersonal, communication, and collaboration skills. The chosen candidate should embrace and model our core values of diversity and inclusion, including fostering a supportive culture where all can thrive. The chosen candidate should be able to effectively collaborate in a dynamic, integrated, and multidisciplinary team environment. The chosen candidate should demonstrate a clear ability to perform impactful scientific innovation in a team-oriented manner that builds trusted partnerships across vast stakeholder networks. The chosen candidate should have a demonstrated ability to publish and present research, including an established track record of interaction with the broader academic community. The chosen candidate will join a diverse group of scientific problem solvers who are dedicated to creating the life-changing medicines and vaccines of tomorrow.
Position Qualifications :
Education Minimum Requirement:
A Ph.D. in Engineering, Chemistry, Physics, Biology, Pharmaceutical Sciences, or a closely-related field with at least 3 years of industrial/pharmaceutical or relevant experience
A M.S. in Engineering, Chemistry, Physics, Biology, Pharmaceutical Sciences, or a closely-related field with at least 5 years of industrial/pharmaceutical or relevant experience
A B.S. in in Engineering, Chemistry, Physics, Biology, Pharmaceutical Sciences, or a closely-related field with at least 7 years of industrial/pharmaceutical or relevant experience
Required Experience and Skills:
Relevant working experience in identifying and implementing high-throughput process development (HTPD) solutions for application to large biomolecule process development (e.g. viral vectors, vaccines, therapeutic proteins).
Strong technical background in large biomolecules upstream (e.g. microbial fermentation, mammalian cell & virus culture) or downstream (e.g. harvest, filtration, chromatography, conjugation) unit operations.
Experience in developing and implementing microscale models for large molecule upstream or downstream process unit operations.
Highly-motivated and technology-centric scientist that is passionate about modernizing our Company's process development practices across biologics, vaccines, and small molecule modalities.
Demonstrated scientific ability through publications and presentations in scientific conferences.
Excellent communication skills, demonstrated creativity, and effective interpersonal skills.
Ability to deliver complex solutions under compressed timelines in a dynamic environment.
Ability to work in a team environment with cross-functional interactions.
Preferred Experience and Skills:
Expertise in implementing data science tools to accelerate high-throughput lab automation capabilities.
Experience in new technology research, including a demonstrated track record of identifying, developing, and deploying data-rich tools and methodologies.
Collaborative research efforts that are praised by the broader scientific community and are exemplary of a multidisciplinary group.
Evidence of cross-functional collaboration in an academic or industrial setting.
Motivated to learn new skills, willingness to take on new challenges, and scientific curiosity.
NOTICE FOR INTERNAL APPLICANTS
In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.
If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.
Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.
Current Employees apply HERE (https://wd5.myworkday.com/msd/d/task/1422$6687.htmld)
Current Contingent Workers apply HERE (https://wd5.myworkday.com/msd/d/task/1422$4020.htmld)
US and Puerto Rico Residents Only:
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here (https://survey.sogosurvey.com/r/aCdfqL) if you need an accommodation during the application or hiring process.
We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
EEOC Know Your Rights (https://www.eeoc.gov/sites/default/files/2022-10/22-088_EEOC_KnowYourRights_10_20.pdf)
EEOC GINA Supplement
Pay Transparency Nondiscrimination (https://www.dol.gov/sites/dolgov/files/OFCCP/pdf/pay-transp_%20English_formattedESQA508c.pdf)
We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.
Learn more about your rights, including under California, Colorado and other US State Acts (https://www.msdprivacy.com/us/en/CCPA-notice/)
U.S. Hybrid Work Model
Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as -remote-.
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status:
Regular
Relocation:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
Not Applicable
Shift:
Valid Driving License:
Hazardous Material(s):
Job Posting End Date:
10/11/2024
*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Job Posting End Date: 10/11/2024
A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Requisition ID: R315421
Job Description
IPT Quality Lead
M2
The Associate Director within Quality is responsible for providing Quality direction and oversight to one of our sites in the quality systems, such as Training, Documentation (including Standard Operating Procedures and Master Batch Records), Annual Product Review, Change Control, Inspection Management, Quality Management System, and Risk Management to maintain compliance with Regulatory requirements.
The individual is an Advocate and Leader for the development, execution and deployment of the site and our priorities. The Associate Director drives quality improvement activities and ensures alignment across the organization in the execution of their assigned areas. The Associate Director is responsible for Quality oversight of vaccine formulation and filling operations as well as the associated Quality Systems. The qualified candidate ensures compliance to Divisional, Company, and Site standards and procedures. The incumbent manages a team of Quality Specialists, responsible for elevating our compliance posture. This role partners with the Operations and Technical Operations Leaders to ensure that products are manufactured and tested according to approved processes and comply with all applicable regulatory and internal requirements.
The qualified candidate must demonstrate strong analytical and scientific acumen to assist with troubleshooting of processes and systems. Excellent leadership capabilities, including cross-functional collaboration, written and verbal communication skills, structured problem solving, disciplined decision-making, and talent management are required. The incumbent will actively participate in external regulatory inspections.
Primary activities include but are not limited to:
Directly leads activities in the execution of quality system functions relating to GMP compliance; additionally, champions multi-department teams regarding various compliance initiatives and assessments.
Coordinates and directs a team of multi-disciplined professionals in areas of process and systems as they relate to support and enhancements of the quality system(s)
Ensure personnel operate within established policies/procedures of our Company and in compliance with cGMPs and all applicable government regulations. Responsible for hiring and ensuring personnel are trained and performing per expectations.
Manage and coach the Quality team (direct and indirect reports) to deliver strong results while developing individual and team capabilities.
Ensure that all team members operate safely and comply with established safety and environmental policies and procedures (Corporate, Site, and Governmental)
Serve on local and site governance committees, including IPT and End to End Leadership Teams, Technical/Operations Reviews, and regulatory forums as well as strategic initiatives.
Acquire and maintain technical process knowledge relevant to operations and testing. Ensure that documentation and products manufactured comply with all applicable standards and procedures, and governing regulations.
Proactively partner to identify and implement continuous improvement actions to solve problems and implementation corrective and preventative including but not limited to reducing deviations, reducing lead-time, improving safety and eliminate waste, while maintaining compliance.
Review and approve deviations, corrective / preventative actions, commitments, change requests, and other Quality documents.
Minimum Education Requirements and Experience:
Bachelor's Degree in Science, Engineering, or another technical field with eight (8) years' experience in a functional area, such as Operations, Quality, Technical Operations, Technology, Engineering, Maintenance, and/or Supply Chain OR
Master's degree in Science, Engineering, or another technical field with six (6) years' experience in a functional area, such as Operations, Quality, Technical Operations, Technology, Engineering, Maintenance, and/or Supply Chain
Required Experience and Skills:
Minimum two (2) concurrent years' experience managing direct reports.
Strong understanding of CGMPs, FDA, and EMEA regulatory standards and strong compliance mindset.
Proven analytical aptitude, critical thinking skills, and ability to apply key concepts.
Preferred Experience and Skills:
Compliance - Responsible for creating and sustaining a culture that ensures that compliance (Safety, Environment, cGMP, etc.) are imperatives for the business. Responsible for establishing a Right First-Time culture by reducing waste and constantly driving continuous improvement. Responsible to author, review and/or approve compliance documents, as per procedures or need. Has experience and ability to achieve compliance goals, through a risk-based approach has a deep understanding of GMP and EHS compliance and compliance risk.
Working Across Boundaries - Must possess excellent interpersonal, communication, collaboration, negotiation to work outside boundaries as a norm.
Business Outcomes /Drive Results - Ability to use deep knowledge and expertise in production operations to drive results and business outcomes.
Demonstrated experience of interacting with site, divisional or regulatory audits
Demonstrated ability to create an engaged workforce using Inclusion as the How
Demonstrated knowledge of High Performing Organization tools and methodology, including MPS/lean processing and Inclusion. MPS experience - LSS Green Belt certification or equivalent experience.
Demonstrated success with Talent Management including leading and mentoring
Proven ability to manage multiple projects simultaneously.
Applies knowledge of internal/external business challenges to improve products, processes, or services.
Solves complex problems; takes a new perspective using existing solutions.
Works independently, receives minimal guidance.
Demonstrated self-starter with capability to develop innovative solutions to challenges.
Aseptic/sterile processing experience
Quality or Operations experience in Pharmaceutical, Biologics, Vaccines, or Therapeutic Protein manufacturing
NOTICE FOR INTERNAL APPLICANTS
In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.
If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.
Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.
Current Employees apply HERE (https://wd5.myworkday.com/msd/d/task/1422$6687.htmld)
Current Contingent Workers apply HERE (https://wd5.myworkday.com/msd/d/task/1422$4020.htmld)
US and Puerto Rico Residents Only:
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here (https://survey.sogosurvey.com/r/aCdfqL) if you need an accommodation during the application or hiring process.
We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
EEOC Know Your Rights (https://www.eeoc.gov/sites/default/files/2022-10/22-088_EEOC_KnowYourRights_10_20.pdf)
EEOC GINA Supplement
Pay Transparency Nondiscrimination (https://www.dol.gov/sites/dolgov/files/OFCCP/pdf/pay-transp_%20English_formattedESQA508c.pdf)
We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.
Learn more about your rights, including under California, Colorado and other US State Acts (https://www.msdprivacy.com/us/en/CCPA-notice/)
U.S. Hybrid Work Model
Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as -remote-.
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status:
Regular
Relocation:
No relocation
VISA Sponsorship:
No
Travel Requirements:
10%
Flexible Work Arrangements:
Not Applicable
Shift:
1st - Day
Valid Driving License:
Yes
Hazardous Material(s):
N/A
Job Posting End Date:
10/7/2024
*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Job Posting End Date: 10/07/2024
A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Requisition ID: R315384
Job Description
An opportunity has arisen for an External Manufacturing Operations Associate Director. Our Manufacturing & Supply Division is dedicated to being the most trusted supplier of biopharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create a reliable global manufacturing network that's devoted to delivering a high quality, reliable supply to customers and patients on time, every time.
Based out of the United States, the ExM Operations Associate Director is accountable for meeting customer demand at the Contract Manufacturing Organizations (CMOs) they manage by achieving excellence in Compliance, Supply, Continuous Improvement & Cost. This is achieved through their direction as a key contributor within Focus Factory, and in partnership with those CMOs while leveraging lean manufacturing principles and the E2E supply chain.
You will be accountable for potentially new project support as well as commercial oversight between our Manufacturing Division and the CMO, by establishing strong business partnership as well as boundaries and ground rules of engagement.
You will steer a cross-functional team (Supply Chain, Quality, Technical Ops, Procurement...) who are accountable for delivering daily/weekly/monthly/annual requirements at their external partner(s).
Bring energy, knowledge, innovation to carry out the following:
Ensure compliance (Quality Risk management, Deviation Management, Product Release, Change Control); Meeting Demand; Dispute resolution (w/ appropriate escalation); Production Planning; Materials Management & Logistics; Technology issues; Oversight of shop floor production (determining when an ExM functional rep should be deployed to the External Party's (EP) facility); Lean Manufacturing and Continuous Improvement activities; Linking E2E (upstream and downstream) and with Supply Chain Management ensure and optimize flow of materials
Maintain a virtual presence at external partners site on the production floor either virtually or physically; builds a strong co-dependent relationship with the sites leadership team and can assess (-read a site-) & diagnose the current condition. Assess risks at a partners site and formulate in partnership with the external partner and our Company cross-functional team action orientated and time bound improvement plans. This may be executed virtually as well through use of innovative technologies that allow for remote sharing of information
Partner with internal ExM team members including Procurement, Quality, Project management and Technology on commercial aspects of relationship, including Identify, Select, Negotiate and Re-negotiate/terminate, as required. The External Manufacturing Operations Associate Director may not be involved in all transactional interactions if they can be managed/delegated to a functional area but will be kept apprised of status/resolutions, etc
Participate in and represents External Manufacturing on the cross-functional teams with Supply Chain Management/Product Source Management/ Procurement/ Integrated Development and Supply Team for due diligence ahead of siting approval & post siting approval to support Source of Supply (SOS)/New Product Introduction (NPI) changes at an external party and assume primary ownership of the new relationship.
Ensure there is a plan with clear actions and timelines in place to deliver SOS or NPI
Work with the external partner to comprehend CMO capacity (e.g., stated capacity, firm capacity, future capacity plans, time horizon / lead times required, etc.) and future capacity based on established improvements.
Accountable for maintaining the integrity of the Master Supply Agreement ensuring alignment with the Supply and Quality agreements and appropriate document revision and distribution control and for ensuring contract terms established upon by our Manufacturing Division and the External Party are executed including purchase orders, forecasts, deliveries, and approving invoice payments.
Accountable for inventory control. Based on the location of goods (at External Party or at our Company), External Manufacturing Operations Associate Director ensures adequate documentation of material disposition. In some markets, External Manufacturing Operations may need to witness the destruction of goods (to prevent counterfeiting) or have the External Party certify the destruction, per destruction procedures.
Act as our Company operational excellence leader & coach for own team and works with external partner and lean manufacturing resources, as needed, to identify External Party OpEx / continuous improvement opportunities and supports implementation once approved.
Lead with the Virtual external partner periodic Business and Operations Review Meetings (Joint Steering Committee). Based on our Company and External Manufacturing strategy the External Manufacturing Operations Associate Director develops with their cross functional team and their external partner the annual plan for the relationship with clear goals and targets
Participate in the creation and maintenance of an External Manufacturing Organization Handbook containing Global External Manufacturing policies, procedures, templates, etc
Minimum education required:
Required experience and skills:
Minimum 8 years' experience in commercial / business and manufacturing (sterile operations, quality, technology, planning)
Role requires a portion in management/leadership positions or project management.
At least two (2) years of experience in management/leadership positions which may include Employee Business Resource Group (EBRG) management experience such as Women's Network, LEAD or mentoring.
Ability to achieve compliance goals, through a risk-based approach has a deep comprehension of GMP and EHS compliance and compliance risk in Sterile Operations.
Proven Lean Six Sigma skills (operational excellence) to deliver compliant supply and achieve highest quality, lowest cost and shortest lead-time.
Skills to comprehend and intelligently apply economic, financial and industry data to make business decisions that drive value for our Company and our customers.
Can Visualize the way forward, identifying opportunities that add value to the work and proactively mitigate risk across the value chain.
Possess excellent interactive, communication, partnership and negotiation skills to work outside boundaries as a norm.
Ability to use deep knowledge and expertise in production operations to drive results and business outcomes.
Ability to apply comprehension of end-to-end supply chain within external and internal network and stakeholders across the network to achieve results and contribute to supply chain optimization.
Direct Health Authority Audit experience is desirable.
NOTICE FOR INTERNAL APPLICANTS
In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.
If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.
Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.
Current Employees apply HERE (https://wd5.myworkday.com/msd/d/task/1422$6687.htmld)
Current Contingent Workers apply HERE (https://wd5.myworkday.com/msd/d/task/1422$4020.htmld)
US and Puerto Rico Residents Only:
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here (https://survey.sogosurvey.com/r/aCdfqL) if you need an accommodation during the application or hiring process.
We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
EEOC Know Your Rights (https://www.eeoc.gov/sites/default/files/2022-10/22-088_EEOC_KnowYourRights_10_20.pdf)
EEOC GINA Supplement
Pay Transparency Nondiscrimination (https://www.dol.gov/sites/dolgov/files/OFCCP/pdf/pay-transp_%20English_formattedESQA508c.pdf)
We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.
Learn more about your rights, including under California, Colorado and other US State Acts (https://www.msdprivacy.com/us/en/CCPA-notice/)
U.S. Hybrid Work Model
Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as -remote-.
The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate's relevant skills, experience, and education.
Expected US salary range:
$122,800.00 - $193,300.00
Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. A summary of benefits is listed here (https://www.benefitsatmerck.com/) .
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status:
Regular
Relocation:
No relocation
VISA Sponsorship:
No
Travel Requirements:
25%
Flexible Work Arrangements:
Remote
Shift:
Not Indicated
Valid Driving License:
No
Hazardous Material(s):
n/a
Job Posting End Date:
10/7/2024
*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Job Posting End Date: 10/07/2024
A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Requisition ID: R315367
Job Description
The Quantitative Pharmacology and Pharmacometrics (QP2) Department of our Company's Research Laboratories is seeking a curious and collaborative Director to support our rapidly expanding ophthalmology pipeline. This position can be located in West Point, PA, Rahway, NJ, San Francisco or Boston.
As a director, you will serve as an expert QP2 representative on cross-functional teams of experienced scientists to discover and advance the clinical development of novel therapeutic agents for ophthalmologic disorders. You will work on the discovery and development of small molecules, biologics and non-traditional therapeutics like peptides, novel biological The Director is a skilled quantitative drug developer, with a strong, integrated understanding of the strategic elements of drug discovery and development. The Director should demonstrate outstanding leadership and communication skills and should work independently with minimal supervision. Within QP2, you have a unique opportunity to accelerate your professional career as a quantitative drug developer taking advantage of our end-to-end pipeline support in one of the world's most research-intensive biopharmaceutical companies.
Responsibilities:
Develop model-based strategies (translational PK/PD strategies, mechanistic model, POPPK/PD, clinical trial simulations, etc.) for quantitative analyses, within and across development programs and/or departments, to inform and optimize drug discovery and all phases of drug development including, but not limited to dose selection, clinical trial design, and go/no-go decisions.
Represent QP2 on ophthalmology discovery, early clinical development and late clinical development teams, leveraging quantitative approaches to drive streamlined development of programs within our growing ophthalmology portfolio.
Collaborate with other functional areas, as well as with external vendors and partners, creating an aligned, quantitative and model-informed regulatory framework to impact strategies and decisions of drug discovery and development teams.
Collaborate with other functional areas, as well as with external vendors and partners, on activities related to study design, protocol development, study execution, reporting and interpretation of data.
Maintain a comprehensive understanding of global regulatory expectations and shape, present and defend regulatory documents and submissions.
Work closely with pharmacometrics team members and provides input related to analysis and reporting of modeling activities.
Mentor or supervise early career scientists to grow their skill sets to perform project related duties.
Required:
(a Ph.D. or equivalent degree with at least seven years of experience) OR (a PharmD or equivalent degree with at least nine years of experience) OR (an MS or equivalent degree with at least 11 years of experience), where -experience- means having a record of increasing responsibility and independence in a similar role in pharmaceutical drug development, regulatory agency, or academia.
Educational background in biopharmaceutics, pharmaceutical sciences, pharmacometrics, chemical/biomedical engineering, or a related field.
An exemplary record of increasing responsibility, independence, and demonstrated impact in driving drug development decisions through application of model-based approaches in the pharmaceutical industry.
Direct experience in regulatory interactions.
Proficiency in written and verbal communication, interdisciplinary collaboration, and problem scoping and planning.
Demonstrated ability to participate in and to lead an interdisciplinary team, and to oversee the work of other scientists.
Knowledge in modeling of complex therapeutics.
Flexibility to react rapidly to changing situations/environment.
Knowledge in ophthalmology and/or cardiometabolic clinical drug development programs
Knowledge in modeling of complex ophthalmology therapeutics.
Preferred:
Ability to influence regulatory strategies including independently formulating registration packages to support global filings, a strong understanding of clinical pharmacology studies to support intrinsic/extrinsic factors, ability to independently author, defend regulatory filings.
Experience in performing population PK/PKPD analyses using standard pharmacometrics software (e.g. NONMEM, Monolix, Phoenix, etc.)
Expert skills in experimental design, mathematical problem solving, critical data analysis/interpretation, and statistics.
Scientific understanding of biopharmaceutical and ADME properties of small molecules and/or biologics
Experience with modeling programing language(s) (e.g. R, NONMEM, R, Phoenix, or other similar packages)
Your role at our Company is integral to helping the world meet new breakthroughs that affect generations to come, and we're counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At our Company, we're inventing for life.
NOTICE FOR INTERNAL APPLICANTS
In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.
If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.
Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.
Current Employees apply HERE (https://wd5.myworkday.com/msd/d/task/1422$6687.htmld)
Current Contingent Workers apply HERE (https://wd5.myworkday.com/msd/d/task/1422$4020.htmld)
US and Puerto Rico Residents Only:
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here (https://survey.sogosurvey.com/r/aCdfqL) if you need an accommodation during the application or hiring process.
We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
EEOC Know Your Rights (https://www.eeoc.gov/sites/default/files/2022-10/22-088_EEOC_KnowYourRights_10_20.pdf)
EEOC GINA Supplement
Pay Transparency Nondiscrimination (https://www.dol.gov/sites/dolgov/files/OFCCP/pdf/pay-transp_%20English_formattedESQA508c.pdf)
We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.
Learn more about your rights, including under California, Colorado and other US State Acts (https://www.msdprivacy.com/us/en/CCPA-notice/)
U.S. Hybrid Work Model
Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as -remote-.
The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate's relevant skills, experience, and education.
Expected US salary range:
$181,600.00 - $285,800.00
Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. A summary of benefits is listed here (https://www.benefitsatmerck.com/) .
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status:
Regular
Relocation:
Domestic/International
VISA Sponsorship:
Yes
Travel Requirements:
10%
Flexible Work Arrangements:
Hybrid
Shift:
Not Indicated
Valid Driving License:
No
Hazardous Material(s):
N/A
Required Skills:
Business Intelligence (BI), Database Design, Data Engineering, Data Modeling, Data Science, Data Visualization, Machine Learning, Software Development, Stakeholder Relationship Management, Waterfall Project Management
Preferred Skills:
Job Posting End Date:
10/31/2024
*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Job Posting End Date: 10/31/2024
A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Requisition ID: R315438
Job Description
An opportunity has arisen for an External Manufacturing Operations Associate Director. Our Manufacturing & Supply Division is dedicated to being the most trusted supplier of biopharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create a reliable global manufacturing network that's devoted to delivering a high quality, reliable supply to customers and patients on time, every time.
Based out of the United States, the ExM Operations Associate Director is accountable for meeting customer demand at the Contract Manufacturing Organizations (CMOs) they manage by achieving excellence in Compliance, Supply, Continuous Improvement & Cost. This is achieved through their direction as a key contributor within Focus Factory, and in partnership with those CMOs while leveraging lean manufacturing principles and the E2E supply chain.
You will be accountable for potentially new project support as well as commercial oversight between our Manufacturing Division and the CMO, by establishing strong business partnership as well as boundaries and ground rules of engagement.
You will steer a cross-functional team (Supply Chain, Quality, Technical Ops, Procurement...) who are accountable for delivering daily/weekly/monthly/annual requirements at their external partner(s).
Bring energy, knowledge, innovation to carry out the following:
Ensure compliance (Quality Risk management, Deviation Management, Product Release, Change Control); Meeting Demand; Dispute resolution (w/ appropriate escalation); Production Planning; Materials Management & Logistics; Technology issues; Oversight of shop floor production (determining when an ExM functional rep should be deployed to the External Party's (EP) facility); Lean Manufacturing and Continuous Improvement activities; Linking E2E (upstream and downstream) and with Supply Chain Management ensure and optimize flow of materials
Maintain a virtual presence at external partners site on the production floor either virtually or physically; builds a strong co-dependent relationship with the sites leadership team and can assess (-read a site-) & diagnose the current condition. Assess risks at a partners site and formulate in partnership with the external partner and our Company cross-functional team action orientated and time bound improvement plans. This may be executed virtually as well through use of innovative technologies that allow for remote sharing of information
Partner with internal ExM team members including Procurement, Quality, Project management and Technology on commercial aspects of relationship, including Identify, Select, Negotiate and Re-negotiate/terminate, as required. The External Manufacturing Operations Associate Director may not be involved in all transactional interactions if they can be managed/delegated to a functional area but will be kept apprised of status/resolutions, etc
Participate in and represents External Manufacturing on the cross-functional teams with Supply Chain Management/Product Source Management/ Procurement/ Integrated Development and Supply Team for due diligence ahead of siting approval & post siting approval to support Source of Supply (SOS)/New Product Introduction (NPI) changes at an external party and assume primary ownership of the new relationship.
Ensure there is a plan with clear actions and timelines in place to deliver SOS or NPI
Work with the external partner to comprehend CMO capacity (e.g., stated capacity, firm capacity, future capacity plans, time horizon / lead times required, etc.) and future capacity based on established improvements.
Accountable for maintaining the integrity of the Master Supply Agreement ensuring alignment with the Supply and Quality agreements and appropriate document revision and distribution control and for ensuring contract terms established upon by our Manufacturing Division and the External Party are executed including purchase orders, forecasts, deliveries, and approving invoice payments.
Accountable for inventory control. Based on the location of goods (at External Party or at our Company), External Manufacturing Operations Associate Director ensures adequate documentation of material disposition. In some markets, External Manufacturing Operations may need to witness the destruction of goods (to prevent counterfeiting) or have the External Party certify the destruction, per destruction procedures.
Act as our Company operational excellence leader & coach for own team and works with external partner and lean manufacturing resources, as needed, to identify External Party OpEx / continuous improvement opportunities and supports implementation once approved.
Lead with the Virtual external partner periodic Business and Operations Review Meetings (Joint Steering Committee). Based on our Company and External Manufacturing strategy the External Manufacturing Operations Associate Director develops with their cross functional team and their external partner the annual plan for the relationship with clear goals and targets
Participate in the creation and maintenance of an External Manufacturing Organization Handbook containing Global External Manufacturing policies, procedures, templates, etc
Minimum education required:
Required experience and skills:
Minimum 8 years' experience in commercial / business and manufacturing (sterile operations, quality, technology, planning)
Role requires a portion in management/leadership positions or project management.
At least two (2) years of experience in management/leadership positions which may include Employee Business Resource Group (EBRG) management experience such as Women's Network, LEAD or mentoring.
Ability to achieve compliance goals, through a risk-based approach has a deep comprehension of GMP and EHS compliance and compliance risk in Sterile Operations.
Proven Lean Six Sigma skills (operational excellence) to deliver compliant supply and achieve highest quality, lowest cost and shortest lead-time.
Skills to comprehend and intelligently apply economic, financial and industry data to make business decisions that drive value for our Company and our customers.
Can Visualize the way forward, identifying opportunities that add value to the work and proactively mitigate risk across the value chain.
Possess excellent interactive, communication, partnership and negotiation skills to work outside boundaries as a norm.
Ability to use deep knowledge and expertise in production operations to drive results and business outcomes.
Ability to apply comprehension of end-to-end supply chain within external and internal network and stakeholders across the network to achieve results and contribute to supply chain optimization.
Direct Health Authority Audit experience is desirable.
NOTICE FOR INTERNAL APPLICANTS
In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.
If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.
Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.
Current Employees apply HERE (https://wd5.myworkday.com/msd/d/task/1422$6687.htmld)
Current Contingent Workers apply HERE (https://wd5.myworkday.com/msd/d/task/1422$4020.htmld)
US and Puerto Rico Residents Only:
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here (https://survey.sogosurvey.com/r/aCdfqL) if you need an accommodation during the application or hiring process.
We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
EEOC Know Your Rights (https://www.eeoc.gov/sites/default/files/2022-10/22-088_EEOC_KnowYourRights_10_20.pdf)
EEOC GINA Supplement
Pay Transparency Nondiscrimination (https://www.dol.gov/sites/dolgov/files/OFCCP/pdf/pay-transp_%20English_formattedESQA508c.pdf)
We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.
Learn more about your rights, including under California, Colorado and other US State Acts (https://www.msdprivacy.com/us/en/CCPA-notice/)
U.S. Hybrid Work Model
Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as -remote-.
The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate's relevant skills, experience, and education.
Expected US salary range:
$122,800.00 - $193,300.00
Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. A summary of benefits is listed here (https://www.benefitsatmerck.com/) .
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status:
Regular
Relocation:
No relocation
VISA Sponsorship:
No
Travel Requirements:
25%
Flexible Work Arrangements:
Remote
Shift:
Not Indicated
Valid Driving License:
No
Hazardous Material(s):
n/a
Job Posting End Date:
10/7/2024
*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Job Posting End Date: 10/07/2024
A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Requisition ID: R315367
Job Description
We are seeking a Senior Scientist to join our Data-Rich Experimentation (DRE) organization, within Process Research & Developing Enabling Technologies (PR&D ET), located in West Point, PA.
Primary Responsibilities:
In this role, the chosen candidate will work with a team of scientists tasked with identifying, developing, and deploying data-rich technologies aimed at improving the manner in which process understanding is gathered. The tools that we develop are as diverse as the team developing them, and in this Senior Scientist role, the chosen candidate will leverage high-throughput experimentation and data science technologies to enable our process research and development efforts across our Company's small molecule, biologics, and vaccines portfolio.
Our Data-Rich Experimentation ( DRE) organization is responsible for the invention and application of new data-rich tools to support the scientists across process research and development at our Company. We aspire to embed data-intense technologies into the fabric of our Company's process development culture.
This Senior Scientist role is a scientific position tasked with solving complex process research and development challenges in an interdisciplinary, collaborative environment via invention, development, and application of innovative high-throughput experimentation tools. Ultimately, using cutting-edge automation and data science capabilities, we aim to elucidate a deeper understanding of our processes across diverse medicines and vaccines.
In this Senior Scientist role, the chosen candidate will leverage high-throughput experimentation and data science capabilities to help advance process-focused scientific research.
This includes, but is not limited to:
delivering high throughput process development (HTPD) solutions to process teams and conducting microscale screening experiments as required to drive large molecule development,
identifying opportunities to utilize HTPD and developing novel HTPD workflows to enhance process understanding,
efficient programming, implementing and maintaining robotic systems with liquid-handling hardware,
leveraging digital tools to enable automated data pipeline such as algorithm-assisted experimental planning and automated data aggregation, analysis and visualization.
In addition to a passion for high-throughput experimentation and data science, the chosen candidate should have excellent interpersonal, communication, and collaboration skills. The chosen candidate should embrace and model our core values of diversity and inclusion, including fostering a supportive culture where all can thrive.
The chosen candidate should be able to effectively collaborate in a dynamic, integrated, and multidisciplinary team environment. The chosen candidate should demonstrate a clear ability to perform impactful scientific innovation in a team-oriented manner that builds trusted partnerships across vast stakeholder networks. The chosen candidate should have a demonstrated ability to publish and present research, including an established track record of interaction with the broader academic community. The chosen candidate will join a diverse group of scientific problem solvers who are dedicated to creating the life-changing medicines and vaccines of tomorrow.
Position Qualifications :
Education Minimum Requirement:
A Ph.D. in Engineering, Chemistry, Physics, Biology, Pharmaceutical Sciences, or a closely-related field
A M.S. in Engineering, Chemistry, Physics, Biology, Pharmaceutical Sciences, or a closely-related field with at least 2 years of industrial/pharmaceutical or relevant experience
A B.S. in in Engineering, Chemistry, Physics, Biology, Pharmaceutical Sciences, or a closely-related field with at least 4 years of industrial/pharmaceutical or relevant experience
Required Experience and Skills:
Relevant working experience in identifying and implementing high-throughput process development (HTPD) solutions for application to large biomolecule process development (e.g. viral vectors, vaccines, therapeutic proteins).
Strong technical background in large biomolecules upstream (e.g. microbial fermentation, mammalian cell & virus culture) or downstream (e.g. harvest, filtration, chromatography, conjugation) unit operations.
Experience in developing and implementing microscale models for large molecule upstream or downstream process unit operations .
Highly-motivated and technology-centric scientist that is passionate about modernizing our Company's process development practices across biologics, vaccines, and small molecule modalities.
Demonstrated scientific ability through publications and presentations in scientific conferences.
Excellent communication skills, demonstrated creativity, and effective interpersonal skills.
Ability to deliver complex solutions under compressed timelines in a dynamic environment.
Ability to work in a team environment with cross-functional interactions.
Preferred Experience and Skills:
Expertise in implementing data science tools to accelerate high-throughput lab automation capabilities
Experience in new technology research, including a demonstrated track record of identifying, developing, and deploying data-rich tools and methodologies.
Collaborative research efforts that are praised by the broader scientific community and are exemplary of a multidisciplinary group.
Evidence of cross-functional collaboration in an academic or industrial setting.
Motivated to learn new skills, willingness to take on new challenges, and scientific curiosity.
NOTICE FOR INTERNAL APPLICANTS
In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.
If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.
Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.
Current Employees apply HERE (https://wd5.myworkday.com/msd/d/task/1422$6687.htmld)
Current Contingent Workers apply HERE (https://wd5.myworkday.com/msd/d/task/1422$4020.htmld)
US and Puerto Rico Residents Only:
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here (https://survey.sogosurvey.com/r/aCdfqL) if you need an accommodation during the application or hiring process.
We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
EEOC Know Your Rights (https://www.eeoc.gov/sites/default/files/2022-10/22-088_EEOC_KnowYourRights_10_20.pdf)
EEOC GINA Supplement
Pay Transparency Nondiscrimination (https://www.dol.gov/sites/dolgov/files/OFCCP/pdf/pay-transp_%20English_formattedESQA508c.pdf)
We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.
Learn more about your rights, including under California, Colorado and other US State Acts (https://www.msdprivacy.com/us/en/CCPA-notice/)
U.S. Hybrid Work Model
Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as -remote-.
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status:
Regular
Relocation:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
Not Applicable
Shift:
Valid Driving License:
Hazardous Material(s):
Job Posting End Date:
10/11/2024
*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Job Posting End Date: 10/11/2024
A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Requisition ID: R315420
Job Description
An opportunity has arisen for an External Manufacturing Operations Associate Director. Our Manufacturing & Supply Division is dedicated to being the most trusted supplier of biopharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create a reliable global manufacturing network that's devoted to delivering a high quality, reliable supply to customers and patients on time, every time.
Based out of the United States, the ExM Operations Associate Director is accountable for meeting customer demand at the Contract Manufacturing Organizations (CMOs) they manage by achieving excellence in Compliance, Supply, Continuous Improvement & Cost. This is achieved through their direction as a key contributor within Focus Factory, and in partnership with those CMOs while leveraging lean manufacturing principles and the E2E supply chain.
You will be accountable for potentially new project support as well as commercial oversight between our Manufacturing Division and the CMO, by establishing strong business partnership as well as boundaries and ground rules of engagement.
You will steer a cross-functional team (Supply Chain, Quality, Technical Ops, Procurement...) who are accountable for delivering daily/weekly/monthly/annual requirements at their external partner(s).
Bring energy, knowledge, innovation to carry out the following:
Ensure compliance (Quality Risk management, Deviation Management, Product Release, Change Control); Meeting Demand; Dispute resolution (w/ appropriate escalation); Production Planning; Materials Management & Logistics; Technology issues; Oversight of shop floor production (determining when an ExM functional rep should be deployed to the External Party's (EP) facility); Lean Manufacturing and Continuous Improvement activities; Linking E2E (upstream and downstream) and with Supply Chain Management ensure and optimize flow of materials
Maintain a virtual presence at external partners site on the production floor either virtually or physically; builds a strong co-dependent relationship with the sites leadership team and can assess (-read a site-) & diagnose the current condition. Assess risks at a partners site and formulate in partnership with the external partner and our Company cross-functional team action orientated and time bound improvement plans. This may be executed virtually as well through use of innovative technologies that allow for remote sharing of information
Partner with internal ExM team members including Procurement, Quality, Project management and Technology on commercial aspects of relationship, including Identify, Select, Negotiate and Re-negotiate/terminate, as required. The External Manufacturing Operations Associate Director may not be involved in all transactional interactions if they can be managed/delegated to a functional area but will be kept apprised of status/resolutions, etc
Participate in and represents External Manufacturing on the cross-functional teams with Supply Chain Management/Product Source Management/ Procurement/ Integrated Development and Supply Team for due diligence ahead of siting approval & post siting approval to support Source of Supply (SOS)/New Product Introduction (NPI) changes at an external party and assume primary ownership of the new relationship.
Ensure there is a plan with clear actions and timelines in place to deliver SOS or NPI
Work with the external partner to comprehend CMO capacity (e.g., stated capacity, firm capacity, future capacity plans, time horizon / lead times required, etc.) and future capacity based on established improvements.
Accountable for maintaining the integrity of the Master Supply Agreement ensuring alignment with the Supply and Quality agreements and appropriate document revision and distribution control and for ensuring contract terms established upon by our Manufacturing Division and the External Party are executed including purchase orders, forecasts, deliveries, and approving invoice payments.
Accountable for inventory control. Based on the location of goods (at External Party or at our Company), External Manufacturing Operations Associate Director ensures adequate documentation of material disposition. In some markets, External Manufacturing Operations may need to witness the destruction of goods (to prevent counterfeiting) or have the External Party certify the destruction, per destruction procedures.
Act as our Company operational excellence leader & coach for own team and works with external partner and lean manufacturing resources, as needed, to identify External Party OpEx / continuous improvement opportunities and supports implementation once approved.
Lead with the Virtual external partner periodic Business and Operations Review Meetings (Joint Steering Committee). Based on our Company and External Manufacturing strategy the External Manufacturing Operations Associate Director develops with their cross functional team and their external partner the annual plan for the relationship with clear goals and targets
Participate in the creation and maintenance of an External Manufacturing Organization Handbook containing Global External Manufacturing policies, procedures, templates, etc
Minimum education required:
Required experience and skills:
Minimum 8 years' experience in commercial / business and manufacturing (sterile operations, quality, technology, planning)
Role requires a portion in management/leadership positions or project management.
At least two (2) years of experience in management/leadership positions which may include Employee Business Resource Group (EBRG) management experience such as Women's Network, LEAD or mentoring.
Ability to achieve compliance goals, through a risk-based approach has a deep comprehension of GMP and EHS compliance and compliance risk in Sterile Operations.
Proven Lean Six Sigma skills (operational excellence) to deliver compliant supply and achieve highest quality, lowest cost and shortest lead-time.
Skills to comprehend and intelligently apply economic, financial and industry data to make business decisions that drive value for our Company and our customers.
Can Visualize the way forward, identifying opportunities that add value to the work and proactively mitigate risk across the value chain.
Possess excellent interactive, communication, partnership and negotiation skills to work outside boundaries as a norm.
Ability to use deep knowledge and expertise in production operations to drive results and business outcomes.
Ability to apply comprehension of end-to-end supply chain within external and internal network and stakeholders across the network to achieve results and contribute to supply chain optimization.
Direct Health Authority Audit experience is desirable.
NOTICE FOR INTERNAL APPLICANTS
In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.
If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.
Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.
Current Employees apply HERE (https://wd5.myworkday.com/msd/d/task/1422$6687.htmld)
Current Contingent Workers apply HERE (https://wd5.myworkday.com/msd/d/task/1422$4020.htmld)
US and Puerto Rico Residents Only:
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here (https://survey.sogosurvey.com/r/aCdfqL) if you need an accommodation during the application or hiring process.
We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
EEOC Know Your Rights (https://www.eeoc.gov/sites/default/files/2022-10/22-088_EEOC_KnowYourRights_10_20.pdf)
EEOC GINA Supplement
Pay Transparency Nondiscrimination (https://www.dol.gov/sites/dolgov/files/OFCCP/pdf/pay-transp_%20English_formattedESQA508c.pdf)
We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.
Learn more about your rights, including under California, Colorado and other US State Acts (https://www.msdprivacy.com/us/en/CCPA-notice/)
U.S. Hybrid Work Model
Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as -remote-.
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status:
Regular
Relocation:
No relocation
VISA Sponsorship:
No
Travel Requirements:
25%
Flexible Work Arrangements:
Remote
Shift:
Not Indicated
Valid Driving License:
No
Hazardous Material(s):
n/a
Job Posting End Date:
10/7/2024
*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Job Posting End Date: 10/07/2024
A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Requisition ID: R315369
Job Description
An opportunity has arisen for an External Manufacturing Operations Associate Director. Our Manufacturing & Supply Division is dedicated to being the most trusted supplier of biopharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create a reliable global manufacturing network that's devoted to delivering a high quality, reliable supply to customers and patients on time, every time.
Based out of the United States, the ExM Operations Associate Director is accountable for meeting customer demand at the Contract Manufacturing Organizations (CMOs) they manage by achieving excellence in Compliance, Supply, Continuous Improvement & Cost. This is achieved through their direction as a key contributor within Focus Factory, and in partnership with those CMOs while leveraging lean manufacturing principles and the E2E supply chain.
You will be accountable for potentially new project support as well as commercial oversight between our Manufacturing Division and the CMO, by establishing strong business partnership as well as boundaries and ground rules of engagement.
You will steer a cross-functional team (Supply Chain, Quality, Technical Ops, Procurement...) who are accountable for delivering daily/weekly/monthly/annual requirements at their external partner(s).
Bring energy, knowledge, innovation to carry out the following:
Ensure compliance (Quality Risk management, Deviation Management, Product Release, Change Control); Meeting Demand; Dispute resolution (w/ appropriate escalation); Production Planning; Materials Management & Logistics; Technology issues; Oversight of shop floor production (determining when an ExM functional rep should be deployed to the External Party's (EP) facility); Lean Manufacturing and Continuous Improvement activities; Linking E2E (upstream and downstream) and with Supply Chain Management ensure and optimize flow of materials
Maintain a virtual presence at external partners site on the production floor either virtually or physically; builds a strong co-dependent relationship with the sites leadership team and can assess (-read a site-) & diagnose the current condition. Assess risks at a partners site and formulate in partnership with the external partner and our Company cross-functional team action orientated and time bound improvement plans. This may be executed virtually as well through use of innovative technologies that allow for remote sharing of information
Partner with internal ExM team members including Procurement, Quality, Project management and Technology on commercial aspects of relationship, including Identify, Select, Negotiate and Re-negotiate/terminate, as required. The External Manufacturing Operations Associate Director may not be involved in all transactional interactions if they can be managed/delegated to a functional area but will be kept apprised of status/resolutions, etc
Participate in and represents External Manufacturing on the cross-functional teams with Supply Chain Management/Product Source Management/ Procurement/ Integrated Development and Supply Team for due diligence ahead of siting approval & post siting approval to support Source of Supply (SOS)/New Product Introduction (NPI) changes at an external party and assume primary ownership of the new relationship.
Ensure there is a plan with clear actions and timelines in place to deliver SOS or NPI
Work with the external partner to comprehend CMO capacity (e.g., stated capacity, firm capacity, future capacity plans, time horizon / lead times required, etc.) and future capacity based on established improvements.
Accountable for maintaining the integrity of the Master Supply Agreement ensuring alignment with the Supply and Quality agreements and appropriate document revision and distribution control and for ensuring contract terms established upon by our Manufacturing Division and the External Party are executed including purchase orders, forecasts, deliveries, and approving invoice payments.
Accountable for inventory control. Based on the location of goods (at External Party or at our Company), External Manufacturing Operations Associate Director ensures adequate documentation of material disposition. In some markets, External Manufacturing Operations may need to witness the destruction of goods (to prevent counterfeiting) or have the External Party certify the destruction, per destruction procedures.
Act as our Company operational excellence leader & coach for own team and works with external partner and lean manufacturing resources, as needed, to identify External Party OpEx / continuous improvement opportunities and supports implementation once approved.
Lead with the Virtual external partner periodic Business and Operations Review Meetings (Joint Steering Committee). Based on our Company and External Manufacturing strategy the External Manufacturing Operations Associate Director develops with their cross functional team and their external partner the annual plan for the relationship with clear goals and targets
Participate in the creation and maintenance of an External Manufacturing Organization Handbook containing Global External Manufacturing policies, procedures, templates, etc
Minimum education required:
Required experience and skills:
Minimum 8 years' experience in commercial / business and manufacturing (sterile operations, quality, technology, planning)
Role requires a portion in management/leadership positions or project management.
At least two (2) years of experience in management/leadership positions which may include Employee Business Resource Group (EBRG) management experience such as Women's Network, LEAD or mentoring.
Ability to achieve compliance goals, through a risk-based approach has a deep comprehension of GMP and EHS compliance and compliance risk in Sterile Operations.
Proven Lean Six Sigma skills (operational excellence) to deliver compliant supply and achieve highest quality, lowest cost and shortest lead-time.
Skills to comprehend and intelligently apply economic, financial and industry data to make business decisions that drive value for our Company and our customers.
Can Visualize the way forward, identifying opportunities that add value to the work and proactively mitigate risk across the value chain.
Possess excellent interactive, communication, partnership and negotiation skills to work outside boundaries as a norm.
Ability to use deep knowledge and expertise in production operations to drive results and business outcomes.
Ability to apply comprehension of end-to-end supply chain within external and internal network and stakeholders across the network to achieve results and contribute to supply chain optimization.
Direct Health Authority Audit experience is desirable.
NOTICE FOR INTERNAL APPLICANTS
In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.
If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.
Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.
Current Employees apply HERE (https://wd5.myworkday.com/msd/d/task/1422$6687.htmld)
Current Contingent Workers apply HERE (https://wd5.myworkday.com/msd/d/task/1422$4020.htmld)
US and Puerto Rico Residents Only:
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here (https://survey.sogosurvey.com/r/aCdfqL) if you need an accommodation during the application or hiring process.
We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
EEOC Know Your Rights (https://www.eeoc.gov/sites/default/files/2022-10/22-088_EEOC_KnowYourRights_10_20.pdf)
EEOC GINA Supplement
Pay Transparency Nondiscrimination (https://www.dol.gov/sites/dolgov/files/OFCCP/pdf/pay-transp_%20English_formattedESQA508c.pdf)
We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.
Learn more about your rights, including under California, Colorado and other US State Acts (https://www.msdprivacy.com/us/en/CCPA-notice/)
U.S. Hybrid Work Model
Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as -remote-.
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status:
Regular
Relocation:
No relocation
VISA Sponsorship:
No
Travel Requirements:
25%
Flexible Work Arrangements:
Remote
Shift:
Not Indicated
Valid Driving License:
No
Hazardous Material(s):
n/a
Job Posting End Date:
10/7/2024
*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Job Posting End Date: 10/07/2024
A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Requisition ID: R315369
Job Description
The Associate Director, Technical Operations, is responsible for the management and oversight of a team providing technical support for a live virus vaccine drug substance manufacturing facility at the West Point site. The primary responsibility of the individual will be leading the technical team in their support of run the business activities that include executing and directing production process performance, operations support, process validation, cleaning and sterilization validation activities, equipment/automation troubleshooting, implementation of process / equipment / analytical changes, collaboration with the deviation management team and installation of robust CAPAs, among other related duties. The Associate Director will have overall responsibility for the performance and results of the technical operations team supporting the integrated production team (IPT). Limited off-shift or weekend coverage may be required based on business unit needs and specific assignments.
GENERAL PROFILE:
Builds talent by recruiting, coaching, and developing the members of the Technical Operations team to ensure appropriate breadth, depth and skill sets across the team to maintain and drive the business forward. Provides/solicits regular feedback from team and colleagues. Develops technical/professional staff through coaching, assignment selection and associated training.
Manages team resources and prioritizes in alignment with business needs including run the business support, project support, and continuous improvement activities - e.g. improve safety/compliance, reduce cost, and increase consistency and efficiency.
Provides leadership on schedule, priorities, and issue resolution to aid the team in accomplishing business objectives.
Adapts and implements departmental plans and priorities based on Site and End-to-End scorecard to address local business, service, and operational challenges.
Collaborates and engages with multiple functional organizations such as Operations, Technology, Quality, Maintenance, Automation, Global Engineering Services, Procurement, Finance, Above-Site Technology, Regulatory, among others, to develop and maintain processes that meet cGMP and business requirements.
Provides technical guidance to staff, colleagues or customers as well as anticipates and interprets the customer needs to identify solutions. Includes approval of technical documentation including investigations, protocols, qualification, validation etc. as required.
Responsible for presenting technical discussions to regulatory agencies during inspections.
FUNCTIONAL EXPERTISE:
Coaches, manages, and develops a team of engineers through a direct reporting relationship. Recruits and hires engineers and scientists to support manufacturing operations.
Leads and/or coaches employees on complex manufacturing investigations and projects.
Has ability to examine an issue from diverse perspectives (safety, compliance, automation, equipment, process, and people) to best understand and resolve the root cause.
Monitors the health of the process through continuous monitoring and the annual process review or continuing validation activities.
Develops and assures consistent application of standardized work, engineering, and process tools.
Provides technical support to manufacturing for complex problems and issues.
Coaches those providing technical support to manufacturing.
Designs and conducts experimental protocols as needed using the Technical Operations lab facilities and/or production equipment at full scale.
Authors and updates technical and manufacturing documents as necessary for investigations, process design/definition, engineering studies, process demonstrations, change control and validation.
Serve as a primary technical reviewer/approver for investigations and significant process changes.
Links with key functional leads on site and above site to provide input on behalf of the site team.
Takes a leadership role in regulatory inspection activities for the facility.
PROBLEM SOLVING:
Identifies and resolves technical and operational problems using lean/six sigma tools.
Effectively collaborates with peers on site and above site as required.
Expert application of problem-solving skills.
IMPACT:
Influence
Explains difficult concepts and persuades others to adopt point of view.
Communicates information, asks questions and checks for understanding.
Accountability
Decision Making
Makes decisions - guided by policies, procedures, and department objectives.
Consults on an as-needed basis with next-level manager on more complex decisions.
STRATEGIC PLANNING:
Working Relationships:
Reports to Technical Operations Director.
Manages employees within own department.
Interacts with employees within own department and from other departments.
Interacts with representatives from regulatory agencies.
Interacts with external suppliers
Minimum Education Requirement and Experience:
Bachelor of Science (B.S.) degree in Engineering or Sciences with eight (8) years post-bachelor's degree experience in GMP manufacturing and/or technical support of GMP manufacturing operations. OR
Master of Science (M.S.) degree in Engineering or Sciences with six (6) years post-bachelor's degree experience in GMP manufacturing and/or technical support of GMP manufacturing operations. OR
PhD in Engineering or Sciences with four (4) years post-bachelor's degree experience in GMP manufacturing and/or technical support of GMP manufacturing operations.
Required Experience and Skills:
Experience in biologics, vaccine or bulk sterile manufacturing facilities in a process or validation support role.
Highly developed communication, leadership, and teamwork skills.
Experience leading and managing departmental or cross-functional teams.
Preferred Experience and Skills:
Advanced degree (M.S., PhD) in science or engineering.
Previous management or supervisory experience
Sterile manufacturing experience.
Validation experience
Regulatory inspection presentation experience with external regulatory authority representatives.
NOTICE FOR INTERNAL APPLICANTS
In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.
If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.
Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.
Current Employees apply HERE (https://wd5.myworkday.com/msd/d/task/1422$6687.htmld)
Current Contingent Workers apply HERE (https://wd5.myworkday.com/msd/d/task/1422$4020.htmld)
US and Puerto Rico Residents Only:
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here (https://survey.sogosurvey.com/r/aCdfqL) if you need an accommodation during the application or hiring process.
We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
EEOC Know Your Rights (https://www.eeoc.gov/sites/default/files/2022-10/22-088_EEOC_KnowYourRights_10_20.pdf)
EEOC GINA Supplement
Pay Transparency Nondiscrimination (https://www.dol.gov/sites/dolgov/files/OFCCP/pdf/pay-transp_%20English_formattedESQA508c.pdf)
We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.
Learn more about your rights, including under California, Colorado and other US State Acts (https://www.msdprivacy.com/us/en/CCPA-notice/)
U.S. Hybrid Work Model
Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as -remote-.
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status:
Regular
Relocation:
Domestic
VISA Sponsorship:
No
Travel Requirements:
10%
Flexible Work Arrangements:
Hybrid
Shift:
1st - Day
Valid Driving License:
No
Hazardous Material(s):
n/a
Job Posting End Date:
10/6/2024
*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Job Posting End Date: 10/06/2024
A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Requisition ID: R314625
Job Description
The candidate selected for this hybrid position will have responsibilities as both an Institutional Account Lead (IAL) and Payer Account Executive within the assigned geography and for assigned accounts. The Primary Territory for this position covers Minnesota, South Dakota, and North Dakota, therefore, the percentage of travel required may be less, or more, depending on where a candidate resides in or near the geography.
Primary Activities & Responsibilities include but are not limited to the following:
The IAL Hybrid Institutional Account Lead / Payer Account Executive will manage the business relationship between our Company and assigned customer accounts with the following goals:
Establishing profitable product access within our Company's product strategy
Optimizing Net Sales and Contract Performance across a portfolio of our Company products
Ensuring proper oversight and compliance with our Company policies and exercising appropriate financial stewardship
IAL Primary Activities:
The IAL is responsible for appropriately addressing customer educational needs, interacting with multiple stakeholders within the assigned account to enhance our Company's business relationship with its customers. Each IAL is responsible for the following designated customers as assigned by the HCS Regional Director:
Integrated Delivery Network (IDN, including hospital outpatient and home-infusion if IDN owned)
Federal accounts (including Veterans' Affairs and Military Treatment Facilities)
Corrections
The IAL engages senior Institutional Leadership and is responsible for building trust and credibility with their assigned customers through strong interpersonal relationships, in depth knowledge of the customer's organization, objectives, and business and environmental issues impacting the customer, and in-depth knowledge of the same for our Company. The IAL engages senior Institutional Leadership in the following roles using approved messages and resources:
Pharmacy Service Line, and will serve as lead for the assigned customers across our Company's account teams with overlapping contacts with the customer
Information Technology Departments and will serve as lead for assigned customers across our Company's account teams with overlapping contacts with the customer
Veterans Integrated Service Network (VISN) & VISN Pharmacy Executive within the Veterans'' Affairs system
C-Suite in top assigned accounts
Develops strategic and tactical account plans for assigned accounts. The responsibilities could include the following:
Economic:
Persuasively presenting Group Purchasing Organization (GPO) brand pricing programs to pharmacy leadership
Negotiate direct contracts, where appropriate
Communicating approved financial, health care economic and budget impact models
Operational:
Communicating product access with overlay Field Based Employees (FBE) for assigned IDN accounts
Confirming customer contracts are properly loaded to provide the appropriate contract pricing to the eligible sites of care
Communicating approved information to customer Information Technology departments
Leads account planning for assigned IDN Accounts with other IAM colleagues and FBE's
Manages on going communications to extended Team
Account coordination and access facilitation to overlapping contacts with FBE's
Promote assigned our Company products along entire continuum of care (transition of care) using approved messages and resources
Conducts appropriate business review of account performance to optimize net sales for our Company
Clinical:
Communicate to customers the clinical value proposition for assigned products using approved messages and resources
Appropriately use approved our Company resources to meet customer educational needs
Payer Account Executive Primary Activities
The Payer Account Executive leads the development and implementation of long-term Customer Account Plans. The AE collaborates with the customer team to identify and pursue areas of mutual opportunity (Payers and HCP's) based on better health outcomes for patients. Negotiates contract terms and conditions with the customer. Responsible for P&L (revenue/expenses) for the Payer business.
Customer Account Planning and Management
Accountable for payer customer/portfolio P&L (revenue and expenses); works with other stakeholders (Customer Manager, Directors, Planners) to provide input on resource allocation decisions across customer targets within the larger geography.
Serves as the primary interface and owner for the customer (payer) account and is responsible for the overall (payer) customer experience.
Establishes relationships and maintains a pervasive communication network with the (payer) customer at many levels, including corporate personnel, medical directors in charge of provider networks, quality directors, pharmacy directors, financial directors, COO, CEO.
Conducts business strategy discussions and performance reviews with key customers on a regular basis (plays a significant role in ensuring that the Director of Commercial Operations, Customer Team Leader(s), and understand the (payer) customer's business strategy and support it at the local HCP level)
Proactively meet with (payer) customers to solicit feedback and adjust plans on a regular basis
Develop Customer Account plans aligned with Managed Care and brand strategies over a 3-5-year time horizon. Solicits input from Director of Commercial Operations, Customer Team Leader(s), and other relevant stakeholders to develop the long-term customer plan. Assesses competitor position as part of account plan development.
Identifies, understands and can articulate the key drivers affecting the customers' business including the customer's long-term plan and objectives.
Utilizes customer account strategy to define the objectives of the customer relationship
Identifies potential customer issues and needs (clinical, financial, business)
Collaborates with the customer to identify and pursue areas of mutual opportunity, focused on better health outcomes for patients
Develop innovative contracting to support better health outcomes
Leverages programs and services designed to improve treatment and better outcomes for patients
Represents the voice of the customer and advocates on behalf of the customer
Coordinates and manages the communication process between customers and identified internal or external expert(s) and ensures customer needs are accurately identified and addressed
Proactively identifies the internal and external experts needed to communicate complex clinical and scientific information to customers
Based on customer needs, provide appropriate clinical support and knowledge related to our Company products.
Communicates our Company activities that would be relevant to the Customer including promotional positioning (support of appropriate utilization) and/or provider quality and outcomes-based activities.
Provides feedback to and gains feedback from, the Solutions Consultant to ensure solution meets customer need.
Business Operations:
Interface with Contract Management and serve as the primary negotiator with the customer for product price discounts
Develops negotiation strategy in collaboration with Financial-Contracting Manager/Director
Develops innovative contracting to support better health outcomes
Communicates actively with Customer Team Leader and customer team members regarding customer priorities, issues, and initiatives
Coordinates with Customer Team Leader counterparts on a very frequent basis to ensure understanding of the customer's business issues and appropriately leverage opportunities to improve alignment between the HCP and Payer customers (identify issues, opportunities and interdependencies between Payers and Providers)
Understands of the interplay of key MC customers and regional stakeholders (provider networks, state and local government, clients (employer and member)) to establish relationships with influencers that will impact the customer relationship and maximize customer value
Qualifications:
Minimum Qualifications:
Bachelor's degree candidates: 3+ years of recent Sales or Account Management experience
Demonstrated leadership skills
Strong business and financial acumen of the external healthcare environment.
Strong interpersonal and communication skills.
Data Analytics capability
Valid Driver's License
Ability to travel and cover the assigned geography to meet with customers in-person
Preferred Qualifications:
Advanced degree candidates (MBA, PharmD, MSN): 3+ years of relevant external health care experience
Negotiation skills
Experience working in cross-functional teams
NOTICE FOR INTERNAL APPLICANTS
In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.
If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.
Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.
Current Employees apply HERE (https://wd5.myworkday.com/msd/d/task/1422$6687.htmld)
Current Contingent Workers apply HERE (https://wd5.myworkday.com/msd/d/task/1422$4020.htmld)
US and Puerto Rico Residents Only:
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here (https://survey.sogosurvey.com/r/aCdfqL) if you need an accommodation during the application or hiring process.
We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
EEOC Know Your Rights (https://www.eeoc.gov/sites/default/files/2022-10/22-088_EEOC_KnowYourRights_10_20.pdf)
EEOC GINA Supplement
Pay Transparency Nondiscrimination (https://www.dol.gov/sites/dolgov/files/OFCCP/pdf/pay-transp_%20English_formattedESQA508c.pdf)
We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.
Learn more about your rights, including under California, Colorado and other US State Acts (https://www.msdprivacy.com/us/en/CCPA-notice/)
U.S. Hybrid Work Model
Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as -remote-.
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status:
Regular
Relocation:
No relocation
VISA Sponsorship:
No
Travel Requirements:
50%
Flexible Work Arrangements:
Remote
Shift:
Not Indicated
Valid Driving License:
Yes
Hazardous Material(s):
n/a
Job Posting End Date:
10/7/2024
*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Job Posting End Date: 10/07/2024
A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Requisition ID: R314626
Job Description
The candidate selected for this hybrid position will have responsibilities as both an Institutional Account Lead (IAL) and Payer Account Executive within the assigned geography and for assigned accounts. The Primary Territory for this position covers Minnesota, South Dakota, and North Dakota, therefore, the percentage of travel required may be less, or more, depending on where a candidate resides in or near the geography.
Primary Activities & Responsibilities include but are not limited to the following:
The IAL Hybrid Institutional Account Lead / Payer Account Executive will manage the business relationship between our Company and assigned customer accounts with the following goals:
Establishing profitable product access within our Company's product strategy
Optimizing Net Sales and Contract Performance across a portfolio of our Company products
Ensuring proper oversight and compliance with our Company policies and exercising appropriate financial stewardship
IAL Primary Activities:
The IAL is responsible for appropriately addressing customer educational needs, interacting with multiple stakeholders within the assigned account to enhance our Company's business relationship with its customers. Each IAL is responsible for the following designated customers as assigned by the HCS Regional Director:
Integrated Delivery Network (IDN, including hospital outpatient and home-infusion if IDN owned)
Federal accounts (including Veterans' Affairs and Military Treatment Facilities)
Corrections
The IAL engages senior Institutional Leadership and is responsible for building trust and credibility with their assigned customers through strong interpersonal relationships, in depth knowledge of the customer's organization, objectives, and business and environmental issues impacting the customer, and in-depth knowledge of the same for our Company. The IAL engages senior Institutional Leadership in the following roles using approved messages and resources:
Pharmacy Service Line, and will serve as lead for the assigned customers across our Company's account teams with overlapping contacts with the customer
Information Technology Departments and will serve as lead for assigned customers across our Company's account teams with overlapping contacts with the customer
Veterans Integrated Service Network (VISN) & VISN Pharmacy Executive within the Veterans'' Affairs system
C-Suite in top assigned accounts
Develops strategic and tactical account plans for assigned accounts. The responsibilities could include the following:
Economic:
Persuasively presenting Group Purchasing Organization (GPO) brand pricing programs to pharmacy leadership
Negotiate direct contracts, where appropriate
Communicating approved financial, health care economic and budget impact models
Operational:
Communicating product access with overlay Field Based Employees (FBE) for assigned IDN accounts
Confirming customer contracts are properly loaded to provide the appropriate contract pricing to the eligible sites of care
Communicating approved information to customer Information Technology departments
Leads account planning for assigned IDN Accounts with other IAM colleagues and FBE's
Manages on going communications to extended Team
Account coordination and access facilitation to overlapping contacts with FBE's
Promote assigned our Company products along entire continuum of care (transition of care) using approved messages and resources
Conducts appropriate business review of account performance to optimize net sales for our Company
Clinical:
Communicate to customers the clinical value proposition for assigned products using approved messages and resources
Appropriately use approved our Company resources to meet customer educational needs
Payer Account Executive Primary Activities
The Payer Account Executive leads the development and implementation of long-term Customer Account Plans. The AE collaborates with the customer team to identify and pursue areas of mutual opportunity (Payers and HCP's) based on better health outcomes for patients. Negotiates contract terms and conditions with the customer. Responsible for P&L (revenue/expenses) for the Payer business.
Customer Account Planning and Management
Accountable for payer customer/portfolio P&L (revenue and expenses); works with other stakeholders (Customer Manager, Directors, Planners) to provide input on resource allocation decisions across customer targets within the larger geography.
Serves as the primary interface and owner for the customer (payer) account and is responsible for the overall (payer) customer experience.
Establishes relationships and maintains a pervasive communication network with the (payer) customer at many levels, including corporate personnel, medical directors in charge of provider networks, quality directors, pharmacy directors, financial directors, COO, CEO.
Conducts business strategy discussions and performance reviews with key customers on a regular basis (plays a significant role in ensuring that the Director of Commercial Operations, Customer Team Leader(s), and understand the (payer) customer's business strategy and support it at the local HCP level)
Proactively meet with (payer) customers to solicit feedback and adjust plans on a regular basis
Develop Customer Account plans aligned with Managed Care and brand strategies over a 3-5-year time horizon. Solicits input from Director of Commercial Operations, Customer Team Leader(s), and other relevant stakeholders to develop the long-term customer plan. Assesses competitor position as part of account plan development.
Identifies, understands and can articulate the key drivers affecting the customers' business including the customer's long-term plan and objectives.
Utilizes customer account strategy to define the objectives of the customer relationship
Identifies potential customer issues and needs (clinical, financial, business)
Collaborates with the customer to identify and pursue areas of mutual opportunity, focused on better health outcomes for patients
Develop innovative contracting to support better health outcomes
Leverages programs and services designed to improve treatment and better outcomes for patients
Represents the voice of the customer and advocates on behalf of the customer
Coordinates and manages the communication process between customers and identified internal or external expert(s) and ensures customer needs are accurately identified and addressed
Proactively identifies the internal and external experts needed to communicate complex clinical and scientific information to customers
Based on customer needs, provide appropriate clinical support and knowledge related to our Company products.
Communicates our Company activities that would be relevant to the Customer including promotional positioning (support of appropriate utilization) and/or provider quality and outcomes-based activities.
Provides feedback to and gains feedback from, the Solutions Consultant to ensure solution meets customer need.
Business Operations:
Interface with Contract Management and serve as the primary negotiator with the customer for product price discounts
Develops negotiation strategy in collaboration with Financial-Contracting Manager/Director
Develops innovative contracting to support better health outcomes
Communicates actively with Customer Team Leader and customer team members regarding customer priorities, issues, and initiatives
Coordinates with Customer Team Leader counterparts on a very frequent basis to ensure understanding of the customer's business issues and appropriately leverage opportunities to improve alignment between the HCP and Payer customers (identify issues, opportunities and interdependencies between Payers and Providers)
Understands of the interplay of key MC customers and regional stakeholders (provider networks, state and local government, clients (employer and member)) to establish relationships with influencers that will impact the customer relationship and maximize customer value
Qualifications:
Minimum Qualifications:
Bachelor's degree candidates: 3+ years of recent Sales or Account Management experience
Demonstrated leadership skills
Strong business and financial acumen of the external healthcare environment.
Strong interpersonal and communication skills.
Data Analytics capability
Valid Driver's License
Ability to travel and cover the assigned geography to meet with customers in-person
Preferred Qualifications:
Advanced degree candidates (MBA, PharmD, MSN): 3+ years of relevant external health care experience
Negotiation skills
Experience working in cross-functional teams
NOTICE FOR INTERNAL APPLICANTS
In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.
If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.
Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.
Current Employees apply HERE (https://wd5.myworkday.com/msd/d/task/1422$6687.htmld)
Current Contingent Workers apply HERE (https://wd5.myworkday.com/msd/d/task/1422$4020.htmld)
US and Puerto Rico Residents Only:
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here (https://survey.sogosurvey.com/r/aCdfqL) if you need an accommodation during the application or hiring process.
We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
EEOC Know Your Rights (https://www.eeoc.gov/sites/default/files/2022-10/22-088_EEOC_KnowYourRights_10_20.pdf)
EEOC GINA Supplement
Pay Transparency Nondiscrimination (https://www.dol.gov/sites/dolgov/files/OFCCP/pdf/pay-transp_%20English_formattedESQA508c.pdf)
We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.
Learn more about your rights, including under California, Colorado and other US State Acts (https://www.msdprivacy.com/us/en/CCPA-notice/)
U.S. Hybrid Work Model
Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as -remote-.
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status:
Regular
Relocation:
No relocation
VISA Sponsorship:
No
Travel Requirements:
50%
Flexible Work Arrangements:
Remote
Shift:
Not Indicated
Valid Driving License:
Yes
Hazardous Material(s):
n/a
Job Posting End Date:
10/7/2024
*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Job Posting End Date: 10/07/2024
A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Requisition ID: R314626
Job Description
Position Description:
Quality Assurance (QA) Senior Specialist - Large Molecule Analytical
We are seeking a quality leader for the role of Senior Specialist, Quality Assurance in the Large Molecule Analytical Sciences Quality group.
Large Molecule Analytical Sciences Quality is part of the Global Biologics Quality Organization and is responsible for technical, operational and strategic quality oversight of a growing and fast-moving large molecule pipeline. LMAS Quality is specifically focused on quality oversight for large molecule drug substance commercial support, Analytical Method Transfers, and analytical product lifecycle activities.
This position is responsible for the management, execution and leadership of quality activities to further the analytical product lifecycle of large molecule programs and to ensure compliance with cGMPs, applicable worldwide regulations, and our Company's requirements for supported area(s).
The Senior Specialist is also responsible for providing assessments to senior management as to the compliance status and risk posture of supported area(s) and guidance on alignment of policies and procedures with current regulatory expectations.
Responsibilities include but are not limited to:
Remain informed of current GMP requirements and industry trends in the large molecule, analytical, areas to applicable worldwide regulations and industry standards. Provide comments on proposed regulations and communicate impacts to client areas using a risk-based, phase-appropriate approach for decision making. Maintain an expert level of knowledge related to specialized area of technical expertise, specifically for analytical areas
Ensure departmental SOPs reflect departmental procedures and the current regulations. Responsible for oversight of SOPs in supported areas and ensure periodic updates, as appropriate
Manage the review and/or approval of analytical GMP documentation for applicable regulatory filings, clinical supply, development, and technology transfer
Represent the department or area on project teams or committees establishing GMP, or quality standards, policies or expectations within our Company
Support a team of professionals to execute on quality oversight deliverables for large molecule drug substance analytical product lifecycle.
Apply technical / quality expertise to help teams remove obstacles, overcome technical
challenges, and make impactful clinical disposition decisions
Review and approve analytical documents
Collaborate with peer leaders in LMAS Quality Assurance to drive strategic initiatives and continuous improvement opportunities
Contribute to establishment and sustainability of a safety first, compliance always culture
Primary skills include but are not limited to:
Strong scientific/technical expertise in the commercial space, coupled with the ability to collaborate with subject matter experts
Strong compliance knowledge and understanding of health authority regulations, and interpretation and application of GMPs within a commercial environment.
Possess and apply large molecule drug substance technical knowledge (such as analytical method / development / transfer); demonstrated ability to share knowledge
Ability to support cross-functional analytical initiatives
Demonstrated experience with quality risk management.
Strong cross-functional teamwork and collaboration skills
Demonstrated ability to communicate (oral and written) effectively with diverse individuals / groups
Position Qualifications :
Education Minimum Requirement:
Required Experience and Skills:
NOTICE FOR INTERNAL APPLICANTS
In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.
If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.
Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.
Current Employees apply HERE (https://wd5.myworkday.com/msd/d/task/1422$6687.htmld)
Current Contingent Workers apply HERE (https://wd5.myworkday.com/msd/d/task/1422$4020.htmld)
US and Puerto Rico Residents Only:
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here (https://survey.sogosurvey.com/r/aCdfqL) if you need an accommodation during the application or hiring process.
We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
EEOC Know Your Rights (https://www.eeoc.gov/sites/default/files/2022-10/22-088_EEOC_KnowYourRights_10_20.pdf)
EEOC GINA Supplement
Pay Transparency Nondiscrimination (https://www.dol.gov/sites/dolgov/files/OFCCP/pdf/pay-transp_%20English_formattedESQA508c.pdf)
We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.
Learn more about your rights, including under California, Colorado and other US State Acts (https://www.msdprivacy.com/us/en/CCPA-notice/)
U.S. Hybrid Work Model
Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as -remote-.
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status:
Regular
Relocation:
No relocation
VISA Sponsorship:
No
Travel Requirements:
10%
Flexible Work Arrangements:
Hybrid
Shift:
1st - Day
Valid Driving License:
No
Hazardous Material(s):
N/A
Job Posting End Date:
10/8/2024
*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Job Posting End Date: 10/08/2024
A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Requisition ID: R314897
Job Description
Our Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network dedicated to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.
The Laboratory Specialist within the Quality Assurance Center of Excellence, with guidance from the Associate Director of Quality Assurance, provides Quality support to Laboratory Operations. The Laboratory Specialist will review laboratory data to ensure that all laboratory data is maintained in accordance with prescribed specifications, procedures and Good Documentation Practices. Data review will include the evaluation of raw data as well as verification of final data integrity (i.e., calculations, adherence to SOPs, BATs, BLPs, Compendia). The Laboratory Specialist will also approve Master Laboratory worksheets prior to issuance to Laboratory Operations.
The Laboratory Specialist will represent quality on the shop floor and perform documentation accuracy and completeness checks while on the shop floor. He or she will work closely with the assigned laboratory in a team environment to ensure timely reviews of documentation and to ensure that documentation is completed right the first time. The Laboratory Specialist will work with Laboratory Operations staff and management to remediate comments and errors in documentation. He or she may also assist Laboratory Operations in conducting investigations associated with laboratory data review. Additionally, the Laboratory Specialist will utilize time on the shop floor to provide Quality coaching and guidance to Laboratory Operations and technology personnel, to enable right first time testing and to ensure compliance with cGMPs and regulatory requirements.
The Laboratory Specialist will also be trained to support Quality Assurance system functions and to support End to End Quality Operations as needed.
Primary Activities:
Present on shop floor to provide compliance support and to provide Quality coaching and guidance to Laboratory Operations and Technology personnel.
Actively participate in the Tier process and use this forum to make concerns visible and to partner with Laboratory Operations on resolution.
Responsible for the independent auditing of laboratory data in alignment with the policies of the department, division, company and other applicable mandates. Maintain the highest level of proficiency in terms of those duties and responsibilities required of auditors.
a. Maintain metrics and tracking associated with these documentation reviews.
b. Complete the remediation activities for all data reviews, to ensure errors are appropriately corrected and documented following departmental and site procedures.
Perform review and approval of qualification documents as needed.
Ensure that laboratory data is in compliance with cGMPs, GLPs and departmental procedures and assay methods and is of the highest integrity, quality and accuracy.
Responsible for approval of Master Laboratory Worksheets prior to issuance to floor for use.
Responsible for issuance of new and reconciliation of completed laboratory worksheets.
Foster a customer service attitude within Laboratory Operations.
Review laboratory notebooks, logbooks and CTU records to ensure accuracy and data integrity compliance.
Assist with training of incoming personnel.
Provide support to Regulatory Agency inspections as needed.
Education Requirements
Bachelor's degree. Degree in life science, scientific discipline or engineering preferred OR M.S. degree in life science, scientific discipline or engineering
In lieu of a Life Sciences or other Bachelor's degree, equivalent direct experience of 6 years of working in a GMP environment, direct experience with documentation review and / or control, or prior experience supporting Regulatory Agency inspections is required.
Experience and Skills
Required
Minimum 1-2 years experience in GMP Manufacturing environment, Pharmaceutical / Biological Quality, Operational, Technical or Regulatory function supporting manufacturing or testing operations, or related industry experience in a laboratory, manufacturing, science related or regulated setting.
Leadership skills connected with strategic and effective verbal and written communication skills
Understanding of cGMPs and of regulatory requirements as they apply to the pharmaceutical field or a related area
Demonstrated interpersonal skills including flexibility, collaboration and inclusion skills and ability to work in a team environment
Titers may be required
Preferred
Demonstrated analytical aptitude, critical thinking skills and problem solving skills.
Demonstrated ability to upskill / coach others.
Strong written and verbal communication skills.
Experience in pharmaceutical laboratory operations or related environment
NOTICE FOR INTERNAL APPLICANTS
In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.
If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.
VETJOBS
#MSJR
Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.
Current Employees apply HERE (https://wd5.myworkday.com/msd/d/task/1422$6687.htmld)
Current Contingent Workers apply HERE (https://wd5.myworkday.com/msd/d/task/1422$4020.htmld)
US and Puerto Rico Residents Only:
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here (https://survey.sogosurvey.com/r/aCdfqL) if you need an accommodation during the application or hiring process.
We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
EEOC Know Your Rights (https://www.eeoc.gov/sites/default/files/2022-10/22-088_EEOC_KnowYourRights_10_20.pdf)
EEOC GINA Supplement
Pay Transparency Nondiscrimination (https://www.dol.gov/sites/dolgov/files/OFCCP/pdf/pay-transp_%20English_formattedESQA508c.pdf)
We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.
Learn more about your rights, including under California, Colorado and other US State Acts (https://www.msdprivacy.com/us/en/CCPA-notice/)
U.S. Hybrid Work Model
Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as -remote-.
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status:
Regular
Relocation:
No relocation
VISA Sponsorship:
No
Travel Requirements:
No Travel Required
Flexible Work Arrangements:
Not Applicable
Shift:
1st - Day
Valid Driving License:
No
Hazardous Material(s):
N/A
Job Posting End Date:
10/7/2024
*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Job Posting End Date: 10/07/2024
A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Requisition ID: R314198
Job Description
Our IT team operates as a business partner proposing ideas and innovative solutions that enable new organizational capabilities. We collaborate internationally to deliver the services and solutions that help everyone to be more productive and enable innovation.
The Senior ServiceNow Engineering position will be responsible for providing tier 3 engineering and operational support for the Enterprise Services - Digital Enablement Value Team with an emphasis on Design, development and deployment. The position responsibilities will include but not limited to the following:
Consult on any proposed utilization of platform
Manage technical aspects of standups which includes estimation and supporting refinement of stories
Execute on defined release strategy for the platform
Responsible for documentation of all procedures to support the development, deployment and use of the platform
Design, Development and Testing of proposed enhancements to ServiceNow
Provide tier 3 (engineering level) support for operations of the platform for ServiceNow.
Coordination of Problem Investigations (includes documenting)
Education Minimum Requirement:
Required Experience and Skills:
Detailed knowledge of ServiceNow platform, hands-on experience in ServiceNow modules (CMDB/ITSM, ITOM Discovery, Portal, Mobile, Portal and Automation)
Minimum of 3 years of ServiceNow engineering/development experience
Excellent verbal and written communication skills
Excellent documentation writing skills
Knowledge of Javascript, Python, API integration, and web services calls
Knowledge of relational Databases and capability to write own queries and create database view/schema
Preferred Experience and Skills:
Knowledge of automation principles, YAML and Ansible
Oracle or other relational databases
Knowledge of other ITSM tools
ITIL Foundation v3 or newer
Agile Development
Our Support Functions deliver services and makes recommendations about ways to enhance our workplace and the experience of working at our organization. Our Support Functions include HR, Finance, Information Technology, Legal, Procurement, Administration, Facilities and Security.
What we offer:
Exciting work in a great team
Competitive salary
Position in leading global healthcare company
Global projects, international environment
Opportunity to learn and grow professionally within the company globally
Hybrid working model
Pension and health insurance contributions
Internal reward system - INSPIRE - with redeeming option as services, goods, or vouchers
NOTICE FOR INTERNAL APPLICANTS
In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.
If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.
Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.
Current Employees apply HERE (https://wd5.myworkday.com/msd/d/task/1422$6687.htmld)
Current Contingent Workers apply HERE (https://wd5.myworkday.com/msd/d/task/1422$4020.htmld)
US and Puerto Rico Residents Only:
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here (https://survey.sogosurvey.com/r/aCdfqL) if you need an accommodation during the application or hiring process.
We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
EEOC Know Your Rights (https://www.eeoc.gov/sites/default/files/2022-10/22-088_EEOC_KnowYourRights_10_20.pdf)
EEOC GINA Supplement
Pay Transparency Nondiscrimination (https://www.dol.gov/sites/dolgov/files/OFCCP/pdf/pay-transp_%20English_formattedESQA508c.pdf)
We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.
Learn more about your rights, including under California, Colorado and other US State Acts (https://www.msdprivacy.com/us/en/CCPA-notice/)
U.S. Hybrid Work Model
Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as -remote-.
The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate's relevant skills, experience, and education.
Expected US salary range:
$111,400.00 - $175,300.00
Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. A summary of benefits is listed here (https://www.benefitsatmerck.com/) .
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status:
Regular
Relocation:
No relocation
VISA Sponsorship:
No
Travel Requirements:
10%
Flexible Work Arrangements:
Hybrid
Shift:
Not Indicated
Valid Driving License:
No
Hazardous Material(s):
na
Required Skills:
Configuration Management (CM), Data Engineering, Data Visualization, Design Applications, Perform Testing, Software Development, System Designs, Systems Development Lifecycle (SDLC), Systems Integration
Preferred Skills:
Automation Engineering, Automation Engineering, Automation Testing Tools, Cloud Integrations, Communication, Continuous Deployment, Database Schemas, Database Systems, Documentations, Employment Strategies, Human Resource Management, Information Technology Strategies, IT Business Management, IT Documentation, IT Executive Management, ITIL Management, IT Performance Management, IT Project Lifecycle, IT Service Delivery, Oracle Business Intelligence Applications (OBIA), Policy Development, Project Integration, Purchasing Management, Relational Database Management System (RDBMS), Relational Database Programming {+ 13 more}
Job Posting End Date:
10/3/2024
*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Job Posting End Date: 10/03/2024
A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Requisition ID: R311671
Job Description
Our IT team operates as a business partner proposing ideas and innovative solutions that enable new organizational capabilities. We collaborate internationally to deliver the services and solutions that help everyone to be more productive and enable innovation.
The Senior ServiceNow Engineering position will be responsible for providing tier 3 engineering and operational support for the Enterprise Services - Digital Enablement Value Team with an emphasis on Design, development and deployment. The position responsibilities will include but not limited to the following:
Consult on any proposed utilization of platform
Manage technical aspects of standups which includes estimation and supporting refinement of stories
Execute on defined release strategy for the platform
Responsible for documentation of all procedures to support the development, deployment and use of the platform
Design, Development and Testing of proposed enhancements to ServiceNow
Provide tier 3 (engineering level) support for operations of the platform for ServiceNow.
Coordination of Problem Investigations (includes documenting)
Education Minimum Requirement:
Required Experience and Skills:
Detailed knowledge of ServiceNow platform, hands-on experience in ServiceNow modules (CMDB/ITSM, ITOM Discovery, Portal, Mobile, Portal and Automation)
Minimum of 3 years of ServiceNow engineering/development experience
Excellent verbal and written communication skills
Excellent documentation writing skills
Knowledge of Javascript, Python, API integration, and web services calls
Knowledge of relational Databases and capability to write own queries and create database view/schema
Preferred Experience and Skills:
Knowledge of automation principles, YAML and Ansible
Oracle or other relational databases
Knowledge of other ITSM tools
ITIL Foundation v3 or newer
Agile Development
Our Support Functions deliver services and makes recommendations about ways to enhance our workplace and the experience of working at our organization. Our Support Functions include HR, Finance, Information Technology, Legal, Procurement, Administration, Facilities and Security.
What we offer:
Exciting work in a great team
Competitive salary
Position in leading global healthcare company
Global projects, international environment
Opportunity to learn and grow professionally within the company globally
Hybrid working model
Pension and health insurance contributions
Internal reward system - INSPIRE - with redeeming option as services, goods, or vouchers
NOTICE FOR INTERNAL APPLICANTS
In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.
If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.
Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.
Current Employees apply HERE (https://wd5.myworkday.com/msd/d/task/1422$6687.htmld)
Current Contingent Workers apply HERE (https://wd5.myworkday.com/msd/d/task/1422$4020.htmld)
US and Puerto Rico Residents Only:
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here (https://survey.sogosurvey.com/r/aCdfqL) if you need an accommodation during the application or hiring process.
We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
EEOC Know Your Rights (https://www.eeoc.gov/sites/default/files/2022-10/22-088_EEOC_KnowYourRights_10_20.pdf)
EEOC GINA Supplement
Pay Transparency Nondiscrimination (https://www.dol.gov/sites/dolgov/files/OFCCP/pdf/pay-transp_%20English_formattedESQA508c.pdf)
We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.
Learn more about your rights, including under California, Colorado and other US State Acts (https://www.msdprivacy.com/us/en/CCPA-notice/)
U.S. Hybrid Work Model
Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as -remote-.
The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate's relevant skills, experience, and education.
Expected US salary range:
$111,400.00 - $175,300.00
Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. A summary of benefits is listed here (https://www.benefitsatmerck.com/) .
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status:
Regular
Relocation:
No relocation
VISA Sponsorship:
No
Travel Requirements:
10%
Flexible Work Arrangements:
Hybrid
Shift:
Not Indicated
Valid Driving License:
No
Hazardous Material(s):
na
Required Skills:
Configuration Management (CM), Data Engineering, Data Visualization, Design Applications, Perform Testing, Software Development, System Designs, Systems Development Lifecycle (SDLC), Systems Integration
Preferred Skills:
Automation Engineering, Automation Engineering, Automation Testing Tools, Cloud Integrations, Communication, Continuous Deployment, Database Schemas, Database Systems, Documentations, Employment Strategies, Human Resource Management, Information Technology Strategies, IT Business Management, IT Documentation, IT Executive Management, ITIL Management, IT Performance Management, IT Project Lifecycle, IT Service Delivery, Oracle Business Intelligence Applications (OBIA), Policy Development, Project Integration, Purchasing Management, Relational Database Management System (RDBMS), Relational Database Programming {+ 13 more}
Job Posting End Date:
10/3/2024
*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Job Posting End Date: 10/03/2024
A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Requisition ID: R311671
Job Description
Our IT team operates as a business partner proposing ideas and innovative solutions that enable new organizational capabilities. We collaborate internationally to deliver the services and solutions that help everyone to be more productive and enable innovation.
The Senior ServiceNow Engineering position will be responsible for providing tier 3 engineering and operational support for the Enterprise Services - Digital Enablement Value Team with an emphasis on Design, development and deployment. The position responsibilities will include but not limited to the following:
Consult on any proposed utilization of platform
Manage technical aspects of standups which includes estimation and supporting refinement of stories
Execute on defined release strategy for the platform
Responsible for documentation of all procedures to support the development, deployment and use of the platform
Design, Development and Testing of proposed enhancements to ServiceNow
Provide tier 3 (engineering level) support for operations of the platform for ServiceNow.
Coordination of Problem Investigations (includes documenting)
Education Minimum Requirement:
Required Experience and Skills:
Detailed knowledge of ServiceNow platform, hands-on experience in ServiceNow modules (CMDB/ITSM, ITOM Discovery, Portal, Mobile, Portal and Automation)
Minimum of 3 years of ServiceNow engineering/development experience
Excellent verbal and written communication skills
Excellent documentation writing skills
Knowledge of Javascript, Python, API integration, and web services calls
Knowledge of relational Databases and capability to write own queries and create database view/schema
Preferred Experience and Skills:
Knowledge of automation principles, YAML and Ansible
Oracle or other relational databases
Knowledge of other ITSM tools
ITIL Foundation v3 or newer
Agile Development
Our Support Functions deliver services and makes recommendations about ways to enhance our workplace and the experience of working at our organization. Our Support Functions include HR, Finance, Information Technology, Legal, Procurement, Administration, Facilities and Security.
What we offer:
Exciting work in a great team
Competitive salary
Position in leading global healthcare company
Global projects, international environment
Opportunity to learn and grow professionally within the company globally
Hybrid working model
Pension and health insurance contributions
Internal reward system - INSPIRE - with redeeming option as services, goods, or vouchers
NOTICE FOR INTERNAL APPLICANTS
In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.
If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.
Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.
Current Employees apply HERE (https://wd5.myworkday.com/msd/d/task/1422$6687.htmld)
Current Contingent Workers apply HERE (https://wd5.myworkday.com/msd/d/task/1422$4020.htmld)
US and Puerto Rico Residents Only:
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here (https://survey.sogosurvey.com/r/aCdfqL) if you need an accommodation during the application or hiring process.
We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
EEOC Know Your Rights (https://www.eeoc.gov/sites/default/files/2022-10/22-088_EEOC_KnowYourRights_10_20.pdf)
EEOC GINA Supplement
Pay Transparency Nondiscrimination (https://www.dol.gov/sites/dolgov/files/OFCCP/pdf/pay-transp_%20English_formattedESQA508c.pdf)
We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.
Learn more about your rights, including under California, Colorado and other US State Acts (https://www.msdprivacy.com/us/en/CCPA-notice/)
U.S. Hybrid Work Model
Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as -remote-.
The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate's relevant skills, experience, and education.
Expected US salary range:
$111,400.00 - $175,300.00
Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. A summary of benefits is listed here (https://www.benefitsatmerck.com/) .
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status:
Regular
Relocation:
No relocation
VISA Sponsorship:
No
Travel Requirements:
10%
Flexible Work Arrangements:
Hybrid
Shift:
Not Indicated
Valid Driving License:
No
Hazardous Material(s):
na
Required Skills:
Configuration Management (CM), Data Engineering, Data Visualization, Design Applications, Perform Testing, Software Development, System Designs, Systems Development Lifecycle (SDLC), Systems Integration
Preferred Skills:
Automation Engineering, Automation Engineering, Automation Testing Tools, Cloud Integrations, Communication, Continuous Deployment, Database Schemas, Database Systems, Documentations, Employment Strategies, Human Resource Management, Information Technology Strategies, IT Business Management, IT Documentation, IT Executive Management, ITIL Management, IT Performance Management, IT Project Lifecycle, IT Service Delivery, Oracle Business Intelligence Applications (OBIA), Policy Development, Project Integration, Purchasing Management, Relational Database Management System (RDBMS), Relational Database Programming {+ 13 more}
Job Posting End Date:
10/3/2024
*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Job Posting End Date: 10/03/2024
A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Requisition ID: R311671
Job Description
Our IT team operates as a business partner proposing ideas and innovative solutions that enable new organizational capabilities. We collaborate internationally to deliver the services and solutions that help everyone to be more productive and enable innovation.
The Senior ServiceNow Engineering position will be responsible for providing tier 3 engineering and operational support for the Enterprise Services - Digital Enablement Value Team with an emphasis on Design, development and deployment. The position responsibilities will include but not limited to the following:
Consult on any proposed utilization of platform
Manage technical aspects of standups which includes estimation and supporting refinement of stories
Execute on defined release strategy for the platform
Responsible for documentation of all procedures to support the development, deployment and use of the platform
Design, Development and Testing of proposed enhancements to ServiceNow
Provide tier 3 (engineering level) support for operations of the platform for ServiceNow.
Coordination of Problem Investigations (includes documenting)
Education Minimum Requirement:
Required Experience and Skills:
Detailed knowledge of ServiceNow platform, hands-on experience in ServiceNow modules (CMDB/ITSM, ITOM Discovery, Portal, Mobile, Portal and Automation)
Minimum of 3 years of ServiceNow engineering/development experience
Excellent verbal and written communication skills
Excellent documentation writing skills
Knowledge of Javascript, Python, API integration, and web services calls
Knowledge of relational Databases and capability to write own queries and create database view/schema
Preferred Experience and Skills:
Knowledge of automation principles, YAML and Ansible
Oracle or other relational databases
Knowledge of other ITSM tools
ITIL Foundation v3 or newer
Agile Development
Our Support Functions deliver services and makes recommendations about ways to enhance our workplace and the experience of working at our organization. Our Support Functions include HR, Finance, Information Technology, Legal, Procurement, Administration, Facilities and Security.
What we offer:
Exciting work in a great team
Competitive salary
Position in leading global healthcare company
Global projects, international environment
Opportunity to learn and grow professionally within the company globally
Hybrid working model
Pension and health insurance contributions
Internal reward system - INSPIRE - with redeeming option as services, goods, or vouchers
NOTICE FOR INTERNAL APPLICANTS
In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.
If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.
Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.
Current Employees apply HERE (https://wd5.myworkday.com/msd/d/task/1422$6687.htmld)
Current Contingent Workers apply HERE (https://wd5.myworkday.com/msd/d/task/1422$4020.htmld)
US and Puerto Rico Residents Only:
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here (https://survey.sogosurvey.com/r/aCdfqL) if you need an accommodation during the application or hiring process.
We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
EEOC Know Your Rights (https://www.eeoc.gov/sites/default/files/2022-10/22-088_EEOC_KnowYourRights_10_20.pdf)
EEOC GINA Supplement
Pay Transparency Nondiscrimination (https://www.dol.gov/sites/dolgov/files/OFCCP/pdf/pay-transp_%20English_formattedESQA508c.pdf)
We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.
Learn more about your rights, including under California, Colorado and other US State Acts (https://www.msdprivacy.com/us/en/CCPA-notice/)
U.S. Hybrid Work Model
Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as -remote-.
The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate's relevant skills, experience, and education.
Expected US salary range:
$111,400.00 - $175,300.00
Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. A summary of benefits is listed here (https://www.benefitsatmerck.com/) .
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status:
Regular
Relocation:
No relocation
VISA Sponsorship:
No
Travel Requirements:
10%
Flexible Work Arrangements:
Hybrid
Shift:
Not Indicated
Valid Driving License:
No
Hazardous Material(s):
na
Required Skills:
Configuration Management (CM), Data Engineering, Data Visualization, Design Applications, Perform Testing, Software Development, System Designs, Systems Development Lifecycle (SDLC), Systems Integration
Preferred Skills:
Automation Engineering, Automation Engineering, Automation Testing Tools, Cloud Integrations, Communication, Continuous Deployment, Database Schemas, Database Systems, Documentations, Employment Strategies, Human Resource Management, Information Technology Strategies, IT Business Management, IT Documentation, IT Executive Management, ITIL Management, IT Performance Management, IT Project Lifecycle, IT Service Delivery, Oracle Business Intelligence Applications (OBIA), Policy Development, Project Integration, Purchasing Management, Relational Database Management System (RDBMS), Relational Database Programming {+ 13 more}
Job Posting End Date:
10/3/2024
*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Job Posting End Date: 10/03/2024
A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Requisition ID: R311671
Job Description
Our Territory Representatives interact face to face with our customers, understand their needs and consult to offer the right solutions. We work collaboratively in field sales teams and play a critical role in supporting our customer centric business model.
This position is responsible for working in their respective territory to understand and identify veterinary clinic, shelter facility, and corporate account customer needs, by selling our Company's Animal Health (AH) Companion Animal product portfolio, supporting pull-through activities relative to the customer strategy, and ensuring that our Company's Animal Health division is viewed as bringing value and technical innovations aligned to our strategic focus - The Science of Healthier Animals. In addition, the Territory Representative demonstrates an understanding of the resources available across our Company's Animal Health division and our Distribution Partners.
This role will cover the Spring, TX Territory. It is required that our sales employees reside in the territory in which they support.
Essential Accountabilities:
Communicates about our company's Animal Health's product portfolio in a way that's meaningful and relevant to each individual customer; customizes discussions and interactions based on understanding of customer's needs.
Primary point of contact for assigned customers, meet with key personnel/decision makers to understand practice structure, business model, key influencers (Owner/Practice Manager/Key Tech/Associate Vet/Front office staff), customer needs and identifies business opportunities.
Develop customer strategy - outlining strategy for interactions/relationship, solutions, partner involvement and potential offerings for customer resulting in solutions, partner involvement and potential offerings for customers resulting in sales opportunities and account sales growth of Animal Health products and services.
Develop territory and specific account plans for all key customers. Partners with National Account Managers, Corporate Account Team, and Distribution Field Partners to maintain strong focus on key accounts and corporate owned clinics to drive occupancy and sales growth.
Work collaboratively to foster a 'One Company' approach to foster our Company's approach to enhance knowledge of the entire Animal Health product portfolio.
Shares with other team members within the region to foster growth and development within the team.
Analyze monthly sales results and manage expenses within budget guidelines.
Identifies and selects programs/services available within Animal Health's available resources to address customer needs and provide education & training opportunities to accounts.
Works with leadership and Field Professional Services to develop and deliver relevant offerings that address desired customer needs.
Develop current understanding of Animal Health products, industry trends and competitor landscape.
Articulates and communicates relevant customer, industry, product, and market trends appropriately through the organization.
Responsible for developing and meeting learning and development objectives agreed upon with leadership.
Background & Education
Required Skills/Abilities:
Excellent interpersonal/communication and presentation skills
Demonstrated motivation and focus on achieving measurable, tangible results.
Commitment to collaboration as the normal mode of working and resolving problems.
Demonstrated understanding of positions' contribution to the business goals and willingness to adopt changes to current processes to meet customer needs.
Demonstrated ability to independently understand customers' evolving needs and expectations and combines with knowledge of customers' organization and culture to drive results.
Effective application of selling techniques and approaches, simultaneously managing multiple customers/accounts at different stages of the sales process, articulating the value of Animal Health products using approved resources.
Demonstrated ability to identify, develop and manage a diverse mix of accounts independently within a territory, including some complex accounts, and to develop plans based on unique opportunities and customer needs.
Proficient computer skills including working knowledge of Word, Excel and PowerPoint and the ability to use an iPad.
Ability to work both independently and as part of a team.
Ability to travel overnight and some weekend activity.
Preferred Skills/Abilities
Sales experience and/or experience within the Animal Health Industry.
Knowledge of animal health biological and pharmaceutical products.
Understanding or experience working with distribution.
Multi-lingual fluency preferred, particularly in Spanish.
#MSJR
#NSN2024
CABUEXP24
NOTICE FOR INTERNAL APPLICANTS
In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.
If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separationpackage, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.
Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.
Current Employees apply HERE (https://wd5.myworkday.com/msd/d/task/1422$6687.htmld)
Current Contingent Workers apply HERE (https://wd5.myworkday.com/msd/d/task/1422$4020.htmld)
US and Puerto Rico Residents Only:
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here (https://survey.sogosurvey.com/r/aCdfqL) if you need an accommodation during the application or hiring process.
We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
EEOC Know Your Rights (https://www.eeoc.gov/sites/default/files/2022-10/22-088_EEOC_KnowYourRights_10_20.pdf)
EEOC GINA Supplement
Pay Transparency Nondiscrimination (https://www.dol.gov/sites/dolgov/files/OFCCP/pdf/pay-transp_%20English_formattedESQA508c.pdf)
We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.
Learn more about your rights, including under California, Colorado and other US State Acts (https://www.msdprivacy.com/us/en/CCPA-notice/)
U.S. Hybrid Work Model
Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as -remote-.
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status:
Regular
Relocation:
No relocation
VISA Sponsorship:
No
Travel Requirements:
25%
Flexible Work Arrangements:
Remote
Shift:
1st - Day
Valid Driving License:
Yes
Hazardous Material(s):
n/a
Job Posting End Date:
09/30/2024
*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Job Posting End Date: 09/30/2024
A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Requisition ID: R315514