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Job Description

Associate Director, Raw Material & Release Management

Within Planning and Manufacturing Systems (PAMS) in our Research Division's Bioprocess Clinical Manufacturing and Technology (BCMT), the Associate Director, Raw Material & Release Management (P4) is the single accountable lead for end-to-end management of raw materials, culture media/buffers, excipients, single-use components, and GMP supplies that support pilot-scale GMP manufacture of clinical biologic bulk (vaccines, therapeutic proteins, monoclonal antibodies). Based in the Biologics Pilot Plant (BPP) / VAX PR&D environment, this role combines advanced materials planning and procurement with release management, validated system stewardship, and cross‑functional leadership to ensure compliant, timely, and cost‑effective material readiness for multiple clinical campaigns.

The role operates at the intersection of Manufacturing, Process Development, Quality/Release, Procurement, Manufacturing and Research divisions network, Biological Support Operations (BSO), and external suppliers. The Associate Director is responsible for strategy and execution across sourcing, inventory, release, documentation, and continuous improvement, and will represent material readiness risks and mitigations to senior stakeholders.

Key Responsibilities:

• Own end‑to‑end lifecycle for raw materials, culture media/buffers, excipients, single‑use components and GMP supplies for pilot‑scale clinical bulk manufacturing: forecasting, prioritization, sourcing (internal Manufacturing and Research divisions and external vendors), procurement, receiving, storage, distribution, and disposition.

• Lead release activities: author/review release documentation, coordinate testing submissions and lab turnaround, and ensure timely product availability for clinical campaign timelines.

• Manage validated systems and data integrity for release and inventory workflows (SAP, RLIMS2, Veeva, MEDS): define requirements, support enhancements, and act as SME liaison between end users and Quality.

• Translate regulatory and quality expectations (cGMP, CFR, data integrity/ALCOA+) into procedures and system controls; partner with Quality to define acceptance criteria, manage deviations/CAPAs, and support filings/audits.

• Coordinate culture media/buffer manufacture (internal and external): forecasting, scheduling, batch documentation, and lead laboratory studies with Process Development when required to define critical parameters.

• Maintain and optimize inventory visibility and storage capacity (including single‑use), implement replenishment strategies, and drive mitigation plans for shortages, supplier issues, or quality holds.

• Author and enforce SOPs, release protocols, work instructions, and change‑control documentation using validated repositories and tools.

• Lead cross‑functional projects: develop charters/scopes/schedules/resource plans/risk registers/budgets; manage vendors, run status meetings, and report KPIs and risks to stakeholders.

• Provide production support: coordinate incident management for material shortages or release failures, perform root cause analysis, and implement corrective/preventive actions with Quality and Procurement.

• Drive continuous improvement initiatives to reduce lead times, improve inventory turns, reduce cost, and enhance compliance (Lean/Six Sigma principles).

• Mentor and provide technical guidance to planners and release staff; participate in network benchmarking and standardization across sites.

• Must be available for occasional off‑shift or overtime work to support critical campaign execution.

Education Requirements :

• BS, MS, or MBA degree in Engineering or Biological Sciences with a minimum of 7 years of relevant experience within the Pharmaceutical or Biopharmaceutical industry.

Required Experience and Skills:

• Demonstrated experience in raw material planning/procurement and inventory management for GMP manufacturing is required, with SAP experience.

• Proven experience in release management for raw materials and culture media, including generation and review of release documentation, coordination with testing laboratories, and disposition decisions, is essential.

• Serve as primary point of contact for Supplier Change Notifications: track, review, assess impact, coordinate supplier/internal mitigation or qualification activities, and document outcomes in change‑control systems.

• Practical experience with validated systems and document repositories (for example RLIMS2, SAP, Veeva, MEDS)

• The candidate must have strong knowledge of regulatory requirements governing clinical supply manufacture and release (cGMP, CFR) and data integrity best practices.

• The role requires proven project management and stakeholder management skills—scope, schedule, resource, risk and issue management—and comfort reporting to senior stakeholders.

• Excellent analytical, problem‑solving skills, strong attention to detail, advanced Excel capabilities, and strong interpersonal and communication skills capable of influencing cross‑functional teams in a fast‑paced environment are also required.

• The candidate must be able to work effectively in a dynamic environment where priorities constantly shift, quickly reprioritizing tasks and decisions to support time-sensitive clinical manufacturing campaigns.

Preferred Qualifications :

• Preferred experience includes work in biologics pilot-scale or aseptic manufacturing supporting clinical campaign timelines, experience managing single-use technology inventory and supply chains, and experience with supplier qualification and vendor management for biological raw materials.

• Formal training or certification in Lean/Six Sigma, PMP, or GAMP is desirable.

• Experience supervising or mentoring staff and leading cross-functional teams is preferred.

PRD #PRD

Required Skills:

Adaptability, Adaptability, Chemical Engineering, Customer-Focused, Data-Driven Decision Making, Data Integrity, Drug Product Development, Estimation and Planning, GMP Compliance, Inventory Management, Manufacturing Quality Control, Monoclonal Antibodies, Pharmaceutical Process Development, Polyclonal Antibody Production, Process Control Automation, Process Optimization, Procurement, Product Formulation, Production Support, Project Management, Release Documentation, Release Management, Safety Compliance, Stakeholder Management, Strategic Thinking {+ 2 more}

Preferred Skills:

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.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. 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​

We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills 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, Monday - 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 salary range for this role is

$142,400.00 - $224,100.00

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits .

You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance

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:

Not Applicable

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

N/A

Job Posting End Date:

04/29/2026

*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: R393523