Associate Director, Engineering
Merck
2 hours ago
On-site
West Point, PA
Operations
Associate Director, Raw Material & Release Management
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 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.
- 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 CAPA with Quality and Procurement.
- Drive continuous improvement (Lean/Six Sigma) to reduce lead times, improve inventory turns, reduce cost, and enhance compliance.
- Mentor planners and release staff; participate in network benchmarking and standardization.
- Be available for occasional off-shift or overtime to support critical campaign execution.
Education Requirements
- BS, MS, or MBA in Engineering or Biological Sciences; minimum 7 years relevant industry experience in Pharmaceutical/Biopharmaceuticals, including minimum 5 years relevant experience.
Required Experience And Skills
- Raw material planning/procurement and inventory management for GMP manufacturing; SAP experience required.
- Release management experience for raw materials and culture media (release documentation, lab coordination, disposition decisions).
- Primary point of contact for Supplier Change Notifications (track/review/assess impact, coordinate mitigation/qualification, document outcomes in change control).
- Experience with validated systems and document repositories (e.g., RLIMS2, SAP, Veeva, MEDS).
- Knowledge of regulatory requirements for clinical supply manufacture/release (cGMP, CFR) and data integrity best practices.
- Project management and stakeholder management skills (scope/schedule/resource/risk/issue management) with comfort reporting to senior stakeholders.
- Strong analytical/problem-solving skills, attention to detail, advanced Excel, and communication/interpersonal skills to influence cross-functional teams.
- Ability to work in a dynamic environment with shifting priorities.
Preferred Qualifications
- Biologics pilot-scale or aseptic manufacturing experience supporting clinical timelines; single-use inventory/supply chain management; supplier qualification and vendor management for biological raw materials.
- Lean/Six Sigma, PMP, or GAMP training/certification.
- Experience supervising/mentoring staff and leading cross-functional teams.
Application
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub for current employees). Application deadline is listed on the posting.
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 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.
- 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 CAPA with Quality and Procurement.
- Drive continuous improvement (Lean/Six Sigma) to reduce lead times, improve inventory turns, reduce cost, and enhance compliance.
- Mentor planners and release staff; participate in network benchmarking and standardization.
- Be available for occasional off-shift or overtime to support critical campaign execution.
Education Requirements
- BS, MS, or MBA in Engineering or Biological Sciences; minimum 7 years relevant industry experience in Pharmaceutical/Biopharmaceuticals, including minimum 5 years relevant experience.
Required Experience And Skills
- Raw material planning/procurement and inventory management for GMP manufacturing; SAP experience required.
- Release management experience for raw materials and culture media (release documentation, lab coordination, disposition decisions).
- Primary point of contact for Supplier Change Notifications (track/review/assess impact, coordinate mitigation/qualification, document outcomes in change control).
- Experience with validated systems and document repositories (e.g., RLIMS2, SAP, Veeva, MEDS).
- Knowledge of regulatory requirements for clinical supply manufacture/release (cGMP, CFR) and data integrity best practices.
- Project management and stakeholder management skills (scope/schedule/resource/risk/issue management) with comfort reporting to senior stakeholders.
- Strong analytical/problem-solving skills, attention to detail, advanced Excel, and communication/interpersonal skills to influence cross-functional teams.
- Ability to work in a dynamic environment with shifting priorities.
Preferred Qualifications
- Biologics pilot-scale or aseptic manufacturing experience supporting clinical timelines; single-use inventory/supply chain management; supplier qualification and vendor management for biological raw materials.
- Lean/Six Sigma, PMP, or GAMP training/certification.
- Experience supervising/mentoring staff and leading cross-functional teams.
Application
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub for current employees). Application deadline is listed on the posting.