Associate Director, Engineering

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 with a minimum of 5 years of relevant experience.

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.