Manager, External ManufacturingPosition SummaryWe are seeking a Manager, External Manufacturing, to be responsible for managing external manufacturing partners and clinical supply activities supporting the company's cell therapy pipeline. The role will serve as the primary point of contact for assigned CMOs/CDMOs and critical suppliers while also leading clinical supply planning, inventory management, and distribution activities.
This role will ensure manufacturing capacity, materials, clinical supply, quality, and timelines are aligned with program needs. The Manager will work closely with Technical Operations, CMC, Quality, Clinical Operations, Procurement, Regulatory, and other cross-functional teams to manage external partners, anticipate supply risks, and ensure reliable and compliant clinical supply. This is a hybrid office role for our South San Francisco, CA headquarters.
Key Responsibilities- Manage day-to-day relationships with CMOs/CDMOs and critical suppliers, including schedules, deliverables, performance, costs, and invoices.
- Develop and maintain manufacturing and clinical supply plans aligned with clinical timelines, enrollment forecasts, demand, inventory, lead times, and product expiry.
- Coordinate manufacturing activities, campaigns, technology transfers, materials, shipments, and deliverables with external partners.
- Forecast clinical supply requirements and manage inventory, safety stock, reorder points, product expiry, and potential stockout or excess supply risks.
- Coordinate procurement and availability of critical raw materials, components, and manufacturing supplies.
- Coordinate clinical supply distribution from CMOs/CDMOs to depots and clinical sites, including cold-chain and international shipments.
- Monitor CMO/CDMO and supplier performance and proactively identify and mitigate risks related to capacity, materials, quality, lead times, cost, and supply continuity.
- Partner with Technical Operations, CMC, and Quality on supplier qualification, deviations, changes, investigations, audits, inspections, and other GMP activities.
- Ensure external manufacturing and clinical supply activities comply with applicable GMP, GCP, regulatory, and company requirements, including appropriate controls for clinical trial blinding where applicable.
- Maintain accurate, audit-ready SOPs, trackers, records, and documentation related to manufacturing, inventory, shipments, reconciliations, and supply activities.
- Partner with Clinical Operations, Logistics, Regulatory, and other stakeholders on site activation, enrollment, IRT/IVRS/IWRS parameters, resupply, import/export, and country-specific supply requirements.
- Develop contingency plans and alternate-source strategies for critical materials, manufacturing activities, and clinical supply needs.
- Provide regular updates on manufacturing and clinical supply status, risks, issues, and mitigation plans to cross-functional and program leadership.
- Occasional travel is required to sites for face-to-face meetings with contractors and/or vendors.
Qualifications- Bachelor's degree in Supply Chain, Operations, Life Sciences, Engineering, Business, or a related field; advanced degree preferred.
- 8+ years of experience in biotechnology, pharmaceutical, cell therapy, biologics, or another GMP-regulated environment, with meaningful experience in both external manufacturing and clinical supply.
- Demonstrated experience managing CMOs/CDMOs and external suppliers, including manufacturing schedules, material planning, performance management, and issue resolution.
- Strong experience with clinical supply planning, forecasting, inventory management, clinical distribution, and supply risk management.
- Experience supporting clinical-stage programs and working cross-functionally with Technical Operations/CMC, Quality, Clinical Operations, Regulatory, Procurement, and Logistics.
- Cell therapy, gene therapy, biologics, or other advanced therapy experience strongly preferred.
- Working knowledge of GMP, GCP, clinical supply-chain processes, and pharmaceutical/biotechnology manufacturing operations.
- Experience with IRT/IVRS/IWRS systems and clinical supply parameters preferred.
- Strong project management, analytical, organizational, and communication skills, with the ability to manage multiple external partners and competing priorities.
- Demonstrated ability to anticipate supply risks, develop mitigation and contingency plans, and drive complex issues through resolution in a fast-paced environment.
This job description is not exhaustive and not intended to cover all activities of the position. Duties, responsibilities and activities may change, or new ones may be assigned at any time with or without notice.
