Associate Director, Manufacturing Technical Project Management (MSAT)

Role: Lead technical project management within MSAT for pharmaceutical manufacturing, primarily focusing on drug substance (API) initiatives at external CMOs. Objectives include ensuring disciplined execution, cross-functional alignment, and timely delivery of technical projects supporting commercial supply readiness and lifecycle changes. Responsibilities involve developing integrated project plans, managing CMO interfaces, overseeing technology transfer, process changes, and end-to-end CMC projects across drug substance, drug product, and supply chain. The role entails leading and developing a team of MSAT project managers, coordinating technical deliverables, managing risks and issues, and ensuring compliance with GMP standards. Qualifications include a Bachelor’s in Engineering, Chemistry, or related fields, with 10-12 years in pharmaceutical manufacturing, MSAT, or technical project management, with demonstrated experience managing external CMO projects. Preferred skills are expertise in small-molecule drug substance manufacturing, GMP-regulated project execution, and team leadership in regulated environments; PMP certification is a plus. High-value specifics include API-focused projects, support for Phase 3 outcomes trials, and collaboration across R&D, Quality, Supply Chain, and Regulatory teams. The position reports to MSAT leadership, does not own regulatory or medical strategy, and is based in a hybrid work setup, with a focus on building scalable project management capabilities within a regulated biopharma environment.