Senior Manager, External Manufacturing

Role: Senior Manager, External Manufacturing overseeing external CDMO operations for gene-editing and late-stage cell therapy products, ensuring supply chain continuity and compliance. Responsibilities: manage external manufacturing relationships, lead cross-functional Joint Management Teams, establish manufacturing agreements, oversee quality release processes, monitor KPIs, and drive continuous improvement initiatives. Collaborate with Quality Assurance, Supply Chain, and Finance teams to ensure capacity planning, budget management, and timely product delivery. Requirements: Bachelor's in science or engineering, 8+ years GMP pharmaceutical manufacturing experience; biologics or cell therapy experience preferred; knowledge of RNA/protein manufacturing, CMC regulatory submissions, and late-stage clinical or commercial processes highly desirable. Skills: leadership, strong communication, organizational, and financial acumen; experience managing external CMO relationships; ability to work independently and travel up to 20%. High-Value: biologics/cell therapy manufacturing, gene editing, late-stage clinical/regulatory experience, GMP compliance, cross-functional leadership, US work authorization, remote/hybrid options.