Sr. Manager, External Manufacturing

Role: Senior Manufacturing & CMC Lead overseeing external Contract Manufacturing Organizations (CMOs) for commercial biologics or small molecules, ensuring supply chain reliability and compliance. Responsibilities: manage day-to-day CMO operations, develop governance frameworks, optimize vendor performance, oversee technical aspects like technology transfer, process validation, and lifecycle management; ensure adherence to cGMP, support regulatory submissions, and facilitate cross-functional collaboration with Supply Chain, Quality, Regulatory, and Commercial teams. Requirements: Bachelor's in Chemical Engineering, Pharmacy, or Chemistry; 7+ years in pharmaceutical manufacturing or CMC, with demonstrated experience managing external CMOs for commercial products; strong knowledge of cGMP, process validation, and tech transfer. Preferred: advanced degrees, experience in small-molecule (oral/sterile) manufacturing, regulatory inspection support, and supply chain management. HighValue: commercial scale biologics or small-molecule manufacturing, cGMP compliance, vendor governance, lifecycle management, regulatory submissions, external CMO oversight. WorkSetup: not specified.