Senior Manager, Manufacturing

Role: Senior Manager, Drug Substance Manufacturing overseeing late-stage and commercial API production for small molecules. Responsibilities: manage external GMP manufacturing, supervise non-GMP raw material supply, lead process transfer, validation, deviation investigations, change control, and continuous improvement; collaborate with Quality, Regulatory, Supply Chain, and Process Chemistry teams; ensure compliance with cGMP, ICH guidelines, and regulatory submissions. Requirements: Master’s or Ph.D. in Chemistry, Chemical Engineering, or related; 8+ years (Master’s) or 5+ years (Ph.D.) in small molecule API manufacturing, including late-phase development, process validation, and regulatory support; experience with CMO management, raw material sourcing, impurity control, and process transfer. HighValue: small molecule APIs, late-phase (clinical/validation/launch), cGMP compliance, process validation, regulatory filings (NDA/MAA). WorkSetup: US-based, full-time; no specific travel mentioned.