Senior Manager, CMC Operations

Role: Senior Manager, CMC Operations within Early Phase Development & Manufacturing, responsible for overseeing external development and manufacturing activities from IND-enabling studies through Phase 2 across multiple programs. Key duties include developing integrated project plans, managing CDMO partnerships, ensuring delivery on quality, cost, and timelines, and optimizing business processes and governance frameworks. Responsibilities also involve cross-functional coordination with R&D, Quality, Supply Chain, and Finance to facilitate seamless transition into GMP operations, managing risks, dependencies, and budget spend. Requirements: Bachelor’s in Chemical Engineering, Chemistry, or related field; 8+ years (BS) or 5+ years (MS/PhD) in biotech/pharma CMC development and manufacturing, with strong expertise in early-phase operations and external partnerships. Preferred skills include experience with governance, risk management, and technical integration. HighValue: focus on early-stage biologics or small molecules, IND-enabling to Phase 2, external CDMO management, cross-functional collaboration, operational framework development. Work setup: information not specified; likely hybrid or on-site based on nature of external partnerships.