Director/Senior Director, CMC, Drug Substance

Role: Senior Director/Director, CMC Drug Substance, overseeing small molecule API development and manufacturing for late-stage clinical trials. Responsibilities: manage API development, oversee CDMO selection and technical transfer, ensure regulatory compliance, author and review CMC documentation, and coordinate with supply chain and cross-functional teams. Requirements: PhD in Chemistry, Chemical Engineering, or related field with at least 10 years' pharma/biotech experience, proven track record managing API manufacturing at CDMOs, and experience with NDA/MAA filings. HighValue: focus on cGMP APIs for clinical and commercial use, strong expertise in regulatory submissions, CDMO management, and API process technology transfer. Work Setup: hybrid Boston MA with some international travel; remote options considered for exceptional candidates.