Associate Director, CMC, Drug Substance

Role Associate Director, CMC, Drug Substance, to oversee development and manufacturing of small molecule APIs for clinical trials in a biopharma setting. Responsibilities manage API process development and cGMP manufacturing campaigns via CDMOs evaluate and select vendors facilitate technology transfer collaborate with supply chain to align manufacturing plans with clinical demand author and review regulatory CMC documents for IND/NDA/MAA submissions participate in audits manage API budgets Requirements PhD in Chemistry or related field with 10+ years of pharma/biotech experience proven track record managing API development at CDMOs expertise in cGMP regulations authoring regulatory sections vendor management Preferred experience with global filings strong communication skills ability to travel up to 15% experience in virtual manufacturing settings HighValue focus on small molecule APIs late-stage development regulatory filings international collaboration API process tech transfer WorkSetup based in Boston, MA, with potential remote options; international travel may be required. #J-18808-Ljbffr