Director, Drug Product Manufacturing

Role: Lead drug product manufacturing for clinical and commercial biopharmaceutical programs, overseeing external CMO/CDMO partnerships, technology transfer, process validation, and manufacturing readiness. Responsibilities: develop manufacturing strategies, manage performance, ensure integration with supply chain, support regulatory submissions, and maintain cGMP compliance; lead risk mitigation and facilitate cross-functional collaboration. Requirements: PhD in Chemical Engineering, Pharmaceutical Sciences, Chemistry, Biochemistry, or related; 15+ years in pharma/biotech manufacturing, with extensive experience managing outsourced production, process validation, and regulatory support; strong knowledge of cGMP and supply chain management. HighValue: biologics and small molecules experience preferred; involvement in NDA/BLA/MAA processes; expertise supporting late-stage development, regulatory approvals, and commercial launch; experience in oncology and metabolic diseases advantageous. WorkSetup: hybrid in Norwood, Massachusetts.