Director, Drug Product Manufacturing
Listed on 2026-10-12
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Pharmaceutical
Pharmaceutical Manufacturing, Regulatory Compliance Specialist
Lead drug product manufacturing for clinical and commercial biopharmaceutical programs, overseeing external CMO/CDMO partnerships, technology transfer, process validation, and manufacturing readiness.
Responsibilitiesdevelop manufacturing strategies, manage performance, ensure integration with supply chain, support regulatory submissions, and maintain cGMP compliance; lead risk mitigation and facilitate cross-functional collaboration.
RequirementsPhD 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.
High Valuebiologics 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.
Work Setuphybrid in Norwood, Massachusetts.
We have an opening for a Director, Drug Product Manufacturing in Norwood, MA, United States within Management & Operations, Engineering.
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