Senior Director, Drug Product Manufacturing

Role: Senior Director of Drug Product Manufacturing overseeing clinical and commercial drug product activities. Responsibilities: lead manufacturing strategy, manage external CMOs/CDMOs, oversee technology transfer, process validation, and commercial readiness; collaborate with Regulatory on filings and inspections; ensure cGMP compliance, manage supply chain integration, and mitigate manufacturing risks; support transition from clinical to commercial scale. Qualifications: PhD in Chemical Engineering, Pharma Sciences, Chemistry, or related; 15+ years in pharma/biotech manufacturing, with significant experience in late-stage development, process validation, regulatory support, and supply chain management; strong CMC regulatory expertise; proven leadership managing external manufacturing partners. Preferred: biologics and small molecule manufacturing experience, NDA/BLA/MAA support, and oncology or metabolic disease expertise. Biopharma specifics: focus on biologics or small molecules, late-stage development, regulatory submissions, commercial manufacturing, and supply chain planning. Collaboration with Regulatory, Quality, and cross-functional teams; based hybrid in Norwood, MA, with no travel specified.