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

• Collaboration with Regulatory, Quality, and cross-functional teams;

Location

• based hybrid in Norwood, MA, with no travel specified.

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