Director, CMC External Manufacturing
Core
Lead and manage outsourced manufacturing operations (CDMOs) for drug substance and drug product to ensure compliant, timely supply of clinical materials for a clinical-stage biotech.
Role type
Director, External Manufacturing (CMC)
Builds
Clinical supply of drug substance (API) and drug product for CNS disorder therapies
Domain
Biopharmaceuticals / CMC / Outsourced Manufacturing
Required skills
CMC strategy, CDMO management, technology transfer, GMP compliance, supply chain optimization, vendor negotiation, risk mitigation, project management
Preferred skills
Advanced degree in Chemistry/Chemical Engineering/Pharmaceutical Sciences, experience with commercial-scale manufacturing
Technologies
GMP, GDP, ICH guidelines
Responsibilities
Lead strategy and selection of CDMOs; oversee technology transfer, scale-up, and validation; manage end-to-end supply chain and inventory; negotiate contracts with suppliers; ensure GMP compliance and performance monitoring of external partners.
Seniority
Director, strategic leadership with hands-on operational oversight