Senior Manager, Commercial Manufacturing, Drug Substance
Core
Lead commercial manufacturing operations for small molecule drug substances, overseeing external CDMO partners, technology transfer, and supply continuity for oncology medicines.
Role type
Senior Manager, Commercial Manufacturing (Drug Substance)
Builds
Commercial supply of small molecule drug substances (APIs) for oncology treatments.
Domain
Pharmaceutical manufacturing / Oncology
Required skills
Small molecule drug substance manufacturing, Technology transfer, Process validation, Commercial manufacturing, Continued Process Verification (CPV), Lifecycle management, CDMO management, GMP compliance, Capacity planning, Supply chain strategy
Preferred skills
Strategic leadership, Business acumen, Cross-functional team development, Operational excellence
Technologies
GMP, CDMO networks, Manufacturing execution systems (implied)
Responsibilities
Oversee commercial drug substance manufacturing activities including PPQ, CPV, and lifecycle management; Develop and execute manufacturing capacity strategies; Assess and expand manufacturing network capabilities; Mitigate manufacturing and supply risks; Support technology transfer and validation at external sites; Manage CDMO selection and onboarding; Write and approve technical manufacturing documentation; Partner cross-functionally for regulatory submissions and launch readiness.
Seniority
Senior Manager, hands-on leadership