Manager, Outsourced Manufacturing
Core
Ensuring uninterrupted supply of clinical and commercial small molecule drug substances by executing manufacturing campaigns within a global external contract manufacturing network.
Role type
Manager, Global External Manufacturing (Small Molecule Drug Substance)
Builds
Clinical and commercial supply of small molecule drug substances
Domain
Pharmaceutical manufacturing / Contract Manufacturing Organizations (CMO)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
cGMP compliance, supplier performance management, technology transfer coordination, change control management, cross-functional collaboration, continuous improvement
Preferred skills
Drug substance manufacturing experience, CMO landscape knowledge, worldwide regulatory requirements understanding
Technologies
cGMP, Master Production Record, Material Review Board
Responsibilities
Execute network strategy and tactical execution with external manufacturers, coordinate inter- and intra-company technical transfers, manage CMOs to ensure adherence to registered processes, resolve manufacturing and compliance issues, foster continuous improvement of production processes, represent manufacturing on cross-functional teams
Seniority
Manager, tactical execution & supplier management
