Senior External Manufacturing Specialist
Core
Serve as the operational contact for contract manufacturing and business partner sites, coordinating external manufacturing activities, scheduling batches, and ensuring cGMP compliance.
Role type
Senior External Manufacturing Specialist
Builds
Drug product manufacturing operations at contract and business partner sites
Domain
Biopharmaceutical manufacturing / cGMP compliance
Deliverable
client delivery
Required skills
cGMP manufacturing operations, batch scheduling, regulatory compliance (FDA/ICH/EU), master batch record review, sub-team leadership, continuous process improvement
Preferred skills
Excel, PowerPoint, Visio, Word
Responsibilities
Coordinate external manufacturing activities at contract sites, schedule batches and manage material supply, liaise between internal departments and external partners, lead sub-team in process improvements, support investigations of external manufacturing operations, monitor cGMP compliance at partners, review pre-production and executed batch records
Seniority
Senior, hands-on IC
