Principal External Manufacturing Specialist (Drug Product)
Core
Oversees external contract manufacturing operations (filling, assembly, packaging) for drug products, ensuring cGMP compliance and timely delivery.
Role type
Principal External Manufacturing Specialist (Drug Product)
Builds
External manufacturing batches and finished products for Regeneron
Domain
Biopharmaceutical manufacturing / Contract Manufacturing Organizations (CMOs)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
cGMP compliance, FDA regulations, ICH guidelines, EU regulations, batch record review, audit support, data trend analysis, cross-functional liaison, process improvement leadership, travel management
Preferred skills
German or French (oral and written), Excel, PowerPoint, Visio, Oracle
Responsibilities
Coordinate external manufacturing activities at contract sites, lead sub-teams in continuous process improvements, support investigations concerning external manufacturing, perform reviews of pre-production and executed batch records, author documents and procedures, support internal and external audit operations, analyze data for trends and potential issues
Seniority
Principal, hands-on IC with strategic guidance
