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
External Manufacturing Specialist (Drug Product)
Builds
Drug product batches via contract manufacturers
Domain
Biopharmaceutical manufacturing / Contract Manufacturing Operations
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
cGMP manufacturing operations, regulatory compliance (FDA, ICH, EU), batch record review, contract manufacturer liaison, data analysis, process improvement, audit support
Preferred skills
Experience with CMOs/CROs, formulation to final package knowledge, Excel/Visio/Oracle proficiency
Technologies
Oracle, Excel, PowerPoint, Visio, Word
Responsibilities
Coordinate external manufacturing activities at contract sites, liaise between internal departments and external partners, lead sub-teams in continuous process improvements, support investigations of external manufacturing operations, review pre-production and executed batch records, author documents and procedures, support audit operations
Seniority
Mid-level, hands-on operational specialist