Manager, Fill Finish Drug Product Manufacturing - Weekend Operations - 2nd Shift
Core
Managing day-to-day fill & finish manufacturing operations, including formulation, filtration, filling, and troubleshooting in a validated cGMP environment.
Role type
Manager, Drug Product Manufacturing (Fill & Finish)
Builds
Drug product batches for biopharma clients
Domain
Biopharmaceutical manufacturing / Fill & Finish
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work -> product features (drug product batches)
Required skills
cGMP compliance, regulatory requirements, chemistry (fillers and processes), QAD, Master Control, LIMS, RAM
Preferred skills
None stated
Technologies
QAD, Master Control, LIMS, RAM
Responsibilities
Oversee daily operations including formulation, filtration, filling, and troubleshooting; conduct batch record review and generation; coordinate strategic planning and scheduling with DP manufacturing; manage client interactions and meetings; lead internal investigations (deviations, CAPA, product quality); plan facility shutdowns, maintenance, and media fills; respond to audits and regulatory inspections; coach, mentor, and develop the team; set performance standards and manage employee engagement.
Seniority
Manager, supervisory level