Manager, Drug Product Manufacturing - 2nd Shift
Core
Manage day-to-day fill & finish manufacturing operations, including formulation, filtration, and filling, in a validated cGMP environment.
Role type
Manager, Drug Product Manufacturing
Builds
Drug product batches for biopharma clients
Domain
Biopharmaceutical manufacturing
Required skills
cGMP compliance, regulatory requirements, chemistry (fillers and processes), QAD, Master Control, LIMS, RAM
Preferred skills
Leadership, team coaching, strategic planning, audit response
Technologies
QAD, Master Control, LIMS, RAM
Responsibilities
Oversee daily operations including formulation, filtration, filling, and troubleshooting; conduct batch record review and generation; manage strategic planning and scheduling; handle client calls and meetings; lead internal investigations (deviations, CAPA, OOS); plan facility shutdowns and maintenance; respond to audits and regulatory inspections; coach and develop team members.
Seniority
Manager, supervisory level