Manager, Fill Finish Drug Product Manufacturing - Weekend Operations - 2nd Shift
Core
Managing day-to-day fill & finish manufacturing operations, including formulation, filtration, filling, troubleshooting, and batch record review 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
Required skills
cGMP compliance, regulatory requirements, chemistry (fillers/processes), QAD, Master Control, LIMS, RAM, leadership, strategic planning, audit response, quality investigations
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 production schedules and facility planning (shutdowns, maintenance); manage audit responses and quality interactions (EM, OOS, Deviation investigations); recruit, coach, and mentor team members; maintain transparent communication with internal and external stakeholders.
Seniority
Manager, supervisory level
