Syringe Filling PCU Lead
Core
Lead the Line 7 Syringe Filling Process Centric Unit (PCU) for aseptic filling operations, ensuring 24-hour performance, safety, quality, and financial results for a team of 35-45 members.
Role type
Senior manufacturing operations lead (aseptic filling)
Builds
Syringe filling units and aseptic manufacturing processes
Domain
Biopharmaceutical manufacturing (aseptic processing)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
cGMP compliance, aseptic manufacturing operations, team leadership, regulatory audit management, budget management, process improvement, safety standards, cross-functional collaboration
Preferred skills
External regulatory inspection experience, root cause analysis, SOP review, multi-priority production management
Technologies
SMS 2.0, GPS (Global Process System), cGMP systems
Responsibilities
Provide leadership and direction to the PCU and team of managers; ensure compliance with FDA and corporate quality requirements; manage headcount and expenses to meet budget expectations; drive continuous improvement and operational efficiency; resolve operational issues and implement changes; develop direct reports and set performance standards.
Seniority
Senior, hands-on IC with management responsibilities
