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)
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
