Manufacturing Supervisor

Responsibilities

• Lead and supervise a manufacturing team in aseptic and medical device production, including equipment preparation, filling, and lyophilization activities
• Ensure all manufacturing operations comply with FDA, cGMP, and PCI Health, Safety, and Environmental programs
• Coordinate personnel and production schedules to meet capacity demands and operational goals
• Recruit, train, and coach staff, managing performance through evaluations and professional development
• Oversee the timely completion of investigations, deviations, and CAPAs to ensure "Right First Time" batch reviews
• Identify continuous improvement opportunities and mitigate operational or organizational risks
• Maintain inspection readiness for assigned manufacturing areas and participate in external regulatory audits
• Collaborate with cross-functional teams including Engineering, QA, R&D, and Materials Management

Requirements

• High School Diploma or equivalent
• 5-7 years of experience working in a GMP environment
• 3-5 years of experience leading direct reports or managing teams
• Strong knowledge of FDA and other regulatory agency requirements
• Proven problem-solving skills and the ability to make real-time decisions regarding safety and scheduling
• Ability to prioritize multiple tasks and manage resources in a fast-paced production environment

About the Company

PCI Pharma Services is a global provider of pharmaceutical services, dedicated to building the bridge between life-changing therapies and the patients who need them. We invest in people who drive progress and create a better tomorrow through a culture of purposeful work and operational excellence.