Supervisor, Manufacturing

About the role

Lead a manufacturing team in a variety of complex tasks in accordance with FDA and other regulatory agencies while following all safety guidelines of PCI. Supervise a 12-hour production shift for aseptic manufacturing, including equipment preparation, formulation, filtration, aseptic/non-aseptic compounding, filling in an isolator, and lyophilization activities.

Responsibilities

• Ensure execution of the production plan across multiple shifts and manage staff performance against department operational goals.
• Maintain safety of the manufacturing area and work practices in accordance with PCI Health, Safety, and Environmental programs.
• Act as a highly visible, hands-on team builder to motivate, coach, support, inspire, and retain highly effective teams while managing for high performance and developing others.
• Coordinate and supervise manufacturing personnel in cGMP operations to meet all scheduled manufacturing work.
• Guide and train employees to ensure FDA and other regulatory agency requirements are properly implemented and continually met.
• Plan and execute manufacturing instructions for equipment preparation, compounding, filtration, formulation, and fill activities for aseptic and terminally non-aseptic products in accordance with Good Manufacturing Practices (GMP).
• Provide leadership, guidance, and direction to staff in alignment with cGMP requirements, department goals, and corporate quality standards.
• Partner with Planning to ensure effective prioritization, schedule adherence, and capacity demands.
• Collaborate with enabling groups to optimize processes.
• Recruit and supervise staff to execute department functions; ensure effective utilization of resources through consistent performance management.
• Proactively identify, assess, and mitigate operational and organizational risks; escalate key risks and issues to manufacturing senior management and cross-functional support teams.
• Establish key performance indicators in alignment with department goals, maintain and report applicable area or organizational metrics.
• Collaborate with training to design and execute department training plans; ensure training materials are accurate and sufficiently detailed.
• Commit to timely completion of investigations, deviations, and CAPAs; utilize quality metrics to measure, analyze, and improve team performance; ensure real-time batch review and "Right First Time."
• Enhance and reinforce inspection readiness of assigned manufacturing areas; participate in inspections conducted by external regulators.
• Identify continuous improvement opportunities to enhance processes and practices.

Requirements

• Minimum High School Diploma.
• 5-7 years of experience in a GMP environment.
• 3-5 years of experience leading direct reports or teams is preferred.
• Experience with GMPs, FDA, and other regulated agency environments.
• Ability to make real-time decisions on safety, process, scheduling, and personnel-related issues.
• Proven leadership, persuasiveness, initiative, and problem-solving skills.
• Ability to prioritize and manage multiple resources in a production environment with flexibility to meet organizational needs.

Schedule

This role will start on an 8-hour Monday–Friday schedule with the intent of moving to a 12-hour 3-2-3 schedule in early 2027.