Aseptic Manufacturing Supervisor & Team Leader

PCI Pharma Services; Bedford (NH); Vor Ort; USD 90.000 - 120.000; Vollzeit

Zusammenfassung

PCI Pharma Services is seeking a Manufacturing Supervisor to lead a 12-hour aseptic production shift, ensuring GMP adherence and safe, compliant operations. You will oversee equipment prep, formulation, filtration, aseptic filling in isolators and lyophilization, while driving performance across shifts.

The role requires significant GMP experience and leadership to guide teams, coordinate schedules, and maintain regulatory standards.

Qualifikationen

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

Aufgaben

• Ensure safety of manufacturing area and work practices per PCI Health, Safety and Environmental program.
• Be 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 the cGMP operations to meet all scheduled manufacturing work.
• Guide and train employees to ensure FDA and other regulatory agency requirements have been properly implemented and are continually met.
• Plan and execute manufacturing instructions for equipment preparation, compounding, filtration, formulation and fill activities for aseptic and non-aseptic products in accordance with GMP.
• Provide leadership, guidance, and direction to staff in alignment with cGMP requirements and department goals.
• Partner with Planning to ensure effective prioritization and schedule adherence to meet capacity demands.
• Collaborate with enabling groups to optimize processes.
• Recruit and supervise staff to execute department functions; ensure resources are used efficiently.
• Identify and mitigate operational and organizational risks; escalate issues to senior management.
• Establish KPIs aligned with department goals and report metrics.
• Collaborate with training to design and execute training plans; ensure materials are accurate.
• Complete investigations, deviations and CAPAs; use quality metrics to improve performance; ensure real-time batch review and Right First Time.
• Enhance inspection readiness; participate in regulator inspections.
• Identify continuous improvement opportunities to improve processes and practices.

Kenntnisse

Leadership

Problem solving

Decision making

Prioritization

Communication

GMP knowledge

Regulatory compliance

Ausbildung

High School Diploma

Jobbeschreibung

PCI Pharma Services is seeking a Manufacturing Supervisor to lead a 12-hour aseptic production shift, ensuring GMP adherence and safe, compliant operations. You will oversee equipment prep, formulation, filtration, aseptic filling in isolators and lyophilization, while driving performance across shifts.

The role requires significant GMP experience and leadership to guide teams, coordinate schedules, and maintain regulatory standards.