Supervisor, Manufacturing

PCI Pharma Services; Bedford (NH); On-site; USD 90,000 - 120,000; Full time

Job summary

PCI Pharma Services is seeking a Manufacturing Supervisor to lead a 12-hour aseptic production shift, supervise a GMP environment and drive Right First Time results. You will ensure safety, quality, and compliance while coordinating with planning and support groups to meet production goals.

The role requires strong leadership, real-time decision-making, and a focus on process improvements within a regulated manufacturing setting.

Qualifications

• Minimum High School Diploma.
• 5–7 years in a GMP environment.
• 3–5 years leading direct reports or teams preferred.
• Experience with GMPs, FDA and regulated agencies.
• Ability to make real-time safety, process, scheduling decisions.
• Prioritize and manage multiple resources in production.
• Strong leadership, persuasiveness, initiative and problem solving.

Responsibilities

• Lead a 12-hour shift for aseptic manufacturing, including equipment prep, formulation, filtration, aseptic/non-aseptic compounding, filling in an isolator and lyophilization.
• Ensure execution of production plans across shifts and manage staff performance against goals.
• Coordinate and supervise Manufacturing personnel in cGMP operations to meet scheduled work.
• Train employees to ensure FDA and regulatory requirements are met.
• Plan and execute manufacturing instructions for GMP activities.
• Provide leadership aligned with cGMP requirements and quality standards.
• Partner with Planning to prioritize work and meet capacity demands.
• Collaborate with enabling groups to optimize processes.
• Recruit and supervise staff to ensure resource utilization and performance.
• Identify and mitigate risks; escalate to management and cross-functional teams.
• Establish KPIs and report area metrics; maintain readiness for inspections.
• Work with Training to develop and execute training plans; ensure accuracy of materials.
• Complete investigations, deviations and CAPAs; drive Right First Time.

Skills

Leadership

GMP knowledge

FDA compliance

Quality metrics

Training and coaching

Education

High School Diploma

Job description

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.

We are PCI.

Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.

The Manufacturing Supervisor leads a manufacturing team in a variety of complex tasks in accordance with the FDA and other regulatory agencies while following all safety guidelines of PCI. They will be responsible for supervising a 12-hour production shift for aseptic manufacturing including equipment preparation, formulation, filtration, aseptic / non-aseptic compounding, filling in an isolator and Lyophilization activities. Ensure execution of production plan across multiple shifts and manage staff performance against department's operational goals.

• Ensure safety of manufacturing area and work practices in accordance with all 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 in order to perform 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 and schedule adherence and to meet all required 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 identifies, assesses, and mitigates operational and organizational risks; accelerate 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 department training plan and training plan execution. Ensure Training materials are accurate and sufficiently detailed
• Commit and work to honor timely completion of investigations and 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. Participates in inspections conducted by external regulators
• Identifies continuous improvement opportunities to improve processes and practices

Qualifications:

• Minimum High School Diploma
• 5-7 years of experience in a GMPs environment required
• 3-5 years of experience 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

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

Join us and be part of building the bridge between life changing therapies and patients. Let's talk future

Equal Employment Opportunity (EEO) Statement:

PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.