Supervisor, Manufacturing

PCI Pharma Services•Bedford, NH

12d

About The Position

The Manufacturing Supervisor leads a manufacturing team performing complex work under FDA and other regulatory requirements and PCI safety guidelines. The role supervises aseptic and medical device manufacturing activities, including equipment preparation, filling, and lyophilization, and ensures production plans are executed across multiple shifts. The supervisor manages staff performance in support of department operational goals and works with cross-functional teams to maintain compliant, effective manufacturing operations. The position provides hands-on leadership, coaching, training, and performance management for manufacturing staff, including multiple direct reports at various Manufacturing Technician levels. The supervisor is responsible for production scheduling and capacity coordination, inspection readiness, training execution, real-time batch review, and timely handling of investigations, deviations, and CAPAs. The role also monitors operational metrics, identifies risks and continuous improvement opportunities, communicates project status to the Manufacturing Manager, and supports employee evaluations and disciplinary actions as needed.

Requirements

High school diploma or equivalent; the stated minimum is a High School Diploma.
5–7 years of experience in a GMP environment.
Experience with GMPs, FDA, and other regulated agency environments.
Experience making real-time decisions regarding safety, processes, scheduling, and personnel issues.
Ability to prioritize and manage multiple resources in a production environment and flexibly meet organizational needs.
Demonstrated leadership, persuasiveness, initiative, and problem-solving skills.
Ability to lift, push, or pull up to 40 pounds, with this activity occurring less than 25% of the time.

Nice To Haves

3–5 years of experience leading direct reports or teams is preferred.

Responsibilities

Ensure manufacturing-area safety and compliant work practices in accordance with PCI Health, Safety and Environmental programs.
Build, motivate, coach, support, inspire, and retain effective teams while developing staff and managing performance.
Coordinate and supervise Manufacturing personnel in cGMP operations to meet scheduled manufacturing work.
Partner with Planning to prioritize work, maintain schedule adherence, and meet capacity demands.
Guide and train employees to implement and maintain FDA and other regulatory requirements.
Plan and execute manufacturing instructions for equipment preparation and filling of aseptic and non-aseptic products in accordance with GMP.
Collaborate with other supervisors and enabling groups to optimize processes.
Recruit and supervise staff and ensure effective resource utilization through performance management.
Provide leadership, guidance, and direction aligned with cGMP requirements, department goals, and corporate quality standards.
Identify, assess, and mitigate operational and organizational risks; escalate key risks and issues to senior manufacturing management and cross-functional support teams.
Establish key performance indicators aligned with department goals and maintain and report applicable metrics.
Collaborate with Training to design and execute department training plans, ensuring materials are accurate and sufficiently detailed.
Ensure timely completion of investigations, deviations, and CAPAs; use quality metrics to analyze and improve team performance.
Ensure real-time batch review, right-first-time performance, and inspection readiness for assigned manufacturing areas.
Participate in inspections conducted by external clients and regulators.
Identify continuous improvement opportunities to improve processes and practices.
Communicate the status of all projects to the Manufacturing Manager.
Interact with cross-functional support teams, including Operations, Materials Management, Engineering, MTS, R&D, Validation, and QA.
Direct staff activities, prepare performance evaluations, recommend merit increases, and identify employee issues and recommend or carry out disciplinary action as necessary.
Collaborate with other Manufacturing Supervisors to carry out responsibilities.
Travel between PCI facilities as needed.
Prioritize and manage multiple tasks and projects.