Supervisor, Manufacturing Mon to Fri 3PM to 11:30 PM

PCI TRGR Penn Pharmaceutical Services Ltd; Madison (WI); On-site; USD 85,000 - 120,000; Full time

Job summary

PCI Pharma Services in the United States is seeking a Manufacturing Supervisor to lead an aseptic and medical device manufacturing team, ensure execution of production plans across multiple shifts, and maintain compliance with cGMP and FDA regulations.

You will coach staff, manage safety, drive continuous improvement, and partner with cross-functional teams to optimize operations while meeting quality metrics and regulatory expectations.

Qualifications

• Minimum High School Diploma or equivalent.
• 5-7 years of experience in GMP environments.
• 3-5 years of leadership or supervisory experience.
• Experience with GMP, FDA and other regulated environments.
• Able to make real-time decisions on safety, process, scheduling.
• Strong prioritization and resource management in production.

Responsibilities

• Ensure safety of manufacturing areas and adherence to PCI HSE programs.
• Motivate and coach teams to drive high performance.
• Supervise cGMP operations to meet scheduled production work.
• Plan and execute equipment prep and fill activities per GMP.
• Collaborate to optimize processes with other supervisors.
• Recruit and manage staff and ensure resource utilization.
• Provide leadership aligned with cGMP and quality standards.
• Identify and mitigate operational risks and escalate as needed.
• Establish KPIs and report metrics for the area.
• Work with training to implement department training plans.
• Ensure training materials are accurate and detailed.
• Ensure timely investigations, deviations and CAPAs.
• Use quality metrics to drive team performance.
• Support real-time batch review and Right First Time.
• Maintain inspection readiness in assigned areas.
• Participate in client and regulator inspections.
• Identify continuous improvement opportunities.

Skills

Leadership

GMP

FDA compliance

Team building

Quality metrics

Training & coaching

Risk management

Education

High School Diploma

Tools

GMP training software

Job description

Job Overview

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 an aseptic and medical device manufacturing team (ex. equipment preparation, filling and Lyophilization activities). Ensure execution of production plans across multiple shifts and manage staff performance against department’s operational goals.

Essential Duties and Responsibilities

• 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.


• Plan and execute manufacturing instructions in order to perform equipment preparation, and fill activities for aseptic and non‑aseptic products in accordance with Good Manufacturing Practices (GMP).


• Collaborate with the other supervisors and enabling groups to optimize processes.


• Recruit and supervise staff to execute department functions; ensure effective utilization of resources through consistent performance management.


• Provide leadership, guidance, and direction to staff in alignment with cGMP requirements, department goals and corporate quality standards.


• Proactively identifies, assesses, and mitigates operational and organizational risks; escalates 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.


• Ensure 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".


• Ensure Inspection readiness of assigned manufacturing areas.


• Participates in inspections conducted by external clients and regulators.


• Identifies continuous improvement opportunities to improve processes and practices.

Special Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee must be physically capable to perform the duties listed below with or without reasonable accommodations which may be made to enable individuals with disabilities to perform the essential functions.

Qualities

• Attention to detail


• Team oriented


• Results driven


• Collaboration


• Comfortable with communication skills to all levels of the organization

Communications & Contacts

The supervisor will be responsible for communicating the status of all projects to their Manufacturing Manager. Interacts with cross functional support teams such as Operations, Materials Management, Engineering, MTS, R&D, Validation, QA, etc.

Managerial & Supervisory Responsibilities

Responsible for directing activities of staff members. Prepare employee performance evaluations. Recommend merit increases based on performance. Must be able to observe and identify potential employees’ issues and recommend/carryout disciplinary action as necessary. There are multiple direct reports including various levels of Manufacturing Technicians. Collaborate with other Manufacturing Supervisors as necessary to carryout responsibilities.

Work Environment

Work is primarily performed at a desk and/or in an office environment for 3/4 of the day and up. Work is also performed in ISO‑rated cleanroom environments, requiring special factors such as sterile gowning. The noise level in the work environment is typically, moderate.

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.

Equal Employment Opportunity 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.

Why Work for PCI Pharma Services

At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real‑life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don’t say no, we figure out how.