Supervisor, Manufacturing, M-F 4PM to 12:30 AM

PCI TRGR Penn Pharmaceutical Services Ltd; Bedford (NH); Hybrid; USD 90,000 - 120,000; Full time

Job summary

PCI Pharma Services seeks a Supervisor, Manufacturing to lead a 12-hour aseptic production shift in Bedford, NH. This role oversees equipment prep, formulation, filtration, aseptic/non-aseptic filling in an isolator, and lyophilization to execute the production plan across shifts while ensuring safety and quality.

You will coach and develop staff, implement training, monitor KPIs, and work with Planning and cross-functional teams to optimize processes and address deviations in a strong cGMP

Qualifications

• Minimum High School Diploma.
• 5-7 years of experience in a GMP environment.
• 3-5 years of experience leading direct reports or teams.
• Experience with GMPs, FDA and other regulated agency environments is required.
• Ability to make 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.

Responsibilities

• Lead a 12-hour production shift for aseptic manufacturing.
• Ensure safety of manufacturing area and work practices.
• Coach, motivate, and retain high-performing teams.
• Coordinate and supervise Manufacturing personnel in cGMP operations.
• Train employees to ensure FDA and regulatory requirements are met.
• Plan and execute manufacturing instructions for equipment prep, compounding, filtration, formulation and fill activities.
• Partner with Planning to ensure scheduling adherence and capacity.
• Collaborate with enabling groups to optimize processes.
• Recruit and supervise staff and manage resources.
• Identify risks and escalate issues to management.
• Establish KPIs and report metrics.
• Collaborate with Training to design and execute training plans.
• Ensure investigations and CAPAs are completed timely and perform Real time batch review.

Skills

Team leadership

GMP experience

Regulatory knowledge

Priority management

Problem solving

Safety decisions

Education

High School Diploma

Job description

## Supervisor, Manufacturing, M-F 4PM to 12:30 AMApplylocations: Bedford, NH, USAtime type: Full timeposted on: Posted Todayjob requisition id: JR119079Life 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; 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 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:** The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.* 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#LI-LL1Join 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.*