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Bedford, Massachusetts, United States
Onsite
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; 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
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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.
