PCI Pharma Services

PCI Pharma Services

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

Madison, WI, USA

Sponsorship not specifiedDetected 32 days ago
CompliancePerformance ManagementGMPFDA RegulatoryMedical DevicesLeadershipCommunicationCollaborationProblem Solving

About the role

  • Bridge to thousands of biopharma companies and their patients.
  • They will be responsible for supervising an aseptic and medical device manufacturing team (ex. equipment preparation, filling and Lyophilization activities).
  • Ensure Training materials are accurate and sufficiently detailed - Ensure Timely completion of investigations, deviations and CAPAs.

Responsibilities

  • 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
  • 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
  • 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
  • Interacts with cross functional support teams such as Operations, Materials Management, Engineering, MTS, R&D, Validation, QA, etc.

Requirements

  • The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position.
  • 5-7 years of experience in a GMPs environment required
  • Experience with GMPs, FDA and other regulated agency environments is required
  • Proven leadership, persuasiveness, initiative, and problem solving skills
  • 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
  • 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
  • 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.

Nice to have

  • 3-5 years of experience leading direct reports or teams is preferred

Benefits

  • Ensure safety of manufacturing area and work practices in accordance with all PCI Health, Safety and Environmental program.

Company info

  • 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.

Equal opportunity

  • 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.

Visa & Work Authorization

  • 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 o
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This listing is sourced directly from PCI Pharma Services's careers page and normalized into a canonical job model.