PCI Pharma Services

PCI Pharma Services

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

Bedford, NH, USA · Senior

Sponsorship not specifiedDetected 25 days ago
CompliancePerformance ManagementGMPFDA RegulatoryMedical DevicesLeadershipCommunicationCollaborationProblem SolvingTime ManagementWriting

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).
  • The essential duties and responsibilities include the following but other duties may be assigned. - Ensure the safety of manufacturing area and work practices in accordance with all PCI Health, Safety, and Environmental programs.

Responsibilities

  • Be a highly visible, hands-on team builder to motivate, coach, support, inspire and retain highly effective teams while managing for high performance and developing others
  • Ensure audit inspection readiness of assigned manufacturing areas. Participates and takes a lead role, as needed, in inspections conducted by external clients and governmental regulatory agencies.
  • 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)
  • Lead and collaborate with the other supervisors and enabling groups to optimize processes, with specific focus on Continuous Improvement projects tied to corporate and site-specific initiatives
  • Proactively identifies, evaluates, and mitigates operational and organizational risks; escalate key risks and issues to manufacturing senior management and cross-functional support teams
  • Create and 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
  • Provide leadership, guidance, and direction to staff in alignment with cGMP requirements, department goals, and corporate quality standards. Ability to lead the operations area in the absence of the Manufacturing Manager.
  • Able to take lead role for department on cross-functional technical projects
  • Ability to prioritize and manage multiple resources in a production environment with flexibility to meet organizational needs

Requirements

  • The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position.
  • 7-10 years of experience in a GMPs environment required
  • 4+ years of experience leading direct reports or teams is required
  • Very High Reasoning: Ability to define problems, collect data, establish facts, and draw valid conclusions.
  • 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.
  • Required:
  • Minimum High School Diploma
  • College Level Mathematical Skills
  • Intermediate Computer Skills: Ability to perform more complex computer tasks and has knowledge of various computer programs.
  • Very High Reasoning: Ability to define problems, collect data, establish facts, and draw valid conclusions. Be able to interpret an extensive variety of technical instructions in math or diagram form and deal with several abstract/concrete variables.
  • Preferred

Nice to have

  • Ability to display excellent time management skills.
  • Ability to display a willingness to make decisions.

Skills

  • 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.
  • Proven leadership, persuasiveness, initiative, and problem solving skills
  • Attention to detail
  • Team oriented
  • Results driven
  • Collaboration
  • Adept communication skills to all levels of the organization
  • Strong technical writing skills
  • Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs.
  • Bachelor's Degree in related science field preferred
  • Ability to effectively present information to various people as the job requires.

Benefits

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

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.