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External Manufacturing Manager (Contract)

Navy Yard, PA 19112

Posted: 03/10/2025 Employment Type: Contract Job Category: Manufacturing Job Number: 617754 Is job remote?: No Country: United States

Job Description

 
  • Location: Onsite in Philadelphia – Navy Yard
  • Start Date: ASAP
  • Duration: 6–12 month contract (potential for conversion based on performance and headcount approval)
  • Travel: May require 10–15% travel to support Person In Plant (PIP) activities at various CMOs
A small life sciences company is seeking a Contract External Manufacturing Manager for a 6–12-month engagement (potential contract-to-hire opportunity). This role reports to the Director of External Manufacturing and Supply and will be responsible for managing manufacturing compliance through change control management, project execution, manufacturing procedure/workflow development, onsite oversight at CDMOs (Person In Plant - PIP responsibilities). Additionally, the role includes tactical planning, project management support, and oversight of on-the-floor manufacturing operations in Philadelphia. Occasional travel (10–15%) to headquarters in the Bay Area may be required for meetings and functions.

Requirements:
  • Bachelor’s degree with 6+ years of experience in pharmaceutical manufacturing, technology transfer, and process development.
  • At least 2 years of experience in cell therapies.
  • Prior experience providing manufacturing oversight at a CMO (Person In Plant).
  • Expertise in cGMP manufacturing and regulatory requirements for biopharmaceutical products and ATMPs.
  • Strong knowledge of manufacturing operations for clinical trial products, including aseptic processes with a focus on cell therapies.
  • Proven ability to manage relationships within a CMO network.
Responsibilities:
  • Serve as Person In Plant (PIP), overseeing manufacturing, shipping, receiving, and warehousing operations within a network of Manufacturing CDMOs.
  • Conduct batch record reviews and deviation initiation, acting as the first responder to any issues that arise during manufacturing.
  • Develop and enhance documentation, process flows, and internal business processes, collaborating with internal and external stakeholders to evaluate business needs.
  • Act as a liaison between the sponsor and CDMOs, coordinating with internal quality and supply chain teams to improve Vein-to-Vein time, support regulatory filings, and drive continuous improvement.
  • Manage and execute change controls as required.
  • Implement tracking, analysis, and solutions to ensure operational excellence across key Suppliers/CMOs, utilizing KPIs/KQIs/KRIs to monitor vendor performance.
  • Work with functional leadership to design, implement, and maintain Risk-Based Quality Management strategies in support of clinical programs.
  • Support business development due diligence projects, assessing external opportunities as needed.
  • Ensure timely issue resolution and that all deliverables are met as required.
  • Identify and document best practices for supplier partnerships and develop a supplier contact database.
  • Use an operational excellence mindset to review and refine processes, procedures, and documentation, ensuring simplicity, accuracy, and robustness.
  • Collaborate with program teams to support and execute program goals, including document revisions and process definition.

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma is an equal opportunity employer. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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Although this hasn't been an issue at Planet Pharma, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.