King of Prussia, PA

Job Description

My client is seeking to fill the position of Cell & Gene Therapy Project Manager.  This role will focus on the analytical testing for cell and gene therapy products supporting the life cycle of the product from discovery to post-commercialization, in both non-GMP and GMP environments.
Primary Responsibilities:
  • Establish project management processes (scope, time, quality, resources, cost) for projects in the CGT facility
  • Coordinate with the entire team to ensure the highest level of client service
  • Act as client liaison for Cell & Gene Therapy projects being transferred from development into GMP
  • Manage client expectations with timely and relevant communications
  • Manage the transfer of all internal and external projects into GMP
    • Prepare and manage detailed Gantt charts
    • Prepare SOPs, protocols, data summaries, and reports for ongoing studies
    • Meeting management – scheduling, agendas, minutes, actions, follow-up
    • Detailed project planning, tracking, and reporting of project progress
    • Responsible for ensuring risk analysis and mitigation strategies for projects are in place
  • Acquire and apply knowledge of the Cell & Gene Therapy industry and GMP/non-GMP operations to improve business processes and support company growth

Candidate Requirements:

  • Degree (M.S. or Ph.D.) in pharmaceutical sciences, biochemistry, life sciences, or pharmacology
  • Minimum 5 years’ relevant industry experience: in-depth knowledge of the pharmaceutical/biotech industry, specifically cGMP
  • Excellent communication skills (verbal and written)
  • Working knowledge of advanced therapeutics development and GxP compliance
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