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