The Cell Processing Facility Manager will provide direct technical and managerial leadership to the group as well as indirectly to the entire cell therapy development and manufacturing organization.
The responsibilities of primary importance are ensuring the successful GMP manufacture and release of cell therapy products and promoting a culture of quality, compliance, and continuous improvement. The position will involve managing manufacturing operations and the supervision of approximately 15 manufacturing staff. The successful applicant will interact with the clinical trial sponsors, QA/QC, research scientists, and the manufacturing staff in the GMP Cell Processing Facility.
Required qualifications include:
- 10+ years experience in cell culture based GMP manufacturing operations. The ideal candidate will have experience in cell therapy applications with T-cells and stem cells, however, recognizing that this is a nascent field the candidate may have transferable skills from other biotech fields.
- Expert knowledge of FDA regulations and GMP systems for the manufacture of therapeutic products.
- Experience managing a multi-product GMP manufacturing facility involving the complex scheduling and coordination of staff, materials, and manufacturing operations
- Experience with cell culture based manufacturing methods (cell selections, cell culture, harvest, cryopreservation)
- Managerial experience in supervising other technical professional, goal setting, managing budgets.
- Ability to perform long term project planning in terms of project plans, timelines, and budget forecasting.
- BS or higher degree in engineering, biological sciences, or other relevant experience/education
If interested, please apply online at http://track.tmpservice.com/ApplyClick.aspx?id=2191286-2647-9121