The New York Stem Cell Foundation (NYSCF) is a rapidly growing and highly successful nonprofit whose mission is to accelerate cures through stem cell research. We are a vibrant organization that advances cutting-edge stem cell research in our own laboratory and through the support of talented scientists at other institutions.
NYSCF is now translating its research directly into the clinic and as such is seeking a Director, GMP Process Development as a key participant in this effort.
The Director of GMP Process Development will manage a team to develop cGMP processes and assays for autologous and allogeneic induced Pluripotent Stem Cell (iPSC) based cell therapies. The Director of GMP Process Development will be responsible for the development of cGMP compliant processes to support biosample processing, cell culture, reprogramming, differentiation, and other lab activities to support the clinical development of novel iPSC based cell therapies.
The Director of GMP Process Development is a full time position, located at the NYSCF Research Institute in New York, NY.
- Manage a team to:
- Develop procedures and methods related to the production of live cells at both bench and manufacturing scales; identify equipment and components necessary for scale GMP production.
- Develop novel cell culture, reprogramming, and next generation differentiation steps to increase yield and process robustness.
- Identify and implement necessary changes to process and reagents for GMP compliance.
- Execute technology transfer projects, resolve processing issues, and conduct technical assessments on process/product impact due to changes in equipment, scale, and raw materials.
- Identify assays for product characterization in collaboration with existing lab personnel, including: identity, purity, potency, and mechanism of action.
- Lead effort in FMEA and DOE to develop experimental plan for identification of Critical Process Parameters, ranges and criteria for iPSC and differentiated cell therapy products. Lead and execute the plan both personally and with a team.
- Create CMC Master File/IMPD submissions, prepare process descriptions, and draft information for batch records. Review and approve final batch records for tech transfer.
- Provide technical and on-the-floor support to assist in the troubleshooting of clinical drug substance manufacturing.
- Support the GMP manufacturing process.
- Create and maintain accurate and complete development records and protocols.
- Communicate in written and oral form with a multidisciplinary team including: Investigators, Scientific Staff, Quality Assurance, Manufacturing, Operations, R&D, etc.