Director GMP Process Development

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. RESPONSIBILITIES: 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. MINIMUM JOB QUALIFICATIONS: PhD in Biology/Biochemistry or other relevant field with a minimum of 5 years of experience in a development laboratory in the field of cell therapy or involving cell culture. At least 3 years of experience in a Biotech/Pharma Process Development and/or Manufacturing Support role for drug substance manufacturing. Experience with Design of Experiment (DOE) and JMP/SPSS or other relevant statistical software. Experience in transferring a development process into GMP manufacturing, developing a tech transfer package, acting as subject matter expert for tech transfer. Knowledge of FDA and EU cGMP regulations and requirements as they relate to process and assay development. Experience in developing assays for transfer into a GMP testing lab. Understanding of cell culture processes, such as: scale up factors from bench to clinical/commercial, metabolism profiling, influence of raw material attributes and impact of process deviations to growth and quality attributes, harvest and clarification processes. Excellent written, verbal, and interpersonal communication skills. Demonstrated ability to work independently. Able to analyze and interpret data. Be a self-starter with the ability to take on several projects at one time. Excellent critical thinking, organizational, and analytical skills. Highly motivated, with the ability to work independently and as a leader of a team of either direct reports or matrix-project based reports. Adaptability to work in a fast-paced and changing environment. NYSCF is an Equal Opportunity Employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

Created: 2024-11-02