Associate Scientist / Senior Research Associate, cGMP Cell Line Development
Fates Cellular Reprogramming and Engineering Department is seeking a skilled and highly motivated cGMP manufacturing associate scientist/senior research associate to participate in cell line development through cellular reprogramming and genetic engineering in compliance with cGXP guidelines to further the development of novel off-the-shelf cellular therapeutics for the treatment of cancer and immune disorders. The successful candidate will play a key role in the advancement of the companys induced pluripotent stem cell (iPSC) platform. The candidate should have experience with strong expertise in cell line development and banking. Experience with cGMP manufacturing is highly desirable. This is a full- time position reporting to a Scientist, Reprogramming Biology, and is located at our corporate headquarters in San Diego, CA.
- Participate in iPSC line and other cell line development and banking by adhering to established cGMP SOPs and BRs covering, but not limited to: media preparation, cell culture and scale up, genetic engineering, and banking
- Execute and document batch records and SOPs with high level of compliance to safety policies, quality system and cGMP guidance
- Participates in writing or suggesting changes to controlled documents as needed to ensure defined quality objectives are met.
- Participate in evaluation of process automation for introduction into GMP manufacturing
- Participate in process and product development activities and write research report as needed
- Present manufacturing activities and updates during departments meetings
- BS/MS in cell biology or similar discipline with a minimum of 3 years of experience in academic, biotechnology, or pharmaceutical setting. cGMP manufacturing experience is highly desirable.
- Proficiency with aseptic techniques for working with mammalian cell culture
- Preferred experience in any of the following: Cell culture and scale up of iPSCs or immune cells o Cryopreservation processes and equipment o Flow cytometry o iPSC reprogramming o Genetic engineering o Knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy o manufacturing Hands-on experience in cell therapy cGMP manufacturing o Strong hands-on experience in aseptic processing in ISO 5 BSC and ISO 7 clean rooms and o universal precautions for handling human derived materials in BSL-2 containment areas
- Demonstrated ability to work both independently and in a team-oriented environment
- Excellent communication, attention to detail, and time management/organizational skills
- Positive outlook and a team-oriented attitude
Working Conditions and Physical Requirements:
- Will require working with cells and cell lines of human origin
- Occasional weekend and/or evening hours as necessary
- 100% on-site work at corporate headquarters in San Diego, CA
The preceding job description indicates the general nature and level of work performed by employees within this classification. Additional and incidental duties related to the primary duties may be required.
About Fate Therapeutics, Inc.
Fate Therapeutics is a clinical-stage biopharmaceutical company dedicated to the development of first-in-class cellular immunotherapies for patients with cancer. The Company has established a leadership position in the clinical development and manufacture of universal, off-the-shelf cell products using its proprietary induced pluripotent stem cell (iPSC) product platform. The Company’s immuno-oncology pipeline includes off-the-shelf, iPSC-derived natural killer (NK) cell and T-cell product candidates, which are designed to synergize with well-established cancer therapies, including immune checkpoint inhibitors and monoclonal antibodies, and to target tumor-associated antigens using chimeric antigen receptors (CARs). Fate Therapeutics is headquartered in San Diego, CA. For more information, please visit www.fatetherapeutics.com.