Scientist / Associate Scientist, cGMP Cell Line Development

Location
San Diego, CA, United States
Posted
Sep 28, 2020
Ref
383LF
Hotbed
Biotech Beach
Required Education
Bachelors Degree
Position Type
Full time
Fate's Cellular Reprogramming and Engineering Department is seeking a skilled and highly motivated cGMP manufacturing scientist / associate scientist 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 Company's induced pluripotent stem cell (iPSC) platform. The candidate should have experience in cGMP manufacturing with strong expertise in cell line development and banking. This is a full-time position and located at our corporate headquarters in San Diego, CA reporting to a Senior Scientist, Cancer Immunotherapy.

Responsibilities:
• Draft, execute and document batch records and SOPs with high level of compliance to safety policies, quality system and cGMP guidance
• Participate in iPSC 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
• Document manufacturing procedures in compliance with cGDP requirements
• Participate in process and product development activities and write research report as
needed
• Present manufacturing activities and updates during departments meetings

Qualifications
• BS/MS in cell biology or similar discipline with 3 plus years of experience in cGMP manufacturing, or PhD with 1 plus year of cGMP experience
• Strong hands-on experience in aseptic processing in ISO 5 BSC and ISO 7 clean rooms
and universal precautions for handling human derived materials in BSL-2 containment areas
• Knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing
• Hands-on experience in cell therapy cGMP manufacturing is required
• Preferred experience in any of the following: o Cell culture and scale up of iPSCs or immune cells o Cryopreservation processes and equipment o Genetic engineering
o Flow cytometry
• 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 from time to time. For consideration send cover letter and curriculum vitae to: careers@fatetherapeutics.com
and reference Job Code 383LF.

About Fate Therapeutics, Inc.
Fate Therapeutics is a clinical-stage biopharmaceutical company dedicated to the development of first-in-class cellular immunotherapies for cancer and immune disorders. 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 product candidates include natural killer (NK) cell and T-cell cancer immunotherapies, which are designed to synergize with well-established cancer therapies, including immune checkpoint inhibitors and monoclonal antibodies, and to target tumor-associated antigens with chimeric antigen receptors (CARs). The Company's immuno-regulatory product candidates include ProTmune™, a pharmacologically modulated, donor cell graft that is currently being
evaluated in a Phase 2 clinical trial for the prevention of graft-versus-host disease, and a myeloid-derived suppressor cell immunotherapy for promoting immune tolerance in patients with immune disorders. Fate Therapeutics is headquartered in San Diego, CA. For more information, please visit www.fatetherapeutics.com.