Associate Scientist / Senior Research Associate, cGMP Cell Line Development

Location
San Diego, CA, United States
Posted
Apr 24, 2021
Ref
483MR
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 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 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 reporting to the Manager, cGMP Cell Line Development, and is located at our corporate headquarters in San Diego, CA.

Responsibilities
• 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
• Evaluate and enroll raw material for quality assessment prior to use
• Present manufacturing activities and updates during department meetings

Qualifications
• BS/MS in cell biology or similar discipline with a minimum of 3 years of experience in cGMP manufacturing
• 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 Flow cytometry
o Genetic engineering
• 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 resume to: careers@fatetherapeutics.com and reference
job code 483MR.

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). The Company's pipeline also includes
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 in patients with hematologic
malignancies undergoing allogeneic stem cell transplant. Fate Therapeutics is headquartered in San
Diego, CA. For more information, please visit www.fatetherapeutics.com.