Associate Scientist / Senior Research Associate, Process Development Engineering

Location
San Diego, CA, United States
Posted
Jun 18, 2021
Ref
505YQ
Hotbed
Biotech Beach
Required Education
Bachelors Degree
Position Type
Full time
Fate Therapeutics is seeking an enthusiastic and skilled researcher to join our company's Process Development Engineering Team. The successful candidate will join a multidisciplinary team evaluating new technologies and developing novel processes for the scaled-up manufacturing of cellular immune therapies from human induced pluripotent stem cells (iPSC). This position will assist senior members of the Process Development Engineering team in the development of scaled-up culture, differentiation, purification and characterization methods for iPSC-derived cellular therapy products. This position will actively support laboratory operations by coordinating the inventory, purchase and aliquoting of key reagents. This is a full-time position reporting to the Associate Director, Process Development Engineering. This position will require dedicated weekend hours and is located at our corporate headquarters in San Diego, CA.

Responsibilities
• Assist the development and tech transfer of GMP-compliant fill-finish processes
• Assist in the selection and evaluation of appropriate bioreactor platforms for the maintenance and expansion of feeder and iPSC-derived CAR-NK or CAR-T cell lines
• Extensive cell culture including the maintenance and expansion of feeder and iPSC-derived CAR-NK or CAR-T cell lines
• Apply engineering principles to design and implement system modifications, introduction of new processes and execution of new projects
• Track process trend, analyze problems, develop and propose solutions using data-driven techniques like RCA, SPC, Six Sigma etc.
• Support the inventory and ordering of general laboratory reagents and materials, as well as aseptic preparation of reagent stocks, including media, cytokines and small molecules
• Timely and detailed record keeping of all activities according to Fate's Good Document Practices (GDP) requirements
• Communicate experimental results to relevant team members and presentations at project and MSAT team meetings

Qualifications
• B.S. / M.S. degree in Biological, Biomedical Engineering, Chemical or Biochemical Engineering, Process Science or related fields with a minimum of 3 plus years of relevant biopharmaceutical operations / manufacturing experience. Position depends on education and experience.
• Expertise with small- and large-scale mammalian cell culture
• Hands-on experience with wave, stirred-tank bioreactor, and/or Grex platforms preferred
• Hands-on experience with manual/automated vial-filling platform preferred
• Experience using MES in a GMP-compliant environment preferred
• Hands-on experience with computation design of experiments (DoE) and statistical modeling/data analysis with R, SAS, SPSS or JMP software preferred
• Understanding of process development and immunology preferred
• Experience working in a regulated environment and/or be familiar with GMP quality systems/process such as change control, non-conformances, corrective and preventive actions (CAPA) and qualification/validation preferred
• Excellent record-keeping, communication and presentation skills; experience with Good Document Practices (GDP)/cGMP preferred
• Highly organized, self-motivated, possess a strong work ethic, and have the desire to acquire new technical skills in a fast-paced environment

Working Conditions and Physical Requirements
• Will require working with cells and cell lines of human and/or animal origin
• Will require working with hazardous materials
• 100% on-site work at corporate headquarters in San Diego, CA
• Evening and weekend work (Saturday or Sunday with equivalent time off in the
week)
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 505YQ.

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.