Scientist, Process Development
Fate Therapeutics is seeking a skilled and highly motivated cell biologist to join our companys Process Development team to support the companys off-the-shelf cellular immunotherapy programs. The successful candidate will be part of a multidisciplinary, compliance-focused team to ensure that iPSC-derived products are manufactured to the highest regulatory standards. This role will be responsible to support preclinical activities including investigation and optimization of process-critical materials used in iPSC expansion, CD34 differentiation, and iNK and iT differentiation and expansion. Candidates must have extensive cell culture experience, experience with embryonic stem cells or iPSCs is a plus, and an understanding of immunology is preferred. This position requires prior experience in process development, with a proven record in design of experiment and optimization of mammalian cell culture processes. Prior experience in a cGMP environment is a plus. This is a full-time position reporting to a Principal Scientist, Process Development, and is located at our corporate headquarters in San Diego, CA.
- Perform, optimize, and analyze experiments involving all stages of iPSC-derived NK- and T- cell product manufacturing (iPSC expansion, CD34 differentiation, iNK differentiation and expansion, and iT differentiation and expansion)
- Perform characterization of stage-specific processes utilizing flow cytometry, FACS sorting, gene expression profiling, and media analysis
- Evaluate and replace process materials to meet cGMP and regulatory requirements of pre- and post-IND products
- Write study protocols under QA-oversight to support higher-grade process-critical material evaluations
- Collaborate with cross-functional teams to drive programs forward to meeting program goals (including IND submission, CMC amendments, initiation of manufacturing, etc)
- Act as a subject matter expert to collaborate with and present data to Process Development, R&D, Tech Ops, Quality and Regulatory and larger program-specific teams
- Collect, organize, and analyze data in a timely manner and in accordance with company policy
- Design and execute experimental plans to achieve project goals within a given time constraint
- Management of reagent inventory and communication to relevant team members.
- Ph.D. with a minimum of 2 years of relevant experience, or M.S. with a minimum of 5 years of relevant experience in biotech or pharmaceutical industry working in a cell biology, immunology, or bioengineering focused field
- Track record in process development of cellular therapy is highly desirable
- Hands-on experience with iPSC/ESC differentiation or immune cell culture is required
- Prior experience in performing laboratory techniques such as, but not limited to, multi- color flow cytometry, cell-based assays including proliferation and killing assays, cytokine detection, and single cell RNAseq
- Familiar with in vivo/in vitro cell models relevant to immune cell function
- Extensive knowledge in QbD, DOE, statistic data analysis is a plus
- Prior knowledge of cGMP materials compliance and testing is a plus
- Strong organization skills and ability to multitask
- Strong communication, writing, and presentation skills
- Positive outlook, willingness to learn, and a desire to work collaboratively in a team 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 as necessary
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.