Senior Research Associate, MSAT
Fate Therapeutics is seeking an enthusiastic and skilled cell biologist to join our companys Manufacturing Science and Technology (MSAT) 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). The candidate will lead and support projects in the Down Stream MSAT team to develop scaled-up or scaled-down 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 Principal Scientist, MSAT. This position will require dedicated weekend hours and is located at our corporate headquarters in San Diego, CA.
- Support/lead studies to characterize and optimize the current manufacturing process for Fates iPSC-derived immunotherapy products
- Support scale-up studies to enable the development of commercial stage processes for Fates products
- Support implementation of process changes and scaled-up processes to cGMP manufacturing
- Conduct phenotypic and functional characterization of Fates products utilizing microscopy, flow cytometry, and cell-based assays
- Conduct cell culture including the maintenance and expansion of feeder cells and iPSC lines and derivatives
- 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 Fates Good Document Practices (GDP) requirements
- Communicating experimental results to relevant team members and by presentations at MSAT team meetings
- B.S. / M.S. degree in Biological sciences, Biomedical Engineering, Chemical or Biochemical Engineering, Process Science or related fields with a minimum of 3 plus years of relevant biopharmaceutical operations / manufacturing experience. Expertise with mammalian cell culture and excellent aseptic technique is required
- Prior experience running multi-color flow cytometry assays and performing data analysis is highly desired
- Experience with downstream drug product fill/finish processing, cell banking and cryopreservation optimization is a plus
- Knowledge of differentiation of iPSCs, bioreactors, process development and/or immunology is a plus
- Excellent record-keeping, communication and presentation skills; experience with Good Document Practices (GDP)/cGMP 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
- Highly organized, 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 and 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.
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.