Senior Associate / Associate Scientist, Quality Control, Cell-based Assay
Fate Therapeutics is seeking a highly motivated Senior Quality Control (QC) Associate/Associate Scientist with cell-based assays, ELISA, and/or flow cytometry experience to support its expanding cellular therapy programs. This role will execute tests for manufacturing in-process control (IPC), lot release, and stability testing of clinical drug product within a GxP environment. Additionally, this role will participate in troubleshooting QC testing and method qualification. The successful candidate will be adept at executing analytical test methods, working with mammalian cell culture, and analyzing emerging data to assess the characteristics of hematopoietic and stem cell-based therapeutics. This is a full-time position reporting to a Scientist, Quality Control and is located at our corporate headquarters in San Diego, CA.
- Perform in-process control, lot release, and stability testing using cell-based assays, ELISA, and/or flow cytometry
- Ensure proper and timely completion of testing and tasks as assigned
- Report results in detailed and organized presentations and reports
- Participate in cross-functional training and identifying and facilitating continuous improvements
- Participate in technical transfer, qualification, and validation protocols for QC assays
- Onboard and organize new materials and reagents
- Identify and support initiation and completion of deviations, CAPAs, and laboratory investigations
- M.S. or B.S. degree in a scientific discipline with minimum of 4 years of biotechnology, clinical, or pharmaceutical laboratory experience is required.
- Hands on experimental skills with ELISA, cell line maintenance, cell-based assay is necessary. Experience with multi-color flow cytometry is preferred.
- Prior experience working in a regulated environment (e.g., GMP, GLP, or CLIA) is highly preferred.
- Experience on evaluating immune cell potency with cytokine release assay or cytolysis assay is a plus
- Experience on multiplex immunoassay (e.g., MSD, ELLA) is a plus.
- Strong scientific, analytical, problem solving, and communication skills as well as sound judgment, with the ability to work both independently and effectively with others.
- Highly organized, detail oriented with excellent record keeping abilities, and computer proficiency.
- Ability to work independently in a high paced team environment, to prioritize activities from multiple projects with little supervision.
Working Conditions and Physical Requirements:
- Will require working with cells and cell lines of human and/or animal origin
- Occasional evening and weekend work will be required
- 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.
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.