Associate Scientist, Potency and Functional Characterization
Fate Therapeutics is seeking a highly motivated and experienced individual to join the Analytical Sciences team to support the development of off-the-shelf pluripotent cell-derived NK and T cell cancer immunotherapies. The successful candidate will participate in method development and qualification of flow cytometry and cell-based assays to assess the function of engineered iPSC-derived NK and T cell therapies. They will also coordinate and enable critical laboratory activities by proactively addressing reagent and equipment needs, assisting in designing and executing key development experiments, and preparing necessary technical documents. The ideal candidate should have experience performing and developing assays for the assessment of cell phenotype, cytotoxicity, cytokine production, cell proliferation and/or cell health. This is a full-time position reporting to the Director, Potency Assays in the Analytical Sciences group and is located at our corporate headquarters and research facilities in San Diego, California.
- Support development and optimization of phase-appropriate cell-based potency (expression and MOA) and other functional bioassays that are used for in-process and final product lot release and stability testing as well as characterization studies for NK and T cell therapy programs
- Design new experiments, coordinate and execute laboratory experiments, and effectively prioritize multiple projects
- Perform data analysis and data trending to track assay performance and product characterization
- Maintain detailed experimental records, interpret data, and present data to functional and project teams
- Author and review technical documents, including technical reports and regulatory documents
- Document, manage, evaluate, and maintain data in a highly organized manner
- Perform assay transfer and training of QC team and provide ongoing technical support including document review
- Culture, maintain, and generate well-documented banks of cell lines and primary cells required for assay development
- Order and maintain stocks of lab reagents and samples
- Perform previously established methods in support of process development, product release and stability, and product characterization
- BS/MS degree with a minimum of 5 years relevant lab experience in flow cytometry and/or cell- based assays
- Experience with developing and troubleshooting cell-based assays for immune cell functional profiling (killing assays, cytokine production, proliferation, and migration), preferably for cell therapy products
- Flow Cytometry experience is preferred, FACSDiva and/or CytoFlex platforms a plus
- Working knowledge of statistical and analytical tools is required
- Experience with cell culture (primary and established cell lines) and aseptic technique is required
- Experience analyzing flow cytometry data with FlowJo or FCS Express software is preferred
- Experience with bioassay/bioanalytical development is strongly preferred
- Experience with cell line engineering and stable clone generation is a plus
- Experience identifying areas of improvement and troubleshooting assays is strongly preferred
- Excellent communication, time management, record keeping, presentation, and data analysis skills are required
- Familiarity with ICH and USP guidelines for analytical method development
- Experience in a GxP environment is strongly preferred
Working conditions and Physical Requirements:
- Will require working with cell lines of human origin
- May require working with rodent models
- 100% on-site work at corporate headquarters and research facilities in San Diego, CA
- Occasional evening and weekend work will be required
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.