Scientist, Potency and Functional Characterization

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Job description

Description:

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 lead the 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 will 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.

Responsibilities:

• Lead development and optimization of phase-appropriate robust 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
• Lead training, qualification, and transfer of analytical methods to 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
• Preparation and qualification of critical reagents
• Perform previously established methods in support of process development, product release and stability, and product characterization

Requirements:

• PhD with 0-3 years, or MS with 8+ year of relevant industry experience in Immunology, Cell Biology, Cancer Biology, or related field.
• 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
• Experience with bioassay/bioanalytical development and identifying areas of improvement and troubleshooting assays
• Excellent communication, time management, record keeping, presentation, and data analysis skills
• Working knowledge of statistical and analytical tools and design of experiments (DoE) using JMP software desired
• Experience with cell culture (primary and established cell lines) and aseptic technique
• Track record of successful transfer and management of analytical methods
• Familiarity with ICH and USP guidelines for analytical method development
• Knowledge of NK and T cell biology is preferred
• Flow Cytometry experience is preferred, FACSDiva and/or CytoFlex platforms is a plus
• Experience analyzing flow cytometry data with FlowJo or FCS Express software is preferred
• Experience with cell line engineering and stable clone generation is a plus
• 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 may 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 .