Quality Control Associate, Assay Development and Quality Control
Fate Therapeutics is seeking a motivated individual with flow cytometry and cell-based assay experience to support Fate’s clinical and manufacturing process development programs. The successful candidate will execute and analyze experiments using flow cytometry and other cell-based assays to assess the potency of hematopoietic and stem cell-based therapeutics under clinical development. Candidates should have experience working with human specimens, including sample preparation, assay development, and analysis of data from cell-based assays, including flow cytometry. This is a full-time position reporting to the Supervisor of Developmental Quality Control and is located at our corporate headquarters in San Diego.
- Accessioning clinical samples, isolating peripheral blood mononuclear cells from human blood products, and cryopreservation of PBMCs
- Perform flow cytometry and other cell-based assays to support Fate’s clinical programs including testing of human specimens from ongoing clinical trials and samples from manufacturing processes
- Execute, and analyze data from flow cytometry experiments using an 8-color, 10-parameter flow cytometer
- Performing ELISA or MSD/Luminex testing
- Compile raw data, perform data trending, and write detailed comprehensive summary reports of assay development and quality control activities
- Provide support in document review, data entry, and data analysis
- Review SOPs and associated forms for documentation of assay performance and reporting of assay results
- Assist with general maintenance of the laboratory, equipment, and inventory
- B.S. degree in Biological Sciences or other related field with a minimum 2+ years of laboratory experience in clinical or biopharmaceutical setting
- Multicolor flow cytometry experience is a must; experience with the BD flow cytometers, BD FACSDiva software and FlowJo are required
- Experience working with human blood and blood products using sterile technique, cell culture or other related experience
- ELISA and/or electrochemiluminescence detection (MSD) experience a plus
- Highly organized, detail oriented with excellent record keeping abilities, and strong analytical and problem solving skills
- Must work well in a collaborative environment and have excellent communication skills (written and verbal)
- Qualified applicants should have familiarity with hematopoetic cell populations
- Familiarity with a GLP, GMP, or CLIA laboratory environment is preferred
Working Conditions and Physical Requirements
- Will require working with cells and cell lines of human and/or animal origin
- Occasional evening and Saturday 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 from time to time.
For consideration send cover letter and curriculum vitae to: firstname.lastname@example.org and reference job 194DF.
About Fate Therapeutics, Inc.
Fate Therapeutics is a clinical-stage biopharmaceutical company dedicated to the development of first-in-class cellular immunotherapies for cancer and immune disorders. The Company is pioneering the development of off-the-shelf cell therapies using its proprietary induced pluripotent stem cell (iPSC) product platform. This platform uniquely enables the single-cell selection of a precisely engineered iPSC clone and the subsequent creation and maintenance of a clonal master iPSC line. Analogous to master cell lines used to manufacture biopharmaceutical drug products such as monoclonal antibodies, clonal master iPSC lines are a renewable source for consistently and repeatedly manufacturing homogeneous cell products in quantities that support the treatment of many thousands of patients in an off-the-shelf manner. The Company’s immuno-oncology pipeline is comprised of FATE-NK100, a donor-derived natural killer (NK) cell cancer immunotherapy that is currently being evaluated in three Phase 1 clinical trials, as well as iPSC-derived NK cell and T-cell immunotherapies, with a focus on developing augmented cell products intended to synergize with checkpoint inhibitor and monoclonal antibody therapies and to target tumor-specific antigens. The Company’s immuno-regulatory pipeline includes ProTmune™, a next-generation donor cell graft that is currently being evaluated in a Phase 2 clinical trial for the prevention of graft-versus-host disease, and a myeloid-derived suppressor cell immunotherapy for promoting immune tolerance in patients with immune disorders. Fate Therapeutics is headquartered in San Diego, CA. For more information, please visit www.fatetherapeutics.com.