Quality Control Associate II

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Job description

Description:

Fate Therapeutics is seeking a highly motivated Quality Control (QC) Associate with molecular biology, flow cytometry, or cell-based assay/ELISA experience to support its expanding cellular therapy programs. This role will support manufacturing in-process control (IPC), lot release, and stability testing of clinical drug product within a GXP environment. Additionally, this role may provide limited technical support and troubleshooting for the support of IPC, lot release, and stability testing. The successful candidate will execute tasks associated with the Sample Testing/Management, and other Lab Support QC functions, as well as have cross-functional interaction with personnel from Quality Assurance, Analytical Development, Manufacturing and Materials Management. This is a full-time position reporting to a Scientist or an Associate Scientist, Quality Control and is located at our corporate headquarters in San Diego, CA.

Responsibilities:

• Work in the Quality Control department to perform on bench molecular biology, flow cytometry or cell-based assay/ELISA testing for in-process control (IPC), lot release, and stability testing of clinical drug product.
• Execute processes to support sample receipt and processing for release/stability samples for testing and retention.
• Ensure proper and timely completion of testing and tasks as assigned.
• Revise test methods or equipment SOPs as appropriate.
• Participate in cross-functional training.
• Identify and facilitate continuous improvements in QC laboratory and systems.
• Maintain instrumentation and supporting documentation in a cGMP compliant manner.
• Assist in the implementation of new assay methodologies and the associated instrumentation.
• Identify and support initiation and completion of deviations, CAPAs, and laboratory investigations.

Qualifications:

• B.S. degree in Biological Sciences or other related field, with a minimum of 2 years of biotechnology, clinical, or pharmaceutical industry.
• Prior experience in QC laboratory or regulated environment (e.g., GMP, GLP, or CLIA) is highly preferred.
• Preferred experimental skills: RNA/DNA extraction, qPCR, FACS, ELISA or cell-based assays.
• Proficient with aseptic techniques for working with cell culture, human blood, and blood products is desired.
• Experience in droplet digital PCR (ddPCR), multi-color flow cytometry, or immune cell functional assays 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 fast-paced team environment and prioritize activities from multiple projects with supervision from manager.

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 .