Senior Scientist, Quality Control

Location
San Diego, CA, United States
Posted
Dec 19, 2020
Ref
444AL
Hotbed
Biotech Beach
Required Education
Doctorate/PHD/MD
Position Type
Full time
Fate Therapeutics, Inc. is seeking a highly motivated Quality Control (QC) Senior Scientist with molecular biological assay experience including qPCR and ddPCR to support its expanding cellular
therapy programs. This role will provide oversight for a team of QC scientists and associates. This team support execution, optimization, transfer, qualification, and validation of methods for manufacturing in-process control (IPC), lot release, and stability testing of clinical drug product within a Good Manufacturing Practices (GMP) environment. This is a full-time position located at our corporate headquarters in San Diego, CA reporting to the Associate Director, Quality Control.

Responsibilities
• Perform QC testing using qPCR, ddPCR and/or flow cytometry, cell-based methods
• Provides assigned assay-related technical expertise in cross-functional teams and perform
method optimization, transfer, qualification, and validation for lot release testing of clinical drug product within a GMP environment
• Author and review method qualification protocols reports and SOPs
• Actively contribute to cross-functional training, as well as assures strict adherence to GMPs and regulations to support clinical manufacture
• Supervise and mentor junior scientists and associates to ensure timely completion of testing and
tasks as assigned by management
• Participate in the evaluation of emerging data and trending analysis
• Participate in lab maintenance and updates on equipment calibrations and equipment use logbooks according to cGMP standards
• Onboard new materials and reagents and participate in materials risk assessment
• Identify and support initiation and completion of deviations, CAPAs, and laboratory investigations

Qualifications
• PhD in Molecular Biology, Biochemistry, or related discipline with a minimum of 2 years in biotechnology, clinical, or pharmaceutical QC laboratory experience is required
• Experience developing and performing qPCR and ddPCR assays in a regulated environment (e.g., GMP, GLP, or CLIA) is highly preferred
• Experience in NGS and/or other molecular biological assays is plus
• Experience in multicolor flow cytometry and/or cell-based assays is plus
• Experience working with cell culture, human blood, and blood products using sterile technique
• 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 in a high-paced team environment, meet deadlines, and prioritize work 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 from time to time. For consideration send cover letter and curriculum vitae to: careers@fatetherapeutics.com and reference job 444AL.

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 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 product candidates include natural killer (NK) cell and T-cell cancer immunotherapies, which are designed to synergize with well-established cancer therapies, including immune checkpoint inhibitors and monoclonal antibodies, and to target tumor-associated antigens with chimeric antigen receptors (CARs). The Company's immuno-regulatory product candidates include ProTmune™, a pharmacologically modulated, 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.