Senior Scientist / Scientist, Quality Control
- Employer
- Fate Therapeutics
- Location
- San Diego, CA, United States
- Start date
- Aug 23, 2020
View more
- Discipline
- Quality, Science/R&D, Biotechnology
- Required Education
- Doctorate/PHD/MD
- Position Type
- Full time
- Hotbed
- Biotech Beach
Job Details
Responsibilities
• Perform GMP IPC, lot release, and stability testing using flow cytometry, qPCR, and/or cell-based methods
• Facilitate and perform method optimization, transfer, qualification, and validation for manufacturing in-process control (IPC), lot release, and stability testing of clinical drug product within a GMP environment
• Ensure timely completion of testing and tasks as assigned
• Report results in detailed and organized presentations and reports
• Participate in the evaluation of emerging data and trending analysis
• Participate in cross-functional training, as well as identifying and facilitating continuous method and process improvements
• Revise test methods, SOPs, raw material specification, and/or sample plans as appropriate
• Participate in lab maintenance and updates on equipment calibrations and equipment use logbooks according to cGMP standards
• Assist in the implementation of new assay methodologies and the associated instrumentation
• 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 Analytical Chemistry, Life Science, Microbiology, Biochemistry, or related discipline with a minimum of 2 years in biotechnology, clinical, or pharmaceutical QC laboratory experience is required
• Experience working in a regulated environment (e.g., GMP, GLP, or CLIA) is highly preferred
• Experience running multicolor flow cytometry, with working knowledge of BD flow cytometers, BD FACSDiva software, and FlowJo
• Experience running ddPCR, qPCR, ELISA, and/or cell-based assays
• 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 375AL.
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.
Company
Fate Therapeutics is a clinical-stage biopharmaceutical company dedicated to bringing a first-in-class pipeline of induced pluripotent stem cell (iPSC)-derived cellular immunotherapies to patients with cancer and autoimmune disorders. Using its proprietary iPSC product platform, the Company has established a leadership position in creating multiplexed-engineered iPSC lines and in the manufacture and clinical development of off-the-shelf, iPSC-derived cell products. The Company’s effector cell pipeline includes multiplexed-engineered, iPSC-derived natural killer (NK) cell and T-cell product candidates, which incorporate novel synthetic controls of cell function, such as chimeric antigen receptors (CARs) to target tumor-associated antigens and are intended to deliver multiple mechanisms of therapeutic importance to patients including in combination with well-established cancer therapies. Fate Therapeutics is headquartered in San Diego, CA. For more information, please visit www.fatetherapeutics.com.
- Website
- http://www.fatetherapeutics.com/
- Phone
- 858.875.1800
- Location
-
12278 Scripps Summit Drive
San Diego
California
92131
United States
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