Fate Therapeutics, Inc. is seeking a highly motivated Senior Scientist or Scientist of Quality Control (QC) with cell-based, flow cytometry and/or ELISA assay experience to support its cellular therapy programs. This role will focus primarily on cell-based potency testing and will also cross-train on flow cytometry and ddPCR analytical methods. This role will be responsible for providing oversight and support for execution, optimization, transfer, qualification, and validation of analytical methods supporting manufacturing in-process control (IPC) and lot release of product, within a Good Manufacturing Practices (GMP) environment. The successful candidate will have experience participating in high performing teams executing analytical test methods, working with mammalian cell culture, analyzing emerging data to assess the characteristics of hematopoietic and stem cell-based therapeutics, and GMP method qualification and validation. This role requires extensive interaction with Research & Development, Quality Assurance, Program Management, Regulatory Affairs, Technical Operations, and Contract Manufacturing Organizations (CMOs). This is a full-time position reporting to the Director, Environmental Monitoring & Microbiology and is located at our corporate headquarters in San Diego, CA.Responsibilities
- Perform GMP IPC, lot release, and stability testing using cell-based methods, flow cytometry, and qPCR.
- 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.
- Establish robust method development strategies and implementation strategies, inclusive of method qualification and validation, to ensure product quality and to meet regulatory requirements.
- Report results in detailed and organized presentations and reports.
- Participate in cross-functional training, as well as identifying and facilitating continuous method and process improvements.
- Write and 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.
- Identify and support initiation and completion of deviations, CAPAs, and laboratory investigation.
- Perform technical review of assay data.
- Participate in and prepare for regulatory audits including representing QC in auditor-facing roles as well as supporting lab audit readiness activities.
- Perform product quality lead activities, including but not limited to keeping detailed manufacturing and testing schedules, tracking completion of method revisions and applicable change controls, and representing QC in cross-functional meetings.
- May supervise or mentor junior team members.
Working conditions & physical requirements
- Ph.D. 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 desired. Master’s degree with a minimum of 6 years of relevant and progressive experience may be considered.
- Experience working in a regulated environment (e.g., GMP, GLP, or CLIA) is required. Experience in a Quality Control laboratory is preferred.
- Well-experienced in immune cell cytotoxicity assay, ELISA, and/or other cell-based assays.
- Well-experienced in multicolor flow cytometry, with working knowledge of flow cytometers (e.g., BD FACSCanto or Beckman Coulter Cytoflex) and analysis software (e.g., FACSDiva, CytExpert, or FlowJo).
- Experienced in molecular biology assays (e.g., qPCR or ddPCR) is a plus.
- Experienced in analytical method development, qualification and/or validation.
- Experienced in OOS and laboratory investigation in GMP environment.
- 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.
- Subject to extended periods of sitting and standing, vision to monitor, and moderate noise levels.
- Will require working with cells and cell lines of human and/or animal origin.
- Will require working with hazardous materials.
- May require work in controlled and cGMP Manufacturing environments requiring special gowning.
- The salary offer will be based on a variety of factors, including level, experience, qualifications, internal equity, and location.
- Fate offers a competitive employment package that includes an annual bonus, equity, and a generous benefits package.
- The anticipated salary range for this role is $130,000 - $150,000.
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.Equal Employment Opportunity
Fate Therapeutics, Inc. is an equal opportunity employer. We value diversity and are committed to creating an inclusive environment for all employees.Privacy Notice
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.About Fate Therapeutics, Inc.
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