Scientist/Associate Scientist, MSAT
San Diego, CA /
Technical Operations – Manufacturing Science and Technology (MSAT) /
Fate Therapeutics is seeking a Scientist to join our Manufacturing Science and Technology (MSAT) team. This position will work alongside a team of scientists and engineers on the late-stage process development, optimization, characterization, validation, and commercialization of Fate’s off-the-shelf, induced pluripotent stem cell (iPSC) product portfolio working closely with Process Development, Analytical Development, Quality Control, Quality Assurance, Manufacturing Operations, Supply Chain, Clinical, and Regulatory functions. This is a full-time, exempt position and is located at our corporate headquarters in San Diego, CA while reporting to the Director, Manufacturing Science and Technology (MSAT).
- Assess, plan, and execute safety and ergonomic initiatives in support of laboratory and manufacturing operations.
- Completion of quality records such a deviations, CAPAs, change controls, complaints and impact assessments.
- Performing risk management activities including assessment and mitigation planning
- Supporting make-assess-release activities for GMP manufacturing- through technical assessments
- Supporting and executing experiments in a pilot plant
- Representing the system owner for validation and enrollment activities pertaining to process equipment and GMP/pilot plant facilities
- Completion and support of guidance documents for development and GMP purposes
- Proposing data-driven initiatives to optimize and develop iNK/iT processes
- Learn, master, and apply process knowledge in support of experimental design, process implementations (tech transfer, process improvements, decommissioning, etc.) and education/training initiatives
- Collaborating within the MSAT team and broader organization, including but not limited to Process Development, Quality, Product Characterization & Analytical Development, Manufacturing Operations, IT and F&E, to align on business priorities and synergistically complete work
- B.S/ M.S degree in Biochemical/Chemical Engineering, Biotechnology, or Biological Sciences with 5+ years of relevant cGMP experience or PhD degree with 1+ years of relevant experience
- Project management experience preferred
- Cell culture process development experience preferred
- Experience leading and collaborating in cross functional team directives
- Experience implementing phase appropriate technology transfers in clinical and commercial preferred
- Knowledgeable in clinical and commercial scale cell/gene therapy manufacturing
- Experience with process characterization, validation & commercial PPQ deliverables
- Knowledgeable in risk management and techniques such as Gap Assessments, Risk Assessments, cause and effect diagrams, decision trees, interviewing, SWOT analysis, impact matrices, etc.
- Experience with change control management and quality systems to ensure proper planning, execution, communication, and deliverables
- Knowledgeable in QBD methodology and life cycle management such as QTPP, CQA, CPP, CMA, design space, control strategies, validation, monitoring, and continuous improvement
- Experience with cGMP best practices, methodology, regulatory, and compendial guidelines
Working Conditions and Physical Requirements
- Will require working with cells and cell lines of human and/or animal origin
- Will require working with hazardous materials
- On-site work at corporate headquarters in San Diego, CA with occasional travel (<10%)
- Evening and weekend work (Saturday or Sunday with equivalent time off in the week) may be required
- 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 $105,000 - $125,000
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.
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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.