Scientist/Senior Scientist, Analytical Development (CONTRACT)
GeneFab•Alameda, CA
•$60 - $75
About The Position
The Scientist/Senior Scientist in Analytical Development will work within GeneFab’s Technical Development department, executing and supporting oversight of analytical functions—including method development, qualification, routine testing, and evaluation of new technologies—that support the development and manufacturing of cell and gene therapy products for new and existing clients. The role also supports GMP readiness through qualification protocol and report writing, qualification planning and strategy, and method lifecycle management.
Requirements
- BS or Ph.D. in a relevant scientific discipline, such as Biochemistry or Molecular Biology.
- For candidates with a BS, at least 7 years of relevant experience in analytical development and testing in the cell and gene therapy field; for candidates with a Ph.D., at least 2 years of relevant experience.
- Hands-on experience with cell therapy modalities such as CAR-T, TIL, CAR-NK, or MSC, and/or gene therapy modalities such as LVV or AAV.
- Ability to independently develop cell and gene therapy release and characterization assays, including drug substance/product identity, residual detection, and potency assays.
- Proficiency in analytical techniques used in cell and gene therapy, including qPCR/dPCR, flow cytometry, ELISA, and HPLC; extensive hands-on experience in flow cytometry and dPCR is required.
- Strong communication and project management skills and a commitment to cross-functional collaboration.
- Knowledge of cGMP and regulatory guidelines, including FDA and EMA guidance, and a track record of ensuring compliance in analytical operations.
- Experience driving assay qualifications and validations.
- Good understanding of ICH guidelines for assay qualification and validation.
- Basic understanding of method lifecycle management from development through validation and beyond.
- Ability to analyze and interpret data in the context of program goals and requirements in a phase-appropriate manner.
Nice To Haves
- Client-facing experience, including representing analytical development in client meetings, presenting data and technical updates clearly, and managing client expectations professionally.
Responsibilities
- Develop, optimize, and troubleshoot analytical methods for cell and gene therapy products.
- Conduct routine testing to support Process Development, including in-process recoveries, stability studies, and cell line characterization.
- Evaluate new technologies for potential implementation into QC.
- Partner with MSAT on process characterization and control strategies.
- Lead assay transfers to the quality control team, including writing SOPs and training QC analysts.
- Lead assay qualification activities, partnering with QC on planning, data analysis, and interpretation.
- Write qualification protocols and reports in accordance with regulatory guidelines.
- Use statistical tools and design of experiments (DOE) to support assay robustness and reliability.
- Provide technical expertise for investigations and troubleshooting.
- Represent GeneFab in analytical SME-to-SME meetings with current and prospective clients and in internal meetings.
- Collaborate with scientists, engineers, and quality teams to support project success and timelines.
- Manage and prioritize responsibilities across concurrent projects while ensuring timely delivery and quality.
- Ensure compliance with process operations that interact with GMP and regulatory guidelines.
- Foster scientific excellence and mentor team members.
- Stay current with industry trends and emerging technologies in cell and gene therapy analytics.
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What This Job Offers
Career Level
Senior
