Scientist/Senior Scientist, Analytical… at GeneFab · Alameda

The Scientist/Senior Scientist in Analytical Development will assume a pivotal role within GeneFab’s Technical Development department, executing against and supporting oversight of the analytical functions (method development, qualification, routine testing, and new technology evaluation) that are integral to the successful development and manufacturing of cell and gene therapy products for new or existing clients. The scientist will also support activities required for GMP readiness (qualification protocol and report writing, qualification planning and strategy and method lifecycle management).

Responsibilities:

• Execute development, optimization and troubleshooting of analytical methods for cell and gene therapy products, ensuring technical excellence.

• Execute routine testing activities to support Process Development (PD), including in-process recoveries, stability studies, and cell line characterization.

• Evaluate new and innovative technologies for implementation into QC.

• Partner with MSAT on process characterization and control strategies.

• Lead assay transfer to quality control team, including writing SOPs and training QC analysts.

• Take a lead role in assay qualification activities, including partnering with QC, planning qualifications, data analysis and interpretation.

• Write qualification protocols and qualification reports in accordance to regulatory guidelines.

• Implement statistical tools and design of experiments (DOE) to ensure robustness and reliability of assays.

• Provide technical expertise and support for investigations and troubleshooting activities.

• Represent GeneFab in analytical SME-to-SME meetings with current and prospective clients as well as in internal meetings.

• Collaborate with cross-functional teams, including scientists, engineers, and quality to support project success and timelines.

• Manage and prioritize responsibilities across multiple concurrent projects, ensuring timely delivery without compromising quality.

• Ensure compliance with process operations which interact with Good Manufacturing Practices (GMP) and regulatory guidelines.

• Foster a culture of scientific excellence and mentor team members.

• Stay current with industry trends and emerging technologies in cell and gene therapy analytics.

Requirements

• BS or Ph.D. in a relevant scientific discipline (e.g., Biochemistry, Molecular Biology), with a minimum of 7+ years of relevant experience (BS) or 2+ years of relevant experience (Ph.D.) in analytical development and testing in the cell and gene therapy field.
• Hands-on experience with cell therapy (e.g., CAR-T, TIL, CAR-NK, MSC) and/or gene therapy (e.g., LVV, AAV) modalities.
• Demonstrated ability to independently develop CGT release and characterization assays, including drug substance/product identity, residual detection, and potency assays etc.
• Proficiency in a broad range of analytical techniques used in cell and gene therapies (qPCR/dPCR, Flow Cytometry, ELISA, HPLC), with extensive, hands-on experience in flow cytometry and dPCR required.
• Strong communication and project management skills, with a commitment to cross functional collaboration.
• Knowledge of cGMP and regulatory guidelines (e.g., FDA, EMA) and a track record of ensuring compliance in analytical operations.
• Experience driving assay qualifications and validations.
• Good understanding of ICH guidelines for assay qualification/validation.
• Basic understanding of method lifecycle management from development to validation and beyond.
• Ability to analyze and interpret data and contextualize with the program goals and requirements in a phase-appropriate manner.
• Client-facing experience is preferred, with the ability to represent analytical development in client meetings, present data and technical updates clearly, and manage client expectations professionally.

(Compensation for this role is determined by candidate experience)

About GeneFab

GeneFab is a contract manufacturing and synthetic biology biofoundry focused on cell and gene therapies. GeneFab was formed in 2023 with a vision to combine industry leading expertise in synthetic biology with advanced cGMP capabilities in order to accelerate the development and commercialization of genetic medicines. GeneFab offers its customers an extensive technology platform and know-how that spans early stage product design, technical development, and cGMP compliant production. GeneFab's technology platform includes bioinformatic-guided discovery of cell type promoters, directed evolution of small molecule-regulated gene switches, and the engineering of highly sensitive kill switches for enhanced safety and control of cellular therapies.

We are committed to an inclusive and diverse GeneFab. We believe that different perspectives lead to better ideas, and better ideas allow us to better understand the needs and interests of our diverse GeneFab team. We welcome people of different backgrounds, experiences, abilities, and perspectives and are an equal opportunity employer.