Senior Scientist, Cell Therapy Process… at GeneFab · Alameda

GeneFab is seeking a highly skilled Senior Scientist to join our Cell Therapy Process Development team in Alameda, CA. In this role, you will lead the design and optimization of integrated processes, bridging the gap between innovative synthetic biology and phase-appropriate cGMP manufacturing. If you have hands-on experience with automated cell processing and a passion for driving clinical readiness for next-generation genetic medicines, we want to hear from you.

Responsibilities:

• Design and perform experiments to optimize integrated processes for cell therapy, including: evaluation of cell sources, isolation and activation of human immune cells, media optimization, viral/non-viral genetic modification, cell expansion, cell harvest/fill/finish, and cryopreservation.

• Cell therapy process scaleup, including: transition from open processes to closed automated systems, understanding analytical methods, using a Design of Experiments (DoE) approach, and evaluating process choices within a Quality by Design (QbD) framework

• Exploration of new technologies or materials for process scale-up or improvements with quality mindset leading to clinical or commercial readiness.

• Cross-functional collaborations in project teams to translate scientific understanding to development of phase appropriate cGMP cell therapy manufacturing unit operations.

• Lead the design, execution, and analysis of experimental studies for new manufacturing technologies and processes

• Author and review study protocols, technical reports, ELNs, regulatory submissions.

• Support authoring of key documentation to enable technology transfer (e.g. sampling plans, batch records, specifications, SOPs, FMEA, flow diagrams, etc.).

• Help coordinate sample management workflow across Process and Analytical Development teams and manage development database

• Serve as a technical resource/SME for GMP operations (e.g. root cause analyses and continuous improvement initiatives)

• Coordinate and prioritize tasks across multiple projects

• Maintain familiarity with current state-of-the-art related to cell therapy processes

Qualifications:

• BS/MS with 6+ years or PhD with 4+ years of experience in science/engineering of biopharmaceutical or cell/gene therapy process development and technology transfer

• Hands-on experience with automated cell processing units or platforms (i.e. bioreactors, automated cell wash, fill and finish) is critical.

• Experience developing and optimizing cell therapy processes for GMP production with quality mindset

• Strong technical writing and communication skills to support both development and tech transfer applications

• Strong critical thinking, organizational skills, ability to work in multi-functional project teams, and attention to detail

• Experience with various types of cell therapy products (i.e. CAR-T, CAR-NK, HSC, MSC) is preferred

• Experience with AI solutions for CGT processes and working with LIMS is a plus

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.