Senior Scientist, Cell Therapy Process Development

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 andperform experiments tooptimizeintegrated 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 analyticalmethods, using a Design of Experiments (DoE) approach,and evaluating process choiceswithin a Quality by Design (QbD) framework Exploration ofnew technologiesor materialsfor process scale-up or improvementswith quality mindsetleading to clinical or commercialreadiness. Cross-functional collaborations inproject teams totranslate scientific understanding to development ofphaseappropriatecGMPcell 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, regulatorysubmissions. 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 teamsand manage development database Serve as a technical resource/SMEfor GMP operations (e.g.root cause analyses and continuous improvement initiatives) Coordinate and prioritize tasks across multiple projects Maintain familiarity with currentstate-of-the-artrelated to cell therapy processes Qualifications BS/MSwith6+yearsorPhDwith4+yearsof experiencein science/engineeringofbiopharmaceutical or cell/gene therapyprocess 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 andoptimizingcell therapy processes for GMP productionwith quality mindset Strong technical writing and communication skills to support both development and tech transfer applications Strongcritical thinking,organizational skills,ability to work in multi-functional project teams, and attention to detail Experience withvarious typesof cell therapy products (i.e.CAR-T, CAR-NK, HSC, MSC) is preferred Experience with AI solutionsforCGT processesand working with LIMSis a plus $140,000 - $175,000 a year 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. #J-18808-Ljbffr GeneFab