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.
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- 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
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- Exploration of new technologies or materials for process scale-up or improvements with quality mindset leading to clinical or commercial readiness.
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- Cross-functional collaborations in project teams to translate scientific understanding to development of phase appropriate cGMP cell therapy manufacturing unit operations.
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- Lead the design, execution, and analysis of experimental studies for new manufacturing technologies and processes
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- Author and review study protocols, technical reports, ELNs, regulatory submissions.
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- Support authoring of key documentation to enable technology transfer (e.g. sampling plans, batch records, specifications, SOPs, FMEA, flow diagrams, etc.).
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- Help coordinate sample management workflow across Process and Analytical Development teams and manage development database
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- Serve as a technical resource/SME for GMP operations (e.g. root cause analyses and continuous improvement initiatives)
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- Coordinate and prioritize tasks across multiple projects
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- Maintain familiarity with current state-of-the-art related to cell therapy processes
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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
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- Hands-on experience with automated cell processing units or platforms (i.e. bioreactors, automated cell wash, fill and finish) is critical.
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- Experience developing and optimizing cell therapy processes for GMP production with quality mindset
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- Strong technical writing and communication skills to support both development and tech transfer applications
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- Strong critical thinking, organizational skills, ability to work in multi-functional project teams, and attention to detail
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- Experience with various types of cell therapy products (i.e. CAR-T, CAR-NK, HSC, MSC) is preferred
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- Experience with AI solutions for CGT processes and working with LIMS is a plus
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$140,000 - $175,000 a year
