GeneFab
Biotech
SeniorScientist,CellTherapyProcessDevelopment
Neural analysis suggests this role is
optimal for Senior candidates.
“Senior Scientist, Cell Therapy Process Development at GeneFab. Skills: Biologics manufacturing, Process validation. Develop and optimize cell therapy processes. Design and execute experiments”
What You'll Achieve.
Develop robust and scalable cell therapy processes; Ensure successful technology transfer; Support regulatory filings; Improve process efficiency and yield
Industry & Context.
Process optimization; Troubleshooting; Root cause analysis
What They're Looking For.
Must Have
4+ years process development experience, Bachelor's degree in a relevant scientific discipline
Nice to Have
Master's or PhD in a relevant scientific discipline, Experience with biologics manufacturing, Experience with cell therapy development
What You'll Do.
Develop and optimize cell therapy processes
Design and execute experiments
Perform process validation studies
Support technology transfer activities
Troubleshoot process deviations
Ensure compliance with GMP regulations
Write technical reports and protocols
Collaborate with cross-functional teams
How You'll Work.
Team & Collaboration
Cross-functional teams; Process development team; Manufacturing team; Quality assurance team
Communication Scope
Technical reports; Technical protocols
Full Job Description
## 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 proc
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