Role Overview

Our client is seeking an accomplished Principal Scientist to join the Vector Biology Upstream Development team, where they will play a critical role in advancing next-generation lentiviral vector (LVV) manufacturing technologies for in vivo CAR-T cell therapy programs. This senior individual contributor will provide scientific leadership across early upstream process development, driving the creation of scalable, robust, and commercially viable manufacturing platforms from initial vector design through bench-scale bioprocess development.

Working at the intersection of molecular biology and bioprocess engineering, this individual will translate construct-level innovations into manufacturable upstream processes while collaborating closely with downstream processing, analytical development, and CMC teams to establish integrated development strategies that support clinical and commercial success.

Key Responsibilities

• Lead the development and optimization of early-stage upstream LVV manufacturing processes, establishing scalable seed train strategies from shake flask through bench-scale bioreactor systems.
• Apply advanced molecular biology expertise to evaluate and optimize vector design, including plasmid architecture, packaging systems, promoter selection, transgene configuration, and transfer vector engineering to maximize manufacturability and biological performance.
• Design, execute, and improve lentiviral production processes utilizing transient transfection methodologies as well as emerging stable producer cell technologies.
• Develop optimized media formulations, feeding strategies, and bioreactor operating parameters while identifying critical process parameters (CPPs) required for successful scale-up beyond laboratory development.
• Partner closely with downstream process development to ensure upstream process decisions align with purification requirements, harvest strategies, clarification methods, and overall product quality objectives.
• Plan and execute statistically driven development studies using Design of Experiments (DoE) and other risk-based methodologies to accelerate process understanding and establish robust development pathways.
• Serve as the scientific subject matter expert for upstream vector biology, providing technical leadership across multidisciplinary teams supporting IND-enabling and early development programs.
• Independently design experiments, interpret complex datasets, troubleshoot technical challenges, and develop mechanistic solutions that advance program objectives with minimal oversight.
• Summarize experimental findings into comprehensive technical reports, development packages, and presentations that support strategic decision-making and stage-gate reviews.
• Ensure all laboratory activities comply with biosafety requirements while maintaining thorough electronic documentation that supports reproducibility, technology transfer, and future GxP development.
• Promote scientific excellence by maintaining rigorous documentation standards and ensuring data integrity throughout all stages of research and process development.

Required Qualifications

• MS with 10+ years or PhD with 5–8+ years of industry experience in Bioengineering, Cell Biology, Chemical Engineering, Virology, Molecular Biology, or a related scientific discipline.
• Extensive hands-on experience developing viral vector manufacturing processes with demonstrated success translating early research into scalable upstream production platforms.
• Strong background in mammalian suspension cell culture, upstream bioprocess development, and viral vector manufacturing.
• Practical experience operating bench-scale bioreactors (up to approximately 50L preferred) with an understanding of process scale-up principles.
• Proven expertise supporting early process development within gene therapy, cell therapy, or viral vector manufacturing environments.
• Strong knowledge of transient transfection systems and/or stable producer cell line development.
• Experience applying Design of Experiments (DoE), multivariate analysis, and data-driven process optimization techniques.
• Familiarity with downstream purification technologies—including clarification, chromatography, and tangential flow filtration—and an understanding of how purification requirements influence upstream process design.
• Excellent organizational, communication, and scientific presentation skills with the ability to influence cross-functional technical teams.
• Demonstrated ability to manage multiple development programs while delivering high-quality scientific results within aggressive timelines.
• Experience maintaining detailed electronic laboratory notebooks and documentation practices that support reproducibility and regulatory readiness.