Sr. Scientist, Lentivirus Upstream Processing
$127.31k - $167.1kLegend Biotech USA, Inc.
Legend Biotech is a global biotechnology company dedicated to treating and, one day, curing life-threatening diseases. Headquartered in Bridgewater, New Jersey, we are advancing the next generation of cell therapy through a portfolio of innovative technologies, including autologous, allogeneic, and in vivo cell therapy approaches. Our research spans chimeric antigen receptor T-cell (CAR-T), T-cell receptor (TCR-T), natural killer (NK) cell-based therapies, and other emerging platforms designed to transform the treatment of serious diseases. From our global network of research and development sites, we are committed to discovering and developing safe, effective, and cutting-edge therapies for patients worldwide. Legend Biotech entered into a global collaboration agreement with Johnson & Johnson to jointly develop and commercialize CARVYKTI® (ciltacabtagene autoleucel; cilta-cel). Through this strategic partnership, we combine complementary expertise and capabilities to advance innovative immunotherapies for patients living with multiple myeloma. Legend Biotech is seeking a Sr. Scientist, Lentivirus Upstream Processing as part of the Technical Development team based in Somerset, NJ. Role Overview The Senior Scientist, Lentivirus Upstream Process Development, will be a core technical contributor responsible for designing, executing, and optimizing upstream production processes for lentiviral vectors (LVV) within our innovative pipeline. This role focuses on delivering high-quality, high-titer vector products to support LVV generation and other advanced cell therapy programs. The successful candidate will apply technical expertise in upstream processing (USP)-including seed train optimization, mammalian cell culture (HEK293/HEK293T), large-scale transient transfection, and bioreactor scale-up-to ensure processes are robust, scalable, and phase-appropriate for GMP manufacturing. This position demands a blend of hands-on technical mastery and strong analytical thinking to support project timelines while maintaining a patient-focused approach. Key Responsibilities
- Design and execute experimental strategies for lentiviral vector upstream production.
- Perform development and optimization of upstream processes, including seed train expansion, suspension mammalian cell culture (HEK293/HEK293T), plasmid transient transfection optimization, and feed batch/perfusion bioprocessing in stir-tank and rocker bioreactors.
- Support the establishment and validation of bioreactor scale-up and scale-down models to ensure process comparability and predictability.
- Support the translation of bench-scale processes to GMP manufacturing, assisting in technology transfer and providing troubleshooting support during clinical production runs.
- Execute study protocols to define operating parameters, feeding strategies, and performance limits; maintain accurate documentation for USP data.
- Communicate technical findings, issues, and potential delays to project leads in a timely manner.
- Collaborate with cross-functional team members, including CMC Project Management and other technical leads, to support project goals.
- Apply scientific knowledge and technology to optimize vector titer, specific productivity, and quality.
- Support team activities by providing technical guidance to junior staff, fostering a culture of scientific rigor and continuous improvement.
- Author and review technical documents, including development reports, SOPs, and relevant sections for regulatory submissions (IND).
- Work closely with Downstream Process Development and Analytical Development teams to ensure integrated process outcomes.
- Support tech transfer activities to/from other Legend sites or CDMOs.
- Ensure compliance with all internal and regulatory requirements.
- Advanced degree (PhD preferred, or MS) in Chemical Engineering, Bioengineering, or a related field.
- Experience: 5-8 years (PhD) or 8+ years (MS) of experience in process development or manufacturing within a biotech or pharmaceutical setting
- Hands-on experience in mammalian cell culture (HEK293, HEK293T), seed train expansion, feeding strategy, and transient transfection optimization specifically for viral vectors (Lentivirus preferred).
- Demonstrated proficiency in developing and implementing bioreactor scale-up and scale-down models.
- Solid understanding of GMP manufacturing requirements and CMC strategies for early-phase clinical trials.
- Direct experience with cell and lentiviral vector technologies within the current emerging field.
- Working knowledge in engineering modeling, mass transfer, and bioprocess optimization.
- Strong interpersonal and communication skills; ability to maintain focus and collaborate effectively during challenging development timelines.
- Analytical and creative thinking.
- Effective troubleshooting skills.
- Preferred experience in handling large-scale (>50L, e.g., 200L/500L) upstream bioreactor processes.
- Language(s):
- English. Mandarin is a plus.
Vacancy posted 10 days ago
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