Sr. Scientist, Lentivirus Upstream Processing
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.
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.
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.
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
Handling large-scale (>50L, e.g., 200L/500L) upstream bioreactor processes.
Mandarin is a plus.