Principal Scientist, Upstream Process, Process Development

Role Overview

The Principal Scientist, Lentivirus Upstream Process Development, will be a key technical leader responsible for designing, optimizing, and scaling 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 highly efficient upstream production strategies for lentiviral vectors.
• Direct the development and optimization of upstream processes including but not limited to: seed train expansion, suspension mammalian cell culture (HEK293/HEK293T), plasmid transient transfection optimization, and feed batch/perfusion bioprocessing in stir-tank and rocker bioreactors.
• Establish and validate robust bioreactor scale-up and scale-down models to ensure process comparability and predictability across different manufacturing scales.
• Direct the translation of bench-scale processes to GMP manufacturing, ensuring seamless technology transfer and providing troubleshooting support during clinical production runs.
• Provide hands-on training as needed.
• Lead the execution of study protocols to define operating parameters, feeding strategies, and performance limits; implement state-of-the-art knowledge management for USP data.
• Communicate the potential for issues and delays along with solutions and mitigation approaches.
• In collaboration with the Senior Leaders, CMC Project Manager, Project Leader, and other technical leads, identify project acceleration opportunities.
• Leverage advanced science and technology to maximize vector titer, specific productivity, and quality, identifying creative solutions to define unknowns in the viral vector production field.
• Guide a team of scientists in the execution of project-specific activities, fostering a culture of transparency, scientific rigor, and continuous improvement.
• Author and serve as a primary reviewer for technical documents, including development reports, SOPs, and CMC sections for regulatory submissions (IND).
• Work closely with Downstream Process Development and Analytical Development teams to ensure integrated and holistic process outcomes.
• Tech transfer process to/from other Legend sites or CDMOs.
• Resolve conflict and proactively identify/address performance issues.
• Ensure compliance with regulatory requirements.

Requirements

• Advanced degree (PhD preferred, or MS) in Chemical Engineering, Biomedical Engineering, Virology, Molecular Biology, or a related field.
• 8+ years (PhD) or 10+ years (MS) of experience in process development or manufacturing within a biotech or pharmaceutical setting.
• Deep technical hands-on experience in mammalian cell culture (HEK293, HEK293T), seed train expansion, feeding strategy and transient transfection optimization specifically for viral vectors (Lentivirus preferred).
• Proven expertise in developing and implementing bioreactor scale-up and scale-down models.
• Strong understanding of GMP manufacturing requirements and CMC strategies for early-phase clinical trials.
• Deep knowledge and hands-on experiences in cell and lentiviral vector technologies within the current emerging field.
• Strong knowledge in engineering modeling, mass transfer, and bioprocess optimization.
• Excellent leadership, emotional intelligence, and communication skills; ability to maintain composure and strategic focus during challenging development timelines.
• Creative, strategic thinking.
• Strong troubleshooting skills.
• PREFERRED: Experience in handling large-scale (>50L, e.g., 200L/500L) upstream bioreactor processes.
• Language(s): English. Mandarin is a plus.

Pay Range (Base Pay)

$146,410 - $192,164 USD