Principal Scientist, Lentivirus Downstream Process Development

Key Responsibilities

• Design and execute highly efficient purification strategies for lentiviral vectors, specifically optimized for CAR-T applications.
• Direct the development and optimization of downstream processes including and not limited to: clarification (depth filtration, centrifugation), chromatography (AEX, SEC, HIC), and Tangential Flow Filtration (TFF) for concentration and diafiltration.
• Provide hands-on training as needed.
• Direct the translation of bench-scale processes to GMP manufacturing, ensuring seamless technology transfer and providing troubleshooting support during clinical production runs.
• Lead the execution of study protocols to define operating parameters and performance limits; implement state-of-the-art knowledge management for DSP 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 recovery, purity, and potency, identifying creative solutions to define unknowns in the viral vector 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/IMPD).
• Work closely with Upstream 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 purification, chromatography, and TFF specifically for viral vectors (Lentivirus preferred).
• 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.
• Ability to implement closed-system processes and maximize cost effectiveness.
• Strong knowledge in engineering modeling and 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 developing vector processes tailored for CAR-T generation and systemic delivery
• PREFERRED: Experience in handling large scale (>50L) purification process.