Principal Scientist, Lentivirus Downstream Process Development
- 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.
- 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.
- Language: English. Mandarin is a plus.
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