Senior Scientist, Lentiviral Vector Downstream Process Development

Key Responsibilities

• Explore, design and execute experiments to develop scalable, cost-effective LVV purification processes for in vivo applications, targeting yield, purity, potency, and consistency.

• Execute and optimize clarification, chromatography, UF/DF/TFF, sterile filtration, formulation, and fill/finish steps; define early-stage in-process controls and operating ranges.

• Develop representative scale-down models; support scale-up to pilot and clinical manufacturing.

• Evaluate and implement next-generation purification technologies and consumables to improve efficiency, quality and robustness.

• As functional representative, participate in pipeline development or innovation program advancement.

• In collaboration with the Senior Leaders, CMC Project Manager, Project Leader, and other technical leads identify project acceleration opportunities.

• Author and serve as a primary reviewer for technical documents, including development reports, SOPs, and CMC sections for regulatory submissions.

• 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

• Ensure compliance with regulatory requirements.

Qualifications：

• PhD degree in Virology, Chemical Engineering, Biomedical Engineering, Molecular Biology, or a related field.

• 1+ years of industry experience in down-stream process development within a biotech or pharmaceutical setting.

• Practical proficiency in clarification, chromatography, UF/DF/TFF, sterile filtration, and formulation; understanding of viral vector-specific impurity profiles (host cell proteins/DNA, process residuals) and strategies to control them.

• Proven troubleshooting skills, and creative and strategic thinking.

• Excellent leadership, emotional intelligence, and communication skills; ability to maintain composure and strategic focus during challenging development timelines.

• Strong self-motivation and keeping learning.

• Language(s): Mandarin and English.