Lentiviral Vector Upstream Process Development

Key Responsibilities

• Explore, design and execute upstream process strategies of lentiviral vectors to increase quality and yield, and decrease impurities and cost, with a focus on innovation.

• Efficiently identify and solve technical problems during process development by leveraging solid knowledge of lentiviral vector science and technology.

• Work closely with Downstream Process Development and Analytical Development teams to ensure integrated and holistic process outcomes.

• 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.

• Tech transfer process to/from other Legend sites or CDMOs.

• Ensure compliance with regulatory requirements.

Requirements

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

• 1+ years of industry experience in mammalian suspension cell culture in bioreactor and upstream bioprocessing within a biotech or pharmaceutical setting.

• Understanding of process-related impurity profiles (harvest host cell proteins/DNA) 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.