Scientist II, Analytical Development, Gene Editing and Molecular Assays

Responsibilities

• Develop, optimize, and qualify molecular biology methods for parameters such as VCN, gene editing proficiency, and infectious titer
• Serve as a subject matter expert supporting routine testing of final product (GMP), stability, and in-process samples
• Perform review of testing data, including data packets, final lot files, and COA review
• Author and review technical documents such as test methods, SOPs, specifications, and trend reports
• Manage equipment maintenance, calibration, and laboratory inventories
• Work collaboratively to establish analytical control strategies for established methods

Requirements

• BS, MS, or Ph.D. in Molecular Biology, Cell Biology, Biochemistry, or a related field
• Relevant experience: BS (6-8 years), MS (4-6 years), or Ph.D. (1-3 years) in QC testing and method development for gene/cell therapy or biologics
• Demonstrated experience in assay development and GMP QC testing (e.g., qPCR, dPCR, ddPCR, ELISA, Cell culture)
• Ability to follow and apply Global Regulatory and cGMP requirements
• Proficiency in laboratory data analysis tools (e.g., GraphPad Prism, JMP, LIMS, ELN)
• Strong written and verbal communication skills

Preferred Qualifications

• Expertise in analytical method qualification, validation, and tech transfer for CAR-T, Vaccine, Antibody, or AAV
• Knowledge of Veeva, PowerBI, or LabVantage
• Fluency in Mandarin

About the Company

Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases through advanced cell therapies, including CAR-T and NK cell-based immunotherapy.