Scientist II, Analytical Development

Responsibilities

• Focus on assay development and optimization, including potency, flow cytometry, and bioanalytical assays
• Develop and qualify analytical methods to support LVV characterization, including infectious titer and vector potency assays
• Manage tech transfer of methods to QC and perform assay pre-qualification and qualification activities
• Generate standard operating procedures (SOPs) and laboratory protocols for product release and characterization
• Collaborate cross-functionally with PD, QC, and Manufacturing teams
• Present scientific data and trends at internal and external forums
• Maintain proper documentation including ELN, test method development plans, and equipment logs

Requirements

• PhD or Master in scientific discipline or engineering with 2-5 years of related experience
• Expertise in analytical method development and qualification/validation
• Experience in multicolor flow cytometry, cell culture, potency assays, and immunoassays
• Experience developing LVV residual impurities assays
• Solid understanding of ICH guidelines and regulatory expectations
• Proficiency with GraphPad Prism, FlowJo, and ELN systems
• Excellent scientific/technical writing and presentation skills

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, TCR-T, and NK cell-based immunotherapies.