Scientist II, Analytical Development, Gene Editing and Molecular Assays

Legend Biotech is a global biotechnology company dedicated to treating and, one day, curing life-threatening diseases. Headquartered in Bridgewater, New Jersey, we are advancing the next generation of cell therapy through a portfolio of innovative technologies, including autologous, allogeneic, and in vivo cell therapy approaches. Our research spans chimeric antigen receptor T-cell (CAR-T), T-cell receptor (TCR-T), natural killer (NK) cell-based therapies, and other emerging platforms designed to transform the treatment of serious diseases. From our global network of research and development sites, we are committed to discovering and developing safe, effective, and cutting-edge therapies for patients worldwide.

Legend Biotech entered into a global collaboration agreement with Johnson & Johnson to jointly develop and commercialize CARVYKTI® (ciltacabtagene autoleucel; cilta-cel). Through this strategic partnership, we combine complementary expertise and capabilities to advance innovative immunotherapies for patients living with multiple myeloma.

Legend Biotech is seeking a Scientist II, Analytical Development, Gene Editing and Molecular Assays as part of the Technical Development team based in Somerset, NJ .

Role Overview

This position will be responsible for developing analytical methods and performing QC and in process sample testing to support the manufacture and characterization of Legend’s gene and cellular therapy pipeline and first-in-human/new IND products. The individual will be responsible for analytical methods development, qualification and internal or external transfer; routine testing of final product (GMP), stability, and in-process samples; and performing data review and verification, lab and instrument maintenance etc. The position will be responsible for maintaining accurate and contemporaneous records in a lab notebook and reporting results in a timely manner.

Key Responsibilities

• Develop, optimize and qualify molecular biology methods for parameters such as: VCN, gene editing proficiency, infectious titer, genomic titer, rapid mycoplasma, surrogate RCL, residual DNA, etc.
• Subject matter expert supporting routine testing of final product (GMP), stability, and in-process.
• Perform review of testing data (e.g., data packets, final lot file, COA review).
• Perform data verification, data review and review of GMP documentation for multiple methods (general and complex) and/or products.
• Cross trained in multiple complex analytical methods and/or multiple products.
• Train others on multiple QC test methods, processes and procedures.
• Author and review/ revise technical documents such as test methods, SOPs, specifications, trend reports and/or sample plans as appropriate.
• Maintain accurate and updated lab notebooks.
• Manage equipment and records for maintenance, calibration and operation. Contribute to maintenance of laboratory inventories.
• Procure and qualify required materials to perform experiments or testing.
• Work collaboratively with members of Analytical Development team to establish the analytical control strategy of the established methods.
• Perform other tasks as assigned.
• Typically, you have the authority to make decisions related to planning and execution of assay development runs. You can also make decisions related to weekly work priority. Higher-level approvals are required for those related to significant assay development methodology change, strategic shifts, or collaborations with other functional teams.

Requirements

• BS, MS or Ph.D. in Molecular Biology, Cell Biology, Biochemistry, or a related field.
• A BS with 6-8 years of significant practical experience; a MS with 4-6 years of hands-on experience in QC testing and method development and qualification of gene and cell therapy products, Vaccine, Antibody, AAV, other Biologics; or a Ph.D. with 1-3 years of assay development exper