Scientist II, Analytical Development, Gene Editing and Molecular Assays

Scientist II, Analytical Development, Gene Editing and Molecular Assays

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.

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 develop analytical methods, qualify and transfer them internally or externally, perform routine testing of final product (GMP), stability, and in‑process samples, and review and verify data.

The role also includes lab and instrument maintenance, maintaining accurate records in a lab notebook, and reporting results in a timely manner.

• 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.
• Serve as subject matter expert supporting routine testing of final product (GMP), stability, and in‑process.
• Review testing data (e.g., data packets, final lot file, COA review).
• Perform data verification and review of GMP documentation for multiple methods (general and complex) and/or products.
• Cross‑train in multiple complex analytical methods and/or multiple products.
• Train others on multiple QC test methods, processes and procedures.
• Author and review or 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.
• Have authority to make decisions related to planning and execution of assay development runs and weekly work priority; higher‑level approvals are required for significant changes or collaborations with other functional teams.

• 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, or other Biologics; or a Ph.D. with 1‑3 years of assay development experience in the pharmaceutical field.
• Demonstrated experience in assay development and GMP QC testing of biologicals (e.g., qPCR, dPCR, ddPCR, ELISA, cell culture and cell‑based assays).
• Ability to accurately understand, follow, interpret and apply Global Regulatory and cGMP requirements.
• Strong communication skills with peers, department management and cross‑functional colleagues about task status, roadblocks and needs.
• Advanced ability to work in a fast‑paced team environment, meet deadlines, and prioritize work from multiple projects.
• Advanced knowledge of LIMS, ELN, Veeva, Graph Pad Prism, JMP and laboratory data analysis systems preferred.
• Expertise in analytical method qualification and validation, and tech transfer in In Vivo CAR‑T, Vaccine, Antibody, AAV, or other Biologics is a plus.
• Mandarin language preferred.

It is the policy of Legend Biotech to provide equal employment opportunities without regard to actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, related medical conditions and lactation), gender identity or gender expression (including transgender status), sexual orientation, marital status, military service and veteran status, disability, genetic information, or any other protected characteristic under applicable federal, state or local laws or ordinances.

Employment is at‑will and may be terminated at any time with or without cause or notice by the employee or the company.

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