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 Somerset, New Jersey, we develop advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T‑cell, T‑cell receptor (TCR‑T), and natural killer (NK) cell‑based immunotherapy. From our three R&D sites around the world, we apply these innovative technologies to pursue the discovery of safe, efficacious and cutting‑edge therapeutics for patients worldwide.

Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop and commercialize ciltacabtagene autolecuel (cilta‑cel). Our strategic partnership is designed to combine the strengths and expertise of both companies to advance the promise of an immunotherapy in the treatment of multiple myeloma.

We are 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 develop analytical methods and perform QC and in‑process sample testing to support the manufacture and characterization of Legend’s gene and cellular therapy pipeline, including first‑in‑human and new IND products. Responsibilities include analytical methods development, qualification and transfer; routine testing of final product (GMP), stability, and in‑process samples; data review and verification; instrument maintenance; accurate record‑keeping; and timely reporting of results.

• 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 samples.
• Review testing data (data packets, final lot file, COA).
• Perform data verification and review of GMP documentation for multiple methods and products.
• Cross‑train in multiple complex analytical methods and/or products.
• Train others on QC test methods, processes and procedures.
• Author and review/revise technical documents such as test methods, SOPs, specifications, trend reports and sample plans.
• Maintain accurate and updated lab notebooks.
• Manage equipment and records for maintenance, calibration and operation; contribute to laboratory inventory maintenance.
• Procure and qualify materials required for experiments or testing.
• Collaborate with Analytical Development team to establish analytical control strategy for established methods.
• Perform other tasks as assigned.
• Make decisions related to planning and execution of assay development runs; set weekly work priorities; seek higher‑level approval for significant methodological changes or strategic shifts.

• BS, MS, or Ph.D. in Molecular Biology, Cell Biology, Biochemistry, or a related field.
• BS: 6‑8 years of significant practical experience; MS: 4‑6 years of hands‑on experience in QC testing and method development for gene and cell therapy products, vaccine, antibody, AAV, or other biologics;
  Ph.D.: 1‑3 years of assay development experience in the pharmaceutical field.
• Demonstrated experience in assay development and GMP QC testing of biologics (qPCR, dPCR, ddPCR, ELISA, cell culture and cell‑based assays).
• Ability to understand, interpret, and apply global regulatory and cGMP requirements.
• Strong written and verbal communication; ability to collaborate with peers, management and cross‑functional teams.
• Proficiency working in fast‑paced environments, meeting deadlines, and prioritizing multiple projects.
• Advanced knowledge of LIMS, ELN, Veeva, Graph Pad Prism, JMP, and laboratory data analysis systems preferred.
• Expertise in analytical method qualification, validation, and tech transfer in In‑Vivo CAR‑T, vaccine, antibody, AAV, or other biologics is a plus.
• Mandarin language skills preferred.

Pay Range (Base Pay): $110,706 USD – $145,303 USD.

Performance‑based bonus and/or equity are available to eligible roles. Benefits include…