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 are developing 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.

Scientist II, Analytical Development, Gene Editing and Molecular Assays – Technical Development team, 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, qualify, and transfer analytical methods; conduct routine testing of final product (GMP), stability, and in‑process samples; review and verify data; and maintain accurate records in a lab notebook while 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, and residual DNA.
• Serve as subject‑matter expert supporting routine testing of final product (GMP), stability, and in‑process samples.
• Review testing data, including data packets, final lot files, and COA reviews.
• Perform data verification and review of GMP documentation for multiple methods and products.
• Cross‑train in multiple complex analytical methods and products.
• Train others on QC test methods, processes, and procedures.
• Author and review 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 management.
• Procure and qualify required materials to perform experiments or testing.
• Collaborate with Analytical Development team to establish the analytical control strategy of established methods.
• Perform other tasks as assigned.
• Exercise authority on planning and execution of assay development runs and weekly work priorities; higher‑level approvals required for significant assay development methodology changes or strategic shifts.

• BS, MS or Ph.D. in Molecular Biology, Cell Biology, Biochemistry, or a related field.
• BS with 6‑8 years of practical experience; MS with 4‑6 years of hands‑on QC testing and method development; or Ph.D. with 1‑3 years of assay development experience in the pharmaceutical field.
• Demonstrated experience in assay development and GMP QC testing of biologics (e.g., qPCR, dPCR, ddPCR, ELISA, cell culture and cell‑based assays).
• Ability to understand, follow, interpret, and apply global regulatory and cGMP requirements.
• Effective communication skills with peers, management, and cross‑functional teams.
• Strong 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.
• Proficiency with Excel, Word, PowerPoint, Graph Pad Prism, Power
  
  BI, JAMMP, ELN, and Lab Vantage.
• Mandarin preferred.

Base pay range: $110,706 – $145,303 USD (actual compensation may vary based on experience and qualifications).…