Description

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 experience in 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 and completely understand, follow, interpret and apply Global Regulatory and cGMP requirements.
• Ability to communicate effectively with peers, department management and cross-functional peers 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, GraphPad 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 plus.
• Strong communication skills, both written and verbal, with a demonstrated capacity to thrive in collaborative, team-driven environments.
• Excel, Word, PowerPoint, etc
• GraphPad Prism, other data analysis tools (PowerBI, JMP, etc)
• ELN, LabVantage, etc
• Mandarin preferred.

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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.

Please note: These benefits are offered exclusively to permanent full-time employees. Contractors are not eligible for benefits through Legend Biotech.

EEO Statement

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.

For information related to our privacy notice, please review: Legend Biotech Privacy Notice .