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

Work Authorization & Employment Eligibility

Applicants must be authorized to work in the United States. As part of our commitment to maintaining a lawful workforce and ensuring compliance with federal employment regulations we participate in the E-Verify program. If you are selected for employment you will be required to complete the Form I-9 process and your employment eligibility will be verified through E-Verify in accordance with applicable federal law. We are committed to providing a fair transparent and welcoming hiring experience for all candidates.

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.