Scientist I, Analytical Development

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 I Analytical Development as part of the Research and Development team based in Somerset NJ.

Role Overview

We are seeking a dynamic and scientifically driven Scientist I to join Functional Flow Cytometry and BioAnalytics team within our empowered Analytical Development organization. This role will focus on the establishment development and qualification of analytical methods including compendial methods flow cytometry cell-based potency and immunoassays to support the development and manufacture of Legends cell and gene therapy pipeline. This laboratory-focused role will require that candidates develop optimize and execute analytical methods for product characterization release and stability testing. This role will require authoring and reviewing documents maintaining electronic laboratory notebooks and contributing to cross-functional collaboration with other functional teams.

Key Responsibilities

• Develop optimize and execute analytical methods to support viral vector and CAR-T product characterization including compendial methods titer particle size flow cytometry and cell-based potency methods.
• Author and review methods protocols and reports.
• Maintain reagent inventory and order materials as laboratory activities require.
• Generate and qualify critical materials for analytical methods.
• Observe all laboratory safety standards including PPE use and BSL2 best practices.
• Performing pre-qualification assay qualification product release testing and product characterization testing in a quality control environment.
• Technology transfer of methods to QC and external collaborators and receive methods from internal and external collaborators.
• Maintain contemporaneous and accurate electronic laboratory records including instrument maintenance records and sample inventory following ALCOA standards.
• Perform peer review and data integrity reviews in the analytical development and quality control environments.
• Collaborate cross-functionally with PD QC and Manufacturing teams to ensure seamless assay execution troubleshooting and continuous improvement.
• Present scientific data at internal and external forums.
• Balance multiple projects while meeting established timelines.
• This role is empowered to make decisions related to day-to-day planning and execution of assay development runs according to timelines determined at the group level. Collaboration consensus and alignment with management are required for decisions related to methodology assay development strategy or interactions with other functional teams.

Requirements

• Bachelors degree in a related field with 5 or more years of relevant experience or Masters degree with 3 to 5 years of experience or PhD with 0 to 2 years of experience.
• Strong laboratory background including experience with developing flow cytometry mammalian cell culture ELISA and cell-based assays.
• Experience implementing or executing compendial methods is preferred.
• Experience with lentiviral vector characterization including infectious titer potency and transduction efficacy assays.
• Solid understanding of ICH guidelines and regulatory expectations for method qualification.
• Experience with assay qualification release testing and product characterization testing in a regulated environment.
• Experience with document change management and document review/approval workflows is preferred.
• Guide the establishing and authoring of SOPs/procedures for established methods
• Detail-oriented with expertise in problem solving and solid decision-making abilities.
• Excellent verbal and written communication skills.
• Excel Word PowerPoint etc.
• GraphPad Prism other data analysis tools (PowerBI JUMP R).
• CytoExpert FCS express NovoExpress FlowJo etc.
• ELN LabVantage etc.
• Language(s): Strong written and verbal English skills are required. 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.