Legend Biotech is seeking a Scientist II, Analytical Development as part of the Technical Development team based in Somerset, NJ.

Role Overview

We are seeking a dynamic and scientifically driven Scientist II 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 Legend’s 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

• Bachelor’s degree in a related field with 7 or more years of relevant experience, or Master’s degree with 5 to 7 years of experience, or PhD with 2 to 4 years of experience or relevant post-doctoral research.
• 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.
• Experience in:
  • 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.
• AI Literacy: Possesses a working knowledge of AI technologies and approved AI tools, applies them responsibly to enhance productivity and decision-making, exercises appropriate human oversight of AI-generated outputs, and complies with organizational policies governing AI use.

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