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 Flow Cytometry and Functional Assays team within our empowered Analytical Development organization. This role will focus on the establishment, development and qualification of flow cytometry-based methods, cell-based potency assays, and other bioanalytical strategies to support the release, characterization and stability assessment of cell therapy products (multiple types of cell product, in vivo vector product, etc). This position will report directly to a Principal scientist in Analytical Development team . The ideal candidate will develop, optimize and execute analytical methods for product characterization, release and stability testing, and contribute to cross-functional collaboration with other functional teams.

Key Responsibilities

• Focus on assay development and optimization, including but not limited to potency (cell-based), flow cytometry, and bioanalytical (e.g., ELISA) assays.
• Develop and qualify analytical methods to support LVV characterization, including infectious titer assays, vector potency assays, and vector-specific flow cytometry panels.
• Responsible for tech transfer of methods to QC and execution of methods in QC. Perform the assay pre-qualification and qualification activities as needed. Identify and refine critical parameters and material/reagents during assay prequalification activities and generate critical materials including cell banks.
• Ensure the generation of standard operating procedures (SOPs) and laboratory protocols that support product release testing and characterization.
• Collaborate cross-functionally with PD, QC and Manufacturing teams to ensure seamless assay execution, troubleshooting, and continuous improvement.
• Present scientific data and trends at internal and external forums.
• Ensure proper documentation practices including ELN, test method development plan and report, equipment maintenance logs, etc. Contribute to maintenance of laboratory inventories.
• Simultaneously working on multiple projects to meet established timeline while maintaining the highest quality and data integrity standards.
• 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

• For Scientist II, PhD or Master in scientific discipline or equivalent in engineering, and a minimum of 2-5 years related experience; may include post-doctoral experience. Expert knowledge of scientific principles and concepts.
• Expertise in analytical method development and qualification/validation is required.
• Experience in developing multicolor flow cytometry methods, cell culture including reporter gene cell line development, potency assays, cytotoxicity assays and cytokine release assays, immunoassays, infectious titer assays.
• Experience in developing LVV residual impurities assays.
• Exercises independent judgment in developing methods, techniques and evaluation criteria for obtaining results.
• Solid understanding of ICH guidelines and regulatory expectations for method qualification. Guide the design and execution of method qualification.
• Guide the establishing and authoring of SOPs/procedures for established methods.
• Detail-oriented with expertise in problem solving and solid decision-making abilities.
• Excellent presentation skills and scientific/technical writing skills.
• Excel, Word, PowerPoint, etc.
• GraphPad Prism, other data analysis tools (PowerBI, JUMP, etc).
• CytoExpert, FCS express, NovoExpress, FlowJo, etc.
• ELN, LabVantage, etc.
• Language(s):English preferred and Mandarin is a plus.
  
  

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