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

Role Overview

We are seeking a dynamic and scientifically driven Senior Scientist to join our empowered Analytical Development organization. This role will focus on the establishment, development and qualification of analytical assays, including but not limited to flow cytometry-based methods, cell culture-based methods, immunoassays, compendial methods, and other bioanalytical strategies to support the development and manufacturing of Legend’s pipelines. The ideal candidate will be a hands-on leading scientist, capable of mentoring junior scientists while also contributing strategically to cross-functional collaborations with other functional teams, and deeply understanding of GxP requirement.

Key Responsibilities

• Develop, optimize, and execute analytical methods to support cell and gene therapy product releasing and characterization, including but not limited to compendial methods, titer, particle size, flow cytometry, cell-based potency or functional methods, and bioanalytical (e.g., ELISA) assays.
• Guide method development activities to support phase-appropriate analytical deliverables (including potency, purity, safety, etc.) with an emphasis on scientific rigor, data integrity, and patient-centricity.
• Drive the timely tech transfer of assays from collaborators to AD, and/or from AD to QC and external collaborators.
• Identify and refine critical parameters and material/reagents during assay prequalification activities; generate and qualify critical materials including but not limited to cell banks.
• Drive the development and qualification of release assays for early-phase clinical programs, and ensure execution on aggressive timelines.
• Author and review analytical related documentation including but not limited to analytical methods, SOPs, protocols, and reports.
• Performing pre-qualification, assay qualification, product release testing, and product stability testing in a quality control environment.
• Collaborate cross-functionally with QC, PD 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 lab notebooks, QC records, and equipment maintenance logs.
• Balance multiple projects while meeting established timelines.
• This role is empowered to make independent decisions related to the planning, execution, analysis, and troubleshooting of analytical method development, qualification, transfer, and characterization activities within established project timelines and departmental objectives. The Senior Scientist is expected to exercise scientific judgment in experimental design, data interpretation, risk assessment, and the recommendation of technical solutions to complex analytical challenges. Collaboration, consensus, and alignment with management are required for decisions that may impact program strategy, regulatory submissions, project timelines, resource allocation, quality systems, or cross-functional development activities. The position is also expected to provide technical guidance to junior staff and contribute to scientific decision-making across multidisciplinary project teams.

Requirements

• Advanced degree (PhD or Master) in immunology, cell biology, biomedical engineering, or equivalent. 5-8 years (PhD) or 8-10 years (Master) of experience in method development of gene-modified products in analytical development and/or QC in a biotech, or pharmaceutical setting. Technical training / certification is desirable.
• Uses professional concepts in accordance with company objectives to solve complex problems in creative and effective ways.
• Expertise in analytical method development and qualification is required (Vaccine, Biologics, Viral Vector, or CGT).
• Solid understanding of ICH guidelines and regulatory expectations for method development and qualification/validation.
• Expertise in analytical method development and validation in late stage is preferred.
• Experience in analytical comparability strategy, method bridging, method transfer activities for early and late phase in product development. Global experience is a plus.
• Experience in developing lentiviral vector product releasing and characterization methods including multicolor flow cytometry methods, cell culture including reporter gene cell line development, potency assays, cytotoxicity assays and cytokine release assays, immunoassays, infectious titer assays.
• Exercises independent judgment in developing methods, techniques and evaluation criteria for obtaining results.
• Deep understanding and experience in analytical data trending, critical reagent and material determination and qualification, establishment of product releasing specification for early and late stage product development.
• Guide the establishing and authoring of SOPs/procedures, protocols, and reports for analytical methods and activities.
• Authorship in IND/BLA preparation is preferred.
• Demonstrated ability to lead, mentor, and develop junior staff in a matrixed and collaborative environment.
• Detail-oriented with expertise in problem solving and solid decision-making abilities.
• Experience implementing or executing compendial methods (HPLC, Ph, Osmolality, Particulate Matter, etc) is preferred.
• Excellent presentation skills, scientific/technical writing skills, and communication skills.
• Guide the establishing and authoring of SOPs/procedures for established methods.
• Experience with:
  • 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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