Senior Scientist, Analytical Development (FFBA)

About the role

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.

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.
• Perform 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