Senior Scientist, Analytical Development (FFBA)

Legend Biotech US; New Jersey; On-site; USD 140,000 - 200,000; Full time

Job summary

Legend Biotech US seeks a Senior Scientist, Analytical Development (FFBA) to join the Technical Development team in Somerset, NJ. The role centers on establishing, developing, and qualifying analytical assays to support cell and gene therapy products, including flow cytometry, immunoassays, and release testing.

The ideal candidate will be hands-on, mentor junior staff, and collaborate with QC, PD and Manufacturing to ensure data integrity, timely tech transfer, and compliance with GxP and

Qualifications

• Advanced degree 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 or QC.

Responsibilities

• Develop, optimize, and qualify analytical methods to support cell and gene therapy product release and characterization (flow cytometry, cell-based potency, ELISA, etc.).
• Guide method development activities for phase-appropriate analytical deliverables with emphasis on data integrity and regulatory compliance.
• Lead tech transfer of assays to QC or external collaborators and collaborate cross-functionally with QC, PD, and Manufacturing.

Skills

Analytical method development

GxP compliance

Mentoring

Cross-functional collaboration

Education

PhD

Master

Job description

Senior Scientist, Analytical Development (FFBA)

Somerset, New Jersey, United States

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 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, Bi