Scientist I, Analytical Development

Legendcareers; New Jersey; On-site; USD 90,000 - 130,000; Full time

Job summary

Legend Biotech in Somerset, NJ is seeking a Scientist I, Analytical Development to join the Research and Development team. This role focuses on establishing, developing and qualifying analytical methods to support the company’s cell therapy programs, including flow cytometry, cell-based potency and immunoassays for product characterization and release testing.

The candidate will author and review methods, maintain electronic lab records, and collaborate with PD, QC and Manufacturing to ensure

Qualifications

• Strong laboratory background with experience in flow cytometry, cell-based assays and protein detection.
• Experience implementing or executing compendial methods is preferred.
• Knowledge of GMP/QA concepts is a plus.

Responsibilities

• Develop, optimize, and validate analytical methods for viral vector and CAR‑T product characterization.
• Author and review methods, protocols, and reports to support release and stability testing.
• Maintain reagent inventories and order materials as needed.
• Transfer methods to QC and external partners and receive methods from others.
• Maintain ALCOA+ compliant electronic lab records and instrument logs.
• Collaborate cross-functionally with PD, QC and Manufacturing teams.
• Present scientific data at internal and external forums.
• Balance multiple projects to meet timelines.

Skills

Flow cytometry

Mammalian cell culture

ELISA

Cell-based assays

Education

Bachelor’s degree in related field

Master’s degree

PhD

Tools

none

Job description

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 Scientist I, Analytical Development as part of the Research and Development team based in Somerset, NJ.

Role Overview

We are seeking a dynamic and scientifically driven Scientist I 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 5 or more years of relevant experience, or Master’s degree with 3 to 5 years of experience, or PhD with 0 to 2 years of experience.
• 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 tit…