Scientist II, Analytical Development, Flow, Function and Bioanalytical Assays

Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell, T-cell receptor (TCR-T), and natural killer (NK) cell-based immunotherapy. From our three R D sites around the world, we apply these innovative technologies to pursue the discovery of safe, efficacious and cutting-edge therapeutics for patients worldwide.

Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson Johnson, to jointly develop and commercialize ciltacabtagene autolecuel (cilta-cel). Our strategic partnership is designed to combine the strengths and expertise of both companies to advance the promise of an immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking a Scientist II, Analytical Development as part of the Technical Developmen t team based in Somerset, N J.

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

, 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.