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Senior Scientist, MSAT

Somerset, New Jersey, United States

Company Information

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 and natural killer (NK) cell-based immunotherapy. 

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) in 2017. 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 Senior Scientist as part of the Global MSAT team based in Somerset, NJ.

Role Overview

We are seeking an experienced Senior Scientist to join our MS&T team, responsible for driving the development, implementation, and optimization of innovative manufacturing processes for autologous and allogeneic cellular therapy products, including CAR-T. As a senior member of the team, you will lead the design, execution, and interpretation of complex process development experiments, collaborate with cross-functional teams, and ensure seamless technology transfers to GMP manufacturing groups.

Key Responsibilities  

  • Lead the development of automated manufacturing processes, including cell selection, activation, expansion, and harvest
  • Design, execute, and interpret complex process development experiments
  • Author, review, and coordinate technical documents, protocols, and reports
  • Analyze and present data in a clear and concise manner
  • Ensure GMP compliance in laboratory notebooks, protocols, and reports
  • Collaborate with internal and external partners to evaluate, develop, and implement new process technologies
  • Author technical documents to support regulatory filings
  • Conduct technical discussions & meetings with internal stakeholders including procurement, quality, development and finance, and facilitate implementation of new automated processes
  • Provide technical leadership and mentorship to junior team members
  • Design and execute proof-of-concept experiments to demonstrate feasibility of new technologies or processes
  • Generate and analyze data to demonstrate compatibility of new technologies or processes with existing manufacturing systems
  • Lead technology transfer activities to ensure successful implementation of new processes or technologies in GMP manufacturing environments

Requirements

  • PhD, MS, or BS in Cell Biology, Immunology, Biomedical Engineering, or other related discipline.
  • 7+ years of experience in MS&T, process development, or a related field
  • Strong expertise in cell therapy, automation, and bioprocessing
  • Excellent leadership, communication, and project management skills
  • Experience with technology transfers, GMP manufacturing, and regulatory filings
  • Ability to work effectively in a fast-paced, dynamic environment
  • Knowledge of automation technologies
  • Experience with GMP implementation, including but not limited to: 
    • GMP regulations and guidelines
    • Quality management systems
    • Process validation and verification
  • Experience with CAR-T cell therapy or similar cellular therapy products
  • Knowledge of regulatory requirements for cellular therapy products
  • Familiarity with design of experiments (DOE) and statistical process control (SPC)

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Legend Biotech is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is Legend’s policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by law.

Legend Biotech maintains a drug-free workplace.

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