Scientist II

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 Scientist II as part of the Manufacturing Technology team based in Somerset, NJ. 

Role Overview

We are seeking an experienced Scientist II to join our MSAT team, responsible for driving the development, implementation, and optimization of innovative manufacturing processes for autologous and allogeneic cellular therapy products, including CAR-T. 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
• Make independent decisions regarding routine laboratory execution, minor troubleshooting, and data analysis within approved study protocols. Guidance is sought from senior team members for experimental design, major troubleshooting steps, and changes to validated processes.

Requirements

• PhD, MS, or BS in Cell Biology, Immunology, Biomedical Engineering, or other related discipline.
• 5-7 years of experience in MSAT, 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, including but not limited to:
• 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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Please note: These benefits are offered exclusively to permanent full-time employees. Contractors are not eligible for benefits through Legend Biotech.

EEO Statement

It is the policy of Legend Biotech to provide equal employment opportunities without regard to actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, related medical conditions and lactation), gender identity or gender expression (including transgender status), sexual orientation, marital status, military service and veteran status, disability, genetic information, or any other protected characteristic under applicable federal, state or local laws or ordinances.

Employment is at-will and may be terminated at any time with or without cause or notice by the employee or the company.