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 Sr. Investigator Compliance Specialist as part of the Technical Operations team based in Raritan, NJ.

REQUIREMENTS

• BS/BA required in technical discipline: Engineering, science or similar field.
• A minimum of five (5) years experience within a cGMP environment in the biotech/biopharma industry and Cell/Gene Therapy cGMP manufacturing experience preferred.
• Support writing of SOPs for Manufacturing and Quality Risk Assessments for existing and new/changed processes
• Ability to work independently and successfully, prioritize and manage multiple tasks simultaneously, integrate cross-functional issues and balance competing priorities effectively. Must be able to manage shifting priorities to meet critical deadlines in a fast paced and dynamic, growing environment.
• Support Manufacturing team to troubleshoot and resolve complex scientific/technical problems.
• Provide technical expertise to drive the implementation of process improvements that would provide reduction in COGs, increase throughput, capacity and quality compliance.
• Provide technical expertise in automation projects from user requirements, design evaluation, specification review through to testing and implementation in a GMP manufacturing environment.
• Work cross-functionally across Technical Operations and interface with external vendors to drive the design and implementation of automation platforms for cell therapy development and manufacturing.
• Perform technical feasibility studies related to process improvement and implementation of new manufacturing technologies.
• Provide SME expertise to perform process characterization of cell therapy automation technologies, including process development, FATs, SATs, and IQ/OQ/PQ testing.
• Ensure successful manufacturing process comparability and process validation runs by assessing risk, establishing preventative measures, investigating, and troubleshooting equipment and process issues prior to implementation into manufacturing.
• An ability to build strong partnerships and effectively integrate with external collaborators to drive projects/programs forward in a matrixed environment.
• Build strong partnerships with Manufacturing, Engineering and Quality to ensure seamless execution of daily production schedules
  

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ROLE OVERVIEW

The CAR-T Compliance Auditor (Sr. Investigator) will be a key member of the Technical Operations team, responsible for ensuring adherence to regulatory requirements and internal quality standards across cell and gene therapy manufacturing processes. This role combines deep expertise in CAR-T process technologies with a strong focus on compliance auditing, risk assessment, and continuous improvement.
The Compliance Auditor will conduct internal audits, support regulatory inspections, and lead investigations to ensure process integrity and GMP compliance. Additionally, the role includes overseeing and enhancing manufacturing standards, implementing innovative technologies, and collaborating cross-functionally to drive operational excellence in a highly regulated environment.

KEY RESPONSIBILITIES

• Lead manufacturing and cross functional investigations from end to end.
• Ensure thorough root cause analysis, impact assessment, and CAPA/EC determination.
• Work cross functionally with SME’s and Quality to ensure robustness of investigations, as well as accuracy and ensuring compliance.
• Support and manage change controls and maintain permanent inspection readiness and actively support regulatory inspections.
• Serves as Subject Matter Expert (SME) in preparation for and during internal and external regulatory audits (including FDA, EMEA).
• Ensure investigations are processing timely according to site specified requirements
• Provide technical expertise in the Technical Operations group, own the process knowledge of the cell and gene therapy manufacturing process technology and maintain oversight on process capability to ensure processes are robust and continuously improving.
• Ensure seamless flow of knowledge and information across functions, and with other sites when applicable.
• Provide technical/scientific process support.
• Provide support and technical expertise to the Manufacturing team in support of ongoing technical transfer and manufacturing operations.
• Support the implementation of manufacturing and process automation strategies through cell therapy manufacturing process design qualification, vendor evaluation, and enterprise system interface engineering support for GMP manufacturing of engineered autologous T cell therapy products.
• Write and/or review user requirements, functional requirement specifications, qualification protocols, enterprise or system interface, process development reports, and provide technical assessments, rationales, and approval for engineering and process changes to meet regulatory requirements.
• Work closely with cross-functional teams to design and implement cell therapy processes, manage equipment qualification strategy, and support process validation activities for cell therapy platforms.
• Work cross-functionally across Technical Operations and interface with external vendors to drive the design and implementation of automation platforms for cell therapy development and manufacturing.
• Primary role is to support deviation investigation writing
• Follow up to determine if corrective actions adequately addressed root cause of NC event.
• Report and track deviations, events and key process parameters and provides reports to management on trending, and status as requested.
• Recognize and act on potential compliance issues and opportunities for process changes/continuous improvement.