Investigator; I​/II

Role Overview

Legend Biotech is seeking an Investigator I/II as part of the Technical Operations team based in Raritan, NJ
.

The CAR‑T Investigator will be part of the Technical Operation team and will be responsible for providing specialist knowledge and expertise of cell and gene therapy processes and/or process technologies. They will also oversee processes and standards to maintain and improve existing capabilities and implement new innovative manufacturing technologies.

• 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 SMEs 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.
• Ensure investigations are processed 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.

• 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…