Manufacturing Engineer

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 Manufacturing Engineer as part of the Technical Operations team based in Raritan, NJ. 

Role Overview

The CAR-T Manufacturing Engineer will be part of the Technical Operation team and will be responsible to provide 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 and to implement new innovative manufacturing technologies. Will participate and assist in technical transfer activities into and out of the Raritan facility.

Key Responsibilities  

• Provide technical expertise in the Technical Operations group, own the process knowledge of the cell and gene therapy manufacturing process technology to support technical activities for transfers into and out of the Raritan facility. 
• Support and identify opportunities for process improvements, support improvement projects, and drive implementation strategy. Ensure seamless flow of knowledge and information across functions, and with other sites when applicable. 
• Provide support and technical expertise to the Manufacturing team in support of ongoing technical transfer and manufacturing operations. 
• Write and/or review manufacturing process transfer plans, protocols, and reports. 
• Design studies, draft protocol, oversee execution and draft reports necessary to support the implementation of process improvements. 
• Provide technical/scientific recommendations and support and manage applicable change controls. 
• Technical assessor of change controls. 
• Provide review of process flow diagrams as well as protocol and reports from development. 
• Support the implementation of manufacturing and process improvement 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. 
• Work closely with cross-functional teams to design and implement cell therapy processes for cell therapy platforms.
• Work cross-functionally across Technical Operations and interface with external vendors to drive the design and implementation of automation platforms and/or new raw materials and consumables for cell therapy development and manufacturing. 
• Work with vendors to evaluate new raw materials and consumables for compatibility with the Manufacturing process. 
• Draft Process Risk Assessments for implementation of process changes.

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.
• Provide support and technical expertise to the Manufacturing team in support of ongoing technical transfer and manufacturing operations.
• Support facility fit assessments for evaluation of changes between sending and receiving sites.
• Build strong partnerships with Manufacturing, Engineering and Quality to ensure seamless implementation of technical transfer activities and/or process improvements.
• Work closely with the development organization to ensure translation of changes from concept to implementation.
• Support writing of MBRs and 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.
• Provide technical expertise to support the implementation of process improvements that would provide reduction in COGs, increase throughput, capacity and quality compliance.