Legend Biotech is seeking Associate Technical Lead as part of the Technical Operations team based in Raritan, NJ.

Role Overview

The Associate Technical Lead will be part of Technical Operations and will be responsible for supporting the Manufacturing Excellence team as a technical individual contributor by providing specialist knowledge and expertise of cell and gene therapy processes and/or process technologies. This individual will also oversee the processes and standards to maintain and improve existing and to implement new innovative manufacturing technologies.

Key Responsibilities

• This individual with provide direct support to the Director of Manufacturing Excellence by providing technical expertise to Technical Operations and ensure safe and compliant manufacturing operations according to cGMP requirements.
• This individual will support the hiring and development of Manufacturing Excellence associates.
• This individual will also 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.
• Work with the Data Management and Integration Lead and Process Validation lead on the establishment and management of a process monitoring program.
• Establish metrics for process and team performance. Ensures seamless flow of knowledge and information across functions, and with other sites when applicable.
• Provides technical/scientific process support. Support manufacturing investigations, support and manage change controls and maintain permanent inspection readiness and actively support regulatory inspections.
• This individual will also 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.

Requirements

• A minimum of a Bachelor's degree in engineering or related field or equivalent experience required. Advanced degree preferred.
• 8 years of operations experience within a cGMP environment in the biotech/biopharma industry. 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 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.
  
• Strong analytical, problem solving and critical thinking skills and the ability to lead as a change agent to promote flexibility, creativity, and accountability.
  
• Clear and succinct verbal and written communication skills.
  
• Ability to accommodate shift work including evenings and weekends as required by the manufacturing process.
  
• Ability to accommodate unplanned overtime on little to no prior notice.

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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.