Associate Manufacturing Engineer

Legend Biotech is a global biotechnology company dedicated to treating and, one day, curing life-threatening diseases. Headquartered in Bridgewater, New Jersey, we are advancing the next generation of cell therapy through a portfolio of innovative technologies, including autologous, allogeneic, and in vivo cell therapy approaches. Our research spans chimeric antigen receptor T-cell (CAR-T), T-cell receptor (TCR-T), natural killer (NK) cell-based therapies, and other emerging platforms designed to transform the treatment of serious diseases.

From our global network of research and development sites, we are committed to discovering and developing safe, effective, and cutting-edge therapies for patients worldwide.

Legend Biotech entered into a global collaboration agreement with Johnson & Johnson to jointly develop and commercialize CARVYKTI® (ciltacabtagene autoleucel; cilta-cel). Through this strategic partnership, we combine complementary expertise and capabilities to advance innovative immunotherapies for patients living with multiple myeloma.

Legend Biotech is seeking an Associate Manufacturing Engineer as part of the Manufacturing & Supply team based in Raritan, NJ.

The Associate Manufacturing Engineer, Tech Support will be part of the Technical Support team and be responsible to support the development and routine operation of a new CAR-T manufacturing process. They will be a subject matter expert for the manufacturing process and equipment primarily responsible for providing front line support to address and resolve manufacturing issues.

• This individual will partner closely with Quality, Compliance, and technical experts to drive accelerated, robust, and consistent resolution and escalation of process issues as applicable while ensuring batch quality and adherence to procedures and instructions.
• Support compliant manufacturing investigations and CAPAs, as subject matter experts.
• Be a point of contact with equipment suppliers for timely and continuous support.
• Understand key process indicators of the manufacturing process and process execution and support opportunities for improvement and waste reduction.
• Perform regular manufacturing observations to collect process health data for the identification of process improvement and waste reduction opportunities.
• Act as a primary point of contact across all manufacturing and support organizations. Ability to interact with all levels within the organization.
  
  Act as a primary point of contact across all manufacturing and support organizations. Ability to interact with all levels within the organization.

• A minimum of a Bachelor’s degree in engineering or related field or equivalent experience required. Advanced degree preferred.
• 2-3 years of operations 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 manufacturing operations.
• Ability to accommodate changes in the schedule including working on shift as necessary to support operational needs.
• Support initiatives for process, operational, and quality improvements for manufacturing.
• Maintain processes at a state of audit readiness and support internal and external inspections as required.
• Support writing of SOPs for Manufacturing and Quality Risk Assessments for existing and new/changed processes.
• Ability to work with oversight and successfully execute and manage tasks for timely completion, Must respond to shifting priorities to meet critical deadlines in a fast paced and dynamic, growing environment.
• Support the Manufacturing team to troubleshoot and resolve complex scientific/technical…