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Technical Steward

Raritan, New Jersey, United States

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

Role Overview

The Technical Steward 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 processes and to implement new innovative manufacturing technologies. They will also oversee and/or support in technology 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.
  • Drive/provide support in identifying opportunities for process improvements, support those improvement projects, and drive implementation strategy.
  • Ensure seamless flow of knowledge and information across functions, and with other sites when applicable.
  • Drive/provide support for integration of new technologies, developing the URS, FAT, SAT, vendor evaluation, design qualifications, protocols, technical evaluation and assessments.
  • Provide support and technical expertise to the Manufacturing team in support of ongoing technical transfer and manufacturing operations.
  • Write and/or review manufacturing process/technology transfer plans, protocols, and reports. Provide support for process validation activities (on the floor support as needed)
  • Design implementation strategies, study requirements, protocols, 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 or technical owner 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.
  • Ownership of process Fit to Plants, gap and risk assessments associated with technology transfers, process changes, change integration and automation. 

Requirements

  • A minimum of a Bachelor’s degree in engineering or related field or equivalent experience required. Advanced degree preferred.
  • 5 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 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 RiskAssessments 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.
  • Provide technical expertise in the evaluation of potential process changes for effectiveness, value, and risk.
  • 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.
  • 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.
  • Strong analytical, problem solving and critical thinking skills and the ability to lead as a change agent to promote flexibility, creativity, and accountability

#Li-BZ1

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The anticipated base pay range is:

$107,482 - $141,070 USD

Benefits:

We are committed to creating a workplace where employees can thrive - both professionally and personally. To attract and retain top talent in a highly competitive industry, we offer a best-in-class benefits package that supports well-being, financial stability, and long-term career growth. Our offerings are designed to meet the diverse needs of our team members and their families, ensuring they feel valued and supported every step of the way. Highlights include medical, dental, and vision insurance as well as a 401(k)-retirement plan with company match that vest fully on day one. Equity and stock options are available to employees in eligible roles, we offer eight weeks of paid parental leave after just three months of employment, and a paid time off policy that includes 15 vacation days, 5 personal days, 5 sick days, 11 U.S. national holidays, and 3 floating holidays. Additional benefits include flexible spending and health savings accounts, life and AD&D insurance, short- and long-term disability coverage, legal assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance. We also provide commuter benefits, family planning and care resources, well-being initiatives, and peer-to-peer recognition programs - demonstrating our ongoing commitment to building a culture where our people feel empowered, supported, and inspired to do their best work.

EEO Statement

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 applicable law.

Employment is at-will and may be terminated at any time with or without cause or notice by the employee or the company. Legend may adjust base salary or other discretionary compensation at any time based on individual, team, performance, or market conditions.

Legend Biotech maintains a drug-free workplace.

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