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 Senior Scientist, CMO MSAT as part of the External Manufacturing team based in Raritan, NJ. 

Role Overview

The position will be part of the CMO MSAT team driving the capacity ramp-up and supporting commercial manufacture of Carvykti at our external manufacture partners. He/she is part of an integrated virtual management team, working with our partner JNJ, to oversee the technical side of the CMO operation. 

Key Responsibilities  

• Manage and oversee all technical side of the CMO activities: deviation investigation, change control and risk assessment, process improvement, continuous process validation.
  
• Support commercial and developmental batches as a technical PIP as needed
  
• Provide timely and accurate update on the timeline, status of the projects, risk and mitigation strategy to the manager and cross functional stakeholders.
  
• Monitor manufacture performance. Identify, investigate and act upon out-of-trend critical process parameters (CPP) in-process testing and CQAs.
  
• Work with the global MSAT team on global change control and process improvement,

Requirements

• B.S. or more advanced degree is required, Ph. D is preferred, in related technical disciplines: engineering, biological science, pharmaceutical science etc.
  
• Minimum 5 years for BS/MS, 3 years for PhD of industrial biologics CMC development or manufacturing experience, Cell therapy manufacture experience is highly desirable.
  
• Experience working with CMO is a preferred.
  
• Results driven with strong analytical, problem solving and critical thinking skills.
  
• Experience in a fast-paced and dynamic environment.
  
• Excellent time-management, organizational and communication skills.
  
• Strong business acumen and change management experience. 

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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.