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Associate Director, CMO Operation

Raritan, New Jersey, United States

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 Associate Director, CMO Operation as part of the Global Manufacturing and Supply team based in Raritan, NJ. 

Role Overview

 The position will be part of the integrated CMO virtual management team working with our partner JNJ, to oversee the day-to-day operation at CMO for carvykti commercial manufacture.

Key Responsibilities  

  • Working with integrated business planning team (IBP) and Vein to vein team (V2V) to plan, schedule and track the manufacture of autologous cell product batches at CMO
  • Monitor the progress of product batches, identify and escalate deviation and other manufacture issues
  • Collect, calculate the KPI, and mitigate/remedy gaps of the CMO manufacture performance
  • Collaborating with procurement team/financial team on new orders, invoice and payment
  • Collaborating with MSAT team on deviation investigation, process change, ramp up activities
  • Provide timely and accurate update on the CMO performance to the manager and cross functional stakeholders.

Requirements

  • BS/MS is required, in related technical disciplines: engineering, biology, chemistry, pharmaceutics etc.
  • Minimum 8 years for BS/MS, 5 years for PhD of industrial biologics manufacturing experience, autologous cell therapy manufacture experience is highly desirable.
  • Significant experience of proposal review, contract negotiation and independently managing CMO management is essential.
  • Highly Organized, detail oriented and collaborative
  • Experience in a fast-paced and dynamic environment
  • Excellent time-management, communication skills and business acumen.

#Li-Onsite

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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.

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