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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

#Li-JK2

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