Director, Head of Drug Product Development and Manufacturing

Company: Job Juncture
Location: New Brunswick
Posted on: January 16, 2020

Job Description:

My client is expanding and looking for a Director, Drug Product Development and Manufacturing.-- The ideal candidate will support various drug modalities, including biologics, gene therapies, and small molecules, from early development through commercialization and life cycle management.
The ideal candidate will take on the following tasks:

• 
  
• Leads formulation development for AAV gene therapies including drug product process development, packaging development, tech transfer support, and drug product characterization
  
• Guides, designs and executes activities from early phase development through lifecycle management, for both gene therapy and therapeutic programs
  
• Direct external CMOs for drug formulation development and drug product manufacturing
  
• Supports GMP manufacturing including PIP, data monitoring and data analysis, troubleshooting manufacturing issues, and deviation closeout as appropriate
  
• Maintains currency with applicable global regulations and industry standards. Prepare source documents to support regulatory filing, review the dossier
  
  The ideal candidate will possess the following qualities:
  
  • 
    
  • MS/PhD and 10+ years of pharmaceutical drug product development experience in gene therapy and biologics, including including suspension, fill/finish, and prefilled syringe
    
  • Experience in early stage and late stage development programs, and launch/commercial stage products
    
  • Willingness to travel 10-30%
    
  • Tele-commuting option -- can be based in NYC, Boston, Philadelphia or Washington DC areas
    
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Keywords: Job Juncture, New Brunswick , Director, Head of Drug Product Development and Manufacturing, Executive , New Brunswick, New Jersey