Director, Gene Therapy Upstream Process Development

Company: Job Juncture
Location: New Brunswick
Posted on: January 17, 2020

Job Description:

My client seeks a Director of Gene Therapy Upstream Process Development and manufacturing.

The ideal candidate will take on the following tasks:

• 
  
• Lead the upstream process development for gene therapy programs
  
• Manage CROs and ensure: cell line and process development activities for AAV viral vector production, plasmid design and manufacturing, GMP cell banking and product manufacturing activities
  
• Develop efficient bioreactor processes for gene therapies and optimize cell culture media as appropriate
  
• Assist in technology transfer to GMP manufacturing facilities
  
• Support GMP manufacturing including person in plant, data monitoring and data analysis, troubleshooting manufacturing issues, and deviation closeout as appropriate
  
• Prepare documents to support regulatory filings
  
  The ideal candidate will possess the following qualities:
  
  
  • 
    
  • PhD and record of developing cell lines for viral vector production
    
  • Previous experience developing and transferring cell culture processes and cell culture media to GMP manufacturing
    
  • Ability to determine and communicate risks, as well as develop and execute contingency plans
    
  • Knowledge of Intellectual Property landscape
    
  • Ability to travel 10-30%
    
  • Tele-commuting option -- can be based in NYC, Boston, Philadelphia or Washington DC areas
    

Keywords: Job Juncture, New Brunswick , Director, Gene Therapy Upstream Process Development, Executive , New Brunswick, New Jersey