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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

Click here to apply!

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