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Boston, MA Full Time Posted: Tuesday, 14 January 2020

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

Boston, MA, United States of America
Job Juncture
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1/14/2020 11:52:39 PM

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