Director of Gene Therapy
Job Opportunity at KOB Solutions, Inc.

Posted on Sep 13

http://www.kobsolutions.com/    412-851-9696

Location: Pittsburgh, PA
Job Type: Full Time
Job ID: W4167493

Director of Gene Therapy Process Development

My client seeks a Director to manage a group and take on the following tasks:
  • Refine strategy for gene therapy Process Development (PD) group with an immediate focus on completing the PD and finalizing the process to be used for GMP runs and Process Performance Qualification (PPQ)
  • Develop a tech transfer plan for processes going from PD and to GMP manufacturing
  • Assist in developing a robust PPQ protocol strategy, to include generation of appropriate acceptance criteria
  • Direct all stages process development (FIH, CPD, MSAT) for all programs within the pipeline
  • Oversee the development and implementation of drug substance and drug product release specifications
  • Lead authoring efforts for specific CMC sections of regulatory filings -- INDs, BLAs, and formal responses to regulatory inquiries
The ideal candidate will possess the following qualities:
  • PhD and 5-7+ years of experience in viral vector or related PD (or MS with 10+ years or BS with 12+ years)
  • Expert in viral vector bioprocessing strategies to include the current analytical tools
  • An excellent leader with experience managing teams
  • Deep technical understanding of viral vector manufacturing platforms or recombinant proteins
  • A demonstrated record of scientific expertise (including publications, patents and presentations)
  • An excellent communicator with an ability to work effectively in a matrix environment
  • Experienced with developing and delivering presentations to C-level
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