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Head of Process Development

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Cranberry Township, PA
Job Type
Direct Hire
Bachelor of Science, Doctor of Philosophy, Master of Science
Dec 14, 2018
Job ID
Head of Process Development

My client seeks a Director to manage a group and take on the following tasks:
  • Refine strategy for Process Development 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 protein or related PD (or MS with 10+ years or BS with 12+ years)
  • Expert in bioprocessing strategies to include the current analytical tools
  • An excellent leader with experience managing teams
  • Deep technical understanding of biologic manufacturing platforms 
  • 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
Title and salary are commensurate with experience.