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Head of Process Development

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Location
Cranberry Township, PA
Job Type
Direct Hire
Degree
Bachelor of Science, Doctor of Philosophy, Master of Science
Date
Dec 14, 2018
Job ID
2644237
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.