Associate Director, Device CMC Leader at Lab Pros

New Haven, CT

About the Job

Description: 

Associate Director, Device CMC Leader

The Associate Director, Device CMC Leader will support the CMC Program Leader as it pertains to CMC Program Management, specifically, the development of device and combination products within Global Operations. This matrix role will collaborate cross-functionally with stake-holders across Global Operations, including Product Development, Quality Assurance, Analytical Services, Clinical Manufacturing and Supply and Commercial Supply Chain.  The Associate Director will chair and lead functional execution teams dedicated to the oversight and monitoring of activities, deliverables, and milestones associated with device/combination product development. This is a key matrix position within Global Operations and involves some interaction with senior management.

Required Qualifications:

  • Bachelors’ degree in scientific discipline
  • Minimum of 7 years of experience in the biopharmaceutical industry, with minimum of 3 years in a CMC Project/Program Management role, specific to devices and combination products
  • Deep experience with the CMC development and regulatory pathway specifically associated with combination products and drug delivery devices
  • Demonstrated ability to organize and lead teams
  • Demonstrated tactical capabilities with forward looking perspective
  • Strong communication, leadership and collaboration skills are required

 

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