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

My client is expanding and seeks a Sr Director to lead CMC Development. The ideal candidate will take on the following tasks:

  • Drives comprehensive development strategies to meet timelines across different functions, drug substance, drug product, analytical, quality, clinical supplies, and regulatory
  • Ensures appropriate technical, scale-up, and production strategies and timelines are in place to meet clinical supply, registration and potential commercial needs, and ensures production, technology transfer, validation and regulatory outcomes, meets/exceeds industry standards
  • Oversees CMOs and CROs. Supports GMP manufacturing including PIP, data monitoring and analysis, troubleshooting manufacturing issues, and deviation closeout
  • Provides scientific and technical leadership and advocacy to support the development of robust manufacturing processes and products, integrating current regulatory and industry standards
  • Directs CMC team and work closely with stakeholders including quality, preclinical research, clinical operations, clinical and commercial supply and regulatory

The ideal candidate will possess the following qualities:

  • PhD and 10+ years of pharmaceutical development experience with exposure to all stages and aspects of product development including late phase and commercial development experience
  • Oligonucleotide experience is a plus
  • Ability to travel 25%
  • Telecommuting option -- can be based in NYC, Boston, Philadelphia or Washington DC

Boston, MA, United States of America
Click apply
1/14/2020 11:53:11 PM

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