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Senior Director, CMC Development

Posted on Jan 15, 2020 by Job Juncture

New York, NY 10001
Accountancy
Immediate Start
Annual Salary
Full-Time

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

Reference: 828427984

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