Kelly

Analytical Development, Stability & CMC Quality Specialist

Summary

Kelly is a scientist and CMC specialist with 15 years of experience in analytical development, stability strategy, and quality systems across the pharmaceutical industry. She helps organizations strengthen analytical and stability programs that support product development, regulatory readiness, and lifecycle management. Kelly also works at the intersection of analytical science, supply chain risk management, and AI-driven modeling to better understand temperature excursion risk and protect pharmaceutical products during global distribution.

Core Expertise

  • Analytical Development & Quality Control
  • Stability Program Strategy & Management
  • Drug Substance and Drug Product Release Testing
  • CDMO & Analytical CRO Oversight
  • AI Modeling for Temperature Excursions & Supply Chain Risk

Career Highlights

  • Analytical Development & Regulatory Support: Drafted CMC sections of global regulatory filings, led analytical development teams through inspection readiness activities, and managed analytical CRO partners supporting stability and release testing programs.
  • CMC Infrastructure & Method Development: Implemented validated systems to strengthen CMC infrastructure and developed analytical methods supporting regulatory submissions and product development programs.
  • Temperature Excursion Modeling Innovation: Co-developed a platform applying AI and advanced modeling to predict and manage temperature excursions during pharmaceutical shipping, helping organizations design more robust packaging and distribution strategies.

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