Katy Newell, Director, CMC Drug Substance
Professional Overview
Katy Newell is an accomplished pharmaceutical industry leader with extensive expertise in CMC (Chemistry, Manufacturing, and Controls) drug substance development and global supply chain management. As the Director of CMC Drug Substance at EyeBio, she oversees the strategic planning, implementation, and optimization of critical drug substance manufacturing processes to ensure the successful delivery of innovative ophthalmic therapies.
Experience Summary
Current Role
As the Director of CMC Drug Substance at EyeBio, Katy is responsible for leading a talented team of scientists and engineers in the development, scale-up, and commercialization of complex drug substance manufacturing processes. She is instrumental in driving process understanding, implementing quality-by-design principles, and ensuring regulatory compliance to support the company's pipeline of novel ophthalmic drug candidates. Under her leadership, EyeBio has successfully navigated multiple regulatory inspections and achieved significant milestones in the advancement of its drug substance portfolio.
Career Progression
Prior to joining EyeBio, Katy held various roles of increasing responsibility at GlaxoSmithKline (GSK), where she demonstrated her expertise in upstream process research, process understanding, and global supply chain management. As the Upstream Manager within the MSAT (Manufacturing Science and Technology) team, she led cross-functional initiatives to enhance process efficiency and robustness, contributing to the successful launch of several key pharmaceutical products. Earlier in her career, Katy served as a Team Leader for Upstream Process Verification, where she played a pivotal role in ensuring the seamless scale-up and implementation of new drug substance manufacturing processes.
Academic Background
Katy holds a Ph.D. in Chemical Engineering from the University of Cambridge, where she specialized in the optimization of biopharmaceutical upstream processing. Her research has been recognized through multiple publications in peer-reviewed journals and presentations at industry conferences.
Areas of Expertise
- CMC drug substance development and scale-up
- Process understanding and Quality-by-Design (QbD)
- Upstream process research and optimization
- Global supply chain management and MSAT
- Cross-functional team leadership and collaboration
- Regulatory compliance and inspections
Professional Impact
Throughout her career, Katy has made significant contributions to the pharmaceutical industry. As a recognized expert in her field, she has been invited to speak at industry events, sharing her insights on best practices in drug substance manufacturing and supply chain optimization. Her innovative approaches to process understanding and quality control have been instrumental in the successful advancement of several novel drug candidates, positively impacting patient outcomes.
Conclusion
With her exceptional technical expertise, strategic leadership, and proven track record of delivering results, Katy Newell is poised to continue making a lasting impact in the pharmaceutical industry. As the Director of CMC Drug Substance at EyeBio, she is committed to driving the development and commercialization of transformative ophthalmic therapies that will improve the lives of patients worldwide.
