Cytokinetics
Sr Manager
Currently serving as the Senior Manager, Validation at Cytokinetics Inc., South San Francisco, I lead validation efforts across process, packaging, and analytical disciplines for both Drug Substance and Drug Product. With over 18 years of expertise in pharmaceutical quality, validation, and product development, I am a seasoned leader in driving end-to-end strategies across process validation, technology transfer, regulatory compliance, and product commercialization. I have successfully championed lifecycle-based validation strategies, implemented robust continued process monitoring systems, and supported critical regulatory submissions. Leveraging a strong foundation in statistical analysis and Six Sigma methodologies, I bring a data-driven mindset to solving complex challenges in regulated environments.
I hold a Ph.D in Chemical Engineering with an additional three years of post-doctoral experience.