Charles Cook
Vice President CMC
Seasoned pharmaceutical executive with over 20 years of diverse experience in the life sciences industry. Currently serving as the Vice President of CMC (Chemistry, Manufacturing, and Controls) at NiKang Therapeutics Inc., where he oversees the development and manufacturing of the company's innovative drug candidates. Additionally, Charles holds board and consulting roles that further demonstrate his industry impact and technical expertise.
Professional Overview
As a versatile leader in the pharmaceutical space, Charles leverages his extensive background in CMC operations, process development, and regulatory affairs to drive the success of complex R&D initiatives. He is adept at navigating the dynamic regulatory landscape, ensuring compliance and establishing robust quality control measures across all stages of the product lifecycle.
Experience Summary
Current Role
As Vice President of CMC at NiKang Therapeutics, Charles is responsible for leading the company's manufacturing and supply chain strategies, supporting the progression of multiple drug candidates through clinical development and commercialization. He has played a pivotal role in establishing the organization's CMC infrastructure, implementing efficient workflows and mitigating risk to ensure the timely delivery of high-quality pharmaceuticals.
Career Progression
Prior to his role at NiKang, Charles served as the Vice President of CMC at Reata Pharmaceuticals, where he was instrumental in the successful scale-up and tech transfer of several late-stage assets. He has also held positions as the Chief Technical Officer at a private life sciences investment group, as well as a Principal Consultant at CMC SQUARED, where he leveraged his deep industry expertise to provide strategic guidance to emerging biotechnology companies.
Academic Background
Charles holds a Bachelor of Science in Chemical Engineering from the University of Texas at Austin, where he graduated with honors. His academic achievements, combined with his extensive industry experience, have positioned him as a respected authority in the field of pharmaceutical manufacturing and quality control.
Areas of Expertise
- Pharmaceutical process development and scale-up
- Regulatory compliance and quality assurance
- Supplier management and supply chain optimization
- Cross-functional team leadership and collaboration
- Strategic planning and risk mitigation
Professional Impact
Throughout his career, Charles has played a crucial role in advancing the development of innovative therapies, contributing to the successful progression of multiple drug candidates through clinical trials and regulatory approvals. His expertise and strategic vision have been instrumental in helping both emerging and established pharmaceutical companies navigate the complexities of the industry and achieve their product development goals.
Conclusion
With a proven track record of success and a deep understanding of the evolving pharmaceutical landscape, Charles continues to drive positive change and make a meaningful impact on the industry. As he focuses on his current role at NiKang Therapeutics, he remains committed to leveraging his technical skills and leadership abilities to deliver transformative solutions that improve patient outcomes.
