Ck Harinarayan is the VP and Head of Quality & Compliance. She is a seasoned leader with over 25 years of expertise in clinical and commercial Cell Therapy and Biologics, across Quality, Development and Technical Operations. With a solid technical foundation and a strong Quality mindset, she is dedicated to delivering innovative solutions to patients while fostering a culture of inclusion and empowerment. Most recently, as Head of Clinical GMP Quality at Kite Pharma, she spearheaded the implementation of Phase-Appropriate Quality Systems and was responsible for the CMC product quality strategy across Kite’s clinical pipeline programs. Successfully scaled quality at Kite’s El Segundo commercial manufacturing unit and played a pivotal role in the commercialization of Tecartus and Yescarta. Additionally, she has led the design, construction, and operationalization of multiple GMP facilities, including Genentech’s Vacaville Facility, Kite’s RDMC, Clinical Viral Vector and QC laboratories. Throughout her career, Ck has delivered on over 25 successful regulatory inspections and internal auditors in support of products progressing to clinical and commercial milestones. She holds a Bachelor of Science in Chemical Engineering from Birla Institute of Technology and Science and Masters of Science in Chemical Engineering from Colorado State University.
