Kuldip Sra, Ph.D.
Dr. Kuldip Sra has over 30 years of experience of working in Biotech and Biopharma companies. Over his extended experience, Dr. Sra has worked on CMC product developments for Vaccines, C&G Therapy, Crispr Gene editing, Mabs and Vectors. During his career, he has worked on commercialization of 5 approved drugs and worked on over 15 INDs/IMPDs submissions. He has written CMC sections for briefing documents, INDs, BLA, CTAs, and has written responses and justifications to Regulatory agencies’ inquiries.
Most recently Kuldip served as Executive Director of Late-Stage Development at Crispr Therapeutics where he led both analytical and Quality control functions for allogenic and autologous clinical drug products (in C&G products, Hematology, RegenMed modalities).
Prior to Crispr, he was QC Director at Kite managing clinical lot release & raw material testing and environmental monitoring groups. At Kite, Dr. Sra worked on Kite’s two commercial products: Yescarta and Tecartus. His contributions were critical to significantly reducing QC release from 6 weeks to < 1 week (reduction of >80% in time of release).
Kuldip worked for 15 years in Aviron/MedImmune/AstraZeneca in various capacities. He was involved in commercialization of three vaccine drug products and has designed and executed product comparability protocol for Vaccine drug products manufactured in Europe and in the US. He obtained an MS and PhD degrees in Biochemistry from Seton Hall University in Biochemistry and B.Sc. with Honors from Panjab University, India.