Keerti Kiran

A highly enthusiastic, innovative & performance-driven Technical/People leader with 15+ years’ experience in the CMC space like Process Development, Manufacturing Sciences & Technology, Analytical Development, Aseptic & Single-use cGMP systems, Project Management and Regulatory Affairs. As a technical leader, I have Spearheaded end-end Process Development & Characterization by QbD concepts in an extremely fast-paced environment for Therapeutic mAbs, Gene Therapy, Viral/Bacterial/Nucleic acid Vaccines & Oncolytic therapeutic viral vaccines. As an SME in the technical space, my greatest strength is innovative problem solving with a proven track record of helping cross-functional teams/organizations to solve complex CMC challenges and accelerate therapeutics reach to the clinic and people suffering with complex diseases. As a capable leader, I have Led & facilitated multiple complex cross-functional teams/projects in the CMC space, a few examples are - Development & characterization of the purification process for OgivriTM by QbD concepts which accelerated the US FDA approval to be the first Trastuzumab bio-similar to reach the market. - Spearheaded and developed a complete aseptic manufacturing process using single-use technologies for oncolytic vaccinia virus to produce super high titers to support high dose clinical program. Areas of Expertise: •People & Technical Leadership •Strategic Planning •Early->Late Stage Process Development by QBD •Analytical Development • Scale-up/Tech-transfer & Single-use Technology • cGMP & Aseptic Process manufacturing • CMC Planning for Pre-clinical & Clinical Program development.