Keerti Kiran
Associate Director @ Genezen | Process Development & MSAT
- Role
- Associate Director Downstream Pd & Msat at Genezen
- Location
- Indianapolis, IN, US
- LinkedIn followers
- 500 followers
About 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.
Experience
Associate Director Downstream Pd & Msat
Jun 2023 — Present · Fishers, IN, US
Education
Bangalore University
Bachelor of Science (B.Sc.), Genetics, Biotechnology and Bio-chemistry
Flinders University
Master's of Science, Biotechnology
University of Agricultural Sciences, Bangalore
Certificate study, Apiculture
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