Ganesh Reddy heads the microbial, mammalian drug substance and drug product manufacturing sites for biosimilars manufacturing, leading a team of 1,200+ people in production and engineering.
He joined Biocon in 2014 and has extensive experience of over 30 years in process development, technology transfer, manufacturing, new facility commissioning and approvals, new product launches and product life cycle management for biologics. Over the past 7 years, he has been key to pegfilgrastim (first biosimilar pegfilgrastim approved in the US) and trastuzumab (first biosimilar trastuzumab approval in the world) approvals in the US and EU, in addition to several other key approvals from U.S. FDA, EMEA and other regulatory agencies.
Ganesh has effectively and meticulously managed several large-scale and multi-product manufacturing operations for production of biologic molecules with varying complexities, and has extensive experience in fungal, yeast, E.coli and CHO expression systems. He has also consistently demonstrated success in designing, commissioning, and validating, quality systems management and EHS management in the biologics manufacturing plant. He has managed significantly large manufacturing operations and projects and has extensive experience with regulatory filings, pre-approvals, and routine GMP audits from various agencies, including the US and EU, and interactions with regulatory agencies including EMEA and FDA. Prior to joining Biocon Biologics, Ganesh was a Director at Dr Reddy’s Laboratories.
He holds a Master’s degree in microbiology, and a Bachelor’s in Botany, Zoology and Chemistry.
