Global Head – Biologics Manufacturing
Ganesh Reddy is the global head of Biologics Manufacturing. He heads the microbial, mammalian drug substance and drug product manufacturing sites for biosimilars manufacturing, leading a team of 1200+ people in production and engineering.
He joined Biocon in the year 2014 and has got an 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. During 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 US and EU, in addition to several other key approvals from USFDA, EMEA and other regulatory agencies.
In his career, he has effectively and meticulously managed several large-scale and multi-product manufacturing operations for production of biologic molecules with varying complexities. Has extensive experience in fungal, yeast, E.coli and CHO expression systems. That apart, he has consistently demonstrated success in designing, commissioning, validation, quality systems management and EHS management in biologics manufacturing plant. He has managed significantly large manufacturing operations and projects.
He has got extensive experience with regulatory filings, pre-approval, 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, he has worked with Dr Reddy’s Laboratories as a Director.
He holds a master’s degree in microbiology, and has done his Bachelors in Botany, Zoology and Chemistry.