Rajesh G. Beri, Ph.D.
Prin. Consultant
Dr. Beri has over 30 years’ experience in the Biotech Industry, starting as a bench scientist with Lonza Biologics in 1996 and progressing to Executive Level Leadership positions at Senda Biosciences and Goodwin Biotech, prior to launching his consulting career. During his career, Rajesh has managed over 70 biologics projects from pre-clinical through commercial approval and has played a key role in approval and life cycle management of leading biologics products such as YERVOY®, ORENCIA®, OPDIVO®, ARZERRA®, BENLYSTA®, SOLIRIS® and StrenSIQ®. He has established and led development, manufacturing sciences, technical operations and CMC functions at several organizations while promoting a culture of technical excellence and quality compliance. His teams have supported manufacturing, supply chain, engineering, quality, regulatory and business development functions. Dr. Beri has a strong track record of active participation at industry events with over 20 presentations and 5 publications, 2 granted patents and 1 patent pending approval. He has been a key steering committee member of Biophorum Operations group (BPOG), contributing to the publication of white papers covering Characterization, Validation and Continued Monitoring of Biologics and a Technology Roadmap for Biomanufacturing. Based on his experience, Dr. Beri is well positioned to assist pharma and biotech companies with a broad range of technical, operational, and strategic expertise in development and manufacturing of multiple product modalities manufactured using both mammalian and microbial expression systems such as recombinant proteins, monoclonal antibodies, ADC’s, mRNA, and Lipid nanoparticles. Rajesh’s expertise spans from cell line generation to drug product manufacturing and packaging, and from pre-clinical through post approval and the associated regulatory interactions. Dr. Beri received his Bachelor of Technology in Chemical Engineering from the Indian Institute of Technology, Mumbai, India and his Masters, and Doctorate degrees in Chemical Engineering from Worcester Polytechnic Institute.