Ranga Godavarti is currently a vice president of the Bioprocess Research and Development group at Pfizer, overseeing cell line development, process development, and non-clinical and clinical manufacturing of all biologics and vaccines. Prior to joining Pfizer (formerly Wyeth) in 1997, he received his master’s degree in Chemical Engineering Practice and a PhD in Chemical Engineering from the Massachusetts Institute of Technology (MIT) under the direction of professor Charles Cooney and professor Robert Langer. He has authored several publications and has been a co-inventor on multiple patents. He has over 20 years of experience in process development, covering a wide range of responsibilities. His group is responsible for the development, characterization, and technology transfer of upstream and downstream processes for all large molecules (proteins and vaccines, including mRNA vaccines) in the early and late stages of development.
Godavarti has overseen and supported commercial manufacturing for several of Pfizer’s licensed products. He is a thought leader/Subject Matter Expert (SME) on Process Validation and Quality by Design (QbD) and was a member of the Parenteral Drug Association (PDA) task force on process validation. He has made multiple presentations to the Food and Drug Administration (FDA) and European Medicines Agency (EMA) on topics related to QbD. He has been leading a team responsible for developing a strategy for implementing QbD for biologics in Pfizer.
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