Prakash Bedre, Ph.D
About Prakash Bedre, Ph.D
Prakash Bedre, Ph.D., is a Senior Director of CMC/MS&T at Wave Life Sciences, where he has worked since 2023. He has extensive experience in biopharmaceutical manufacturing, specializing in Quality by Design and Process Analytical Technology.
Current Role at Wave Life Sciences
Prakash Bedre, Ph.D., serves as the Senior Director of CMC/MS&T at Wave Life Sciences, a position he has held since 2023. In this role, he oversees critical aspects of Chemistry, Manufacturing, and Controls (CMC) as well as Manufacturing Science and Technology (MS&T). His responsibilities include ensuring the quality and compliance of biopharmaceutical processes, leveraging his extensive experience in the field.
Previous Experience at Wave Life Sciences
Prior to his current role, Prakash Bedre worked at Wave Life Sciences in various capacities. He served as the Director of CMC/MS&T from 2020 to 2022, and before that, he held the position of Associate Director for Process Validation and Manufacturing from 2018 to 2020. His tenure at Wave Life Sciences contributed to the advancement of biopharmaceutical manufacturing processes.
Education and Expertise
Prakash Bedre earned his Master of Pharmaceutical Sciences (M. Pharm) from the University of Mumbai. He furthered his education at the University of Rhode Island (URI), where he obtained a Ph.D. in Pharmaceutical Sciences. His academic background supports his expertise in Quality by Design (QbD) and Process Analytical Technology (PAT), particularly in the context of Continued Process Verification (CPV) using multivariate statistical analysis.
Career Background in Biopharmaceuticals
Prakash Bedre has a robust career in the biopharmaceutical industry. He worked at Rentschler Biopharma SE as Director of Validation for five months in 2020. Prior to that, he spent 14 years at Amgen as Principal Validation Engineer and Senior Manager in Contract Manufacturing Quality from 2004 to 2018. His experience includes a strong focus on cleaning validation and ensuring compliance in biopharmaceutical processes.
Skills in Continuous Improvement and Validation
Prakash Bedre possesses strong skills in continuous improvement and process validation within the biotechnology sector. His expertise encompasses enhancing manufacturing processes and ensuring compliance with industry standards, which are critical for the successful development and production of biopharmaceutical products.