Dr. Kumar Dhanasekharan, is building a CMC-led biologics development company with an initial pipeline of differentiated biosimilars and other biologics. Most recently, he served as the Senior Vice President of Technical Operations at Voyager Therapeutics, where he oversaw multi-modality CMC development, manufacturing, quality control, and supply chain functions encompassing AAV gene therapy programs and non-viral therapeutic platforms. He and his team developed and scaled-up gene therapy manufacturing up to 2000L scale while substantially lowering COGS with novel cell lines and plasmid-design approaches.
Beyond AAV gene therapy, he has worked across broad biologics modalities including biosimilars, mAbs, ERTs and other complex protein therapeutics. He has extensive global experience building both internal manufacturing capabilities and external partnerships through contract manufacturing and testing networks, ensuring strong operational oversight and strategic collaborations and partnerships. Dr. Dhanasekharan has advanced numerous protein therapeutics and AAV gene therapy programs into clinical stages, leading process and analytical development. He has also successfully led late-stage process characterization, validation campaigns, and BLA-enabling activities.
Throughout his career, while growing in leadership CMC roles in organizations such as SwanBio Therapeutics, Amicus Therapeutics, Genzyme-Sanofi, and Catalent (CDMO), he has delivered on multiple INDs and BLAs across a wide range of modalities and biologic molecules ensuring continued drug supply. His leadership experience includes C-suite responsibilities, collaborating with executive teams and boards to define long-range strategies, implementing CMC roadmaps, and pursuing accelerated approval pathways.
Dr. Dhanasekharan earned his Ph.D. in Food Science from Rutgers University, focusing on engineering and manufacturing, and holds a bachelor’s degree in chemical engineering from the Indian Institute of Technology, Chennai. He has delivered more than 50 conference presentations and authored over 10 peer-reviewed publications.
Aligning strategic relationship management, manufacturing science, and CDMO execution
· Technology Fit and Platform Compatibility
· Transferring Process Knowledge, Not Just Methods
· Process Robustness, Scalability, and Lifecycle Thinking
· Managing Change in a Science-Driven Environment
· Enablers: Governance Models That Support Technical Excellence