Arun Tholudur is an Executive Director of Process Development at Amgen where he leads the Drug Substance Technologies and Engineering organization that is accountable for ensuring successful implementation of multi-modality drug substance processes in the GMP environment from first-in-human clinical to commercial manufacturing across Amgen's internal and external manufacturing network. The team’s responsibilities span technology transfer, process validation, process monitoring, regulatory submission authoring and inspection support, continued process optimization for yield and robustness, sophisticated digital capabilities including advanced process/plant modeling and design, new next-gen facility startup, and ensuring technology readiness for manufacturing implementation.
Arun has previously held several leadership roles in Process Development at Amgen including Executive Director Secondary Packaging Engineering responsible for developing, characterizing, qualifying, and implementing secondary packaging for various final drug product configurations including vials, syringes, and advanced combination products as well as developing advanced process and equipment technologies for secondary packaging for Amgen’s manufacturing network; Director Global Operations Leader responsible for all CMC aspects of IMLYGIC (the first oncolytic viral therapy approved in the United States) commercialization leading to commercial approval and launch, including process and product development, manufacturing, quality, regulatory, and supply chain; and Director Amgen Colorado Process Engineering where his team was responsible for process technical support for commercial and clinical drug substance manufacturing operations for mammalian cell culture and microbial process for Prolia/Xgeva, Epogen, Nplate, and trebananib, including technology transfer/scale-up, process validation, non-conformance resolution, and change controls as well as pilot plant operations supporting process characterization and technology transfer activities for process scale-up.
Prior to joining Amgen in 2006, Arun Led the development and/or transfer of over 15 cell culture (CHO, NS0, Sf-21, etc.) and microbial (E. coli, P. pastoris, etc.) processes for clinical to commercial GMP production of biotherapeutic molecules at Diosynth Biotechnologies. He has a Ph.D. and B. Tech in Chemical Engineering from the University of Colorado at Boulder and Indian Institute of Technology, Madras, respectively.