Chaoju Xiao, Ph.D. is Director of Formulation Development at R&D US Pharma, Fresenius Kabi USA, where she leads the U.S. Formulation Development organization and is responsible for advancing formulation strategies, technical capabilities, and product development for complex injectable, parenteral, and specialty pharmaceutical products. With more than 19 years of pharmaceutical industry experience, she has extensive expertise in formulation and process development, CMC strategy, regulatory submissions, and lifecycle management across both generic and innovative drug products.
Dr. Xiao earned her B.S. and M.S. in Pharmaceutical Sciences from Peking University Health Science Center, one of China’s most prestigious research institutions, and later obtained her Ph.D. in Pharmaceutical Sciences in the United States. Prior to joining Fresenius Kabi, she held formulation development roles at several pharmaceutical companies, including Mylan, where she built broad experience in complex generic drug development and global regulatory filings. During her more than decade-long tenure at Fresenius Kabi, she has led numerous injectable product development programs and strategic R&D initiatives.
Her technical expertise includes complex injectables, emulsions, peptide formulations, advanced drug delivery systems, Quality by Design (QbD), and global CMC regulatory strategy. Dr. Xiao has contributed to multiple ANDA, 505(b)(2) NDA products, is an inventor on several Orange Book-listed patents, and has helped advance innovative regulatory approaches for complex pharmaceutical products. In addition to her scientific contributions, she is passionate about developing technical talent, building high-performing teams, and driving innovation that accelerates the delivery of high-quality medicines to patients worldwide.
