Mukesh Mayani | Senior Director, Global CMC Development
Ultragenyx

Dr. Mukesh Mayani is a Senior Director in Global CMC Development at Ultragenyx (Woburn, MA, USA) bringing over 18 years of biopharmaceutical CMC development experience across LVV, AAV, RNA vaccines, and mAb platforms. In his current role, Dr. Mayani leads purification development teams and provides strategic oversight of drug substance (DS), drug product (DP), and formulation activities, playing a critical role in advancing in vivo gene therapy programs to address significant unmet medical needs. With a strong foundation in process and manufacturing technologies, Dr. Mayani has a proven track record of directly leading cross‑functional teams, including Upstream, Downstream, Pilot Plant, and Technology Transfer, from early development through commercialization. His expertise includes navigating process development, process characterizations, tech transfer, PPQs, IND, IMPD and BLA submissions, ensuring compliance with quality standards, and optimizing commercial manufacturing processes to deliver safe, effective, and scalable therapies. Dr. Mayani is deeply committed to advancing the field of cell and gene therapy, leveraging robust CMC strategies to accelerate development timelines and resolve complex technical challenges. His strategic leadership, cross-functional oversight combined with a hands‑on, data‑driven approach, has established him as a trusted and respected leader within the industry. He holds a PhD in Chemical Engineering and is a licensed Professional Engineer.