Akshay Nadkarni

Akshay Nadkarni is the Director of CMC Program Management in the Project Management Office at Kymanox. With over 10 years of experience in implementing risk-based approaches to drug product, medical device, and combination product development, Akshay leads projects in the areas of GMP manufacturing process and analytical method development, scale-up, and technology transfer for clinical and commercial-stage products. Akshay also has experience authoring CMC modules for multiple IND and NDA filings with the FDA. As part of the Kymanox Project Management Office, Akshay provides oversight for projects within the Kymanox portfolio to ensure they are effectively managed and remain on schedule and within budget.

Apart from working at Kymanox, Akshay has held positions in the product development groups at Nicox Ophthalmics and Envisia Therapeutics. Akshay earned his Master of Science in Biomanufacturing from North Carolina State University, and his Bachelor of Science in Biomedical Engineering from Duke University.