- Analyzing the link between CMC development speed and clinical progress, with a focus on rare and ultra-rare diseases
- Balancing accelerated timelines with quality control and regulatory compliance
- Organizing teams and processes to achieve fast, efficient development while maintaining regulatory standards
- Defining key criteria and strategic approaches for selecting and advancing novel therapies
- Optimizing time from early development through to clinical stages for timely and effective therapy delivery
John Pinion
Executive Vice President Translational Sciences, Chief Quality Operations Officer
Ultragenyx
John Pinion has over 30 years of global biotech leadership experience across multiple modalities, including gene therapy, and spanning multiple functions across CMC and translational sciences.
John joined Ultragenyx in July 2015 and provides leadership for Quality, Compliance and Translational Sciences to include Pharmacology, Toxicology, Research and Bioanalytical Development. As an executive leader, he contributes to corporate strategy and portfolio management.
Prior to joining Ultragenyx, Mr. Pinion held senior leadership roles at Roche and Genentech departing the organization as Senior Vice President, Global Head of Quality and Compliance. Prior to Genentech, Mr. Pinion spent 17 years in operational and global senior leadership roles at Baxter International.
In addition to his position at Ultragenyx, John is currently COO of Amlogenyx, a subsidiary of Ultragenyx and is a member of the Board of Directors of Aroa Biosurgery Ltd.
He holds a B.S. in Mechanical Engineering from West Virginia University.
