| Timothy W. Graul is a Director in the Global CMC Advisory Office within Pfizer at the Groton, CT site. He received his B.S. Degree in Chemistry at James Madison University and then Ph.D. in Analytical Chemistry at The Florida State University. After completing studies, Tim joined Pfizer Analytical R&D and supported the development of drug product formulations and drug substance synthetic routes. He has been fortunate to have contributed to the successful approval of life-changing products. During his time at Pfizer, Tim has been recognized as a leader in Quality by Design for analytical methods. He has collaborated on publications that have been at the forefront of industry in this area. He is the PhRMA Deputy Topic lead on the ICH Q2/Q14 Expert Working Group. Tim has been a member of industry groups including Land O’ Lakes Pharmaceutical Analysis Conference Planning Committee, IQ groups such as Analytical Leadership, AQbD, Dissolution, Control Strategy Harmonization Metrics, and Worldwide Specification Harmonization; and ISPE. |
