Timothy Graul

Director, CMC Advisory Office, Pfizer, Inc.

Timothy W. Graul is a Director in the 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. Tim has served as the PhRMA Deputy Topic lead on the ICH Q2/Q14 Expert Working Group and is looking forward to the implementation of the revised Q2 Guideline and the new guideline, Q14. He has been a member of industry groups including Land O’ Lakes Pharmaceutical Analysis Conference Planning Committee and AAPS Summer Scientific Forum since 2010, IQ groups such as Analytical Leadership, AQbD, Dissolution, Control Strategy Harmonization Metrics, and Worldwide Specification Harmonization; and ISPE PQLI group on Analytical Methods.