Container Closure Integrity Testing – Basic Course - Fall Edition

Allison Dill, Ph.D. is a Principal Research Scientist in Bioproducts Research and Development at Eli Lilly and Company, Indianapolis, IN. She received a BS in Chemistry and Biology from Indiana University and worked for 4 years as an analytical chemist in Product Research and Development before attending graduate school. She received her Ph.D. in Analytical Chemistry from Purdue University, studying imaging mass spectrometry for disease state characterization. While at Lilly, she has been responsible for the analytical control strategy of many solid oral and parenteral dosage forms and has contributed to many regulatory submissions. Her contributions were recognized with an Eli Lilly Top 100 Innovator Award. She has contributed to the corporate CCI strategy as well as the strategy for multiple molecules with a concentration in on-line high voltage leak detection for 100% inspection. In her current role, she provides technical leadership enabling the delivery of the bioproducts portfolio within a complex global network with responsibility for the analytical control strategy of both drug substance and drug product across all phases of development.

Dr. Lei Li currently serves as an engineering advisor at Delivery Device and Connected Solutions, Eli Lilly and Company. Dr. Li’s has 9 years of experience in pharmaceutical and medical device industry, with focus on API and drug product packaging and cold-chain distribution development for biologic products. His current responsibilities include designing and evaluating container closure systems for pipeline molecules, supporting clinical development, tech transfer, and product commercialization. He is a frequent speaker at PDA conferences and author of peer-reviewed articles and book chapters on CCI test methods. Dr. Li received his Ph. D. in Analytical Chemistry from West Virginia University; prior to joining Eli Lilly, he worked at GE Plastics as an analytical and material scientist.