Douglas Kiehl Eli Lilly and Company

Douglas Kiehl is a Research Advisor at Eli Lilly and Company and leads the Characterization Mass Spectrometry, Extractables/Leachables and Elemental Impurities team.  He is responsible for Lilly’s global E&L strategy supporting development and qualification of container/closure and manufacturing systems and drug delivery devices.  His team’s responsibilities include performing structural characterization of process impurities, related substances, degradation products and contaminants across development and commercialization phases for the small and large molecule portfolios.  Mr. Kiehl has over 36 years' experience with application of advanced mass spectrometry in characterization of diverse chemical entities, 24 years of which are in the Pharmaceutical Industry.  He is a member of the USP Packaging and Distribution Expert Committee, the USP Expert Panel on Biocompatibility of Materials Used in Packaging Systems, Medical Devices and Implants, the USP Expert Panel on Elastomeric Closure for Injections, the ELSIE (Extractables/Leachables Safety Information Exchange) Board of Directors, the SPIE Defense and Commercial Sensing Committee and AAPS Impurities Steering Committee.  His research interests include the development of advanced mass spectrometry based mapping and visualization techniques to enable the rapid and comprehensive characterization of highly complex mixtures of structurally diverse chemical entities.