Mark Schweitzer PhD Mark Schweitzer Consulting LLC

Dr. Schweitzer has held senior positions in analytical development, quality control and quality over the past 38+ years with Novartis, AbbVie, Searle/Pharmacia/Pfiizer, Battelle Memorial Institute and Rohm & Haas developing experience in the analysis of impurities in a wide variety of matrixes. He was active in ICH as the rapporteur for ICH Q3D: Elemental Impurities Expert Working group and was the PhRMA topic lead in the EWG until his retirement from industry. He is currently the Chair of the USP General Chapters Microbiology Expert Committee and served previously as a member and Vice-Chair of the USP General Chapters Chemical Analysis Expert Committee. While volunteering at USP, he has been involved in sub-committees defining the standards for elemental impurities and chaired the USP Joint Subcommittee for Nitrosamine Impurities in Pharmaceuticals. Dr. Schweitzer earned his PhD from The Ohio State University Department of Chemistry. His career has been focused on analytical method development, validation and transfer of chromatographic analyses and complex hybrid methods. Additional areas of experience include: assurance of data integrity, development and validation of IT applications (e.g. LIMS), elemental impurity product assessments, and development of analytical strategies to improve compliance with new and evolving regulations, quality and efficiency improvement.