Mark Schweitzer, PhD

Principal, Mark Schweitzer Consulting, LLC
Chair, USP Microbiology Expert Committee

Over the past 38+ years, Dr. Schweitzer has held senior positions in analytical development, quality control and quality, the most recent of which was as the Global Head of Analytical Science & Technology and Scientific Initiatives in Novartis Quality. Prior to joining Novartis, he was the Global Head of Analytical Development (small molecules and biologicals) for AbbVie. Additional positions in Analytical and Formulation Development (Searle/Pharmacia/Pfizer) and specialty analytical (Battelle Memorial Institute and Rohm & Haas) provided increasing breadth and depth of experience in the analysis of impurities in a wide variety of matrices. While at Novartis, Dr. Schweitzer directed the development of the strategic approach to the assessment of nitrosamine impurities and elemental impurities in pharmaceuticals.

He has been active in ICH as the rapporteur for ICH Q3D: Elemental Impurities Expert Working group through step 2 and was the PhRMA topic lead in the EWG until his retirement from industry. As a member and the Vice-Chair of the USP General Chapters Chemical Analysis Expert Committee through 1.5 cycles, he was involved in sub-committees defining the standards for elemental impurities and chaired the USP Joint Subcommittee for Nitrosamine Impurities in Pharmaceuticals. He is currently the Chair of the USP General Chapters Microbiology Expert Committee.
Dr. Schweitzer earned his Ph.D. from The Ohio State University Department of Chemistry and a B.A. (chemistry) from Thiel College. He has focused his career on analytical method development, validation and transfer of chromatographic analyses and complex methods (e.g., HPLC-MS/MS and GC-MS/MS). 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 testing strategies to improve compliance with new and evolving regulations, quality and efficiency improvement.

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