Mark Schweitzer
- Role
- Member, Usp General Chapters Dosage Forms Expert Committee at US Pharmacopeia
- Location
- Milford, OH, US
- LinkedIn followers
- 500 followers
About Mark Schweitzer
Strong technical/scientific/regulatory background in analytical method development, validation and transfer, forced degradation studies (design and interpretation), GxP requirements and quality system implementation, investigations, preparation of regulatory responses to queries and inspection findings, laboratory investigations (technical, quality and data integrity)Significant experience in development and validation of quantitative analytical methods (impurities, degradation products, residual solvents, N-nitrosamines) USP General Chapters - Chemical Analysis (2015 to present)- current Vice-Chair; Chair, USO Joint Subcommittee for Nitrosamine impuritiesICH Q3D Elemental Impurities (rapporteur through Step 2 and PhRMA topic lead for R1 through Step 2)Experience in development and governance/oversight of Laboratory Operations Quality System (strategy, documentation development, implementation, and annual quality system review)Proven developer of high performing teamsProven technical and staff development leadership of development and quality organizationsExpertise in development of compendial strategy and monograph elaboration
Experience
Member, Usp General Chapters Dosage Forms Expert Committee
Jul 2025 — Present
Education
Thiel College
BA
1975 — 1979
The Ohio State University
Ph.D.
1979 — 1984
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