Amanda Guiraldelli, PhD profile page

Amanda Guiraldelli Mahr is a Senior Scientist at RIC Group in Belgium, specialized in analytical strategies for the analysis of biopharmaceuticals and small molecules. She leads the development and optimization of analytical procedures for release testing, stability studies and structural characterization of large molecules, supporting the implementation of ICH Q2(R2), Q14 and Analytical Quality by Design (AQbD) principles in collaboration with key biopharmaceutical partners. Amanda serves as an expert advisor to the United States Pharmacopeia (USP) Analytical Procedure Lifecycle Joint Subcommittee and is a board member of the ECA Analytical Quality Control Group. She spent more than 12 years at USP, where she held roles as Senior Scientist and Scientific Affairs Manager. During this time, she contributed to the development of key standards, including <1220> Analytical Procedure Lifecycle and <1225> Analytical Procedure Validation. She also led cross-functional initiatives applying AQbD and predictive modeling to method development, trace impurities analysis by LC-MS and GC-MS and reference standards characterization, while collaborating closely with global regulatory agencies and industry partners. An expert in chromatography and mass spectrometry for both small and large molecule characterization, Amanda has held visiting scientist roles at TU Berlin and Leiden University, focusing on LC-HRMS-based protein analysis and method development. She holds a PhD in Analytical Chemistry from the University of São Paulo (with a focus on MS-based metabolomics) and mentors students on AQbD projects at UNICAMP and Fiocruz in Brazil.