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1

Christopher Cool

Topher Cool has a background in benchtop molecular biology and microbiology, and more than five years of experience in FDA-regulated businesses as a validation and quality control technical professional. He is currently a Senior Validation Scientist and Project Manager with Commissioning Agents, Inc. His roles have included molecular biology, microbiology, CQV, technology transfer, data auditing, and compliance/regulatory as they pertain to quality control of GMP pharmaceuticals manufacturing.

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Amanda Guiraldelli

Amanda Guiraldelli has been with USP since 2012 and holds the position of scientific affairs manager and principle scientist in the compendial science group-general chapters. She is the scientific liaison to the USP Measurement and Data Quality Expert Committee, where she works to develop and revise USP standards. Previously, Amanda worked as senior scientist at the USP reference standard laboratory for 8 years with characterization of compendial standards. She is visiting professor at the University of Campinas (UNICAMP) Brazil at the Institute of Chemistry and is a frequent speaker and instructor on topics related to analytical procedure life cycle and Analytical Quality by Design (AQbD). Amanda is specialist in chromatography, mass spectrometry and chemometrics and has more than 14 years of experience in pharmaceutical R&D areas. Prior to joining USP, she was R&D scientist in a pharmaceutical industry and visiting scientist at TU Berlin in Germany and Leiden University in Netherlands (Center for Proteomics and Metabolomics) working on proteins characterization by LC-HRMS and method development using UHPLC-HRMS. Amanda is graduated in pharmacy biochemistry and holds a Ph.D. in analytical chemistry from the University of São Paulo (metabolomics by UHPLC-HRMS, GC-MS and 1H NMR and chemometrics).

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