Rachel Monsef is a consultant to the biopharmaceutical and pharmaceutical industries for analytical and quality control. She has 19 years of experience working with many types of assays for all stages of drug development. Ms. Monsef has been responsible for method development, method qualification, method validation, assay transfers, characterization work, and stability studies. She has been involved in method troubleshooting and assisting with troubled validations. Ms. Monsef has worked extensively with coordinating method development and validation work performed at CMOs as well as troubleshooting methods that do not have the robustness needed for regulatory compliance. She previously worked at Alder (now Lundbeck) and Seattle Genetics and is consulting for both companies.
