Edwin Hooijschuur
Senior Consultant
Expertise
After completing his PhD research at the Free University of Amsterdam / TNO Prins Maurits Laboratory in 2000, Edwin started his career in the pharmaceutical industry at Pharma Bio-Research (which later became PRA Health Sciences, currenty ICON). Edwin has worked in several positions in the laboratory business of this Clinical Research Organisation (CRO). As a project manager in small molecule bioanalysis he worked on the development, validation and application of numerous bioanalytical assays (mainly HPLC, LC-MS) under GLP and in accordance with FDA and/or EMA guidelines.
In the next phase of his career Edwin moved into manager/director roles in program management and operational management where ultimately, he became responsible for the small and large molecules bioanalysis and QC departments. As part of the management team Edwin was involved in strategic development and continuous improvement programs in a rapidly growing organization. He was also involved in many regulatory inspections, e.g. FDA and governmental bodies (GxP’s) and was a member of the European Bioanalysis Forum (EBF) for several years.
Before joining Progress Edwin stepped out of the pharmaceutical industry for a short period to head the laboratory at the Netherlands Inspection Service for Horticulture. In this role he was responsible for daily operation (including ISO17025 certified assays) and setup of an integrated change/improvement program. In his current position as Senior Consultant Edwin has supported clients as project manager for a new laboratory design and construction project, and as quality consultant upgrading existing Quality Management Systems to meet current regulatory standards.
Personal
Edwin lives in Zuidlaren, Drenthe and has a daughter. He enjoys running, hiking and cycling but also more relaxing activities like cooking and going to concerts and the theatre.
Specialties
- Project management, program management
- Line / Interim management
- Bioanalysis, FDA, EMA guidances
- GxP’s, ISO