expertise in leading cdmo projects (cGMP and development) on Biological Drug substances (upstream, downstream, qc) within eurofins amatsigroup nv.
experienced Project Manager, leading to successes in IVD new Product Development, IVD product life cycle management, and cdmo project delivery, focused on Business Processes as well as management of people.
Project LeaderZwijnaarde, Ghent, Belgium
Since November 2016
Analytical Method Validation
Nov 2016 – Present
• Project leader for international clients.
• Responsible for on-time and within-budget delivery of projects.
• Project Management for development of processes (upstream - fermentation, downstream - purification) and analytical methods (SDS-PAGE CBB & WB, BCA, SE-UPLC, RP-UPLC, cIEF, ELISA, …).
• Focused on manufacturing of biologicals for Tox studies or Phase I studies (GMP).
• Successfully managed projects within the global Eurofins CDMO organization (manufacturing of Drug Substance, fill and finish of Drug Product, labeling and secondary packaging of therapeutic unit, analytical method validation, stability studies, and QC release tests.
Senior Developer Zwijnaarde, Ghent, BelgiumJuly 1993 --- October 2017
DiabetesVerificationValidationVaccinesSequence AnalysisRisk Managementreal-time PCRQuality Management System (QMS)Quality Control (QC)Quality Assurance (QA)Protein PurificationProtein ExpressionProduct developmentPharmaceuticalsMedical DevicesLife SciencesInfectious diseasesIn vitro diagnostics (IVD)Good Manufacturing Practice (GMP)Good Laboratory Practice (GLP)GeneticsFailure Mode and Effect Analysis (FMEA)Drug substancesDNACAPA
Skills and Expertise
project managementDrug SubstanceDrug Productin vitro diagnisticsinfectious diseasesMycobacteriumHPVContract Development and ManufacturingBiologicalsQMSFMEA
Expert has 2 publications (Will be avalible with full profile)