I'm passionate about working with people in production environments, getting things done togheter in a challenging and demanding environment.
Production Supervisor S2F2 - Pilot plant
Since December 2012
Responsible for coordinating the timely production of Phase III clinical batches.
Supervisor Laboratory Administration and Operational Efficiency
April 2012 --- December 2012
Merging 2 administrative teams in to one harmonized polyvalent team, by reviewing and optimizing the current administrative processes such as sample receipt, stock, requisitioning, archiving, document system. Responsible for the timely and correct role out of the Lean Lab project
Lean Labs project lead
September 2010 --- April 2012
Leading the QC laboratories in their transition to become a more LEAN environment. Managing several teams in rolling out levelling strategies, standard work, 5S, gemba walks, visual managment, method improvement program, Human error reduction program throughout all QC lab centers.
Project engineer Chemical Lab
June 2006 --- August 2010
Analytical Product support: Protein/Biopharmaceuticals Subject Matter Expert Validation activities: Analytical method validation - cleaning method validation - Equipment validation - Analytical Method Transfers. Certified six sigma Green belt
QA systems assosciate
September 2005 --- May 2006
Supporting Quality Investigations at the Cypher facility (coating of stents),
January 2000 --- January 2004
Synthesis and evaluation of radiolableled compounds for the specific detection of systemic infection via scintigraphic imaging.
Analytical thinkingInterest in knowledgeProblem solvingSelf-disciplineSociabilityTrustWillingness to compromiseDependabilityCuriosityCreative thinkingCollaborationAuthenticityFlexibility
Animal models Biochemistry Cell biology R&D Scientific writingBiopharmaceuticalsBiomarkersCAPAChemistryClinical operationsCross-functional team leadershipELISAEnglishEnzyme-linked immunosorbent assay (ELISA)FDAFlow CytometryGMPGood Manufacturing Practice (GMP)HPLCICH GCP guidelinesImmunofluorescenceImmunohistochemistry (IHC)In VitroIn VivoInfectious diseasesInflammationKnowledge of the drug development processLaboratoryMedical DevicesMedical ImagingMicrobiologyMicrosoft ExcelMicrosoft Officepeople managementPharmaceutical IndustryPilot scale batchesPowerPointProblem-solving methods and troubleshootingProcess improvementProject ManagementPulmonary diseasesQualificationQuality Assurance (QA)R&DScientific WritingSDS-PAGESOPStatisticsTeam LeadershipUnderstanding of regulatory guidelinesUnderstand how results translate to practiceUnderstand levels of research evidenceValidationVerificationWriting Study Procedures and SOPs
Skills and Expertise
Analyze data Assure medical quality Control data Create SOPs Develop protocols Guide students Interact with nurses Interact with physicians Interpret data Lab scale batches Search literature on clinical trials Write papersAdjust methodsAdjust processes Adjust processes and methodsAdministrative supportAnalyze dataAnalyze proteinAPI synthesis route developmentAttend seminarsAttend investigator meetingCoachConduct research at universitiesConduct university research Control protocol versionscoordinating research projectsCreate SOPsCreate standard operating procedure (SOP)Creates a collaborative team environmentDesign data reporting systemsDesign database Design studyDesign tracking systemDirect co-workersEvaluate protocolsFollow-up of internal auditsFollow-up of external auditsFollow-up of quality assurance activitiesFollow-up of Quality Management System (QMS) processesImplement Quality Management System (QMS)Maintain Quality Management System (QMS)Manage data collection systemManufacture of GMP batchesmanaging a small teamManufacture of non-GMP and GMP batchesNetworkOffice managementOrganise meetingsPilot scale batchesPresent data at congressProvide input to process improvement initiativesProvide trainingPublication of articlesQuality control processRead medical literatureResearch at universitiesReport non-compliance incidentsRespond to audit findingsReview manufacturing documentationSupervise techniciansTrain on site staffValidate dataVerify dataWork under specific instructionsWrite papers
PhD in Pharmaceutical Sciences - Radiopharmacy from Universiteit Gent in 2005
Msc in Chemistry from Universidad de Santiago de Compostela in 2001
Msc in Chemistry from Universiteit Gent in 2001
Bachelor in Chemistry from Universiteit Hasselt in 1998
highschool in Latin - Science from st. Michielscollege in 1995