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Experiences

Current Experience

  • Research and Development Manager

    Beernem
    Since January 2015

    after 4 years being employed as r&d Scientist, i became manager of the r&d department. i am responsible for:

     

    a) optimization of existing products (Diagnostics and culture media for human reproduction)

    b) development of new products (Diagnostics, culture media and recombinant Proteins)

    c) support of the quality department (scientific support, development and Validation of new qc Assays)

    d) Manufacturing support (Process development and Validation)

    e) support of the regulatory department (Clinical evaluation and set-up of technical files of Medical Devices class 1-3 and medicinal substances, Internal Auditor)

    beside, i am also biosafety Coordinator.

     

    After 4 years being employed as R&D scientist, I became manager of the R&D department. I am responsible for:

     

    a) Optimization of existing products (diagnostics and culture media for human reproduction)

    b) Development of new products (diagnostics, culture media and recombinant proteins)

    c) Support of the quality department (scientific support, development and validation of new QC assays)

    d) Manufacturing support (process development and validation)

    e) Support of the regulatory department (clinical evaluation and set-up of technical files of medical devices class 1-3 and medicinal substances, internal auditor)

    Beside, I am also biosafety coordinator.

     

  • Biosafety coordinator


    Since January 2015

Past Experience

  • employee R&D department Beernem, Belgium

    November 2009 --- December 2014

    .

  • PhD student Ghent, Belgium

    January 2004 --- October 2009
    my phd thesis, entitled “interindividual variation of the sex hormone status and the effects of testosterone in men: Research for genetic determinants “ implied the study of association between sex hormone status and polymorphisms of candidate genes, more in particular snp and repeat Analysis of genes responsible for testosterone Metabolism and Protein binding.

Personality

Self Assessment :
Analytical thinkingApproachabilityAssertivenessAttention to detailAuthenticityCharmCollaborationCommunicativeCompetitivenessCoordinationCreative thinkingCritical thinkingCuriosityDependabilityDiligenceEfficiencyEmotional reactivityFlexibilityIndependenceInnovative thinkingInterest in knowledgeKindnessOptimismOrganizationOrientationPerspectiveProactivityProblem solvingResiliencyResult OrientedSelf-confidenceSelf-disciplineSelf-disclosureService orientedSociabilityStrategic thinkingResponsibilityStrivingTrustWillingness to compromise

Knowledge

Self Assessment :
Biochemistry Biostatistics Cell biology Lab scale batches Medical devices Negotiation R&D Scientific writing21 CFR Part 11Actions and modes of action of human physiologyAnalysisAnalytical Method ValidationAnalytical methodsAnalytical techniquesAntibodiesAseptic ProcessingAseptic TechniquesAssay developmentAuditingAutomationBioanalysisBiochemistryBioinformaticsBiologyBiotechnologieBiotechnologyCell Based AssaysCell biologyCell CultureCellular Product DevelopmentChange ControlCharacterizationChemistryChemistry, Manufacturing, and Controls (CMC)ChromatographyCleaning ValidationData AnalysisData entryDatabase design and maintenanceDatabasesDiagnostic marketDiagnosticsDNADNA extractionDNA sequencingElectrophoresisEMAELISAEndocrinology and metabolismEndocrinologyEnglishEnzyme AssaysEnzyme-linked immunosorbent assay (ELISA)ExperimentationFluorescence MicroscopyFlow CytometryFormulationGel ElectrophoresisGenetic polymorphismGeneticsGenomicsGood Laboratory Practice (GLP)Good Publication Practice (GPP)Grant PreparationGrant Writinggrant writing and designHPLCICH guidelinesImmunoassaysImmunocytochemistry (ICC)In VitroIn vitro diagnostics (IVD)LaboratoryLaboratory ManagementLaboratory ResearchLaboratory SkillsLaboratory TechniquesLaboratory testingLarge MoleculesLife SciencesLiquid Chromatography-UV (LC-UV)Mammalian Cell CulturemanagementMedical DevicesMedical writingMetabolismMicrobiological TechniquesMicrobiologyMicroscopyMicrosoft ExcelMicrosoft OfficeMicrosoft PowerpointMicrosoft ProjectMicrosoft WordMolecular & Cellular Biologymolecular biologyMolecular CloningMolecular DiagnosticsMolecular geneticsMolecular ModelingOutlookPCRPeptidesPowerPointProblem SolvingProblem-solving methods and troubleshootingProcess improvementProduct designProduct developmentProduct launchProduct managementProject ManagementProject PlanningProject Portfolio ManagementProtein ExpressionProtein PurificationProteinsProtocolqPCRPurificationQualitative ResearchQuality ManagementR&Dreal-time PCRRegistration of the productRegulatory affairsReport WritingResearchRT-PCRscienceScientific CommunicationsScientific methodologyScientific WritingSDS-PAGESPSSSpectroscopySocial SkillsStatisticsStability testsStandard Operating Procedure (SOP)Statistical Data AnalysisStem cell researchStem CellsSterile drug productsSterilizationTeam BuildingTeam LeadershipTeam ManagementTeachingTeamworkTechnical reportsTechnical SupportTechnology transferTime ManagementTrainingTransfectionTranslationTranslational MedicineTroubleshootingUnderstand how results translate to practiceUnderstand levels of research evidenceUnderstanding of regulatory guidelinesValidationVerificationWriting Study Procedures and SOPsWestern Blotting
LinkedIn Assessment :
Medical DevicesR&DValidationFDABiomedical EngineeringISO 13485ISO9001 AuditorStatistical Data AnalysisMammalian Cell CultureWestern BlottingImmunofluorescenceFragment analysisDNA sequencingSNP genotypingreal-time PCRGel ElectrophoresisAuditingSPSSSOLARLinuxGenABELMicrosoft OfficeDatabasesmolecular biologyLifesciencesLife SciencesBiochemistryqPCRBiotechnologyCell biologyCell CultureGeneticsPCRImmunology

Skills and Expertise

Self Assessment :
Analytical skills Analyze data Control data Create SOPs Develop protocols Guide students Interpret data Lab scale batches Molecular Diagnostics Report data Write papers Write protocolsAdjust methodsAdjust processes Analyze proteinArchive documentationAseptic techniquesAseptic processingAssist with experimentsAssist with proceduresbudgeting of R&D activitiesCell cultureCoachCollaborate with project teamCommunicate with investigatorConduct literature searchesConduct studiesConduct university research Create SOPsData validationData verificationDesign data collection systemsDesign data reporting systemsDesign database Design protocolDesign studiesDesign scientific experimentsDesign study documentsDesign the studyDesign tracking systemDetermine needsDevelop protocolsEnsure data consistencyEvaluate impurity identificationEvaluate impurity synthesisEvaluate post-marketing surveillance studyEvaluate stability data Execute scientific projectsFollow-up of internal auditsGuide staffInteract with statisticiansInterpret analytical resultsInterpret dataInterpret research resultsInterpret scientific dataLead studiesLead teamsLiaise with research teamManage research projectsManufacture of non-GMP batchesManuscript preparation and reviewNon-aseptic processingOversee data collectionpcrPeople managementPilot scale batchesPlan experimentsPlan work to meet objectives and deadlinesPrepare final reportPrepare internal auditsPrepare manuscriptPrepare regulatory documentsPresent data at congressproject managementProtocol managementProvide trainingPublish scientific projectsPublication of articlesR&DRead medical literatureRegulatory documentationRelease productsResearch at universitiesReview data interpretationReview exclusion criteriaReview inclusion criteriaReview manufacturing documentationReview protocolsReview quality control activitiesReview study protocolsSet up research projectsSetup of research equipmentSolve problemsStatistical analysisStudy execution planSupervise PhD studentsTeachingTrain StaffTrain on site staffUnderstand protocolsUse laboratory techniquesUse western blotting techniqueValidate dataVerify dataWork cross-functionallyWrite final reportsWrite papersWrite statistical reportsWritten presentationmedical devicesauditerqPCRsnp genotyping

Education

  • PhD in Reproductive endocrinology (Medical Sciences) from University of Ghent in 2008
  • Master in Biotechnology from University of Ghent in 2004

Training and Certification

  • Analysis of Variance in 2007 Training
  • Introductory Statistics: Basics of statistical inference in 2007 Training
  • Linear Regression Analysis in 2007 Training
  • Short course in Family-based Genetic Association Testing (FBAT) in 2006 Training
  • SNPs and human diseases (Erasmus Postgraduate School of Molecular Medicine, Rotterdam) in 2006 Training
  • Advanced Academic English: conference skills in 2005 Training
  • Amelior: Auditor according to ISO9001 version 2008 (principles of auditing, standards and norms, practical aspects of auditing, communicative aspects of auditing) in 2014 Certification

Languages

BrightOwl Assessment:
Self Assessment:
Dutch
Native
English
Full Proficiency
French
Elementary Proficiency
German
Elementary Proficiency

Work Preferences

  • Notice Period:
    5 weeks
  • Positions I am interested in:
    R&D manager Development Manager Field Project Manager Lead Consultant Lecturer Management Consultant Manager Project Assistant Project Leader Project Manager QA Consultant R&D Director Research Assistant Research associate Research Trainee Science teacher Scientific Advisor Scientific consultant Scientific Researcher Senior Consultant Senior Project Manager (PM) Senior Strategy Consultant Teacher Trainee
  • Work From Home:
    No
  • Work Regime:
    Permanent position :    80% FTE
  • International:
    No

Publications

    Expert has 17 publications (Will be avalible with full profile)

Area / Region

Beernem, Belgium

Others

Driving License
  • Yes

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