Success is no accident. It is hard work, perseverance, learning, studying, sacrifice and most of all, love of what you are doing or learning to do.
☺ Who am I
► An in vitro diagnostic systems (IVD) polyvalent professional with almost 20 years of engagement with Innogenetics-Fujirebio Europe.
► Participate as a project lead in different IVD projects, leading to success in New Product Development.
► Participate as a project lead and core team member in Product Life Cycle Management projects.
► Team player, persevering, result oriented, analytical problem solver, organizer, strategic thinking.
► Qualified for first aid
► Polyglot: Dutch (mother tongue), English (fluent), French (good knowledge), Spanish & Italian (Basic)
► Statistical analysis and problem solving: Minitab, SPC, DMAIC, FMEA, DOE and other Six Sigma aspects.
► Coached Leadership
► Specialized in nucleic acid related molecular techniques, with knowledge of protein based assays.
► Project management
► URS, supplier selection, Validation (IQ/OQ/PQ)
► DCP: process qualification, verification and validation, GxP
► Expert in Process and Product Development, QC development, Product Life Cycle management (PLM) and Validation.
► My interests go to Project leadership in Assay Development and Process Development, Process Engineering and Project Management in the Biotechnology, Pharma or Chemistry.
► A Life Science company which gives the opportunity to grow further personally and professionally
Since January 2012
Analytical thinkingAssertivenessCollaborationCoordinationEfficiencyFlexibilityIndependenceInterest in knowledgeKindnessOrganizationPerspectiveProblem solvingResiliencyResponsibilitySelf-disciplineResult OrientedStrategic thinkingWillingness to compromise
Skills and Expertise
Analytical skills Analyze data Create SOPs Develop protocols Interpret data Lab scale batches Molecular Diagnostics Report data Write protocolsAdjust methodsAdjust processes Adjust processes and methodsAlzheimerAnalyze data/information to determine potential relationships.Assess product quality issuesassess the needs of the project(s)/program(s) and make changes in process, work flow and/or assignments.Assist with experimentsAssist with proceduresAssist with routine testsClinical data collectionCoachCoach and provide guidance to clinical staff.Collaborate with project teamConduct limited data and/or statistical analysis.Coordinate ethics committeeCoordinate projectsCreate SOPsCreate standard operating procedure (SOP)Data verificationDesign scientific experimentsDesign protocolsDevelop protocolsDevelop Quality Risk Management (QRM) initiativesEvaluate stability data Evaluate protocolsImplement ProcessesInteract with statisticiansmanaging a small teamLead teamsInterpret analytical resultsInterpret dataExtrapolate dataDirect co-workers to achieve resultDirect co-workersLiaise with professionals in other divisions of the company as requiredlifescienceOptimize assay performancepcrPeople managementPerform routine testsPilot scale batchesProvide input to process improvement initiativesProvide benefit risk assessmentQuality control processR&DReview dataReview data interpretationReview experimental plansReview protocolsReview reportsStatistical analysisSupervise techniciansUse laboratory techniquesVerify dataWrite documents
Master (engineer) in Applied Science from AVANS (NL) in 2003
Bachelor in Pharmaceutical & Biological techniques from Erasmus Hogeschool Brussel in 1986
Training and Certification
Qualified as Validation expert (intra company training) in 2014 Training
Dialogue & listening skills in 2012 Training
Office a la carte Excel in 2012 Training
Statistical insight trough Minitab in 2012 Training
Statistical Process Control in 2012 Training
Communication techniques in 2010 Training
Presentation techniques in 2010 Training
Time Management in 2010 Training
Industrial & mercantile statistics in 2007 Training
Leadership, a particular subject in 2004 Training