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Summary

technical expertise of In Vitro Diagnostic (IVD) systems built up over 23 years of engagement with innogenetics – fujirebio europe.

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.

Experiences

Current Experience

  • Project Leader

    Zwijnaarde, Ghent, Belgium
    Since November 2016
    Analytical Method Validation

    Project Leader

    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.

Past Experience

  • Senior Developer Zwijnaarde, Ghent, Belgium

    July 1993 --- October 2017
    Change Control

Knowledge

Self Assessment :
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

Self Assessment :
project managementDrug SubstanceDrug Productin vitro diagnisticsinfectious diseasesMycobacteriumHPVContract Development and ManufacturingBiologicalsQMSFMEA

Languages

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

Work Preferences

  • Locations I am interested in:
    Ghent, Belgium
  • Work From Home:
    Yes, 0 to 5 days per week
  • Work Regime:
    Permanent position :    100% FTE
  • International:
    No

Publications

    Expert has 2 publications (Will be avalible with full profile)

Area / Region

Ghent, Belgium

Others

Driving License
  • Yes

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