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Summary

Expert in cGMP and QA related processes in Regenerative Medicine. Specialities: Managing, coordinating and supervising manufacturing activities Starting up of manufacturing processes in cleanroom facilities QA compliance Product implementation into cleanroom production facilities. Intern and extern audits Research background in; Process development, Cell Culturing, Animal Studies, Immuno-fluorescent and histological staining procedures, RT-qPCR, ELISA, FACS, Westernblot

Experiences

Current Experience

  • Manager Production and Warehouse GLN
    Since June 2014
    Responsible for managing, coordinating and supervising manufacturing activities (production and warehouse) in the Cell Expansion Facility located in Sittard-Geleen. Responsible for delivering quality products on time and ensuring compliance with all cGMP and safety standards. Responsible to introduce new cell therapeutic products into state-of-the-art production facility and ensuring full compliance with current regulatory guidelines. Delegate Responsible Person.

Past Experience

  • Manufacturing Manager
    August 2012 --- June 2014
    Responsible for managing, coordinating and supervising manufacturing activities (production and warehouse) in the Cell Expansion Facility located in Sittard-Geleen. Responsible for delivering quality products on time and ensuring compliance with all existing GMP and safety standards.

  • QA Compliance Officer -QA Lead-
    January 2012 --- July 2012
    To take care of all QA related issues by implementing new products into Genzyme’s production facilities.

  • QA Compliance Officer -Process Reviewer-
    June 2011 --- July 2012
    Process Reviewing, Intern inspections, Handle Quality Events, Deviations,and CAPA's. Actively involved during external audits by e.g. FAGG and FDA.

  • R&D Scientist
    August 2008 --- June 2011
    cGMP Cell Culturing, Tissue Engineering, Process and Assay Development

  • PhD student
    March 2003 --- August 2008
    Title thesis "de novo apoA-I synthesis: regulation and nutritional effects" Cell and animal based studies were performed during this thesis, and various molecular techniques were used, such as ELISA, Westernblot, RT-qPCR, cell transfections, and Agilent microarrays.

Knowledge

LinkedIn Assessment :
ELISACell CultureFACSImmunologyMicrobiologyWesternblotSDS-PAGERT-PCRQA complianceCleanroom Grade D-AGMPIn VitroCell

Education

  • MSc in Gene Therapy from VU University Amsterdam in 2003
  • BSc in Biologie en Medisch Laboratorium onderzoek from Hogeschool Zuyd (Maastricht, Heerlen, Sittard) in 2000

Area / Region

Zonhoven, België

Others

Driving License
  • No