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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. 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

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