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Marjorie GAPP

PARIS

En résumé

Mes compétences :
Biologie
Biotechnologie
Contrôle qualité
Microbiologie
Qualité
Responsable qualité
Validation

Entreprises

  • LabCorp Clinical Trials, A LabCorp Company - Global Manager Scientific Affairs

    2013 - maintenant
  • LabCorp Clinical Trials, A LabCorp Company - Scientific Affairs Manager

    2011 - maintenant
  • Clearstone Central Laboratories, A LabCorp Company - R&D Manager, Assay Validation & Development

    2010 - 2011 • Manage Global R&D Lab Technologists and Engineer (China, Canada, Singapore, France);
    • Define and manage the resources necessary for the implementation of the objectives;
    • Global lead for the validation & development of over 20 new assays including esoteric, biomarker and routine tests on automated platforms
    (ETI-Max 3000, Modular P, Immulite 2000, AxSym, SpectraMax Plus 384);
    • Lead the technology transfer over 50 assays (immunoassays, biochemistry, hemostase);
    • Play a key role in the establishment of fit-for-purpose assay validation process with plate-based and bead-based immunoassays
    • Lead the scientific preparation/review of all documentation related to assay validation
    (plan, report, biomarker checklist, raw data, SOPs);
    • Provide recommendations of acceptance criteria for in-study testing;
    • Act as liaison with other Department to ensure sponsor satisfaction;
    • Proceed to structural reorganization of the R&D Lab.
  • Clearstone Central Laboratories - Quality Engineer (QC Lab Specialist)

    Paris 2007 - 2010 • Led the follow up of internal quality controls for esoteric and biomarker testing;
    • Implementation of quality system (QC follow up);
    • Led semi-annual instrument-to-instrument comparison; over 250 tests
    (biochemistry, haematology, hemostase, immuno-assays and flow cytometry);
    • Participated to laboratory internal/external audit;
    • Played a key role in the preparation of the CAP accreditation and self-accreditation;
    • Ensured and followed up external Proficiency Testing program and Quality Controls(CAP, NGSP, CDC Lipid);
    • Prepared or reviewed SOPs; trained lab technologists.
  • (start-up) - Start-up creation project

    2006 - 2006 • Scientific review for marketing study;
    • Business plan elaboration;
    • Presentation to academic and private investors and partners.
  • Synth'E163 - Strasbourg - Research Engineer

    2002 - 2005 • Synthesis of over 250 molecules exhibiting antibacterial and antifungal properties;
    • Development of a structure-activity relationship drug libraries (antimicrobial/antiviral);
    • Optimization of properties, activity, stability;
    • Identification of 2 leads;
    • Raising of 300K€ capital with private investors and business angels.
  • Laboratoire de Physiopathologie et d'antibiologie microbienne - Strasbourg - Research Engineer

    2001 - 2001 Development and Validation of an HPLC method for a new molecule against S. aureus.

Formations

  • Université Cergy Pontoise (Cergy Pontoise)

    Cergy Pontoise 2007 - 2008 Chimie / Contrôle Qualité
  • Université Strasbourg 1 Louis Pasteur

    Strasbourg 2001 - 2002 DESS Substances Naturelles Vegetales d'Intéret Economique

    Physico-Chimie / Biologie / Genie Pharmaceutique

Réseau

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