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Emmanuel MOREAU

Suresnes

En résumé

OBJECTIVE
Lead and promote the development of innovative products, from design to market access.

HARD and SOFT COMPETENCIES
- 9 years of expertise of IVD products development and registration
- Ability to manage research projects, with a focus on deliverables
- Strong team spirit, excellent cross-functions communication
- International oriented

ASSAY DEVELOPMENT EXPERTISE
- Feasibility : technical evaluation, raw materials selection, assay prototyping, performance evaluation
- Design and implementation: performance optimization, robustness assessment, design freeze
- Verification and Validation: CLSI-compliant protocols and execution, technical reports fit for CE marking, FDA and CFDA registration
- Support: Clinical affairs for execution and trouleshooting of clinical trials; Regulatory Affairs for meetings with regulatory bodies (FDA), Marketing for sales force documentation, Quality Management

EDUCATION
- PhD in Immunology, Université Paris 5 (France), 2004
- DEA in Biotechnology, Université Paris 7 (France), 2000
- Maîtrise in Biochemistry and Molecular Biology, Université Paris 7 (France), 1999

Mes compétences :
Diagnostic in vitro
Immunologie
Leadership
Manager
Antibody
HIV/AIDS
Immunization
Cell Culture
Protein array platform design
Companion diagnostics
Immunoassay design
Develop collaborators
Virology
Pharmacology
Microsoft Office
Microarrays
Immunology
Immunoassay
ELISA
Digital Publishing
DNA cloning
Affinity Chromatography
Adobe Indesign

Entreprises

  • Philips - Technical Project Lead Assay

    Suresnes 2016 - maintenant * Head of IVD assay performance verification & validation in the R&D group
    * Interfaces with Quality and Regulatory Affairs for product compliance (CE marking, FDA registration)
    * Scientific support to Medical Affairs and Marketing for optimal market access
    * Biobank management

  • BioMérieux - R&D Technical Leader

    MARCY-L'ETOILE 2009 - 2016 * Design & development of IVD-labeled automatized immunoassay solutions for clinical routine and companion diagnostics
    * Biological and chemical raw material selection & assessment
    * Verification and validation of immunoassay kit performances for registration
    * Secure production scale-up

  • Mc Gill University Micro and Nanobiotechnology laboratory - Research Associate

    2008 - 2009 Development of a microfluidic antibody microarray platform for biomarkers detection
    . selecting antibodies and artificial binders for miniaturized sandwich ELISA
    . developing, troubleshooting and establishing SOPs for multiplex quantification of biomarkers
    . leading industrial collaborations to promote our technological platform

    Design of a chip display libraries for selection of affinity binders
    . design of chip-display devices for cell-free selection of synthetic binders
    . set up of the selection of affinity binders : proof of concept using reference antibodies and targets
    . development of technological applications (parallelized selection against multiple antigens)

  • INRS Armand-Frappier - Immunovirology laboratory - Post-doctoral fellow

    2004 - 2008 Hepatitis C Virus interactions with immune cells
    . establishing an ex vivo infectious HCV production system
    . characterizing dendritic cells, monocytes and lymphocytes interactions with HCV

    Engineered antibodies targeting selected epitopes of human cytomegalovirus glycoprotein B
    . cloning CMV-immunized transgenic mouse variable antibody repertoire
    . building recombinant antibody libraries for selection by phage display technology
    . supporting scientific collaborations with Dr M. Ohlin, Lund, Sweden.

Formations

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