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Christophe MONTERO

MONACO

En résumé

I wish to bring to customers my expertise forged over 13 years of projects management of analytical studies in various environments as R&D, QC and regulatory affairs, and I want to be the guarantor of all partners involved in the projects in order to facilitate the achievement of the defined objectives.
I implement this approach in a conscientious, stable and reactive manner, by interacting in transverse and by being open to new challenges constantly.


Mes compétences :
Analytical Development
Project Management
Analytical Transfer
Analytical Validation

Entreprises

  • TEVA Pharmaceuticals - Head of Analytical Development - Monachem

    2011 - maintenant TECHNOLOGY TRANSFERS PROJECTS :
    - Lead transfers of analytical methods to backup or subcontractors international industrial sites
    - Define roles and responsibilities, writing of protocols and reports, planning and coordination of studies, technical support, interpretation of results, final decision of laboratories qualification

    ANALYTICAL DEVELOPMENT PROJECTS :
    - Development, optimization and validation of analytical methods according to ICH, SFSTP, EP and USP : planning of studies, organization of resources, training of technicians, writing of protocols and reports
    - Management of the analytical development laboratory activity, training apprentices Master 2 FoQual

    CHEMICAL DEVELOPMENT PROJECTS :
    - Analytical Support to the chemical development/rationalization of processes, scale-up, industrial validation of processes, qualification of raw materials sources, analytical subcontractors coordination
    - Characterization of degradation and synthesis impurities

    INDUSTRIAL DEVELOPMENT PROJECTS :
    - Industrial incident troubleshooting, contamination research, development of reprocessing method

    STARLIMS ADMINISTRATOR :
    - Training in Israël (2 weeks), implementing and updating LIMS software, technicians training

    STABILITY COORDINATOR :
    - Planning of API stability studies according to ICH, follow-up of trends

    QC MANAGER BACKUP :
    - Management of QC activity according to manufacturing planning, batches release

    REGULATORY AFFAIRS PROJECTS
    - Participating in regulatory inspections and audits
    - Writing of DMF and CEP Part. 3.2.S (EMA - FDA), responses to regulatory issues
    - RAQP follow-up
    - Regulatory monitoring ICH, EP, USP
  • TEVA Pharmaceuticals - Head of Analytical Development

    2011 - maintenant
  • Merck KGaA - Head of Analytical Development - Monachem

    Darmstadt 2003 - 2010 TECHNOLOGY TRANSFERS PROJECTS :
    - Lead transfers of analytical methods to backup or subcontractors international industrial sites
    - Define roles and responsibilities, writing of protocols and reports, planning and coordination of studies, technical support, interpretation of results, final decision of laboratories qualification

    ANALYTICAL DEVELOPMENT PROJECTS :
    - Development, optimization and validation of analytical methods according to ICH, SFSTP, EP and USP : planning of studies, organization of resources, training of technicians, writing of protocols and reports
    - Management of the analytical development laboratory activity, training apprentices Master 2 FoQual

    CHEMICAL DEVELOPMENT PROJECTS :
    - Analytical Support to the chemical development/rationalization of processes, scale-up, industrial validation of processes, qualification of raw materials sources, analytical subcontractors coordination
    - Characterization of degradation and synthesis impurities

    INDUSTRIAL DEVELOPMENT PROJECTS :
    - Industrial incident troubleshooting, contamination research, development of reprocessing method

    QC MANAGER BACKUP :
    - Management of QC activity according to manufacturing planning, batches release

    REGULATORY AFFAIRS PROJECTS
    - Participating in regulatory inspections and audits
    - Writing of DMF and CEP Part. 3.2.S (EMA - FDA), responses to regulatory issues
    - RAQP follow-up
    - Regulatory monitoring ICH, EP, USP
  • Allergan - Superior Analyst - R&D Europe

    Courbevoie 2001 - 2002 ANALYTICAL DEVELOPMENT PROJECTS :
    - Development and validation of analytical methods for maintenance of liquid and pasty products
    - Transfers of analytical methods (USA, China, Mexico), Stability studies according to ICH
  • Bayer - Analytical Research Apprenticeship

    Lyon 1998 - 1999 ANALYTICAL DEVELOPMENT PROJECTS :
    - Extraction of volatile compounds from Boletus Edulis by SPME and supercritical Co2 , GC-MS analysis
    - QC analysis (HPLC, GC-MS), organoleptic control of raw materials

Formations

  • Université Nice Sophia Antipolis

    Nice-Sophia Antipolis 1998 - 1999
  • Université Nice Sophia Antipolis (Nice-Sophia Antipolis)

    Nice-Sophia Antipolis 1998 - 1999 ONE YEAR POSTGRADUATE DEGREE IN CHEMISTRY, Analysis, Quality, (Master 2 Pro FOQUAL - DESS FOQUAL)

    .
    JURY MEMBER OF MASTER 2 FOQUAL VAE since 2007
    Report : Volatile compounds extraction from Boletus Edulis
  • Université Nice Sophia Antipolis (Nice-Sophia Antipolis)

    Nice-Sophia Antipolis 1997 - 1998 MASTER'S DEGREE IN CHEMISTRY (Master 1 Chimie)

    - Report : Inhibitors of HIV NcP7

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