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Stephane CONTENT

Carros

En résumé

PROFIL NON MIS A JOUR, CF MA PAGE LINKEDIN

15 ans d'expérience dans l'Industrie Pharmaceutique. Développement de procédés chimiques pour transfert en usine pilote ou de fabrication. Elaboration de synthèses visant les contraintes de coûts, sécurité, qualité et d'impact sur l'environnement. Rédaction des documents de transfert. Résolution des problèmes. Utilisation des principes de la "green chemistry". Travail en équipes pluri-disciplinaires (analytique, sécurité, usine , régulatoire...), CMC et brevet.

Aussi sous linkedin :

http://uk.linkedin.com/in/stephanecontent

Mes compétences :
Optimisation des process
Gestion de projet
Industrie pharmaceutique

Entreprises

  • Virbac - API Project Development Manager

    Carros 2011 - maintenant VIRBAC – Coordination Pharmaceutique (Carros - France)
    API Project Development Manager
    Within the CMC team, supporting the evaluation and the qualification of Active Pharmaceutical Ingredients, gathering the required information for the quality part of the Dossier and contributing to answering the Authorities' questions.

    Assessement of patent risks for synthesis and polymorphism. Argumentation in cases of oppositions to patents.
    Assessment of APIs in their evaluation phase, (regulatory and the technical risks), following their development with the formulation and analytical teams.
    Writing the quality and regulatory specifications for the sourcing of newly sourced APIs, following up the contracted out development work.
    Subject matter expert when technical problems arise to contribute solving issues
    Gathering the scientific studies necessary to write the quality part of the dossier for the Marketing Authorisation
    Writing of variations and answering the questions from the Authorities.

  • Pfizer - Process R&D

    Paris 2004 - 2010 Selection & optimisation of new processes to deliver appropriate synthetic route to new API
    Design of experiments, lab experimentation, and data analysis
    Ensure robustness of process, safety and environmental testing in place
    Communicate with cross-functional groups
    Transfer from lab to kilo lab to pilot plant
    Right-First-Time and Britest
    Redaction of appropriate documentation
    Electronic laboratory notebook.

  • Pfizer - Research scientist

    Paris 1997 - 2003 Route design, synthesis, characterisation of molecules targeted at biological activities
    Use of hemi-synthesis, parallel synthesis, resins
    Use of automated equipment for synthesis and purification..
    Large scale synthesis ( up to 20litres reactors)

  • CEPPOL - Scientifique du Contingent

    1995 - 1996 Scientifique du contingent at CEPPOL (Brest, France) (Comity Fighting against sea-pollution)

    CEPPOL is the Navy unit responsible for the logistic operations of depollution in case of oil or chemical contamination on the French littoral. The equipment is evaluated and maintained across the country. CEPPOL is also responsible for the training of personels and is collaborating closely with the CEDRE.
    - statistics about the transport of dangerous cargos crossing the Channel
    - Training of the Navy personnel dealing with the sea pollution
    - on-call to perform analysis in case of sea pollution
    - cartography of the dispersing fluid spreading limits

  • Organon - Trainee

    1994 - 1994 Synthesis of biologically active molecules

  • DDASS - Trainee

    1992 - 1992 Trainee at the water department of the DDASS (Saint-Etienne, France) ( Direction Departemental de l'Action Sanitaire et Sociale)
    - "lagunage" sampling and water works sampling

  • GEREP - Technician

    Paris 1989 - 1989 Chemical technician at GEREP ( Mitry-Mory , France) chemical waste incineration plant.

Formations

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