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Géraldine ZINGONE

TOULOUSE

En résumé

Pas de description

Entreprises

  • Genticel - Group Leader Bioprocess & Manufacturing

    2009 - maintenant Development of therapeutic vaccines against cervical cancer for women infected by Human Papillomavirus (HPV).
    Work from pre-clinical to Phase III clinical stage

    • Definition of CMC strategic and operational objectives
    • Management of Process team
    • Select and Pilot CMOs/CROs
    • Manage Process Development, Transfer and Scale-up (Pre-clinical to Phase III clinical stages
    • Manage Manufacturing and Release of Clinical batches (for Phase I and Phase II)
    • Manage WCB and MCB Manufacturing
    • Participate to preparation of regulatory files related to CMC for UE and US
    • Screening of new therapeutic vaccine candidates
    • Ensure the proper quality compliance level in accordance with Company standards
    • Represent Bioprocess team in multidisciplinary project teams
  • Genticel - Bioprocess Scientist

    2007 - 2008 • Development and optimization of Upstream, Downstream and Formulation processes for recombinant proteins
    • Screening of new therapeutic vaccine candidates
    • Optimisation of Expression System
  • UCB Celltech - Fermentation Scientist

    COLOMBES 2005 - 2007 Process Optimisation to increase Fab’ production rate in the periplasm
    • Optimisation of Fab’ extraction process
    • Conduct robustness studies on fermentation process to get supportive data in the context of AMM and BLA submissions
    • Training of four persons to batch and fed batch fermentation processes

Formations

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