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Renaud LEPINE

PARIS

En résumé

Experienced project leader with more than nine years working in the pharmaceutical industry. From bench to project management, moving from the academic field to big companies and now Biotech Company, I am fully aware of research and development environment and issues.
Able to work independently, to innovate, analyse, prioritise, manage cross-functional teams, in a high-pressure environment. In this very competitive landscape, I have the ability to negotiate with suppliers and to deal with a difficult partner, knowing the field and the pharmaceutical market.

Entreprises

  • Galapagos - CMC Chemistry Lead

    2011 - maintenant Responsible for the manufacturing of Drug substances in four different projects: in Oncology, Inflammatory and Anti-infective field (More than 1M€/kg of Drug substance). Elaboration of project’s planning and budgeting. Coordination and management of Chemistry, Manufacturing and Control (CMC) activities with our external partners (CRO and CMOs), in order to obtain the compound for FIH and further development phases. Make sure that the drug substance meets GMP and ICH guidelines (Analytical and Monitoring method) and quality requirements for regulatory filings during development and commercial registration (IMPD writing, PGI statement and control). Management of the technology transfer from lab’s scale to pilot’s lab and further scale up.

  • Galapagos - Chimiste medicinal

    2005 - 2011 Medicinal chemist working in the Anti-infective field: 5 projects based on Natural product chemistry.
    In charge of literature review, competitive intelligence, laboratory work, analysis of experimental data, natural product production by fermentation.
    Responsible of the design of scientific plans: strategic decision on synthesis, work allocation to team members. Also playing a key role in the inter-departmental coordination by the supervision of project progress in both Chemistry and Biology departments, regulars reporting to customers, management and stakeholders on project status and pending actions.
    Management of outsourcing contracts: repartition of work to externalised chemistry teams.
    Scientific supervision of technicians/scientists/senior scientist (up to 9 FTE)
    One Pre Clinical Candidate delivered, two patents and one publication.

Formations

Pas de formation renseignée

Réseau

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