Dr. Gert Thurau

Bis 2016, Vizedirektor Pharmazeutische Produktregistrierung, F. Hoffmann La-Roche
Basel, Switzerland

Fähigkeiten und Kenntnisse

Pharmaceutical development and technology transfer
Process Analytical Technology
Quality by Design
QbD
Pharmaceutical technical registration
Technical Regulatory
CMC regulatory

Werdegang

Berufserfahrung von Gert Thurau

  • Current 10 years and 2 months, since Apr 2016

    Global Head Technical Regulatory Small Molecule Development

    F.Hoffman-La Roche

    Leader of small molecule technical regulatory development group at Roche, supporting clinical trial registration and intial market application world-wide. Responsible for >30 staff in Basel and San Francisco Area, member of Roche Global Regulatory Leadership Team.

  • 2 years and 7 months, Sep 2013 - Mar 2016

    Vizedirektor Pharmazeutische Produktregistrierung

    F. Hoffmann La-Roche

    Group leader in the Technical Regulatory Department, responsible for registration of Roche small molecule pipeline products from entry human (Phase I) to market authorization. Leading a team of technical registration experts in the Basel headquarter site. Member of the Roche small molecule Quality by Design (QbD) strategy team to opportunistically deploy QbD approaches to the small molecule network.

  • 3 years and 4 months, Apr 2010 - Jul 2013

    Director Process Analytical Technology

    Merck & Co., Inc.

    Director PAT Merck Head of the Merck corporate PAT team, leading group of >20 scientists in multiple locations in support of R&D and Manufacturing of chemical, formulation and biologics/vaccines products. Responsible for global PAT strategy and implementation at Merck. Member of core Merck Quality by Design Implementation team

  • 1 year and 3 months, Jan 2009 - Mar 2010

    Associate Director Analytical Sciences Leader

    Merck & Co., Inc.

    Analytical Sciences Leader in the Merck Commercialization Plant in Ballydine, Ireland. Responsible for analytical development and advanced production supports for all techniques, including Process Analytical Technology (PAT). Member of the Merck Quality by Design (QbD) Strategy Team.

  • 3 years and 1 month, Dec 2005 - Dec 2008

    Associate Director

    Merck & Co., Inc.

    Head of Merck Global Process Analytical Technology (PAT) group. Member of Merck Quality by Design (QbD) Strategy Team.

  • 5 years and 6 months, Jun 2000 - Nov 2005

    Scientist

    Merck & Co., Inc.

    Process Analytical Technology Scientist in Merck Manufacturing Division.

Ausbildung von Gert Thurau

  • 9 years and 6 months, Oct 1989 - Mar 1999

    Chemistry

    University of Goettingen

    Physical Chemistry, laser spectroscopy, reaction kinetics.

Sprachen

  • English

    C1 (Fließend)

  • French

    B1-B2 (Gute Kenntnisse)

  • German

    C2 (Verhandlungssicher / Muttersprachlich)

  • Italian

    A1-A2 (Grundkenntnisse)

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