Dr. Adrian Huber

Angestellt, Senior Quality and Regulatory Manager, Five Office Ltd

Wetzikon, Schweiz

Fähigkeiten und Kenntnisse

Risk Assessment - Scientific Advice - Scientific C
Marketing Authorization Application (MAA)
First-In-Man (Clinical Phase I)
Preclinical and Regulatory Drug Development
Preclinical Modules of the CTD (Common Technical D
Pharmacology
Pharmacokinetics
Toxicology
ICH (International Conference on Harmonisation)
Environmental Risk Assessment (ERA)
Swissmedic
Generics Biosimilars
Vaccines
Immunology
Autoimmunity
Virology (HIV Dengue)
Animal disease models
Prokaryotic and Eukaryotic Protein Expression
Protein Engineering and Phage Display
Protein Purification
Biotechnology Biochemistry
GMP GDP GLP
Pharmacovigilance
Inspections Audits
Qualified Person QP
Fachtechnisch verantwortliche Person FvP

Werdegang

Berufserfahrung von Adrian Huber

  • Bis heute 9 Jahre und 1 Monat, seit Mai 2015

    Senior Quality and Regulatory Manager

    Five Office Ltd

  • 5 Jahre und 4 Monate, Jan. 2010 - Apr. 2015

    Preclinical Reviewer and GLP Inspector

    Swissmedic

    As a Preclinical Reviewer, I am responsible for marketing approvals of all kinds of pharmaceuticals and for the permit of Phase I studies. I give scientific advice to companies and manage the cooperation with external experts. I lead the inspection of enterprises working according to the GLP regulations.

  • 7 Jahre und 1 Monat, Juni 2002 - Juni 2009

    Laboratory Head

    Cytos Biotechnology AG

    I was developping vaccines against HIV, dengue fever, chikungunya virus, meningococcus, and autoimmune diseases. I have produced, fermented, and purified vaccines that were based on a VLP technology (virus-like particles). These were then assessed pharmacodynamically in in vitro and in vivo animal models.

Ausbildung von Adrian Huber

  • 1 Jahr und 11 Monate, Juli 2000 - Mai 2002

    Protein Engineering

    The Scripps Research Institute, San Diego

    Phage display, protein engineering, DNA-nucleases, DNA-libraries

  • 3 Jahre und 7 Monate, Dez. 1996 - Juni 2000

    Pharmaceutical Sciences

    ETH Zurich

    Phage display, molecular biology, protein engineering, DNA-libraries, prokaryotic and eukaryotic protein expression, protein purification

  • 7 Monate, Mai 1996 - Nov. 1996

    Biochemistry

    Zurich University

    Purification of a tumor marker from human blood

  • 5 Jahre und 6 Monate, Nov. 1990 - Apr. 1996

    Biochemistry

    Zurich University

    - Biochemistry (major) and ecology (minor subject) - Master thesis: Basic research in cell biology, neuronal gene regulation

Sprachen

  • Englisch

    Fließend

  • Deutsch

    Muttersprache

  • Französisch

    Gut

  • Italienisch

    Grundlagen

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