Experience

Orgenesis Inc.

• United States
• Biotechnology
• 1 - 100 Employee

• Associate Director Quality Management GCP

  • May 2021 - Present

  Process development, establishment and maintenance of a QM-system in accordance with Good Clinical Practice Close alignment with Good Manufacturing Practice for cell therapy products GCP Trainer Sponsor oversight tasks Third-Party Management Process development, establishment and maintenance of a QM-system in accordance with Good Clinical Practice Close alignment with Good Manufacturing Practice for cell therapy products GCP Trainer Sponsor oversight tasks Third-Party Management



Medizinische Hochschule Hannover

• Germany
• Higher Education
• 700 & Above Employee

• Head of Staff Office Quality Management in Clinical Research

  • Mar 2018 - Mar 2021

  On behalf of the sponsor Hannover Medical School supervisory and control tasks for clinical trials. Advisor for the President of the MHH in study matters GCP-support and advice for trial sites at Hannover Medical School On behalf of the sponsor Hannover Medical School supervisory and control tasks for clinical trials. Advisor for the President of the MHH in study matters GCP-support and advice for trial sites at Hannover Medical School



Hannover Clinical Trial Center GmbH

• Germany
• Pharmaceutical Manufacturing

• Head of Quality Management Unit

  • Aug 2008 - Feb 2018

  Establishment and maintenance of a QM-system in accordance with Good Clinical Practice

• Clinical Research Associate

  • Oct 2007 - Jul 2008



Medizinische Hochschule Hannover

• Germany
• Higher Education
• 700 & Above Employee

• Postdoctoral Researcher

  • Jul 2002 - Nov 2007

  Lung research in rat model- Institute of Functional and Applied Anatomy,

• Doctoral Student

  • Oct 1999 - Jun 2002

  PhD-Thesis (Dr. rer. nat.):Pulmonary effects of the synthetic lipopeptide MALP-2: in vivo and in vitro studies to characterize the leukocyte accumulation in the rat lung - Institute of Functional and Applied Anatomy,