Experience

Fraunhofer IZI

• Germany
• Biotechnology Research
• 100 - 200 Employee

• Head of Department GMP Cell and Gene Therapy

  • Jan 2016 - Present

• Qualified Person acc. §15 German Drug Law

  • Jan 2011 - Present

  Key words: GMP Compliance Certification of ATMPs, Batch Release

• Head of QC

  • May 2008 - Present

  Establishment of own quality control area including infrastructure for technical devices and work flow needed for cell therapeutic products.Key words: qualification of devices, establishment of quality controls and validation (e.g. flow cytometry, sterility testing, Endotoxin testing, Mycoplasma testing), raw material release, Method Transfer, stability studies

• Head of GMP Unit

  • Sep 2009 - Dec 2015

  Key words: management of GMP cell engineering group

• Scientific Staff

  • Apr 2006 - May 2008

  Establishment of the quality assurance system and preparation of cell therapy manufacturing processes.key words: qualification of devices, validation of processes, SOP compiling acc. to EU-GMP-Guidelines



Northwest Biotherapeutics GmbH

• Consultant

  • Oct 2013 - Dec 2016

  Consultant Key words: qualified person acc. to §15 German Drug Act (AMG); supporting QC and QA related tasks Consultant Key words: qualified person acc. to §15 German Drug Act (AMG); supporting QC and QA related tasks



Innovastem GmbH

• Germany
• Food and Beverage Services
• 1 - 100 Employee

• Consultant

  • Nov 2009 - Jul 2013

  Consultant in the scope of supporting the establishment of a quality assurance system for an ATMP Key words: support in quality assurance issues and QC related questions during the establishment of the company Consultant in the scope of supporting the establishment of a quality assurance system for an ATMP Key words: support in quality assurance issues and QC related questions during the establishment of the company



Institut BiLaCon

• Quality Assurance Mananger

  • Apr 2005 - Apr 2006

  Management of Quality Assurance System acc. to DIN EN ISO IEC 17025 and in compliance with GMP. Management of Quality Assurance System acc. to DIN EN ISO IEC 17025 and in compliance with GMP.