Professional career

2011 - present Interim Management for leadership positions in BigPharma industry
Reference Projects:
  • QA Compliance Consultant – EU GMP inspection readiness
    • Set up a EU GMP compliant quality management system at a non EU manufacturers site of generic products (solid dosage and forms and non sterile liquids)
    • Update of existing SOP and GMP documentation system to achieve EU GMP compliance
    • Qualification of Facility, Utility (HVAC; water system, compressed air) and Equipment (production and packaging line)
    • Cleaning Validation and environmental monitoring
    • Establish QbD in pharmaceutical development according to ICH Q8-Q11
    • Auditing of 3rd parties and supplier qualification
    • Prepare site for inspection by conducting personal training and perform mock audit
  • CMC Dossier Expert / Regulatory Affairs
    • Securing the CMC Regulatory Compliance for development projects
    • Contribution to CMC regulatory strategy document
    • Authoring of IMPD/IND for Phase I, II, III
    • Authoring of Module 3 for MAA/NDA
    • Post approval variations
    • Interaction with health authorities (EMA, FDA, ANVISA)
    • Development of regulatory strategies
  • Lab Head of Analytical Development
    • Development of analytical control strategies for NCEs (sterile and solid dosage forms)
    • Establishment of PAT
  • Member in "FDA readiness" project teams
  • Technical Project Manager
    • Development of a pedriatic dosage form according to ICH Q8 QbD using DoEs and manufacturing IMPs thereof
    • Product Technology transfer to and Process validation at second supplier for sterile marketed product
    • Formulation development of a lyophilized injectable formulation as part of a combination product and manufacturing IMPs thereof
  • Head of pharmaceutical development and Production Manager according to § 12 AMWHV for a global acting contract manufacturer: pharmaceutical development according to ICH Q8 QbD using DoEs
  • QA Manager - Quality Operations Development
  • Head of clinical trial supplies and Production Manager according to § 12 AMWHV for global acting contract manufacturer
  • Head of formulation and technology development for generic products: strategic formulation development considering current patent situation to achieve optimal market entry for generic products
2006 - present Pharmaceutical Drug Development consultant for various BioTech companies
Consulting service on issues regarding GMP, Quality and Regulatory Compliance
  • Pharmaceutical development
  • Production and Quality control of API’s and IMP
  • Drug supply for preclinical studies
  • Compiling GMP documentation and IMPD writing
  • Interaction with BfArm, EMA and FDA
  • Project Monitoring
  • Auditing of CMOs
2006 - 2011 Director Drug Supply
4SC AG, Martinsried
Responsible for pharmaceutical developement in its entirety
  • Managing production and quality control of API and IMP
  • Preparation of the IMPD for clinical trial applications Phase I and II
  • Clinical trial supply for international clinical studies interfacing with clinical development, study centres and external service providers
2005 - 2006 Director Drug Supply
Morphochem AG, Munich
Responsible for pharmaceutical development in its entirety
  • Managing production and quality control of API and IMP
  • Preparation of the IMPD for clinical trial applications Phase I
2001 - 2004 Head of Formulation Design
MCS MicroCarrierSystems GmbH, Neuss
Development of new formulations for preclinical and clinical studies, especially liquid and semi-solid preparations for parenteral, topical and pulmonary application of poorly soluble NCE’s with low bioavailability or sensitive drug such as proteins and peptides.
2001 Consultant
courage communication gmbh, Berlin
  • Strategic marketing and advertising for pharmaceutical companies

Academic career

1997 - 2000 Post-doctoral fellowship, Research Group: Drug Targeting
Max-Delbrück-Center for Molecular Medicine, Berlin-Buch
Research Field:
  • Interaction of Plasma Proteins with Liposomes for Conventional and Gene Therapy and its Influence on Therapeutic Efficiency
  • Liposomal Dry Powder Aerosol for Pulmonary Application - Increased Therapeutic Efficiency using Surfactant-Protein Mediated Drug Targeting
1994 - 1997 Post-doctoral fellowship, Research Group of Prof. Dr. Rainer H. Müller
Free University Berlin, Department of Pharmaceutics, Biopharmaceutics and Biotechnology, Berlin
Research Field:
  • Plasma Protein Adsorption onto Liposomes - Influence of Physico-Chemical Characteristics on Adsorption Patterns and Protein Conformation
  • Research Scientist in and Project Co-ordinator of the DFG-Research Group: Colloidal Drug Carriers for Side Specific Drug Delivery

Education

2012 - 2014 Training as certified systemic business coach

1990 - 1994 PhD Student - Pharmaceutical Technology
Institute of Pharmaceutics and Biopharmaceutics, Christian-Albrechts-Universität Kiel
  • Thesis Title: Surfactant-Liposomes for the Treatment of IRDS - Characterisation and Scaling Up (Thesis Advisor: Prof. Dr. Rainer H. Müller)
1990 Licensure as Pharmacist
Ministry of Social Affairs Schleswig Holstein, Kiel, Germany

1989 Internship as Pharmacist
Pharmacy Dr. Sievert, Kiel

1988 State examination in Pharmaceutical Sciences
Christian-Albrechts-University, Kiel

1984 - 1988 Study in Pharmaceutical Sciences
Christian-Albrechts-University, Kiel
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