I am a pharmacist by training and completed my academic education by earning a Ph.D. in Pharmaceutical Technology. During 10 year in basic research I gained extensive experience in formulation development and drug targeting.
As a knowledgeable CMC specialist being responsible for pharmaceutical development of small molecules and its drug product for many years, I have extensive amount of work experience in drug development as well as project management working in an interdisciplinary drug development team. In addition logistics and drug supply for international clinical trials were also part of my responsibilities interfacing with clinical development, study centres and external service providers.
A profound knowledge of regulatory requirements completes my experience in drug development. Apart from managing production and quality control of API and IMP I have a successful track record authoring IMPDs and INDs for international clinical trial applications and preparing Module 3 for MAA/NRA dossiers. I gained sound knowledge in pharmaceutical quality assurance compliance by set up and managing quality management systems and conducting audits of 3rd parties and pre-site inspection.
At the beginning of 2011, I decided to start my own business and became an independent consultant offering consulting service in pharmaceutical drug development on issues regarding GMP, quality assurance and regulatory compliance as well as interims management for executive positions in BigPharma industry. To expand my expertise I completed an education as certified systemic business coach in 2014.
As a knowledgeable CMC specialist being responsible for pharmaceutical development of small molecules and its drug product for many years, I have extensive amount of work experience in drug development as well as project management working in an interdisciplinary drug development team. In addition logistics and drug supply for international clinical trials were also part of my responsibilities interfacing with clinical development, study centres and external service providers.
A profound knowledge of regulatory requirements completes my experience in drug development. Apart from managing production and quality control of API and IMP I have a successful track record authoring IMPDs and INDs for international clinical trial applications and preparing Module 3 for MAA/NRA dossiers. I gained sound knowledge in pharmaceutical quality assurance compliance by set up and managing quality management systems and conducting audits of 3rd parties and pre-site inspection.
At the beginning of 2011, I decided to start my own business and became an independent consultant offering consulting service in pharmaceutical drug development on issues regarding GMP, quality assurance and regulatory compliance as well as interims management for executive positions in BigPharma industry. To expand my expertise I completed an education as certified systemic business coach in 2014.
Professional career
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
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
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
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
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.
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.
courage communication gmbh, Berlin
- Strategic marketing and advertising for pharmaceutical companies
Academic career
Max-Delbrück-Center for Molecular Medicine, Berlin-Buch
Research Field:
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
Free University Berlin, Department of Pharmaceutics, Biopharmaceutics and Biotechnology, Berlin
Research Field:
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
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| 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 |