i am a Molecular Biologist and Chemist with work experience in the Biotechnology sectors in germany and canada. took over various rols from Research Director, prenatal Diagnostics and Pharmacogenomics, molegular Genetics Assay development, new technologies, to scientific producs Account Manager and Regulatory Affairs Director at Medical Device companies. am analytical, courious and adventerous and am currently looking for interesting scientific and or regulatory positions where creative thinking and Problem Solving scills are needed.
Director Regulatory Affairs & Quality Assurance Markham, ON, CanadaJuly 2009 --- October 2013
managing all ivdd Manufacturing ra and qa activities of btnx's rapid response tm branded Medical Devices in canada, usa, europe and the central- and latin americas. activities include proper registration and Licensing of new ivdd products with domestic and foreign Health authorities, support the company's foreign distributors with Licensing and importation clearance with their Health ministries, streamlining the company's Quality Management System activities and supervising its iso13485:2003 re-certification audits, overseeing adherence to mandatory pre and post market surveillance by the canadian Medical Device regulations.
Account Manager - Life Sciences Ottawa, ON, CanadaAugust 2008 --- February 2009
providing Sales and Technical Support for DNA genotek’s main product line “oragene DNA”, a DNA self – collection kit from saliva, to academic and governmental institutes in the German speaking countries of europe.
Principal Scientist Toronto, ON, CanadaOctober 2004 --- October 2006
oversaw Validation and Technology transfer process of the proprietary triplex-assay tm for fast snp detection from ingeneus corp. interacted with inventors, key scientists, medical and regulatory consultants and Venture Capital investors for coordinating the Diagnostic Product Development.
Director Research for the non-invasive prenatal genetic diagnostic projects Münster, GermanyMarch 1999 --- May 2004
directed the Start-ups Research efforts and team of scientists in the development of non-invasive prenatal genetic Diagnostic tests for the early detection of fetal metabolic diseases out of maternal blood samples. headed the company’s r&d project for a fluorescent probe based fetal Cell separation technology out of a maternal blood sample. supervised the company efforts to become a licensed reference Lab for paternity Testing and forensic Genetics services.
Scientific Director, Pharmacogenetics Montreal, QC, CanadaMarch 1997 --- February 1999
headed the genetic test development and implementation for large scale genomic Analysis and Discovery of new pharmacogenomic markers in patient/control cohorts suffering from alzheimer’s, parkinson’s and als disease. the Discovery process involved genetic association studies of case/control cohorts using Biostatistics and medical Epidemiology methods.
Analytical thinkingAttention to detailCritical thinkingCuriosityIndependenceProblem solvingResiliencySelf-discipline
Biochemistry Biostatistics Medical devices Scientific writing R&DBiotechnologyBiomarkersCardiovascular diseasesChemistryDiagnosticsDNA sequencingEnglishFDAFlow CytometryEnzyme-linked immunosorbent assay (ELISA)GeneticsGenetic polymorphismGermanMedical DevicesMedical writingmolecular biologyPCRPharmacogenomics (study of genetic variation)Phenotype Problem-solving methods and troubleshootingQuantitative PCR (qPCR)Regulatory affairsUnderstanding of regulatory guidelinesScientific WritingRT-PCRRegulatory submissions
Skills and Expertise
Molecular Diagnostics Analyze data Write papersAlzheimerBiomarker ResearchCommunicate with sponsorConduct university research Create SOPsDevelop regulatory strategylifesciencePublication of articlesWrite combined statistical and medical reportsReview manufacturing documentationReview quality control activitiesRespond to audit findingsResearch at universitiesRegulatory submissionsGuide staff
Ph.D. in Biochemistry and Molecular Biology from Wesphaelische Wilhems Universitaet Muenster in 1996
Advanced Master in Chemistry and Biochemistry from Wesphaelische Wilhems Universitaet Muenster in 1989
Bachelor in Chemistry from University of Dortmund Germany in 1985
Expert has 2 publications (Will be avalible with full profile)