Curriculum Vitae


Name Burckhardt, Johann Jakob
Date of birth June 07, 1945 in Zurich
Citizenship Swiss
Marital Status married
Children two
Education & Training
1974 University of Zurich, Faculty of Veterinary Medicine, Doctoral Thesis, DVM
1970 Final Federal Exam and diploma
1964 - 1970 University of Zurich, Faculty of Veterinary Medicine
Recent Mandates
2007 - 2009 RRC power solutions, GmbH, Homburg/Saar, Germany: Quality Management System certification for medical devices/products (ISO 13485)
2006 - 2007 Roche Diagnostics GmbH, Mannheim, Germany: Diabetes Care - Compliance & Internal Audits
2004 - 2006 Roche Diagnostics GmbH, Mannheim, Germany: Near Patient Testing - Project support, esp. validation (process & methods) and qualification
2003 - 2004 Disetronic Medical Systems AG, Burgdorf, Switzerland: Project leader "Process validation & FDA-Documentation (Warning Letter)"
2002 - 2003 Roche Diagnostics GmbH, Graz, Austria: Project leader "Process validation new site"
2002 Burckhardt Healthcare Consulting AG
2000 Burckhardt Healthcare Consulting
1987 -2000 Red Cross Foundation "ZLB Central Laboratory Blood Transfusion Service SRC"
1996  Senior Vice President
1994  Head Blood Transfusion Service ZLB (incl. cGMP-responsibility under FDA licence
         for the New York Blood Centre)
1993  Vice President
1988  Head Department Laboratory Services and blood donation screening,
         Member of the Board ZLB
1981 - 1987 F. Hoffmann-La Roche & Co. Ltd. Diagnostica, Basel, Switzerland,
Research & Development
1984  Proxy holder "ppa."
1982  Head "Immunology"
1981  Head "Hepatitis Group"
1973 - 1980 University of Zurich, Medical Faculty, Dental Institute: Department for Oral Microbiology and General Immunology (Prof. B. Guggenheim)
1975  Senior Lecturer
1973  Postdoctoral position
1971 - 1973 University of Zurich, Faculty of Veterinary Medicine, Institute for Pharmacology & Biochemistry: Thesis work in the Laboratory for Immunology (PD R.von Fellenberg)
2001 SAQ: Quality Management Course A 3.3-74 "Quality-Audits"
1990 FAMH-Certificate as Specialist in Laboratory Medicine, esp. Clinical Immunology (2001 Addendum: "incl. DNA/RNA Technologies")
1990 Degree "FVH" for Laboratory Medicine and Basic Research, Discipline "Basic Research"
Functions on behalf of the Swiss Federal Office of Public Health
1988 Head National Reference Centre for Transfusion Transmitted Infections
1988 Head Confirmatory Laboratory for HIV-Serology
Additional Experiences
1997 & 1999 Pass FDA inspections without citing on Form 483 (Blood Transfusion Service ZLB)
1999 Implement Hepatitis C-Virus PCR screening for blood donations in Blood Transfusion Service ZLB, acquire third party Regional Blood Transfusion Services totalling about 2/3 of all blood donations in Switzerland
1996 Implement Internal Quality Standards for infectious disease screening in Blood Transfusion Service Swiss Red Cross
1992 - 1995 Head AIS-Project: ex vivo-expansion of CD8-Tcells for therapy; plan, build, and
validate a laboratory for cell culture for human use; approved by Swiss authorities for clinical trials
1990 Implement Anti-HCV-screening in Switzerland (BTS SRC, by August 1),
implement centralized confirmation procedure in Bern (ZLB)
1988 - 2000 Responsible Head for the external proficiency scheme for the Blood Transfusion Service Swiss Red Cross
1988 Successfully compete the training course in transfusion medicine (one week, organised by the German Association for Transfusion Medicine and Immunohaematology, DGTI), Bad Nauheim
1985 Launch of four Enzyme Immuno Assays: Roche Hepatitis B EIA-Line, including the first test containing recombinant HBcore Antigen on the world market
1979 - 1980 Visiting scientist (Swiss National Science Foundation): Cellular Immunobiology Unit, Tumour Institute, University of Alabama in Birmingham, AL, USA (Prof. Max D. Cooper, MD) - generate, select and grow hybridomas to produce monoclonal antibodies
1973 - 1997 Applied research in dental caries and periodontal disease using animal models in gnotobiotic rats
Proffessional Affiliations
American Association of Blood Banks, AABB
American Society for Microbiology, ASM
ISBT, and its Working Party for Transfusion Transmitted Diseases
German Society for Transfusion Medicine and Immunohaematology (DGTI)
FAMH (Swiss Association for Laboratory Services)
Founding Member of SEVHEP
Swiss Society for Haematology
Swiss Society for Microbiology
Swiss Society for Allergology and Immunology
Swiss Society for Clinical Chemistry and Genetics
Federal Expert Committee for AIDS, and its Subcommittee "Laboratory" (til 2000)