Syva, Dade Behring
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Syva, Dade Behring Employees
Redwood Bioscience November 2013 - Present
Amgen May 2012 - November 2013
Theravance January 2011 - December 2011
Amgen, South San Francisco February 2010 - January 2011
Elan November 1998 - February 2009
Telik, Inc. 1994 - 1998
Syva Dade Behring 1994 - 1995
Skills
SDS-PAGE, Cell Based Assays, LC-MS, Western Blotting, Cell Culture, Protein Purification, Robotics, Spotfire, In Vitro, Analytical Chemistry, Mass Spectrometry, ELISA, Drug Discovery, Validation, Protein Chemistry, Biochemistry, Biotechnology, Life Sciences, Chromatography, UV-Vis, Bioanalysis, Pharmacokinetics, Pharmaceuticals, Purification, Drug Metabolism, DMPK, R&D, Research, ADME, HPLC, Chemistry, Peptides, Cell
Education
Brigham Young University
B.S., Chemistry
University of Wisconsin-Madison
M.S., Biochemistry
Centofanti Consulting, Inc. July 2002 - Present
Centofanti Consulting, Inc. 2009 - 2012
Centofanti Consulting, Inc. March 2005 - November 2008
Centofanti Consulting, Inc. 2002 - 2007
ePhysician 2000 - 2001
LifeScan 1996 - 2000
Syva, Dade Behring 1989 - 1996
Syva Company 1978 - 1989
Skills
Medical Devices, Biotechnology, Design Control, Cross-functional Team..., Lifesciences, Product Development, Commercialization, R&D, Pharmaceutical Industry, Product Launch, Project Management, Clinical Trials, Start-ups, PMP, V&V, Product Management, Strategy, Biomedical Engineering, Drug Discovery, Clinical Development, Biopharmaceuticals, Technology Transfer, 21 CFR Part 11, Drug Development, Infectious Diseases, Regulatory Affairs, Life Sciences
Education
Stanford University 1972 — 1976
Bachelor of Science (B.S.), Biological Sciences
Threshold Enterprises November 2010 - Present
Syva 1978 - 2008
Dade Behring January 1978 - December 2007
Syva, Dade Behring 1978 - 2007
Syva, a Syntex Pharmaceuticals Company & Behring Diagnostics 1978 - 2007
Skills
CAPA, FDA, GLP, Medical Devices, Regulatory Affairs, V&V, Lifesciences, Quality System, Biotechnology, Pharmaceutical Industry, Quality Assurance, ISO 13485, HPLC, 21 CFR Part 11, Quality Control, Microbiology, Cross-functional Team..., Root Cause Analysis, Change Control, Chemistry, Design Control, Sop, GxP, 21 CFR, Computer System..., ISO 14971, LIMS, Hardware Diagnostics, Biopharmaceuticals, FDA GMP, Cleaning Validation, Chromatography, Infectious Diseases, Immunology, Technology Transfer, Analytical Chemistry, R&D, GCP, Regulatory Submissions, Regulatory Requirements, Laboratory, Quality Auditing, Vaccines, Clinical Trials, Commercialization
Education
San Jose State University 1971 — 1975
Bachelor of Science (BSc)BA, Medical Microbiology Residency Program, 3.875
Abbott Vascular 2005 - Present
Ciphergen Biosystems Inc. Fremont,CA 2002 - 2004
Oculex phamaceutical inc. April 2000 - March 2002
Dade Behring 1990 - 2000
Syva Dade Behring 1990 - 2000
Syva 1990 - 2000
Skills
Biotechnology, FDA, Validation, GMP, GLP, HPLC, Lifesciences, Medical Devices, Assay Development, Drug Discovery, CAPA, Pharmaceutical Industry
Education
Dai hoc Quôc Gia Tp. Hô Chí Minh 1986 — 1990
Cepheid 1998 - 2006
Syva Company 1977 - 1997
Syva, Dade Behring 1977 - 1997
John Curtin School of Medical Research 1974 - 1975
Skills
Medical Devices, FDA, Biotechnology, Design Control, Cross-functional Team..., Clinical Trials, R&D, CAPA, Product Launch, Lifesciences, Strategic Planning, Infectious Diseases, GMP, Hardware Diagnostics, ISO 13485, Commercialization, Validation, Product Development, Technology Transfer, Assay Development, V&V, Biomedical Engineering, Clinical Development, Laboratory, GLP, Medical Diagnostics, Quality System, Microbiology, 21 CFR Part 11
Education
The Australian National University 1972 — 1974
Genentech February 2012 - Present
Del Monte Foods August 2011 - January 2012
Del Monte Foods January 2009 - August 2011
J&J GPSG ALZA November 2003 - January 2009
J&J GPSG ALZA February 2001 - November 2003
Syva - Dade Behring May 1994 - November 1996
Syntex Pharmaceuticals February 1993 - May 1994
Skills
Manufacturing, Project Management, Cross-functional Team..., GMP, Packaging, FDA, Leadership, Lean Manufacturing, Packaging Engineering, Procurement, Six Sigma, Supply Chain
Education
San Jose State University 1986 — 1991
Bachelor of Science (BS), Industrial Technology - Packaging
Carolyn J Haley Consulting 2013 - 2015
Thermo Fisher Scientific 2010 - 2012
Haley-DeChene Biotech Consulting 2010 - March 2011
Medarex 2007 - 2009
Genentech 2005 - 2007
MedImmune / Aviron 2001 - 2005
Syva Dade Behring 2000 - 2001
Syva Dade Behring 1991 - 2001
IDEXX Laboratories 1990 - 1991
BioRad Laboratories 1985 - 1990
Skills
Immunology, Drug Development, Biotechnology, Clinical Research, FDA, Pharmaceutical Industry, Drug Discovery, Biopharmaceuticals, Lifesciences, Clinical Development, Oncology, Clinical Trials, Validation, Commercialization, GLP, Regulatory Affairs, 21 CFR Part 11, Molecular Biology, Vaccines, Sop, Life Sciences, GMP, Technology Transfer, Biochemistry, Cell Culture, CRO, Infectious Diseases, GCP, Cross-functional Team..., R&D
Education
University of Wisconsin-Madison
Ph. D., Biochemistry
Texas A&M University
M.S., Biochemistry
Texas A&M University
B.S., Chemistry
Gilead Sciences 2015 - Present
Novartis June 2013 - Present
Boehringer-Ingelheim May 2012 - October 2013
Amgen 2007 - 2011
Amgen 2007 - March 2010
Novartis 2008 - 2009
Chiron 1997 - 2007
Novartis Vaccines and Diagnostics 1997 - 2007
Syva, Dade Behring 1978 - 1997
Syva 1978 - 1997
Skills
Quality Assurance, GMP, CAPA, Change Control, FDA, Validation, Sop, 21 CFR Part 11, Pharmaceutical Industry, Biotechnology, Biopharmaceuticals, Quality System
Education
University of San Francisco 1992 — 1994
Bachelor of Business Administration (BBA), Business
University of Phoenix 2002 — 2004
MBA, Accounting and Business, 3.8
San Francisco State University 1980 — 1988
Clinical Chemistry, 3.5
Predicant Biosciences 2002 - 2005
Careside, Inc. 1999 - 2001
Syva, Dade Behring 1990 - 1997
Crystal Diagnostics 1987 - 1990
Analytix 1986 - 1987
Bayer Diagnostics (Miles Laboratories) 1979 - 1986
Skills
Biotechnology, Technology Transfer, Lifesciences, Medical Devices, Validation, Product Development, FDA, Molecular Biology, R&D, Hardware Diagnostics, Commercialization, Cross-functional Team..., Start-ups, Chemistry, Biochemistry, Genomics, ISO 13485, Assay Development, GLP, Immunoassays, GMP, Laboratory Automation, Pharmaceutical Industry, Design Control, Molecular Diagnostics, Drug Discovery, Biopharmaceuticals, V&V, Protein Chemistry, Chromatography, Monoclonal Antibodies, Purification, Drug Development
Education
Harvard Medical School
Postdoctoral, Hematology
University of Delaware
Ph.D, Chemistry
University of Massachusetts, Amherst
BS, Chemistry