Calypte Biomedical
Industry: Company
DescriptionHeadquarters: Portland, OR Founded: 1988 Subsidiary: Beijing Calypte Biomedical Technology Ltd.
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Calypte Biomedical Employees
DiaSorin June 2009 - Present
National Jewish Medical and Research Center November 2008 - March 2009
Mayo Medical Labs New England February 2006 - August 2007
ARIAD Pharmaceuticals July 2005 - February 2006
Genentech December 2001 - June 2005
Calypte Biomedical August 2000 - December 2001
Skills
LIMS, Clinical Research, Clinical Trials, Microsoft Excel, Testing, Biotechnology, Medical Devices, Molecular Biology, GMP, Validation, FDA, Lifesciences, GLP, Quality System, Immunoassays, Assay Development, Troubleshooting, Laboratory, V&V, Sop, Quality Control, Hardware Diagnostics, Life Sciences, SOP
Education
Colorado State University 2011 — 2013
Master's degree, Management
Worcester Polytechnic Institute 1993 — 1997
B.S., Biotechnology
Chronix Biomedical April 2001 - Present
Calypte Biomedical June 1988 - March 2001
Washington University School of Medicine June 1979 - June 1981
Skills
Biotechnology, Genomics, Intellectual Property, Cancer, Cancer Research, Immunology, Infectious Diseases, Molecular Biology, Bioinformatics, Lifesciences
Education
University of Michigan 1975 — 1979
PhD, Microbiology and Immunology
University of Michigan 1974 — 1975
MS, Microbiology and Immunology
University of Michigan 1971 — 1974
BS, Honors College
PDx BioTech/ALT BioScience September 2010 - Present
QuantRx Biomedical February 2007 - August 2010
Raptecon, LLC May 2002 - August 2010
Calypte Biomedical March 2005 - February 2007
OraSure Technologies June 1998 - May 2002
Saliva Diagnostic Systems December 1993 - May 1998
USDA-ARS 1989 - 1993
Kendrick Labs 1987 - 1989
Skills
Medical Devices, Product Development, R&D, Biotechnology, Lifesciences, Validation, Technology Transfer, Hardware Diagnostics, Design Control, Healthcare, FDA, Commercialization, ISO 13485, GMP, Biopharmaceuticals, Biochemistry, Diagnostics
Education
University of Wisconsin-Madison 1982 — 1987
Postdoctoral studies - Molecular Biology & Biophysics
University of Illinois at Urbana-Champaign
PhD (1982), Biochemistry
Valparaiso University
BA (1975), Chemistry
CR Bard, Inc. 2013 - Present
Maxim Bio 2005 - 2013
Calypte Biomedical 2001 - 2005
Skills
Biotechnology, FDA, GMP, Lean Manufacturing, Manufacturing, Validation, CAPA, GLP, Medical Devices, Quality Assurance, Quality System, SOP
Education
Bloomfield College
Bachelor of Science (BSc), Biology/Chemistry
University of Maryland University College
MSM, Project Management
Abbott Diabetes Care October 2012 - Present
Kodak Imaging Network / Kodak Gallery January 2004 - July 2012
Calypte Biomedical October 2002 - June 2003
LifeScan, Inc. (J&J) December 1996 - October 2002
Hill-Rom (Hillenbrand Industries) October 1995 - December 1996
Wesley-Jessen (Schering-Plough Corporation) December 1993 - October 1995
Schering Plough Healthcare Corporation March 1991 - December 1993
Jergens, Inc. 1989 - 1991
Procter & Gamble 1985 - 1989
Skills
Customer Insight, Segmentation, Analytics, Product Management, Competitive Analysis, Market Research, Marketing Research, Market Analysis, Product Marketing, Product Launch, Web Analytics, Cross-functional Team..., Product Development, Competitive Intelligence, New Product Validation, Qualitative Research, Quantitative Research, Start-ups, Strategy, Usability Testing, Marketing, E-commerce
Education
Purdue University
BA, Psychological Sciences
Purdue University - Krannert School of Management
BS, Economics
LabCorp Clincal Trials - Companion Diagnostics Department May 2008 - Present
DiaSorin August 2005 - March 2008
Calypte Biomedical September 1999 - April 2005
Organon Teknika January 1994 - September 1999
NCRAF 1995 - 1996
Murex Diagnostics September 1992 - January 1994
Wellcome Diagnostics – Division of Burroughs Wellcome Company September 1989 - September 1992
Private Regulatory Consultant August 1987 - September 1989
Roche Diagnostics January 1984 - August 1987
Skills
Quality Assurance, FDA, In Vitro, Healthcare, Medical Devices, Product Development, Sop, GMP, Regulatory Submissions, Clinical Trials, Regulatory Affairs, Training, Immunology, Quality System, Biologics, Research, Lifesciences, Internal Audit, IND, CAPA, Regulations, Quality Control, Management, Medical Diagnostics, Pharmaceutical Industry, ISO 13485, Negotiation, Auditing, Business Strategy, Clinical Research, Budgets, Commercialization, PMA, Hardware Diagnostics, Biotechnology, Project Planning, Infectious Diseases, Regulatory Requirements, Molecular Biology, GCP, Immunoassays, Technology Transfer, Strategic Planning, Human Resources, Oncology, 21 CFR Part 11, Drug Development, Microbiology, Change Control, Validation
Education
California State University-Long Beach 1969 — 1972
BA, Anthropology
Chapman University 1967 — 1968
Pre-Engineering
PharmAthene December 2012 - March 2015
PharmAthene September 2011 - December 2012
PharmAthene October 2010 - September 2011
Covance Laboratories June 2005 - October 2010
Calypte Biomedical 2004 - 2005
Skills
ELISA, Biotechnology, GLP, Assay Development, Validation, Bioanalysis, Drug Development, Drug Discovery, Lifesciences, CRO, Vaccines, GMP, Protein Chemistry, Biopharmaceuticals, Clinical Development, Life Sciences
Education
American University 2005 — 2006
M.S., Biotechnology
University of Illinois at Urbana-Champaign 1998 — 2002
B.S., Biology
Azzur Group January 2015 - Present
cGMP Validation LLC March 2007 - January 2015
Actavis 2002 - 2007
Genentech 1999 - June 2002
Bayer 1996 - 1998
Calypte Biomedical 1995 - 1996
Biowhittaker Inc. 1992 - 1995
Skills
21 CFR Part 11, Computer System..., Validation, GMP, CAPA, ISO 13485, Medical Devices, LIMS, ISO 14971, FDA, Software Quality..., Document Management, Software Documentation, Laboratory Automation, Cloud Computing, Risk Management, Risk Assessment, HIPAA, SAP, Software Project..., MS Project, Regression Testing, ERP, Software Engineering, Data Security, SaaS, System Testing, Computer Security, Risk Mitigation, IT Auditing, Healthcare IT, IT Governance, IT Outsourcing, Life Sciences, Software Design, Compliance Audits, Software Development..., 21CFR Part 820, 21CFR Part 210/ 211, ISO 62304, HIPAA Security Rule, Data Privacy, Laboratory Experience, Healthcare Compliance, cGMP, Pharmaceuticals, SOP/ Policy Development, Integration Testing, Quality Systems, V&V
Education
Hood College 1993 — 2000
MS, Biology
Radford University 1987 — 1991
BS, Biology, Chemistry
Alfasi Consulting (Israel) January 2014 - Present
LIMAGRAIN 2014 - 2015
Jibe Consulting 2012 - 2014
Oracle 2002 - 2012
LDSI September 1998 - July 2002
Ouray Sportswear January 1995 - September 1998
Calypte Biomedical January 1992 - January 1995
Berkely Antibody Company January 1990 - January 1992
Ernst & Young January 1984 - January 1990
Amoco Minerals January 1979 - January 1984
Skills
JD Edwards, Project Management, IT Solutions, System Migration, Financials, Business Planning, Corporate Finance, Financial Forecasting, Data Migration, Billing Systems, Purchasing, Manufacturing, QuickBooks, Business Analysis, ERP, Management, Start-ups, Enterprise Software, Business Process, Leadership, Consulting, Requirements Analysis, Oracle, Integration, Business Intelligence, Software Project...
Education
Claremont Men's College
BA, Economics
University of Denver
MBA, Finance
MedImmune August 2011 - Present
Hygieia- Red Rock Biologics October 2009 - October 2010
Calypte Biomedical 2003 - 2004
Skills
Cell Culture, SDS-PAGE, Cell Based Assay, ELISA, Assay Development, Cell
Education
San Jose State University 2001 — 2003
B.Sc., Molecular Biology
Genentech October 2011 - Present
Genentech July 2011 - Present
Drug Information Association June 2011 - Present
Livesey Consulting 2010 - Present
Genentech April 2011 - August 2011
Afferent Pharmaceuticals March 2010 - October 2010
Roche June 2006 - April 2010
Barrier Therapeutics 2002 - 2006
Genentech 1994 - 2002
Calypte Biomedical 1991 - 1994
Skills
Oncology, Dermatology, Virology, Drug Development, Cross-functional Team..., Immunology, Strategic Planning, Leadership, Clinical Development, Biotechnology, Pharmaceutical Industry, Clinical Trials, FDA advisory committees, Regulatory Submissions, Project Management, Clinical Research, IND, Pharmacology, Drug Discovery, Toxicology, Infectious Diseases, GCP, Biopharmaceuticals, GLP, Lifesciences, Development Coaching, CRO, Team-spirited, Advisory Committee..., Mentoring, Regulatory Affairs, Technology Transfer, Commercialization, Sop, 21 CFR Part 11, Strategy, Validation, Vaccines, Quality Assurance, CTMS, Cancer, Medical Devices, R&D
Education
California Polytechnic State University-San Luis Obispo 1987 — 1991
BS, Biological Sciences
Golden Gate University
MBA, Dual Concentration; Marketing and Operations and Supply Chain Management
U.S. Pharmacopeia June 2007 - Present
U.S. Pharmacopeia September 2004 - June 2007
U.S. Pharmacopeia July 2001 - September 2004
Calypte Biomedical August 2000 - July 2001
Thomas Medical Products, a GE Healthcare Company January 1999 - August 2000
Education
Rensselaer Polytechnic Institute 1994 — 1998
B.S., Biomedical Engineering
BloodSource 2002 - Present
Chiron Corporation March 1997 - February 2002
Liquid Sugar, Inc/MCP October 1996 - February 1997
Calypte Biomedical July 1996 - September 1996
Skills
Validation, Quality Assurance, GMP, Quality System, Regulatory Affairs, CAPA, Medical Devices, FDA, GxP, Manufacturing, Biotechnology, Change Control, SOP, Blood Bank, AABB, Biologics
Education
University of California, Davis 1991 — 1995
Bachelor of Science, Biochemistry
Quintiles January 2014 - Present
ICON plc 2011 - December 2013
Charles River Laboratories August 2010 - May 2011
PharmaNet Development Group, Inc. March 2009 - August 2010
Calypte Biomedical October 2007 - November 2008
Oregon Health & Science University June 1998 - October 2007
Skills
Drug Development, Business Development, Clinical Development, Pharmaceutical Industry, Business Planning
Education
Portland State University 1996 — 1998
BS, Psychology
SANROSE Information Services Inc March 2015 - Present
SanRose Information Services July 2013 - Present
Fast Switch October 2012 - July 2013
Riviera Consulting October 2011 - December 2012
H2 Performance Consulting January 2011 - October 2011
H2 Performance Consulting February 2008 - January 2011
Kaegan Corporation February 2007 - February 2008
Raytheon April 2000 - July 2004
Calypte Biomedical June 1997 - April 2000
US Navy June 1976 - June 1997
Skills
Project Management..., IT certifications: MCP,..., DAWIA Executive Level..., DAWIA Executive Level..., Certificate in..., 6-Sigma Specialist, ITIL, Security+, PMP, Contract Management, Financial Management, Six Sigma, DoD, Agile, Change Management, Process Improvement, Program Management, Organizational..., MS Project, Business Process..., Management Consulting, Process Engineering, Team Building, Strategic Planning, Planning, Performance Management, Business Strategy, Risk Management, Procurement, Contract Negotiation, Microsoft Office, Operations Management, Business Analysis, Cross-functional Team..., Earned Value Management, Project Planning, Compliance, Excel, Access, PowerPoint, Employee Relations, Continuous Improvement, SharePoint, Budgeting, Problem Solving, Business Process, Leadership Development, Process Mapping, Analysis, Performance Measurement
Education
University of West Florida 2006 — 2007
MA, Industrial/Organizational Psychology
Drexel University 1990 — 1991
Masters Certificate, Production Operations Control
Naval Postgraduate School 1984 — 1985
MS, Management
Cornell University 1972 — 1976
BA, Psychology
Webgility July 2010 - Present
The CMO CLUB March 2009 - November 2010
Satmetrix Systems August 2009 - January 2010
Orange County Business Incubation Network (OCBIN) October 2008 - June 2009
Beckman Coulter June 2008 - September 2008
Novartis June 2003 - September 2007
Calypte Biomedical 2001 - 2003
Skills
Business Development, Project Management, Analytics, Event Planning, Marketing, Market Research, SEM, Email Marketing, Web Design, CRM, Lead Generation, Marketing Communications, E-commerce, SEO, Marketing Management, Advertising, Online Advertising, Management, Brand Management, Strategic Planning, Product Marketing, Social Media Marketing
Education
University of California, Irvine - The Paul Merage School of Business 2007 — 2009
MBA, Marketing and Strategy
University of California, Davis 1998 — 2001
BS, Microbiology
Clovis West High School
Health Ventures August 2013 - Present
Healthfundr May 2013 - Present
Zona Health February 2013 - Present
Ketchum Innovation Center March 2014 - Present
City of Sun Valley, Idaho December 2012 - Present
Wild Gift January 2014 - Present
Chronix Biomedical June 2000 - Present
St. Luke's Health System December 2011 - August 2013
Quest Ventures June 1988 - 2000
Calypte Biomedical March 1990 - May 1995
Skills
Strategic Planning, Entrepreneurship, Healthcare, Start-ups, Fundraising, Strategy, Business Development, Nonprofits, Leadership, Business Strategy, Management Consulting, Public Speaking, Research, Management, Marketing Strategy, Executive Management
Education
Harvard University
MBA
Williams College
BS
Rapid Pathogen Screening, Inc. June 2013 - Present
Calypte Biomedical July 2009 - June 2013
Shriners Hospitals for Children July 2005 - February 2009
Sir Albert Sakzewski Virus Research Center 1998 - 2002
BioEdit 1998 - 1999
Westmead Hospital Institute of Clinical Pathology and Medical Research July 1991 - December 1992
Skills
HIV biology, HIV diagnostics, in vitro diagnostics, cell culture, Product Management, FDA regulatory processes, cell signaling, molecular biology, cell biology, scholarly communication, Scientific Writing, molecular parasitology, lateral flow technology, Research Project..., POC/rapid testing, Regulatory Affairs, business IP, PCR, Molecular Biology, Biology, Cell Biology, Cell Signaling, Cell Culture, Science, Protein Chemistry, Project Management, Immunofluorescence, Vaccines
Education
The University of Queensland 1993 — 1997
PhD, molecular parasitology
The University of Queensland 1987 — 1990
BSc Hons, organic chemistry, molecular biology double major, Hons in mol biol
Affiliated Engineers HR DirectorAffiliated Engineers2005 - 2009
Calypte Biomedical 1998 - 2003
Fremont Compensation 1992 - 1997
Skills
Human Resources, Change Management, Interviews, Technical Recruiting, Employee Benefits, Leadership, Employee Training, Process Engineering, Leadership Development, Team Building, Deferred Compensation, Talent Acquisition, Coaching, Strategy, HR Policies, Performance Management, Employee Engagement, Recruiting, Applicant Tracking..., Onboarding, Workforce Planning, Management, Employee Relations, Benefits Administration
Education
St. Mary's College of California 1983 — 1987
Bachelor's Degree, Business Administration/Economics
Haemonetics May 2011 - Present
Bio-Rad Laboratories December 2003 - March 2010
BIO-RAD LABORATORIES December 2003 - March 2010
EXPERIENC E January 2005 - 2009
QSD Products December 2003 - January 2005
Calypte Biomedical January 2001 - January 2003
Calypte Biomedical 2001 - 2003
Calypte Biomedical January 2001 - January 2002
SMITH WHITTIER CONSULTING SERVICES January 1999 - January 2001
Smith Whittier Consulting 1997 - 2001
Skills
Cross-functional Team..., Product Management, Medical Devices, Strategic Partnerships, Sales, CRM, Product Development, Healthcare, Management, Start-ups, Lifesciences, Product Launch, Medical Technology, Business Development, Coaching, Commercialization, Strategy, Marketing, Leadership, Hardware Diagnostics, Marketing Management, Sales Operations, Strategic Planning, Biotechnology
Education
Northeastern University 1968 — 1973
BA
AFFILIATION S
Master of Arts
Agawam
Northeastern University
Bachelor of Arts
University of Northern Colorado
MA
SFBAC Boy Scouts July 2005 - Present
Recombinant Capital October 2000 - November 2002
Calypte Biomedical February 1999 - April 2000
Re:Launch June 1998 - February 1999
V & W Patio Door and Window Company October 1997 - June 1998
Skills
Data Entry, Calendaring, Administrative..., Office Management, Spreadsheets, Filing, QuickBooks, Outlook, 10 Key, PowerPoint, Invoicing, Customer Service, Process Scheduler, Fax, Telephone Skills, Travel Arrangements, Office Administration, Administrative...
Education
University of Phoenix 2008 — 2010
Bachelor of Science (BS), Criminal Justice Administration
University of Phoenix 2006 — 2010
Bachelor of Science, Criminal Justice Administration
National Holistic Institute 1999 — 1999
Certificate, Massage Therapy/Therapeutic Massage
BioMarin Pharmaceutical Inc. April 2014 - Present
Janssen Alzheimer Immunotherapy Research and Development August 2009 - 2013
Elan Pharmaceuticals April 2003 - September 2009
Elan April 2003 - September 2009
Deltagen 2002 - 2003
Bio-Rad Laboratories 2000 - 2002
Bayer 1999 - 2000
Elan 1998 - 1999
Calypte Biomedical 1998 - 1998
Skills
ELISA, Pharmaceutical Industry, Biotechnology, GLP, FDA, Lifesciences, GMP, Drug Discovery, Antibodies, Clinical Development, Sop, HPLC, Assay Development, Validation, LIMS, Immunology, Protein Chemistry, Molecular Biology, Biopharmaceuticals
Education
University of California, Berkeley 1992 — 1997
BA, Immunology
Corium International February 2015 - Present
Corium International via Aerotek July 2014 - January 2015
Novartis Pharmaceuticals January 2012 - June 2014
Novartis Pharmaceuticals January 2009 - December 2011
Nektar Therapeutics February 2006 - January 2009
SUGEN, Inc. 1998 - 2003
Protein Design Labs 1996 - 1998
Calypte Biomedical 1994 - 1996
Skills
Technology Transfer, Analytical Chemistry, GLP, Research, Drug Discovery, Pharmaceutical Industry, HPLC, Life Sciences, Validation, Biotechnology, FDA, Drug Development, GMP, SOP
Education
University of California, Santa Cruz
Bachelor's degree, Psychbiology
InterMune, Inc. January 2000 - June 2015
Dendreon January 1998 - January 2000
Calypte Biomedical March 1995 - June 1997
Education
University of California, Berkeley 1989 — 1994
BA, Molecular and Cell Biology
Connor Group August 2013 - Present
Connor Group November 2012 - August 2013
Glam Media August 2010 - December 2012
Glam Media May 2008 - December 2012
Business Engine May 2000 - April 2008
Lumisys November 1998 - May 2000
Cell Genesys 1997 - November 1998
Calypte Biomedical 1992 - 1997
PricewaterhouseCoopers 1989 - 1992
Skills
SEC filings, Revenue Recognition, IPO, Sarbanes-Oxley Act, US GAAP, Mergers, GAAP, Accounting, Consolidation, Financial Analysis, Financial Reporting, CPA, Due Diligence, Financial Accounting, Start-ups, Corporate Governance, Public Companies
Education
Santa Clara University 1985 — 1989
BS, Accounting
Institute of European Studies 1987 — 1987
QIAGEN 2015 - Present
PharmAthene November 2009 - 2015
Maxim Biomedical 2005 - December 2009
Calypte Biomedical 2000 - 2005
bioMerieux 1997 - 2000
Cambridge Biotech Corporation 1994 - 1997
Army National Guard 1991 - 1994
Skills
GMP, Materials Management, FDA, Supply Chain Management, Validation, ISO 13485, Quality System, Quality Assurance, Sop, GLP, Medical Devices, Project Management, Quality Control, Technology Transfer, Design Control, Biopharmaceuticals, Contract Manufacturing, CAPA, ISO, 21 CFR Part 11, V&V, Manufacturing, Purification, Purchase Management, Vendor Management, Clinical Trials, FDA GMP, SOP, Biotechnology, Pharmaceutical Industry, Life Sciences, Cross-functional Team..., Management, Leadership
Education
Hampton University 1988 — 1992
Biology, Secondary Education
carroll high school
carroll high school
Integra Lifesciences 2011 - Present
Inverness Medical Corporate Headquarters 2010 - 2011
Inverness Medical, Nutritional Division 2007 - 2010
Inverness Medical, Cholestech Division 2005 - 2007
Calypte Biomedical 2001 - 2004
LifeScan, a Johnson & Johnson Company 1996 - 2000
Vistakon, a Johnson & Johnson company 1990 - 1996
NORTHERN TELECOM ELECTRONICS 1987 - 1990
Ethicon, a Johnson & Johnson company 1982 - 1986
Skills
FDA, Start-ups, Mergers, Management, ISO 13485, Quality System, V&V, Medical Devices, Validation, GMP, Sop, Continuous Improvement, Manufacturing, Quality Assurance, Materials Management, Process Improvement, Supply Chain Management, Product Management, Strategic Planning, Project Management
Education
Claremont Graduate University - Peter F. Drucker and Masatoshi Ito Graduate School of Management 1986 — 1987
MBA, Finance, Strategic Planning
Penn State University 1978 — 1982
Bachelors, Engineering
PPD January 2015 - Present
UCSF 2008 - March 2014
Genitope 2004 - 2008
Calypte Biomedical 2002 - 2004
NDNU 2000 - 2002
Skills
ELISA, Biotechnology, GLP, Molecular Biology, Cell Culture, PCR, Purification, Assay Development, Validation, Biochemistry, Cell, cGMP, Cell Based Assays, Genomics, Genetics, Pharmacogenomics
Education
University of California, San Francisco 2008 — 2014
Doctor of Philosophy (Ph.D.), Pharmacogenetics
Notre Dame de Namur University 1998 — 2002
Bachelor of Science (BS), Biology/Biological Sciences, General
GlaxoSmithKline April 2013 - Present
Daiichi Sankyo June 2010 - April 2013
sanofi-aventis September 2009 - March 2010
Human Genome Sciences November 2000 - September 2009
HGS 2000 - 2009
Human Genome Sciences 2000 - 2004
Calypte Biomedical 1997 - 2000
Skills
21 CFR Part 11, GLP, Regulatory Affairs, Sop, GCP, GMP, FDA, CAPA, Clinical Research, Biopharmaceuticals, Clinical Development, Clinical Operations, Clinical Trials, Quality Assurance, Regulatory Submissions, Change Control, Validation
Education
Hood College 2001 — 2003
Regulatory Affairs Masters Certificate, Regulatory Affairs
Marshall University 1984 — 1986
Bachelor of Science (B.S.), Biology, General
URS Corporation 2010 - Present
URS Corporation June 2007 - September 2010
American Red Cross 2004 - 2007
Calypte Biomedical 2002 - 2004
Baxter Healthcare 2001 - 2003
Skills
CSSGB (ASQ), ISO 9001:2008 Lead..., Quality System, Six Sigma, Iso 9000, ISO 13485, ISO, Sustainability
Education
University of Vermont
Advanced Certificate in Sustainable Innovation, Sustainability Studies
Rochester Institute of Technology 1990 — 1996
Master's, Clinical Chemistry
Northeastern University 1976 — 1980
BS, Medical Technology
Bio-Rad Laboratories July 2008 - Present
Bio-Rad Laboratories May 2002 - July 2008
Calypte Biomedical November 2000 - April 2002
DPC July 1998 - March 2000
Biocircuits April 1997 - June 1998
Stanford University School of Medicine July 1992 - March 1997
Skills
FDA, R&D, Biotechnology, Lifesciences, Medical Devices, Hardware Diagnostics, Commercialization, Immunoassays, Life Sciences, Validation, Assay Development, GMP, Product Development, Molecular Biology, ELISA, Product Launch, HPLC, Immunology, SOP, Cross-functional Team...
Education
Stanford University 1993 — 1996
Master's degree, Biological and Biomedical Sciences
University of California, San Diego 1987 — 1992
Bachelor of Science (BS), Bioengineering and Biomedical Engineering: Premedical
Biotronik March 2009 - Present
Columbia Clinical Research Consulting January 2009 - December 2011
Hemcon Medical Technologies May 2006 - December 2008
Calypte Biomedical December 2004 - May 2006
OraSure Technologies 2000 - 2004
OraSure Technologies 1997 - 2000
Epitope, Inc March 1991 - 1997
Skills
Operational Excellence, Quality System, Project Management, Personnel Management, Strategic Partnerships, Partner Management, Grant Writing, Presentations, Budget Process, Mentoring, FDA submissions, Strategic Planning, International Project..., Clinical Research, Medical Devices, diagnostics, Program Management, Design Control, FDA, Clinical Trials, Cross-functional Team..., GMP, R&D, Product Development, Infectious Diseases, Commercialization, Biotechnology, Hardware Diagnostics, Regulatory Submissions, Cardiology, Medical Diagnostics
Education
Humboldt State University 1985 — 1990
BS, Cellular/Molecular Biology
Humboldt State University
Bachelor of Science, Cellular/ Molecular Biology
AstraZeneca June 2013 - Present
AstraZeneca September 2009 - June 2013
AstraZeneca Pharmaceuticals January 2009 - October 2009
AstraZeneca May 2008 - February 2009
AstraZeneca May 2006 - June 2008
AstraZeneca July 2001 - April 2006
Calypte biomedical November 1994 - July 2001
Skills
Pharmaceutical Industry, GMP, Cross-functional Team..., Sop, Quality System, Quality Assurance, Process Improvement, Manufacturing, CAPA, Aseptic Processing, Validation, Operational Excellence, FDA, 21 CFR Part 11, Change Control, Biopharmaceuticals, Regulatory Requirements, SOP
Education
University of Maryland Baltimore County 1990 — 1994
BS, Biochemistry & Molecular Biology
University of Maryland Baltimore County 1990 — 1994
Bachelor's degree, Biochemistry and Molecular Biology
SynteractHCR November 2013 - Present
Eurofins Medinet April 2009 - October 2013
Eurofins Medinet August 2005 - March 2009
Covance June 2004 - July 2005
BioReliance 2002 - 2004
Calypte Biomedical May 2001 - June 2002
Skills
Motivated self-starter..., Global Management, Clinical Trials, Business Process..., Process Implementation, Risk Management, Vendor, Strategic Planning, Supply Chain Management, Cross-functional Team..., Clinical Protocols, Budget Process, Pharmaceutical Industry, Validation, Clinical Development, CTMS, Biotechnology, Vendor Management, LIMS, Life Sciences, Lifesciences, Quality Assurance, Project Management, GCP, GLP
Education
Bharathidasan University 1996 — 1998
M.Sc, Microbiology
Medivation June 2014 - Present
BioMarin Pharmaceutical Inc. January 2014 - June 2014
XOMA November 2013 - January 2014
XOMA February 2009 - November 2013
XOMA June 2005 - February 2009
XOMA November 2001 - June 2005
Roche Diagnostics May 2001 - November 2001
Calypte Biomedical May 1998 - May 2001
Skills
Livelink, Change Control, cGMP, HPLC, Biotechnology, Stability Testing, Stability Programs, ELISA, SDS-PAGE, Quality System, Quality Assurance, Western Blotting, Trackwise, Assay Development, GLP, 21 CFR Part 11, Chromatography, Biochemistry, Regulatory Affairs, Deviations, Analytical Chemistry, Monoclonal Antibodies, DNA, Quality Control, Sop, CAPA, LIMS, Validation, GMP, Biopharmaceuticals, Technology Transfer, Laboratory, Chemistry, Purification, Protein Chemistry, SOP
Education
De La Salle University 1991 — 1994
Bachelor's degree, Chemistry
Union Bank 2007 - 2015
Kaiser Permanente 2005 - 2007
Kaiser Permanente 2002 - 2005
Nexant 1998 - 2002
Calypte Biomedical 1997 - 1998
Skills
Customer Service, Project Management, Leadership, Strategic Planning, Microsoft Word, Microsoft Excel, PowerPoint, Time Management, Organizational...
Education
San Francisco State University
Bachelor of Arts (B.A.), Clinical Psychology
Sedia Biosciences Corp. January 2009 - Present
Calypte Biomedical April 2003 - December 2008
Creative BioSolutions LLC January 2001 - April 2003
OraSure Technologies (Epitope Inc.) April 1995 - January 2001
Eli Lilly and Company (Pacific Biotech) January 1992 - January 1995
Hygeia Sciences / Tambrands Inc. / Carter-Wallace 1986 - 1992
Warner-Lambert 1982 - 1986
Skills
Corporate Governance, Start-ups, Fundraising, Strategic Planning, Medical Devices, Medical Device R&D, Contract Negotiation, Biotechnology, Project Management, FDA, China Manufacturing, SFDA, Point of Care Tests, Technology Transfer, Assay Development, Regulatory Affairs, Design Control, Validation, Lateral Flow Assays, Quality System, GLP, GMP, ISO 13485, Molecular Biology, Cell Culture, Protein Purification, ELISA, Hybridoma, Monoclonal Antibodies, Patents, Clinical Trials, Microbiology, Quality Assurance, Immunology, Biochemistry, Commercialization, Lifesciences, DNA, Life Sciences, Protein Chemistry
Education
University of Illinois at Urbana-Champaign
Doctor of Philosophy (Ph.D.), Microbiology
The Ohio State University
Master of Science (M.S.), Microbiology
The Ohio State University
Bachelor of Science (B.S.), Microbiology
Wellstat Diagnostics July 2011 - Present
Wellstat Biologics February 2006 - July 2011
Sanaria Inc June 2004 - February 2006
Calypte Biomedical August 2002 - June 2004
Skills
Biotechnology, GLP, Assay Development, GMP, Immunoassays, FDA, Validation, CAPA, Lifesciences, Biopharmaceuticals, Product Development, ISO 13485, Microbiology, Sop, Medical Devices, Quality System, Cell Culture, Pharmaceutical Industry, R&D, Aseptic Processing, Biochemistry, Technology Transfer, Virus Culture, PCR, Molecular Biology, Plaque Assay, ELISA, SDS-PAGE, nasba, hybridomas, DNA Extraction, DNA Sequencing, Western Blotting, Life Sciences, SOP
Education
Penn State University
Wayne State University
MedImmune June 2002 - Present
Calypte Biomedical May 2001 - May 2002
Skills
QUMAS, Trackwise, ITIL v3 Foundations..., Document Management, 21 CFR Part 11, Quality Assurance, Biotechnology, Crystal Reports, Computer System..., Quality System
Education
Hood College 2009 — 2014
Master of Science (M.S.), Information Technology
Mount Saint Mary's College 1997 — 2000
Bachelor of Arts (BA), Political Science and Government
Saint Vincent College 1996 — 1997
Political Science and Government