Calypte Biomedical

Industry: Company

Description

Headquarters: Portland, OR Founded: 1988 Subsidiary: Beijing Calypte Biomedical Technology Ltd.

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Calypte Biomedical Employees

Employee
Years
Job
Industry
Craig Ashby Craig Ashby Greater Denver Area Details
Craig Ashby's Calypte Biomedical Experience August 2000 - December 2001
Job Applications Specialist at DiaSorin
Industry Biotechnology
Experience
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

Howard Urnovitz Howard Urnovitz San Francisco Bay Area Details
Howard Urnovitz's Calypte Biomedical Experience June 1988 - March 2001
Job CEO at Chronix Biomedical
Industry Medical Devices
Experience
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

Anthony Burgess-Cassler Anthony Burgess-Cassler Vancouver, Washington Details
Anthony Burgess-Cassler's Calypte Biomedical Experience March 2005 - February 2007
Job VP at PDx BioTech (ALT BioScience, LLC)
Industry Medical Devices
Experience
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

Cillia Prosper Cillia Prosper Covington, Georgia Details
Cillia Prosper's Calypte Biomedical Experience 2001 - 2005
Job Operations Supervisor
Industry Medical Devices
Experience
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

Lori Tarabek Lori Tarabek San Francisco Bay Area Details
Lori Tarabek's Calypte Biomedical Experience October 2002 - June 2003
Job Market Research, Consumer Insights Professional
Industry Market Research
Experience
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

Don Kafader Don Kafader Raleigh-Durham, North Carolina Area Details
Don Kafader's Calypte Biomedical Experience September 1999 - April 2005
Job Director, Regulatory Affairs at LabCorp/Esoterix/Companion Diagnostics
Industry Medical Devices
Experience
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

Otis Nelson III, M.S. Otis Nelson III, M.S. Baltimore, Maryland Area Details
Otis Nelson III, M.S.'s Calypte Biomedical Experience 2004 - 2005
Job Senior Manager, Bioanalysis at PharmAthene
Industry Biotechnology
Experience
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

Doug Shaw CISA, CRISC Doug Shaw CISA, CRISC Annapolis, Maryland Details
Doug Shaw CISA, CRISC's Calypte Biomedical Experience 1995 - 1996
Job Director of IT & CSV Consulting at Azzur Group
Industry Medical Devices
Experience
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

Paul Siegel Paul Siegel Denver, Colorado Details
Paul Siegel's Calypte Biomedical Experience January 1992 - January 1995
Job President at Alfasi Consulting (Israel)
Industry Information Technology and Services
Experience
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

Sarieh Azshirvani Sarieh Azshirvani San Francisco Bay Area Details
Sarieh Azshirvani's Calypte Biomedical Experience 2003 - 2004
Job Biotech Professional
Industry Biotechnology
Experience
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

Michele Livesey Michele Livesey San Francisco Bay Area Details
Michele Livesey's Calypte Biomedical Experience 1991 - 1994
Job Independent BioPharmaceutical Project Managment/Drug Development Consultant and Contractor at Livesey Consulting
Industry Biotechnology
Experience
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

Sarah Koegel Sarah Koegel Rockville, Maryland Details
Sarah Koegel's Calypte Biomedical Experience August 2000 - July 2001
Job Sr. Manager, RSP Operations at U.S. Pharmacopeia
Industry Pharmaceuticals
Experience
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

Karen Dosanjh Karen Dosanjh Sacramento, California Area Details
Karen Dosanjh's Calypte Biomedical Experience July 1996 - September 1996
Job Director, Quality Assurance at BloodSource
Industry Hospital & Health Care
Experience
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

Heather Brooks Heather Brooks Portland, Oregon Area Details
Heather Brooks's Calypte Biomedical Experience October 2007 - November 2008
Job Biopharma Advocate Providing Global Clinical Development Solutions to West Coast Biopharma
Industry Biotechnology
Experience
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

Christopher McGrath, PMP, MCP, MCTS Christopher McGrath, PMP, MCP, MCTS Pensacola, Florida Area Details
Christopher McGrath, PMP, MCP, MCTS's Calypte Biomedical Experience June 1997 - April 2000
Job Project Manager at the Florida Department of Education (FLDOE)
Industry Management Consulting
Experience
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

Brenda Le Brenda Le San Francisco Bay Area Details
Brenda Le's Calypte Biomedical Experience 2001 - 2003
Job Senior Marketing Manager at Webgility, Inc
Industry Computer Software
Experience
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

Bill Boeger Bill Boeger Sun Valley, Idaho Details
Bill Boeger's Calypte Biomedical Experience March 1990 - May 1995
Job Healthcare Consultant
Industry Biotechnology
Experience
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

CW Hooker CW Hooker Sarasota, Florida Area Details
CW Hooker's Calypte Biomedical Experience July 2009 - June 2013
Job Principal Scientist at Rapid Pathogen Screening, Inc.
Industry Biotechnology
Experience
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

Nancy Yu, PHR Nancy Yu, PHR San Francisco Bay Area Details
Nancy Yu, PHR's Calypte Biomedical Experience 1998 - 2003
Job HR/Managing Director at Affiliated Engineers
Industry Design
Experience
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

Joe Whittier Joe Whittier Sacramento, California Area Details
Joe Whittier's Calypte Biomedical Experience January 2001 - January 2003
Job Project Manager at Haemonetics
Industry Medical Devices
Experience
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

Emily Determan Emily Determan San Francisco Bay Area Details
Emily Determan's Calypte Biomedical Experience February 1999 - April 2000
Job Administrative Assistant at San Francisco Bay Area Council
Industry Executive Office
Experience
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

Bertrand Blank Bertrand Blank San Francisco Bay Area Details
Bertrand Blank's Calypte Biomedical Experience 1998 - 1998
Job Scientist at Janssen Alzheimer Immunotherapy Research and Development
Industry Biotechnology
Experience
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

Bill Duffield Bill Duffield San Francisco Bay Area Details
Bill Duffield's Calypte Biomedical Experience 1994 - 1996
Job Senior Scientist I at Corium International
Industry Pharmaceuticals
Experience
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

Pitsata Joy Malveda Pitsata Joy Malveda San Francisco Bay Area Details
Pitsata Joy Malveda's Calypte Biomedical Experience March 1995 - June 1997
Job Associate Director, Supply Chain Mgmt. at InterMune, Inc.
Industry Biotechnology
Experience
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

Roxanne Brady Roxanne Brady San Francisco Bay Area Details
Roxanne Brady's Calypte Biomedical Experience 1992 - 1997
Job Director, Financial Operations at Connor Group
Industry Accounting
Experience
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

Jason Hightower Jason Hightower Washington D.C. Metro Area Details
Jason Hightower's Calypte Biomedical Experience 2000 - 2005
Job Senior Supply Chain Professional | Manufacturing | Operations | Quality Background
Industry Biotechnology
Experience
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

Barbara McAleer Barbara McAleer Greater New York City Area Details
Barbara McAleer's Calypte Biomedical Experience 2001 - 2004
Job Business Leader
Industry Medical Devices
Experience
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

Janine Micheli Janine Micheli Richmond, Virginia Area Details
Janine Micheli's Calypte Biomedical Experience 2002 - 2004
Job Associate Research Scientist at PPD
Industry Biotechnology
Experience
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

Retta Horner Retta Horner Greater New York City Area Details
Retta Horner's Calypte Biomedical Experience 1997 - 2000
Job QA & Regulatory Compliance at GlaxoSmithKline
Industry Pharmaceuticals
Experience
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

Avis Bullard Avis Bullard Washington D.C. Metro Area Details
Avis Bullard's Calypte Biomedical Experience 2002 - 2004
Job Project Manager at URS Corporation
Industry Defense & Space
Experience
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

Tony Prestigiacomo Tony Prestigiacomo San Francisco Bay Area Details
Tony Prestigiacomo's Calypte Biomedical Experience November 2000 - April 2002
Job Director of R&D at BioRad Laboratories
Industry Biotechnology
Experience
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

Leslie North Leslie North United States Details
Leslie North's Calypte Biomedical Experience December 2004 - May 2006
Job PMP Certified, Sr. Project Manager at Biotronik
Industry Biotechnology
Experience
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

Heath Christie Heath Christie Greater Philadelphia Area Details
Heath Christie's Calypte Biomedical Experience November 1994 - July 2001
Job Executive Director & General Manager at AstraZeneca
Industry Pharmaceuticals
Experience
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

Lakshmi Kumar Lakshmi Kumar Washington D.C. Metro Area Details
Lakshmi Kumar's Calypte Biomedical Experience May 2001 - June 2002
Job Project Manager/Study Delivery Manager (GSK) at SynteractHCR
Industry Pharmaceuticals
Experience
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

Maricar Hernandez Maricar Hernandez San Francisco Bay Area Details
Maricar Hernandez's Calypte Biomedical Experience May 1998 - May 2001
Job Manager, GMP Quality Control at Medivation
Industry Biotechnology
Experience
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

Kerry Meech Kerry Meech San Francisco Bay Area Details
Kerry Meech's Calypte Biomedical Experience 1997 - 1998
Job Analyst / Executive Assistant
Industry Legal Services
Experience
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

Ronald Mink Ronald Mink Portland, Oregon Area Details
Ronald Mink's Calypte Biomedical Experience April 2003 - December 2008
Job President and Chief Science Officer at Sedia Biosciences Corp.
Industry Biotechnology
Experience
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

Gabriel Castille Gabriel Castille Washington D.C. Metro Area Details
Gabriel Castille's Calypte Biomedical Experience August 2002 - June 2004
Job Product Development Associate at Wellstat Diagnostics
Industry Biotechnology
Experience
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

Seryozha Kadel Seryozha Kadel Frederick, Maryland Details
Seryozha Kadel's Calypte Biomedical Experience May 2001 - May 2002
Job Operations Information Systems Engineer at MedImmune
Industry Biotechnology
Experience
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

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