Osmetech Molecular Diagnostics
Industry: Company
DescriptionFounded: 1993 Parent organization: GenMark Diagnostics
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Osmetech Molecular Diagnostics Employees
Focus Diagnostics April 2013 - Present
Antech Diagnostics December 2010 - April 2013
Proteogenix Inc March 2008 - December 2010
Osmetech Molecular Diagnostics March 2004 - March 2008
University of Kansas Medical Center March 2003 - March 2004
Skills
Molecular Biology, Lifesciences, Cell Culture, Assay Development, Biotechnology, RT-PCR, PCR, ELISA, FDA, Flow Cytometry, qPCR, Immunology, Biomarkers, Microbiology, Validation, Antibodies, Immunoassays, Cell, In Vitro
Education
University of Kansas Medical Center 2000 — 2003
Postdoctoral Fellow, Molecular Virology
University of Madras 1994 — 2000
PhD, Virology, Molecular Biology
Complete Genomics Inc. January 2015 - Present
sBioMed LLC January 2014 - December 2014
Independent Consultant May 2013 - December 2013
Ossur Americas January 2009 - April 2013
IndusTerra Energy Inc. June 2007 - December 2008
Osmetech Molecular Diagnostics January 2006 - May 2007
Motorola Life Sciences/Clinical MicroSensors July 2002 - December 2005
Motorola Singapore Pte Ltd/Motorola India September 2000 - June 2002
Motorola Singapore Pte Ltd March 1998 - August 2000
Whiteoak Semiconductor November 1996 - February 1998
Skills
Start-ups, Corporate Finance, Finance, Forecasting, Mergers & Acquisitions, Financial Analysis, Financial Modeling, Managerial Finance, Cross-functional Team..., Business Strategy, Process Improvement, Strategic Planning, Strategic Financial..., Due Diligence, Financial Reporting, Change Management, Strategy, Management, Team Building, Business Process..., Sarbanes-Oxley Act, Medical Devices, Restructuring, Accounting, Six Sigma, Business Planning, Internal Controls, Leadership, Coaching
Education
Indian Institute of Management, Bangalore 1978 — 1980
MBA, Finance, Systems
Delhi University 1975 — 1978
1975, B Comm (Hons)
St Xavier's Delhi 1970 — 1975
High School, Accounting and Finance
St Joseph's Mussoorie 1967 — 1970
Middle School
Mission Biomedical Consulting February 2014 - Present
Pfizer December 2007 - January 2014
Mission Scientific January 2004 - December 2007
Osmetech Molecular Diagnostics January 2002 - August 2004
Surecide Technologies December 2000 - August 2001
SpaceLabs Medical April 1999 - December 2000
Mission Scientific January 1992 - January 1999
AVL Photronics Corporation May 1989 - August 1992
Baxter Healthcare June 1987 - June 1989
mesa diagnostics 1986 - 1988
Skills
Diagnostics, Due Diligence, Personalized Medicine, Genomics, Research, Biomedical Engineering, Business Planning, Concept Development, Market Research, Budget Preparation, Public Speaking, Medical Devices, FDA, R&D, Pharmaceuticals, Clinical Trials, Pharmaceutical Industry, Hardware Diagnostics, Biotechnology, Lifesciences, Oncology, Clinical Development, Molecular Biology, Clinical Research, Vaccines, Biomarkers, Microbiology, Drug Development, Biopharmaceuticals, Immunology, Neuroscience, Technology Transfer, Drug Discovery, Proteomics, Commercialization, Science, Medical Diagnostics, GLP, Budgets, CRO, IND, Regulatory Affairs, Protocol, Infectious Diseases, Assay Development, Immunoassays, Chemistry, Regulatory Submissions, Translational Medicine, Medical Writing
Education
University Of Connecticut Health Center 1980 — 1982
ABMM Post Doctoral/ Residency in Infectious Diseases
The University of New Mexico School of Medicine 1977 — 1980
Ph.D., Microbiology/Medical Sciences, 4.0
University of Nevada 1975 — 1977
MS, Biology (Microbiology/Immunology)
The University of Connecticut
BA Microbiology (High honors), Medical Microbiology and Chemistry
Henry Mayo Newhall Hospital November 2011 - Present
Henry Mayo Newhall Memorial Hospital November 2010 - November 2011
Henry Mayo Newhall Memorial Hospital June 2009 - November 2010
Henry Mayo Newhall Memorial Hospital October 2006 - June 2009
Osmetech Molecular Diagnostics April 2006 - October 2006
Roche Diagnostics April 2004 - April 2006
Bayer Diagnostics February 2003 - April 2004
Bayer Diagnostics February 2002 - February 2003
Bayer Diagnostics April 1999 - February 2002
Chiron Corporation December 1996 - April 1999
Skills
Healthcare, Hospitals, Healthcare Management, Project Management, Leadership, Process Improvement, Program Management, Public Speaking, Strategic Planning, Business Development, Business Planning, Healthcare Information...
Education
University of California, Berkeley 1982 — 1983
Master of Public Health (MPH), Biomedical Sciences
UC San Diego 1977 — 1982
Bachelor of Arts (B.A.), Biochemistry and Cell Biology
Radius Health, Inc. via Randstadt June 2015 - Present
ARIAD Pharmaceuticals, Inc. June 2014 - March 2015
Genzyme November 2013 - March 2014
Sensata Technologies July 2013 - October 2013
Corridor Company November 2010 - June 2013
NOVARTIS INSTITUTES FOR BIOMEDICAL Research September 2008 - October 2010
Sunday River Skiway December 2006 - April 2009
Osmetech Molecular Diagnostics October 2007 - January 2008
AVECIA BIOTECHNOLOGY, INC December 2001 - October 2007
Avecia Biotechnology December 2001 - December 2002
Skills
SharePoint, Software Documentation, Validation, Process Improvement, Biotechnology, GMP, Business Analysis, Project Management, SharePoint Designer, InfoPath, Microsoft Office..., Change Control, Process Simulation, Lifesciences, Document Management, Training, Technology Transfer, HPLC, CAPA, Pharmaceutical Industry, R&D, Sop, Site-directed..., GLP, Change Management, Document Review, Pharmacology, Batch Records, Quality Assurance, 21 CFR Part 11, MALDI-TOF, Lean Manufacturing, Information Architecture, Continuous Improvement, Contract Negotiation, Gas Chromatography, Technical Documentation, Access, Manufacturing, SharePoint 2010, SharePoint 2007, Organizational..., Contract Management, Workflow Design, IQ/OQ/PQ, Process Development, SDLC, Strategy, Technical Writing, SOP
Education
Stony Brook University 1990 — 1993
MS, Molecular & Cellular Pharmacology
Stony Brook University 1983 — 1987
BS, Biochemistry
Sachem High School
Sachem High School
Sachem High School
Sachem High School
Agensys, Inc. September 2011 - Present
Osmetech Molecular Diagnostics February 2007 - August 2010
Blackman & Holberton September 2005 - February 2007
Los Angeles Unified School District August 2002 - September 2005
Alltel Information Services September 2001 - August 2002
Skills
Payroll, Calendars, Administrative..., Sop, Microsoft Excel, Microsoft Office, Confidentiality, Medical Devices, Human Resources, Customer Service, Proposal Writing, FDA, Employee Benefits, Office Management, Project Coordination, Budgets, Social Networking, Invoicing, PowerPoint, Problem Solving, Management, Quality Assurance, Process Improvement, Sales, Project Planning, Interviews, Event Management, Accounting, Filing, Biotechnology, Microsoft Word, Pharmaceutical Industry, Travel Arrangements, Software Documentation, QuickBooks, Time Management, Telephone Skills, Editing, Cross-functional Team...
Education
Cerritos College 2000 — 2003
Associate Arts, General Studies
Johnson & Johnson January 2012 - Present
PSC Biotech June 2009 - January 2012
PSC Biotech June 2009 - December 2010
Osmetech Molecular Diagnostics December 1998 - December 2008
Novalon Pharmaceutical Corporation 1997 - 1998
California Institute of Technology October 1995 - July 1997
Education
University of North Carolina at Chapel Hill 1989 — 1995
PhD, Inorganic Chemistry
Sewanee-The University of the South 1984 — 1988
BS, Chemistry
Advanced Biotechtonics Consulting February 2010 - Present
Osmetech Molecular Diagnostics January 2009 - July 2009
Osmetech Molecular Diagnostics November 2004 - December 2008
Dick Keys Consulting February 2002 - November 2004
V.I. Technologies, Inc. August 2000 - February 2002
bioMerieux January 1999 - April 2000
Biotechtonics, Inc. May 1996 - January 1999
Hoffmann-La Roche March 1986 - May 1996
Skills
R&D, Quality Assurance, SOP, Outsourcing, IP, Sop, Biotechnology, Management, Validation, Medical Devices, Chemistry, FDA, Immunoassays, HPLC, PCR, GMP, Assay Development, CAPA, ISO 13485, Design Control, Quality System, Laboratory, DNA, Genomics, Purification, Analytical Chemistry, Biochemistry, In Vitro, Infectious Diseases, Hardware Diagnostics, Clinical Trials, Organic Chemistry, Molecular Diagnostics, Fluorescence, GLP, Commercialization, Lifesciences, Genetics, Molecular Biology, Drug Discovery, Immunology, Life Sciences
Education
Penn State University 1979 — 1983
Ph.D., Organic Chemistry
Western New England University 1973 — 1978
B.S., Chemistry
Imiolek Consulting November 2009 - Present
Sigma-Aldrich 2007 - 2009
Osmetech Molecular Diagnostics 2006 - 2007
Roche Diagnostics 2003 - 2005
Roche Diagnostics 1999 - 2003
Roche Diagnostics 1992 - 1999
Various companies: Biotech 1984 - 1992
Education
Purdue University 1986 — 1990
MS, Biology
Carnegie Mellon University 1979 — 1984
BS, Molecular and Cell Biology
Whitford Corporation October 2014 - Present
IntelligentMDx March 2013 - June 2014
Novartis February 2011 - March 2013
Histogenics January 2010 - October 2010
Insulet Corporation January 2009 - October 2009
Osmetech Molecular Diagnostics March 2008 - December 2008
Osmetech Molecular Diagnostics July 2005 - March 2008
Tepnel Lifecodes Corporation August 2003 - July 2005
Lifecodes Corporation July 2000 - August 2003
Education
Westfield State University
Bachelor of Science Degree, Biology
Harvard University
ALM, Extension Studies
Gilead Sciences July 2011 - Present
Osmetech Molecular Diagnostics September 2005 - July 2011
Skills
FDA, GLP, Quality System, CAPA, Validation, Biotechnology, GMP, Medical Devices, Sop, Lifesciences, Design Control, Quality Assurance, Molecular Biology, R&D, ISO
Education
University of California, Irvine 1999 — 2003
BS, Biology/Biological Sciences, General
Land Bank of Taiwan, Los Angeles Branch September 2010 - Present
Osmetech Molecular Diagnostics July 2003 - July 2010
Computer Sciences Corporation March 2000 - July 2003
Education
Vancouver, BC, Canada 1995 — 1996
MBA, Financial Management
California State University-Los Angeles 1988 — 1992
BS, Finance & Economics
Baxalta Inc March 2014 - Present
Bausch + Lomb July 2013 - February 2014
Baxter Healthcare May 2011 - June 2013
GenMark Diagnostics (previously Osmetech Molecular Diagnostics) November 2007 - April 2011
Osmetech Molecular Diagnostics May 2007 - November 2007
Xencor February 2006 - March 2007
California State University, Los Angeles June 2001 - January 2005
Skills
FDA, Cell Culture, CAPA, ISO 13485, PCR, Molecular Biology, Quality Assurance, GMP, Biotechnology, Lifesciences, Quality Management, Quality Control, Laboratory, Biochemistry, GLP, Design Control, 21 CFR Part 11, Pharmaceutical Industry, Validation, Medical Devices, Sop, Regulatory Affairs, R&D, Immunology, Assay Development, Hardware Diagnostics, Immunoassays, Biopharmaceuticals, Protein Chemistry, Clinical Trials, V&V, Microbiology, Drug Discovery, Oncology, LIMS, Technology Transfer, Purification, Trackwise, Quality System, Change Control, RT-PCR, DNA, Root Cause Analysis, DMAIC, Molecular Diagnostics, cGMP practices, FDA GMP, HPLC, 21 CFR, Quality Auditing
Education
California State University-Los Angeles 2000 — 2005
BS, Biology
DataXu April 2015 - Present
Conservation Services Group October 2014 - March 2015
QD Vision, Inc. April 2012 - 2014
QD Vision, Inc. March 2009 - April 2012
Osmetech Molecular Diagnostics October 2008 - February 2009
Northwestern University 2002 - 2008
Skills
SQL, R, Data Analysis, Data Visualization, Python, Machine Learning, Databases, Data Mining, Git, MS SQL Server, Octave, Characterization, Thin Films, Nanomaterials, Spectroscopy, Optoelectronics, formulation, Biosensors, oligo/peptides chemistry
Education
Northwestern University
PhD, Chemistry
Tongji University
BS, MS, Organic Chemistry
Bioness June 2015 - Present
Stratec Biomedical USA January 2011 - May 2015
Celerus Diagnostics July 2008 - January 2011
Dako September 2007 - July 2008
Osmetech Molecular Diagnostics 2000 - 2007
Motorola Life Sciences 2000 - 2007
Skills
Quality Assurance, FDA, CAPA, Medical Devices, ISO 13485, Validation, GMP, Quality System, V&V, Design Control, Lifesciences, Biotechnology, Hardware Diagnostics, Sop, Immunoassays, Process Improvement, Manufacturing, Regulatory Affairs, ISO, Change Control, 21 CFR Part 11, Product Development, LIMS, Pharmaceutical Industry, Quality Management, Software Documentation, Cross-functional Team..., Testing, Clinical Trials, Life Sciences, SOP
Education
Point Loma Nazarene University 1995 — 1997
BA, Biology
Hycor Biomedical August 2011 - Present
System Integration December 2008 - Present
Osmetech Molecular Diagnostics May 2000 - December 2008
Rolling Hills Covenant Church 2003 - 2007
Motorola Life Sciences June 2000 - July 2006
Clinical Micro Sensors, A Motorola business 2000 - 2005
System Integration December 1992 - May 2000
Miami University September 1996 - May 1997
Institute of Advanced Manufacturing Sciences September 1992 - May 1994
Skills
Programming, Troubleshooting, Software Project..., Software Validation, FDA, Electronics, Product Management, C, Software Development, Windows, Microsoft Office, Medical Devices, Testing, Software Engineering, Problem Solving, Visual Basic, Software Design, TCP/IP, Life Sciences, Requirements Analysis, Hardware, Quality Assurance, Validation, Integration, Manufacturing, Design Control, Visual Studio, Software Documentation, Project Management, Lifesciences, Microsoft Excel, Product Development, Quality System, Process Improvement, Computer System..., Labview, 21 CFR Part 11, CAPA, Leadership, R&D, Systems Engineering, Management, Cross-functional Team..., Change Control, Hardware Diagnostics, Embedded Software, Analysis, V&V, ISO 13485, Biotechnology
Education
Miami University 1995 — 1996
MS, Systems Analysis, Computer Science
Miami University 1989 — 1993
BSME,, Manufacturing Engineering
Hospira December 2011 - Present
Covidien December 2009 - December 2011
Gen Probe 2009 - 2009
Osmetech Molecular Diagnostics 2008 - 2008
Alcon Labs, Irvine CA 2005 - 2008
Cardinal Health 2002 - 2005
KLA-Tencor 2000 - 2002
Escalate 1995 - 1996
Skills
SQL database design, C++, C#, Object Oriented Design, MFC, Visual C++, ODBC, Rational Rose, UML, XML, SQL Server, C, TCP/IP, LINQ, ADO.NET, Unix, PVCS, OLEDB, FxCop, Test Track Pro, VSTS, Perforce, AIX, ADO, Threads, VSS, .NET, Visual Studio, DCOM, COM, Agile, Visual Basic, Software Development, SQL, WinForms, DB2, Software Design, OOAD, Java, IBM DOORS, JIRA, DevTrack, IEC 62304, ISO 14971, AAMI TIR32, Eclipse, Software Requirements, Software Verification, FDA, Microsoft SQL Server
Education
University of California, San Diego 2002 — 2012
Professional Certifications, Computers, Software, A
Delft University of Technology
M.Sc., Applied Physics, Delft University of Technology, Delft, Netherlands
LynxCom Partners LLC July 2008 - Present
Biocept October 2013 - Present
Vermillion Inc. June 2011 - December 2013
Trovagene, Inc. October 2009 - June 2010
AlliedPath 2008 - May 2010
Osmetech Molecular Diagnostics May 2005 - July 2008
Nanogen August 2002 - September 2004
Gen-Probe Incorporated 1996 - 2002
Gen-Probe Incorporated August 1992 - January 1996
QUIDEL Corporation 1988 - 1992
Skills
Cancer, Personalized Medicine, Healthcare, Infectious Diseases, Oncology, Pharmacogenomics, Diagnostics, Immunology, Genomics, Business Planning, Biotechnology, Strategic Planning, FDA, Quality Systems, Science, Market Analysis, Business Strategy, Marketing Strategy, Strategy Development, New Business Development, Competitive Analysis, Molecular Biology, Hardware Diagnostics, Strategy, Cross-functional Team..., Quality System, Medical Devices, Clinical Development, Commercialization, Technology Transfer, Market Development, Leadership, Pharmaceutical Industry, Validation, Lifesciences, R&D, Clinical Trials, Regulatory Affairs, Management, Laboratory, Biopharmaceuticals, Product Marketing, Drug Discovery, Product Launch, Drug Development, Business Development, ISO 13485, GMP, Vaccines, Global Marketing
Education
Columbia University - Columbia Business School 1997 — 1997
Senior Executive Management, Executive Management
University of Wisconsin-La Crosse 1968 — 1972
BS ♠, Chemistry♠
Amphastar Pharmaceuticals, Inc. June 2013 - Present
B. Braun Medical August 2011 - June 2013
Girindus America Inc. March 2010 - August 2011
Neutrogena 2009 - 2009
La Jolla Pharmaceutical Company 2008 - 2009
Osmetech Molecular Diagnostics 2005 - 2008
Motorola Life Sciences 2000 - 2005
clinical micro sensors 1998 - 2000
Skills
ICH guidelines, GMP, Validation, Medical Devices, R&D, Lifesciences, HPLC, CAPA, Analytical Chemistry, Biotechnology, Chemistry, Technology Transfer, FDA, UV/Vis
Education
University of California, San Diego 1993 — 1998
Ph.D., Chemistry
The University of Chicago 1993 — 1994
M.S., Chemistry
Nanjing University 1986 — 1990
B.S., Chemistry
Chinese Academy of Sciences
Master of Science (MSc), Chemistry
Claremont BioSolutions Chief Technology OfficerClinical MicroSensors/Motorola Life Sciences2007 - Present
Claremont Bio 2007 - Present
Keck Graduate Institute of Applied Life Sciences 2006 - Present
Keck Graduate Institute 2006 - Present
Clinical Micro Sensors, Inc. 2006 - Present
Osmetech Molecular Diagnostics 2000 - 2005
Clinical Micro Sensors, A Motorola business 2000 - 2005
clinical Micro Sensors April 1999 - 2005
Education
California Polytechnic State University-San Luis Obispo 1969 — 1973
GenMark Diagnostics October 2011 - Present
APICS 1975 - Present
Osmetech Molecular Diagnostics March 2009 - September 2011
Donald H Lindsey November 2008 - March 2009
Bourke Consulting Associates November 2008 - March 2009
APICS 1977 - 2009
Strategic Information Group July 2006 - November 2008
Eaton Aerospace 2002 - 2006
Acuity 2001 - 2002
BSSI 1999 - 2001
Skills
Supply Chain Management, APICS, ERP, QAD, MRP, Materials Management, Supply Chain, Business Analysis, Forecasting, Inventory Management, Operations Management, Demand Planning, Production Planning, Purchasing, Supply Management, Procurement, Analysis, Data Analysis, ERP Implementations, Business Process..., Process Improvement, Manufacturing, Business Process, Process Engineering, Six Sigma, Strategy, Continuous Improvement, Lean Manufacturing, Cross-functional Team..., Value Stream Mapping, Enterprise Software, Management, Software Documentation, Program Management, Product Development, Quality Assurance, Leadership, Change Management, Strategic Sourcing, Team Building, SAP, ISO, Troubleshooting, Sourcing, Consulting, Vendor Management, Logistics, Project Planning, Training, Project Management
Education
California State University-Fullerton - College of Business and Economics 1971 — 1973
Bachelor's degree, Business Administration and Management, General
San Jose State University 1968 — 1969
Guided Therapeutics-formerly SpectRx Inc. September 2005 - Present
Spectrx, Inc. 2005 - December 2011
Osmetech Molecular Diagnostics November 2004 - March 2005
CIBA Vision 2002 - 2004
AVL Scientific 1996 - 2004
AVL Medical / Roche Diagnostics 1998 - 2002
Rensselaer Polytechnic Institute 1987 - 1992
Skills
Biotechnology, R&D, Diagnostics, Biochemistry, Medical Devices, Clinical Trials, Clinical Trial..., Clinical Data Management, Clinical Supervision, Product Development, MS Office Suite, Research, ABAP, Program Management, Project Planning, Project Coordination, Project Execution, Project Delivery, Microsoft Office, Project Management, Hardware Diagnostics, Biomedical Engineering, 21 CFR Part 11, FDA, Clinical Research, Commercialization, Design Control, Manufacturing, Lifesciences, Spectroscopy, Quality System, Chemistry, ISO 13485, Validation, V&V, CTMS, Life Sciences, Cross-functional Team..., GMP, Pharmaceutical Industry, Management, Cancer, Technology Transfer, Medical Diagnostics, CAPA
Education
Rensselaer Polytechnic Institute 1986 — 1992
Ph.D., Chemistry, Biochemistry and Biophysics
Indian Institute of Technology, Kanpur 1984 — 1986
Masters of Science, Chemistry
St. Stephen's College 1981 — 1984
B.Sc., chemistry
Microsoft July 2014 - Present
Microsoft January 2013 - July 2014
Amazon 2011 - 2012
Boeing 2010 - 2010
Pacific Biosciences 2008 - 2009
Applied Biosystems 2007 - 2008
Osmetech Molecular Diagnostics 2005 - 2007
Skills
Web Analytics, Competitive Analysis, Market Research, Product Marketing, Product Development, Digital Marketing, Customer Segmentation..., Machine Learning, comScore, Predictive Modeling, A/B testing, Customer Satisfaction, Public Speaking, Persuasive Presentations
Education
University of Washington, Michael G. Foster School of Business 2009 — 2011
MBA, Marketing
University of Southern California 2000 — 2005
Ph.D., Neuroscience
Peking University 1996 — 2000
B.Sc., Biochemistry and Molecular Biology
Neumedinicines, Inc. 2009 - Present
Osmetech Molecular Diagnostics 2008 - 2008
Amgen 2005 - 2007
Amgen 2000 - 2005
Amgen 1997 - 2000
Amgen 1991 - 1997
Whitby Research 1990 - 1991
Syntax, Inc. (now Roche) 1989 - 1989
Education
Pepperdine University, The George L. Graziadio School of Business and Management
MBA
University of California, Santa Barbara
BA, Pharmacology
Osmetech Molecular Diagnostics January 2008 - Present
Amgen March 2002 - October 2007
Alpha Therapeutics Corporation May 1998 - March 2002
Education
University of California, Los Angeles 1987 — 1992
HH Medical Consulting January 1985 - Present
Osmetech Molecular Diagnostics December 2003 - August 2008
Mentor O & O, Inc. March 1992 - August 1996
Skills
R&D, Design Control, Medical Devices, FDA, GMP, Lean Manufacturing, Electronics, Engineering Management, CAPA, Patents, Software Development, Product Development, Hardware Diagnostics, ISO 13485, V&V, Engineering, Quality System, Validation, Biotechnology, Project Management, Commercialization, Systems Engineering, Chemistry, Manufacturing, Product Launch, Technology Transfer, Lifesciences, Cross-functional Team..., Biomedical Engineering, Market Development, Regulatory Affairs
Education
University of California, Los Angeles 1972 — 1978
Ph.D., Chemistry
Innoventz February 2004 - Present
Osmetech Molecular Diagnostics 2008 - 2009
NuVasive 2006 - 2008
Medtronic 2004 - 2007
Skills
Medical Devices, Diabetes, Biotechnology, Clinical Trials, Clinical Research
Education
University of Southern California 1993 — 1995
Master of Science (MS), Biomedical Engineering
USC 1989 — 1993
Bachelor of Science (BS), Biomedical and Electrical Engineering
Northfield Mount Hermon 1986 — 1989
High School
Inova Diagnostics September 2015 - Present
Thermo Fisher Scientific (formerly Life Technologies) November 2010 - August 2015
GenMark Dx (formerly Osmetech Molecular Dx) August 2008 - October 2010
Osmetech Molecular Diagnostics February 2008 - August 2008
Hemosense/Inverness September 2006 - February 2008
Bayer Diagnostics 2005 - 2006
Bayer (formerly Chiron Diagnostics) 1998 - 2004
Chiron Diagnostics 1995 - 1998
LAC-USC Medical Center 1990 - 1995
Skills
Medical Devices, Diagnostics, Oncology, Lifesciences, Hardware Diagnostics, Immunoassays, Product Development, Biotechnology, Capital Equipment, FDA, Quality System, Validation, Clinical Research, Molecular Biology, Healthcare, CAPA, Design Control, Commercialization, DNA sequencing, Market Development, Sequencing, Technology Transfer, Quality Assurance, PCR, R&D, Competitive Analysis, Product Management, Pharmaceutical Industry, qPCR, Proteomics, Infectious Diseases, Biomedical Engineering, Product Marketing, Genomics, Sop, Medical Technology, Cross-functional Team..., ISO 13485, Molecular Diagnostics, DNA, Laboratory Automation, Clinical Trials, Hematology, Medical Diagnostics, Product Launch, Cardiology, Hospitals, Troubleshooting, GLP, GMP
Education
LAC+USC Medical Center 1985 — 1986
Clinical Laboratory Scientist
California State University-Northridge
MS
University of California, Los Angeles
BS
Avioq, Inc. November 2009 - Present
Osmetech Molecular Diagnostics March 2009 - November 2009
bioMerieux, Inc. July 2001 - January 2008
Organon Teknika 1991 - 2001
GenBio May 1989 - May 1991
Mazeika & Thompson Associates 1988 - 1989
Ortho Diagnostics 1982 - 1988
International Diagnostic Technology 1980 - 1982
Beckman Instruments 1975 - 1980
Skills
Immunology, Molecular Diagnostics, Infectious Diseases, Immunoassays, ELISA, Capital Equipment, Product Launch, Hardware Diagnostics, Biotechnology, Molecular Biology, Medical Devices, Competitive Analysis, Market Development, Selling, Commercialization, Laboratory Medicine, Product Development, Protein Chemistry, Western Blotting, Lifesciences, Laboratory, FDA, Pharmaceutical Industry, Laboratory Automation, Microbiology, Life Sciences
Education
University of Nebraska College of Medicine 1964 — 1975
M.S., Medical Technology, Biochemisty
Osmetech Molecular Diagnostics CEO & PresidentConsinertech Group, LLC2011 - 2012
Education
University of Massachusetts Lowell 2003 — 2006
Applied BioCode inc September 2009 - Present
Osmetech Molecular Diagnostics 2006 - 2008
Beckman Coulter 2003 - 2005
Beckman Instruments 1979 - 2003
Beckman Instruments & SmithKline Beckman Inc 1979 - 1982
Skills
Laboratory Automation, GMP, GLP, Continuous Improvement, Supply Chain Management, JIT, Immunochemistry, QFD, Medical Devices, RT-PCR, Biotechnology, R&D, Lifesciences, Validation, FDA, ISO 13485, Hardware Diagnostics, Quality System, Product Management, Field Service, Chromatography, Product Launch, Cross-functional Team..., Capital Equipment, Product Development, Laboratory, Quality Assurance, CAPA, Molecular Diagnostics, Genetics, Design Control, V&V, Commercialization, Technology Transfer, Genomics, Chemistry, Pharmaceutical Industry, Strategy, Medical Diagnostics, Molecular Biology, Sequencing, DNA, Start-ups, Oncology, Life Sciences
Education
Ohio Institute of Technology 1975 — 1979
BSEE, Electronic Engineering
University of Phoenix
MBA, Marketing, minor in International Finance
Thermo Fisher Scientific September 2011 - Present
Beckman Coulter October 2007 - September 2011
Osmetech Molecular Diagnostics 2003 - 2007
Education
University of Illinois at Chicago
B.S., Biochemistry
Henry Mayo Newhall Memorial Hospital March 2009 - Present
Osmetech Molecular Diagnostics November 2007 - December 2008
BeJane.com 2006 - 2007
Metrocities Mortgage July 2004 - March 2006
Brooks Automation 1999 - 2003
Skills
PowerPoint, Human Resources, Microsoft Excel, Employee Relations, Software Documentation, Microsoft Office, Troubleshooting, Budgets, Customer Service, Team Building, Microsoft Word, Leadership, Recruiting, Data Entry, Business Strategy, Inventory Management, Team Leadership, Payroll, Public Speaking, Event Planning, Outlook, Research, Change Management, Account Management, Negotiation, System Administration, Product Development, Biotechnology, Project Planning, Management, HTML, Project Management, Quality Assurance, Social Media, Marketing, Strategic Planning, Healthcare, Hospitals, SAP, Office Management, Marketing Strategy, Process Improvement, Training, Access, Public Relations, Operations Management, Social Networking, Windows, Event Management, Nonprofits
Education
California State University-Fullerton
BCI Corporation January 2011 - Present
PrimeraDX, Inc. 2010 - 2011
Osmetech Molecular Diagnostics 2005 - 2009
Gentra Systems 2004 - 2005
Applied Imaging 1999 - 2003
IDEXX Laboratories 1992 - 1998
Abbott Diagnostics 1989 - 1992
Education
California State University Stanislaus
BA
California State University-Chico
MA
SeraCare Life Sciences June 2013 - Present
Grifols July 2010 - May 2013
Osmetech Molecular Diagnostics September 2008 - May 2010
Third Wave Molecular February 2007 - September 2008
Prometheus Laboratories October 2005 - February 2007
TriPath Care Technologies October 2000 - October 2005
Skills
Oncology, Infectious Diseases, Life Sciences, Medical Devices, Biotechnology, Capital Equipment, Product Launch, Cardiology, Immunology, Sales Operations, Laboratory, Pharmaceutical Industry, Molecular Biology, Hematology, Medical Diagnostics, Hardware Diagnostics, Validation, Cross-functional Team..., Microbiology, Market Development, Genomics, Hospitals, ELISA, Sales, Endocrinology, Commercialization, Healthcare, Clinical Research, Pharmaceutical Sales, Cell, Management, Genetics, Sales Management, FDA, New Business Development, DNA, Urology, Sales Process, Sales Force Development, Account Management, Sales Effectiveness, Neurology, Managed Care, Medical Sales, Hospital Sales, Laboratory Medicine, Biopharmaceuticals, GMP, Medicine, Quality Assurance
Education
Southern Connecticut State University 1993 — 1997
Bachelor of Science, Sports Medicine-Exercise Science and Athletic Training
Sayreville War Memorial High School
Sayreville War Memorial High School
Abrisa Technologies December 2013 - Present
Osmetech Molecular Diagnostics September 2008 - December 2008
Amgen May 1988 - October 2007
Skills
21 CFR Part 11, GMP, Sop, Change Control, Validation, CAPA, Biotechnology, Document Management, Pharmaceutical Industry, Quality Assurance, Quality System, GxP, FDA, Biopharmaceuticals, Management, Process Flow..., Documentation Practices, Engineering Change...
Education
California Lutheran University
BS Business Administration, Business
Biomatrica May 2012 - Present
UCLA July 2011 - May 2012
Southern California Biomedical Council May 2008 - September 2011
GenMark Diagnostics March 2010 - April 2011
Osmetech Molecular Diagnostics May 2008 - February 2010
Osmetech Molecular Diagnostics January 2007 - May 2008
Osmetech Molecular Diagnostics July 2005 - December 2006
Motorola July 2004 - July 2005
Motorola July 2002 - June 2004
Clinical Micro Sensors May 2000 - June 2002
Skills
Strategic Planning, PCR, ERP, Software Development, Sequencing, Hardware, Electrochemistry, Biosensors, Biotechnology, Signal Processing, Capillary..., Lifesciences, Medical Devices, FDA, Technology Transfer, GMP, R&D, Hardware Diagnostics, ISO 13485, Business Development, Protein Chemistry, Six Sigma, Strategy, Regulatory Affairs, Entrepreneurship, CAPA, Immunology, Molecular Biology, DNA, Oncology, Manufacturing, Biochemistry, Commercialization, Quality System, Biopharmaceuticals, Start-ups, Product Development, Clinical Trials, Laboratory, Pharmaceutical Industry, Validation, Infectious Diseases, Drug Discovery, Genetics, Design Control, Genomics, GLP, Medical Diagnostics, Drug Development, Life Sciences
Education
University of California, Berkeley 1998 — 2000
Post Doctorate, Sensors and Microfluidics
University of California, Riverside 1993 — 1998
Ph.D., Chemistry
Indian Institute of Technology (Banaras Hindu University), Varanasi 1988 — 1992
B.Tech, Chemical Engineering
Prolacta Bioscience 2006 - Present
Monrovia Growers 2000 - Present
Osmetech Molecular Diagnostics 2004 - 2006
Baxter Healthcare 1991 - 2004
Deloitte & Touche 1987 - 1991
Education
University of California, Los Angeles - The Anderson School of Management 1995 — 1998
MBA
California State University-Northridge 1984 — 1987
BS, Business
Larry Gayleard Consulting Services 2008 - Present
Osmetech Molecular Diagnostics 2003 - 2007
Motorola Life Sciences 2003 - 2005
Alpha Therapeutic Corp. 1988 - 2003
Skills
FDA, Validation, CAPA, Manufacturing, GMP, Medical Devices, 21 CFR Part 11, Quality Assurance, Change Control, Quality System, ISO 13485, V&V, Biotechnology, Technology Transfer
Education
University of California, Irvine
3M Health Care September 2013 - Present
3M Health Care August 2010 - August 2013
Osmetech Molecular Diagnostics August 2007 - August 2010
Osmetech Molecular Diagnostics August 2005 - August 2007
Clinical Micro Sensors, Motorola January 2001 - August 2005
Skills
Validation, Quality Assurance, Quality System, R&D, Manufacturing, Software Documentation, Leadership, Testing, FDA, CAPA, Medical Devices, GMP, ISO 13485, Design Control, 21 CFR Part 11, Biotechnology, Process Simulation, Sop, V&V, GLP, Six Sigma, Strategic Planning, Team Building, Change Management, SOP, Cross-functional Team...
Education
University of Phoenix 2002 — 2005
Masters, Healthcare Administration
California State University-Northridge 1995 — 2000
Bachelors, Biology
Siemens Healthcare July 2009 - Present
Osmetech Molecular Diagnostics November 2008 - December 2008
SeraCare Life Sciences 2003 - 2008
bioMerieux 1986 - 2003
bioMerieux 1986 - 2003
Skills
GMP, Biotechnology, Validation, FDA, Sop, Change Control, ISO, Quality Assurance, Biochemistry, Regulatory Submissions, 21 CFR Part 11, Quality Management, CAPA, Cross-functional Team..., Medical Devices, Analytical Chemistry, Laboratory, Continuous Improvement, ISO 13485, Pharmaceutical Industry, Quality Control, Regulatory Affairs, Molecular Biology, GLP, Biopharmaceuticals
Education
Albertus Magnus College
BA, Biology
Huntsman Chemicals, Los Angeles November 2010 - Present
Peninsula Club 174 - Toastmasters 2010 - 2011
Toastmasters - Winners Circle 2010 - 2011
South Bay Professional Association January 2009 - October 2010
Osmetech Molecular Diagnostics February 2008 - December 2008
Hills Pet Nutrition June 2005 - February 2007
Los Angels Chapter - APICS July 2003 - June 2004
Virco Manufacturing Corporation February 2001 - September 2003
Barton Instrument Systems May 1998 - February 2001
Helysis, Inc October 1997 - March 1998
Skills
Supply Chain, Production Planning, Inventory Management, Logistics, Purchasing, MRP, Materials Management, Supplier Management, SAP, Kanban, Master Scheduling, ERP, Manufacturing, Forecasting, Inventory Control
Education
El Camino College 1990 — 1996
AS, Manufacturing Technology Management
DxTerity Diagnostics July 2015 - Present
DxTerity Diagnostics May 2011 - Present
GenMark Diagnostics July 2010 - May 2011
Osmetech Molecular Diagnostics September 2009 - July 2010
Osmetech Molecular Diagnostics July 2007 - September 2009
Osmetech Molecular Diagnostics July 2005 - July 2007
Clinical Micro Sensors, A Motorola Company March 2004 - July 2005
National Institutes of Health June 2001 - March 2004
Skills
Biotechnology, Regulatory Submissions, Medical Devices, Molecular Diagnostics, FDA, Sequence Analysis, R&D, Validation, Molecular Biology, Lifesciences, Technology Transfer, Assay Development, Genomics, Commercialization, Bioinformatics, 21 CFR Part 11, CAPA, DNA, Clinical Trials, Product Development, ISO 13485, Genetics, Regulatory Affairs, GMP, Design Control, Life Sciences
Education
The George Washington University 1996 — 2001
PhD, Genetics
University of Michigan 1992 — 1996
B.S, Biology
Valspec February 2015 - March 2015
Genzyme November 2012 - October 2013
Biogen Idec August 2011 - June 2012
Lonza 2011 - 2011
Sepracor January 2007 - February 2009
AEROTEK SCIENTIFIC LLC June 2007 - October 2007
AEROTEK SCIENTIFIC LLC November 2006 - June 2007
Osmetech Molecular Diagnostics 2006 - 2007
SeraCare Life Sciences May 2005 - October 2006
Per Diem March 2002 - April 2005
Skills
GMP, Biotechnology, Sop, Validation, HPLC, CAPA, Manufacturing, Quality Assurance, Sourcing, SOP, Training, Management, Applicant Tracking..., Quality Control, Pharmaceutical Industry, Microsoft Office, R&D, Leadership, FDA, Project Management
Education
Apollo College 2000 — 2002
Pharamacy
UNITED STATES AIR FORCE
EAST BRIDGEWATER HIGH SCHOOL EAST
General
Bridgewater State University
BS, Chemistry
3M Health Care January 2013 - Present
Sakura Finetek USA, Inc. June 2011 - January 2013
GenMark Diagnostics April 2010 - June 2011
Osmetech Molecular Diagnostics December 2009 - June 2011
Osmetech Molecular Diagnostics April 2001 - December 2009
Skills
FDA, Quality System, Biotechnology, CAPA, Medical Devices, Cross-functional Team..., Validation, R&D, Lifesciences, Technology Transfer, Hardware Diagnostics, 21 CFR Part 11, Sop, GMP, Quality Assurance, V&V, PCR, ISO 13485, Laboratory
Education
San Francisco State University 1993 — 2001
B.S, Biochemistry
Anthony C Capece, Consultant January 2009 - Present
Osmetech Molecular Diagnostics October 2006 - December 2008
Seracare Life Sciences April 2004 - June 2006
Boston Biomedica, Inc. January 1994 - April 2004
Badger Engineering 1989 - 1993
Education
Massasoit Community College
Business Administration
Dental eShare 2014 - Present
Dexis October 2008 - June 2014
Osmetech Molecular Diagnostics October 2006 - September 2008
Applied Imaging April 2002 - January 2004
Ventana Medical Systems August 1998 - March 2002
Skills
Strategic Planning, Program Management, Team Building, Sales Management, Leadership, Medical Devices, Cross-functional Team..., Sales, Account Management, Cold Calling, Business Development, Sales Process, Capital Equipment, Operations Management
Education
United States Naval Academy 1986 — 1990
BS General Science, Science and Engineering
Bridgton Academy
Osmetech Molecular Diagnostics November 2009 - Present
Osmetech Molecular Diagnostics April 2008 - December 2008
Osmetech Molecular Diagnostics May 2007 - April 2008
Fiserv Credstar 2001 - 2006
Lim, Ruger and Kim 2000 - 2001
Atma Mortgage Corporation 1999 - 2000
North by Northwest 1998 - 1999
Skills
Pharmaceutical Industry, FDA, Biotechnology, Validation, Molecular Biology, Research, Medical Devices, Oncology, Lifesciences, GMP, Laboratory, R&D, PCR
Education
University of Arizona
Saint Anne's Hospital January 2014 - Present
Osmetech Molecular Diagnostics May 2006 - December 2008
GeoLabs, Inc. January 2001 - November 2004
Skills
Biotechnology, Lifesciences, Molecular Biology, Pharmaceutical Industry, Microsoft Office, Cell Culture, Biochemistry, PCR, Research, Project Management, Microsoft Excel, GMP, Medical Devices, Strategic Planning, Microbiology
Education
Curry College
Bachelor's degree, Nursing
Curry College
Bachelor's degree, Chemistry
Tetraphase Pharmaceuticals April 2015 - Present
Cubist Pharmaceuticals April 2009 - March 2015
Osmetech Molecular Diagnostics June 2008 - April 2009
Department of Chemistry, Mount Holyoke College September 2007 - May 2008
Skills
HPLC, UPLC, Mass Spectrometry, Permeability, Liquid Handling, FTIR, Peptides, Chemistry, Drug Discovery, Pharmaceutical Industry, Analytical Chemistry, Chromatography, LC-MS, Formulation, Assay Development, UV/Vis, In Vivo, GLP, Drug Development
Education
Mount Holyoke College 2004 — 2008
Bachelor of Arts, Chemistry
Sheet Metal Workers Local 110 March 2008 - Present
Osmetech Molecular Diagnostics 2004 - 2007
United States Marine Corps 1996 - 2003
Skills
Contract Management, Contract Negotiation, Project Management, Budgets, Maintenance & Repair, Quality Control, Strategic Planning, Purchasing
Education
Pasadena City College 2005 — 2006
N/A, Business