OraSure Technologies
Industry: Medical device company
DescriptionOrasure Technologies is a Bethlehem, Pennsylvania based company in the medical device industry. Their products include diagnostic testing kits. The company had recently developed OraQuick testing kit, the first over-the-counter home HIV test. CEO: Douglas A Michels (Jun 23, 2004–) Headquarters: Bethlehem, PA Subsidiary: DNA Genotek Inc.
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OraSure Technologies Employees
Abbott Laboratories June 2010 - Present
Medical Advocacy Services for Healthcare, Inc. February 2009 - June 2010
OraSure Technologies 2008 - October 2008
First Franklin / Merrill Lynch January 2004 - December 2007
First Franklin / National City Bank April 2003 - December 2003
Abbott Diagnostics 2000 - 2003
Abbott Diagnostics 1999 - 2000
Abbott Diagnostics 1993 - 1998
Skills
Forecasting, Leadership, Strategic Thinking, Recruiting, Product Management, Capital Equipment, Medical Devices, Product Launch, Sales Management, Employee Training, Management, Strategy, Change Management, Team Building, Salesforce.com, CRM, Sales, Marketing, Business Strategy, Key Account Management, Selling, Sales Process, Negotiation, Healthcare, Cross-functional Team..., Training, Business Development, Competitive Analysis, New Business Development, Contract Negotiation, Sales Operations, Pricing, Direct Sales, Account Management, Strategic Planning, Product Development, Business Planning, Pharmaceutical Industry, Sales Presentations, Cold Calling, Pharmaceutical Sales, Market Analysis, Cardiology, Sales Force Development, Market Development, Sales Effectiveness, Market Planning, Selling Skills, Coaching, Urology
Education
Texas A&M University 1982 — 1986
Biology / Chemistry
OraSure Technologies April 2013 - Present
Oxford Immunotec October 2008 - Present
Oxford Immunotec 2008 - 2011
Polymedco 2003 - 2008
Skills
Sales, Medical Devices, Account Management, Sales Presentations, Customer Retention, Cold Calling, Customer Support, Customer Service, Product Launch, Selling, Healthcare
Education
University of New Brunswick
BMLS, Medical Lab Science
OraSure Technologies July 2006 - Present
David and Ivory Ministries, Inc 1999 - 2013
Skills
Sales&Marketing, Criminal Justice, Drug Testing, Background Checks, Training, Healthcare, Policy, Marketing, Leadership, Public Speaking, Customer Satisfaction, Sales Process, Operating Room, Gastroenterology, Contract Negotiation, Hematology, Government, Program Development, Microsoft Word, Project Management, Recruiting, Market Research, Leadership Development
Education
University of Houston
Bachelor of Science (BS), Criminal Justice and Corrections
BIOTRONIK April 2012 - Present
Wiz Bang Toys May 2004 - May 2011
BIOTRONIK February 2001 - May 2004
OraSure Technologies January 2000 - February 2001
Nelson Laboratories, Inc. March 1996 - July 1999
American Red Cross National Testing Laboratories April 1995 - November 1995
Epitope January 1991 - May 1994
Skills
Clinical Trials, FDA, Medical Devices, Clinical Monitoring, CTMS, GCP, Cardiology, Biotechnology, Clinical Development, ICH-GCP, Clinical Research, EDC, CRO, Regulatory Submissions, Customer Service, Management, Quality Assurance
Education
Oregon State University
Bachelor of Science (B.S.), Microbiology, General
Redmond High School
Redmond High School
Trajan Scientific Americas Inc February 2014 - Present
OraSure Technologies, Inc. 2004 - 2013
OraSure Technologies 1997 - 2004
OraSure Technologies 1992 - 1997
St. Luke's Hospital 1992 - 1992
Skills
Product Launch, Healthcare, Management, SAP R/3, Cross-functional Team..., Change Management, Strategy, CRM, Team Building, Training, Medical Devices, Leadership, Leadership Development, Project Planning, Client Relations Skills, People Skills, Contract Management, Process Improvement, Process Management, Motivation, Start-ups, Group Purchasing, SOX Compliancy
Education
Penn State University
BS, Medical Technology
Thomas Edison State College
MS, Management
Villanova University 2011 — 2012
Commercial Contracts
The American College 2015 — 2015
Certificate in Paraplanner Development
OraSure Technologies July 2015 - Present
Cardinal Health August 2011 - June 2014
Hettich Instruments October 2010 - May 2011
Thermo Fisher Scientific, MBD August 2004 - August 2010
McKesson November 2002 - July 2004
NEW MEDICAL TECHNOLOGY, Inc January 2001 - November 2002
BD January 1999 - January 2000
BD January 1996 - January 1999
BD January 1993 - January 1996
BD January 1986 - January 1993
Skills
New Business Development, Sales, Management, Medical Devices, Healthcare, Sales Process, Hospitals, Capital Equipment, Direct Sales, Sales Management, Sales Presentations, Competitive Analysis, Strategic Partnerships, Nuclear Medicine, IDNs, Relationship Management, Teamwork, Key Account Management, Contract Negotiation, Organization
Education
Stonehill College 1975 — 1979
BS, Business Administration, Marketing Management
Xaverian Brothers High School 1971 — 1975
Warn Industries November 2014 - Present
Leupold & Stevens, Inc. November 2007 - August 2014
Trailblazer Food Products January 2003 - June 2007
OraSure Technologies 2001 - 2003
Janas Classics 1998 - 2000
Stone Mill Foods, Inc. 1994 - 1998
Yoshida Foods 1993 - 1994
Skills
Microsoft Excel, Microsoft Word, Technical Writing, Oracle Applications, Research, Leadership, Training, Analytical Skills, Laboratory Techniques, Sensory Evaluation, Optical Microscopy, Calibration
Education
Oregon State University 1988 — 1992
Bachelor of Science (BS), Microbiology, General
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
OraSure Technologies October 2015 - Present
OraSure Technologies December 2013 - October 2015
Merck June 2013 - December 2013
OraSure Technologies June 2012 - March 2013
Benchmark Analytics, Inc. January 2012 - June 2012
Skills
Biotechnology, HPLC, Validation, Immunoassays, R, Medical Devices, ELISA, Immunology, Microbiology, Sop, Infectious Diseases, GC-MS, Laboratory, Clinical Development, Chromatography, LIMS, Mass Spectrometry, LC-MS, Toxicology, Aseptic Technique, FDA, Scientific Writing, Internal Investigations, Internal Audit
Education
Pennsylvania State University-Penn State Berks 2007 — 2011
BS Genetic and Developmental Biology
Merrit Jacobs Consulting September 2006 - Present
Merrit Jacobs Consulting, LLC September 2006 - Present
Merrit Jacobs Consulting August 2006 - Present
Merrit Jacobs Consulting August 2006 - Present
Vital Scentific 2007 - 2010
Elitech Group 2007 - 2010
OraSure Technologies 2006 - 2010
Princess Cruises 1999 - 2010
RTEmd 2007 - 2009
Ortho Clinical Diagnostics January 1995 - September 2006
Skills
Six Sigma Black Belt, Medical Devices, Process Validation, cGMP, Product Development, Integration, Process Improvement, R&D, Optimization, Biomedical Engineering, Analysis, Requirements Analysis, Process Engineering, Diagnostics, Problem Solving, Troubleshooting, Six Sigma, V&V, Design Control, Hardware Diagnostics, Optimizations, FDA, GMP, Quality System, Commercialization, Cross-functional Team..., Validation, Systems Engineering, Root Cause Analysis, Quality Assurance, Design of Experiments, Technology Transfer, CAPA, Testing, Regulatory Affairs, Product Launch, Lean Manufacturing, Engineering, Biotechnology, Quality Control, Software Documentation, ISO, Quality Management, Manufacturing, Process Simulation, Change Control, Lifesciences, DMAIC, Sop, FMEA
Education
State University of New York at Stony Brook 1966 — 1970
Bachelor of Engineering Sciences, Engineering Science
Monroe HS
Regents Diploma, Science and Math
Cutanea Life Sciences, Inc March 2012 - Present
GL Feiss Consulting LLC January 2005 - Present
Saladax Biomedical April 2010 - March 2012
OraSure Technologies March 2006 - April 2010
sanofi-aventis 2003 - 2005
Covalent Group 2000 - 2003
Rhone-Poulenc Rorer 1987 - 2000
Skills
Pharmaceutical Industry, Clinical Development, Medical Devices, FDA, Regulatory Affairs, Clinical Trials, Clinical Research, GCP, Product Development, Dermatology, CRO, Pharmaceutics, Biotechnology, Oncology, Clinical Operations, Lifesciences, Infectious Diseases, Cardiology, Hardware Diagnostics, Product Launch, Sop
Education
University of Arizona 1984 — 1986
MS
Penn State University 1980 — 1984
BS
OraSure Technologies July 2014 - Present
QIAGEN November 2012 - July 2014
QIAGEN February 2012 - November 2012
QIAGEN September 2011 - January 2012
QIAGEN July 2008 - September 2011
Johns Hopkins University July 2007 - June 2008
Anne Arundel Medical Center Emergency Room August 2001 - February 2003
Skills
Data Analysis, Marketing, Marketing Strategy, Marketing Communications, Social Media Marketing, Marketing Management, Direct Marketing, Digital Marketing, Instrument Validation, Formal Verification, Molecular & Cellular..., Cloning, Sample Preparation, ELISA, Tissue Culture, Validation, Cell Culture, Genetics, Laboratory, R&D, Product Development, Genomics, Molecular Biology, Medical Devices
Education
The Johns Hopkins University 2009 — 2012
M.S. /M.B.A; dual, Biotechnology
University of Maryland Baltimore County 2002 — 2007
BS, Biology
University of Maryland Baltimore County 2002 — 2007
BA, Psychology
Pearson - Assessment & Instruction / BioBDx 2009 - 2014
OraSure Technologies 2008 - 2009
Immunicon Corporation 2002 - 2008
ThauMDx 2000 - 2002
Intracel 1997 - 2000
International Technidyne Corporation 1994 - 1997
Skills
marketing, Medical Diagnostics, Executive Management, Medical Devices, Commercialization, Capital Equipment, Biotechnology, Pharmaceutical Industry, Product Launch, Lifesciences, Healthcare, Oncology, Market Development, Product Development, Global Marketing, FDA, Cross-functional Team..., Product Marketing, Sales Management, Marketing Strategy, Cardiology, Product Management, Competitive Intelligence, Clinical Trials, ISO 13485, Cell, Start-ups, Marketing, Strategy, Infectious Diseases, Business Development, CRM, Salesforce.com, Leadership, Life Sciences
Education
Princeton University 1980 — 1984
BA, Molecular Biology/Biochemistry
University of Scranton 1985 — 1987
MBA, Marketing
Independant Consultant July 2007 - Present
OraSure Technologies November 2001 - July 2007
Miller-Keystone Blood Center August 1998 - November 2001
Skills
FDA, ISO 13485, Validation, Medical Devices, Design Control, CAPA, ISO, Compliance, Quality Assurance, Quality Auditing, Process Improvement, Manufacturing, Document Management, Sop, Quality System, V&V, Quality Control, GMP, Quality Management, Project Management, Regulatory Affairs, Cross-functional Team..., GLP, Biopharmaceuticals, Laboratory, Aseptic Processing, LIMS, 21 CFR, 21 CFR Part 11, Commercialization, R&D, Hardware Diagnostics, Clinical Trials, Clinical Development, Regulatory Requirements, Root Cause Analysis, Change Control, Risk Management, Regulatory Submissions, CE Mark, 510 K, Microbiology, Testing, Technology Transfer, Lifesciences, Medical Device Directive, Pharmaceutical Industry, ISO 14971, Biotechnology, Cleaning Validation
Education
Shippensburg University of Pennsylvania 1981 — 1985
BS, Medical Technology
OraSure Technologies September 2015 - Present
OraSure Technologies October 2013 - August 2015
OraSure Technologies March 2012 - October 2013
OraSure Technologies May 2006 - March 2012
Blue Mountain Health Systems May 2003 - May 2006
Skills
Quality Assurance, FDA, Medical Devices, Quality Control, ISO 13485, ISO, V&V, GMP, Microsoft Office, Minitab, Six Sigma, SAP, Statistics, Microsoft Excel, Quality System, Microsoft Word, Lean Manufacturing, Hardware Diagnostics, Quality Auditing, Diagnostics, Quality Systems, Excel, Word, FDA GMP, SOP, Supplier Quality
Education
Penn State University 1999 — 2003
BS, Biology
Mott Corporation February 2012 - Present
Acme Monaco Corporation June 2010 - February 2012
U.S. Coast Guard Academy August 2009 - May 2010
Talsico LLC 2008 - 2009
OraSure Technologies August 2006 - November 2008
Gow-Mac Instrument Company January 1999 - August 2006
Liquid Carbonic/Praxair 1990 - 1998
United States Air Force 1985 - 1990
Skills
ISO 13485, CAPA, Quality System, Validation, FDA, Medical Devices, GMP, Six Sigma, Quality Assurance, 21 CFR Part 11, Lean Manufacturing, V&V, Quality Auditing, Cross-functional Team..., Quality Control, Process Improvement, Product Development, Analytical Chemistry, SPC, ISO, Design of Experiments, Root Cause Analysis, Process Simulation
Education
Northeastern University 1984 — 1985
M.S., Chemistry
Virginia Military Institute 1976 — 1980
B.S., Chemistry
Drive Medical August 2015 - Present
UBC Consulting LLC January 2011 - July 2015
OraSure Technologies August 2007 - December 2010
Chanel May 2005 - September 2007
Pfizer October 2001 - May 2005
Pfizer August 1999 - October 2001
Consulting Engineering July 1997 - July 1999
SmithKline Beecham February 1995 - July 1997
VTS October 1994 - February 1995
Mova June 1993 - October 1994
Skills
FDA, 21 CFR Part 11, ISO 13485, Validation, Quality Assurance, GMP, CAPA, Sop, Computer System..., Quality System, Pharmaceutical Industry, Aseptic Processing, Quality Auditing, Technology Transfer, Production Managment, Medical Devices, Change Control, V&V, Cleaning Validation, GAMP, Document Management, Quality Management, ISO, Equipment Qualification, Calibration, Biopharmaceuticals, Process Engineering, Process Improvement, Deviations, Auditing, Biotechnology, Manufacturing, Continuous Improvement, Cross-functional Team..., Pharmaceutics, R&D, Regulatory Affairs, Design Control, Quality Control, 21 CFR, SOP, ISO 14971, Testing, Root Cause Analysis, LIMS, GxP, Trackwise, GLP, Process Simulation, Laboratory
Education
University of Dayton 1989 — 1990
MSEM, Engineering Management
University of Dayton 1988 — 1989
MSMS, Management Science
Universidad Politécnica de Puerto Rico 1982 — 1986
IE
BD July 2011 - Present
OraSure Technologies January 2008 - December 2010
Abbott Diagnostics 2005 - 2008
Pitney Bowes 2003 - 2005
Skills
Cold Calling, Capital Equipment, Product Launch, Leadership, Pharmaceutical Sales, Medical Devices, Sales Operations, Selling, Sales, Sales Management
Education
University of Kentucky
Bachelor of Science, Accounting
University of Kentucky
Bachelor of Business Administration, Finance
Saladax Biomedical Inc February 2011 - Present
Saladax Biomedical January 2010 - January 2011
Saladax Biomedical 2004 - August 2010
OraSure Technologies 2003 - 2004
Skills
complete in-vitro..., particle agglutination..., pharmacology, drug..., Commercialization, R&D, Biotechnology, Life Sciences, Assay Development, Validation, Chemistry, Product Development, Cross-functional Team..., Oncology
Education
University of Pennsylvania 1998 — 2003
Ph.D, Polymer Chemistry; Polymer Chemistry
Peking University 1994 — 1998
BS, Chemistry
Beijing No. 4 High School 1991 — 1994
High School
Sigma America November 2010 - Present
OraSure Technologies 2007 - 2008
Skills
Sales Management, New Business Development, Account Management, Product Development, Sales, Key Account Management, Product Management, Negotiation, Customer Service, Business Development, Microsoft Office, Management
Education
State University of New York Empire State College
Associate's degree, Business Management/Human Resources
Northampton Community College
Business, Management, Marketing, and Related Support Services
Suffolk County Community College
Buiness Management
OraSure Technologies May 2013 - Present
D.S. Katz Consulting, LLC July 2012 - May 2013
Alexion Pharmaceuticals 2011 - August 2012
Genentech March 2007 - April 2011
Roche Pharmaceuticals 2003 - 2007
Roche Pharmaceuticals 2001 - 2003
Quintiles 1999 - 2001
American Liver Foundation 1997 - 1999
Skills
Consumer Marketing, Consumer Healthcare, Consumer Insight, Relationship Marketing, Building Relationships, Strategic Planning, Digital Strategy, Marketing Strategy, Web Development, Web Analytics, Web Content, Pharmaceutical Industry, Pharmaceutical Sales, REMS, Project Management, Product Launch, Infectious Diseases, Neurology, Integrated Marketing, CRM, Marketing, Segmentation, Digital Marketing, Global Marketing, Product Development
Education
Temple University
Bachelor of Science (BS), Marketing
Inflection Point Solutions, LLC 2015 - Present
Alfa Wassermann Diagnostic Technologies 2010 - 2014
Marketing Consultant for Double Helix and Optimal Strategix 2008 - 2010
HCD Research 2002 - 2008
Orasure Technologies 1999 - 2001
Bayer HealthCare 1996 - 1999
DuPont Medical Products 1993 - 1995
DuPont Medical Products 1990 - 1993
DuPont Medical Products 1988 - 1990
DuPont Medical Products 1986 - 1988
Skills
Market Research, Marketing Strategy, Cross-functional Team..., Market Planning, Customer Satisfaction, Product Innovation, Segmentation, Customer Insight, Analytics, Market Analysis, Strategic Consulting, New Business Development, Business Development, Competitive Intelligence, Product Development, Commercialization, Project Management, Medical Devices, P&L Management, Product Launch, Strategy, Competitive Analysis, Marketing Management, Strategic Planning, Market Development, Product Marketing, Business Planning, Marketing Communications, Pharmaceutical Industry, Management
Education
Stanford University
Bachelor of Science (BS)
University of Pennsylvania - The Wharton School
Master of Business Administration (M.B.A.)
Controltek April 2011 - Present
RS Medical 2010 - April 2011
Hemcon Medical Technologies 2007 - 2010
Cascade Biologics October 2005 - June 2007
American Red Cross January 2004 - October 2005
OraSure Technologies October 1999 - February 2004
Celtrix Pharmaceuticals March 1994 - November 1998
Genentech August 1985 - April 1992
Education
San Francisco State University
BS, Biochemistry
OraSure Technologies March 2010 - Present
OraSure Technologies July 2009 - March 2010
Rutgers University September 2007 - May 2009
Cigna June 2008 - August 2008
Amylin Pharmaceuticals May 2007 - August 2007
Amylin Pharmaceuticals May 2006 - August 2006
Skills
Formulation, Laboratory, Research
Education
Rutgers University-New Brunswick 2005 — 2009
Bachelor of Arts (BA), Biochemistry and Molecular Biology, 3.333
OraSure Technologies July 2015 - Present
VIVOS Professional Services,LLC May 2014 - Present
Mederi Therapeutics October 2013 - May 2014
Angiotech November 1997 - October 2013
Skills
Solidworks, PLC troubleshooting, Machining, Medical Devices, FDA, Design Control, ISO, R&D, Testing, V&V, Product Development, 21 CFR Part 11, Validation, ISO 13485, ISO 14971, Quality System, Design for Manufacturing, CAPA, Manufacturing, Solid Modeling
Education
Penn State University 1997 — 2002
BS, Electro-Mechanical Engineering Technology
Follett Corporation June 2013 - Present
OraSure Technologies August 2011 - May 2013
Church & Dwight January 2010 - August 2011
Covidien September 2006 - January 2010
US Army October 2003 - October 2006
L'Oreal June 2003 - October 2003
Skills
Root Cause, Six Sigma, Quality System, Medical Devices, FDA, ISO 13485, Analysis, Troubleshooting, Continuous Improvement, Lean Manufacturing, FMEA, Manufacturing, Supplier Quality, Quality Management, CQE, Root Cause Analysis, CAPA, Quality Auditing, Minitab, CQA, GMP, Engineering, 5S, ISO 14971, Iso 9000, Quality Control, V&V, Design Control, DMAIC, Validation, Quality Assurance
Education
Rutgers University-New Brunswick 2001 — 2003
Masters of Science, Aerospace&Mechanical Engineering
Orta Doğu Teknik Üniversitesi / Middle East Technical University 1996 — 2000
Bachelor of Science, Aerospace Engineering
OraSure Technologies 2013 - Present
OraSure Technologies 2012 - 2013
Novartis Vaccines and Diagnostics 2011 - 2012
Novartis Diagnostics 2010 - 2011
Siemens Healthcare 2008 - 2010
Siemens Healthcare Diagnostics 2007 - 2010
Diagnostic Products Corporation 2006 - 2007
Skills
Medical Devices, Biotechnology, FDA, Lifesciences, Validation, R&D, Technology Transfer, GMP, Pharmaceutical Industry, CAPA, Quality System, Infectious Diseases, Sop, ISO 13485, Regulatory Affairs, V&V, Cross-functional Team..., Oncology, 21 CFR Part 11, Product Development, Design Control, Change Control
Education
University of Illinois at Urbana-Champaign 1988 — 1994
Ph. D, Microbiology
St. Olaf College 1979 — 1983
B. A, Chemistry, Psychology
Fidato Partners, LLC June 2015 - Present
Albright College 2006 - Present
Brentwood Industries September 2012 - February 2015
Kutztown University January 2009 - May 2013
Various assignments October 2010 - September 2012
Customers Bank August 2012 - August 2012
Janssen, Pharmaceutical Companies of Johnson and Johnson October 2011 - July 2012
PPL Corporation June 2011 - August 2011
OraSure Technologies March 2011 - May 2011
United Technologies October 2010 - March 2011
Skills
Process Improvement, Accounting, Forecasting, Financial Reporting, Financial Analysis, Internal Controls, Cost Accounting, Financial Accounting, Managerial Finance, Accounts Payable, General Ledger, Variance Analysis, Payroll, Account Reconciliation, Business Process..., Accounts Receivable, Business Planning, Project Planning, Access, Nonprofits, Leadership, Analysis, Finance, Budgets, Strategic Financial..., Sarbanes-Oxley Act, Mergers & Acquisitions, ERP, Internal Audit, Management
Education
Saint Joseph's University 1988 — 1992
MBA
Penn State University
BS
Siemens Healthcare November 2014 - Present
Siemens Healthcare January 2013 - November 2014
OraSure Technologies, Inc. September 2012 - January 2013
OraSure Technologies November 2008 - January 2013
International Technidyne Corporation November 2005 - November 2008
Physician Sales and Service March 2002 - November 2005
Patterson Dental March 1999 - March 2002
Sysco Food Services December 1996 - March 1999
Skills
Capital Equipment, Medical Devices, Selling, Cardiology, Product Launch, Operating Room, Market Development, Medical Sales, Capital Equipment Sales, Cross-functional Team..., Cold Calling, Sales, Sales Operations, Pharmaceutical Sales, Infectious Diseases, Contract Negotiation, Oncology, Healthcare, Biotechnology, Commercialization, Hospitals, Sales Effectiveness, Managed Care, Urology, Medical Diagnostics, Hematology, Orthopedic, Diabetes, Disposables, Pharmaceutical Industry, Sales Force Development, Surgeons
Education
The University of Texas at San Antonio 1992 — 1996
bioMerieux August 2013 - Present
Crayola December 2010 - August 2013
OraSure Technologies August 2007 - December 2010
Skills
Six Sigma, Lean Manufacturing, Solidworks, AutoCAD, Cross-functional Team..., Engineering, Design for Manufacturing, Product Development, Medical Devices, 5S, Process Improvement, Injection Molding, Manufacturing, Continuous Improvement, Machine Tools, Plastics, FMEA, Product Design, Minitab, Root Cause Analysis, Quality System, R&D, FDA, Kaizen, ISO, DMAIC, ISO 13485, SolidWorks
Education
Stevens Institute of Technology 2003 — 2007
Bachelors, Mechanical Engineering
OraSure Technologies October 2013 - Present
Pirimal critical care August 2013 - October 2013
Carmike Cinemas January 2006 - January 2010
jcpenney October 2004 - October 2005
Skills
Microsoft Word, Microsoft Excel, microsoft powerpoint, lab instrumentation, assembling lab equipment, Arabic, Microsoft Office, Teamwork, Research, PowerPoint, Public Speaking
Education
Penn State University 2012 — 2013
Bachelor of Science (BS), Life Science
Temple University 2009 — 2012
QIAGEN September 2015 - Present
IMS Consulting Group September 2014 - September 2015
Capgemini Consulting 2012 - September 2014
bioStrategies Group 2006 - December 2012
OraSure Technologies 2009 - 2010
Abbott 2004 - 2006
Abbott Laboratories 2002 - 2004
Abbott Laboratories 2001 - 2002
Kellogg School of Management, Northwestern University 1999 - 2002
TAP Pharmaceuticals Inc. 1999 - 2001
Skills
Market Research, Product Development, Segmentation, Diagnostics, Tactical Planning, Pharmaceuticals, Product Launch, Product Life Cycle..., Biotechnology, Life Sciences, Managed Care, Strategy Development, Healthcare, Pharmaceutical Sales, Marketing Strategy, E-commerce, Digital Marketing, Medical Devices, Commercialization, Pharmaceutical Industry, Strategy, Lifesciences, Product Lifecycle..., Hardware Diagnostics, Digital Strategy, Marketing Communications, SEO, Marketing, Integrated Marketing, Global Marketing, Cross-functional Team..., Strategic Planning, Management Consulting, Competitive Intelligence, Leadership, Business Development, P&L Management, Multi-channel Marketing, Market Analysis, Brand Development, Management, Oncology, Strategic Thinking, Competitive Analysis, Analytics, Positioning, Consulting, Strategic Partnerships, Product Marketing, Marketing Research
Education
Northwestern University - Kellogg School of Management 1999 — 2002
MBA, Marketing, Technology
University of Notre Dame 1985 — 1989
BA, Psychology, English
Solvay June 2015 - Present
Solvay September 2013 - July 2015
OraSure Technologies August 2012 - August 2013
ConvaTec March 2011 - August 2012
GE Healthcare August 2009 - February 2011
UMDNJ June 2008 - June 2009
Bristol-Myers Squibb July 2006 - August 2008
OHM LABORATORIES May 2005 - March 2006
SOUTH CLINTON RESEARCH INC May 2004 - May 2005
UMDNJ September 2003 - May 2004
Skills
Public Health, Lifesciences, Biotechnology, Healthcare, FDA, Epidemiology, Research, Industrial Hygiene, Validation, Occupational Health, Data Analysis, SPSS, Microsoft Office, Risk Assessment, EHS, Environmental Awareness, Ergonomics, Project Management, Sop, Program Management, Software Documentation, SOP
Education
University of Medicine and Dentistry of New Jersey 2007 — 2009
MPH, Environmental and Occupational Health
Rutgers College 2001 — 2005
Bachelor of Arts, Molecular Biology and Biochemistry; Molecular Biology & Biochemistry Research
In-Vitro Diagnostics, Medical Devices, Point of Care Dx, Alliance Management April 2015 - Present
BD Diagnostics January 2014 - March 2015
BD Diagnostics February 2005 - December 2013
OraSure Technologies May 2001 - August 2004
Ortho Clinical Diagnostics January 1997 - April 2001
Intracel Corporation May 1995 - September 1996
Zynaxis, Inc March 1993 - March 1995
Medical Technology Corporation May 1992 - February 1993
Serono Baker Diagnostics April 1990 - April 1992
Serono Diagnostics, LTD June 1987 - March 1990
Skills
Medical Devices, Biotechnology, FDA, Life Sciences, Regulatory Affairs, Lifesciences, Validation, R&D, Pharmaceutical Industry, Product Development, Healthcare, Research, Commercialization, Microsoft Excel, GMP, Microsoft Office, Cross-functional Team..., Assay Development, Customer Service, ISO 13485, Technology Transfer, Point of Care test..., Clinical Trials, Global Alliance..., Scientific Affairs, Project Management, Coaching, Training & Development, Technical Support, Strategy, Laboratory, Product Launch, Management, Biochemistry, Leadership, Functional Verification, New Product Validation, Customer Technical..., ELISA
Education
University of London 1982 — 1985
Doctor of Philosophy (Ph.D.), Biochemistry
American Medical Depot June 2015 - Present
OraSure Technologies January 2010 - June 2015
Skills
Medical Devices, Sales Operations, Product Launch, Capital Equipment, Market Development, Account Management, Business Strategy, Cardiology, Commercialization, Cross-functional Team..., Global Marketing, Hardware Diagnostics, Healthcare, Marketing Management, Marketing Strategy, New Business Development, Pharmaceutical Industry, Sales Management, Sales, Strategic Planning, Selling
Education
Robert Morris University 1980 — 1983
Bachelor of Science (BS), Business, Management, Marketing, and Related Support Services
New Product Venture; Marketing and Management Consulting 2014 - Present
OraSure Technologies 2007 - 2013
Bausch & Lomb 2005 - 2007
Playtex Products 2004 - 2005
Playtex Products 1999 - 2004
Playtex Products 1998 - 1999
Reckitt 1997 - 1998
Reckitt 1994 - 1996
Reckitt 1991 - 1993
Reckitt 1989 - 1991
Skills
Cross-functional Team..., Strategy, Integrated Marketing, Product Development, Product Launch, Market Research, Marketing, Leadership, Management, Strategic Planning, P&L Management, Market Planning, Customer Insight, Brand Management, Advertising, Business Development, Sales Management, Digital Marketing, Social Media, Innovation, Marketing Strategy, Competitive Analysis, Consumer Products
Education
Rutgers, The State University of New Jersey-Newark
MBA, Masters of Business Administration, 3.7 GPA
University of South Carolina-Columbia
BS, Marketing
OraSure Technologies January 2007 - Present
Skills
Change Control, ISO 13485, Quality Assurance, CAPA
Education
University of Phoenix 2013 — 2014
Nike August 2013 - Present
Hemcon Medical Technologies 2012 - August 2013
Hemcon Medical Technologies November 2003 - March 2012
Oregon Crime Lab June 2003 - November 2003
OraSure Technologies 2000 - 2003
Epitope Inc 1997 - 2000
MDT Biologics January 1996 - August 1996
Skills
Medical Devices, Product Development, Project Planning, Design Control, Risk Assessment, Continuous Improvement, Validation Master Plans, Validations, ISO 11137, Sterility Assurance, Class III, 510 K, ISO 10993, Biocompatibility, Sampling Plans, Medical Diagnostics, ISO, Validation, V&V, FDA, Biotechnology, Biomedical Engineering, GMP, Assay Development, ELISA, Microbiology, GLP, CAPA
Education
State University of New York College at Geneseo 1991 — 1995
BS, Chemistry
Mount Mercy 1987 — 1991
OraSure Technologies September 2014 - Present
Merck & Co. December 2003 - April 2014
Merck, Novartis, Schering-Plough, and Alpharma-Purepac January 1992 - December 2003
Skills
Pharmaceutical Industry, GMP, Quality Assurance, Validation, Cross-functional Team..., Change Control, Medical Devices, Biotechnology, Aseptic Processing, Vaccines, Quality System, Process Engineering, Six Sigma, Quality Engineering, Manufacturing, GLP, CAPA, Quality Systems, Compliance, Biopharmaceuticals, Quality by Design, Process Development, Risk Management, Project Management, Technology Transfer, SOP, CSV, Design of Experiments, PAT, Commercialization, QSR, ISO, Investigations, Root Cause Analysis, Process Improvement, Lean Sigma, Statistics, Technical Writing, Automation, Cleaning Validation
Education
Stevens Institute of Technology 2005 — 2014
R&D, manufacturing, QA & regulatory compliance for pharmaceuticals, biologics & medical devices
The Cooper Union for the Advancement of Science and Art 1983 — 1987
B.E., Engineering
Lost River Real Estate June 2013 - Present
Lost River Trading Post July 2013 - Present
Donald Hitchcock Consulting January 2014 - Present
Gertrude Stein Democratic Club 2001 - Present
Wardensville Fitness Center January 2015 - Present
Hardy County Tour and Crafts Association January 2015 - Present
OraSure Technologies February 2010 - December 2013
National Stonewall Democrats 2000 - 2012
GetEQUAL 2009 - 2011
Advocates for Youth April 2008 - February 2010
Skills
Community Outreach, Fundraising, Community Organizing, Non-profits, Public Policy, Politics, Grant Writing, Volunteer Management, Coalitions, Strategic Communications, Political Campaigns, Policy Analysis, Grassroots Organizing, Public Speaking, Program Development, International..., Leadership, Nonprofits, Public Relations, Government, Public Health, Legislative Relations, Policy, Program Evaluation, Research
Education
The George Washington University 2007 — 2010
MPP, Public Policy
Stetson University 1990 — 1994
BA, BS, Spanish, Mathematics
Universidad Autónoma de Guadalajara 1993 — 1993
Mexican History and Literature
Universidad Complutense de Madrid 1991 — 1992
Spanish
Sterling Infosystems, Inc. December 2013 - May 2015
Sterling Infosystems, Inc. December 2011 - December 2013
OraSure Technologies 2008 - 2011
OraSure Technologies 2004 - 2008
IKARIA, Inc. (formerly INO Therapeutics, Inc.) 2002 - 2004
Skills
Selling, Sales, Customer Satisfaction, Strategic Planning, Business Planning, Sales Operations, Cold Calling, Direct Sales, New Business Development, Salesforce.com, Account Management, Sales Management, Forecasting, Cross-functional Team..., Business Development, Team Building, Recruiting, Training, Coaching, Solution Selling, Sales Process, Contract Negotiation, Key Account Management, Performance Management, Leadership, Strategic Partnerships, Product Launch
Education
Shippensburg University of Pennsylvania 1999 — 2002
BSBA, Marketing
KPMG LLP January 2013 - Present
EPI-USE March 2010 - December 2012
NorthgateArinso July 2006 - November 2009
Cascade Employers Associaton December 2004 - June 2006
Concordia University September 2004 - July 2005
North Pacific March 2003 - March 2004
Good Spirits, Inc. January 2001 - March 2003
OraSure Technologies January 1997 - December 1999
Rentrak 1994 - 1996
Skills
Business Process Design, SAP HCM implementations, Metastorm Provision..., Change Management, Business Process, SAP HR, HRIS, Human Resources, SAP, Business Process..., Personnel Management, Development Tools, Program Management, HR Transformation, Metastorm, ERP, Software Documentation, Payroll, Consulting, Management Consulting, Deferred Compensation, Business Analysis, Training, Budgets
Education
University of Minnesota - Carlson School of Management 1973 — 1977
MBA, Industrial Relations
University of Wisconsin-Madison 1969 — 1973
BA, Philosophy
Geneia April 2015 - Present
Friend Family Health Center April 2014 - Present
Gerson Lehrman Group May 2010 - Present
Zynx Health May 2013 - April 2015
ICNet Systems Inc. June 2011 - May 2013
OraSure Technologies November 2009 - April 2011
Monogram Biosciences November 2007 - November 2009
Gilead Sciences April 2003 - November 2007
Johnson & Johnson January 1999 - April 2003
McMaster-Carr May 1996 - January 1999
Skills
Healthcare, Hospitals, Strategy, Medical Devices, Leadership, Sales Operations, Selling, Infectious Diseases, Product Launch, Management, Pharmaceutical Industry, Contract Negotiation, Clinical Research, Team Building, Market Development, Business Development, Biotechnology, Product Marketing, Pharmaceutical Sales, Cross-functional Team..., Healthcare Industry, Sales Process, Hospital Sales, Capital Equipment, Training, Negotiation, New Business Development, Oncology, Commercialization, Start-ups, Product Demonstration, Infection Control, Product Launches, Commercial Strategy, Business Analysis, Presentations, Analysis, International Business, Accountable Care, Sales
Education
Purdue University 1991 — 1995
BS, Economics
Assurex Health August 2015 - Present
bioMerieux November 2011 - August 2015
Indepent rep February 2011 - November 2011
OraSure Technologies August 2010 - December 2010
Hologic February 1999 - June 2010
RUSCH INCORPORATED January 1997 - January 1999
Skills
Capital Equipment, Medical Devices, Cardiology, Disposables, Hospitals, Managed Care, Oncology, Pharmaceutical Sales, Infectious Diseases, Healthcare, OB/GYN, Pharmaceutical Industry, Urology, Orthopedic, Hematology, Surgical Instruments, Molecular Diagnostics, Biotechnology, Hardware Diagnostics, Operating Room, Selling, Sales, Lifesciences, Sales Operations, Hospital Sales, Cold Calling, Medical Sales, Surgery, Market Development, Sales Force Development, Product Launch
Education
University of Rhode Island 1993 — 1997
BS, Dietetics
B. Braun Medical April 2010 - Present
SunGard Availability Services June 2007 - November 2009
Aspect Software April 2006 - April 2007
Siemens Communications October 1994 - April 2006
Orasure Technologies June 2003 - January 2005
ADP April 1986 - October 1994
Skills
Medical Devices, Salesforce.com, Miller Heiman, Call Center, Project Management, Business Strategy, Lean Manufacturing, Contract Manufacturing, Pharmaceutical Industry, Channel Partners, Cross-functional Team..., Program Management, Sales Operations, Solution Selling, Strategy, Management, New Business Development, Start-ups, Leadership, Sales Management
Education
Rutgers University – Camden 1978 — 1983
BA, Business
West Pharmaceutical Services June 2015 - Present
Authentidate Holding Corp. July 2014 - May 2015
Teva Pharmaceuticals/NuPathe Inc September 2013 - 2014
OraSure Technologies June 2010 - September 2013
OraSure Technologies December 2008 - June 2010
Accupac, Inc. August 2004 - December 2008
GlaxoSmithKline 2002 - 2004
GlaxoSmithKline January 2000 - August 2003
Wyeth 1998 - 2000
Skills
GMP, FDA, CAPA, Regulatory Affairs, Quality Assurance, Validation, V&V, Sop, Change Control, 21 CFR Part 11, Quality System, Pharmaceutical Industry, Technology Transfer, GLP, Regulatory Submissions, ISO 13485, Biotechnology, Biopharmaceuticals, Aseptic Processing, Cleaning Validation, GxP, Quality Auditing, Medical Devices, Lifesciences, Quality Control, FDA GMP, Design Control, LIMS, ISO 14971, Trackwise, Microbiology, Cross-functional Team..., Computer System..., Laboratory, Product Development, Bioburden, Class III Medical..., Pharmaceutical..., Project Planning, Calibration, IVDD, Sterility Assurance, Dossier Preparation, Supplier Quality, Protocol Design, Environmental..., FMEA, Global Regulatory..., Safety Management..., Manufacturing
Education
Temple University 2000 — 2003
MSc, Quality Assurance & Regulatory Affairs
University of the Sciences in Philadelphia 1992 — 1998
BSc, Microbiology
Nanuet Senior High 1988 — 1992
High School
Strategic Sales Partners, LLC. August 2013 - March 2015
IDS, Inc. March 2012 - July 2013
BioMerieux August 2010 - March 2012
Coloplast January 2009 - August 2010
JEC Consulting Group, LLC August 2008 - December 2008
Orasure Technologies March 2004 - June 2008
MD's Medical 2001 - 2004
Bayer 1998 - 2001
MedCorp./MedCare January 1996 - January 1998
Skills
Product Launch, Capital Equipment, Cardiology, Pharmaceutical Industry, Pharmaceutical Sales, Market Development, Biotechnology, Medical Devices, Selling, Sales Management, Infectious Diseases, Marketing Strategy, Account Management, New Business Development, Forecasting, Healthcare, Market Analysis, Direct Sales, Key Account Management, Market Research, Strategic Planning, Hospitals, Business Intelligence, Managed Care, Budgets, Consultative Selling, Life Sciences, Competitive Analysis, Market Planning, Product Launches, Pharmaceuticals, Customer Relations, Budgeting, Acute Care, Biopharma, Diagnostics, Contract Negotiations, Competitive Intelligence, Global Marketing, Strategy Development, Cold Calling, Contract Negotiation, Strategy, Sales
Education
Southern New Hampshire University 2015 — 2016
Master of Science (M.S.), Marketing
Southern New Hampshire University 2013 — 2014
Bachelor's Degree, Marketing, Magna Cum Laude
Mercuri International 2010 — 2010
Certificate, Sales Excellence Program
Miller Heiman 2004 — 2005
Certificate, Strategic and Conceptual Selling
Bayer AG 1998 — 1998
Certificate, Professional Pharmaceutical Sales
San Juan Bautista School of Medicine 1994 — 1995
None, Basic Clinical Sciences
PUCPR 1986 — 1990
General Sciences, PreMedicine, English
Accriva Diagnostics November 2012 - Present
OraSure Technologies May 2012 - November 2012
Alere, Inc. November 2007 - March 2012
HemoSense November 2006 - November 2007
Streck, Inc April 2004 - October 2006
Fisher HealthCare December 1995 - March 2004
Elan Diagnostic 1995 - 1996
Curtin Matheson Scientific 1978 - 1995
Skills
Medical Devices, Capital Equipment, Biotechnology, Market Development, Infectious Diseases, Hardware Diagnostics, Leadership, Sales Management, Sales Operations, Strategy, Immunoassays, Cardiology, Healthcare, Product Launch, Hematology
Education
Saint Louis University 1972 — 1976
BA, Chemistry, Biology
Fisher Clinical Services August 2013 - Present
OraSure Technologies October 2011 - Present
OraSure Technologies May 2010 - October 2011
OraSure Technologies December 2007 - May 2010
Organon BioSciences January 2005 - November 2007
Merck 1997 - 2005
Skills
Validation, Process Improvement, Design Control, FDA, CAPA, Quality System, V&V, Management, GMP, Medical Devices, ISO 13485, Six Sigma, Manufacturing, Root Cause Analysis, Minitab
Education
University of Delaware 1993 — 1997
BChE, Chemical Engineering
Emmaus High School 1990 — 1993
MBio Diagnostics March 2013 - Present
ConMed Linvatec May 2009 - March 2013
OraSure Technologies August 2005 - May 2009
Serologicals January 2001 - June 2005
Serological (now Millipore) 2001 - 2005
Ortho Clinical Diagnostics(Johnson & Johnson) 1998 - 2001
Johnson and Johnson - Ortho Clinical Diagnostics September 1998 - December 2000
Ortho Clinical Diagnostics 1998 - 2000
Skills
Regulatory Affairs, Quality Assurance, ISO13485, FDA - Consent Decree..., CAPA, GMP, Quality Systems, Validation, Clinical and Medical..., EHS, Six Sigma, LEAN Manufacturing, Biologics, Biotechnology, CE marking, Change Control, FDA, ISO 13485, ISO 14971, Leadership, Lean Manufacturing, Lifesciences, Medical Devices, Quality Auditing, Quality Management, Quality System, V
Education
Georgia Institute of Technology - Georgia Tech College of Management 2002 — 2004
Executive Masters, Mangement of Technology
Queens University of Charlotte 1970 — 1974
BA, Biochemistry
OraSure Technologies January 2010 - Present
AccuVein May 2008 - December 2009
Cardinal Health May 2003 - December 2003
Education
Robert Morris University 1979 — 1983
Bachelor of Science (BS), Business Administration and Marketing, Magna Cum Laude
Siemens Healthcare January 2013 - Present
OraSure Technologies January 2011 - January 2013
Orasure Technologies October 2008 - January 2011
Pedigo June 2007 - October 2008
Fisher Scientific July 2004 - May 2007
Boston Scientific 1995 - 2000
Skills
Medical Devices, Distributors, Capital Equipment, Management, Infectious Diseases, Market Development, Process Improvement, Team Leadership, Cardiology, Cross-functional Team..., Product Launch, Biotechnology, Sales Process, Start-ups, Sales Operations, Leadership, Sales Leadership..., Sales Management, Team Building, Sales, Program Management, Pharmaceutical Sales, Urology, Managed Care, Selling, Commercialization, Competitive Analysis, Healthcare, Neurology, Operating Room, Sales Effectiveness
Education
United States Military Academy at West Point 1982 — 1986
United State Military Academy Prep School 1981 — 1982
Leupold & Stevens, Inc. November 2007 - Present
Trailblazer Foods, Inc. 2003 - 2007
OraSure Technologies 2001 - 2003
Jana's Classics, Inc. 1998 - 2001
Stone Mill Foods, Inc. 1994 - 1998
Yoshida Foods International 1993 - 1994
Oregon State University Extension Service, Hood River, OR 1990 - 1992
Skills
ISO, Quality Assurance, Testing, Software Documentation, Quality Control, Laboratory Equipment, Technical Analysis
Education
Oregon State University 1988 — 1992
Bachelor of Science, Microbiology
OraSure Technologies November 2001 - Present
Skills
Biotechnology, Treasury Management, Medical Devices, Commercialization, Mergers & Acquisitions, Lifesciences, Pharmaceutical Industry, Strategy, Competitive Analysis, Forecasting, Product Launch, Start-ups, Corporate Development, Cross-functional Team..., Business Development
Education
Rider University 1980 — 1982
M.B.A., Finance
Rider University 1973 — 1977
B.S., Accounting & Business Administration
ITC- Augusta February 2010 - June 2012
EMD Serono, Inc. October 2007 - February 2010
OraSure Technologies April 2004 - October 2007
EMD SERONO Incorporated March 2000 - December 2002
Abbott Laboratories September 1997 - March 2000
Abbott Laboratories June 1991 - September 1997
Boots / Knoll 1991 - 1997
WILLIAMS BROTHERS CONCRETE COMPANY September 1986 - January 1991
Skills
Biotechnology Industry, Pharmaceutical Industry, Medical Diagnostics, Strategic Planning, Sales Operations, Healthcare, New Business Development, Contract Negotiation, Pharmaceutical Sales, Product Launch, Endocrinology
Education
The University of Georgia 1981 — 1986
BA, Economics
University at Buffalo September 2011 - May 2013
OraSure Technologies March 2007 - June 2010
Skills
Public Health, Data Analysis, Healthcare, Program Development, SPSS, Program Evaluation, Grant Writing, Research, Nutrition, Teaching, Lifesciences, PowerPoint, Social Media, Public Speaking, Event Planning, Leadership
Education
University at Buffalo 2014 — 2018
Doctor of Philosophy (Ph.D.), Community Health and Health Behavior
State University of New York at Buffalo 2010 — 2013
MS, Nutrition Science
Lincoln Technical Institute 2008 — 2009
Certification, Massage Therapy
Widener University 2002 — 2005
BS, Biology
OraSure Technologies March 2010 - Present
DJO March 2009 - March 2010
HemoCue AB February 2002 - February 2009
Epicor 1998 - 2001
Education
Santa Ana College 1995 — 1998
Business Administration
WomanCare Global January 2014 - Present
telmedx 2013 - 2014
OraSure Technologies 2005 - 2013
Quidel 2002 - 2005
EMD - Affiliates of Merck KGaA, Darmstadt, Germany 1998 - 2002
EMD - Affiliates of Merck KGaA, Darmstadt, Germany 1996 - 1998
EMD - Affiliates of Merck KGaA, Darmstadt, Germany 1993 - 1996
EMD - Affiliates of Merck KGaA, Darmstadt, Germany 1992 - 1993
Skills
Life Sciences, Latin America, Portuguese, French, Diagnostics, Medical Devices, Spanish, Lifesciences, Hardware Diagnostics, Market Development, Pharmaceutical Industry, Biotechnology, Multilingual, Capital Equipment, International Sales, Product Launch, Global Marketing, Commercialization, Entrepreneurship, P&L Management, International Business, Managing Distribution..., Strategic Negotiations, Strategic Planning, Leadership, Selling, International Marketing, Management, Sales, Business Development, Marketing, Cross-functional Team..., Negotiation, Oncology, Market Analysis, Competitive Analysis, Product Marketing, Healthcare, Pharmaceutical Sales, Sales Operations, Sales Effectiveness, Medical Diagnostics, Molecular Diagnostics, Immunoassays, Urology, Infectious Diseases, Regulatory Affairs, FDA, Strategy, Biopharmaceuticals
Education
Federal Univeristy of Bahia, Brazil
Bachelor of Science
University of San Diego
Master's Certificate in International Business
OraSure Technologies June 2009 - Present
OraSure Technologies October 2001 - June 2009
Lehigh University February 1998 - September 2001
Skills
Medical Devices, Immunoassays, Diagnostics, Clinical Trials, R&D, Infectious Diseases, Product Development, Point of Care, IVD, GLP, Validation, Clinical Development, Assay Development, FDA, Biotechnology
Education
Université Nice Sophia Antipolis 1988 — 1996
Ph.D., Chemistry
OraSure Technologies November 2006 - Present
Tru- Comfort Inc. April 1999 - March 2006
Tru- Comfort Inc April 1999 - March 2006
Skills
Certified Air Balancing, Certified Carbon..., master electrical..., HVAC, Heating, Air Conditioning, Refrigeration, Ventilation, HVAC Controls, Preventive Maintenance, Indoor Air Quality, Troubleshooting, Quality System, Building Maintenance, GMP, Medical Devices, Validation, Biotechnology, Facilities Management, Maintenance & Repair, CAPA, V&V, ISO 13485, FDA, Calibration, Design Control, Building Automation, Change Control, Clean Rooms, Hardware Diagnostics, Sop, FDA GMP, 21 CFR Part 11, cGMP practices, Quality Control, ISO, Manufacturing, SOP
Education
Northampton Community College 1997 — 2000
Specialized dipoloma HVAV, Hvac
Allentown Christian Schhol 1975 — 1978
OraSure Technologies 2014 - Present
EMD Chemicals June 2008 - March 2011
Emerson Resources, Inc January 2006 - June 2008
Emerson Resources, Inc January 2006 - June 2008
Sharp Corporation (dba Sharp Packaging Solutions) September 2003 - January 2006
Alcan Packaging October 2002 - September 2003
Skills
GMP, Protein Purification, Biopharmaceuticals, FDA, Sop, Regulatory Affairs, Immunology, Validation, Quality Assurance, Tissue Culture, Bioinformatics, Product Launch, Cell Culture, Sales Operations, PCR, DNA extraction, Molecular Diagnostics, Molecular & Cellular..., Western Blotting, Gel Electrophoresis, RNA isolation, recombinant DNA..., Genotyping, Bacterial Transformation, Microbial Genetics, Human Genetics, SDS-PAGE, Aseptic Technique, Product Management, Quality Control, Animal Husbandry, Marketing Management, Document Review, Advertising, Project Management, Customer Experience, Supply Chain, Cross-functional Team..., Pharmaceutical Packaging, Pharmaceutical...
Education
Thomas Jefferson University 2012 — 2013
Master’s Degree, Biotechnology/Applied Molecular Technology
Moravian College 1999 — 2002
BS, Biology
bioMerieux September 2015 - Present
bioMerieux July 2014 - Present
bioMerieux June 2013 - June 2014
OraSure Technologies February 2010 - May 2013
OraSure Technologies February 2008 - January 2011
Teva Pharmaceuticals 2006 - 2008
Teva USA November 2005 - February 2006
Teva USA February 2003 - November 2005
Skills
Medical Devices, FDA, Pharmaceutical Industry, GMP, CAPA, Validation, Quality System, Six Sigma, ISO 13485, Lean Manufacturing, Process Improvement, Manufacturing, Sop, R&D, V&V, Change Control, Commercialization, Cross-functional Team..., Design Control, ISO, Minitab, Quality Assurance, Root Cause Analysis, Biotechnology, 21 CFR Part 11, SOP
Education
Penn State University 1999 — 2002
B.S., Biochemistry and Molecular Biology
Penn State University
B.S. Biochemistry and Molecular Biology
Siemens Healthcare November 2012 - Present
Siemens Healthcare Diagnostics 2009 - November 2012
OraSure Technologies August 2006 - December 2008
Siemens Healthcare March 2006 - August 2006
Siemens Healthcare 2001 - 2006
Siemens Healthcare 1999 - 2001
Education
University of Rhode Island 1984 — 1988
MS, Biochemistry
OraSure Technologies August 2012 - Present
Florida Department of Health July 2009 - August 2012
Florida Department of Health August 2007 - July 2009
Georgia Department of Human Resources January 2004 - February 2007
City of Houston April 1999 - January 2004
Skills
Public Health, Health Education, Infectious Diseases, Program Evaluation, Health Communication, Program Development, Health Policy, Grants, Grant Writing, Health Promotion, Qualitative Research, Healthcare, Fundraising, Volunteer Management, Prevention, Nonprofits, Public Speaking, Proposal Writing, Policy, Community Outreach, Policy Analysis, Social Services, Community Development, Case Managment, Data Collection, SPSS, Public Policy, Community Engagement, Report Writing, Plannning
Education
Texas A&M University 1995 — 1999
Health, Community Health
AUTHORITY medical group August 2015 - Present
Hemcon Medical Technologies August 2013 - August 2015
Intelligent Hospital Systems June 2010 - July 2013
Oligos Etc. Inc. October 2008 - June 2010
Parata Systems August 2003 - March 2008
OraSure Technologies July 1995 - August 2003
Skills
Medical Devices, Capital Equipment, Urology, Commercialization, Market Development, Cross-functional Team..., Product Launch, Biotechnology, Cardiology, Pharmaceutical Industry, Lifesciences, Hardware Diagnostics, Product Development, Healthcare, Sales Operations, FDA, New Business Development, Strategy, Surgical Instruments, Business Development, Disposables, Surgeons, Business Strategy, Strategic Planning, Sales Process, Product Marketing, Managed Care, P&L Management, Hematology, Sales Force Development, Selling, Strategic Partnerships, Product Management, Start-ups, Sales, Direct Sales, Executive Management
Education
State University of New York at New Paltz 1990 — 1992
3.8 GPA
Vistakon January 2015 - Present
ConMed October 2013 - January 2014
Hospira March 2013 - August 2013
Terumo Cardiovascular Systems March 2012 - March 2013
St. Jude Medical, Neuromodulation Div. September 2011 - December 2011
Eos Energy Storage, LLC May 2011 - August 2011
Lehigh University September 2007 - April 2010
OraSure Technologies 1998 - 2003
BD 1992 - 1995
Baker Instruments 1978 - 1990
Skills
Medical Devices, FDA, Quality Assurance, Validation, R&D, V&V, Solidworks, Manufacturing, Design for Manufacturing, Quality Control, Hardware Diagnostics, Injection Molding, Chemistry, Automation, CAPA, Design Control, Design of Experiments, ISO 13485
Education
Stevens Institute of Technology 1966 — 1973
MS, Medical Engineering (Mechanical Eng)
Roche Molecular Systems 2012 - Present
Puget Sound Blood Center and Northwest Tissue Services 2010 - 2012
OraSure Technologies 2008 - 2009
Roche Diagnostics 2006 - 2008
Roche Diagnostics 2005 - 2006
Roche Diagnostics 2002 - 2005
Diagnostic Products Corporation 2000 - 2002
Diagnostic Products Corporation 1998 - 2000
Johns Hopkins University 1994 - 1998
Johns Hopkins Hospital 1991 - 1994
Education
Slippery Rock University of Pennsylvania
Bachelors, Biology
St. Vincent's School of Medical Technology
MT (ASCP), Medical Technology
The Johns Hopkins University - Carey Business School
Masters, Business & Regulatory Affairs
University of California, Santa Barbara September 2014 - Present
Lehigh University January 2014 - May 2014
Lehigh University September 2007 - December 2013
OraSure Technologies June 2003 - January 2006
Skills
Fluorescence, Protein Expression, HPLC, DLS, ELISA, Lifesciences, Membrane Proteins, Molecular Cloning, Protein Purification, SDS-PAGE, AUC, SEC, MALDI-TOF, Antibody purification, Structural Biology /..., Biochemistry, Biophysics, Protein Chemistry, Purification, Immunoassays, Characterization, Life Sciences, NMR, Antibodies, Chemistry
Education
Lehigh University 2005 — 2013
PhD, Chemistry
University of Delaware 1999 — 2003
BS, Biochemistry
Otsuka Pharmaceutical Companies (U.S.) August 2012 - Present
Boehringer Ingelheim August 2011 - August 2012
Regeneron Pharmaceuticals April 2011 - August 2011
OSI Pharmaceuticals 2010 - 2011
Merck Pharmaceuticals February 2009 - July 2010
OraSure Technologies 2007 - 2009
Skills
CTMS, Clinical Research, Protocol, Clinical Trials, Project Management, Clinical Development, Oncology, CRO, GCP, Clinical Monitoring, ICH-GCP, EDC, Biotechnology, Therapeutic Areas, SOP
Education
Teachers College of Columbia University 2002 — 2003
MA, Psychology in Education
University of Massachusetts, Amherst 1995 — 1999
BS, Psychology and Biology
OraSure Technologies March 2010 - Present
DJO Global March 2009 - March 2010
HemoCue January 2002 - March 2009
Skills
Cardiology, Medical Devices, Market Development, Capital Equipment, Product Launch, Contract Negotiation, Disposables, Hospitals, Leadership, Operating Room, Sales, Sales Operations, Selling, Selling Skills, Urology, Account Management, Cross-functional Team..., Healthcare, Sales Management, Sales Process
Education
Santa Ana College 1994 — 1998
OraSure Technologies September 2012 - Present
Excelsior Medical Corp. August 2007 - August 2012
Skills
Biomedical Engineering, Six Sigma, Microsoft Excel, Matlab, Simulink, PowerPoint, C++, ProE, Excel, Word, Outlook, Access, ProCal, Fortran, Dreamweaver, Wireless Networking, Windows 95 - Windows 8.1
Education
SUNY Stony Brook 2005 — 2006
MS, Biomedical Engineering
Rutgers University 2001 — 2005
BS, Biomedical Engineering
Just Born January 2012 - February 2012
Just Born, Inc January 2012 - February 2012
Arista November 2008 - October 2011
OraSure Technologies October 2006 - July 2007
Blommer January 2006 - September 2006
Gulbrandsen Technologies April 2001 - October 2005
Binney and Smith May 2000 - October 2000
Dyets, Inc May 1997 - April 2000
Skills
Quality Assurance, Quality, Problem Solving, Customer Service, Microsoft Office
Education
Penn State University 1991 — 1996
Bachelor of Science (BS), Biology, General
Alere, Inc. January 2014 - Present
Trinity Biotech February 2007 - January 2014
OraSure Technologies September 2003 - February 2007
Novo Nordisk A/S November 2000 - April 2003
Skills
Experienced Sales..., Territory..., Public Speaking, Experienced Trainer, Medical Devices, Sales Operations, Hospitals, Salesforce.com, Healthcare, Market Development, Product Launch, Account Management, Hospital Sales, Program Management, Marketing, Sales
Education
Western Carolina University - MBA 1998 — 2001
Master of Business Administration (MBA), Business Administration and Management, General
University of North Carolina at Greensboro 1988 — 1992
Bachelor of Applied Science (B.A.Sc.), Business, Management, Marketing, and Related Support Services
OraSure Technologies May 2014 - Present
Allied Personnel Services June 2013 - May 2014
Skills
Pharmaceutical..., Pharmaceutical Packaging, Clean Rooms, Laboratory Skills, Electronics..., Electronics Packaging, Quality Control, Assembly Lines, Soldering, Loss Prevention, Inventory Management, Part Identification, Electrostatic Discharge
Education
Penn State University 2008 — 2012
Bachelor of Science (BS), Chemical Engineering