GENE-TRAK Systems
Industry: Company
DescriptionFounded: 1986 Parent organization: Abbott Laboratories
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GENE-TRAK Systems Employees
Employee
Years
Job
Industry
Carl Buyer Carl Buyer's GENE-TRAK Systems Experience January 1985 - April 1991
Job Program Director, Canon Virginia Inc.
Industry Medical Devices
Experience
Canon Virginia, Inc November 2014 - Present
Vapotherm April 2013 - Present
Hospira 2013 - 2014
Hospira 2013 - 2014
Vapotherm March 2006 - April 2013
Johnson and Johnson MD&D April 1991 - March 2005
j&j May 2003 - January 2005
Johnson & Johnson January 2001 - May 2003
Johnson & Johnson April 1991 - January 2001
Gene-Trak Systems January 1985 - April 1991
Skills
Design Control, Medical Devices, Product Development, FDA, ISO 13485, CAPA, Six Sigma, Validation, Quality System, Manufacturing, GMP, R&D, Design for Manufacturing, SPC, ISO 14971, Engineering, Electronics, ISO, Program Management, Management, Design of Experiments, Continuous Improvement, Product Design, V&V, Biotechnology, Root Cause Analysis, Quality Management
Education
Capitol College 1972 — 1976
BS, Electrical and Electronics Engineering
Canon Virginia, Inc November 2014 - Present
Vapotherm April 2013 - Present
Hospira 2013 - 2014
Hospira 2013 - 2014
Vapotherm March 2006 - April 2013
Johnson and Johnson MD&D April 1991 - March 2005
j&j May 2003 - January 2005
Johnson & Johnson January 2001 - May 2003
Johnson & Johnson April 1991 - January 2001
Gene-Trak Systems January 1985 - April 1991
Skills
Design Control, Medical Devices, Product Development, FDA, ISO 13485, CAPA, Six Sigma, Validation, Quality System, Manufacturing, GMP, R&D, Design for Manufacturing, SPC, ISO 14971, Engineering, Electronics, ISO, Program Management, Management, Design of Experiments, Continuous Improvement, Product Design, V&V, Biotechnology, Root Cause Analysis, Quality Management
Education
Capitol College 1972 — 1976
BS, Electrical and Electronics Engineering
Cecile Blomquist Cecile Blomquist's GENE-TRAK Systems Experience 1987 - 1995
Job Principal Developer, President at Excelerate Solutions LLC
Industry Medical Devices
Experience
Excel-erate Solutions LLC June 2013 - Present
Insulet Corporation January 2012 - April 2013
Covidien May 2008 - January 2012
Amgen Inc. 2006 - 2007
Genzyme 1996 - 2005
GENE-TRAK Systems 1987 - 1995
Skills
R&D, Process Improvement, Product Development, Quality System, Medical Devices, Data Analysis, Validation, FDA, CAPA, ISO 13485, Software Documentation, V&V, 21 CFR Part 11, Design Control, Change Control, Sop, GMP, Quality Control, SPC, Biopharmaceuticals, Quality Auditing, ISO 14971, Process Simulation, Computer System..., FDA GMP, Quality Assurance, GxP, Biotechnology, Minitab, GAMP, Statistical Data..., SOP
Education
Univ. of Mass
Bachelor of Science (BS), Zoology/Animal Biology
Boston University 2001 — 2002
Masters Certificate, Windows Programming
University of Massachusetts, Amherst
BS, Zoology
Excel-erate Solutions LLC June 2013 - Present
Insulet Corporation January 2012 - April 2013
Covidien May 2008 - January 2012
Amgen Inc. 2006 - 2007
Genzyme 1996 - 2005
GENE-TRAK Systems 1987 - 1995
Skills
R&D, Process Improvement, Product Development, Quality System, Medical Devices, Data Analysis, Validation, FDA, CAPA, ISO 13485, Software Documentation, V&V, 21 CFR Part 11, Design Control, Change Control, Sop, GMP, Quality Control, SPC, Biopharmaceuticals, Quality Auditing, ISO 14971, Process Simulation, Computer System..., FDA GMP, Quality Assurance, GxP, Biotechnology, Minitab, GAMP, Statistical Data..., SOP
Education
Univ. of Mass
Bachelor of Science (BS), Zoology/Animal Biology
Boston University 2001 — 2002
Masters Certificate, Windows Programming
University of Massachusetts, Amherst
BS, Zoology
Donald Halbert Donald Halbert's GENE-TRAK Systems Experience 1985 - 1991
Job Divisional Vice President at Abbvie Retired
Industry Pharmaceuticals
Experience
Habitat for Humanity of Brunswick County January 2015 - Present
Invent Now November 2013 - Present
Abbvie July 2013 - Present
AbbVie March 2011 - June 2013
Abbott Laboratories November 2007 - February 2011
Iconix Biosciences March 2005 - November 2007
Gene-Trak Systems 1985 - 1991
Skills
FDA, Medical Devices, Biochemistry, Biomarkers, Translational Medicine, Science, Structural Biology, Cheminformatics, Drug Development, Technology Transfer, Biopharmaceuticals, Regulatory Affairs, Immunology, R&D, Biotechnology, Assay Development, Chromatography, Drug Discovery, Pharmacology, Pharmacogenetics, Process Improvement, HPLC, Infectious Diseases, Cell Culture, Purification, Lifesciences, Patents, Protein Chemistry, Clinical Research, Microbiology, Regulatory Submissions, Pharmaceutical Industry, Cross-functional Team..., Life Sciences
Education
Washington University in St. Louis 1975 — 1981
Doctor of Philosophy (Ph.D.), Biochemistry and Molecular Biology
University at Buffalo 1971 — 1975
BS, Biology
Habitat for Humanity of Brunswick County January 2015 - Present
Invent Now November 2013 - Present
Abbvie July 2013 - Present
AbbVie March 2011 - June 2013
Abbott Laboratories November 2007 - February 2011
Iconix Biosciences March 2005 - November 2007
Gene-Trak Systems 1985 - 1991
Skills
FDA, Medical Devices, Biochemistry, Biomarkers, Translational Medicine, Science, Structural Biology, Cheminformatics, Drug Development, Technology Transfer, Biopharmaceuticals, Regulatory Affairs, Immunology, R&D, Biotechnology, Assay Development, Chromatography, Drug Discovery, Pharmacology, Pharmacogenetics, Process Improvement, HPLC, Infectious Diseases, Cell Culture, Purification, Lifesciences, Patents, Protein Chemistry, Clinical Research, Microbiology, Regulatory Submissions, Pharmaceutical Industry, Cross-functional Team..., Life Sciences
Education
Washington University in St. Louis 1975 — 1981
Doctor of Philosophy (Ph.D.), Biochemistry and Molecular Biology
University at Buffalo 1971 — 1975
BS, Biology
Barry Sall's GENE-TRAK Systems Experience 1984 - 1988
Job Medical device regulatory expert at PAREXEL
Industry Medical Devices
Experience
PAREXEL April 2006 - Present
PAREXEL June 1996 - March 2006
PAREXEL International 1993 - 1996
PAREXEL International 1989 - 1992
Integrated Genetics 1988 - 1989
GENE-TRAK Systems 1984 - 1988
Skills
Biotechnology, Medical Devices, Clinical Trials, Regulatory Submissions, Regulatory Affairs, FDA, Life Sciences, Clinical Development, CRO, SOP, GMP, GCP, Validation, Clinical Research, 21 CFR Part 11
Education
Boston University 1974 — 1978
B.A., Biology.
PAREXEL April 2006 - Present
PAREXEL June 1996 - March 2006
PAREXEL International 1993 - 1996
PAREXEL International 1989 - 1992
Integrated Genetics 1988 - 1989
GENE-TRAK Systems 1984 - 1988
Skills
Biotechnology, Medical Devices, Clinical Trials, Regulatory Submissions, Regulatory Affairs, FDA, Life Sciences, Clinical Development, CRO, SOP, GMP, GCP, Validation, Clinical Research, 21 CFR Part 11
Education
Boston University 1974 — 1978
B.A., Biology.
Will Weisburg Will Weisburg's GENE-TRAK Systems Experience April 1988 - August 1995
Job Senior Director, Scientific Affairs at Exact Sciences
Industry Biotechnology
Experience
Exact Sciences August 2010 - Present
Granite BioResearch Consulting September 2009 - December 2011
Nanogen October 2003 - July 2009
Gen Probe September 1995 - October 2003
Gene-Trak Systems April 1988 - August 1995
Skills
Biotechnology, Molecular Biology, Lifesciences, FDA, Genomics, Assay Development, Medical Devices, Genetics, Oncology, Commercialization, DNA, Cancer, GMP, Microbiology, R&D, Molecular Diagnostics, Hardware Diagnostics, Validation, Pharmaceutical Industry, Infectious Diseases, PCR, Clinical Trials, DNA sequencing, Biochemistry, Immunoassays, Science, Analytical Chemistry, GLP, Immunology, Drug Discovery, Technology Transfer, ELISA, qPCR, Protein Chemistry, Drug Development, Cell Culture, Biopharmaceuticals, Cell Biology, HPLC, Protein Purification, Proteomics, Life Sciences
Education
University of Illinois at Urbana-Champaign 1980 — 1986
Ph.D., Biology
University of Rochester 1973 — 1977
B.A., Biology
Exact Sciences August 2010 - Present
Granite BioResearch Consulting September 2009 - December 2011
Nanogen October 2003 - July 2009
Gen Probe September 1995 - October 2003
Gene-Trak Systems April 1988 - August 1995
Skills
Biotechnology, Molecular Biology, Lifesciences, FDA, Genomics, Assay Development, Medical Devices, Genetics, Oncology, Commercialization, DNA, Cancer, GMP, Microbiology, R&D, Molecular Diagnostics, Hardware Diagnostics, Validation, Pharmaceutical Industry, Infectious Diseases, PCR, Clinical Trials, DNA sequencing, Biochemistry, Immunoassays, Science, Analytical Chemistry, GLP, Immunology, Drug Discovery, Technology Transfer, ELISA, qPCR, Protein Chemistry, Drug Development, Cell Culture, Biopharmaceuticals, Cell Biology, HPLC, Protein Purification, Proteomics, Life Sciences
Education
University of Illinois at Urbana-Champaign 1980 — 1986
Ph.D., Biology
University of Rochester 1973 — 1977
B.A., Biology
James Aswell James Aswell's GENE-TRAK Systems Experience 1987 - 1991
Job Sr. Project Manager, Process Development at BarryWehmiller Design Group
Industry Medical Devices
Experience
Barry-Wehmiller Design Group January 2011 - Present
PharmaSys, Inc. 2007 - December 2010
BioMerieux 2006 - 2007
BioMerieux 2004 - 2006
Variagenics 2001 - 2004
Bayer Diagnostics 1991 - 2001
Gene Trak Systems 1987 - 1991
Serono Laboratories 1984 - 1987
BBLMicrobiology Systems / Johnston Labs 1978 - 1984
Skills
FDA, Validation, Biotechnology, Technology Transfer, R&D, Quality System, Design of Experiments, Process Simulation, Immunology, Hardware Diagnostics, Laboratory, Automation, GMP, 21 CFR Part 11, CAPA, V&V, Change Control, Design Control, Pharmaceutical Industry, Microbiology, Clinical Trials, Assay Development, Regulatory Affairs, Oncology, Lifesciences, Medical Devices, Clinical Development, Infectious Diseases, Commercialization
Education
Virginia Polytechnic Institute and State University 1976 — 1978
Post Doc, Microbiology, Anaerobic
University of Mississippi Medical Center 1972 — 1976
Ph D, Medical Microbiology and Bacteriology
Southeastern Louisiana University 1968 — 1972
BS, MICROBIOLOGY
U. S. Army, 101st Airborne Division 1966 — 1968
MOS 43/11CE5P (Rigger/Weapons-Sergeant-Paratrooper)
Barry-Wehmiller Design Group January 2011 - Present
PharmaSys, Inc. 2007 - December 2010
BioMerieux 2006 - 2007
BioMerieux 2004 - 2006
Variagenics 2001 - 2004
Bayer Diagnostics 1991 - 2001
Gene Trak Systems 1987 - 1991
Serono Laboratories 1984 - 1987
BBLMicrobiology Systems / Johnston Labs 1978 - 1984
Skills
FDA, Validation, Biotechnology, Technology Transfer, R&D, Quality System, Design of Experiments, Process Simulation, Immunology, Hardware Diagnostics, Laboratory, Automation, GMP, 21 CFR Part 11, CAPA, V&V, Change Control, Design Control, Pharmaceutical Industry, Microbiology, Clinical Trials, Assay Development, Regulatory Affairs, Oncology, Lifesciences, Medical Devices, Clinical Development, Infectious Diseases, Commercialization
Education
Virginia Polytechnic Institute and State University 1976 — 1978
Post Doc, Microbiology, Anaerobic
University of Mississippi Medical Center 1972 — 1976
Ph D, Medical Microbiology and Bacteriology
Southeastern Louisiana University 1968 — 1972
BS, MICROBIOLOGY
U. S. Army, 101st Airborne Division 1966 — 1968
MOS 43/11CE5P (Rigger/Weapons-Sergeant-Paratrooper)
Cheryl A. Callahan MT (ASCP) Cheryl A. Callahan MT (ASCP)'s GENE-TRAK Systems Experience 1992 - 1995
Job Manager, LeadCare Technical Service
Industry Medical Devices
Experience
Magellan Diagnostics, Inc. January 2007 - Present
Saints Medical Center 2002 - 2007
University of Massachusetts Lowell 2005 - 2006
Saints Memorial Medical Center 2003 - 2006
Dorling Kindersley Family Learning 1999 - 2002
Intergen Company 1995 - 1999
Gene-Trak Systems 1992 - 1995
CHASMA SCIENTIFIC, INC. 1985 - 1992
Skills
Blood Bank, Medical Technology, Chemistry, Medical Devices, Microsoft Office, Quality Assurance, Product Support, Laboratory, Complaint Handling, Technical Services, Salesforce.com, Troubleshooting..., CAPA, SOP development, Microsoft Excel, Microsoft Word, Assay Development, Clinical Chemistry, Validation, Quality System, V&V, Clinical Research, FDA, Chromatography, ISO 13485, ELISA, Laboratory Medicine, Hematology, Quality Control, HPLC, Commercialization, GMP, Biotechnology, Testing, Lifesciences, DNA, Hardware Diagnostics, Complaint Management, Sop, Design Control, GLP, Microbiology, R&D, Analytical Chemistry, Infectious Diseases, Life Sciences, Immunology, SOP
Education
BS, MT (ASCP)
Bachelor of Science (BS), Clinical Laboratory Science/Medical Technology/Technologist
University of Massachusetts Lowell
BS, Medical Technology
Magellan Diagnostics, Inc. January 2007 - Present
Saints Medical Center 2002 - 2007
University of Massachusetts Lowell 2005 - 2006
Saints Memorial Medical Center 2003 - 2006
Dorling Kindersley Family Learning 1999 - 2002
Intergen Company 1995 - 1999
Gene-Trak Systems 1992 - 1995
CHASMA SCIENTIFIC, INC. 1985 - 1992
Skills
Blood Bank, Medical Technology, Chemistry, Medical Devices, Microsoft Office, Quality Assurance, Product Support, Laboratory, Complaint Handling, Technical Services, Salesforce.com, Troubleshooting..., CAPA, SOP development, Microsoft Excel, Microsoft Word, Assay Development, Clinical Chemistry, Validation, Quality System, V&V, Clinical Research, FDA, Chromatography, ISO 13485, ELISA, Laboratory Medicine, Hematology, Quality Control, HPLC, Commercialization, GMP, Biotechnology, Testing, Lifesciences, DNA, Hardware Diagnostics, Complaint Management, Sop, Design Control, GLP, Microbiology, R&D, Analytical Chemistry, Infectious Diseases, Life Sciences, Immunology, SOP
Education
BS, MT (ASCP)
Bachelor of Science (BS), Clinical Laboratory Science/Medical Technology/Technologist
University of Massachusetts Lowell
BS, Medical Technology
Frank Fazio Frank Fazio's GENE-TRAK Systems Experience 1988 - 1991
Job Deputy Director Manufacturing and Facilities at MassBiologics
Industry Biotechnology
Experience
MassBiologics January 2010 - Present
Formatech Inc September 2004 - January 2010
RenalPlant Corporation 2000 - 2004
Becton Dickinson 1997 - 2000
Strato / Infusaid 1993 - 1997
Boston Scientific Corp 1991 - 1993
Gene-Trak Systems 1988 - 1991
Education
University of Massachusetts at Lowell 1997 — 2000
MS, Work Environment
Anna Maria College 1989 — 1991
MBA, Operations
Framingham State University 1984 — 1988
BS, Biology
MassBiologics January 2010 - Present
Formatech Inc September 2004 - January 2010
RenalPlant Corporation 2000 - 2004
Becton Dickinson 1997 - 2000
Strato / Infusaid 1993 - 1997
Boston Scientific Corp 1991 - 1993
Gene-Trak Systems 1988 - 1991
Education
University of Massachusetts at Lowell 1997 — 2000
MS, Work Environment
Anna Maria College 1989 — 1991
MBA, Operations
Framingham State University 1984 — 1988
BS, Biology
Debra Dobbins Debra Dobbins's GENE-TRAK Systems Experience 1991 - 1993
Job Sr. Director Global Quality Audit at Sanofi
Industry Pharmaceuticals
Experience
Sanofi January 2012 - Present
Genzyme Corporation June 2010 - January 2012
Novartis Vaccines & Diagnostics September 2006 - May 2010
Biogen Idec December 2001 - September 2006
Biopure Corporation December 1997 - December 2001
Genzyme Corporation 1993 - 1997
Gene Trak Systems 1991 - 1993
Skills
GMP, Validation, GxP, CAPA, FDA, Quality Assurance, Regulatory Affairs, Biopharmaceuticals, Quality Auditing, Quality Control, Biotechnology, Sop, Change Control, Vaccines, Regulatory Requirements, GLP, SOP
Education
Boston College - Wallace E. Carroll Graduate School of Management 1997 — 2001
MBA, Operations/Strategic Mgmt
Regis College 1975 — 1979
BA, Molecular Biology
Sanofi January 2012 - Present
Genzyme Corporation June 2010 - January 2012
Novartis Vaccines & Diagnostics September 2006 - May 2010
Biogen Idec December 2001 - September 2006
Biopure Corporation December 1997 - December 2001
Genzyme Corporation 1993 - 1997
Gene Trak Systems 1991 - 1993
Skills
GMP, Validation, GxP, CAPA, FDA, Quality Assurance, Regulatory Affairs, Biopharmaceuticals, Quality Auditing, Quality Control, Biotechnology, Sop, Change Control, Vaccines, Regulatory Requirements, GLP, SOP
Education
Boston College - Wallace E. Carroll Graduate School of Management 1997 — 2001
MBA, Operations/Strategic Mgmt
Regis College 1975 — 1979
BA, Molecular Biology
Drew O'Brien's GENE-TRAK Systems Experience May 1992 - 1995
Job
Industry Biotechnology
Experience
Merrimack Pharmaceuticals January 2005 - Present
Amgen 2000 - 2005
Genzyme Corporation 1995 - 2000
Gene Trak Systems May 1992 - 1995
Skills
Biotechnology, GMP, Biopharmaceuticals, LIMS, Validation, FDA, CAPA, Sop, GLP, Pharmaceutical Industry, Lifesciences, Technology Transfer, HPLC, Monoclonal Antibodies, Aseptic Technique, GxP, Quality Control, Regulatory Affairs, Chromatography, Aseptic Processing, Analytical Chemistry, ELISA, Life Sciences, SOP
Education
University of Strathclyde 2010 — 2013
MSc
University of Massachusetts, Amherst 1988 — 1992
BS
Merrimack Pharmaceuticals January 2005 - Present
Amgen 2000 - 2005
Genzyme Corporation 1995 - 2000
Gene Trak Systems May 1992 - 1995
Skills
Biotechnology, GMP, Biopharmaceuticals, LIMS, Validation, FDA, CAPA, Sop, GLP, Pharmaceutical Industry, Lifesciences, Technology Transfer, HPLC, Monoclonal Antibodies, Aseptic Technique, GxP, Quality Control, Regulatory Affairs, Chromatography, Aseptic Processing, Analytical Chemistry, ELISA, Life Sciences, SOP
Education
University of Strathclyde 2010 — 2013
MSc
University of Massachusetts, Amherst 1988 — 1992
BS
Theresa Bonn's GENE-TRAK Systems Experience 1990 - 1995
Job QS Engineer Principal at Genzyme
Industry Biotechnology
Experience
Genzyme August 2014 - Present
Genzyme Biosurgery February 2009 - July 2014
Genzyme 1996 - February 2009
Genetrak 1990 - 1995
Gene-Trak Systems 1990 - 1995
Gene-Trak 1990 - 1995
Skills
Biotechnology, Validation, GMP, Manufacturing, Sop, FDA, Quality Control, Change Control, Cross-functional Team..., Leadership, Risk Management, Aseptic Processing
Education
Hobart and William Smith Colleges 1982 — 1986
Genzyme August 2014 - Present
Genzyme Biosurgery February 2009 - July 2014
Genzyme 1996 - February 2009
Genetrak 1990 - 1995
Gene-Trak Systems 1990 - 1995
Gene-Trak 1990 - 1995
Skills
Biotechnology, Validation, GMP, Manufacturing, Sop, FDA, Quality Control, Change Control, Cross-functional Team..., Leadership, Risk Management, Aseptic Processing
Education
Hobart and William Smith Colleges 1982 — 1986
Todd Savage's GENE-TRAK Systems Experience February 1993 - May 1995
Job BIOVIA Sr. Technical Support Engineer at Dassault Systèmes
Industry Biotechnology
Experience
Dassault Systèmes May 2014 - Present
Accelrys August 2013 - May 2014
Sanofi September 2012 - August 2013
Genzyme September 2008 - November 2012
AstraZeneca Pharmaceuticals May 2000 - September 2008
AstraZeneca Pharmaceuticals March 1996 - May 2000
Ciba Corning Diagnostics May 1995 - March 1996
Gene Trak Systems February 1993 - May 1995
Binax January 1989 - March 1993
Skills
Microsoft SQL Server, SQL, Databases, JavaScript, Java, Project Management, IT Service Management, Integration, System Administration, Windows Server, HTML, Citrix, EdgeSight, ITIL, GMP, Visual Basic, Bioinformatics, Drug Development
Education
Brandeis University 2004 — 2010
Masters of Science, Bioinformatics
Worcester Polytechnic Institute 2000 — 2000
Certificate, Web Development
Clark University 1996 — 1999
Business Administration
Worcester Polytechnic Institute 1993 — 1994
Business Administration
University of Southern Maine 1990 — 1993
Immunology
University of Maine 1983 — 1987
B.S., Biology and Marine Sciences
Kennebunk High School 1979 — 1983
Dassault Systèmes May 2014 - Present
Accelrys August 2013 - May 2014
Sanofi September 2012 - August 2013
Genzyme September 2008 - November 2012
AstraZeneca Pharmaceuticals May 2000 - September 2008
AstraZeneca Pharmaceuticals March 1996 - May 2000
Ciba Corning Diagnostics May 1995 - March 1996
Gene Trak Systems February 1993 - May 1995
Binax January 1989 - March 1993
Skills
Microsoft SQL Server, SQL, Databases, JavaScript, Java, Project Management, IT Service Management, Integration, System Administration, Windows Server, HTML, Citrix, EdgeSight, ITIL, GMP, Visual Basic, Bioinformatics, Drug Development
Education
Brandeis University 2004 — 2010
Masters of Science, Bioinformatics
Worcester Polytechnic Institute 2000 — 2000
Certificate, Web Development
Clark University 1996 — 1999
Business Administration
Worcester Polytechnic Institute 1993 — 1994
Business Administration
University of Southern Maine 1990 — 1993
Immunology
University of Maine 1983 — 1987
B.S., Biology and Marine Sciences
Kennebunk High School 1979 — 1983
Massimo (Max) Lombardo's GENE-TRAK Systems Experience 1988 - 1992
Job EH&S Manager at PerkinElmer, Inc.
Industry Biotechnology
Experience
PerkinElmer 2014 - Present
AstraZeneca 2011 - 2013
Johnson Matthey Pharma Services 2008 - 2010
Safety Partners, Inc. 2004 - 2008
Omega PharmServices, Inc. 2000 - 2003
Hybridon Inc. 1997 - 2000
Hybridon, Inc. 1996 - 1997
ATC Diagnostics, Inc. 1993 - 1996
GENE-TRAK Systems 1988 - 1992
GENE-TRAK Systems 1984 - 1988
Skills
Hazardous Waste..., Environmental..., Environmental Awareness, Policy, EPA, Emergency Management, Root Cause Analysis, Radiation Safety, Biosafety, Chemical Safety, FDA, GMP, Laboratory, EHS, Occupational Health, Lifesciences, Risk Assessment, Chemistry, Quality Control, Analytical Chemistry, Validation, CAPA, Biotechnology, Quality System, Sop, Pharmaceutical Industry, HPLC, Regulatory Affairs, Quality Auditing, Technology Transfer, R&D, LIMS, Regulatory Requirements, Drug Discovery, Biopharmaceuticals, Chromatography, GLP, Change Control, Microbiology, 21 CFR Part 11, V&V, Gas Chromatography, Environmental Monitoring, Drug Development, LC-MS, Purification, Phase I, GxP, Process Simulation, Computer System...
Education
Framingham State University 1979 — 1984
Bachelor of Science
Bentley University 1994 — 1995
Certificate
PerkinElmer 2014 - Present
AstraZeneca 2011 - 2013
Johnson Matthey Pharma Services 2008 - 2010
Safety Partners, Inc. 2004 - 2008
Omega PharmServices, Inc. 2000 - 2003
Hybridon Inc. 1997 - 2000
Hybridon, Inc. 1996 - 1997
ATC Diagnostics, Inc. 1993 - 1996
GENE-TRAK Systems 1988 - 1992
GENE-TRAK Systems 1984 - 1988
Skills
Hazardous Waste..., Environmental..., Environmental Awareness, Policy, EPA, Emergency Management, Root Cause Analysis, Radiation Safety, Biosafety, Chemical Safety, FDA, GMP, Laboratory, EHS, Occupational Health, Lifesciences, Risk Assessment, Chemistry, Quality Control, Analytical Chemistry, Validation, CAPA, Biotechnology, Quality System, Sop, Pharmaceutical Industry, HPLC, Regulatory Affairs, Quality Auditing, Technology Transfer, R&D, LIMS, Regulatory Requirements, Drug Discovery, Biopharmaceuticals, Chromatography, GLP, Change Control, Microbiology, 21 CFR Part 11, V&V, Gas Chromatography, Environmental Monitoring, Drug Development, LC-MS, Purification, Phase I, GxP, Process Simulation, Computer System...
Education
Framingham State University 1979 — 1984
Bachelor of Science
Bentley University 1994 — 1995
Certificate
Tom Shimei's GENE-TRAK Systems Experience 1989 - 1995
Job Director Engineering and Product Support at Hologic (Formerly GenProbe)
Industry Medical Devices
Experience
Hologic (Formerly Gen-Probe) 2012 - Present
Gen Probe 2006 - 2012
Gen-Probe 1996 - 2006
Gene-Trak Systems 1989 - 1995
Skills
Engineering, FDA, Medical Devices, ISO 13485, Validation, Design Control, Biotechnology, GMP, CAPA, R&D, Quality System, Hardware Diagnostics, V&V, Lifesciences, Commercialization
Education
University of Michigan
MS Bioengineering
Michigan State University
BS Biochemistry
Hologic (Formerly Gen-Probe) 2012 - Present
Gen Probe 2006 - 2012
Gen-Probe 1996 - 2006
Gene-Trak Systems 1989 - 1995
Skills
Engineering, FDA, Medical Devices, ISO 13485, Validation, Design Control, Biotechnology, GMP, CAPA, R&D, Quality System, Hardware Diagnostics, V&V, Lifesciences, Commercialization
Education
University of Michigan
MS Bioengineering
Michigan State University
BS Biochemistry
Gary Breton's GENE-TRAK Systems Experience 1993 - 1995
Job Clinical Affairs at Boston Heart Diagnostics
Industry Biotechnology
Experience
Boston Heart Diagnostics 2013 - Present
Interleukin Genetics 2009 - 2013
Interleukin Genetics 2004 - 2009
Genome Therapeutics Corp 1995 - 2004
Gene Trak Systems 1993 - 1995
Skills
Genomics, Genetics, DNA sequencing, Molecular Biology, Sequencing, Biotechnology, PCR, DNA, Lifesciences, Cell Culture, Drug Discovery, Immunology, Biochemistry, Technology Transfer, Assay Development, Immunoassays, Marketing, Business Development, Operations Management, Project Management, Alliance Management, CLIA, Genotyping, qPCR, Personalized Medicine, Microarrays, Infectious Diseases, Diagnostics, Clinical, Process Development, Data Analysis, Life Sciences, Validation, RNA isolation, Laboratory Automation, Laboratory, Bioinformatics, Human Genetics, Molecular Diagnostics
Education
Syracuse University
Bachelor of Science (BS), Molecular Biology
Boston Heart Diagnostics 2013 - Present
Interleukin Genetics 2009 - 2013
Interleukin Genetics 2004 - 2009
Genome Therapeutics Corp 1995 - 2004
Gene Trak Systems 1993 - 1995
Skills
Genomics, Genetics, DNA sequencing, Molecular Biology, Sequencing, Biotechnology, PCR, DNA, Lifesciences, Cell Culture, Drug Discovery, Immunology, Biochemistry, Technology Transfer, Assay Development, Immunoassays, Marketing, Business Development, Operations Management, Project Management, Alliance Management, CLIA, Genotyping, qPCR, Personalized Medicine, Microarrays, Infectious Diseases, Diagnostics, Clinical, Process Development, Data Analysis, Life Sciences, Validation, RNA isolation, Laboratory Automation, Laboratory, Bioinformatics, Human Genetics, Molecular Diagnostics
Education
Syracuse University
Bachelor of Science (BS), Molecular Biology
Vicki Anastasi's GENE-TRAK Systems Experience 1993 - 1995
Job Global Head, Medical Device & Diagnostics Research at ICON plc
Industry Medical Devices
Experience
ICON plc October 2014 - Present
Aptiv Solutions September 2007 - October 2014
MDCI, an Aptiv Solutions company September 2007 - January 2012
TissueLink Medical February 2000 - September 2007
TissueLink 2000 - 2007
Salient Surgical Technologies (TissueLink) 2000 - 2007
Gene-Trak 1993 - 1995
Gene-Trak Systems 1993 - 1995
Gene-Trak Systems (An Amoco Company) 1993 - 1995
bioMerieux July 1989 - September 1994
Skills
Clinical Trials, Regulatory Affairs, Pharmaceutical Industry, FDA, Biotechnology, Life Sciences, Cross-functional Team..., Clinical Development, Product Launch
Education
University of Connecticut 1979 — 1983
BS, Chemistry and Biochemistry
ICON plc October 2014 - Present
Aptiv Solutions September 2007 - October 2014
MDCI, an Aptiv Solutions company September 2007 - January 2012
TissueLink Medical February 2000 - September 2007
TissueLink 2000 - 2007
Salient Surgical Technologies (TissueLink) 2000 - 2007
Gene-Trak 1993 - 1995
Gene-Trak Systems 1993 - 1995
Gene-Trak Systems (An Amoco Company) 1993 - 1995
bioMerieux July 1989 - September 1994
Skills
Clinical Trials, Regulatory Affairs, Pharmaceutical Industry, FDA, Biotechnology, Life Sciences, Cross-functional Team..., Clinical Development, Product Launch
Education
University of Connecticut 1979 — 1983
BS, Chemistry and Biochemistry
William Lichtman's GENE-TRAK Systems Experience 1992 - 1996
Job Associate Director Mfg at Biogen Idec Inc
Industry Biotechnology
Experience
Biogen Idec Inc January 2006 - Present
Genzyme Corporation August 1996 - January 2001
Gene Trak Systems 1992 - 1996
Matritech 1988 - 1992
Skills
Biotechnology, GMP, Technology Transfer, Aseptic Processing, Validation, Lifesciences, FDA, Biopharmaceuticals, Change Control, Chromatography, CAPA, Pharmaceutical Industry
Education
Souther New Hampshire Univeristy 2000 — 2005
Masters in Business Administration
Union College 1981 — 1985
BS/MBA, Biology
Biogen Idec Inc January 2006 - Present
Genzyme Corporation August 1996 - January 2001
Gene Trak Systems 1992 - 1996
Matritech 1988 - 1992
Skills
Biotechnology, GMP, Technology Transfer, Aseptic Processing, Validation, Lifesciences, FDA, Biopharmaceuticals, Change Control, Chromatography, CAPA, Pharmaceutical Industry
Education
Souther New Hampshire Univeristy 2000 — 2005
Masters in Business Administration
Union College 1981 — 1985
BS/MBA, Biology
Bruce Neri's GENE-TRAK Systems Experience 1992 - 1995
Job Retired consultant
Industry Biotechnology
Experience
Consultant August 2014 - Present
Metabolon August 2010 - August 2014
Eveia Medical, Inc. 2009 - August 2010
Prometheus Laboratories 2003 - 2008
Third Wave Technologies 1998 - 2004
Becton Dickinson 1991 - 1996
Gene-Trak Systems 1992 - 1995
Instrumentation Laboratory 1975 - 1980
Abbott Laboratories 1974 - 1980
Medical Laboratories Asscociates 1972 - 1974
Skills
FDA, Diagnostics, Biotechnology, Molecular Biology, Infectious Diseases, Product Development, Clinical, GMP, Intellectual Property, Genomics, PCR, Research, Analysis, R&D, Medical Devices, Hardware Diagnostics, Clinical Research, Lifesciences, Pharmaceutical Industry, Chemistry, Biochemistry, Technology Transfer, Commercialization, GLP, Validation, Drug Development, Assay Development, Protein Chemistry, Clinical Development, Immunology, Drug Discovery, Biopharmaceuticals, Microbiology, Cell, Oncology, Cell Culture, Laboratory Automation, Life Sciences
Education
University of Arizona 1968 — 1972
Ph.D., Analytical Chemistry
Cornell College 1964 — 1968
BA, Chemistry
Consultant August 2014 - Present
Metabolon August 2010 - August 2014
Eveia Medical, Inc. 2009 - August 2010
Prometheus Laboratories 2003 - 2008
Third Wave Technologies 1998 - 2004
Becton Dickinson 1991 - 1996
Gene-Trak Systems 1992 - 1995
Instrumentation Laboratory 1975 - 1980
Abbott Laboratories 1974 - 1980
Medical Laboratories Asscociates 1972 - 1974
Skills
FDA, Diagnostics, Biotechnology, Molecular Biology, Infectious Diseases, Product Development, Clinical, GMP, Intellectual Property, Genomics, PCR, Research, Analysis, R&D, Medical Devices, Hardware Diagnostics, Clinical Research, Lifesciences, Pharmaceutical Industry, Chemistry, Biochemistry, Technology Transfer, Commercialization, GLP, Validation, Drug Development, Assay Development, Protein Chemistry, Clinical Development, Immunology, Drug Discovery, Biopharmaceuticals, Microbiology, Cell, Oncology, Cell Culture, Laboratory Automation, Life Sciences
Education
University of Arizona 1968 — 1972
Ph.D., Analytical Chemistry
Cornell College 1964 — 1968
BA, Chemistry
Ray Nietupski's GENE-TRAK Systems Experience 1987 - 1994
Job Scientist at Thorne Diagnostics
Industry Biotechnology
Experience
Thorne Diagnostics 2002 - Present
Cereon Genomics 1998 - 2002
Genome Therapeutics 1995 - 1998
Gene Trak Systems 1987 - 1994
University of Massachusetts Medical School 1984 - 1987
Skills
PCR, Molecular Biology, DNA, Biotechnology
Education
Western New England College School of Law 1989 — 1993
JD, Law
University of Massachusetts, Amherst 1980 — 1984
BS, Biochemistry
Thorne Diagnostics 2002 - Present
Cereon Genomics 1998 - 2002
Genome Therapeutics 1995 - 1998
Gene Trak Systems 1987 - 1994
University of Massachusetts Medical School 1984 - 1987
Skills
PCR, Molecular Biology, DNA, Biotechnology
Education
Western New England College School of Law 1989 — 1993
JD, Law
University of Massachusetts, Amherst 1980 — 1984
BS, Biochemistry
Susan Garramone's GENE-TRAK Systems Experience 1989 - 2002
Job Manager, Technology Development and Assessment at Magellan Diagnostics, Inc.
Industry Biotechnology
Experience
Magellan Diagnostics, Inc. January 2012 - Present
Magellan Diagnostics, Inc. September 2010 - January 2012
Sisterra Essential Products, Inc 2007 - September 2010
Epic Therapeutics 1992 - 2002
Gene-Trak Systems 1989 - 2002
Integrated Genetics 1985 - 1991
Brandeis University 1983 - 1985
Skills
Biotechnology, Life Sciences, FDA, GMP, Technology Transfer, R&D, Validation, Medical Devices, Immunology, Biopharmaceuticals, Manufacturing, Lifesciences, Program Management, ISO 13485, Business Development, Customer Service, Product Development
Education
Bryant University 2009 — 2010
Executive Development Center, Project Management, Project Management Certification
Framingham State University 1979 — 1983
BS, Biomedical Science
Magellan Diagnostics, Inc. January 2012 - Present
Magellan Diagnostics, Inc. September 2010 - January 2012
Sisterra Essential Products, Inc 2007 - September 2010
Epic Therapeutics 1992 - 2002
Gene-Trak Systems 1989 - 2002
Integrated Genetics 1985 - 1991
Brandeis University 1983 - 1985
Skills
Biotechnology, Life Sciences, FDA, GMP, Technology Transfer, R&D, Validation, Medical Devices, Immunology, Biopharmaceuticals, Manufacturing, Lifesciences, Program Management, ISO 13485, Business Development, Customer Service, Product Development
Education
Bryant University 2009 — 2010
Executive Development Center, Project Management, Project Management Certification
Framingham State University 1979 — 1983
BS, Biomedical Science
Ginny Halfpenny's GENE-TRAK Systems Experience 1991 - 1993
Job
Industry
Experience
Waters Corporation 1997 - Present
Waters Corporation 1997 - Present
Immulogic Pharmacuetical 1993 - 1997
ImmuLogic Pharmaceutical Corporation 1993 - 1997
Gene-Trak Systems 1991 - 1993
Hygeia Sciences 1990 - 1991
Education
Framingham State University 1987 — 1991
Bachelor's of Science, Biology
Waters Corporation 1997 - Present
Waters Corporation 1997 - Present
Immulogic Pharmacuetical 1993 - 1997
ImmuLogic Pharmaceutical Corporation 1993 - 1997
Gene-Trak Systems 1991 - 1993
Hygeia Sciences 1990 - 1991
Education
Framingham State University 1987 — 1991
Bachelor's of Science, Biology
Sheila Warren's GENE-TRAK Systems Experience 1989 - 1990
Job Supervisor, International Filing Department at Hamilton, Brook, Smith & Reynolds, P.C.
Industry Law Practice
Experience
Hamilton, Brook, Smith & Reynolds, P.C. November 2000 - Present
Allmerica Financial 1996 - 2000
Wolf, Greenfield & Sacks 1990 - 1993
Gene-Trak Systems 1989 - 1990
Skills
Client Counseling, Biotechnology, Patentability, Trademarks, Patent Applications, Patent Litigation, Medical Devices, Patents, Licensing, Intellectual Property, Legal Research, Pharmaceutical Industry, Lifesciences, Due Diligence, Legal Writing, Patent Prosecution
Education
Middlesex Community College 1990 — 1991
Certificate, Paralegal Certificate
Elliot Community Hospital School of Nursing
RN, Nursing
Hamilton, Brook, Smith & Reynolds, P.C. November 2000 - Present
Allmerica Financial 1996 - 2000
Wolf, Greenfield & Sacks 1990 - 1993
Gene-Trak Systems 1989 - 1990
Skills
Client Counseling, Biotechnology, Patentability, Trademarks, Patent Applications, Patent Litigation, Medical Devices, Patents, Licensing, Intellectual Property, Legal Research, Pharmaceutical Industry, Lifesciences, Due Diligence, Legal Writing, Patent Prosecution
Education
Middlesex Community College 1990 — 1991
Certificate, Paralegal Certificate
Elliot Community Hospital School of Nursing
RN, Nursing
Paul Geuser's GENE-TRAK Systems Experience 1996 - 2001
Job Consultant
Industry Biotechnology
Experience
QA/QC 2009 - Present
Bionostics 2001 - 2009
GENE-TRAK Systems 1996 - 2001
GENE-TRAK Systems 1992 - 1996
Nestle, Westreco 1991 - 1992
United Technologies, Hamilton Standard division 1990 - 1991
Heublien Incorporated 1989 - 1990
Skills
R&D, Medical Devices, FDA, Quality System, GMP
Education
The University of Montana
B.S., Microbiology, Chemistry
QA/QC 2009 - Present
Bionostics 2001 - 2009
GENE-TRAK Systems 1996 - 2001
GENE-TRAK Systems 1992 - 1996
Nestle, Westreco 1991 - 1992
United Technologies, Hamilton Standard division 1990 - 1991
Heublien Incorporated 1989 - 1990
Skills
R&D, Medical Devices, FDA, Quality System, GMP
Education
The University of Montana
B.S., Microbiology, Chemistry
R. Scott Decker's GENE-TRAK Systems Experience 1986 - 1990
Job Security
Industry Security and Investigations
Experience
Bio-Logic Security, LLC November 2014 - Present
American International Biotechnology, LLC 2012 - 2014
FBI 1990 - 2011
Gene-Trak Systems 1986 - 1990
Skills
Enforcement, Private Investigations, Criminal Investigations, Security Operations, Counterterrorism, Security, Homeland Security, Executive Protection
Education
Harvard Medical School 1983 — 1986
Postdoctoral Fellow, Department of Biological Chemistry
University of Michigan
Doctor of Philosophy (Ph.D.), Human Genetics
University of Rhode Island
Bachelor’s Degree, Zoology
Bio-Logic Security, LLC November 2014 - Present
American International Biotechnology, LLC 2012 - 2014
FBI 1990 - 2011
Gene-Trak Systems 1986 - 1990
Skills
Enforcement, Private Investigations, Criminal Investigations, Security Operations, Counterterrorism, Security, Homeland Security, Executive Protection
Education
Harvard Medical School 1983 — 1986
Postdoctoral Fellow, Department of Biological Chemistry
University of Michigan
Doctor of Philosophy (Ph.D.), Human Genetics
University of Rhode Island
Bachelor’s Degree, Zoology
Deloitte
PwC
Ernst & Young
Walgreens
Procter & Gamble
KPMG
PricewaterhouseCoopers
EY