KMI/Parexel Company
Industry: Company
DescriptionFounded: 1982 Parent organization: PAREXEL
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KMI/Parexel Employees
Employee
Years
Job
Industry
Cheryl Wagoner Cheryl Wagoner's KMI/Parexel Experience June 2002 - May 2003
Job Regulatory, quality, and compliance professional in medical device, pharmaceutical and biologics
Industry Medical Devices
Experience
Wagoner Consulting LLC August 2013 - Present
Baxano Surgical (formerly TranS1) September 2012 - December 2013
Baxano Surgical (formerly TranS1) March 2009 - September 2012
Baxano Surgical (formerly TranS1) June 2003 - February 2009
KMI/Parexel June 2002 - May 2003
Shark Technology 1998 - April 2003
Jeiven Pharmaceutical Consulting 2000 - 2001
AAI 1993 - 1998
Skills
Medical Devices, Quality Systems, Quality Assurance, Life Sciences, Compliance, Regulatory Affairs, Pharmaceuticals, Biologics, Auditing, Due Diligence, Regulatory Reporting, Regulatory Strategy, Regulatory Submissions, CE marking, ISO 13485, ISO 9001, 21 CFR Part 11, cfr 820, project management, Risk Analysis, Pharmaceutical Industry, Lifesciences, Quality System, Project Management, Cardiology, Clinical Trials, Strategy, Iso 9000, GMP, Validation, Change Control, Design Control, Regulatory Requirements, Sop, CAPA, Quality Auditing, Commercialization, Biotechnology, V&V, GCP, Computer System..., Pharmaceutics, Laboratory, CTMS, Microbiology, GxP, Software Documentation, Oncology, PMA, Clinical Research
Education
University of North Carolina at Wilmington 1995 — 1998
Master of Science, Biology
Southeast Missouri State University 1988 — 1992
Bachelor of Science, Biology
Wagoner Consulting LLC August 2013 - Present
Baxano Surgical (formerly TranS1) September 2012 - December 2013
Baxano Surgical (formerly TranS1) March 2009 - September 2012
Baxano Surgical (formerly TranS1) June 2003 - February 2009
KMI/Parexel June 2002 - May 2003
Shark Technology 1998 - April 2003
Jeiven Pharmaceutical Consulting 2000 - 2001
AAI 1993 - 1998
Skills
Medical Devices, Quality Systems, Quality Assurance, Life Sciences, Compliance, Regulatory Affairs, Pharmaceuticals, Biologics, Auditing, Due Diligence, Regulatory Reporting, Regulatory Strategy, Regulatory Submissions, CE marking, ISO 13485, ISO 9001, 21 CFR Part 11, cfr 820, project management, Risk Analysis, Pharmaceutical Industry, Lifesciences, Quality System, Project Management, Cardiology, Clinical Trials, Strategy, Iso 9000, GMP, Validation, Change Control, Design Control, Regulatory Requirements, Sop, CAPA, Quality Auditing, Commercialization, Biotechnology, V&V, GCP, Computer System..., Pharmaceutics, Laboratory, CTMS, Microbiology, GxP, Software Documentation, Oncology, PMA, Clinical Research
Education
University of North Carolina at Wilmington 1995 — 1998
Master of Science, Biology
Southeast Missouri State University 1988 — 1992
Bachelor of Science, Biology
Deena Venezia Deena Venezia's KMI/Parexel Experience 2001 - 2004
Job President at Venezia SRQ LLC
Industry Pharmaceuticals
Experience
Venezia SRQ LLC January 2007 - Present
Andrx Pharmaceuticals/Watson 2006 - 2007
Andrx Pharmaceuticals 2004 - 2006
KMI/PAREXEL 2001 - 2004
Hoffmann-La Roche 2000 - 2001
Hoffmann-La Roche 1999 - 2000
Hoffmann-La Roche 1996 - 1998
Hoffmann-La Roche 1995 - 1996
Hoffmann-La Roche 1992 - 1995
Schering Plough 1990 - 1992
Skills
GMP, CAPA, FDA, Validation, 21 CFR Part 11, Change Control, Pharmaceutical Industry, V&V, Sop, Regulatory Affairs, Quality System, Technology Transfer, GxP, Biotechnology, Medical Devices, Clinical Trials, Document Management, Quality Control, Biopharmaceuticals, Pharmaceutics, Lifesciences, CRO, Computer System..., Process Improvement, Quality Auditing, Quality Assurance, LIMS, GLP, Software Documentation, Drug Development, Cleaning Validation, Aseptic Processing, Regulatory Submissions, Cross-functional Team..., HPLC, Chromatography, Analytical Chemistry, Regulatory Requirements, Vaccines, GCP, ISO 13485, R&D, Commercialization, Microbiology, Contract Manufacturing, CTMS, Design Control, Manufacturing, Clinical Development, Oncology
Education
Upsala College 1978 — 1982
B.S., Biochemistry
Fairleigh Dickinson University
MBA, Pharmaceutical Chemical Studies
Venezia SRQ LLC January 2007 - Present
Andrx Pharmaceuticals/Watson 2006 - 2007
Andrx Pharmaceuticals 2004 - 2006
KMI/PAREXEL 2001 - 2004
Hoffmann-La Roche 2000 - 2001
Hoffmann-La Roche 1999 - 2000
Hoffmann-La Roche 1996 - 1998
Hoffmann-La Roche 1995 - 1996
Hoffmann-La Roche 1992 - 1995
Schering Plough 1990 - 1992
Skills
GMP, CAPA, FDA, Validation, 21 CFR Part 11, Change Control, Pharmaceutical Industry, V&V, Sop, Regulatory Affairs, Quality System, Technology Transfer, GxP, Biotechnology, Medical Devices, Clinical Trials, Document Management, Quality Control, Biopharmaceuticals, Pharmaceutics, Lifesciences, CRO, Computer System..., Process Improvement, Quality Auditing, Quality Assurance, LIMS, GLP, Software Documentation, Drug Development, Cleaning Validation, Aseptic Processing, Regulatory Submissions, Cross-functional Team..., HPLC, Chromatography, Analytical Chemistry, Regulatory Requirements, Vaccines, GCP, ISO 13485, R&D, Commercialization, Microbiology, Contract Manufacturing, CTMS, Design Control, Manufacturing, Clinical Development, Oncology
Education
Upsala College 1978 — 1982
B.S., Biochemistry
Fairleigh Dickinson University
MBA, Pharmaceutical Chemical Studies
Anil Mathai Anil Mathai's KMI/Parexel Experience July 1997 - April 1999
Job Director Quality Assurance & Regulatory Affairs at Solix BioSystems, Inc.
Industry Pharmaceuticals
Experience
Solix BioSystems, Inc. March 2014 - Present
Bonfils Blood Center November 2010 - October 2013
Merck (Schering Plough) April 2003 - September 2010
Schering Plough Corporation April 2001 - April 2003
Centocor (Johnson & Johnson) April 1999 - April 2001
KMI/PAREXEL July 1997 - April 1999
Skills
Validation, Regulatory Affairs, Strategic Planning, Leadership, Management, FDA, CAPA, GMP, Pharmaceutical Industry, Change Control
Education
Pennsylvania State University-Great Valley Graduate Center 1999 — 2000
MBA, Marketing, International Business
Drexel University 1992 — 1997
BSChE, Chemical Engineering
Alliance Theological Seminary (Nyack College) 2001 — 2009
MDiv, Bible and Theology
Leadership Program of the Rockies 2012 — 2013
Centurions Program (Prison Fellowship) 2011 — 2012
Solix BioSystems, Inc. March 2014 - Present
Bonfils Blood Center November 2010 - October 2013
Merck (Schering Plough) April 2003 - September 2010
Schering Plough Corporation April 2001 - April 2003
Centocor (Johnson & Johnson) April 1999 - April 2001
KMI/PAREXEL July 1997 - April 1999
Skills
Validation, Regulatory Affairs, Strategic Planning, Leadership, Management, FDA, CAPA, GMP, Pharmaceutical Industry, Change Control
Education
Pennsylvania State University-Great Valley Graduate Center 1999 — 2000
MBA, Marketing, International Business
Drexel University 1992 — 1997
BSChE, Chemical Engineering
Alliance Theological Seminary (Nyack College) 2001 — 2009
MDiv, Bible and Theology
Leadership Program of the Rockies 2012 — 2013
Centurions Program (Prison Fellowship) 2011 — 2012
Lisa Ziino-Mobilia Lisa Ziino-Mobilia's KMI/Parexel Experience January 1999 - January 2000
Job State Street Global Advisors | Administration Assistant, Senior Associate
Industry Financial Services
Experience
State Street Global Advisors January 2014 - Present
Symmetric Capital January 2012 - September 2013
Putnam Investments January 2001 - January 2012
Flagship Ventures January 2000 - January 2001
KMI/PAREXEL January 1999 - January 2000
Dragon Systems Inc January 1998 - January 1999
Putnam Investments January 1997 - January 1998
Greater Boston Manufacturing Partnership, Inc January 1995 - January 1997
Wellesley Group Inc January 1985 - January 1995
Skills
Lotus Notes, Travel Arrangements, Invoicing, Human Resources, Calendars, Spreadsheets, Payroll, PowerPoint, Management, Process Scheduler, Finance, Accounting, Marketing, Training, Employee Benefits
Education
Massachusetts Bay Community College
Associates Degree, General Business
State Street Global Advisors January 2014 - Present
Symmetric Capital January 2012 - September 2013
Putnam Investments January 2001 - January 2012
Flagship Ventures January 2000 - January 2001
KMI/PAREXEL January 1999 - January 2000
Dragon Systems Inc January 1998 - January 1999
Putnam Investments January 1997 - January 1998
Greater Boston Manufacturing Partnership, Inc January 1995 - January 1997
Wellesley Group Inc January 1985 - January 1995
Skills
Lotus Notes, Travel Arrangements, Invoicing, Human Resources, Calendars, Spreadsheets, Payroll, PowerPoint, Management, Process Scheduler, Finance, Accounting, Marketing, Training, Employee Benefits
Education
Massachusetts Bay Community College
Associates Degree, General Business
Jessica Veitch Jessica Veitch's KMI/Parexel Experience July 1998 - December 1999
Job Financial Advisor
Industry Financial Services
Experience
Northwestern Mutual May 2013 - Present
Amgen January 2000 - May 2013
KMI/Parexel July 1998 - December 1999
Education
University of Colorado Boulder 1993 — 1998
B.S., Chemical Engineering
University of Colorado at Boulder - College of Engineering and Applied Science 1993 — 1998
Bachelor's of Science in Chemical Engineering, Biotechnology & Pre-med
Northwestern Mutual May 2013 - Present
Amgen January 2000 - May 2013
KMI/Parexel July 1998 - December 1999
Education
University of Colorado Boulder 1993 — 1998
B.S., Chemical Engineering
University of Colorado at Boulder - College of Engineering and Applied Science 1993 — 1998
Bachelor's of Science in Chemical Engineering, Biotechnology & Pre-med
Danylo Mykula Danylo Mykula's KMI/Parexel Experience June 1997 - October 1998
Job Director of Professional Services, ITOM Services at ServiceNow – The Enterprise Cloud Company
Industry Information Technology and Services
Experience
ServiceNow – The Enterprise Cloud Company September 2015 - Present
Bromium January 2015 - August 2015
Bromium October 2013 - December 2014
Verdasys July 2012 - September 2013
Verdasys May 2008 - July 2012
Schering-Plough July 2004 - May 2008
NuGenesis Technologies July 1999 - July 2004
KMI\Parexel June 1997 - October 1998
Skills
Enterprise Software, CRM, Validation, Software, Project Management, Product Management, Program Management, Business Development, Change Management, Process Improvement, Team Leadership, Strategic Planning, Quality Assurance, Leadership, Software Project..., Security, Management, SaaS, Cross-functional Team..., Strategy, Testing, IT Management, Risk Management, Integration, Networking, Cloud Computing, IT Strategy, Start-ups, SDLC, Vendor Management, Software Development, Information Technology, Pre-sales, Enterprise Architecture, ITIL, Managed Services, Professional Services
Education
Stevens Institute of Technology 2005 — 2007
MS, Technology Management
University of Massachusetts, Amherst 1992 — 1997
BS, Chemical Engineering
HS 1988 — 1992
ServiceNow – The Enterprise Cloud Company September 2015 - Present
Bromium January 2015 - August 2015
Bromium October 2013 - December 2014
Verdasys July 2012 - September 2013
Verdasys May 2008 - July 2012
Schering-Plough July 2004 - May 2008
NuGenesis Technologies July 1999 - July 2004
KMI\Parexel June 1997 - October 1998
Skills
Enterprise Software, CRM, Validation, Software, Project Management, Product Management, Program Management, Business Development, Change Management, Process Improvement, Team Leadership, Strategic Planning, Quality Assurance, Leadership, Software Project..., Security, Management, SaaS, Cross-functional Team..., Strategy, Testing, IT Management, Risk Management, Integration, Networking, Cloud Computing, IT Strategy, Start-ups, SDLC, Vendor Management, Software Development, Information Technology, Pre-sales, Enterprise Architecture, ITIL, Managed Services, Professional Services
Education
Stevens Institute of Technology 2005 — 2007
MS, Technology Management
University of Massachusetts, Amherst 1992 — 1997
BS, Chemical Engineering
HS 1988 — 1992
Stephen Audretch's KMI/Parexel Experience 2001 - 2003
Job Project Manager at Aegis Analytical
Industry Information Technology and Services
Experience
Aegis Analytical 2011 - Present
Eli Lilly and Company 2009 - 2010
Eli Lilly and Company 2007 - 2009
Eli Lilly and Company 2006 - 2007
Eli Lilly and Company 2004 - 2006
Computer Task Group 2003 - 2004
KMI/Parexel 2001 - 2003
Cummins 2000 - 2001
Education
University of Notre Dame 2010 — 2011
MBA, Leadership, strategy, marketing, and finance
University of Notre Dame 1997 — 2001
Bachelor of Science, Science-Computing
Aegis Analytical 2011 - Present
Eli Lilly and Company 2009 - 2010
Eli Lilly and Company 2007 - 2009
Eli Lilly and Company 2006 - 2007
Eli Lilly and Company 2004 - 2006
Computer Task Group 2003 - 2004
KMI/Parexel 2001 - 2003
Cummins 2000 - 2001
Education
University of Notre Dame 2010 — 2011
MBA, Leadership, strategy, marketing, and finance
University of Notre Dame 1997 — 2001
Bachelor of Science, Science-Computing
Michael Kreuze's KMI/Parexel Experience September 1997 - November 2000
Job Principal Engineer at Pfizer
Industry Biotechnology
Experience
Pfizer August 2015 - Present
Pfizer (formerly Wyeth and Genetics Institute) November 2000 - Present
Board of Health - Town of Acton, MA August 2009 - Present
KMI/Parexel September 1997 - November 2000
Tracer Technologies September 1994 - June 1997
Aphios June 1993 - September 1994
Medtronic June 1992 - September 1992
Skills
GMP, Validation, V&V, Change Control, CAPA, FDA, Technology Transfer, Computer System..., Biopharmaceuticals, Sop, 21 CFR Part 11, FMEA, Six Sigma, Aseptic Processing, Quality System, GAMP, Biotechnology, Process Simulation, GLP, ISO 13485, Cleaning Validation, Pharmaceutical Industry, SOP
Education
Tufts University 2014 — 2017
Master of Science (MS), Biotechnology Engineering
Massachusetts Institute of Technology 1989 — 1993
Bachelor of Science (B.S.), Chemical Engineering
Pfizer August 2015 - Present
Pfizer (formerly Wyeth and Genetics Institute) November 2000 - Present
Board of Health - Town of Acton, MA August 2009 - Present
KMI/Parexel September 1997 - November 2000
Tracer Technologies September 1994 - June 1997
Aphios June 1993 - September 1994
Medtronic June 1992 - September 1992
Skills
GMP, Validation, V&V, Change Control, CAPA, FDA, Technology Transfer, Computer System..., Biopharmaceuticals, Sop, 21 CFR Part 11, FMEA, Six Sigma, Aseptic Processing, Quality System, GAMP, Biotechnology, Process Simulation, GLP, ISO 13485, Cleaning Validation, Pharmaceutical Industry, SOP
Education
Tufts University 2014 — 2017
Master of Science (MS), Biotechnology Engineering
Massachusetts Institute of Technology 1989 — 1993
Bachelor of Science (B.S.), Chemical Engineering
Aleta O'Brien's KMI/Parexel Experience March 1996 - March 1998
Job Principal Quality Engineer at Genzyme
Industry Pharmaceuticals
Experience
Genzyme May 2011 - Present
ValSource, LLC August 1999 - May 2011
Genetics Institute/Wyeth August 1998 - August 1999
KMI/Parexel March 1996 - March 1998
Skills
Quality Assurance, Validation, Change Control, Sop, V&V, Quality Control, Cross-functional Team...
Education
Western New England University 2000 — 2002
Masters, Business Adminstration
Bentley University 1999 — 1999
Certificate, Project Management
University of Massachusetts, Amherst 1989 — 1995
BS, Chemical Engineering, Minor Chemistry
Genzyme May 2011 - Present
ValSource, LLC August 1999 - May 2011
Genetics Institute/Wyeth August 1998 - August 1999
KMI/Parexel March 1996 - March 1998
Skills
Quality Assurance, Validation, Change Control, Sop, V&V, Quality Control, Cross-functional Team...
Education
Western New England University 2000 — 2002
Masters, Business Adminstration
Bentley University 1999 — 1999
Certificate, Project Management
University of Massachusetts, Amherst 1989 — 1995
BS, Chemical Engineering, Minor Chemistry
Keely Landon's KMI/Parexel Experience 2003 - 2003
Job Senior Manager Microbiology at Pacira Pharmaceuticals, Inc.
Industry Biotechnology
Experience
Pacira Pharmaceuticals, Inc. January 2013 - Present
Althea Technologies August 2008 - January 2013
BB Consulting Services February 2008 - August 2008
Althea Technologies 2008 - 2008
Genentech 2005 - 2007
Cell Genesys 2003 - 2005
KMI/Parexel 2003 - 2003
Alliance Pharmaceuticals 1996 - 2002
Skills
Validation, Microbiology, Quality Control, Pharmaceutical Industry, Laboratory, Sterilization
Education
San Diego State University-California State University 1990 — 1992
BS, Microbiology
Pacira Pharmaceuticals, Inc. January 2013 - Present
Althea Technologies August 2008 - January 2013
BB Consulting Services February 2008 - August 2008
Althea Technologies 2008 - 2008
Genentech 2005 - 2007
Cell Genesys 2003 - 2005
KMI/Parexel 2003 - 2003
Alliance Pharmaceuticals 1996 - 2002
Skills
Validation, Microbiology, Quality Control, Pharmaceutical Industry, Laboratory, Sterilization
Education
San Diego State University-California State University 1990 — 1992
BS, Microbiology
David Crockford's KMI/Parexel Experience June 1992 - September 2004
Job Independent Consultant/Software Quality Engineer at Philips Healthcare
Industry Medical Devices
Experience
Philips Healthcare July 2011 - January 2013
Boston Scientific December 2009 - June 2011
Cubist Pharmaceutical March 2009 - December 2009
Biometrix October 2005 - September 2008
KMI/PAREXEL June 1992 - September 2004
National Technical Systems May 1984 - September 1991
Education
University of Massachusetts Lowell 1984 — 1986
Certificate, Computer Science
University of Massachusetts, Amherst 1978 — 1984
BS, Mechanical Engineering
Philips Healthcare July 2011 - January 2013
Boston Scientific December 2009 - June 2011
Cubist Pharmaceutical March 2009 - December 2009
Biometrix October 2005 - September 2008
KMI/PAREXEL June 1992 - September 2004
National Technical Systems May 1984 - September 1991
Education
University of Massachusetts Lowell 1984 — 1986
Certificate, Computer Science
University of Massachusetts, Amherst 1978 — 1984
BS, Mechanical Engineering
Alison Higgins's KMI/Parexel Experience July 1996 - September 1999
Job Independent Quality Assurance Consultant
Industry Pharmaceuticals
Experience
Independent May 2014 - Present
AMAG Pharmaceuticals February 2013 - April 2014
ImmunoGen, Inc. April 2012 - February 2013
Genzyme September 2011 - April 2012
ImmunoGen, Inc. July 2009 - September 2011
Biopure September 2002 - August 2003
Millipore September 1999 - September 2002
KMI/PAREXEL July 1996 - September 1999
Skills
Validation, GMP, CAPA, 21 CFR Part 11, Change Control, SOP, Quality Assurance, Pharmaceutical Industry, Biotechnology, Internal Audit, External Audit, Deviation Management, CMOS, Vendor Management
Education
Trinity College Dublin 1990 — 1994
Engineering
Independent May 2014 - Present
AMAG Pharmaceuticals February 2013 - April 2014
ImmunoGen, Inc. April 2012 - February 2013
Genzyme September 2011 - April 2012
ImmunoGen, Inc. July 2009 - September 2011
Biopure September 2002 - August 2003
Millipore September 1999 - September 2002
KMI/PAREXEL July 1996 - September 1999
Skills
Validation, GMP, CAPA, 21 CFR Part 11, Change Control, SOP, Quality Assurance, Pharmaceutical Industry, Biotechnology, Internal Audit, External Audit, Deviation Management, CMOS, Vendor Management
Education
Trinity College Dublin 1990 — 1994
Engineering
Armond Lopez's KMI/Parexel Experience May 2000 - May 2003
Job Computer Systems Validation QA Lead at McNeil Consumer Healthcare
Industry Pharmaceuticals
Experience
McNeil Consumer Healthcare (Contractor) August 2012 - Present
Pfizer May 2010 - June 2012
Pfizer (formally Wyeth) May 2010 - June 2012
Pfizer (formally Wyeth) January 2008 - May 2010
Pfizer (formally Wyeth) January 2005 - January 2008
Pfizer (formally Wyeth) May 2003 - January 2005
KMI/PAREXEL May 2000 - May 2003
Validation Technologies January 1998 - May 2000
Wyeth-Ayerst Laboratories January 1997 - January 1998
Ford Electronics February 1983 - January 1997
Skills
GxP, CAPA, GMP, GAMP, Pharmaceutical Industry, Change Control, Computer System..., 21 CFR Part 11, Validation, FDA, V&V, Sop, Quality Assurance, Testing, Quality Control, Regulatory Requirements, LIMS, Technology Transfer, GLP, Software Documentation, Document Management, Regulatory Affairs, Biopharmaceuticals, SOP
Education
Drexel University
Bachelor of Science, Chemical Engineering
Lansdale Catholic High School
McNeil Consumer Healthcare (Contractor) August 2012 - Present
Pfizer May 2010 - June 2012
Pfizer (formally Wyeth) May 2010 - June 2012
Pfizer (formally Wyeth) January 2008 - May 2010
Pfizer (formally Wyeth) January 2005 - January 2008
Pfizer (formally Wyeth) May 2003 - January 2005
KMI/PAREXEL May 2000 - May 2003
Validation Technologies January 1998 - May 2000
Wyeth-Ayerst Laboratories January 1997 - January 1998
Ford Electronics February 1983 - January 1997
Skills
GxP, CAPA, GMP, GAMP, Pharmaceutical Industry, Change Control, Computer System..., 21 CFR Part 11, Validation, FDA, V&V, Sop, Quality Assurance, Testing, Quality Control, Regulatory Requirements, LIMS, Technology Transfer, GLP, Software Documentation, Document Management, Regulatory Affairs, Biopharmaceuticals, SOP
Education
Drexel University
Bachelor of Science, Chemical Engineering
Lansdale Catholic High School
James Jai's KMI/Parexel Experience 1999 - 2000
Job
Industry Pharmaceuticals
Experience
PharmaBio Ser 2011 - 2013
Living Stream Ministry 2009 - 2010
3M Drug Delivery Systems Division 2000 - 2008
KMI/Parexel 1999 - 2000
Fluor Daniel 1990 - 1998
Skills
Process Validation, Validation, Pharmaceuticals, Manufacturing, Engineering, V&V
Education
Auburn University
Master of Science
PharmaBio Ser 2011 - 2013
Living Stream Ministry 2009 - 2010
3M Drug Delivery Systems Division 2000 - 2008
KMI/Parexel 1999 - 2000
Fluor Daniel 1990 - 1998
Skills
Process Validation, Validation, Pharmaceuticals, Manufacturing, Engineering, V&V
Education
Auburn University
Master of Science
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