McCormick LifeScience Consultants, LLC
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McCormick LifeScience Consultants, LLC Employees
AbbVie September 2010 - Present
Millennium Pharmaceuticals, Inc. September 2007 - September 2010
Medfocus July 2007 - September 2007
Mercom Group September 2005 - July 2007
McCormick LifeScience Consultants, LLC 2007 - 2007
Bristol-Myers Squibb Medical Imaging September 2004 - September 2005
Wyeth August 2000 - September 2004
Skills
IDMP, eCTD, 21 CFR Part 11, Regulatory Submissions, Document Management, Regulatory Affairs, Pharmaceutical Industry, SharePoint, Sop, Software Documentation, Computer System..., Validation, Cross-functional Team..., FDA, GxP, GCP, GMP, Clinical Trials, IND, Clinical Development, InSight Manager, Insight Publisher, InSight Viewer, eCTDXPress, ISIPublisher, GlobalSubmit, Publishing, Citrix, Documentum, FirstDoc, Planisware, PowerPoint, Adobe Acrobat, Outlook, Visio, Microsoft Excel, Microsoft Word, Excel, Word, FDA ESG
Education
Boston University 2001 — 2005
BS
New York University 1997 — 1998
McCormick LifeScience Consultants, LLC October 2011 - Present
Allen Fleishman Biostatistics September 2000 - Present
Barrington James Pharmaceutical recuitment 2015 - 2015
Boston Biostatistics (Averion) October 1998 - September 2000
CIBA Vision March 1995 - March 1996
Johnson & Johnson Pharmaceutical Research Institute March 1993 - March 1995
Johnson & Johnson Ethicon February 1992 - 1993
Sandoz 1989 - January 1992
Lederle Laboratories 1980 - 1989
PAREXEL June 1966 - October 1968
Skills
Biostatistics, Statistical Programming, Statistical Consulting, Data Analysis, SAP, Protocol Design, ISS, Power Analysis, ISE, Statistical Analysis..., Team Management, Clinical Trials, CRO, Analysis, FDA, Diabetes, Therapeutic Areas, Biotechnology, Clinical Development, Life Sciences
Education
University of Illinois at Urbana-Champaign 1972 — 1978
PhD
City University of New York 1971 — 1972
BS
TEI Biosciences Inc. March 2013 - Present
Middlesex Community College May 1995 - Present
Middlesex Community College 2000 - Present
McCormick LifeScience Consultants, LLC June 2011 - June 2015
AdvanSource Biomaterials Corp. September 2007 - April 2011
Biogen Idec September 2005 - September 2007
Bristol-Myers Squibb September 2002 - September 2005
Bristol-Myers Squibb March 1999 - September 2002
DuPont Pharmaceuticals January 1992 - September 2002
DuPont Merck September 1996 - September 1998
Skills
Sop, GMP, Quality Assurance, Quality System, Biotechnology, Root Cause Analysis, FDA, Trackwise, Quality Control, Change Control, Technology Transfer, Validation, GxP, 21 CFR Part 11, Manufacturing, LIMS, Pharmaceutical Industry, Clinical Development, HPLC, CAPA, Lifesciences, GLP, Regulatory Affairs, Analytical Chemistry, Biopharmaceuticals, Laboratory, Clinical Trials, ISO 13485, Regulatory Submissions, Microbiology, V&V, Chemistry, Medical Devices, Chromatography, Regulatory Requirements, ELISA, Pharmaceutics, Purification, Quality Auditing, R&D, SOP development, Drug Development, Design Control, CRO, FDA GMP, Cell Culture, Vaccines, Gas Chromatography, Computer System..., Protocol
Education
Springfield College 1989 — 1992
BS
Middlesex Community College 1989 — 1991
McCormick LifeScience Consultants, LLC July 2013 - Present
Handel and Haydn Society 2011 - Present
Self 1992 - Present
Lantheus Medical Imaging July 2010 - March 2013
Alnara Pharmaceuticals April 2009 - March 2010
Altus Pharmaceuticals September 2007 - March 2009
Alkermes, Inc September 2005 - August 2007
The Putney School September 2001 - June 2004
Skills
FDA, Music, Singing, Sight Reading, Ensemble, eCTD, Proofreading, Editing, SOP authoring, Document Management, Change Control, Classical, Validation, Oratorio, Microsoft Office, Choral, GMP, Opera, Quality System, Vocalist, Sop, SOP, Bass, Software Documentation
Education
Longy School of Music 1999 — 2001
Early Music Voice Performance
University of Denver 1992 — 1997
Music
Medtronic April 2015 - Present
Atrium Medical/Maquet Getinge Group September 2013 - April 2015
Philips Healthcare April 2011 - September 2013
Pleiad Inc March 2010 - December 2010
McCormick LifeScience Consultants, LLC 2009 - April 2010
Shire HGT August 2009 - March 2010
Vertex Pharmaceuticals February 2008 - December 2008
Rapid Micro Biosystems 2003 - 2007
Millipore 2001 - 2003
Skills
FDA, Regulatory Affairs, Biotechnology, Lifesciences, Medical Devices, Regulatory Submissions, Pharmaceutical Industry, GMP, GLP, Clinical Trials, CAPA, Validation, ISO 13485, Microbiology, Biopharmaceuticals, Quality Assurance, Quality System, 21 CFR Part 11, Clinical Development, R&D, V&V, Design Control, Change Control
Education
University of Massachusetts Lowell 2005 — 2008
Masters Degree, Clinical Laboratory Sciences
University of Massachusetts Lowell 2003 — 2005
Clinical Pathology Certificate, Pathology
University of Massachusetts, Amherst 1996 — 2001
Bachelors Degree, Microbiology
McCormick LifeScience Consultants, LLC November 2014 - Present
Braintree Laboratories November 2012 - November 2014
Braintree Laboratories August 2005 - November 2012
Braintree Laboratories February 2000 - August 2005
Chiron Diagnostics/Bayer Diagnostics 1995 - 2000
Skills
Regulatory Submissions, Regulatory Affairs, Clinical Research, Medical Writing, Regulatory Requirements, Quality Assurance, Clinical Data Management, Clinical Monitoring, IND, GxP, Medical Affairs, Computer System..., Pharmacovigilance, Clinical Operations, ICH-GCP, Drug Development, Change Control, GCP, GLP, GMP, Clinical Trials, Sop, Communication, 21 CFR Part 11, Pharmaceutical Industry, FDA, CAPA, SOP
Education
Regis College 2003 — 2005
MS, Health Product Regulation/Health Policy
Boston University 2001 — 2003
Public Health
Regis College 1991 — 1995
Master's degree, Biology, Chemistry, English
RAPS
RAC, RAC
Medivector Inc March 2015 - Present
DB Feldman Consulting April 2008 - Present
McCormick LifeScience Consultants, LLC September 2012 - July 2014
Pfizer Pharmaceuticals (Formerly FoldRx Pharmaceuticals) May 2010 - July 2012
Artisan Pharma June 2008 - December 2009
AMAG Pharmaceuticals January 2006 - April 2008
EPIX Pharmaceuticals 2000 - 2006
Skills
Pharmaceutical Industry, Clinical Development, Regulatory Affairs, Clinical Trials, FDA, Biotechnology, Clinical Research, Lifesciences, Drug Development, CMC Regulatory Affairs, GCP, IND, Regulations, Regulatory Submissions, Biologics, Biopharmaceuticals, GMP, CRO, CTMS, Sop, Oncology, Regulatory Requirements, GxP, Vaccines, Therapeutic Areas, eCTD, Pharmacology, GLP, Technology Transfer, NDA, Change Control, Drug Discovery, 21 CFR Part 11, Validation, Drug Safety, Medical Affairs, Medical Writing, Protocol, Aseptic Processing, EDC, Infectious Diseases, V&V, Pharmaceutics, CAPA, ICH-GCP, Clinical Monitoring
Education
Boston University 1999 — 2003
MPH, Masters in Public Health
University of Massachusetts, Amherst
Bachelors
Mersana Therapeutics October 2012 - Present
McCormick LifeScience Consultants, LLC June 2009 - Present
IP Consulting May 2009 - Present
Mersana Therapeutics August 2010 - September 2012
Magen BioSciences January 2007 - April 2009
NitroMed Inc. 1998 - 2006
SunOpta 1988 - 1998
Institute for Enzyme Research, Madison, WI 1982 - 1985
Fox Chase Cancer Center 1980 - 1982
Education
Brown University 1975 — 1979
Ph.D, Chemistry
Indian Institute of Technology, Kanpur 1973 — 1975
M.Sc., Chemistry
Loreto House, Kolkatta
McCormick LifeScience Consultants, LLC January 2012 - Present
Stryker Biotech June 2008 - October 2011
ViviSource Labs July 2006 - June 2008
Azopax Therapeutics October 2005 - June 2006
Phylogix, Inc. August 2004 - September 2005
Skills
ELISA, In Vivo, Non-clinical, Pharmacology, Pre-clinical Studies, Scientific Writing, Editing, Biotechnology, Regulatory Submissions, Regulatory Documentation, DMPK, Animal Work, Laboratory, Data Analysis, CRO, Animal Husbandry, In Vitro, Toxicology, Surgery, Microbiology, Drug Delivery
Education
Franklin Pierce College 1996 — 2000
BA, Anthropology
McCormick LifeScience Consultants, LLC April 2009 - Present
Consulting Tox/Path Services, LLC June 1983 - Present
University of New Hampshire January 1983 - Present
McCormick LifeScience Consultants, LLC May 2009 - October 2009
Skills
Life Sciences, Pathology, Research, Diagnostics, Teaching
Education
Michigan State University 1978 — 1981
Masters in Pathology, Veterinary Pathology
The Ohio State University 1968 — 1972
Doctor of Veterinary Medicine, Veterinary Medicine
Anderson College 1965 — 1968
Preveterinary Medicine