Shire HGT
Industry: Commercial company
DescriptionFounded: 1988 Parent organization: Shire Subsidiary: Premacure AB
Shire HGT List of Employees There's an exhaustive list of past and present employees! Get comprehensive information on the number of employees at Shire HGT. You can filter them based on skills, years of employment, job, education, department, and prior employment.
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Shire HGT Employees
Workman Clinical Consulting, Inc. April 2001 - Present
Thomas Jefferson University Hospital January 2009 - Present
Workman Clinical Consulting, Inc. April 2001 - Present
bioRASI October 2013 - May 2014
Ogontz Fire Company 2002 - Present
Cheltenham Township Fire Department February 2002 - Present
Alexion Pharmaceuticals, Inc. October 2011 - July 2013
MedAvante Inc. September 2010 - September 2011
Shire HGT 2007 - 2010
Omnicare Clinical Research 2002 - 2008
Skills
Pharmaceutical Industry, Clinical Trials, Clinical Research, CTMS, Infectious Diseases, Protocol, Clinical Development
Education
Temple University 1981 — 1985
Master of Public Health, Community Health Education
Villanova University 1972 — 1976
B.A., Geography, Latin American Studies
Price Waterhouse Management Consultants March 2015 - August 2015
Sanofi May 2014 - November 2014
Genzyme June 2011 - May 2013
Shire HGT June 2009 - May 2011
Wyeth 2003 - 2008
Alpharma February 1999 - January 2003
Skills
GMP, Validation, Change Control, V&V, Quality Assurance, Cleaning Validation, Process Improvement, Manufacturing, Pharmaceutics, Sop, FDA, CAPA, 21 CFR Part 11, Pharmaceutical Industry, Biotechnology, Technology Transfer, Aseptic Processing, Computer System..., GxP, LIMS, Trackwise, Regulatory Requirements, GLP, Quality System, GAMP, Biopharmaceuticals, Regulatory Submissions, FDA GMP, Vaccines, Regulatory Affairs, Chromatography, Quality Control, Quality Auditing, Aseptic Technique, HPLC, Drug Development, ISO 13485, Lifesciences, Deviations, GCP, SOP development, Purification, TrackWise, SOP, Life Sciences
Education
Rutgers Business School 2003 — 2006
MBA, Pharmaceutical Management and Marketing
Rutgers Business School 2003 — 2006
Master's degree, Pharmaceutical Marketing and Management, 3.8
PAREXEL October 2014 - Present
inVentiv Health Clinical May 2014 - October 2014
inVentiv Health Clinical April 2013 - April 2014
Shire HGT December 2011 - March 2013
Brigham and Women's Hospital June 2010 - December 2011
Massachusetts General Hospital June 2008 - June 2010
Skills
Clinical Trials, Clinical Research, Clinical Data Management, Oncology, CTMS, EDC, Data Management, GCP, Clinical Development, Protocol, Inform, Regulatory Submissions, CRO, Microsoft Office, Team-oriented, Clinical Monitoring, ICH-GCP, Outcomes Research, Registries, Drug Development, Pharmacovigilance, Medical Writing, NIS, Strategic Partnerships, Business Development
Education
Rutgers, The State University of New Jersey-New Brunswick
BA, Cell Biology & Neuroscience
Sandoz 2012 - Present
Shire HGT September 2011 - 2012
AstraZeneca January 2011 - September 2011
AstraZeneca LP July 2008 - February 2011
AstraZeneca Pharmaceuticals LP January 2007 - August 2007
Skills
GMP, Cross-functional Team..., Supply Chain Management, SAP, Supply Chain, Validation, Pharmaceutical Industry, Materials Management, Supply Chain..., Sop, Change Control, DMAIC, Project Planning
Education
Penn State University 2003 — 2007
BS, Supply Chain and Information Systems
Dale Carnegie
Effective Communications and Human Relations
Nagle LLC Contractor Automation EngineerPfizerOctober 2013 - November 2013
Alexion Pharmaceuticals August 2012 - September 2012
Regeneron Pharmaceuticals Inc. August 2012 - September 2012
Shire HGT October 2011 - September 2012
Taylor Company Investment Bank LLC May 2011 - June 2011
Applied Control Engineering February 2010 - April 2011
Siemens Energy & Automation January 2009 - February 2010
Honeywell Process Solutions January 1990 - December 2008
ABB US Power and Automation (Combustion Engineering Taylor Instrument) January 1987 - December 1989
Invensys (Foxboro Company) July 1981 - December 1986
Skills
Process Automation, Process Control, Automation, SCADA, DCS, Validation, Manufacturing, PLC, Cross-functional Team..., Commissioning, Instrumentation, Integration, GMP, Control Systems Design, Engineering
Education
State University of New York College at Buffalo 1980 — 1981
Bachelor's Degree, Industrial Technology
Novartis Institutes for BioMedical Research December 2012 - Present
Aveo Pharmaceuticals February 2008 - November 2012
SmartCells, Inc. 2007 - 2008
Shire HGT 2003 - 2007
Skills
Drug Discovery, In Vivo, In Vitro, Transfection, Pharmacology, Purification, Cell Biology, Biochemistry, Biomarkers, Drug Development
Education
Roger Williams University 1999 — 2003
BS, Marine Biology and Env.Chemistry
Shire January 2015 - Present
Shire HGT January 2011 - December 2014
Pfizer October 2009 - January 2011
Wyeth September 2005 - September 2009
Testa, Hurwitz & Thibeault, LLP/ K&L Gates November 2002 - September 2006
Hogan & Hartson, LLP August 2000 - September 2002
Human Genome Sciences February 1997 - January 1999
Skills
Patents, Patent Prosecution, Biotechnology, Patentability, Lifesciences, Intellectual Property, Due Diligence, Pharmaceutical Industry, Technology Transfer, Licensing, Trademarks, Patent Litigation, Litigation, Corporate Law, Biopharmaceuticals, Life Sciences, Legal Writing, Trade Secrets
Education
University of Maryland College Park 1992 — 1996
Bachelor of Science (BS), Molecular Biology
The Catholic University of America, Columbus School of Law
Juris Doctor, Law, Magna Cum Laude
Pemzy Group August 2011 - Present
Shire HGT August 2010 - August 2011
Quintessential Business Designs January 2007 - August 2010
Electrocraft September 2006 - March 2008
Brand Partners March 2005 - August 2006
Irving Oil December 2002 - March 2005
Skills
Six Sigma, Strategy, Process Improvement, Lean Manufacturing, Change Management, Program Management, Leadership, Cross-functional Team..., Strategic Planning, Project Management, Team Building, Budgets, Coaching, Management, Organizational..., Supply Chain Management, Operational Excellence, Business Strategy, Kaizen, Operations Management, Business Process..., PMP, Training, Supply Chain, Leadership Development, Human Resources, Business Analysis, Business Planning, Team Leadership, Purchasing, Quality Management, Vendor Management, Analysis, Management Consulting, Keynote, Problem Solving, Certified Six Sigma..., Project Portfolio..., Inventory Management, Strategic Communications, Communications Planning, Business Communications, Enterprise Excellence, Strategy & Optimization, Consulting, Employee Engagement, Voice of the Customer, Marketing
Education
Southern New Hampshire University 2006 — 2009
Masters, Global M.B.A
Southern New Hampshire University 2006 — 2009
Masters of Science, Organizational Development
Pfizer September 2015 - Present
Hospira July 2012 - August 2015
Shire HGT May 2010 - July 2012
Bristol Myers Squibb Medical Imaging November 2001 - May 2010
Skills
GMP, Aseptic Processing, Sop, LIMS, Validation, 21 CFR Part 11, Chromatography, Biotechnology, Trackwise, Change Control, GLP, HPLC, FDA, V&V, Quality System, GxP, Regulatory Affairs, Cleaning Validation
Education
Northeastern University 2007 — 2009
MS, Drug Regulatory Affairs, Regulatory Affairs
St. Olaf College 1996 — 1999
BA, Chemistry, Chemistry
Scott Worldwide Consulting, LLC January 2012 - Present
Shire HGT April 2006 - December 2011
Pfizer Inc October 2001 - March 2006
Skills
Cultural Awareness, Negotiation, R&D experience, Communication Skills, Problem Solving, Executive Management, SAP R/3, Team Leadership, Leadership, Procurement, Supply Chain Management, Program Management, Vendor Management, Business Planning, Business Analysis, Change Management, Strategy, Sourcing, Process Improvement, Pricing, Budgets, Global Sourcing, Project Planning
Education
National Louis University
Master's degree, Business Administration and Management, Organizational Behavior
Rush University
Bachelor of Applied Science (BASc), Medical Technology, Microbiology
Shire HGT February 2013 - Present
Biogen Idec July 2012 - December 2012
Percivia February 2011 - April 2012
Stryker Biotech July 2008 - February 2011
Microbiology Research Associates September 2007 - June 2008
Biovest International January 2006 - September 2007
Cetek Corporation March 2002 - June 2005
Cetek Corporation December 2000 - March 2002
Skills
GMP, Quality Control, ELISA, Problem Solving, Aseptic Technique, Bioassay, Analytical Biochemistry, Microbiology, Improvisational Comedy
Education
Penn State University 1996 — 2000
Bachelor of Science (BS), Biotechnology
Improv Asylum 2011 — 2012
Certificate of Completion, Improvisation
Alkermes September 2014 - Present
Shire, Rare Diseases Business Unit June 2011 - August 2014
Shire HGT November 2009 - May 2011
Shire HGT November 2008 - November 2009
Shire HGT April 2006 - November 2008
Biogen Idec April 2003 - December 2005
HIV/AIDS Bureau, MDPH 1999 - 2001
Skills
Biotechnology, Pharmaceutical Industry, Healthcare, Product Launch, Pharmaceutical Sales, FDA, Biopharmaceuticals, Sop, Technology Transfer, SOP, Management
Education
Oregon State University 1996 — 1998
MPH, Public Health
University of Massachusetts, Amherst 1991 — 1995
BA, Sociology
Johnson & Johnson 2013 - Present
Shire HGT 2010 - 2013
Eisai Research Institute 2008 - 2009
MGI Pharma 2004 - 2008
Zycos, Inc. 2000 - 2004
ImmuLogic Pharmaceutical Inc. 1990 - 1995
Skills
Immunology, Oncology, Clinical Development, Biotechnology, Life Sciences, Orphan Disease, Preclinical Development
Education
State University of New York College at Plattsburgh
B.S., Biology
Tufts University
Ph.D., Immunology
Vertex Pharmaceuticals December 2014 - Present
Vertex Pharmaceuticals November 2013 - December 2014
Vertex Pharmaceuticals October 2012 - October 2013
Vertex Pharmaceuticals July 2011 - October 2012
Idera Pharmaceuticals June 2009 - June 2011
Lightspace Corporation September 2008 - March 2009
Shire HGT January 2008 - September 2008
Sports and Physical Therapy Associates May 2007 - January 2008
Skills
Pharmaceutical Industry, Biotechnology, Validation, Clinical Research, ICH-GCP, Office Administration, Informed Consent, Meeting Planning, Communication Skills, Social Media, Google Analytics, Organizational Culture, Business Ethics, Writing, FDA, Data Analysis, Event Planning, Clinical Development, Outlook, Lotus Notes, GCP, Clinical Trials
Education
Northeastern University 2011 — 2013
B.S., Organizational Communications, 3.488
Northeastern University
Human Services, Accounting
Thomas Crane Public Library June 2015 - Present
Watertown Free Public Library December 2014 - August 2015
Public Library of Brookline January 2015 - June 2015
Somerville Public Library April 2013 - June 2015
Simmons College, Boston, MA May 2013 - September 2013
Simmons College, Boston, MA October 2012 - May 2013
Somerville Public Library January 2013 - April 2013
Shire HGT May 2012 - November 2012
Regan Associates, Chartered November 2004 - May 2012
Times of Acadiana 1998 - 2004
Skills
Library, Editing, Library Science, Social Media, Proofreading, Metadata, FileMaker, Archives, Cataloging, Collection Development, Books, Microsoft Office, Photoshop, Library Management, Library Reference, Electronic Resources, Copy Editing, Writing, Microsoft Word, Event Planning, Libraries, Flickr, Library 2.0, Press Releases, Microsoft Excel, PowerPoint, Access, Adobe Acrobat, Leadership, Millennium ILS, Library Marketing, Library Advocacy, HTML + CSS, PHP, Wikis, Twitter, Adobe Photoshop, Dewey Decimal..., phpMyAdmin, Basecamp, Red Dot, SurveyMonkey, Sierra ILS, SyrsiDynix WorkFlows, OverDrive
Education
Simmons College
Master's Degree, Library and Information Science
University of Louisiana at Lafayette
Bachelor's Degree, Print Journalism
Cerulean Pharma, Inc August 2015 - Present
Revere SandSharks Swim Club June 2007 - Present
Shire Pharmaceuticals February 2015 - July 2015
Shire Pharmaceuticals August 2012 - January 2015
Shire HGT May 2011 - August 2012
Dana-Farber Cancer Institute September 2005 - August 2007
Skills
Research, Biotechnology, Microsoft Office, Molecular Biology, Regulatory Submissions, eCTD, Microsoft Excel, Lifesciences, IND, Regulatory Affairs, Clinical Trials, Biopharmaceuticals, Drug Development, Clinical Development, Clinical Research, GCP
Education
Regis College 2010 — 2013
Regulatory and Clinical Research Management, Health Informatics
Simmons College 2004 — 2008
BS, Biochemistry, Psychology
Ocular Therapeutix, Inc May 2013 - Present
BioSPEQ August 2012 - May 2013
Shire HGT August 2012 - May 2013
UMass Memorial Medical Center May 2011 - August 2011
FLEXcon May 2010 - August 2010
Entegris May 2009 - August 2009
Longwatch, Inc. May 2007 - August 2008
Skills
Microsoft Office, Minitab, Matlab, EMT, Cpr Certified, Gel Electrophoresis, Aspen, Validation, Equipment Validation, Process Validation, Engineering, GMP
Education
Rensselaer Polytechnic Institute 2008 — 2012
Bachelor of Science (B.S.), Chemical Engineering
Gilead Sciences June 2014 - Present
Genzyme April 2011 - June 2014
Shire HGT December 2010 - April 2011
Shire HGT June 2010 - December 2010
UNH September 2009 - December 2009
UNH June 2009 - August 2009
Biodiesel Research September 2007 - December 2008
Amphenol Backplane Systems May 2007 - August 2007
Skills
Purification, GMP, Chromatography, CAPA, Protein Purification, Chemical Engineering, FDA, Fermentation, Change Control, Visio, Process Simulation, Validation, Filtration, Microsoft Word, Microsoft Excel, Sop, Quality System, Technology Transfer, cGMP, Column Chromatography, Quality Systems, Biotechnology, Cell Culture, Process Development, Word, Excel, Microsoft Office, Life Sciences, PowerPoint, Biochemical Engineering, SPC, Statistical Process..., Deviations, Trackwise, Large Scale Systems, Manufacturing Operations, Biologics, Consent Decree, Bioengineering, Small Project Management, PCR, Gel Electrophoresis, Transfection, JMP, Unicorn, Statistics, Statistical Data..., Downstream Processing, Ultrafiltration
Education
Tufts University 2011 — 2014
Master of Engineering (M.Eng.), Bioengineering
University of New Hampshire 2006 — 2010
Bachelor of Science (B.S.), Chemical Engineering
Shire HGT January 2013 - Present
Shire HGT July 2010 - Present
Eisai October 2009 - August 2010
Eisai Research Institute 2000 - 2009
Boston University School of Medicine 1998 - 2000
Skills
Drug Discovery, Drug Development, Biotechnology, Immunology, Rare Diseases, Pharmacology, Biopharmaceuticals, Assay Development, Lifesciences, Technology Transfer, In Vitro, Oncology, Pharmaceutical Industry
Education
Penn State University 1994 — 1998
PhD, Physiology
University of Wisconsin-Madison 1992 — 1994
MS, Kinesiology
University of Wisconsin-Madison 1984 — 1988
BS, Kinesiology
Mass Biotechnolgy
Shire HGT February 2014 - Present
Skills
Selling Skills, Competitive Analysis, Budgets, Finance, Mergers, Storyboarding, Pharmaceutical Industry, Diabetes, Hospitals, Ophthalmology, B2B, Pharmaceutical Sales, Medical Devices, Key Account Management, Pharmaceutics, Allergy, Cold Calling, Healthcare, Sales, Market Planning, Marketing Strategy, Sales Effectiveness, Territory Management, Hospital Sales, Sales Management, Biotechnology, Cross-functional Team..., Managed Care, Account Management, Capital Equipment, Product Launch, Sales Operations, Market Development, Buy & Bill, Market Access, Healthcare Management, Endocrinology, Surgery, Cardiology, Sales Presentations, Infectious Diseases, Selling, Market Analysis, Surgeons, Medical Sales, Clinical Trials, Neurology, Urology, Rheumatology, Gastroenterology
Education
Saint Joseph's University
Bachelor of Science
Alexion Pharmaceuticals, Inc. July 2015 - Present
Synageva BioPharma Corp. April 2015 - Present
Cubist Pharmaceuticals January 2014 - April 2015
ARIAD Pharmaceuticals, Inc. September 2013 - November 2013
Shire HGT July 2012 - September 2013
Bio-Concept Inc. January 2012 - July 2012
BioConcept Laboratories, Inc. September 2010 - January 2012
Salve Regina University November 2007 - May 2010
Salve Regina University September 2007 - May 2010
Bear Workshop November 2004 - January 2008
Skills
HPLC, Chemistry, GMP, Microsoft Office, Lifesciences, Biotechnology, PowerPoint, Microsoft Word
Education
Salve Regina University 2006 — 2010
BS, Biology
Haverhill High School 2002 — 2006
High School Diploma, College Prep
Amgen July 2015 - Present
Shire HGT August 2011 - Present
Shire Pharmaceuticals January 2015 - July 2015
University of Virginia August 2008 - May 2011
Skills
Chromatography, HPLC, Protein Chemistry, UV/Vis, Protein Purification, Biotechnology, Biochemistry, Characterization, Chemical Engineering, Process Simulation, Laboratory, Filtration, Chemistry, Matlab, Experimentation
Education
University of Virginia 2008 — 2011
M.S., Chemical Engineering
Zhejiang University 2004 — 2008
B.S., Bioengineering/Biochemical Engineering
The Hong Kong Polytechnic University 2006 — 2007
Exchange student, Applied Biology with Biotechnology
MedImmune August 2014 - Present
Biogen Idec March 2012 - Present
Shire HGT July 2011 - February 2012
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company April 2004 - November 2010
ImClone System Eli Lilly Subsidiary March 2010 - August 2010
Amersham Pharma February 2003 - March 2004
Anadigics Inc January 1999 - January 2003
Skills
Project Management, Photolithography, Etching, Electroplating, Validation, HPLC, Cell Culture, SDS-PAGE, GMP, CAPA, FDA, Biotechnology
Education
Raritan Valley Community College 2008 — 2009
Certificate, Biotechnology
Katharine Gibbs 2003 — 2005
Certificate, Computer support Networking
Avtech College 2001 — 2003
Diploma, Computer Support
Covance September 2013 - Present
Vertex Pharmaceuticals June 2012 - September 2013
Shire HGT August 2009 - June 2012
Pfizer August 2002 - June 2009
Rhode Island Hospital July 1995 - August 2002
Skills
Immunology, Rheumatology, Clinical Research, Pediatrics, Translational Research, Clinical Development, Medicine, Clinical Trials, Inflammation, Biotechnology, Drug Development, Rheumatoid Arthritis, Medical Affairs, Infectious Diseases, Translational Medicine, Therapeutic Areas, Pharmacovigilance, GCP, Medical Writing
Education
Northwestern University - The Feinberg School of Medicine 1985 — 1989
MD
Bristol-Myers Squibb August 2013 - Present
Shire HGT July 2011 - August 2013
Millipore September 2007 - July 2011
Skills
Chromatography, Purification, Downstream Processing, Design of Experiments, Risk Assessment, UV/Vis, Validation, Technology Transfer, Biopharmaceuticals, Pharmaceutical Industry, Biotechnology, Filtration, Protein Purification, CAPA, Characterization, Cell, GMP, Process Simulation, R&D
Education
Rensselaer Polytechnic Institute 2002 — 2007
Ph D, chemical Engineering
Tianjin University 1995 — 2002
Bachelor of Science (BS), Biochemical Engineering
Bristol-Myers Squibb January 2014 - Present
Shire HGT January 2013 - January 2014
Merck January 2011 - January 2013
Wyeth Pharmaceuticals (Presently Pfizer) January 2006 - 2010
Wyeth Research January 2001 - December 2005
Wyeth Research July 1998 - December 2000
Lederle Labs January 1993 - September 1998
Princeton University 1989 - 1992
Skills
Neuroscience, Protein Chemistry, Infectious Diseases, CMC, Oncology, Project Management
Education
Clarkson University
Ph.D., Biochemistry
Princeton University
Shire HGT March 2008 - Present
Superior Controls 2004 - 2008
Biopure 2001 - 2004
Genetics Institute 2000 - 2001
Biopure 1998 - 2000
Ferrofluidics Corp. 1997 - 1998
Toray Plastics America 1995 - 1997
ASE Americas 1994 - 1995
Mobil Solar Energy Corp. 1992 - 1994
Encur, Inc 1989 - 1991
Skills
Allen-Bradley, Automation, CAPA, Change Control, FDA, GMP, Instrumentation, PLC, Validation
Education
Rutgers University-New Brunswick 1984 — 1989
Raptor Pharmaceuticals May 2014 - Present
Shire - Rare Disease Division January 2014 - May 2014
Shire HGT March 2006 - May 2014
Shire HGT March 2006 - January 2010
Berlex Biosciences May 2002 - March 2006
Skills
Pharmaceutical Industry, Oncology, Pharmaceutical Sales, Biotechnology, Neurology, Cardiology, Managed Care, Hematology, Diabetes, Market Access, Commercial Real Estate, Dermatology, Sales Operations
Education
The Ohio State University 1981 — 1985
BS Business management, Management, Marketing, Accounting
University of Arizona
Shire HGT June 2012 - Present
Lonza May 2011 - May 2012
BioVex January 2010 - May 2010
Lonza November 2008 - March 2009
Skills
GLP, GMP, Sop, LIMS, CAPA, Trackwise, Validation, FDA, Biopharmaceuticals, 21 CFR Part 11, Biotechnology, Aseptic Technique, USP, SOP
Education
Roger Williams University 2004 — 2009
BS, Biology
High School
Shire February 2014 - Present
Shire HGT November 2012 - February 2014
Shire HGT April 2010 - November 2012
AstraZeneca June 2008 - April 2010
AstraZeneca September 2007 - June 2008
AstraZeneca January 2006 - September 2007
Biogen 2001 - 2006
VitaRich Laboratories 2000 - 2002
Coastal Resources Associates 1992 - 1995
Springborn Laboratories 1989 - 1992
Skills
Lean Six Sigma Black..., GMP, Aseptic Processing, CAPA, Trackwise, 21 CFR Part 11, FDA, Validation, Sop, LIMS, Change Control, Pharmaceutical Industry, Quality System, Biotechnology, Biopharmaceuticals, Technology Transfer, GLP, Regulatory Affairs, GxP
Education
Skidmore College 1985 — 1989
BA, Biology
High School
Shire HGT September 2012 - Present
Pfizer October 2009 - September 2012
Wyeth Pharmaceuticals 1988 - October 2009
Skills
Analytical Chemistry, Protein Chemistry, Biopharmaceuticals, Purification, Drug Development, SDS-PAGE, GMP, Pharmaceutical Industry, Quality Control, Biotechnology, Clinical Development, Technology Transfer, Cell Culture, Commercialization, Assay Development, Monoclonal Antibodies, Drug Discovery, Chromatography, HPLC, Lifesciences, Process Simulation, GLP, Western Blotting, Formulation, Validation, Biochemistry
Education
State University of New York College of Environmental Sciences and Forestry 1982 — 1988
BS, MS, Microbiology
Shire HGT July 2012 - Present
Olympus Biotech (formerly Stryker Biotech) February 2011 - July 2012
Stryker Biotech January 2010 - February 2011
Stryker Biotech 2007 - 2010
Stryker Biotech 2007 - 2007
Stryker Biotech 2000 - 2007
Creative Biomolecules 1992 - 1998
Hemagen Diagnostics 1985 - 1987
Seragen Inc 1984 - 1985
Skills
Validation, GMP, Biotechnology, ELISA, R&D, Assay Development, Method Development, Laboratory, FDA, Technology Transfer, Sop, CAPA, Medical Devices, Lifesciences, HPLC, SDS-PAGE, Biopharmaceuticals, Immunoassays, Regulatory Affairs, Purification, Gel Electrophoresis, Quality Control, SOP, Life Sciences
Education
Rochester Institute of Technology 1982 — 1985
MS, Clinical Chemistry
University of Massachusetts Dartmouth 1978 — 1982
BS, Chemistry
Shire May 2012 - Present
Northeastern University September 2007 - May 2012
Adnexus Therapeutics January 2011 - July 2011
Minerva Biotechnologies January 2010 - June 2010
Shire HGT 2009 - 2009
Skills
HPLC, Cell Culture, Chemical Engineering, ELISA, Gel Electrophoresis, AKTA Explorer with...
Education
Northeastern University 2007 — 2012
Bachelor's of Science, Chemical Engineering
gTechBio October 2009 - Present
Univ of Massachusetts Medical School (MassBiologics, Jamaica Plain Campus) November 2004 - August 2009
Validation Training Services 2003 - 2004
Shire HGT 1998 - 2003
TKT 1998 - 2003
Transkaryotic Therapies 1998 - 2003
TKT/Shire 1998 - 2002
Genzyme 1992 - 1998
Chiron 1990 - 1992
Baxter Healthcare 1982 - 1985
Skills
Technology Transfer, Troubleshooting, Process Optimization, cGMP, Biopharmaceuticals, Vaccines, Commercial Production, Protein Chemistry, Validation, Process Validation, Biotechnology, Process Development, Purification, Chromatography, Process Improvement, Biochemistry, GMP, CAPA, FDA, Drug Development, V&V, R&D, Monoclonal Antibodies, Formulation, Lifesciences, Laboratory, LIMS, GLP, Sop, Change Control, 21 CFR Part 11, Immunology, Life Sciences, SOP, Process Simulation
Education
Pepperdine University 1983 — 1986
Masters, Business Adminstration
University of California, Riverside 1973 — 1979
PhD, Biochemistry
Shire February 2015 - Present
Shire HGT January 2011 - February 2015
Shire HGT October 2006 - August 2011
University of Kansas May 2004 - September 2006
Skills
Protein Chemistry, Biotechnology, HPLC, Drug Delivery, Drug Development, Biochemistry, Biophysics, Formulation, Fluorescence..., Circular Dichroism, UV/Vis, DLS, Differential Scanning..., Drug Discovery, Life Sciences
Education
University of Kansas 2004 — 2006
University of Missouri-Kansas City 1999 — 2004
PhD, Pharmaceutical Sciences and Chemistry
University of Tehran 1989 — 1993
Bachelor of Science (B.S.) with honors, Chemistry
R&D Medical Device January 2011 - Present
Shire HGT September 2009 - October 2010
Acushnet Company September 2005 - September 2009
Quaker Fabric Corporation July 2003 - September 2005
Toray Plastics America August 1996 - July 2003
Acushnet Company July 1995 - September 1996
Skills
Troubleshooting, Manufacturing, Lean Manufacturing, Process Engineering, Six Sigma, Continuous Improvement, Process Improvement, Operations Management, Validation, GMP, 5S, Engineering, FDA, Facilities Management, Budgets, Product Development, Program Management, Manufacturing..., SPC, Purchasing, Quality System, Project Management, Cross-functional Team..., Automation, Leadership, Management, Root Cause Analysis, Testing
Education
Regis University 2008 — 2011
Master Degree, Business Administration
University of Massachusetts Dartmouth 1993 — 1996
Bachelors of Science, Mechanical Engineering
Shire Pharmaceuticals February 2014 - Present
Shire HGT February 2012 - February 2014
Shire HGT 2011 - 2012
Shire HGT 2006 - 2011
Transkaryotic Therapies, Inc 1992 - 2006
New England Biolabs January 1990 - June 1992
Institute of Basic Medical Sciences (IBMS) of Chinese Academy of Medical Sciences (CAMS) July 1988 - October 1989
Skills
Protein Chemistry, Protein Purification, Biotechnology, Drug Discovery, Lifesciences, Purification, Biochemistry, Assay Development, Chromatography, Cell Culture, Cell, Biopharmaceuticals, Drug Development, HPLC, ELISA, Technology Transfer, Life Sciences
Education
Peking Union Medical College 1980 — 1988
Doctor of Medicine (M.D.)
Peking University 1980 — 1982
Pre-Medicine/Pre-Medical Studies
American Health Lawyers Association June 2014 - Present
International Institute for Conflict Prevention and Resolution (CPR) July 2014 - Present
American Arbitration Association September 2013 - Present
Mediation Services of North Central MA July 2013 - Present
Axiom, Inc. January 2013 - Present
American Arbitration Association March 2013 - April 2014
Mylan Pharmaceuticals 2010 - 2012
Shire HGT 2009 - 2010
Novartis International AG February 2009 - July 2009
Novartis Animal Health Inc. 2007 - 2009
Skills
Licensing, Mergers, Intellectual Property, Pharmaceutical Industry, Litigation, Biotechnology, Trademarks, Legal Advice, Mergers & Acquisitions, Strategy, Venture Capital, Legal Compliance, Lifesciences, Competition Law, Dispute Resolution, Commercial Litigation, Corporate Governance, Arbitration, Civil Litigation, FCPA, Policy, Securities Regulation, Cross-functional Team..., Corporate Law, Legal Issues, Legal Writing, Mediation, Leadership, Business Development, Due Diligence, Patents, Contract Negotiation, Joint Ventures, Litigation Management, Alternative Dispute..., Trade Secrets, Patent Litigation, Privacy Law, Employment Law, Legal Assistance, Patent Prosecution, International Law, Restructuring, Technology Transfer
Education
University of Chicago Law School 1983 — 1986
J.D., Law
Oberlin College 1981 — 1983
B.A., Government/Political Theory and Dance
Grafton Village Cheese August 2014 - Present
University of Wisconsin-Parkside July 2013 - July 2014
Colorado River Watch July 2012 - July 2013
Shire HGT December 2009 - June 2012
New Hampshire Department of Environmental Services July 2009 - December 2009
Skills
Microsoft Office, Microsoft Excel, Quality Control, LIMS, Laboratory, Water Quality, GMP, Trackwise, Volunteering, Technical Writing, Grant Writing, Documentation Practices, cGMP practices, Deviations, Biotechnology, Volunteer Training, Training, Social Media, HACCP, SQF
Education
Skidmore College 2005 — 2009
BA, Chemistry
AgaMatrix April 2015 - Present
AgaMatrix October 2013 - April 2015
Anika Therapeutics March 2013 - October 2013
Seaside Therapeutics October 2012 - March 2013
Genzyme September 2011 - October 2012
Shire HGT January 2011 - September 2011
Shire HGT August 2009 - January 2011
Shire HGT May 2008 - August 2009
Wyeth Biotech September 2003 - May 2008
Wyeth Biotech 2001 - 2003
Skills
Microsoft Word, Microsoft Excel, Visual D Base, Access 97 & 98, Windows NT Explorer, Adobe Professional, PowerPoint, Windows 98 & 2000, Office XP, Oracle, Vista, MAXIMO, AGILE PLM, TagLink, SAP, Drawing Document..., TrackWise, Microsoft Visio, DataStream (Infor), TrueView, File Maker Pro, Maximo, Access, Document Management, Visio, FDA, GMP, Change Control, Trackwise, Software Documentation, Biotechnology, Pharmaceutical Industry, Sop, CAPA, Product Lifecycle..., Quality System, Microsoft Office Xp, GLP, FileMaker, SOP, Quality Assurance, Validation, Microsoft Office, Windows Vista
Education
Northern Essex Community College
Associates, Business Management with Computer Applications Option
Salem High School
University of Phoenix
Masters, Management
University of Phoenix
Bachelors, Management
Mark R. Hardy Consulting LLC February 2014 - Present
Shire May 2012 - Present
Shire HGT March 2013 - January 2014
Pfizer February 2010 - December 2011
Pfizer October 2009 - February 2010
Wyeth Pharmaceuticals 1996 - October 2009
Oxford GlycoSciences March 1995 - May 1996
ImmunoGen, Inc. February 1991 - March 1995
Dionex 1989 - 1991
Skills
Immunoassays, Biotechnology, Cell, Pharmaceuticals, Protein Analysis, glycobiology, Bioanalytical Chemistry, Process Development, Technological Innovation, Innovation Management, carbohydrate..., impurity assays, Monoclonal Antibodies, vaccines, immunoconjugates, immunotoxins, Assay Development, Carbohydrate, Proteomics, Protein Chemistry, Vaccines, Pharmaceutical Industry, R&D, Analytical Chemistry, GMP, LC-MS, Biochemistry, Biopharmaceuticals, Chemistry, Chromatography, High Throughput..., Process Simulation, Glycosylation, Technology Transfer, Drug Development, Biomarker Discovery, Bioanalysis, GLP, Glycobiology, Mass Spectrometry, SDS-PAGE, Purification
Education
The Johns Hopkins University 1987 — 1988
N/A (Postdoctoral Fellowship), Biochemistry
The Johns Hopkins University 1980 — 1986
PhD, Biology
The Johns Hopkins University 1976 — 1980
BA, Biology
Baltimore Lutheran School 1970 — 1976
Genentech May 2015 - Present
Actelion November 2012 - May 2015
Gentiva Health Services March 2011 - December 2012
Shire HGT July 2009 - March 2011
LifeCell Corp. November 2007 - July 2009
Boston Scientific November 2006 - November 2007
CR Bard November 2005 - November 2006
Pfizer Pharmaceuticals August 1994 - November 2005
United Sates Marine Corps May 1986 - August 1994
Skills
Sales Management, Situational Leadership, Organizational..., Strategic Leadership, Medical Devices, Product Launch, Change Management, Pharmaceutical Sales, Sales, Salesforce Training, Market Analysis, Market Development, Strategic Planning, Sales Effectiveness, Training and Develoment, Sales Rep Training, Sales Operations, Leadership, Training, Selling, Hospital Sales, Gastroenterology, Sales Process, Neurology, Cold Calling, Sales Presentations, Orthopedic, Cardiology, OB/GYN, Selling Skills, Sales Force Development, Leadership Development, Managed Care, Capital Equipment, Pharmaceutical Industry, Urology, Management, Surgeons, Oncology, Rheumatology, Pulmonology, Endocrinology, Diabetes, Dermatology, Nephrology, Allergy, Disposables, Operating Room, Buy & Bill, Medical Sales
Education
Webster University 1990 — 1993
MBA, Finance
The Citadel 1982 — 1986
BS, Business Administration
Riverview High School, Sarasota, FL 1978 — 1982
HS Diploma, N/A
Genzyme July 2011 - Present
Tolerx March 2008 - July 2011
Wyeth 2005 - 2008
TKT 2002 - 2005
Shire HGT 2002 - 2005
Skills
Purification, Protein Chemistry, HPLC, GMP, Chemical Engineering, Biotechnology, Cell Culture
Education
Tufts University 2004 — 2009
Certificate, Biotechnology Engineering
Smith College 1998 — 2002
BA, Neuroscience
Shire HGT February 2012 - Present
Biogen Idec 2010 - 2012
Genzyme 1998 - 2010
Immulogic 1994 - 1997
Boehringer Ingelheim Pharmaceuticals May 1988 - October 1994
Skills
IND, Biopharmaceuticals, Regulatory Submissions, Biotechnology, Technology Transfer, FDA, GMP, Regulatory Affairs, CMC, Drug Development, NDA, Pharmaceutical Industry, eCTD, Validation, GLP, Analytical Method..., Analytical biochemistry, Management
Education
Northeastern University 1982 — 1988
Ph.D., Analytical Chemistry
Tufts University 1976 — 1980
BS, Chemistry, minor in Biology
Alnylam Pharmaceuticals January 2015 - Present
Shire July 2014 - January 2015
Shire August 2012 - July 2014
Shire HGT January 2011 - August 2012
Outcome November 2009 - January 2011
Outcome September 2008 - April 2010
Travizon, Inc May 2007 - September 2008
Skills
Clinical Trials, Clinical Research, CTMS, EDC, Regulatory Submissions, CRO, Pharmaceutical Industry, Biotechnology, Clinical Development, GCP, Lifesciences, FDA, Protocol, Sop, Medical Devices, ICH-GCP
Education
Syracuse University 2002 — 2008
BA, Psychology
HCL Technologies November 2011 - Present
Shire HGT November 2011 - Present
BNY Mellon September 2010 - April 2011
Concordant 2010 - 2010
Skills
Group Policy, System Deployment, Norton Ghost, HP, Blackberry, XP, Hardware, Laptops, Active Directory, Technical Support, System Administration, Windows XP, Desktop Computers, Windows 7, Lotus Notes, Microsoft Office, iPhone, Information Technology, Operating Systems, Troubleshooting
Education
Northern Essex Community College 2007 — 2010
Associates, Computer Science
Northern Essex Community College
Associate of Science (A.S.), Information Technology
CutisPharma, Inc. September 2014 - Present
Bristol-Myers Squibb August 2008 - August 2014
Shire HGT June 2007 - November 2007
Wyeth Biotech March 2005 - April 2007
Skills
Documentum, FileMaker, Sop, Document Management, FDA, GMP, Technical Writing, Microsoft Office, Change Control, 21 CFR Part 11, Pharmaceutical Industry, Validation, Biotechnology, Software Documentation, GLP, Quality Assurance, SharePoint, CAPA, Data Management
Education
Salem State College 1998 — 2004
BS, Geography
Zafgen, Inc. April 2015 - Present
Cubist Pharmaceuticals March 2014 - March 2015
Shire HGT June 2012 - March 2014
Shire HGT July 2010 - August 2012
Shire HGT February 2009 - July 2010
Shire Human Genetic Therapies June 2006 - February 2009
Biogen Idec 2002 - 2006
Skills
Pharmaceuticals, Managed Care, Biotechnology, Strategic Planning, Distribution Strategy, Forecasting, Financial Planning, Orphan Drug Commercial..., Biopharmaceuticals, Distribution Strategies, Management, Pharmaceutical Industry, Product Launch, Strategic Financial..., Strategic Partnerships, Strategy, Leadership, Life Sciences, Business Strategy, Cross-functional Team..., Clinical Development, Pharmaceutical Sales, Medical Devices
Education
Saint Joseph's University - Erivan K. Haub School of Business 2007 — 2009
Master of Business Administration (M.B.A.), Pharmaceutical Marketing and Management
Westfield State College 1993 — 1997
BA
bluebird bio October 2013 - Present
Teva Biopharmaceuticals USA August 2012 - April 2013
Shire HGT 2011 - 2012
Ipsen April 2010 - September 2011
Skills
Protein Purification, DoE Execution, Process Characterization, Molecular Cloning, SDS-PAGE, Western Blotting, Purification, Protein Chemistry, ELISA, Cell Culture, Biochemistry, Biotechnology, Chromatography, HPLC, AKTA
Education
University of Massachusetts, Amherst 2007 — 2009
Bachelor of Science (BS), Biochemistry and Molecular Biology
Saint Michael's College 2004 — 2007
Bachelor of Science (BS), Biology, Chemistry Minor
Philips Healthcare (Contractor) May 2015 - Present
Shire HGT September 2014 - December 2014
Pfizer September 2013 - December 2013
Shire HGT January 2012 - September 2013
Siemens Healthcare September 2010 - March 2011
Genzyme March 2010 - June 2010
Insulet Corporation November 2009 - March 2010
PAREXEL April 2008 - July 2008
EMD Serono April 2007 - December 2007
Wyeth Pharmaceuticals November 2005 - March 2006
Skills
Documentum, Oracle Clinical, Biotechnology, Medical Devices, Data Management, Data Analysis, Clinical Trials, Excel, Word, Quality Assurance, Microsoft Office, Compliance, Clinical Data Management, Outlook, FDA, GMP, GCP, LIMS, Clintrial, Medidata Rave, Phase Forward InForm, SOP review, Software Documentation
Education
St. Lawrence University 1981 — 1985
BS, Biology and Environmental Studies
Ecovative Design June 2011 - Present
Rensselaer Polytechnic Institute September 2009 - November 2012
Biogen Idec June 2010 - January 2011
Shire HGT June 2009 - August 2009
Rensselaer Polytechnic Institute September 2008 - May 2009
Shire HGT June 2008 - August 2008
Education
Rensselaer Polytechnic Institute 2007 — 2011
Bachelors of Science, Biochemistry and Biophysics
Oxyrane UK, Ltd July 2015 - Present
uniQure July 2015 - Present
Oxyrane UK Ltd April 2012 - July 2015
Shire HGT 2006 - June 2012
Wyeth Research 2001 - 2005
Wyeth Research 1999 - 2001
Wyeth Research 1997 - 1999
University of Pittsburgh School of Medicine 1992 - 1997
University of California at San Francisco Medical Center 1991 - 1992
University of California at San Francisco Medical Center 1988 - 1991
Skills
Drug Development, Clinical Development, Clinical Trials, Translational Medicine, Genomics, Human Genetics, Healthcare Information..., Biotechnology, Oncology, Pharmaceutical Industry, Immunology, Psychiatry, Biomarkers, Regulatory Submissions, Lifesciences, Clinical Research, Pharmacology, Biopharmaceuticals, Medical Affairs, Drug Discovery, GCP, CRO, Infectious Diseases, Medicine, Neuroscience
Education
The Ohio State University College of Medicine 1981 — 1984
PhD, Pharmacology
The Ohio State University College of Medicine 1978 — 1981
MD, Medicine
Stanford University 1973 — 1977
BS, Biology
Shire December 2008 - Present
Shire HGT March 2004 - December 2008
Education
Pepperdine University, The George L. Graziadio School of Business and Management
MSOD, Organization Development
Simmons School of Management
MBA, Business
Shire Pharmaceuticals March 2015 - Present
Shire HGT January 2011 - Present
Avecia Biotechnology January 2009 - December 2010
Novartis Institutes for BioMedical Research November 2004 - May 2008
Biogen 2002 - 2004
Art Technology Group 2001 - 2002
Vertex Pharmaceuticals 1997 - 1999
Alpha-Beta Technology 1997 - 1998
Skills
Risk Mitigation, Supplier Management, Contract Negotiation, Supply Chain Security, Supply Chain Management, Supply Agreements, GMP, Biotechnology Industry, Pharmaceutical Industry, Supply Chain..., Supplier Quality, Contract Management, cGMP practices, Materials Management, Raw Materials, Quality Auditing, Supply Management, Procurement, CAPA, Supply, Purchasing, Cross-functional Team..., Global Sourcing, Supply Chain, Risk Management, Biotechnology, Management, Life Sciences, Strategic Sourcing
Education
Rhode Island College
BA, Psychology
Shire HGT May 2009 - March 2013
Shire HGT February 2008 - May 2009
Rhytec April 2005 - January 2008
Genzyme May 2002 - April 2005
Skills
Clinical Trials, Pharmaceutical Industry, Clinical Development, CTMS, Biotechnology, Clinical Research
Education
Northeastern University 1997 — 1999
MS, Clinical Exercise Physiology
University of Massachusetts, Amherst
BS, Business/Exercise Science
TEI Biosciences Inc. November 2012 - Present
Shire HGT April 2011 - November 2013
Ikaria February 2004 - May 2011
Merck February 2003 - December 2004
Novartis January 1998 - December 2003
Henry Company February 1993 - February 1998
Skills
Pharmaceutical Sales, Managed Care, Hospital Sales, Pharmaceutical Industry, Sales Effectiveness, Cardiology, Neurology, Pulmonology, Urology, Buy & Bill, Gastroenterology, Oncology, Cross-functional Team..., Product Launch, Rheumatology, Sales, Sales Management, Dermatology, Product Development, Market Research
Education
Saint Joseph's University - Erivan K. Haub School of Business 2005 — 2008
Master of Business Administration (M.B.A.), Management, 3.94
Purdue University 1987 — 1991
BA, Political Sci/ History, 3.15
Northwestern University September 2010 - August 2015
Johns Hopkins University January 2008 - June 2010
Shire HGT June 2009 - August 2009
Skills
Python, Molecular Biology, Microfabrication, Mammalian Cell Culture, Bacterial Cell Culture, Microsoft Office, PCR, Linux, Bash, Biochemistry, Science, Chemistry, Cell Culture, Materials Science, Flow Cytometry, Molecular Cloning, Microscopy, Tissue Engineering
Education
Northwestern University 2010 — 2015
Doctor of Philosophy (Ph.D.), Chemical and Biological Engineering, 3.80
The Johns Hopkins University 2006 — 2010
Bachelor of Science (BS), Chemical and Biomolecular Engineering, 3.72
Shire HGT October 2011 - Present
Pfizer Pharmaceuticals June 2006 - June 2011
Pfizer September 2000 - June 2006
Pfizer June 1997 - September 2000
Skills
cGMP, Investigations, Compliance, Auditing, Manufacturing, Documentation, Quality Assurance, Quality Systems, Computer System..., GxP, Software Documentation, Quality System, GMP, Document Management, Aseptic Processing, Root Cause Analysis, Change Control, Quality Auditing, Biopharmaceuticals, Private Investigations, V&V, FDA, Validation, Deviations, Management, Technology Transfer, Quality Control, Pharmaceutical Industry, Trackwise, CAPA, Sop, GLP, Cleaning Validation, LIMS, 21 CFR Part 11, Aseptic Technique, Biotechnology, FDA GMP, Regulatory Requirements, SOP
Education
Southern New Hampshire University 1984 — 1988
Bachelor of Science, Business-Hotel & Restaurant Mgmt
Shire Pharmaceuticals March 2014 - Present
Shire HGT April 2011 - March 2014
Pfizer August 2010 - May 2011
Pfizer August 2007 - September 2010
Pfizer August 1997 - July 2007
Skills
Biochemistry, Biology, Biomarkers, Biopharmaceuticals, Biotechnology, Cell Biology, Cell Culture, Clinical Development, Clinical Trials, Drug Development, Drug Discovery, Genetics, Genomics, Human Genetics, Immunology, Lifesciences, Molecular Biology, Oncology, Pharmaceutical Industry, Pharmacogenomics, Pharmacology, Research, Technology Transfer, Bioinformatics, Life Sciences
Education
University of Pittsburgh 1994 — 1997
PhD, Human Genetics
The Johns Hopkins University School of Medicine 1992 — 1994
MS, Molecular Genetics
University of Delaware 1986 — 1990
BA, Biology
Genzyme January 2014 - Present
Genzyme November 2012 - Present
Shire HGT January 2012 - November 2012
Shire HGT 2008 - February 2012
Skills
Manufacturing, Documentation, Troubleshooting, cGMP, Process Improvement, Continuous Improvement, LIMS, Biotechnology, GMP, SOP, Aseptic Technique, Technology Transfer, Validation, Lean Manufacturing, Change Control, Inventory Management, Pharmaceuticals, 21 CFR Part 11, Aseptic Processing, Biopharmaceuticals, Filtration, Cell Culture, Change Management, Excel, Purification, Chromatography, Protein Purification, Word, PowerPoint, CAPA, Quality Systems, Microsoft Office, Process Development, Cross-functional Team..., ERP, Technical Writing, Data Analysis, Materials Management, Supply Chain Management, Root Cause Analysis, MRP, Forecasting, GxP, Pharmaceutical Industry, Quality System, SOP development, Team Leadership, Team Management, Trackwise, Sop
Education
Notre Dame College 1997 — 2001
Bachelor of Science (B.S.), Major Biology Minor Chemistry
Shire March 2014 - Present
Shire HGT October 2009 - March 2014
Eisai Pharmaceuticals (formerly MGI Pharma, INC.), Lexington, MA January 2008 - June 2009
MGI PHARMA February 2004 - January 2008
PPD May 1997 - February 2004
Skills
Osteoporosis, Oncology, Clinical Trials, Clinical Research, Pharmaceutical Industry, EDC, Clinical Development, Drug Development, CTMS, CRO, GCP, Infectious Diseases, Rare Diseases, Pediatrics, International Project..., Therapeutic Areas, Clinical Study Design, Regulatory Submissions, Protocol, Biotechnology
Education
University of Baltimore 2005 — 2006
Graduate Certificate, Business Fundamentals
Towson University
BS, Physical Education / Athletic Training
Bristol-Myers Squibb February 2014 - Present
Pall Life Sciences January 2013 - February 2014
Shire Pharmaceuticals April 2010 - January 2013
Shire HGT April 2010 - April 2011
Lonza May 2008 - April 2010
Tufts-New England Medical Center 2009 - February 2010
University of New Hampshire 2006 - 2007
Skills
Technology Transfer, Downstream Processing, Design of Experiments, Filtration, Process Simulation, GMP, Purification, Quality by Design, CAPA, Chromatography, Ultrafiltration, Biopharmaceuticals, cGMP manufacturing, Column Chromatography, Quality System, Trackwise, JMP, Sop, SPC, Scale-up, Process Modeling, Upstream Processing, Process Validation, Cell Culture, Mammalian Cell Culture, Biotechnology
Education
Tufts University
Master of Engineering, Chemical Engineering, Bioengineering
University of New Hampshire
Bachelor of Science, Biochemistry
Shire HGT January 2012 - Present
Shire HGT June 2008 - June 2012
Amgen July 2002 - February 2008
Immunex Corp January 2002 - July 2002
Wyeth Pharmaceuticals July 2000 - January 2002
Education
Providence College 1996 — 2000
BS, Biology
Alnylam Pharmaceuticals August 2010 - Present
Shire Pharmaceuticals, Inc. 2007 - Present
Shire HGT May 2007 - August 2010
serono 2004 - 2007
millennium 1996 - 2002
Millennium Pharmaceuticals Inc 1996 - 2002
Education
Suffolk University Law School 2000 — 2003
JD, Intellectual Property
ClearView Healthcare Partners July 2015 - Present
ClearView Healthcare Partners December 2013 - July 2015
ClearView Healthcare Partners June 2012 - December 2013
Scientia Advisors January 2010 - July 2011
Scientia Advisors June 2008 - January 2010
Shire HGT June 2007 - June 2008
Skills
Strategy Development, Business Strategy, Market Entry, Medical Devices, Life Sciences, Diagnostics, Pharmaceuticals, Healthcare, Biotechnology, Financial Modeling, Market Research, Marketing Strategy, Lifesciences, Pharmaceutical Industry, Market Analysis, Strategy, Biomedical Engineering, Management Consulting, Strategic Consulting
Education
The Johns Hopkins University
BS
Vertex Pharmaceuticals June 2013 - Present
Seaside Therapeutics October 2012 - June 2013
Shire HGT April 2009 - October 2012
Lonza March 2004 - March 2009
Amgen 2000 - 2002
Skills
CAPA, GMP, Quality Assurance, Auditing, Aseptic Processing, Validation, Trackwise, Quality System, Lifesciences, FDA, Biotechnology, Change Control, LIMS, GxP, Sop
Education
University of Strathclyde 2009 — 2012
Candidate for Master's Degree, Quality Pharmaceuticals and Good Manufacturing Practices
Stony Brook University 1991 — 1995
BS, Biological Sciences
Validation Technologies, Inc. August 2015 - Present
N/A - Independent Contractor April 2010 - August 2015
Pharmalucence 2011 - 2012
Shire HGT 2010 - 2010
Shire HGT 2010 - 2010
Valsource August 2002 - September 2009
Valsource August 2002 - September 2009
Lonza 2008 - 2009
Regeneron Pharmaceuticals, Inc. 2007 - 2009
Regeneron Pharmaceuticals, Inc. 2007 - 2009
Skills
GMP, CAPA, Computer System..., V&V, FDA, Change Control, 21 CFR Part 11, Cleaning Validation, Biotechnology, Pharmaceutical Industry, GxP, Aseptic Processing, Quality System, Technology Transfer, Biopharmaceuticals, Sop, GAMP, Regulatory Affairs, Process Simulation, Validation, SOP
Education
Northeastern University 1989 — 1994
BS, chemical engineering
Number 2 High School Attached to East China Normal University
brookline high school
ARIAD Pharmaceuticals, Inc. October 2012 - Present
Genzyme May 2011 - October 2012
Shire HGT October 2009 - April 2011
General Investment & Development February 2005 - July 2009
Fanning Personnel January 2004 - February 2005
MRI Network June 2001 - August 2003
Skills
Onboarding, Training, Talent Management, SOP, Performance Management, Employee Relations, Human Resources, Training Delivery, GMP, HRIS, Talent Acquisition, Succession Planning, Instructional Design, Process Improvement, Employee Benefits, Organizational..., Learning Management..., Technical Training, Instructor-led Training, Hands-on Training, Blended Learning, Applicant Tracking..., Benefits Administration, Organizational..., Personnel Management, Change Management, New Hire Orientations, Employee Training, HR Policies, GxP, SOP Development
Education
Suffolk University 2007 — 2010
MS, HR
Boston College 1999 — 2003
BA, English
Shire HGT March 2007 - Present
Education
Salem State College
MSN, Nursing
Alexion Pharmaceuticals, Inc. November 2014 - Present
Shire HGT October 2011 - November 2014
Bristol-Myers Squibb/Biotechnology 2007 - October 2011
ImClone Systems 2001 - 2007
Skills
Microbiology, CAPA, Quality Control, Biotechnology, Validation, GMP, FDA, Sop, Change Control, Biopharmaceuticals, 21 CFR Part 11, GLP, LIMS, SOP, Technology Transfer, Pharmaceutical Industry
Education
Seton Hall University
Master in Science, Microbiology
University of Denver
B.A.
OvaScience August 2015 - Present
Shire HGT June 2011 - Present
Cubist Pharmaceuticals May 2007 - June 2011
Wyeth Biotech 2000 - 2007
Skills
Technology Transfer, Biotechnology, Validation, GMP, Biopharmaceuticals, CAPA, FDA
Education
Post University 2013 — 2016
MBA
University of Massachusetts Lowell 1997 — 2006
MS, Chemical Engineering
Shire HGT ScientistShire Human Genetic Therapies2004 - Present
TKT May 2004 - 2005
Skills
Protein Purification, Biotechnology, Protein Chemistry, Cell Culture, ELISA
Education
The University of Texas Southwestern Medical Center at Dallas 1980 — 1988
PhD, biochemistry
bluebird bio July 2015 - Present
Cubist Pharmaceuticals May 2013 - Present
Shire HGT March 2008 - April 2013
Amgen January 2001 - March 2008
ValSource 1999 - 2002
Skills
Validation, CAPA, 21 CFR Part 11, Change Control, Aseptic Processing, GMP, FDA, Biopharmaceuticals, Trackwise, V&V, Quality System, Technology Transfer, Computer System..., Quality Assurance, GxP, Aseptic Technique, Sop, Cleaning Validation, Biotechnology, LIMS, Pharmaceutical Industry, GLP, Deviations, FDA GMP
Education
Salve Regina University 1991 — 1995
Bachelor of Science (B.S.), Biology, General
Sarepta Therapeutics July 2015 - Present
Keryx Biopharmaceuticals April 2014 - May 2015
Vertex Pharmaceuticals July 2010 - November 2013
Shire HGT April 2005 - June 2010
Biogen November 2002 - April 2005
Biogen February 1995 - June 2001
GE Plastics June 1980 - February 1995
Skills
Gastroenterology, Pharmaceutical Industry, Managed Care, Oncology, Biotechnology, Management, Strategy, Business Development, Program Management, Leadership, Product Launch, Process Improvement, CRM
Education
Saint Michael's College 1976 — 1980
BA, Business Administration
Genzyme August 2011 - Present
Shire HGT 2009 - 2011
Wyeth Biotech June 2001 - 2009
Skills
Technology Transfer, GMP, Validation, Biopharmaceuticals, Biotechnology
Education
Stevens Institute of Technology
Graduate Courses, Chemical Engineering
Tufts University
Graduate Courses, Biochemical Engineering
University of Delaware
BS, Chemical Engineering
CKDConsulting April 2002 - Present
LabWare 1996 - Present
Cephalon September 2007 - 2010
General Mills January 2007 - August 2007
Sicor November 2006 - December 2006
Shire HGT April 2006 - November 2006
Teva Pharmaceuticals March 2006 - April 2006
Schering-Plough Pharmaceuticals November 2005 - February 2006
Sicor August 2004 - November 2005
Consumer Testing Labs September 2004 - October 2005
Skills
LIMS, SAP, Validation, 21 CFR Part 11, Computer System..., Laboratory, Pharmaceutical Industry, GAMP, Glassware, Change Control, GxP, FDA, GMP, Informatics, Quality Assurance, Analytical Chemistry, CAPA, Sop, Software Documentation, Lifesciences, Crystal Reports, Software Implementation, V&V, Quality System, Testing, Biotechnology, Oracle, Quality Management, Requirements Analysis, Quality Control, Data Management, Regulatory Affairs, Software Project..., Integration, SDLC, Technology Transfer, Chemistry, R&D, Systems Analysis, GLP, Regulatory Requirements, SAP R/3, Business Process, Medical Devices, Data Migration, Regulatory Submissions, Requirements Gathering, Process Simulation, Databases, Pharmaceutics
Education
Stephen F. Austin State University 1990 — 1996
MS, Conputer Science
East Texas Baptist College 1974 — 1979
BS, Chemistry
Akebia Therapeutics June 2014 - Present
Shire Pharmaceuticals September 2012 - May 2014
Shire HGT September 2008 - September 2012
Critical Therapeutics October 2007 - June 2008
Critical Therapeutics December 2003 - September 2007
Millennium Pharmaceuticals, Inc. 1999 - 2003
Genetics Institute 1996 - 1998
Skills
Certificate in Project..., Clinical Development, Drug Development, Drug Discovery, Cross-functional Team..., Pharmaceutical Industry, Program Management, Biotechnology, Strategy, Strategic Planning
Education
Smith College
BA
Genentech 2013 - Present
Anika Therapeutics 2011 - 2013
Shire HGT 2005 - 2009
Amgen 2004 - 2005
Novo Nordisk 2001 - 2003
Skills
Biopharmaceuticals, Validation, GMP, Process Development, Purification, Technology Transfer, Commissioning, FDA, Process Control, Project Managenment, Manufacturing Support, Design of Experiments, SPC, Process Engineering, Quality by Design, Protein Purification, Cell Culture, Manufacturing, Biotechnology, Process Simulation
Education
The University of British Columbia 1994 — 1997
Masters of Applied Science, Chemical and Biological Engineering
Nanjing University of Technology
Shire Pharmaceuticals March 2014 - Present
Shire HGT October 2011 - March 2014
Shire Human Genetic Therapies October 2010 - October 2011
Covidien October 2008 - November 2010
Delta Point December 2006 - October 2008
Bristol-Myers Squibb 2005 - 2006
Biogen Idec 2002 - 2005
Elan 1997 - 2003
Skills
Managed Care, Neurology, Rheumatology, Pharmaceutical Sales, Oncology, Medical Devices, Pharmaceutical Industry, Infectious Diseases, Biotechnology, Gastroenterology, Cardiology, Market Access, Clinical Research, Training
Education
St. John's University, The Peter J. Tobin College of Business 1995 — 1997
MBA, Management
State University of New York at Albany 1988 — 1992
Shire December 2013 - Present
M+W Group June 2012 - December 2013
Shire HGT August 2011 - June 2012
Bristol-Myers Squibb May 2008 - August 2011
Amgen April 2006 - April 2008
Fluor June 2001 - March 2006
Skills
Validation, Commissioning, Project Engineering, Chromatography, CIP, FMEA, Technical Writing, Preventive Maintenance, P&ID development, Clean Utilities, Bulk Gases, Procedure Development, Super Skids / Modules, Project Execution, Equipment Design, Proposal Development, Purchase Requisitions, PM Development, USP Waster System..., Single Use Systems, Technical Transfers, FAT Planning and..., Continuous Process..., Safety Culture, Quality Risk Management, QbD, CIP / SIP Development, Process Engineering, Vendor Coordination, Aseptic Processing, Fat, GMP, HAZOP, P, Quality by Design
Education
Penn State University 1997 — 2001
BS
Aegerion Pharmaceuticals November 2014 - Present
Shire HGT August 2010 - November 2014
Syndax Pharmaceuticals June 2008 - September 2010
Therion Biologics 2001 - 2006
Education
Rochester Institute of Technology 1997 — 2001
Shire HGT Development CoordinatorMillennium Pharmaceuticals2001 - 2006
Education
Simmons College - Simmons School of Management 2006 — 2008
Lonza February 2014 - Present
Lonza Biologics January 2012 - Present
Lonza Biologics August 2010 - January 2012
Shire HGT March 2010 - August 2010
Pfizer November 2006 - May 2010
Lonza Biologics, Inc. 1999 - 2006
Lonza 1999 - 2006
Skills
Chromatography, Technology Transfer, Biotechnology, Purification, GMP, Biopharmaceuticals, Protein Purification, Cell Culture, LIMS, Validation, Filtration, Sop, Fermentation, HPLC, ELISA, Lifesciences, CAPA, GLP, V&V, Molecular Biology
Education
Plymouth State University 1995 — 1998
BS
Shire Pharmaceuticals April 2014 - Present
Shire HGT December 2009 - April 2014
Eisai Medical Research (formerly MGI Pharma) January 2008 - September 2009
Bristol-Myers Squibb Medical Imaging June 2007 - December 2007
Boston Life Sciences 2004 - 2007
Perceptive Informatics 2002 - 2004
Skills
Clinical Development, Clinical Trials, Clinical Operations, Biotechnology, Pharmaceutical Industry, CRO, Drug Development, GCP, Oncology, Lifesciences, EDC, CTMS, Regulatory Submissions, FDA
Education
Simmons College
Bachelor of Science (BS), Biology
Thermo Fisher Scientific July 2014 - Present
Thermo Fisher Scientific October 2010 - July 2014
Shire HGT August 2008 - October 2010
ValSource, LLC October 2007 - August 2008
Amgen October 2005 - October 2007
Education
Providence College 1999 — 2003
Bachelor of Science
Bishop Hendricken High School 1996 — 1999
Mesoblast March 2012 - Present
Mesoblast, Inc. September 2011 - March 2012
Progenics Pharmaceuticals December 2009 - September 2011
Wyeth, Global Regulatory Affairs April 2009 - December 2009
Shire HGT December 2008 - March 2009
Idera Pharmaceuticals, Inc. 2005 - 2008
Osiris Therapeutics April 2003 - October 2004
Zycos, Inc. 1999 - 2002
Skills
Regulatory Affairs, Regulatory Submissions, Biotechnology, GMP, Pharmaceutical Industry, Quality Control, FDA, Validation, Drug Development, Microbiology, CRO, Quality System, HPLC, Quality Assurance, Clinical Development, Change Control, IND, CMO management, GLP, Clinical Trials, Analytical Chemistry, Protein Chemistry, Biopharmaceuticals, CAPA, ELISA, Technology Transfer, CMC, Vaccines, Assay Development, Monoclonal Antibodies, V&V, Biologics, 21 CFR Part 11, LIMS, Aseptic Processing, Cleaning Validation, Sop, Chromatography, SOP
Education
University of California, San Francisco 1986 — 1988
Postdoctoral Fellow, Biochemistry & Biophysics
Stanford University 1983 — 1986
Postdoctoral Fellow, Molecular Biology
University of Pennsylvania 1975 — 1983
Ph.D., Genetics/Molecular Biology
University of California, Berkeley 1972 — 1974
A.B., Mathematics
Shire Pharmaceuticals April 2014 - Present
Shire HGT February 2011 - Present
ACCELERON PHARMA, INC October 2006 - February 2011
POINT THERAPEUTICS INC December 2002 - August 2006
AVANT IMMUNOTHERAPEUTICS INC February 2000 - June 2002
The Medicines Company October 1998 - February 2000
GENETICS INSTITUTE August 1997 - October 1998
BIOGEN, INC July 1995 - August 1997
Dana-Farber Cancer Institute September 1990 - June 1995
Skills
Biotechnology
Education
Saint Anselm College
Bachelor of Arts, Business
Shire September 2014 - Present
Shire HGT February 2010 - August 2014
Cytosol Laboratories 2009 - February 2010
Wyeth Biotech 1993 - 2008
Wyeth Biotech 2005 - 2007
Wyeth Biotech 2002 - 2004
Wyeth Biotech 2000 - 2001
Wyeth Biotech 1999 - 2000
Wyeth Biotech 1998 - 1999
Wyeth Biotech (Genetics Institute) 1995 - 1997
Skills
GMP, CAPA, Validation, Biotechnology, Change Control, FDA, SOP, Pharmaceutical Industry, Quality System, Biopharmaceuticals, 21 CFR Part 11, Aseptic Processing, 5S, Assay Development, Auditing, Cell, Cell Culture, Clinical Development, Computer System..., Contract Manufacturing, Drug Development, GLP, GxP, Inspection, LIMS, Laboratory, Lean Manufacturing, Leadership, Lifesciences, Management, Manufacturing, Medical Devices, Microbiology, Operational Excellence, Program Management, Project Management, Quality Assurance, Quality Control, Regulatory Affairs, Regulatory Submissions, Six Sigma, Sop, Technology Transfer, Testing, Trackwise, V
Education
Salem State University 1988 — 1992
Bachelor, Biology
Shire Pharmaceuticals June 2010 - Present
Shire HGT June 2009 - June 2010
BD Biosciences January 2004 - April 2008
Education
Saint Anselm College 1998 — 2002
BA, Biology
Retrophin Inc. May 2014 - Present
XenoPort, Inc./PDI Inc. May 2013 - May 2014
Medical Science Solutions March 2010 - May 2013
Celgene April 2009 - March 2010
Shire HGT 1999 - 2008
Genentech BioOncology March 1991 - September 1999
Marion Labs March 1987 - May 1991
Skills
Oncology, Hematology, Clinical Trials, Biotechnology, Endocrinology, Biopharmaceuticals, Clinical Development, Cardiology, Pharmaceutical Industry, Infectious Diseases, Rheumatology, Gastroenterology, Immunology, Genetics, Epidemiology, Start-ups, Buy & Bill, Orphan Drugs, Distributors, Disease Registries, Building Treatment..., Neurology, Pain Management, Coaching- Basketball, Medical Affairs
Education
Walden University 2009 — 2012
PhD (C), Public Health Specializing In Epidemiology, 3.95
Texas State University 1982 — 1985
BBA, Marketing
Vtesse, Inc. June 2015 - Present
Shire Pharmaceuticals August 2012 - June 2015
Shire HGT January 2012 - August 2012
Shire Human Genetic Therapies February 2010 - January 2012
Shire HGT January 2009 - February 2010
Shire Human Genetic Therapies, Inc January 2006 - January 2009
Centocor 2005 - 2006
3M Pharmaceuticals 2000 - 2005
Skills
Market Access, Pharmaceutical Industry, Biotechnology, Clinical Development, Lifesciences, Oncology, Healthcare, Sales, Infectious Diseases, Regulatory Affairs, Biopharmaceuticals, Pharmaceutical Sales, Dermatology, Medical Devices, Managed Care, Team Leadership, Product Launch, Patient Advocacy
Education
The University of Georgia 1993 — 1997
BS, Biochemistry and Molecular Biology
Shire HGT October 2011 - Present
Gilead Sciences June 2009 - November 2011
Cell Genesys 2004 - 2009
Chiron Corporation 1987 - 2004
Education
Saint Mary's College of California 2009 — 2010
MBA, Trans-Global Business
University of California, Davis
BS, Biochemistry
Cook Pharmica June 2014 - June 2015
Biogen Idec 2013 - 2014
Shire HGT 2012 - 2013
Pfizer 2012 - 2012
Avax-Technologies June 2008 - February 2011
AMRI 2011 - 2011
Merck 2008 - 2008
GlaxoSmithKline January 2006 - July 2007
Skills
Dealing with adversity, V&V, Medical Devices, Analytical Chemistry, ISO 13485, GMP, Process Improvement, Chromatography, Change Control, Investigation, Product Development, Compliance, Internal Audit, Validation, Clinical Research, Clean Rooms, Cleaning Validation, Troubleshooting, Translation, Process Engineering, Technology Transfer, Software Documentation, 21 CFR Part 11, GxP, Aseptic Processing, Clinical Development, Root Cause Analysis, LIMS, ISO, Trackwise, Operational Excellence, Computer System..., Vaccines, Scale-up, Six Sigma, Facility Start-up, Equipment Installation, Commissioning, Lean Manufacturing, Stage-Gate, Regulatory Affairs, Risk Assessment, Quality Auditing, Filtration, Regulatory Requirements, Drug Development, Regulatory Submissions, Formulation, Contract Manufacturing, Drug Delivery
Education
Temple University 2008 — 2012
MS QA/RA, Compliance
Temple University 1997 — 2003
B.S., Biochemistry
Shire HGT January 2013 - Present
Shire HGT June 2012 - January 2013
Texas Tech University Health Sciences Center July 2011 - September 2012
Texas Tech University Health Sciences Center June 2010 - May 2011
Texas Tech University Health Sciences Center January 2010 - April 2010
Skills
Aktapurifier, Molecular Cloning, Protein Purification, Protein Expression, SDS-PAGE, Protein Characterization, Affinity Chromatography, Ion Exchange..., FPLC, HPLC, Protein Crystal Screens, Microfluidics-Microfluid..., Site-directed..., Primer Design, TA Cloning, Gateway Cloning, Size exclusion..., Mosquito Crystal Robot, Western Blotting, Protein Chrystallography
Education
Texas Tech University 2009 — 2011
Master's degree, Biotechnology, A
University of Mumbai 2007 — 2009
Master's degree, Zoology, A
Bio-Rad Laboratories November 2012 - Present
Philips Medical Systems April 2011 - November 2012
Shire HGT September 2010 - May 2011
Kinetic Concept Inc. June 2010 - August 2010
Philips Medical Systems June 2009 - April 2010
USC Regulatory Science Program September 2008 - May 2009
Skills
Regulatory Affairs, FDA, Regulatory Submissions, Medical Devices, ISO 13485, Regulatory Requirements, Quality System, GMP, Biotechnology, 21 CFR Part 11, Lifesciences, Sop, GLP, V&V, ISO 14971, CE marking, Quality Assurance, Regulations, Change Control, Design Control
Education
University of Southern California 2008 — 2009
Masters, Regulatory Affairs
Rajiv Gandhi University of Health Sciences 2002 — 2006
Bacholer, Pharmaceutical Sciences
RAPS
Sanofi Pasteur May 2014 - Present
Shire Pharmaceuticals October 2013 - May 2014
Shire HGT October 2010 - September 2013
Shire HGT May 2007 - September 2010
Education
RMIT University 1992 — 1997
PhD, Biochemistry and Biotechnology
Shire HGT April 2012 - Present
Stryker Biotech June 2001 - October 2011
Bayer Diagnostics, Inc January 1999 - June 2001
Bayer August 1996 - June 2001
Bayer HealthCare 1995 - 1999
Bayer Diagnostics 1995 - 1999
Chiron Diagnostics 1995 - 1999
Ciba-Corning Daignostic 1995 - 1999
Skills
SDS-PAGE, ELISA, Lyophilization, Protein Chemistry, Formulation Development, HPLC, Stability Studies, Stability Testing, Karl Fisher, UV/Vis, Solubility, Formulation, Sop, R&D, GMP, Microbiology, GLP, Biotechnology, Validation, FDA, SOP, Technology Transfer, Pharmaceutical Industry
Education
The College of Saint Rose 1992 — 1995
BS, Biochemistry
The College of Saint Rose 1992 — 1995
Bachelor of Science, Biochemistry
Sensitech August 2012 - Present
Exemplar Pharma, LLC, August 2011 - August 2012
Proventys, Inc, June 2010 - May 2011
Anika Therapeutics June 2009 - May 2010
Kraft Foods February 2009 - April 2009
Teleflex Medical August 2008 - January 2009
Analog Devices August 2007 - August 2008
NFPA November 2006 - August 2007
Shire HGT November 2003 - November 2006
Skills
Software Documentation, Technical Writing, Validation, GMP, Quality System, FDA, Document Management, Change Control, Training, V&V, Medical Devices, SDLC
Education
Providence College 1994 — 1998
Bachelor of Arts, English/Writing
Confidential January 2012 - Present
Shire HGT August 2010 - December 2010
Norchem Corporation February 2009 - September 2009
UniFirst Corporation July 2005 - February 2009
Quaker Fabric Corporation June 2002 - April 2005
Mabbett & Associates Inc March 2000 - May 2002
ENSR December 1999 - February 2000
RAYTHEON ENGINEERS & CONSTRUCTORS August 1995 - November 1999
Honeywell-Bull October 1984 - April 1995
Skills
Environmental Compliance, Process Engineering, Air Pollution, Engineering, Process Simulation, Water, Environmental Awareness, Wastewater Treatment, Chemical Engineering, Manufacturing, Water Treatment, Environmental..., Technical Writing, Hazardous Waste..., GMP, Software Documentation, Project Planning, Project Management, Troubleshooting, Filtration
Education
Northeastern University 2013 — 2013
Chemical Engineering
Minuteman Technical School 2010 — 2010
Certification, Biotechnology
Northeastern University 1979 — 1981
Master's degree, Chemical Engineering
Northeastern University 1971 — 1974
BS, Chemical Engineering
Northeastern University
Chemical Engineering
Shire HGT 2006 - 2009
Wyeth Biotech 1997 - 2001
Genetics Institute 1993 - 1997
Genetics Institute 1990 - 1993
Millipore 1984 - 1990
Education
Southern New Hampshire University
MBA
University of Connecticut 1975 — 1979
BS
Medtronic Vascular July 2014 - Present
Medtronic Vascular February 2013 - June 2014
Lonza January 2012 - February 2013
Lonza July 2011 - December 2011
Shire HGT May 2011 - July 2011
Organogenesis Inc. October 2010 - April 2011
Northeastern University August 2009 - April 2011
Infosys Technologies Ltd January 2008 - August 2009
VPMs Polytechnic Institute,Mumbai June 2007 - January 2008
Grant Medical Foundation's Ruby Hall Clinic,Pune July 2006 - January 2007
Education
Northeastern University 2009 — 2011
Masters, Regulatory Affairs for Drugs, Biologics and Medical Devices
University of Mumbai 2003 — 2007
Bachelors, Biomedical Engineering
Shire Pharmaceuticals November 2014 - Present
Shire HGT December 2010 - November 2014
Pfizer October 2009 - September 2010
Wyeth Biotech June 2006 - October 2009
Wyeth September 2003 - June 2006
Skills
Pharmaceutical Industry, Change Control, GMP, Biopharmaceuticals, Technology Transfer, Biotechnology, CMC, Validation
Education
Tufts University, The Gordon Institute 2006 — 2008
MS, Engineering Management
Saint Anselm College 1991 — 1995
BA, Natural Science
Shire Human Genetic Therapies Inc March 2013 - Present
PharmaNet/i3 October 2012 - Present
Biogen Idec October 2012 - January 2013
Shire HGT July 2012 - October 2012
Shire HGT March 2012 - July 2012
Beth Israel Deaconess Medical Center August 2009 - March 2012
Rolmax Law Office May 2006 - September 2006
Anhui High People’s Court May 2005 - September 2005
Skills
Westlaw certified in..., Westlaw certified in..., Westlaw certified..., Research, Legal Research, Project Management, Outsourcing and..., Human Subject Research..., Investigator Initiated..., Clinical Trials, Medical Affairs, Pharmaceutical Industry, Life Sciences, Lifesciences, Management, Regulatory Affairs, Leadership, Biopharmaceuticals, Biotechnology, Clinical Development, Contract Management
Education
Suffolk University Law School 2009 — 2013
JD, Law
Suffolk University Law School 2008 — 2009
L.L.M., International Bussiness Law
Regeneron Pharmaceuticals January 2011 - Present
Shire HGT December 2009 - December 2010
Ista Pharmaceuticals January 2007 - December 2009
Walgreens 2005 - 2007
Eli Lilly 2004 - 2005
Skills
Clinical Trials, Pharmaceutical Industry, Medical Writing, Diabetes, Pharmacology, Medical Education, Training, Training Delivery, Operational Excellence, Public Speaking, Presentations, Presentation Coaching, Ophthalmology, Written & Oral..., Educational Program..., Managed Care, Drug Safety, Patient Safety, Safety, Clinical Development, Clinical Research, Medical Affairs
Education
Texas Tech University Health Sciences Center
PharmD, Pharmacy
Complya Consulting Group LLC December 2014 - Present
Voisin Consulting April 2012 - December 2014
Dyax Corp. February 2010 - February 2012
Sanofi Pasteur August 2008 - February 2010
Shire HGT August 2005 - August 2008
Skills
GMP, Regulatory Affairs, FDA, GLP, Biotechnology, Validation, Pharmaceutical Industry, Technology Transfer, Drug Development, Quality System, Quality Assurance, Biopharmaceuticals, CAPA, GxP, 21 CFR Part 11, SOP, CMC, Life Sciences, Change Control
Education
Portland State University 1984 — 1986
MS., Chemistry
Seattle University 1980 — 1984
BS, Chemistry
Novartis Institutes for BioMedical Research July 2014 - Present
Zalicus Incorporated May 2012 - July 2014
Shire HGT August 2011 - May 2012
Brigham and Women's Hospital; Laboratory for Drug Discovery in Neurodegeneration January 2011 - May 2011
Brigham and Women's Hospital May 2010 - May 2011
Skills
Western Blotting, Cell Culture, Transfection, ELISA, Cell, Assay Development, PCR, Gel Electrophoresis, RNA isolation, DNA, High Throughput..., Affinity Chromatography, GLP, UV/Vis, Enzyme Kinetics, Biomarkers, Validation, GMP, Restriction Digestion, Media Preparation, BCA Protein Assay, Data Analysis, SDS-PAGE
Education
Northeastern University 2009 — 2011
Masters of Pharmaceutical Sciences, Pharmacology
Shire HGT 2011 - 2011
Education
Rochester Institute of Technology 2008 — 2011
Shire HGT November 2011 - Present
Kelly/Shire April 2010 - November 2011
Veritude November 2009 - January 2010
Airgas August 2005 - May 2007
Boston Metal and New England Wire January 1983 - August 2005
Skills
GMP, Biotechnology, SOP, Manufacturing, Cell Culture, Disposable Bioreactors, Aseptic Processing, Aseptic Technique, Purification, FDA, Trackwise, SAP, Laboratory, Change Control, Validation, Management
Education
Worcester Polytechnic Institute 2009 — 2009
Certificate, Biomanufacturing
State University of New York College at Oswego
B.S, Industrial Arts/Manufacturing
Ardea Biosciences September 2011 - Present
An Eye For Detail Consultancy, LLC October 2010 - Present
MyoKardia 2015 - 2015
MyoKardia 2015 - 2015
Proteon Therapeutics October 2010 - August 2011
Shire HGT January 2009 - October 2010
TransMolecular January 2007 - January 2009
Archemix July 2005 - November 2006
Genzyme 1994 - 2005
EMD Serono, Inc. 1995 - 1996
Skills
Oncology, CTMS, Clinical Research, Drug Development, Protocol, Clinical Development, Clinical Trials, Biotechnology, CRO, Pharmaceutical Industry, GCP, FDA, Lifesciences, Clinical Monitoring, EDC, Infectious Diseases, Regulatory Affairs, Sop, Clinical Data Management, Clinical Operations, Biopharmaceuticals, Drug Discovery, Medical Writing, Immunology, IND, Pharmacology, Neurology, ICH-GCP, Cancer, Clinical Study Design, Neuroscience, Therapeutic Areas, Vaccines, Pharmacovigilance, Validation, Medical Devices, Life Sciences
Education
The Sage Colleges - Russell Sage College 1983 — 1987
BA, Psychology
University of Connecticut Health Center August 2010 - Present
Merrimack Pharmaceuticals January 2010 - August 2010
Merrimack Pharmaceuticals January 2009 - June 2009
Shire HGT January 2008 - June 2008
Skills
Cell Culture, Molecular Biology, Western Blotting, SDS-PAGE, Immunohistochemistry, Immunofluorescence, Assay Development, Cell Biology, ELISA, PCR, Animal Models, RNA Isolation, qRT-PCR, Cancer Research, Flow Cytometry, Primary Cell Isolation, Animal Husbandry, Bladder Cancer
Education
The University of Connecticut Health Center 2010 — 2015
Ph.D., Cell Biology
Northeastern University 2006 — 2009
Bachelor's, Biology
Shire HGT May 2012 - May 2013
Shire HGT March 2010 - May 2012
Biogen Idec October 2010 - December 2010
Saurashtra University, Gujarat, India January 2009 - March 2009
Skills
Cell Culture, Biotechnology, ELISA, Cell Based Assays, SDS PAGE, Western Blotting, Immunoassays, Cell, SDS-PAGE, Aseptic Technique, Assay Development, Immunology, GMP, Sop, Mammalian Cell Culture, Cell Biology, Spectrophotometry, Laboratory, Technology Transfer, Lifesciences, Biochemistry, Gel Electrophoresis, Purification, Chromatography, Protein Purification, PCR, Protein Chemistry
Education
University of Massachusetts Lowell 2009 — 2010
MS, Biotechnology, Biology, Chemistry
Saurashtra University 2006 — 2008
Master of Science
Saurashtra University 2003 — 2006
Bachelor of Sciences, Biotechnology, Microbiology, Chemistry
UNIVERSITY OF MASSACHUSETTS
Shire HGT December 2008 - Present
RDK Engineers June 2006 - November 2009
The Gillette Company/ P&G November 1997 - November 2006
Education
Northeastern University
Bachelor of Science (BS), Mechanical Engineering
Shire Pharmaceuticals March 2014 - Present
Shire HGT August 2011 - March 2014
Shire HGT 2006 - 2008
TKT 2002 - 2006
Skills
Protein Chemistry, Biochemistry, Biotechnology, Drug Development, Drug Discovery, Biopharmaceuticals, Molecular Biology, Clinical Development, Lifesciences, Chromatography, Technology Transfer, Protein Expression, Cell, Cell Biology
Education
University of New Hampshire 1997 — 2002
PhD, Biochemistry and Molecular Biology
St. Olaf College 1993 — 1997
Bachelors, Chemistry, Biology
Merrimack Pharmaceuticals November 2013 - Present
Shire HGT October 2011 - November 2013
Lonza October 2009 - October 2011
Lonza February 2006 - October 2009
NERL Diagnostics March 2004 - 2006
J & S Medical Associates April 1998 - March 2004
Behring Diagnostics September 1997 - April 1998
Skills
Trackwise, LIMS, CAPA, GMP, Sop, Biopharmaceuticals, FDA, Change Control, GxP, GLP, Deviations, V&V, Aseptic Technique, Biotechnology, Quality Control, cGMP practices, Contract Manufacturing, FDA GMP, Purification, HPLC, Cleaning Validation, Fermentation, Computer System..., Quality Assurance, ISO 13485, Protein Purification, Quality System, CIP, Downstream Processing, Vaccines, Regulatory Affairs, SOP development, cGMP manufacturing, Chromatography, Regulatory Requirements, Lifesciences, Microbiology, Pharmaceutical Industry, GAMP, Quality Auditing, Sterilization
Education
Quinnipiac University 1993 — 1997
BS, Medical Technology
Mount Saint Charles Academy
Shire HGT May 2010 - Present
Health Canada 2005 - 2008
CTBR 2005 - 2005
CTBR 2004 - 2005
Education
Université de Montréal 2003 — 2005
M. Sc., Drug Development, Pharmaceutical Sciences
Université de Montréal 2000 — 2003
B. Sc., Chemistry
Northeastern University
Certificate, Biopharmaceutical Regulatory Affairs
Shire HGT April 2011 - April 2012
Shire HGT February 2010 - April 2011
Time Products International March 2004 - September 2008
Skills
Biotechnology, GMP, Technology Transfer, Sop, Marketing Communications, Documentation, Technical Documentation, Online Advertising, Development of Training..., cGMP, Trade Show Management, Trade Shows, Project Coordination, Time Management, Software Documentation, Quality System, Quality Assurance, Training, Management, Project Management, Biopharmaceuticals, Manufacturing, SOP
Education
Northwood University 2001 — 2003
B.A., Management Information Systems / Management
Inti College 1999 — 2000
Associate's degree, Business Administration and Management, General
Pharmaceutical Innovations, Inc. July 2015 - Present
Goldey-Beacom College September 2012 - August 2015
Pharmaceutical Innovations, Inc. October 2013 - July 2015
mdi Consultants Inc. April 2013 - September 2013
Shire HGT November 2011 - August 2012
Shire HGT September 2011 - November 2011
Northeastern University July 2010 - July 2011
Northeastern University January 2010 - July 2011
Northeastern University July 2010 - June 2011
Northeastern University July 2010 - August 2010
Skills
IND, Clinical Trials, FDA, Medical Devices, PMA, eCTD, Regulatory Affairs, Regulatory Submissions, Clinical Research, Drug Development, Quality Assurance, Sop, Software Documentation, Pharmaceutics, Quality System, GLP, GMP
Education
Godley-Beacom College 2012 — 2014
Master's degree, Business Administration and Management, General
Northeastern University 2010 — 2011
Master's, Regulatory Affairs for Drugs, Biologics and Medical Devices, 3.63
University of Mumbai 2005 — 2009
Bachelor's, Pharmacy
Thermo Fisher Scientific November 2011 - Present
Shire HGT February 2004 - August 2011
Panacos Pharmaceuticals August 2001 - November 2003
Skills
IC, HPLC, Sample Preparation, Biotechnology, Carbohydrate Chemistry, Protein Chemistry, Protein Characterization, Enzyme Kinetics, ELISA, SDS-PAGE, Western Blotting
Education
Oberlin College 1989 — 1993
BA, Biochemistry
Shire HGT 2011 - Present
Ohio State University 2009 - August 2011
Skills
Biotechnology, Cell Culture, Technology Transfer
Education
The Ohio State University 2003 — 2008
PhD, Chemical & Biomolecular Engineering
Shire HGT August 2011 - Present
Pfizer November 1995 - July 2011
Skills
Sop, GMP, LIMS, Aseptic Processing, Validation, Biopharmaceuticals, Trackwise, Change Control, CAPA, FDA, Pharmaceutical Industry, Technology Transfer, Biotechnology, Purification, 21 CFR Part 11, SOP, TrackWise
Education
Quinsigamond Community College 1993 — 1995
Associates, Certificate Biotechnonlogy
Shire HGT January 2009 - Present
Education
Northwestern University 2002 — 2008
PhD, Chemical Engineering
Tulane University 1998 — 2002
BS, Chemical Engineering
Genzyme August 2013 - Present
Shire HGT July 2011 - July 2013
Amgen March 2003 - June 2011
Stryker Biotech 1998 - 2001
Skills
CAPA, Aseptic Processing, 21 CFR Part 11, Change Control, Validation
Education
Plymouth State University
Bachelor of Science, Environmental Biology
Shire HGT September 2012 - Present
Shire HGT October 2011 - November 2012
Shire Pharmaceuticals July 2008 - October 2011
Shire Pharmaceuticals June 2005 - August 2008
Pfizer August 2001 - June 2005
Skills
Biotechnology, Pharmaceutical Industry, GMP, Biopharmaceuticals, GLP, Continuous Improvement, Supply Chain, Manufacturing, Change Control, Regulatory Affairs, Training, Quality System, Cross-functional Team..., CAPA, Lean Manufacturing, Sop, Validation, 21 CFR Part 11, FDA, Root Cause Analysis, Leadership, Technology Transfer, Value Stream Mapping, Regulatory Submissions, Quality Assurance
Education
SUNY at Buffalo 1990 — 1995
BA, Economics
SUNY Plattsburgh
Master's degree, Administration and Leadership