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
Biogen February 2015 - Present
Biogen Idec July 2013 - February 2015
Shire HGT September 2011 - July 2013
Millennium Pharmaceuticals June 2011 - September 2011
Cambridge NanoTech July 2009 - December 2010
Lockheed Martin Nanosystems July 2008 - December 2008
Skills
Column Chromatography, Characterization, Ultrafiltration/Diafiltr..., Filtration and..., Spectroscopy, Biotechnology, Aseptic Technique, SDS-PAGE, HPLC, Technology Transfer, Cell Culture, Laboratory, PowerPoint, Microsoft Excel, Microsoft Office, Microsoft Word, Software, Sharepoint, ALD, Research, AFM, Magellan, Assay Development, Matlab
Education
Northeastern University 2015 — 2017
Master of Science (MS), Biotechnology
Northeastern University 2006 — 2011
BS, Chemical Engineering
Shire HGT May 2015 - Present
Shire HGT October 2013 - May 2015
Pfizer January 2009 - October 2013
Wyeth November 2006 - January 2009
Genzyme March 2003 - November 2006
Skills
GMP, Validation, Pharmaceutical Industry, FDA, CAPA, Biotechnology, LIMS, Change Control, 21 CFR Part 11, Aseptic Processing, Aseptic Technique, Purification, SAP ERP, SOP, TrackWise, Cell Culture, Chromatography, Manufacturing, SAP, Fermentation, Technology Transfer, Biopharmaceuticals, Protein Purification
Education
Middlesex Community College 2010 — 2016
Shire HGT 2011 - 2013
Shire HGT 2008 - 2011
Shire HGT 2006 - 2008
TKT/Shire Human Genetic Therapies 2003 - 2006
TKT October 2001 - August 2003
Rohm and Haas 1998 - 2000
Skills
Project Management, Cross-functional Team..., Technology Transfer, GMP, CMC development, Biotechnology, Validation, HPLC, Six Sigma, Chromatography, Protein Chemistry, LIMS, Quality Assurance, Purification, Stability Studies, Process Improvement, Management, Department Budget...
Education
University of Strathclyde 2009 — 2014
Master of Science (MS), Pharmaceutical Quality
Northeastern University 1996 — 2001
Bachelor of Science (BS), Biology and Sociology
Allergan February 2014 - Present
Percepta Associates June 2013 - February 2014
Percepta Associates October 2011 - June 2013
Percepta Associates October 2010 - October 2011
Veracyte, Inc. June 2010 - October 2010
Veracyte, Inc. September 2009 - May 2010
Shire HGT June 2009 - August 2009
Skills
Genomics, Proteomics, Molecular & Cellular..., Oncology, Market Research, Marketing Analytics, Biotechnology, van Westendorp Analysis, Conjoint Analysis, Drug Discovery, Product Launch, Market Analysis, Cell Biology, Data Analysis, Cross-functional Team...
Education
Keck Graduate Institute
Master of Bioscience, Business of Bioscience
University of Mumbai
Bachelor of Engineering, Biotechnology
Shire HGT January 2013 - Present
ViroPharma Incorporated November 2008 - January 2013
Biogen Idec August 2006 - November 2008
Accredo Therapeutics April 1998 - August 2006
Skills
Managed Care, Neurology, Biotechnology, Pharmaceutical Sales, Allergy, Orphan Drugs, Sales Presentation..., Public Speaking, New Business Development, Consultative Selling..., Home Infusion, Business Analysis, Pulmonary Hypertension, Territory Growth, Salesforce.com, Business Launch, Multiple Sclerosis, Buy, Genetics, Genetic Counseling, Rheumatology, Medicine, Endocrinology, Pulmonology, Buy & Bill, Cardiology, Real Estate Transactions, Product Launch, Sales Presentations, Sales
Education
Universitiy of Minnesota 1994 — 1998
MSW, social work
Macalester College 1988 — 1992
BA, Psychology
St. Mark's 1984 — 1988
Diploma
Infinity Pharmaceuticals May 2014 - Present
Shire HGT April 2013 - May 2014
Genzyme May 2012 - April 2013
PAREXEL March 2012 - May 2012
Quintiles Transnational October 2008 - March 2012
JCrew February 2004 - March 2012
Eaton Apothecary February 2006 - October 2008
Kinney Drugs May 2001 - January 2006
Skills
Clinical Research, Clinical Trials, GCP, Pharmaceutical Industry, ICH-GCP, Oncology, Oracle Clinical, CRO, EDC, Clinical Data Management, Pharmacovigilance, CTMS, Clinical Development, Inform
Education
Massachusetts College of Pharmacy and Health Sciences 2001 — 2007
Bachelor of Science, Pharmaceutical Marketing and Management
Alnylam Pharmaceuticals July 2015 - Present
Alexion Pharmaceuticals, Inc. June 2013 - Present
Alexion Pharmaceuticals August 2012 - May 2013
Carl Martin Associates April 2011 - August 2012
EMD Serono, Inc. February 2012 - July 2012
Shire HGT February 2007 - January 2011
IBT April 2004 - November 2005
Mass Biologics 2000 - 2004
Harvard Vanguard Medical Associates 1995 - 1997
Travecorp 1994 - 1995
Skills
Talent Acquisition, Talent Management, HRIS, Employee Relations, Training, Interviews, Applicant Tracking..., Recruiting, Management, Biotechnology, Manufacturing, Cross-functional Team..., Succession Planning, Human Resources, Leadership, Executive Search, Performance Management, Sourcing, Employee Engagement, Process Improvement, Temporary Placement, Organizational..., Deferred Compensation, Onboarding, Technical Recruiting, Personnel Management, College Recruiting, Workforce Planning, Contract Recruitment, Employee Benefits, Hiring, Organizational Design, Internet Recruiting, Vendor Management, Screening Resumes, HR Consulting, Employee Training, Employer Branding, Staffing Services, New Hire Orientations, Benefits Negotiation, Career Development, Consulting, Job Descriptions, HR Policies, Organizational..., Recruitment Advertising, Strategic Sourcing, Temporary Staffing, Permanent Placement
Education
Northeastern University 1985 — 1990
Bachelor of Science (BS), Business Administration and Management, General
Northeastern University 1985 — 1990
Yes, Business Administration
Rite Aid March 2012 - Present
PROGRESSIVE PHARMACY SOLUTIONS November 2013 - July 2015
Walgreens June 2010 - March 2012
Lahey, Burlington February 2011 - August 2011
Shire HGT 2005 - 2007
Thermo Fisher Scientific 2005 - 2006
Skills
Biotechnology, Pharmacists, Diabetes, Clinical Research, Lifesciences, Pharmaceutical Industry, Pharmacy, Managed Care, Hospitals, Clinical Pharmacology, Healthcare, Clinical Pharmacy, Informatics, Immunization, Oncology, Compounding, Medication Therapy..., Certified Immunizer, Community Pharmacy, Life Sciences
Education
Massachusetts College of Pharmacy and Health Sciences
PharmD
UMass Boston
Bachelor of Science (BS), Biochemistry/Biology
MannKind Corporation October 2013 - Present
GvH Consulting, Inc. February 2009 - Present
Shire HGT August 2011 - October 2013
OPK Biotech, LLC April 2011 - August 2011
MannKind Corporation October 2010 - April 2011
Shire HGT July 2009 - September 2010
MannKind Corporation August 2004 - July 2009
Bosch October 2003 - October 2006
Validation and Process Associates July 2002 - August 2003
Skills
Commissioning, Process Validation, Cleaning Validation, Validation, Process Engineering, Process Improvement, Engineering, Chromatography, Sop, GAMP, GMP, CAPA, V&V, Change Control, Pharmaceutical Industry, Quality System, Biotechnology, 21 CFR Part 11, Continuous Improvement, Manufacturing, Computer System..., FDA, Testing, Software Documentation, Technology Transfer, Process Simulation, R&D, GxP, Biopharmaceuticals, ISO 13485, Quality Control, Process Optimization, Aseptic Processing, Medical Devices, Quality Auditing, Regulatory Affairs, Pharmaceutics, Filtration, Lifesciences, Quality Assurance
Education
Northeastern University 1997 — 2002
BS, Chemical Engineering
Celldex Therapeutics March 2015 - Present
Novartis Vaccines and Diagnostics March 2011 - March 2015
Novartis Vaccines and Diagnostics October 2010 - March 2011
Shire HGT June 2007 - August 2010
US Navy March 2005 - June 2007
US Navy June 2003 - March 2005
Skills
FDA, Regulatory Submissions, Regulatory Affairs, Pharmaceutical Industry, Administrative..., Publishing, Adobe Acrobat, Sop, Meeting Planning, Microsoft Office, Travel Arrangements, Concur, Clinical Development, Clinical Trials, Office Administration, Desktop Publishing, Filing, Executive Support, eCTD, Validation, Document Management, MS Office Suite, SHREK -Achving System, Web Design, Web Content, Business Meetings, Regulatory Requirements, Change Control, GCP, 21 CFR Part 11, Military Logistics, ISI Toolbox, IND, CAPA, Biopharmaceuticals, Corporate Meetings, Rhythmyx content..., Liquent InSight..., eCTD viewer, eTravel, BLA, NeeS, Health Canada..., Datasets, eCTD Manager (Extedo), Global Submit software, Lorenz Validation..., liquent viewer, SOP
Education
Naval Technical Training Center 2005 — 2005
2005 Certificate; Degree, Naval Administration; Business Administration
Newbury College 1996 — 1999
Business Administration, Business Administration
Genzyme July 2013 - Present
Shire HGT June 2012 - July 2013
Brigham and Women's Hospital January 2012 - June 2012
Brigham and Women's Hospital September 2010 - December 2011
Brigham and Women's Hospital June 2009 - August 2010
Skills
Biotechnology, FDA, Aseptic Technique, Clinical Trials, Pharmaceutical Industry, Medical Devices, Validation, GCP, GMP, CAPA, Sop, Data Analysis, Trackwise, Lifesciences, Biopharmaceuticals, Change Control, Regulatory Submissions, SOP
Education
Northeastern University 2007 — 2011
Bachelor of Science (B.Sc.), Biology, General
Self Employed February 2015 - Present
BBB Therapeutics October 2014 - January 2015
Self Employed July 2014 - September 2014
ImmusanT August 2013 - April 2014
Self Employed August 2011 - July 2013
Shire HGT August 2008 - July 2011
Shire HGT 2008 - July 2011
Coley Pharmaceutical Group April 2006 - March 2008
Pfizer March 2003 - December 2004
Pharmacia 1998 - 2002
Skills
Clinical Development, Biotechnology, Infectious Diseases, Clinical Research, Pharmacovigilance, Vaccines, Medicine, Clinical Trials, Pharmaceutical Industry, Drug Development, Biopharmaceuticals, Immunology, Lifesciences, Sop, CRO, Medical Affairs, CTMS, Regulatory Affairs, Neuroscience, Urology, Process Optimization, Market Access, FDA, GCP, Technology Transfer, Pharmaceutics, Managed Care, Genetics, Drug Discovery, Regulatory Submissions, Project Management, Neurology, Medical Writing, Commercialization, EDC, Protocol, Therapeutic Areas, Diabetes, Life Sciences, Health Economics
Education
National Institute of Allergy and Infectious Diseases 1986 — 1989
Staff Fellow/Senior Staff Fellow, Allergy and Immunology
Jefferson Medical College of Thomas Jefferson University 1979 — 1983
MD
University of Maryland Baltimore County 1975 — 1979
BA, Political Science
WS Development January 2014 - Present
Shire HGT December 2008 - January 2014
Skills
Biotechnology, GMP, Pharmaceutical Industry, Validation, Sop, FDA, Lifesciences, Technology Transfer, Biopharmaceuticals, CAPA, Clinical Development, Cell Culture, Microsoft Office, Microsoft Excel, Management, Microsoft Word, Strategic Planning
Education
National American University 2008 — 2011
Master of Business Administration (MBA), Accounting and Finance
National American University 2006 — 2008
Bachelor of Business Administration (B.B.A.), Accounting and Finance
Massassoit Community College 1979 — 1981
Associate's degree, Business Administration and Management, General
EMD Serono, Inc. September 2013 - Present
Shire HGT July 2008 - April 2013
Ropes & Gray LLP September 1999 - April 2008
Indevus Pharmaceuticals 2008 - 2008
Skills
Patents, Intellectual Property, Biotechnology, Trademarks, Corporate Contracts, Patent Prosecution, Pharmaceutical Industry, Patent Litigation, Patentability, Legal Writing, Technology Transfer, Lifesciences, Life Sciences
Education
New England Law Boston 1998 — 2002
JD, Law
University of Wisconsin-Madison 1991 — 1994
BA, Sociology/Criminal Justice Double Major
Medivators August 2014 - Present
Medivators May 2013 - July 2014
Medtronic Spine & Biologics September 2011 - May 2013
Shire HGT November 2010 - September 2011
Shire HGT June 2010 - November 2010
Pfizer Ltd May 2009 - June 2009
Olcare Laboratories June 2007 - July 2007
Skills
Regulatory Affairs, PMA, Regulatory Requirements, FDA, Change Control, Regulatory Submissions, IND, ISO 13485, Medical Devices, Quality System, ISO 14971, V&V, GCP, 21 CFR, GMP
Education
Northeastern University 2009 — 2011
M.S., Regulatory Affairs
University of Mumbai 2005 — 2009
Bachelor in Pharmacy, Pharmaceutical Sciences
Shire HGT March 2009 - Present
Biogen Idec July 2007 - March 2009
Abbott Bioresearch Center July 2003 - July 2007
Reliance Design & Fabrication 2001 - 2007
Skills
Cell Culture, GMP, Biotechnology, Validation, Sop, Biopharmaceuticals, Pharmaceutical Industry, FDA, CAPA, Technology Transfer, Change Control, Aseptic Processing, LIMS, Quality System, Lifesciences, Aseptic Technique, 21 CFR Part 11, Chromatography, Purification, Protein Purification
Education
Johnson & Wales University
New England Technical Institute
University of Connecticut Health Center August 2011 - Present
University of Connecticut August 2011 - Present
Dow Chemical December 2010 - August 2011
The Forsyth Institute July 2009 - August 2010
Shire HGT June 2008 - December 2008
Skills
UV/Vis
Education
The University of Connecticut Health Center 2011 — 2015
Northeastern University 2006 — 2010
B.S., Chemistry
Shire June 2014 - Present
Shire HGT August 2012 - June 2014
Shire HGT June 2010 - August 2012
Shire HGT June 2010 - August 2010
The Children's Hospital of Philadelphia. Genetics, Abramson Research Center September 2009 - May 2010
Skills
Protein Purification, GMP, Technology Transfer, Sop, Chromatography, Validation, Biotechnology, Biopharmaceuticals, SDS-PAGE, Microbiology, Fermentation, Aseptic Technique, Cell Culture, ELISA, Purification, Aseptic Processing, Downstream Processing, Lifesciences, Filtration, LIMS, GLP, CAPA, Trackwise, SAP, GMP Investigation, Assay Development, PCR
Education
University of Pennsylvania 2008 — 2010
Master's degree, Biotechnology
Lagos State University 2002 — 2007
Bachelor's degree, Microbiology, General
Shire Pharmaceuticals November 2012 - Present
Shire HGT May 2011 - October 2012
Caryn Platt Tatelli, AM, LCSW September 2009 - February 2010
Committee Representing Our Young Adults October 2008 - May 2009
Shire HGT May 2008 - August 2008
Massachusetts General Hospital May 2005 - September 2005
Skills
Pharmaceutical Industry, Policy Analysis, Literature Reviews, Information Systems, Database Design, Records Management, Orphan Drugs, Lifesciences, Assay Development, Spanish, Community Outreach
Education
Lake Forest College 2007 — 2011
Bachelor of Arts, International Relations minor in Sociology/Anthropology focus in Public Health
Richmond, The American International University in London 2010 — 2010
International Law and Legal Studies
First Quality Enterprises January 2015 - Present
PPT Consulting September 2012 - December 2014
Avantor Performance Materials July 2011 - September 2012
Shire HGT January 2010 - June 2011
Rohm and Haas February 2001 - December 2009
Nation Tax Oneline November 1999 - February 2001
SONAT Energy Service Company February 1997 - November 1999
Oracle September 1995 - February 1997
PricewaterhouseCoopers September 1993 - September 1995
Skills
Mergers, Outsourcing, Organizational..., SAP, Cross-functional Team..., Process Engineering, ERP, SAP BW, Global Application..., SAP R/3, Process Improvement, Change Management, Project Management, Six Sigma, Business Intelligence, Vendor Management, Program Management, CRM, Business Process, Integration, Mergers & Acquisitions, SDLC, Management Consulting, Leadership, Strategy, Business Development, Start-ups, Supply Chain, Consulting, Business Process..., ITIL, Enterprise Software, Forecasting, IT Strategy, Strategic Planning, Solution Architecture, Pre-sales, Business Analysis, Project Portfolio..., Executive Management, Budgets, Business Transformation, SAP ERP, IT Management, E-commerce, Information Technology, Service Delivery
Education
Louisiana State University 1979 — 1984
PhD, Chemical Engineering
University of Missouri-Columbia 1975 — 1979
BS, Chemical Engineering
Shire HGT August 2008 - Present
Shire HGT August 2008 - Present
Inch By Inch Child Development Center August 2006 - July 2008
MERRIMACK POLICE SERVICES November 2003 - June 2004
CAMBRIDGE ELLIS SCHOOL October 1999 - June 2004
FIRST STEPS DAY CARE September 1999 - May 2002
Skills
GMP, Trackwise, Sop, LIMS, Biotechnology, Biopharmaceuticals, CAPA, Validation, FDA
Education
Merrimack College
Bachelor of Science (BS), Political Science and Government
Merrimack College
Bachelor of Arts, Political Science
OCCS (Office of Child Care Services)
Simmons College
Shire HGT Lab Analyst llGenzyme BiosurgeryNovember 1999 - November 2010
Skills
Biotechnology, Biopharmaceuticals, GMP, Sop, Laboratory, FDA, ELISA, Pharmaceutical Industry, Immunology, Sanitary Sewer, Technology Transfer, Validation, CAPA
Education
Keene State College
Bachelor of Arts (BA), Journalism
Northeastern University September 2012 - Present
Shire HGT May 2012 - August 2012
Center for Pharmaceutical Biotechnology and Nanomedicine, Northeastern University May 2010 - April 2012
Northeastern University September 2009 - December 2011
Cerulean Pharma, Inc August 2011 - October 2011
MERCURY LABORATORIES,GUJARAT June 2007 - July 2007
Skills
Formulation Development, Biotechnology, Analytical Techniques, Pharmaceutics, Lyophilization, HPLC, Cell Culture, Cell Based Assays, Cell Biology, Microscopy, Fluorescence Microscopy, Enzyme Assays, quality control, pharmaceutical..., Granulation, Gel Electrophoresis, ELISA, Nanoparticles, PCR, RNA isolation, Cell, Fluorescence, Molecular Biology, Transfection, Drug Delivery, SDS-PAGE, UV-Vis, Spectrophotometry, Chromatography, Western Blotting, GLP, In Vitro, DNA extraction, Agarose Gel..., Biochemistry, Analytical Chemistry, SOP, GMP, TLC, Life Sciences, Drug Discovery, cGMP, UV, Tissue Culture, Quality Control, Laboratory, Cancer, Sop, Formulation, UV/Vis
Education
Northeastern University 2009 — 2011
Masters, Pharmaceutical Sciences
Pune University 2004 — 2008
Bachelors, Pharmacy
Tejas Vidyalaya 2002 — 2004
High School, Regular/General High School/Secondary Diploma Program
Dovetail Health March 2015 - Present
Reebok March 2014 - February 2015
North Hill Needham Inc. October 2012 - September 2013
Software Secure, Inc. January 2012 - October 2012
Shire HGT January 2008 - November 2011
Advans Technologies January 2008 - October 2009
WiredCommute May 2006 - September 2007
Skills
System Administration, SQL Server, Microsoft Servers, MCP, Windows Server, Windows 7, Active Directory, Amazon Web Services..., Amazon Cloud, Blackberry Enterprise..., Blackberry OS, Visio, Microsoft Office, Microsoft Exchange, Systems Engineering, Firebox, Firewalls, DHCP, DNS, TCP/IP, iPhone Support, iPad, Network Administration, Microsoft SQL Server, 2008 R2, Symantec Antivirus, SharePoint, Microsoft Certified..., VMware, Servers, Networking
Education
Kaplan University 2010 — 2012
MCSA, MCSA- Microsoft Certified Systems Administrator
Kaplan University
Computer Systems Networking and Telecommunications
Cleartelligence, Inc. December 2013 - Present
Shire Pharmaceuticals July 2008 - December 2013
Shire HGT July 2007 - July 2008
ImClone Systems October 2004 - June 2007
Bristol-Myers Squibb 2002 - 2004
DuPont Pharmaceuticals 2001 - 2002
Forest Laboratories 1994 - 2001
Skills
Sop, Validation, GMP, Software Documentation, Biotechnology, Pharmaceutical Industry, FDA, Quality Assurance, Process Improvement, Change Control, Quality System, Project Management, 21 CFR Part 11, SAP, Troubleshooting, Document Management, Change Management, Project Planning, CAPA, Computer System..., Root Cause Analysis, SDLC, SOP, Documentation, Business Intelligence, Cross-functional Team..., Management, Business Process, Databases, Training, Business Objects
Education
University of Massachusetts at Lowell 2010 — 2012
Pursuing BA, Psychology
Rutgers, The State University of New Jersey-New Brunswick 2006 — 2007
Attended Classes, Psychology
Middlesex County College 2004 — 2006
AA, Liberal Arts, General Studies
Suffolk County Community College 2002 — 2004
Attended Classes, Liberal Arts
State University of New York at Stony Brook 1993 — 1993
Attended Classes, Science
Shire HGT April 2008 - Present
Walmart November 1999 - April 2008
Brookfield Video Barn May 1993 - April 2008
Skills
Biotechnology, Sop, Biopharmaceuticals, FDA, Aseptic Processing, LIMS, Aseptic Technique, Pharmaceutical Industry, Cell Culture, 21 CFR Part 11, GLP, Trackwise, GMP, Acting, Manufacturing, SOP, Microsoft Office, Quality System
Education
Johnson State College 1995 — 1996
none, Secondary Education and Teaching
Quabbin Regional Jr/Sr High School 1989 — 1995
Diploma, College Preparatory with focus on English and History, Top 25%
Shire Pharmaceuticals 2014 - Present
Shire HGT 2012 - 2013
Shire HGT 2009 - 2012
Shire Pharmaceuticals 2002 - 2009
Elan June 2001 - October 2002
Perrigo 1993 - 2001
Education
University of Pennsylvania - The Wharton School 2006 — 2008
MBA, Finance
Michigan State University 1993 — 1998
BS, Chemical Engineering
InfinityQS International June 2015 - Present
InfinityQS International May 2013 - June 2015
Rhodes Technologies July 2011 - May 2013
Northeastern University September 2006 - May 2011
Pfizer July 2010 - December 2010
Shire HGT July 2009 - December 2009
King Industries May 2008 - November 2008
Skills
Chemical Engineering, Validation, GMP, Process Optimization, Engineering, Matlab
Education
Northeastern University 2006 — 2011
Bachelor of Science, Chemical Engineering
Shire HGT March 2008 - Present
Boston Scientific May 2003 - March 2008
Skills
GMP, CAPA, Quality System, FDA, Medical Devices, Pharmaceutical Industry, Validation, Biotechnology, Change Control, 21 CFR Part 11, Sop, Process Improvement, Cross-functional Team..., Biopharmaceuticals, Manufacturing, Quality Assurance, Training, Training Delivery, GxP, Instructional Design, Technical Training
Education
Suffolk University 2005 — 2008
Masters, Organizational Learning
Keene State College 1999 — 2003
Bachelor of Science (BS), Secondary Education and Teaching
Shire Pharmaceuticals June 2014 - Present
Shire Pharmaceuticals March 2013 - June 2014
Shire HGT November 2010 - March 2013
Shire HGT May 2006 - November 2010
ImmunoGen, Inc. 2002 - 2006
Wyeth Biotech 1998 - 2002
Genetics Institute, Inc. 1996 - 1998
Genetics Institute, Inc. 1994 - 1996
Genetics Institute, Inc. 1992 - 1994
U.S. Environmental Protection Agency 1990 - 1992
Skills
Technology Transfer, Biotechnology, Protein Purification, Validation, Global Alliance..., Commercialization, Biopharmaceuticals, Aseptic Processing, Clinical Development, Business Acumen, Contract Manufacturing, GMP, Process Simulation, FDA, CAPA, Sop, Change Control, Collaboration, SOP
Education
University of Massachusetts Lowell
Masters of Science, Chemical Engineering
University of Massachusetts Lowell
Bachelors of Science, Chemical Engineering
MIT Sloan School of Management
Executive Education Certificate, Strategies & Innovations
LeapFrog Systems June 2013 - Present
MUSA Technology Partners, LLC. April 2010 - April 2013
Shire HGT April 2010 - November 2012
Nokia August 2009 - April 2010
CIBER, Inc February 2007 - July 2009
Fresenius Medical Care December 2007 - June 2009
BiogenIdec 2007 - 2007
SunGard January 1998 - November 2006
Putnam Investments January 1996 - January 1998
AMS January 1995 - January 1996
Skills
Requirements Analysis, Business Analysis, SDLC, Program Management, Software Project..., Vendor Management, PMP, Integration, Enterprise Architecture, PMO, IT Management, Project Portfolio..., Agile Methodologies, Agile Project Management, IT Strategy, Project Management, Disaster Recovery, Project Delivery, ITIL, Requirements Gathering, Resource Management, MS Project, Unix, Software Documentation, Quality Assurance, Oracle, Software Development, User Acceptance Testing, Testing, Databases, Data Center, Risk Management, Management, Visio, Analysis, Microsoft SQL Server, Enterprise Software, Project Planning, Outsourcing, Business Intelligence, Business Process, Strategy, Cross-functional Team..., Database Design, Release Management, Microsoft Project
Education
Morse School of Business 1980 — 1981
Program Certificate, Data Processing, COBOL ProgrammingBusiness Administration; Project Management
New Mexico State University 1974 — 1979
Early Childhood Education, Civil Engineering, Early Childhood Ed
Northeastern University
ProgrammingBusiness Administration; Project Management
Wayland High School
Wyss Institute for Biologically Inspired Engineering July 2011 - August 2014
Firefly Bioworks April 2010 - January 2011
Northeastern University CAMMP May 2009 - April 2010
Genzyme June 2009 - January 2010
Shire HGT June 2008 - April 2009
NU Chemical Engineering Machine Shop January 2008 - April 2008
NU ResNet September 2006 - April 2008
Skills
Cell Culture, Labview, Python, Sop, Laboratory, UV/Vis, Microfluidics, LabVIEW, Matlab, Testing
Education
University of Washington 2014 — 2019
Doctor of Philosophy (PhD), Materials Engineering
Northeastern University 2006 — 2011
B.S., Chemical Engineering
Pfizer June 2013 - April 2014
McKay Arts Academy October 2012 - January 2013
Shire HGT March 2003 - May 2012
Transkaryotic Therapies October 1989 - March 2003
Dana-Farber Cancer Institute April 1987 - October 1989
Skills
Meso Scale Discovery, LIMS, ELISA, Cell Culture, Molecular Biology, Biotechnology, SDS-PAGE, Western Blotting, Northern Blotting, Cell Based Assays, Bioanalysis, GLP, Rare Diseases, Cell, Tissue Culture, Cell Biology
Education
Lesley University 2014 — 2015
Master of Education (M.Ed.), High School Education
University at Buffalo 1982 — 1987
B.S., Molecular Biology/Genetics
Northeastern University
Graduate Certificate, Clinical Trial Design and Project Management2006
C1 Consulting January 2015 - Present
C1 Consulting March 2014 - Present
Shire Pharmaceuticals August 2012 - February 2014
Shire HGT January 2011 - August 2012
Shire HGT May 2010 - January 2011
Shire Human Genetic Therapies May 2010 - January 2011
Sanofi 2005 - 2006
Sanofi 2005 - 2006
Adolor 2004 - 2006
Bayer 1998 - 2004
Skills
Pharmaceutical Sales, Pharmaceutical Industry, Biotechnology, Neurology, Managed Care, Gastroenterology, Urology, Cardiology, Oncology, Nephrology, Hospital Sales, Rheumatology, Endocrinology, Sales Effectiveness, Lifesciences, Diabetes, Infectious Diseases, Product Launch, Dermatology, Biopharmaceuticals, Clinical Development, Commercialization, Global Marketing, Market Access, Marketing Strategy, Medical Affairs, Rare Diseases
Education
University of Massachusetts 1997 — 2000
MBA, Finance
McGill University 1990 — 1992
BA, Psychology
Concord Academy 1984 — 1988
High School
Shire HGT April 2006 - Present
21st Century Biochemicals, Inc November 2004 - 2006
Skills
Biotechnology, Biopharmaceuticals, GMP, HPLC, Life Sciences, Technology Transfer, Pharmaceutical Industry, Validation, Protein Chemistry, Chromatography
Education
Northeastern University 2006 — 2010
PSM, Biotechnology
University of Massachusetts, Amherst 1999 — 2004
B.S., Biology
Shire HGT March 2013 - Present
Whole Foods Market 2011 - 2012
purple ink agency January 2011 - June 2011
Skills
Cpr Certified, Sop, Customer Service, Cell Culture, Clinical Research, Manufacturing, Laboratory, Management, Testing, Research, Microsoft Office, Data Entry, PowerPoint, Microsoft Word, Microsoft Excel, Healthcare, Public Health, Teamwork, Time Management, Outlook, Hospitals, SOP
Education
Massachusetts College of Pharmacy and Health Sciences 2014 — 2016
Master's Degree, Clinical Research/Regulations
Regis College 2008 — 2012
Bachelor of Applied Science (B.A.Sc.), Biology/Biological Sciences, General
Northfield Mount Hermon 2007 — 2008
Diploma, General Studies
Biogen Idec February 2014 - Present
Genzyme August 2012 - January 2014
Xcellerex July 2011 - March 2012
Shire HGT September 2005 - February 2011
Skills
Biotechnology, Cell Culture, LIMS, SOP authoring, GMP, Trackwise, Bioreactor, Cross-functional..., Aseptic Processing, Quality Assurance, Compliance, SOP development, Sop, Building Relationships, Pharmaceutical Industry, GDP, Change Control, Quality System
Education
Massachusetts Bay Community College 2004 — 2005
Biotechnology and Forensic Science
Newton North High School 2000 — 2004
Science based classes
Enzymatics June 2014 - Present
Enzymatics February 2014 - June 2014
Enzymatics March 2012 - January 2014
Enzymatics December 2010 - March 2012
Shire HGT September 2008 - December 2010
Northeast Health Systems January 2000 - January 2005
Skills
Biotechnology, GMP, FDA, Technology Transfer, CAPA, Lifesciences, Molecular Biology, Assay Development, Life Sciences, Pharmaceutical Industry, Commercialization, Validation, Biochemistry
Education
Tufts University 2005 — 2008
Bachelor of Science, Chemical Engineering
North Shore Community College 2002 — 2005
Associate of Science, Engineering
Shire HGT April 2010 - Present
Hyaluron Contract Manufacturing October 2009 - March 2010
acusphere 2007 - 2009
Skills
GMP, Sop, LIMS, Aseptic Technique, Technical Writing, Aseptic Processing, Manufacturing, Clean Rooms, Deviations, Document Review, Document Management, Buffer, Trackwise, Technical Documentation, SAP, Validation, SOP, FDA, Pharmaceutical Industry, CAPA, Biotechnology, Change Control, TrackWise
Education
Mount Washington College 2002 — 2003
General
Shire HGT January 2013 - July 2013
tJun17 Life Sciences August 2012 - December 2012
Nanyang Technological University August 2009 - December 2010
Institute of Microelectronics, A*STAR, Singapore May 2009 - July 2009
Skills
Process Control System..., Laboratory Information..., Trackwise, Enterprise Resource..., SAP, Solidworks, Pro Engineer, ANSYS, Microsoft Office, Microsoft Excel, Microsoft Word, PowerPoint, Outlook, Flowcytometry, Spectrophotometry, Column Chromatography, Polymerase Chain..., Gel Electrophoresis, Cell Culture
Education
Northeastern University 2011 — 2013
Master, Regulatory Affairs for Drugs, Biologics, and Medical Devices
Nanyang Technological University 2006 — 2010
Bachelor of Engineering, Major in Biomedical Engineering, Minor in Entrepreneurship
Momenta Pharmaceuticals November 2012 - Present
Biogen Idec April 2012 - August 2012
Novartis Vaccines and Diagnostics 2011 - April 2012
John R. Engen Laboratory, Northeastern University 2008 - 2010
Millennium Pharmaceuticals January 2009 - June 2009
Shire HGT January 2008 - June 2008
Skills
HPLC, Biotechnology, Mass Spectrometry, Assay Development, Analytical Chemistry, Protein Purification, LC-MS, Chromatography, SDS-PAGE, Molecular Biology, UV/Vis
Education
Northeastern University 2008 — 2010
M.S., Chemistry
Northeastern University 2006 — 2010
B.S., Chemistry
ArcherDX, Inc. (formerly Enzymatics, Inc) December 2014 - Present
Enzymatics October 2013 - December 2014
Enzymatics March 2013 - October 2013
Corning Discovery Labware June 2011 - March 2013
Shire HGT August 2010 - June 2011
North Shore Community Action Programs (NSCAP) September 2009 - August 2010
Matheson Tri-Gas November 1998 - September 2008
Multichem Analytical Laboratories June 1997 - August 1998
Toxikon Corporation June 1995 - June 1997
Skills
Troubleshooting, Microsoft Office, Training, Teaching, CAPA, GMP, Analytical Chemistry, Quality Assurance, Quality Control, Instrumentation, FDA, Validation, Six Sigma, Chemistry, Quality System, Laboratory, Biotechnology, R, SOP
Education
Massachusetts College of Liberal Arts
Bachelor, Chemistry
Alnylam Pharmaceuticals November 2014 - Present
Shire HGT October 2011 - October 2014
Shire HGT June 2011 - October 2011
Harvard Medical School December 2010 - May 2011
Center for Drug Discovery, Northeastern University September 2010 - December 2010
APP Pharmaceuticals May 2010 - September 2010
Northeastern University, Department of Pharmacology November 2009 - February 2010
Serum Institute of India Limited November 2008 - December 2008
Skills
HPLC, SDS-PAGE, Western Blotting, Transfection, Immunofluorescence, GMP, Cell Culture
Education
Northeastern University 2009 — 2011
Masters, Pharmacology
Pune University 2005 — 2009
Bachelors, Pharmacy
Biogen Idec October 2010 - Present
BioMed Realty Trust October 2010 - Present
Commissioning Agents, Inc July 2003 - Present
Shire HGT November 2008 - March 2010
Genzyme 2010 - 2010
OPK Biotech, LLC 2010 - 2010
Commissioning Agents, Inc 2003 - 2009
Pfizer February 2008 - November 2008
Progenics Pharmaceuticals 2006 - 2008
Amgen 2003 - 2007
Skills
Validation, Commissioning, Engineering, SOP, Biotechnology, Technical Writing, Quality Assurance, Troubleshooting, Documentation, Process Engineering, Change Management, Problem Solving, Process Improvement, Continuous Improvement, GMP, Testing, Quality Systems, Technical Training, HVAC, cGMP, Project Planning, Scheduling, Measurement and..., Energy Engineering, Sop, Nuclear, Certified Building..., Certified Energy Manager, Energy Audits, Engineering Change..., Change Control, Training, Quality System, Preventive Maintenance, Computer System..., Project Management, Facilities Management, GAMP, Process Simulation, GxP, FDA, 21 CFR Part 11, Root Cause Analysis, Energy, CAPA, R&D, Steam, Automation, Pharmaceutical Industry, Maintenance Management
Education
University of the State of New York 1989 — 1990
BS
North Central College 1978 — 1981
Worked towards BS, Mathematics, Psychology, Computers, Business, Sociology, English, History, Acting, Radio
Naperville North High School 1976 — 1978
Bayshore High School 1974 — 1976
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
Juniper Networks December 2014 - Present
Shire HGT January 2012 - January 2014
Progress Software June 2007 - August 2011
Skills
Accounting, Process Improvement, Accounts Payable, Cash Flow Forecasting, Sarbanes-Oxley Act, SAP ERP, Cross Functional..., Account Reconciliation, Microsoft Excel, Vendor Management, Data Analysis, Compliance, Invoicing, Key Performance..., Employee Training
Education
Mount Washington College 2011 — 2014
Bachelors in Business Administration
Hesser College 2004 — 2006
Associates in Psychology
Shire HGT February 2014 - Present
Shire HGT March 2008 - February 2014
US Army October 1991 - October 1995
Skills
GMP, Trackwise, Sop, Pharmaceutical Industry, SAP ERP, Biopharmaceuticals, SOP, TrackWise
Education
Massasoit Community College 1996 — 1998
Associate's degree, Electronic Technology
Avon Products Inc. January 2014 - Present
Avon Products Inc June 2012 - December 2013
Avon Products Inc. December 2011 - May 2012
Shire HGT December 2010 - December 2011
Shire Brazil April 2009 - December 2010
Itau-Unibanco April 2008 - April 2009
Skills
Financial Reporting, Accounting, Hyperion, Financial Planning, Forecasting, Financial Modeling, Financial Analysis, Budgeting, Excel, ERP, Business Analysis, Strategic Financial..., Budgets, Accounts Receivable, Microsoft Excel, Internal Controls, Variance Analysis, Cash Flow, Corporate Finance, Analysis, Tax, Management, Investments, Consolidation, Leadership, Finance, Account Reconciliation, Managerial Finance, Cost Accounting, Business Planning
Education
New York University 2012 — 2012
Professional Certificate, Financial Analysis
Universidade Presbiteriana Mackenzie 2007 — 2011
Bachelor's degree, Accounting and Finance
Dedham Medical Associates 2011 - Present
Northeastern University RSO January 2010 - Present
Town of Brookline May 2006 - August 2009
Shire HGT January 2009 - June 2009
Skills
Laboratory, Chromatography, Quality Control, Titration, Distillation, Drawing Blood, Dissection, PowerPoint, Microsoft Excel, Autoclave, Microsoft Office, Research
Education
Massachusetts Bay Community College 2011 — 2011
Phlebotomy Certification, Phlebotomy Technician/Phlebotomist, Certification course
Northeastern University 2006 — 2011
New England Controls September 2012 - Present
Proconex September 2011 - September 2012
Formatech, Inc. June 2010 - January 2011
Shire HGT January 2009 - July 2009
Genzyme January 2008 - July 2008
Boston University, Photonics Center June 2005 - August 2005
Skills
SCADA, DCS, ISA-88, Matlab, Laboratory, C++, HPLC, GMP, Control Systems Design, Process Simulation, Automation, Process Engineering
Education
Northeastern University 2006 — 2011
B.S., Chemical Engineering
Brookline High School
Takeda Cambridge August 2014 - Present
Shire HGT May 2012 - July 2014
Shire HGT August 2010 - May 2012
Shire HGT May 2009 - August 2010
Altus Pharmaceuticals May 2007 - March 2009
EnVivo Pharmaceuticals October 2006 - September 2007
Freelance 2004 - 2006
Skills
GMP, FDA, Analytical Chemistry, Regulatory Affairs, Drug Development, Biotechnology, HPLC
Education
Northeastern University 2012 — 2014
MS, Biotechnology
Northeastern University 2008 — 2009
MS, Regulatory Affairs
Salem State University 2003 — 2007
BSc, Chemistry
Renee Cameron Photography September 2010 - Present
Sirtex Medical Limited March 2012 - April 2014
Tetraphase Pharmaceuticals March 2011 - September 2011
Sirtris Pharmaceuticals April 2010 - January 2011
Shire HGT January 2009 - January 2010
EPIX Pharmaceuticals March 2008 - December 2008
Acambis November 2005 - October 2007
Massachusetts General Hospital April 2003 - November 2005
Skills
Photography, Digital Photography, Portrait Photography, Adobe Creative Suite, Photoshop, Fine Art Printing, Travel Photography, Event Photography, Fine Art Photography, Digital Media, Clinical Trials, Clinical Research, CRO, Regulatory Affairs, Sop, Clinical Operations, CTMS, GCP, Clinical Development, Pharmaceutical Industry, Oncology, Biotechnology, Cardiology, Clinical, FDA, Lifesciences, Clinical Study Design
Education
Center for Digital Imaging Arts (Boston University 2009 — 2011
Certificate, Professional Photography, Photography
MGH Institute of Health Professions 2001 — 2003
MS, Clinical Research
University of Cincinnati 1990 — 1995
BS, Psychology/Biology
Vertex Pharmaceuticals January 2014 - Present
Vertex Pharmaceuticals October 2012 - January 2014
Shire HGT April 2011 - November 2012
Novartis Vaccines and Diagnostics August 2010 - April 2011
Novartis Vaccines and Diagnostics April 2010 - 2010
Novartis Vaccines and Diagnostics 2009 - 2010
Novartis Vaccines and Diagnostics 2008 - 2009
Novartis Vaccines 2007 - 2008
BattelleCRO 2004 - November 2007
Education
Middlesex Community College 1984 — 1986
Nursing
Shire HGT January 2015 - Present
Shire HGT December 2010 - January 2015
Diosynth Biotechnology/ Merck May 2001 - November 2010
UNC-Chapel Hill January 1998 - May 2001
University of North Carolina January 1998 - May 2001
Millikin University January 1995 - January 1997
Skills
Validation, GMP, Gel Electrophoresis, Biotechnology, Chromatography, Laboratory, Biopharmaceuticals, Technology Transfer
Education
University of North Carolina at Chapel Hill 1997 — 2001
M.S, Biological Chemistry; Biophysics
Millikin University 1993 — 1997
B.S, Chemistry; Education
Dendreon 2012 - 2013
Dendreon 2011 - 2012
Dendreon 2010 - 2011
Shire HGT 2008 - 2010
Amgen 1999 - 2008
Amgen Technology Ireland 2006 - 2007
Skills
FDA, Validation, Biotechnology, Change Control, Aseptic Processing, GMP, Biopharmaceuticals, CAPA, Sop, Quality System, Technology Transfer, LIMS, Purification..., deviation investigation, Pharmaceutical Industry, Cell Culture, Purification, Aseptic Technique, Cell Culture..., Molecular Biology, 21 CFR Part 11, V, GxP, GLP, V&V, Deviations, SOP
Education
Karl-Franzens-Universität Graz 1998 — 1999
German
University of Colorado at Boulder 1994 — 1998
Bachelor of Science, Molecular Biology, French
Semester at Sea 1996 — 1996
Liberal Arts
Velico Medical February 2013 - Present
Covidien January 2012 - February 2013
Semprus BioSciences January 2011 - February 2012
Tufts University September 2008 - January 2011
Shire Human Genetic Therapies June 2007 - June 2008
Shire Human Genetic Therapies (Shire HGT) July 2006 - December 2006
Shire HGT 2006 - 2006
Rohm and Haas 2005 - 2005
Rohm & Haas Electronic Materials 2005 - 2005
Skills
Biotechnology, Process Simulation, Cell Culture, Technology Transfer, R&D, Drug Delivery, UV/Vis, Chemical Engineering, Medical Devices, GMP, Biomaterials, Protein Purification, Lifesciences, Assay Development, Life Sciences, Validation, SOP, Characterization
Education
Tufts University 2008 — 2010
M.S., Chemical Engineering
Northeastern University 2002 — 2007
BS, Chemical Enginnering, Biochemical Engineering
Canadian Academy
Vertex Pharmaceuticals 2008 - Present
Shire HGT January 2008 - August 2008
Acceleron Pharma October 2007 - December 2007
The Forsyth Institute July 2006 - September 2007
Critical Therapeutics, Inc January 2004 - August 2004
Skills
Cell Culture, ELISA, Assay Development, Immunohistochemistry, siRNA, real-time PCR, Drug Discovery, Electrophoresis, Biotechnology, Pharmacokinetics, Bioanalysis, ADME, Drug Development, DMPK, In Vivo, Dissection, Cell Based Assays, Life Sciences, HPLC, Pharmaceutical Industry, Molecular Biology, qPCR
Education
Northeastern University 2000 — 2006
BS, Biology
Bishop Guertin 1996 — 2000
Diploma
Shire HGT December 2009 - Present
Shire HGT June 2007 - December 2009
UNIVERSITY OF MASSACHUSETTS, BIOLOGIC LABORATORIES January 2004 - June 2007
UNIVERSITY OF MASSACHUSETTS, BIOLOGIC LABORATORIES February 2001 - January 2004
AMERICAN RED CROSS BLOOD SERVICES February 1996 - September 2000
AMERICAN RED CROSS BLOOD SERVICES February 1995 - February 1996
Education
Isenberg School of Management, UMass Amherst
Shire HGT January 2011 - April 2013
Shire HGT 2007 - 2010
Shire HGT 2005 - 2007
Shire HGT 2002 - 2005
Shire HGT 1999 - 2002
Abbott (f/k/a BASF) 1998 - 1999
EMD Serono, Inc. 1996 - 1998
Skills
GMP, Aseptic Processing, Biopharmaceuticals, Technology Transfer, Quality System, Regulatory Submissions, Regulatory Affairs, Biotechnology, CAPA, Program Management, Pharmaceutical Industry, American Society for...
Education
Massachusetts College of Pharmacy and Health Sciences 2003 — 2005
MS, Regulatory Affairs & Health Policy
University of Massachusetts, Amherst 1992 — 1996
BS, Biochemistry
Oso BioPharmaceuticals Manufacturing, LLC May 2015 - Present
Merck January 2013 - April 2015
Merck January 2011 - January 2013
Shire HGT 2009 - March 2011
Amgen November 2005 - 2009
Amgen November 2003 - November 2005
Agilent Technologies 1999 - 2003
Agilent Technologies 1995 - 1999
Skills
Manufacturing, Process Improvement, Start-ups, Product Development, Automation, Validation, GMP, FMEA, Change Control, Technology Transfer, V&V, CAPA, Process Simulation, Engineering, Biopharmaceuticals, Biotechnology, Chromatography, FDA, Lean Manufacturing, Commissioning, Continuous Improvement, Pharmaceutical Industry, Quality Assurance, Aseptic Processing
Education
University of Colorado Boulder 1992 — 1994
MS, Chemical Engineering, specialization Biotechnology
New Mexico State University 1987 — 1991
BS, Chemical Engineering
Ocata Therapeutics September 2009 - Present
Shire HGT December 2008 - March 2009
acusphere, inc August 2005 - July 2008
Bristol-Myers Squibb Medical Imaging April 1982 - November 2003
Skills
GMP, FDA, LIMS, Validation, Aseptic Processing, Quality Assurance, Sop, Quality System, Change Control, CAPA, R&D, 21 CFR Part 11, Manufacturing, Biotechnology, QA Engineering, Process Simulation, Product Development, V&V, Quality Control, Pharmaceutical Industry, QC Tools, Technology Transfer, Clinical Trials, Medical Devices, Deviations, SOP
Education
University of Phoenix 1999 — 2002
BA, Business Marketing
Middlesex Community College 1997 — 1999
AS, Science
Shire Pharmaceuticals 2005 - Present
Shire June 2006 - October 2011
Shire Human Genetic Therapies 2006 - October 2011
Shire HGT June 2006 - March 2008
Stop and Shop October 1988 - August 1995
Education
Northeastern University 2005 — 2007
Middlesex Community College 2002 — 2004
Shire HGT Operations ManagerShire Pharmaceuticals2007 - Present
Amgen 2003 - 2007
ArQule 1996 - 2003
Skills
Biotechnology, GMP, Pharmaceutical Industry, CAPA, Technology Transfer, Sop, FDA, Process Improvement, Change Control, Validation, Quality System, Biopharmaceuticals, Team Leadership, 21 CFR Part 11, Team Building
Education
Ithaca College 1993 — 1995
McCann
SHIRE HGT January 2002 - Present
Wyeth 1988 - 2002
Skills
GMP, Validation, FDA, Aseptic Processing, Biotechnology, Trackwise, HVAC, Quality System, Technology Transfer, Sop, Change Control, Troubleshooting, Manufacturing, Biopharmaceuticals, CAPA, 21 CFR Part 11, Pharmaceutical Industry, Aseptic Technique, V&V, Quality Control, GxP, GLP, GAMP, FDA GMP, LIMS, Computer System...
Education
Coyne Electrician School
Two Year Certificate Program, Electrical/Electronics Maintenance and Repair Technology, 3.0
North Shore Community College
Liberal Arts and Sciences/Liberal Studies
Northeast Technical Institute
Refrigeration, Heating, Air Conditioning, Ventilation and Refrigeration Maintenance Technology/Technician, 4.0
Wentworth Institute of Technology
Industrial Electronics Technology/Technician
Shire HGT March 2014 - Present
Shire Pharmaceuticals (Shire Human Genetic Therapies) 1996 - Present
TKT 1996 - 2009
Education
Northeastern University 1991 — 1995
Onyx Pharmaceuticals November 2012 - Present
Shire HGT September 2011 - July 2012
Shire HGT 2008 - 2011
CuraGen Corporation February 2007 - November 2007
Genentech October 1995 - January 2007
Skills
CMC, Biotechnology, Biopharmaceuticals, GMP, Drug Development, Pharmaceutical Industry, Sop, 21 CFR Part 11, Clinical Development, FDA, Regulatory Submissions, Lifesciences, Oncology, Clinical Trials, Immunology, CRO, GCP, Infectious Diseases, Validation, Technology Transfer, GLP, IND, Professional Mentoring, Regulatory Affairs, Leadership, Project Portfolio..., Strategic Leadership
Education
John F. Kennedy University
MBA
University of California, Santa Cruz
BA Biology
Shire HGT October 2009 - Present
Acusphere, Inc. March 2004 - November 2009
Biopure 1988 - 2005
Stone & Webster 1981 - 1988
Skills
Process Simulation, GMP, Pharmaceutical Industry, FDA, Validation, Technology Transfer, Process Optimization, Biopharmaceuticals, Biotechnology
Education
Massachusetts Institute of Technology 1972 — 1974
MS, Chemical Engineering
Susquehanna International Group 2008 - Present
BioMarin January 2008 - February 2008
Shire HGT June 2006 - August 2007
Skills
Options, Derivatives, Equity Derivatives, Trading
Education
Massachusetts Institute of Technology 2004 — 2008
B.S., Chemical Engineering
Biogen Idec May 2012 - Present
Biogen Idec August 2011 - May 2012
Vertex Pharmaceuticals March 2010 - September 2011
Molecular Insight Pharmaceuticals January 2008 - February 2010
Vertex Pharmaceuticals March 2007 - December 2007
ARIAD Pharmaceuticals, Inc. July 2006 - May 2007
Shire HGT July 2006 - February 2007
Millennium Pharmaceuticals September 2002 - June 2006
Wyeth Pharmaceuticals (GI) October 1999 - September 2002
Parexel Corporation November 1997 - October 1999
Skills
CDISC, Data Management, SAS, Statistical Programming, Analysis, Clinical Trials, CRO, Regulatory Submissions, Pharmaceutical Industry, Clinical Research, Clinical Data Management, SAS programming, Biostatistics, Biotechnology, Statistics
Education
Massachusetts Institute of Technology 1979 — 1986
Confidential July 2011 - Present
Your Command June 2010 - Present
Confidential October 2010 - July 2011
Shire HGT April 2009 - October 2009
Contractor March 2006 - March 2009
Protonex March 2006 - March 2009
BASF Bioresearch / Abbott Laboratories 1999 - 2006
Pharmaplan Hatch / Hatch Biodynamics 1997 - 1999
Raytheon Engineers and Constructors 1990 - 1997
Skills
Automation, Instrumentation, Process Control, Engineering, PLC, Manufacturing, Visual Basic, DCS, Start-ups, Control Systems Design, R&D, FDA, Validation, Quality System, Electronics..., Six Sigma / Lean...
Education
Worcester Polytechnic Institute 2004 — 2005
Graduate Certificate
North Carolina State University
BS & BS
Advinus Therapeutics- A TATA Enterprise June 2013 - Present
Ridgeview Clinical May 2012 - Present
Sai Advantium Pharma Ltd, Pune India December 2007 - May 2012
Shire HGT December 2006 - December 2007
Johnson & Johnson October 2001 - November 2006
Purdue Pharma April 1998 - September 2001
American Cyanamid/Wyeth September 1992 - February 1998
American Cyanamid 1992 - 1998
American Cyanamid 1992 - 1998
American Cyanamid 1992 - 1998
Skills
DMPK, Toxicology, Pharmacology, Biochemistry, Molecular Genetics, Drug Discovery and..., Clinical Pharmacology, Metabonomics, Drug Discovery, Clinical Development, In Vivo, In Vitro, Assay Development, GLP, Bioanalysis, Pharmacokinetics, CRO, Cell, Cell Culture, Clinical Trials, Genomics, Drug Development, Drug Metabolism, Proteomics, Biomarkers, Lifesciences, LC-MS, Pharmaceutical Industry, Analytical Chemistry, ADME, High Throughput..., Regulatory Submissions, R&D, Biotechnology, Laboratory, Biomarker Discovery, Fluorescence, Life Sciences, HPLC
Education
Memorial University of Newfoundland 1981 — 1986
PhD
Ocular Therapeutix, Inc. July 2015 - Present
Ocular Therapeutix, Inc. July 2014 - Present
Integra LifeSciences March 2014 - July 2014
Integra LifeSciences December 2012 - March 2014
Covidien May 2012 - December 2012
Hologic May 2010 - May 2012
CR Bard July 2007 - May 2010
CR Bard July 2007 - March 2009
Bristol-Myers Squibb Medical Imaging December 2005 - July 2007
Shire HGT May 2004 - November 2005
Skills
Regulatory Affairs, FDA, Medical Devices, Regulatory Submissions, Sop, Management, Pharmaceutical Industry, V&V, Remediation, Regulatory Strategy..., Regulatory Standards, Software Documentation, ISO 13485, CAPA, Quality System, CE marking, Regulatory Requirements, Design Control, 21 CFR Part 11, ISO 14971, Technical Writing, Project Management, Biotechnology, Clinical Trials, Cross-functional Team..., Quality Assurance, SOP, Life Sciences, Validation
Education
Northeastern University 2015 — 2016
Master's degree, Organizational Leadership
Northeastern University 2010 — 2014
Bachelor of Science (B.S.), Health Management, summa cum laude
RAPS University 2008 — 2008
Certificate, Medical Devices
Middlesex Community College 2002 — 2008
Associates, Associates Liberal Arts & Sciences
ASME-BPE Subcommittee on Design for Sterility and Cleanability May 2011 - Present
Shire HGT January 2011 - Present
DPS Bio, Inc. September 2009 - January 2011
Decco Process Solutions July 2006 - September 2009
Johnson Matthey Pharma Services March 2004 - September 2005
Artisan Industries September 2000 - March 2004
Artisan Industries June 1999 - September 2000
Skills
Technology Transfer, Filtration, Chromatography, Management, Biotechnology, LC-MS, Medical Devices, Business Strategy, GMP, Project Management, FDA, Manufacturing, Validation, Engineering, CAPA
Education
Northeastern University 1994 — 1999
Bachelor of Science (B.S.), Chemical Engineering
Mansfield High School 1991 — 1994
Shire Pharmaceuticals November 2014 - Present
Shire HGT December 2012 - Present
Shire HGT June 2011 - December 2012
Shire HGT October 2009 - June 2011
Shire HGT February 2008 - October 2009
Shire HGT February 2007 - February 2008
Shire HGT July 2005 - February 2007
Skills
GMP, Validation, Quality System, Manufacturing, Trackwise, Biopharmaceuticals, Biotechnology, LIMS, Filtration, Technology Transfer, CAPA, Change Control, FDA, Standard Operating..., Document Drafting and..., Enterprise Resource..., Weigh and Dispense, Sop, Purification, SOP
Education
Middlesex Community College
Certificate in Biotechnology soon to have associate, Biotechnology
Shire June 2015 - Present
Shire HGT July 2012 - June 2015
Shire HGT July 2009 - July 2012
Genzyme June 2008 - December 2008
Novetide Ltd. (Subsidiary of TEVA Pharmaceuticals) August 2005 - May 2007
Novetide Ltd. (Subsidiary of TEVA Pharmaceuticals) February 2005 - August 2005
Skills
Six Sigma, GMP, Biopharmaceuticals, Biotechnology, Manufacturing, Cross-functional Team..., Product Development, Lifesciences, Project Planning, Leadership, Technology Transfer, Competitive Analysis, Life Sciences
Education
Massachusetts Institute of Technology 2007 — 2009
SM, Biological Engineering
Massachusetts Institute of Technology - Sloan School of Management 2007 — 2009
MBA
Ben-Gurion University 2001 — 2005
BSc, Biotechnology Engineering
uniQure August 2014 - Present
Lonza March 2013 - August 2014
Shire HGT March 2011 - March 2013
Shire HGT January 2010 - March 2011
Textron August 2008 - January 2010
Wyeth Biotech May 2006 - August 2008
GE June 2005 - May 2006
Thoratec December 2004 - May 2005
EMD Millipore October 2000 - May 2004
Skills
Continuous Improvement, Cross-functional Team..., Process Improvement, Biotechnology, Six Sigma, SAP, Supply Chain, MRP, Medical Devices, Procurement, ERP, Supply Chain Management, Process Simulation, Validation, Quality Assurance, Lean Manufacturing, FDA, Quality System, Business Process, Root Cause Analysis, Operational Excellence, Process Engineering, Materials Management, Team Leadership, GMP, Project Management, Supply Management, Manufacturing, 5S, CAPA, Change Control, Contract Manufacturing, DMAIC, Demand Planning, ISO, Kaizen, Leadership, Management, Manufacturing Operations, Manufacturing..., Pharmaceutical Industry, Quality Control, Quality Management, Software Documentation, Sop, Strategic Sourcing, Strategy, Supply Chain..., V&V
Education
University of Massachusetts at Lowell 2010 — 2013
MBA, Management/Finance
Worcester Polytechnic Institute 2007 — 2009
Certificate, Project Manager
General Electric 2005 — 2005
Certificate, Black Belt/Six Sigma
University of Massachusetts Lowell 2002 — 2004
Certificate, Finance/Marketing
Middlesex Community College 1997 — 2001
ESL, English second language
Universidad Escuela de Administración y Finanzas y Tecnologías 1990 — 1997
B.S., Production Engineer
Colegio Maria Auxiliadora 1986 — 1989
Shire May 2015 - Present
Shire Pharmaceuticals January 2014 - May 2015
Shire HGT April 2010 - January 2014
Shire HGT April 2010 - September 2011
Biovex July 2008 - March 2010
Wyeth Biotech 2005 - 2008
Skills
Biopharmaceuticals, GMP, Biotechnology, Technology Transfer, Validation, CAPA, V&V, FDA, Pharmaceutical Industry
Education
Northeastern University
Bachelor of Science (BS), Chemical Engineer
Shire HGT August 2011 - Present
wyeth February 1998 - September 2011
Wyeth Biotech February 1993 - February 1998
Genetics Institute February 1993 - February 1998
Education
Middlesex Community College 1995 — 1997
AS, biotechnology
Shire HGT June 2012 - Present
Shire HGT June 2012 - Present
BioMed Realty Trust April 2008 - June 2012
The Interlake Steamship Company 2004 - 2006
Skills
Budgets, HVAC, Operations Management, Preventive Maintenance, Maintenance Management, Engineering, Facilities Management, Contract Negotiation, GMP, Capital Projects, Contract Management, Management, Process Improvement, Project Planning, Project Management, Electricians
Education
Massachusetts Maritime Academy 2000 — 2008
Master Of Science Facilities Management, Marine Engineering / Facilities
Bristol-Myers Squibb December 2012 - Present
Bristol-Myers Squibb June 2011 - December 2012
Shire HGT June 2009 - June 2011
Biolex Therapeutics October 2008 - June 2009
Diosynth June 2007 - October 2008
Lonza Biologics December 2006 - June 2007
Skills
Project Coordination, UFDF, bulk fill, Aseptic Processing, Aseptic Technique, Process Automation, column packing, Syncade, Delta V, Technical Documentation, SOP development, SOP authoring, Project Management, Column Packing, Validation, Sop, GMP, CAPA, Purification, Biotechnology, FDA, Protein Purification, Filtration, Chromatography, Biopharmaceuticals
Education
University of New Hampshire 2004 — 2006
Masters, Nutritional Sciences
Michigan State University 2001 — 2003
BS Dietetics
Michigan State University 2001 — 2003
bioAD solutions January 2015 - Present
Bluestream Labs April 2014 - November 2014
AVEO Pharmaceuticals September 2011 - April 2014
Shire HGT December 2006 - March 2012
Diosynth Biotechnology 2000 - 2006
Wyeth Vaccines September 1997 - April 2000
NIEHS August 1995 - August 1997
NIH/NIEHS 1995 - 1997
Skills
HPLC, Protein Chemistry, GMP, Analytical Chemistry, LC-MS, ELISA, Technology Transfer, Mass Spectrometry, Validation, SDS-PAGE, Assay Development, Biopharmaceuticals, Immunoassays, Biotechnology, Monoclonal Antibodies, Drug Development, Formulation, Antibodies, V&V, Vaccines, IND, Analytical Methods...
Education
Marquette University
Ph.D., Analytical -Biophysical Chemistry
University of Jaffna
Bachelor of Science (BSc), Chemistry
University of Jaffna
University of Jaffna
Shire HGT July 2012 - Present
Genzyme March 2012 - July 2012
Genzyme May 2009 - March 2012
SPEC March 2008 - April 2009
Widener University February 2007 - March 2008
Schenectady Herdillia Ltd, Mumbai, India August 2005 - April 2006
Skills
DeltaV, Siemens, MES, Simulation, AutoCAD, DCS, Commissioning, Process Control, P&ID, Honeywell Experion, Aspen HYSYS, Process Engineering, Change Control, Simulations, WebDAV, GAMP, Validation, Automation, V&V, GMP, Honeywell DCS, CAPA, Computer System..., Aseptic Processing, Instrumentation, Process Optimization, Chemical Engineering, Process Automation, Process Simulation, Purification, Engineering, Biotechnology, Testing, Manufacturing, HAZOP
Education
Widener University 2006 — 2008
MS, Chemical Engineering
Mahatma Gandhi University 2001 — 2006
BE, Chemical Engineering
University of Mumbai 2001 — 2006
BE, Chemical Engineering
Shire Pharmaceuticals August 2008 - Present
Shire HGT 2005 - 2008
Skills
Biotechnology
Education
Lesley University 2000 — 2004
MS, HR Management
Johnson & Johnson April 2015 - Present
Johnson & Johnson March 2013 - Present
Agenus August 2012 - March 2013
MGH Institute of Health Professions May 2011 - August 2012
Shire HGT October 2010 - May 2011
Shire HGT March 2009 - October 2010
Wyeth Biotech November 2008 - March 2009
Wyeth Biotech September 2006 - November 2008
Skills
GMP, FDA, Validation, Sop, CAPA, Quality Assurance, Quality System, Biotechnology, Regulatory Affairs, Quality Control, Software Documentation, Quality Auditing, Clinical Trials, Vaccines, Cross-functional Team..., Cell Culture, 21 CFR Part 11, Pharmaceutical Industry, Clinical Research, SOP
Education
MGH Institute of Health Professions
BSN, RN, Nursing
Massachusetts Biotechnology Education Foundation
Penn State University
Bachelor of Science, Biobehavioral Health
Rachel Weiss Science and Clinical Writing, Inc. January 2011 - Present
BioBridges, LLC July 2008 - December 2010
Shire HGT 2006 - 2008
Genzyme 2004 - 2006
Inex Pharmaceuticals 2003 - 2004
PRA International 1999 - 2001
Skills
Oncology, Clinical Development, Pharmaceutical Industry, Regulatory Submissions, Biotechnology, Biostatistics, Clinical Research, Lifesciences, Medical Writing, Continuing Education, Evidence-based Medicine, Gerontology, Clinical Trials
Education
The University of Toronto 1990 — 1996
PhD, Epidemiology
The University of British Columbia 1984 — 1986
MSc, Epidemiology
McGill University
Shire Pharmaceuticals February 2015 - Present
Shire February 2014 - Present
Shire HGT April 2011 - February 2014
Shire HGT August 2009 - April 2011
Skills
GMP, Sop, LIMS, ELISA, Quality System, Quality Control, Western Blotting, SDS-PAGE, Validation, Aseptic Technique, Bioassay
Education
Northeastern University 2012 — 2015
Master of Science (M.S.), Biotechnology
Merrimack College 2004 — 2008
Biology
Intercept Pharmaceuticals/JURISolutions July 2015 - Present
RHB & Associates February 2015 - Present
PAREXEL/RHB & Associates Legal Consultant February 2015 - June 2015
Genentech April 2014 - January 2015
Actelion March 2013 - December 2013
Biogen Idec April 2011 - April 2012
Shire HGT May 2009 - April 2011
Neponset Valley Chamber of Commerce 2003 - 2006
Skills
Biotechnology, Clinical Trials, Pharmaceutical Industry, Lifesciences, Clinical Research, FDA, Clinical Development, Regulatory Affairs, CRO, Drug Development, Contract Negotiation, Regulations, Licensing, Intellectual Property, GCP, Regulatory Requirements, Protocol, Clinical Operations, ICH-GCP, Legal Assistance, Medical Affairs, Legal Writing, Management, Oncology, Cross-functional Team..., Biopharmaceuticals, Leadership, Process Improvement
Education
Northeastern University 2009 — 2016
Master of Science, Regulatory Affairs for Drug, Biologics and Medical Devices, 3.75
New England School of Law 2002 — 2008
JD, law
Providence College 1978 — 1983
Bachelor of Science, Health/Health Care Administration/Management
Bishop Feehan High School
Shire HGT November 2013 - Present
Genzyme March 2008 - November 2013
Invitrogen October 2005 - March 2008
Biosource 2002 - 2005
Skills
GMP, Validation, ELISA, Manufacturing, Purification, Change Control, Cell Culture, Aseptic Processing, Chromatography
Education
Mount Wachusett Community College 1997 — 1999
Associates Degree, Computer Graphic Design
Mount Wachusett Community College
MedImmune 2014 - 2015
Alexion Pharmaceuticals, Inc. 2011 - 2013
Shire HGT 2009 - 2009
Centocor Inc 1988 - 2008
Centocor 2001 - 2005
Centocor 2001 - 2005
Centocor 2001 - 2005
Skills
Sop, HPLC, Validation, GxP, GCP, Bioanalysis, LIMS, GLP, 21 CFR Part 11, Monoclonal Antibodies, Leadership, Biopharmaceuticals, Protein Chemistry, Quality Control, Chromatography, FDA, Biochemistry, Regulatory Affairs, CMC, Method Development, Gas Chromatography, Laboratory, Biotechnology, Science, Technology Transfer, Project Management, GMP, SOP
Education
Lehigh University 1983 — 1988
MS, PhD, Biochemistry
Shire HGT May 2011 - Present
Amgen June 2003 - May 2011
Baxter Healthcare April 2001 - June 2003
Education
Montana State University-Bozeman 1998 — 2001
MS, Chemical Engineering
Hefei No. 1 high school
Shire Pharmaceuticals October 2014 - Present
Shire HGT June 2010 - October 2014
Shire HGT August 2008 - June 2010
Biogen Idec August 2004 - August 2008
Biogen Idec August 2004 - August 2008
Biogen Idec August 2004 - August 2008
Skills
Validation, Trackwise, Testing, Technology Transfer, Sop, SOP, Program Management, Process Improvement, Microsoft Office, Manufacturing Operations, Manufacturing, LIMS, GMP, FDA, Clean Rooms, Change Control, Cell Culture, CAPA, Biotechnology, Biopharmaceuticals, Aseptic Technique
Education
Middlesex Community College 2007 — 2011
Associate, Biotechnology
PerkinElmer June 2013 - Present
Shire HGT August 2008 - September 2012
Inch by Inch Child Development Center 2006 - July 2008
Skills
GMP, Trackwise, Sop, LIMS, Biotechnology, Biopharmaceuticals, CAPA, Validation, FDA, CIP, Manufacturing, Change Control, Deviations, Laboratory, 21 CFR Part 11, Assay Development, Quality Control, Quality System, GLP, Quality Assurance, cGMP manufacturing, Calibration, Pharmaceutical Industry, SOP, TrackWise
Education
Merrimack College 2002 — 2006
Bachelor of Science (BS), Political Science and Government
Shire HGT 2008 - Present
Wyeth 2007 - 2008
Education
Middlesex Community College 2006 — 2008
Associate of Science (A.S.)
ThreeWire Inc February 2015 - Present
Optum / Synergy Research June 2014 - October 2014
INC Research July 2012 - October 2012
Medica Corporation June 2011 - February 2012
Medica Corporation June 2011 - January 2012
Shire HGT October 2010 - February 2011
Quintiles January 2008 - July 2010
UHCR September 2005 - February 2007
MIT March 2001 - September 2002
Harvard Medical School, MGH January 1999 - March 2001
Skills
Pharmaceutical Industry, CRO, Clinical Research, Clinical Trials, Oncology
Education
Lomonosov Moscow State University (MSU) 1980 — 1986
Ph.D., Molecular Genetics
Acceleron Pharma Sr. Director, Toxicology and PharmacologyAltus PharmaceuticalsSeptember 2005 - October 2008
TKT 1999 - 2005
Shire HGT 1999 - 2005
Education
Massachusetts Institute of Technology 1969 — 1976
PhD, Microbiology
Shire HGT March 2013 - Present
Genzyme Biologics May 2009 - March 2013
Genzyme 2009 - March 2013
BiogenIdec 2007 - 2008
Biogen 2007 - 2008
Skills
Validation, Biotechnology
Education
Keiser University-Ft Lauderdale 1998 — 2000
Associate of Science (A.S.), Computer Engineering
UCLA January 2011 - July 2012
Shire HGT May 2009 - April 2010
Brigham and Women's Hospital May 2007 - August 2007
Skills
Cell Culture, Molecular Biology, Life Sciences
Education
UCLA 2012 — 2017
PhD, Neurobiology and Behavior
McGill University 2005 — 2009
Bachelor of Science, Biology, Chemistry
Shire HGT 2007 - 2009
PerkinElmer Optoelectronics November 1996 - September 2007
Visibility 1990 - 1996
Education
North Shore Community College
Associates, Business - Accounting
Shire HGT July 2011 - Present
Biogen Idec January 2010 - July 2011
Massachusetts Institute of Technology - Department of Chemical Engineering January 2008 - May 2010
Albany International January 2007 - June 2007
W. R. Grace January 2006 - June 2006
Education
Northeastern University 2004 — 2009
B.S, Chemical Engineering
Shire Pharmaceuticals Training and Compliance Specialist IIShire HGTJuly 2011 - Present
Shire HGT March 2007 - July 2010
Mallett Electric May 2000 - January 2008
Skills
cGMP, GMP, Quality Systems, Biotechnology, SOP, Compliance, Process Improvement, Change Control, Microsoft Office, Quality Assurance, Quality System, Sop, Pharmaceutical Industry, FDA, Validation, V&V, Technology Transfer, CAPA, Aseptic Processing, 21 CFR Part 11, Biopharmaceuticals, GLP, Regulatory Affairs, Computer System..., LIMS, Regulatory Requirements, ISO 13485, Trackwise, Quality Control, Cleaning Validation, Lifesciences, GAMP, Document Management, Medical Devices, Life Sciences
Education
Southern New Hampshire University 1994 — 1998
ASBS, Business Administration Information Technology
Northeastern University
Construction Management
Programming Manager - Remote Team January 2013 - Present
Millennium Pharmaceuticals March 2012 - January 2013
Shire HGT May 2010 - June 2011
Genzyme 2002 - 2010
Serono 1995 - 2001
Skills
CDISC, Biotechnology, Clinical Development, Regulatory Submissions, Biostatistics, Drug Development, Clinical Trials, Oncology, Clinical Study Design, Clinical Data Management, 21 CFR Part 11, CRF design, CRO, EDC, FDA, Statistical Programming, Survival Analysis, SAS programming, Medical Devices, Pharmaceutical Industry, Clinical Research
Education
Suffolk University - Sawyer School of Management 2007 — 2007
MBA, International Business
Northeastern University
Bachelor of Science (BS), Chemical Engineering
Shire HGT 2011 - Present
Biogen Idec 2008 - 2011
Hospira Inc. 2004 - 2008
Abbott Laboratories 1996 - 2004
Hoffman La Roche 1992 - 1996
FDA (New York Regional Laboratory) 1990 - 1991
Skills
Project Management, Cross-functional Team..., Regulatory Submissions, Pharmaceutical process..., Technology Transfer, Due Diligence, Strategic Planning, Biopharmaceuticals, GMP, CMC development, Contract Manufacturing, CMO management, Global Alliance..., Drug Development, Pharmaceutical Industry, Quality System, Product Development, Regulatory Affairs, Validation, R&D, Formulation, IND, Clinical Trials, Analytical Chemistry, FDA, Pharmaceutics, Medical Devices
Education
Northwestern University 2005 — 2007
MPD, Business & Product Development
Lake Forest Graduate School of Management 2006 — 2006
Business Leadership
The Graduate Center, City University of New York 1984 — 1990
Ph.D. & M.Phil., Chemistry
Vical October 2012 - Present
Keck Graduate Institute August 2010 - September 2012
Broadley-James Corporation September 2011 - May 2012
Shire HGT June 2011 - September 2011
Tesco HSC August 2008 - July 2010
Skills
Biotechnology, Cell Culture, cGMP manufacturing, Process Simulation, Biopharmaceuticals, Pharmaceutical Industry, R&D, Data Analysis, Aseptic Technique, Fermentation, ELISA, Process Optimization, Tissue Culture, Microsoft Office, Problem Solving, Purification, Technology Transfer
Education
Keck Graduate Institute 2010 — 2012
MBS
Visvesvaraya Technological University 2004 — 2008
BE
Sri Ramakrishna Vidyashala, Mysore 1999 — 2004
Shire HGT November 2012 - Present
Pfizer 2001 - November 2012
Skills
GMP, HVAC, Facilities Management, Change Control, Reliability, Energy Management, Commissioning, Preventive Maintenance, Root Cause Analysis, Computer System..., Automation, Validation, Capital Projects, Aseptic Processing, Six Sigma, CAPA, Manufacturing, Sop, FDA, Maximo, Medical Devices, Maintenance Management, 21 CFR Part 11, Biotechnology, Engineering, Calibration, Continuous Improvement, Pharmaceutical Industry, R&D, Project Engineering, Lean Manufacturing, V&V, Clean Rooms, Quality System, Biopharmaceuticals, FDA GMP, FMEA, GxP, GAMP, Plant Maintenance, Trackwise, Vaccines
Education
New Jersey Institute of Technology 2002 — 2005
MS, Pharmaceuticals Engineering
New Jersey Institute of Technology 1989 — 1994
BS, Mechanical Engineering
Shire HGT May 2011 - Present
Rustic Luxury September 2013 - Present
Shire HGT September 2009 - May 2011
Wyeth Bipharma January 2002 - September 2009
Skills
GMP, Aseptic Technique, Purification, CAPA, 21 CFR Part 11, Aseptic Processing, Validation, Technology Transfer, Pharmaceutical Industry
Education
Le Cordon Bleu College of Culinary Arts-Cambridge 2011 — 2012
Culinary, Culinary Arts/Chef Training
Shire Pharmaceuticals 2008 - Present
Shire HGT July 2008 - 2012
EMD Serono 2001 - 2007
Skills
FDA, GMP, Manufacturing, Sop, Trackwise, Pharmaceutical Industry, Validation
Education
Salem High School, Salem, MA 1976 — 1981
Middlesex Community College
Biology Technician/Biotechnology Laboratory Technician
Shire HGT September 2011 - Present
On-Q-ity July 2011 - September 2011
YOU ME Patent & Law Firm 1996 - 1999
Skills
Biotechnology
Education
Minuteman Career & Technical School 2011 — 2011
Biomanufacturing
YMCA International Learning Center 2007 — 2009
Intensive English Program
Korea University 1991 — 1995
Bachelor of Science, Food Technology
Shire HGT November 2011 - Present
Pfizer November 1997 - November 2011
BioPure October 1994 - November 1997
Skills
GMP, Validation, SOP, HPLC, cGMP, Documentation, Troubleshooting, SAP, FDA, Manufacturing, Quality Assurance, Problem Solving, Biotechnology, Supervisory Skills, Cell Culture, Process Engineering, LIMS, Chromatography, Filtration, Team Building, Sop, Purification, CAPA, Change Control, Pharmaceutical Industry
Education
Middlesex Community College
Certificate, Biotechnology
Shire HGT September 2009 - Present
Pfizer March 2001 - September 2009
99 Restraunt August 1996 - December 2001
Skills
Training, Troubleshooting, Coaching, GMP, LIMS, CAPA, Deviations, Excavation Safety, Emergency First..., SOP authoring, Start-up Ventures
Education
Hesser College 1995 — 1997
Business
Pinkerton Academy 1988 — 1991
Shire HGT April 2001 - Present
Skills
Microsoft Office, Microsoft Excel, Microsoft Word, Customer Service, PowerPoint, English, Windows, Outlook, Photoshop, HTML, Software Documentation
Education
New England College 1988 — 1992
Bachelor's degree, Business/Corporate Communications
The Stony Brook School 1984 — 1988