Biopure Company
Industry: Company
DescriptionBiopure Corporation was a biopharmaceutical company that specialized in oxygen therapeutics for both human and veterinary use. The company developed, manufactured, and marketed oxygen therapeutics, designed to transport oxygen to the body's tissues. Headquarters: Cambridge, MA Founder: David Judelson Founded: 1984 Number of employees: 4 Key person: Zafiris G Zafirelis
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Biopure Employees
SAMH BLIDA September 2013 - Present
Biopure December 2011 - February 2012
Trefle spa July 2007 - May 2011
Laitiers TREFLE July 2007 - May 2011
Spa Produits Laitiers TREFLE, Blida September 2006 - January 2007
Spa Produits Laitiers TREFLE September 2006 - January 2007
Etablissements HOSNA, January 2004 - May 2006
Etablissements HOSNA January 2004 - May 2006
Skills
International Relations, Customer Service, Retail, Microsoft Excel, Microsoft Office, Inventory Management, Microsoft Word, Forecasting, PowerPoint, Management, Budgets, Merchandising, Sales, Outlook, Teamwork, Team Leadership, Strategic Planning, Leadership, Negotiation, Time Management
Education
Licence, Economie/Planification
Université d’Alger
Licence; Baccalauréat, Sciences Economiques; Planification; Scientifique
Nth Degree May 2015 - Present
McKesson Health Solutions May 2014 - April 2015
McKesson Health Solutions May 2011 - May 2014
IDG Enterprise (Network World Brand) January 2006 - May 2011
Network World (part of IDG) April 2004 - December 2006
Sigma Sigma Sigma Sorority January 2002 - August 2004
Institute for International Research November 2003 - March 2004
Biopure May 1999 - October 2003
Skills
Contract Negotiation, Location Intelligence, Trade Shows, Event Management, Event Planning, Marketing Communications, Social Media Marketing, Onsite Coordination, Social Media, Email Marketing, Marketing Strategy, Marketing, Lead Generation, Salesforce.com, Public Relations, Meeting Planning, Strategic Planning, Account Management, Sales, Budgets, Sponsorship, Management, Start-ups, New Business Development, Project Management, Customer Service, Vendor Management
Education
IAEM 2006 — 2012
Certified, Exhibition Management
Northeastern University 1993 — 1998
BS, Communications
LeMaitre Vascular November 2014 - Present
Hyde Engineering + Consulting May 2014 - November 2014
IntelligentMDx June 2013 - January 2014
Anika Therapeutics April 2012 - May 2013
EMD Millipore October 2010 - April 2012
Sanofi Pasteur 2008 - 2010
Biopure 2006 - 2008
Proteome Systems May 2004 - June 2006
Air Products and Chemicals May 2002 - May 2004
Skills
GMP, Validation, Biotechnology, Chromatography, Technology Transfer, CAPA, Sop, FDA, Purification, Aseptic Technique, Protein Purification, Filtration, Vaccines, Cleaning Validation, Chemical Engineering, Process Engineering, Biopharmaceuticals, Change Control, Design of Experiments, Aseptic Processing, R&D, V&V, Quality Assurance, Fermentation, 21 CFR Part 11, Cell Culture, LIMS, Molecular Biology, ELISA, Root Cause Analysis, GLP, Quality System, Pharmaceutical Industry, SOP
Education
Northeastern University 2005 — 2007
MS, Biotechnology
Penn State University 1997 — 2002
BS, Chemical Engineering
Bristol-Myers Squibb July 2015 - Present
Waters April 2005 - December 2014
Alexion Pharmaceuticals September 2002 - April 2005
Syntonix Pharmaceuticals (now Biogen) April 2002 - August 2002
Biopure 2001 - 2002
Armstrong Laboratories 1999 - 2001
Massachusetts Pesticide Analysis Laboratory September 1998 - July 1999
Skills
HPLC, Gas Chromatography, ELISA, Chemistry, SDS-PAGE, FTIR, UV, Laboratory, Titration, Empower, Calibration, Quality Control, Instrumentation, Quality Assurance, Chromatography, LC-MS, Analytical Chemistry, Mass Spectrometry, Raw Materials, UV/Vis, GMP, GLP, LIMS, Pharmaceutical Industry
Education
University of Massachusetts, Amherst 1994 — 1999
BS, Environmental Science, Chemistry and Toxicology
OvaScience December 2014 - Present
Seattle Cancer Care Alliance May 2009 - November 2014
Zymogenetics, Inc August 2008 - May 2009
Seattle Cancer Care Alliance March 2007 - August 2008
AMGEN 2002 - 2007
Amgen 2002 - 2007
Abbott Bioresearch Center 2000 - 2002
Biopure 1996 - 1997
AstraZeneca 1996 - 1997
Skills
Quality systems..., Risk Management, Investigations/CAPA, Staff Development, Validation, FDA, Quality Systems, CAPA, Compliance, Change Control, cGMP, Risk Assessment, Negotiation, Quality System, LIMS, Facility Qualification, QA Agreements, GMP, Quality Management, Biotechnology, SDLC, Software Documentation, Sop, GTP, Performance management, Collaboration, Trackwise, Six Sigma, Computer System..., GxP, Process Improvement, GLP, Cross-functional Team..., Medical Devices, 21 CFR Part 11, Aseptic Processing, Quality Auditing, Regulatory Affairs, Technology Transfer, V&V, Regulatory Requirements, GCP, SOP development, Laboratory, cGTP, Cell Therapy, Pharmaceutical Industry, Biopharmaceuticals, Microbiology, Regulatory Submissions
Education
Westfield State College 1978 — 1979
Liberal Arts and Sciences/Liberal Studies
Quinsigamond Community College
Westfield State College
VetBiotek, Inc. November 2014 - Present
Sogeval Laboratories June 2012 - October 2014
Sogeval Laboratories May 2006 - May 2012
Biopure January 1999 - May 2004
Skills
Market Analysis, Corporate Sales..., Marketing, Pharmaceutical Sales, Sales, Marketing Strategy, Market Planning, Key Account Management, Product Launch, Sales Operations, Strategic Planning, Product Development, Pharmaceutical Industry, Surgery, Sales Management, Cross-functional Team..., Forecasting, Strategy, B2B
Education
Kennesaw State University - Michael J. Coles College of Business
Bachelor of Business Administration (B.B.A.), Professional Sales
Azzur Group July 2013 - Present
OPK Biotech LLC June 2010 - June 2013
Crosspoint Engineering September 2008 - June 2010
Biopure 1994 - 1998
Skills
Validation, Engineering, Cross-functional Team..., Automation, Biotechnology, Risk Management, Control Systems Design, Cleaning Validation, Risk Assessment, GMP, FDA, CAPA, V&V, Quality System, Change Control, Computer System..., 21 CFR Part 11, Pharmaceutical Industry
Education
University of New Hampshire
FORM + FACET October 2013 - Present
Tablehopping NY February 2012 - Present
Eugenia Kim February 2013 - May 2013
K/LLER COLLECTION May 2012 - September 2012
Complinet Inc. January 2007 - July 2009
JPMorgan Chase August 2006 - December 2006
Biopure March 2004 - May 2005
Frontier Capital Management Co March 2002 - March 2004
Skills
Adobe Creative Suite, Illustrator, Photoshop, InDesign, PowerPoint, Microsoft Office, Microsoft Excel, Mac, Time Management, Event Planning, Microsoft Word, E-commerce, Social Media Marketing, WordPress, Web Design, Graphics, Blogging, Email Marketing, CSS, Graphic Design, Creative Direction, Online Marketing
Education
Fashion Institute of Technology 2011 — 2013
Bachelor of Fine Arts (B.F.A.)
Fashion Institute of Technology 2007 — 2011
AAS
Northeastern University 1995 — 1998
Bachelor of Science (BSc)
Biota Pharmaceuticals June 2014 - Present
Independent September 2012 - June 2014
Inhibitex, Inc., a Subsidiary of Bristol-Myers Squibb July 2010 - August 2012
Peptimmune January 2009 - July 2010
Peptimmune, Inc. October 2004 - January 2009
Altus Pharmaceuticals July 1997 - October 2004
Biopure 1991 - 1997
Skills
Clinical Development, FDA, Clinical Trials, Regulatory Affairs, Pharmaceutical Industry, Supply Chain Management, Regulatory Submissions, Quality Assurance, GxP, Analytical Chemistry, eCTD, Quality Auditing, Due Diligence, GLP, GMP, ICH guidelines, API manufacturing, Solid Oral Dosage Forms, Parenteral, Stability Testing, CTAs, Documentum, eRoom, Analytical Method..., Clinical Research, Protocol Review, Investigator Brochures, Annual Reports, SAP, Safety Compliance, Archival Management, EMA, Training Programs, GCPs, Formulation, Drug Development, Biotechnology, Technology Transfer, Validation, CAPA, Sop, Change Control, Drug Discovery, IND, Biologics, Infectious Diseases, Employee Management, GCP, Quality System
Education
Harvard University 1997 — 2007
Masters (ALM), Biology
Suffolk University 1987 — 1991
BS, Biochemistry
Vidya Kunj Navasari 1975 — 1981
Southwest Florida Symphony Orchestra April 2014 - Present
SEA Quest Associates February 2014 - Present
Controllership and Treasury September 2011 - April 2014
National Amusements December 2008 - August 2011
Biopure August 2008 - November 2008
Self Employed November 2007 - August 2008
Polaroid June 1976 - November 2007
Skills
GAAP, Account Reconciliation, General Ledger, Fixed Assets, Monthly Close, Journal Entries, Financial Reporting, QuickBooks, Accounting, Forecasting, Hyperion Enterprise, Process Improvement, SAP, PeopleSoft, Variance Analysis, Financial Modeling, Financial Analysis, Budgets, Finance, Cash Flow, Cash Management, Auditing, Cost Accounting, Consolidation, Sarbanes-Oxley Act, Revenue Recognition, US GAAP, Internal Controls, Financial Accounting, Internal Audit, Hyperion
Education
Babson College 1975 — 1976
MBA, Accounting & Finance
Babson College 1969 — 1971
B.S./B.A.
Greenwich HS
Biopure March 2015 - Present
IANOR November 2013 - December 2014
Merinal June 2012 - June 2013
Sonatrach March 2011 - May 2011
Linde Gas February 2009 - May 2009
Skills
traitement du gaz, léquifaction des gaz, etude des materiaux, redimentionnement des..., Engineering, Microsoft Office, Microsoft Excel, Product Development, Matlab, Microsoft Word
Education
USTHB 2006 — 2011
Master 2, Génie des Procédés
Université du Québec à Trois-Rivières
Hemoglobin Oxygen Therapeutics LLC October 2014 - Present
OPK Biotech, LLC October 2009 - March 2014
Biopure July 1994 - October 2009
Skills
Sop, GMP, FDA, CAPA, Validation, Biotechnology, Technology Transfer, Pharmaceutical Industry, 21 CFR Part 11, Quality System, Computer System..., GxP, Clinical Development, Medical Devices, HPLC, Lifesciences, Biopharmaceuticals, V&V, Change Control, International Shipping, Supply Chain Management, Accounts Payable, GLP, GCP, SOP
Education
Bunker Hill Community College 1995 — 2000
Associate, Business Management
Genzyme / Sanofi January 2013 - Present
Jacobs Engineering September 2007 - January 2013
Amgen November 2006 - July 2007
Genzyme April 2004 - November 2006
Biopure 2001 - 2004
CR Bard April 1997 - September 1998
Skills
Biotechnology, Process Validation, Validation, cGMP, Technology Transfer, Process Engineering, Aseptic Processing, Plant Optimization, Research and Development, Certified Quality..., Statistical Process..., Testing and..., Project Management, Product Design, Process Optimization, V&V, GMP, GAMP, Process Improvement, Commissioning, Engineering, Medical Devices, Change Control, Process Simulation, Quality System
Education
University College Dublin 1986 — 1990
Bachelor of Engineering, Mechanical Engineering, 1st Hons
Vertex Pharmaceuticals September 2012 - Present
Vertex Pharmaceuticals June 2010 - September 2012
Harvard University August 2008 - May 2010
University of Colorado at Boulder September 2002 - August 2008
Boston College September 2000 - May 2002
Biopure 1999 - 2000
Skills
Organic Chemistry, Chemistry, Organic Synthesis, Mass Spectrometry, LC-MS, HPLC, Drug Discovery, Medicinal Chemistry, Natural Products, Drug Design, Biochemistry, Chromatography, Analytical Chemistry, NMR, Purification, UV/Vis, Drug Development, Biotechnology
Education
Women Unlimited, Inc TEAM Program 2013 — 2014
Management and Leadership Development
Harvard University 2008 — 2010
Mary Fieser Posdoctoral Fellow, Organic Chemistry
University of Colorado at Boulder 2002 — 2008
Ph.D., Organic Chemistry
Boston College 1998 — 2002
B.S., Biochemistry
Drew University Residential School on Medicinal Cheimstry
GSK March 2015 - Present
Novartis Vaccines August 2013 - March 2015
Novartis Vaccines September 2014 - December 2014
Massachusetts Department of Environmental Protection 2013 - 2014
Novartis Vaccines and Diagnostics May 2010 - August 2013
Genzyme 2002 - 2009
Biopure 2000 - 2002
Pfizer (formerly Wyeth, Genetics Institute) 1998 - 2000
Skills
Clinical Development, GCP, Clinical Trials, Vaccines, Pharmaceutical Industry, ICH-GCP, CTMS, Infectious Diseases, Clinical Monitoring, Biotechnology, EDC, Oncology, Regulatory Affairs, Sop, FDA
Education
Tufts University
Master's Degree, Nutrition; Agriculture, Food and the Environment
Tufts University
Graduate Certificate, Environmental Studies
University of Arizona
Bachelor of Science (BS), Biology
Biofficient 2013 - Present
WGBH 2009 - 2012
Biopure 2007 - 2008
Skills
PowerPoint, Broadcast, Microsoft Excel, Digital Media, Microsoft Office, Television, Social Media Marketing, Business Development, Marketing Communications, Public Relations, Social Media, Press Releases, Marketing, Social Networking, Facebook, Online Advertising, Advertising, New Media, Sponsorship, Media Relations, Integrated Marketing, Email Marketing
Education
Providence College 2003 — 2007
BS, Health Policy & Management
Lynnfield High School 1999 — 2003
Avaya September 2010 - Present
Cisco 2008 - 2010
Cisco 1999 - 2008
Oracle Corporation January 1997 - November 1999
Novasoft Systems Inc. January 1995 - January 1997
Biopure 1988 - 1994
Skills
Call Center, Contact Centers, H.323, Unified Messaging, Unified Communications, MGCP, CTI, SIP, Cisco Call Manager, QoS, IVR, Avaya, Routing, ACD, Avaya Technologies, CCNA, Call Centers, Cisco Technologies, Cloud Computing, Ethernet, IP, ISDN, LAN-WAN, MPLS, Managed Services, Network Architecture, Switches, VoIP, Telephony, TCP/IP, WAN, Video Conferencing, SIP Trunking, TDM, Telecommunications, Sales Engineering, Telepresence, Routers
Education
University of Massachusetts Boston 1991 — 1995
BS, Computer Science
Cheetah Medical November 2014 - Present
Massachusetts General Hospital / Harvard University 1991 - Present
GE Healthcare December 2010 - November 2014
Covidien February 2009 - December 2010
Intrepis, LLC March 2005 - December 2009
Hub Management Investment Group, LLC January 2005 - March 2009
Catalyst Oncology 2006 - 2007
Biopure January 2003 - June 2004
eRx Connect January 2000 - December 2003
Emerson Hospital 1999 - 2000
Skills
Due Diligence, Medical Devices, Hospitals, Healthcare, Cancer, Cardiology, Clinical Research, Lifesciences, Healthcare Management, FDA, Biotechnology, R&D, Healthcare Information..., Strategic Planning, Product Development, Oncology, Medicine, Clinical Trials, Medical Education, Cross-functional Team..., Commercialization, Medical Imaging, Research, Investments, Product Launch, Pharmaceutical Industry, Leadership, Informatics, Strategy, Start-ups
Education
Harvard T.H. Chan School of Public Health 1993 — 1994
MPH, Health Care Policy & Managment
University of Illinois College of Medicine 1981 — 1985
MD
University of Illinois at Urbana-Champaign 1977 — 1981
BS, Chemistry & Economics
KRB Group 2004 - Present
First Marblehead January 2008 - December 2008
WR Grace February 2002 - September 2004
WR Grace January 2000 - January 2002
WR Grace January 1998 - January 2000
WR Grace January 1993 - January 1996
WR Grace January 1989 - January 1993
Biopure January 1987 - January 1989
Skills
Operations Leadership, Six Sigma, Product Development, Business Process, Operations Management, Strategic Planning, Business Strategy, Product Management, Budgeting, Product Marketing, P&L Management, Business Planning, Program Management, Operational Excellence, Process Improvement, Budgets, Project Management, Cross-functional Team..., Business Process..., Leadership, Management, Team Leadership, Risk Management, Strategy, Manufacturing, Lean Manufacturing, Process Engineering, Marketing Strategy, Coaching, Team Building, Management Consulting, Marketing
Education
Massachusetts Institute of Technology - Sloan School of Management 2000 — 2001
Business Management
University of New Hampshire 1987 — 1989
Master of Science, Chemical Engineering
University of New Hampshire 1983 — 1987
Bachelor of Science, Chemical Engineering
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
Retired and enjoying time to pursue personal interests and family PartnerTNGApril 2004 - June 2014
State of New Hampshire DRED 2008 - 2011
Control Solutions 2006 - 2009
Control Solutions International January 2006 - May 2008
Biopure July 1997 - April 2004
Skills
Change Management, Team Building, Management Consulting, Auditing, Internal Controls, Accounting, ERP, Management, Strategy, Manufacturing, Project Management, Strategic Planning, Finance
Education
University of Massachusetts Lowell 1966 — 1970
Brayton Point Power Plant April 2014 - Present
OPK Biotech, LLC November 2009 - January 2014
Great Point Energy August 2008 - October 2009
Biopure May 2005 - April 2008
Skills
Commissioning, FDA, Microsoft Excel, Sop, GMP, Validation, CAPA, Change Control, Computer System..., 21 CFR Part 11, GAMP, V&V, LIMS, Technology Transfer, Pharmaceutical Industry, Quality System, GxP, Aseptic Processing, Boilers, Cleaning Validation, Quality Assurance
Education
Peterson School
UMass Dartmouth
Condyne Real Estate September 2014 - Present
Plymouth Real Estate Capital January 2013 - March 2014
Chestnut Hill Realty 2011 - January 2013
Charter Capital Boston, MA November 2006 - August 2010
Cobalt Capital Partners April 2005 - April 2006
Sycamore Networks May 2004 - April 2005
Biopure April 2003 - May 2004
Beacon Power Corporation April 2000 - December 2002
State Street May 1996 - April 1999
Education
Frostburg State University 1990 — 1995
MBA, International Business and Finance
Complya Consulting Group February 2011 - Present
Global Biotech June 2008 - April 2010
Pfizer (Previously Wyeth) October 1997 - April 2010
Biotech External Supply September 2005 - June 2008
Wyeth September 2001 - September 2005
Stockholm, Sweden November 1999 - September 2001
Wyeth (Previously Genetics Institute) October 1997 - November 1999
ImmuLogic Pharmaceutical Corporation October 1995 - October 1997
ImmuLogic June 1995 - October 1997
Biopure September 1993 - October 1995
Skills
GMP, Validation, FDA, CAPA, GxP, Sop, Biotechnology, Pharmaceutical Industry, Quality System, 21 CFR Part 11, V&V, Aseptic Processing, Technology Transfer, Change Control, GLP, Regulatory Affairs, Biopharmaceuticals, LIMS, Quality Assurance, Quality Auditing, Quality Control, Regulatory Submissions, Regulatory Requirements, GCP, Vaccines, Trackwise, Six Sigma, SOP, Cleaning Validation, Clinical Trials, Document Management, Contract Manufacturing, IND, ISO 13485, Lifesciences, Manufacturing, Microbiology, Pharmaceutics, ISO
Education
North Carolina State University 1983 — 1987
B.S, Microbiology
Fresenius Medical Care September 2014 - Present
Fresenius Medical Care January 2014 - September 2014
Covidien October 2012 - September 2013
Covidien December 2007 - October 2012
ViaCell 2003 - 2007
Biopure 1999 - 2003
Skills
Health Economics, Medical Affairs, Medical Devices, Pharmaceutical Industry, Biotechnology, Regulatory Affairs, Clinical Trials, Sop
Education
Fisher College 2011 — 2013
Business Administration and Management, General
Swampscott High School 1990 — 1994
Genzyme August 2011 - Present
Biogen Idec June 2008 - July 2011
Biopure January 2008 - June 2008
Skills
GMP, Quality Assurance, GxP, Trackwise, Microsoft Office, FDA, Validation, CAPA, Pharmaceutical Industry, Verification, Technical Writing, Consent Decree, Manufacturing Operations, Change Control, Internal Audit, Presentations, Biotechnology, Document Management, GLP, TrackWise
Education
Southern New Hampshire University 2014 — 2015
Master of Business Administration (MBA), Project Management
Saint Anselm College 2002 — 2006
Bachelor's degree, Natural Science, Forensics
Sigma-Aldrich January 2015 - Present
Sigma Aldrich 2012 - Present
VWR International September 2003 - April 2012
Life Technologies December 2004 - November 2005
Inscogroup November 2001 - October 2002
Biopure April 1999 - May 2001
Skills
Channel Partners, Leadership, Strategy, Cross-functional Team..., Strategic Planning, Biotechnology, Sales Operations, Pharmaceutical Industry, Life Sciences, Management, Key Account Management, Medical Devices, Biopharmaceuticals, Product Development, Sales, GMP, Sales Process, Business Development, Supply Chain Management, Relationship Management, Technical Scientific..., Channel Management, Pricing Contract..., Key Account Manager, Risk Mitigation..., Effective Negotiation, Customer Hands On..., Consultative Selling, Contract Negotiation, Competitor Intelligence, CRM Databases, SAP ERP, SAP BW, Mammalian Cell Culture, Downstream Processing, Supply Chain Security, Filtration, Disposables, Commodity Risk..., Regulatory Compliance
Education
University of Rhode Island 1995 — 1998
BA, Biology
Rhode Island College 1993 — 1995
Biogen Idec November 2013 - April 2014
Idenix Pharmaceuticals September 2008 - September 2013
Dr. Kenneth B. Levine & Associates 2000 - 2009
Fitzgerald Industries June 2006 - August 2008
Genetic Services June 2004 - June 2006
Biopure August 2003 - October 2003
Skills
Microsoft Office, Microsoft Excel, Microsoft Word, Customer Service, PowerPoint, English, Research, Windows, Outlook, Photoshop, Teaching, HTML, Public Speaking, Budgets, Strategic Planning, Negotiation, Editing, Java, Biotechnology, DNA extraction, Laboratory, Molecular Biology, Project Management, Sales, Training
Education
City Lab Academy / Boston University 2002 — 2003
Certificate, Biomedical and Clinical Laboratory Science
Lesley University 1998 — 2000
Education, Elementary Education
Genoa Lakes Golf Course May 2014 - Present
Biopure November 2013 - February 2014
Destination Tahoe May 2014 - 2014
Edgewood Tahoe Golf Course & Restaurant May 2013 - October 2013
Skills
Microsoft Office, Microsoft Word, Event Planning, Social Media, Writing, Event Management, Public Relations, Management, Marketing, Newsletters, Project Planning, Sales, Time Management, Parties, Public Speaking, Social Media Marketing, Hospitality
Education
University of Nevada-Reno 2014 — 2016
Bachelor's Degree, Business, Management, Marketing, and Related Support Services
Western Nevada College 2010 — 2013
Associate's Degree, Business Administration and Management, General
Eurofins - Nutrition Analysis Center October 2008 - Present
Aeris Therapeutics July 2003 - August 2005
Biopure January 2002 - June 2004
Education
Macalester College
Bachelor of Arts (B.A.), Chemistry
JM Custom Creations 2007 - Present
Biopure 1997 - 2001
Skills
Custom Draperies, Window Treatments, Window Coverings, Roman Shades, Shades, Pillows, Textiles, Blinds, Shutters, Sewing, Cushions, Upholstery, Sales Management, Furnishings, Curtains, Bedding
Education
Brandeis University 1986 — 1990
Bachelor of Science (BS), Biology, General
Pfizer August 2004 - Present
Biopure July 2003 - November 2003
Novartis July 1968 - January 1999
Skills
Clinical Trials, Biotechnology, Quality Control, Pharmaceutical Industry, GMP, Lifesciences, FDA, Validation, Sop, Computer System..., GxP, GLP, LIMS, Vaccines, Change Control, CAPA, SOP, Life Sciences
Education
SUNY Orange 1968 — 1981
Biology, General
SUNY Oneonta 1962 — 1963
Shire Pharmaceuticals 2014 - Present
ARIAD Pharmaceuticals, Inc. 2012 - 2014
Fresenius Biotech North America 2011 - 2012
Genzyme 2006 - 2011
Wyeth 2003 - 2006
Biopure 2002 - 2003
Skills
Regulatory Affairs, Clinical Trials, Biotechnology, FDA, Pharmaceutical Industry, Clinical Development, IND
Education
Regis College 2006 — 2008
MS, Health Product Regulation
Biopure May 2014 - Present
Vincub February 2014 - Present
aucune May 2014 - Present
université de mouloud mammeri de tizi ouzou algerie October 2013 - Present
Skills
Cisco Technologies, Linux, Ubuntu, Java, C++ Language, HTML, phpMyAdmin, MySQL, Microsoft Office, JSP, SOAP, Microsoft Excel, Intellix, Drupal, Telecommunications, English, JavaScript, Project Planning, C++, Administration réseau, Base de données..., Conception bases de...
Education
Université M'Hamed Bougara de Boumerdes 2013 — 2013
les 4 niveau de cisco, formation en réseau informatique
Université Mouloud Mammeri Tizi-Ouzou 2008 — 2013
master 2, informatique, mention très bien
Yvonne M. Rausch D.M.D July 2013 - May 2015
Orlando Dental Group March 2008 - June 2013
BioPure January 2008 - August 2012
Yvonne Rausch, D.M.D., P.A. January 2000 - February 2008
Skills
Periodontics, Local Anesthesia, Digital Radiography, Nitrous Oxide, Eaglesoft, Dentrix, Periodontal Disease, Dentistry, Patient Education, Dental Assisting, Dental Care, Practice Management, Quality Patient Care, X-ray, Appointment Scheduling, Aesthetics, Dental Software, Infection Control, Health Education, Patient Satisfaction, Dental Practice..., Patient Counseling, Marketing
Education
Pensacola Junior College
Associate of Science (A.S.), Dental Hygiene/Hygienist
University of Florida
Dept. of Physical Sciences
Hemoglobin Oxygen Therapeutics LLC. May 2014 - Present
OPK Biotech, LLC January 2010 - April 2014
Globus Medical November 2008 - January 2010
Biopure September 2001 - November 2008
Biopure September 1998 - September 2001
Skills
GMP, FDA, CAPA, Project Management, Medical Devices, Biotechnology, Pharmaceutical Industry, Quality Assurance, Quality System, Manufacturing, PowerPoint, Microsoft Excel, Sop, Budget, Budgets, Validation, ISO 9001, ISO 13485, ISO 22442-2:2007, Product Launch, GLP, Iso 9000, Lifesciences, V&V, Regulatory Affairs, Change Control, Technology Transfer, Biopharmaceuticals
Education
Susquehanna University 1991 — 1995
BS, Biology
Azzur Group March 2013 - Present
OPK Biotech February 2010 - March 2013
Shire HGT October 2007 - February 2010
Genentech December 2003 - October 2007
Pfizer June 2001 - December 2003
Pfizer December 2000 - June 2001
CSL Behring June 2000 - December 2000
Biopure December 1997 - June 2000
PAREXEL (KMI) November 1994 - December 1997
Skills
21 CFR Part 11, Computer System..., Validation, GMP, Change Control, CAPA, FDA, V&V, Sop, GAMP, Quality System, GxP, Aseptic Processing, Biotechnology, Technology Transfer, Cleaning Validation, Quality Assurance, Biopharmaceuticals, Quality Control, Chromatography, Trackwise
Education
Boston College - Wallace E. Carroll Graduate School of Management 1999 — 2001
MBA
Worcester Polytechnic Institute 1990 — 1994
Bachelors of Science, BioMechanical Engineering
BioStrategics Consulting Ltd January 1999 - Present
Biostrategics Consulting Ltd January 1999 - Present
KPMG Advisory 1997 - 1999
Biopure 1995 - 1997
Telor Ophthalmic Pharmaceuticals 1993 - 1995
Sandoz Research Institute 1989 - 1993
Sterling-Winthrop Research Institute 1986 - 1989
Private Practice of Rheumatology 1978 - 1985
Education
University of Chicago - The Pritzker School of Medicine 1969 — 1973
MD, Medicine
University of Iowa Roy J. and Lucille A. Carver College of Medicine 1973 — 1976
Internal Medicine Residency
University of Colorado School of Medicine 1976 — 1978
Rheumatology Fellowship
University of Illinois at Urbana-Champaign 1966 — 1969
BS, Biology
messagingLAB May 2001 - Present
Medikly October 2012 - January 2014
Bridge 6 2010 - 2012
Fisher Center for Alzheimer's Research Foundation August 2008 - July 2009
IconNicholson July 2007 - July 2008
Biopure March 2007 - November 2007
Openwave January 2007 - May 2007
GCI Group 2005 - 2006
Yahoo! 2004 - 2006
Reset/Xceed October 1998 - April 2001
Skills
Marketing, Copywriting, Strategy, Integrated Marketing, Life Sciences, Medical Devices, Messaging, Marketing Strategy, Lifesciences
Education
Naropa University 1990 — 1992
MFA, Creative Writing & Poetics
University of California, Riverside 1985 — 1986
MS, Biochemistry
UC Riverside
BS, Biochemistry
Boehringer Ingelheim June 2013 - Present
Otsuka Pharmaceutical Companies (U.S.) November 2012 - February 2013
Pfizer August 2008 - October 2012
Alexion Pharmaceuticals February 2003 - August 2008
Biopure September 2002 - February 2003
Bristol-Myers Squibb July 2002 - September 2002
Bayer May 2001 - May 2002
New Britain General Hospital 1995 - 2001
Skills
Clinical Research, Clinical Trials, Anti-Infectives, Oncology, Clinical Development, Clinical Monitoring, Emerging Markets, Project Management, Strategic Partnerships, Cardiovascular, Hematology, Blood Substitutes, Trauma, Central Nervous System, Line Management..., Virtual Teams, CRO, CTMS, Infection, Dermatology, Lifesciences, Endocrinology, Nephrology, Sop, Pharmaceutical Industry, Clinical Operations, FDA, Biotechnology, EDC
Education
University of Hartford 1994 — 1997
Psy.D., Clinical Psychology
University of Hartford 1992 — 1994
M.A., Clinical Practices
University of Connecticut 1983 — 1988
B.A., Psychology
Envivo Pharmaceuticals 2008 - 2014
GTC Biotherapeutics 2007 - 2007
RenaMed Biologics 2006 - 2007
Bioscience Associates, LTD. 2004 - 2006
Biopure 1988 - 2004
Baxter International Inc. 1987 - 1987
Rush University Medical Center 1985 - 1987
Rush University Medical Center 1983 - 1985
Education
Antioch College
Bachelor of Science (B.S.), Mathematics and Chemistry
The University of Connecticut Health Center
Doctor of Philosophy (Ph.D.), Biomedical Sciences, Immunology
Boston Heart Diagnostics May 2015 - Present
Quest Diagnostics September 2014 - Present
UMass Memorial Medical Center January 2011 - September 2014
Quest Diagnostics August 2009 - January 2011
Avecia Biotechnology Inc. Oligonucleotides October 2005 - August 2009
Charles River Laboratories 2004 - 2005
TKT 2003 - 2004
Biopure 2002 - 2003
UMass Medical Center 1985 - 2002
Skills
Analytical Chemistry, Biochemistry, Clinical, cGMP, Validation, HPLC, GC/MS, LC-MS, SDS-PAGE, Enzyme Assays, Toxicology, GMP, Quality Control, Cell, Laboratory, Assay Development, Microbiology, GC-MS, GLP, Chromatography, Chemistry, V&V, Gas Chromatography, Biotechnology, LIMS
Education
University of Massachusetts, Amherst 1976 — 1984
Bachelor of Science (B.S.), Microbiology major, Chemistry minor
Amgen April 2015 - Present
Amgen March 2014 - April 2015
Amgen October 2008 - February 2014
MassBiologics February 2007 - August 2008
RenaMed Biologics 2006 - 2006
Therion Biologics 2003 - 2006
Biopure 2000 - 2003
Skills
GMP, Biotechnology, CAPA, Filtration, Manufacturing, Process Simulation, FDA, Sop, Biopharmaceuticals, Technology Transfer, Validation, Purification
Education
Suffolk University
AbbVie January 2013 - Present
Abbott Laboratories November 2011 - December 2012
Abbott Laboratories July 2009 - October 2011
Abbott Laboratories November 2007 - July 2009
Abbott Laboratories July 2007 - November 2007
Abbott Laboratories June 2005 - November 2007
Abbott Laboratories April 2004 - June 2005
Biopure January 2002 - April 2004
Biopure July 2001 - January 2002
Skills
Validation, Manufacturing..., GMP, FDA, Manufacturing, Change Control, CAPA, CIP, SIP, Management, UF/DF, Chromatography, Process Improvement, Biotechnology, Mammalian Cell Culture, Batch Processing, WFI generation and..., RO/DI generation and..., Membrane Filtration, Protein Purification, Water Purification, Team Building, Water Conservation, "Hands on"...
Education
Worcester Polytechnic Institute 2009 — 2017
Master's degree, Biotechnology, Chemical Engineering
University of Massachusetts at Lowell
Bachelor of Science, Mechanical Engineering
EINIG & ASSOCIATES, INC. January 2002 - Present
EINIG & ASSOCIATES, Inc. January 2002 - Present
The Quantic Group, Ltd 2002 - Present
The Center for Professional Advancement 2002 - Present
Sandoz 2002 - 2004
Biopure 2002 - 2004
Johnson-Matthey 1998 - 2001
Skills
FDA, GMP
Education
University of Missouri-Columbia 1981 — 1984
Merrimack Pharmaceuticals January 2009 - Present
Merrimack Pharmaceuticals May 2007 - January 2009
AVANT Immunotherapeutics 2006 - 2007
Cambrex Biosciences 2004 - 2006
Biopure 1998 - 2004
Genzyme Corporation January 1996 - February 1998
ImmunoGen, Inc September 1992 - December 1995
Education
University of Strathclyde 2009 — 2013
Master of Science, Pharmaceutical Quality and Good Manufacturing Practices, with merit
Emerson College 1986 — 1990
Bachelor of Science, Mass Communications
Abiomed Inc. June 2004 - Present
Biopure 2001 - 2004
Education
Hamilton College 1997 — 2001
InVivo Therapeutics January 2014 - Present
InVivo Therapeutics June 2013 - December 2013
Genzyme Biosurgery January 2012 - May 2013
Genzyme Corporation March 2008 - January 2012
V.I.Technologies (Vitex) (Watertown, MA) 2000 - 2003
V.I. Technologies 2000 - 2003
Biopure 1998 - 2000
Skills
FDA, PMA, Regulatory Affairs, Regulatory Submissions, CAPA, IND, GMP, Biotechnology, Pharmaceutical Industry, ISO 13485, Sop, NDA, Medical Devices, Clinical Trials, CE marking, eCTD, Clinical Development, Validation, Lifesciences, Regulatory Requirements, Change Control, 21 CFR Part 11, Biopharmaceuticals, Life Sciences
Education
Northeastern University 2010 — 2012
MS, Regulatory Affairs
Johnson and Wales University 1991 — 1994
Bachelor of Science (BS), Equine Business Mgt
Mass Biologics September 2015 - Present
Amgen January 2004 - Present
Biopure August 2002 - January 2004
Frank I Rounds June 2001 - August 2002
Building Technology Engineers October 1999 - January 2001
Skills
HVAC, Facilities Management, GMP, SCADA, DeltaV, Maximo, BAS, Boilers, clean steam, WFI, USPW, Steam
Education
Massachusetts Maritime Academy 2010 — 2012
MSFM, Facilities Management
Massachusetts Maritime Academy 1994 — 1998
BS, Plant & Facilities Engineering
AbbVie Bioresearch Center January 2013 - Present
Abbott Bioresearch Center 2008 - Present
Abbott Laboratories 2000 - 2008
Biopure 1994 - 2000
Katharani Pharamceuticals 1986 - 1987
Education
University of Massachusetts Lowell 1990 — 1992
Amgen February 2003 - Present
Biopure 2001 - 2003
Advanced Instruments 1995 - 2001
New England Reagent Laboratory 1991 - 1995
Skills
CAPA, Biopharmaceuticals, GMP, Quality Assurance, Change Control, Validation, FDA, 21 CFR Part 11, GxP, Quality Control, Sop, Cleaning Validation, V&V, Trackwise, SOP
Education
Providence College 1987 — 1991
PharMax Consulting LLC December 2011 - Present
Genzyme July 2009 - December 2011
Genzyme June 2006 - June 2009
Genzyme June 1996 - June 2006
Genzyme December 1994 - January 1996
BioPure 1990 - 1993
Skills
Aseptic Processing, Biotechnology, Life Sciences, Microbiology, Lyophilization, Manufacturing, Regulatory Requirements, cGMP, Regulatory Submissions, CAPA, GMP, Environmental Monitoring, Validation, Change Control, Technology Transfer, Aseptic Technique, GLP, Quality Control, FDA, Pharmaceutical Industry, LIMS, Medical Devices, Lifesciences, Regulatory Affairs, Quality System, V&V, Biopharmaceuticals, GxP, 21 CFR Part 11, Sop, Sterilization, Computer System...
Education
Boston University 2000 — 2006
Masters of Science Administration, Business Organization
Michigan State University 1972 — 1976
B.S., Microbiology
Alexion Pharmaceuticals, Inc. February 2014 - January 2015
Genzyme November 2009 - February 2014
Hyaluron Contract Manufacturing June 2008 - October 2009
Biopure January 2007 - May 2008
Wyeth Biopharma May 2003 - January 2007
Circe Biomedical 2000 - 2003
Skills
Environmental Monitoring, Microbiology, Validation, Aseptic Processing, Technology Transfer, Biotechnology, CAPA, GMP, Sop, Lifesciences, Change Control, LIMS, Assay Development, Biopharmaceuticals, Aseptic Technique, Quality Control, FDA, Trackwise, GLP, Cleaning Validation, cGMP practices, Sterilization, GxP, Bioburden, FDA GMP, ELISA, Endotoxin, USP, SOP
Education
Brandeis University 2005 — 2011
Graduate Certificate, Project Management
University of Rochester 1987 — 1991
B.S., Microbiology
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
WaVe Life Sciences May 2015 - Present
Novartis Institutes for BioMedical Research December 2008 - Present
Merck January 2007 - November 2008
Sirna Therapeutics Inc July 1999 - January 2007
Biopure 1993 - July 1999
Unilever 1986 - 1989
Skills
Drug Discovery, HPLC, siRNA, Leadership, Biotechnology, Lifesciences, Mass Spectrometry, Drug Development, Pharmaceutical Industry, Assay Development, Liposomes, Nanoparticles, Scale-up, Ultrafiltration, Chromatography, Life Sciences
Education
University of Massachusetts Lowell
Bachelor's Degree, Chemistry
Harvard University December 2014 - Present
Little Graces, Inc January 2003 - January 2015
Urban Improv January 2013 - December 2014
Neponset Valley Consulting Group, LLC July 2012 - December 2012
Dedham Country Day School June 2008 - October 2012
Biogen August 2001 - April 2002
HR Logic 2001 - 2001
Biopure 2000 - 2001
Boston Scientific June 1999 - September 2000
Art Technology Group 2000 - 2000
Skills
Fundraising, Major Gift Cultivation, Major Donors, Donor Engagement, Donor Management, Donor Solicitation, Donor Development, Applicant Tracking..., Events, Non-profit Fund..., Non-profit Board..., Fundraising Campaign..., Annual Giving, Campaign Strategies, HR Consulting, Human Resources, Executive Search, Talent Management, Onboarding
Education
University of Arizona 1988 — 1992
Bachelor of Arts (B.A.), Economics
AbbVie November 2001 - Present
Abbott Laboratories 2001 - Present
Abbott Labs November 2001 - December 2012
Biopure March 2001 - November 2001
Skills
GMP, CAPA, Managing training plans..., Pharmaceutical Industry, Validation, Change Control, FDA, Biotechnology, 21 CFR Part 11, Sop, GLP, Training
Education
Massachusetts College of Pharmacy and Health Sciences 2002 — 2004
MS, Regulatory Affairs
Claflin University 1991 — 1995
BS, Chemistry
Alkermes January 2009 - Present
Alkermes October 2006 - January 2009
Alkermes August 2004 - October 2007
Alkermes July 1997 - August 2004
Biopure 1995 - July 1997
Skills
Sop, Clinical Trials, Budget, Clinical Research, Project Management, Budgets, Clinical Development, Pharmaceutical Industry, CRO, Medical Writing, Lifesciences, Regulatory Submissions, Medicine, Protocol, EDC, Regulatory Affairs, SOP
Education
Northeastern University
Bachelor of Science (B.S.), Business Administration and Management, General
EMC April 2013 - Present
EMC October 2008 - April 2013
Biopure 1999 - 2008
Wang Government Services 1996 - 1998
Computer Data Systems, Inc 1995 - 1996
Hamilton Acorn, Ltd 1991 - 1994
Sloan Group 1991 - 1994
Heard, Goggan, Blair & Williams 1985 - 1990
Skills
Process Improvement, Business Analysis, ERP, Six Sigma, Project Management, Business Process, Requirements Analysis, Vendor Management, Visio, Program Management, Software Project..., IT Management, Strategic Planning, Software Documentation, Supply Chain, Operations Management, FDA, Cross-functional Team..., Quality Assurance, SDLC, SAP, Business Intelligence, MS Project, Business Process..., Integration, IT Strategy, Enterprise Architecture, Change Management
Education
Southern New Hampshire University 1981 — 1984
BS
PHT Corporation 2014 - Present
MediVector, Inc. 2013 - 2014
Molecular Insight Pharmaceuticals 2010 - 2013
Genzyme 2009 - 2010
Transport Pharmaceuticals 2005 - 2009
V.I. Technologies 2004 - 2005
Biopure 2003 - 2004
Biogen 1998 - 2002
The Open Group 1993 - 1998
Open Software Foundation 1993 - 1998
Skills
FDA, Quality Assurance, GMP, CAPA, Sop, Quality System, Software Documentation, Medical Devices, Technology Transfer, Clinical Trials, Biotechnology, Project Management, Archival Management, GLP, HPLC, eCTD, Aseptic Technique, 21 CFR Part 11, Purification, Infectious Diseases, GCP, Computer System..., CMC, Trackwise, IND, Lifesciences, Design Control, Oncology, Protocol, Regulatory Submissions, Manufacturing, SOP, Drug Development, ISO 13485, Quality Control, Regulatory Requirements, Clinical Development, EDC, Assay Development, GxP, Drug Discovery, Pharmacokinetics, Biopharmaceuticals, Chemistry, CRO, CTMS, R&D, Chromatography, ELISA, LC-MS
Education
University of Massachusetts Boston 2008 — 2008
Certificate, Project Management
American Public University System 2004 — 2007
MS, Public Health
Northeastern University 1998 — 2003
BS, Technical Writing
Discussion Partners Collaborative March 2009 - Present
Novartis September 2004 - March 2008
Biopure 1998 - June 2004
National Medical Care February 1991 - November 1996
Skills
Biotechnology, Strategic Planning, Succession Planning, Talent Management, IPO, Talent Acquisition, Restructures, Organizational Design, Onboarding, Workforce Planning, Employee Relations, Medical Devices, Organizational..., Deferred Compensation, Pharmaceutical Industry, Lifesciences, Executive Coaching, Performance Management, Change Management, HR Transformation, Human Resources, Management, Employee Engagement, Recruiting, HR Policies, Start-ups, Employee Benefits
Education
University of Massachusetts, Amherst
Master of Education (M.Ed.), Industrial and Organizational Psychology, 4.0
OPK Biotech, LLC November 2009 - Present
Biopure March 2007 - October 2009
Biopure Corporation November 2002 - March 2006
Biopure 1991 - November 2002
Skills
Drug Discovery, FDA, Process Simulation, Biotechnology, R&D, Lifesciences, Validation, GMP, Clinical Development, Pharmaceutical Industry, Infectious Diseases, Clinical Trials
Education
Rice University 1981 — 1987
Ph.D., Biochemistry
Hemoglobin Oxygen Therapeutics Production ManagerOPK Biotech, LLCJanuary 2010 - December 2013
Merck May 2009 - April 2010
Biopure May 2000 - June 2008
AppTec 2004 - 2005
Pony Express Brewing Co. 1998 - 1999
Skills
GMP, Sop, FDA, Validation, CAPA, Pharmaceutical Industry, Change Control, Biotechnology, Technology Transfer, Aseptic Processing, V&V, Quality System, Industrial Safety, Public Safety, Environmental Health, Brewing, Management, SOP
Education
Saint Joseph's University 2010 — 2013
Masters of Science, Environmental Protection and Safety Management
Saint Peter's University 1989 — 1992
Bachelor of Arts (B.A.), Classical and Ancient Studies
Bucks County Community College
Professional Certification in Fire Fighter 1 and Hazardous Materials Operations
Temple University
Certificate in Quality Assurance/Regulatory Affairs
InventivHealth Clinical March 2014 - Present
Novartis Institute for BioMedical Research April 2010 - March 2014
Artisan Pharma September 2008 - February 2010
EPIX Pharmaceuticals August 2007 - October 2008
Altus Pharmaceuticals August 2006 - August 2007
Acambis March 2006 - August 2006
Stryker 2003 - 2006
Biopure 2001 - 2002
Skills
Biotechnology, Clinical Research, Clinical Development, Project Management, Medical Writing, Clinical Trials, Oncology, Data Management, CRO, CTMS, GCP, EDC, Drug Development, Clinical Monitoring
Education
University of Oklahoma 1987 — 1991
BS, Physiology
Portsmouth HS 1978 — 1991
Diploma
high school 1981 — 1981
diploma
Shire HGT April 2009 - Present
Biopure Corporation November 2008 - January 2009
Biopure May 2002 - November 2008
Biopure 1991 - 2004
Biopure April 2000 - April 2002
Biopure Corporatoin May 1991 - April 2000
WR Grace August 1988 - April 1991
Dorr-Oliver Inc. August 1984 - May 1987
Columbia University 1977 - 1984
Skills
Technology Transfer, Protein Purification, GMP, Purification, Chromatography, Biopharmaceuticals, Validation, Protein Chemistry, Process Simulation, Filtration, Chemistry, Chemical Engineering, Process Engineering, Ultrafiltration, Biotechnology, Laboratory, Quality Assurance, Product Development, Pharmaceutical Industry, Process Optimization, FDA, Lifesciences, Manufacturing, V&V, CAPA, Life Sciences
Education
University at Albany, SUNY 1973 — 1997
BS, chemistry, biology
Columbia Engineering 1981 — 1984
MS, Chemical/Biochemical Engineering
University at Albany, SUNY 1973 — 1977
bs, chemistry, biology
Shoreline Reliability, LLC May 2009 - Present
Ludeca, Inc. September 2003 - December 2009
Biopure August 2002 - August 2003
Bayer August 1998 - July 2002
Skills
Laser Alignment, Condition Monitoring, Nuclear Power Plants, Project Engineering, Engineering, Reliability, Maintenance Management, Commissioning, Inspection, Vibration Analysis, Nuclear, Root Cause Analysis, Energy Management, Power Plants, Preventive Maintenance, Power Generation, Pumps, Bearings, Energy, Marine Engineering, Steam Turbines, Mechanical Engineering, Boilers, Electricians, Energy Conservation, Steam, HVAC, Gas Turbines, Motors, Turbines, Generators, Hydraulics, Machinery, Air Compressors, Valves, Pneumatics, Instrumentation, Rotating Equipment, Piping, Engineers, Maintenance & Repair, Predictive Maintenance, Plant Maintenance, Reliability Engineering, Lubrication, Refrigeration, Metal Fabrication, Cogeneration, Thermal Imaging, Vibration Testing
Education
Massachusetts Maritime Academy 1994 — 1998
B.S. Facilites and Plant Engineering, Engineering
AVEO Oncology January 2013 - Present
Infinity Pharmaceuticals 2010 - Present
Casale Consulting Group 2007 - 2010
Millennium Pharmaceuticals 2002 - 2006
Millennium Pharmaceuticals 1999 - 2001
Biogen 1994 - 1998
Serono 1992 - 1994
Biopure 1991 - 1992
Skills
Supply Chain, Supply Chain Management, Logistics, Pharmaceutical Industry, Quality Assruance, QA Auditor, Program Management, CMC Development
Education
Northeastern University
Bachelor of Science, Biology
Suffolk University - Sawyer Business School
Masters, Public Administration
Independent May 2014 - Present
AMAG Pharmaceuticals February 2013 - April 2014
ImmunoGen, Inc. April 2012 - February 2013
Genzyme September 2011 - April 2012
ImmunoGen, Inc. July 2009 - September 2011
Biopure September 2002 - August 2003
Millipore September 1999 - September 2002
KMI/PAREXEL July 1996 - September 1999
Skills
Validation, GMP, CAPA, 21 CFR Part 11, Change Control, SOP, Quality Assurance, Pharmaceutical Industry, Biotechnology, Internal Audit, External Audit, Deviation Management, CMOS, Vendor Management
Education
Trinity College Dublin 1990 — 1994
Engineering
CSL Behring March 2015 - Present
CSL Behring March 2014 - Present
OPK Biotech, LLC January 2010 - February 2014
AMAG Pharmaceuticals May 2009 - January 2010
Crosspoint Engineering December 2008 - May 2009
Biopure September 2006 - December 2008
Boston Scientific September 2005 - September 2006
Crosspoint Engineering 2004 - 2005
Abbott 2004 - 2005
Shire Pharmaceuticals 1999 - 2004
Skills
GMP, Change Control, Metrology, Validation, Biotechnology, FDA, Calibration, Sop, Manufacturing, Pharmaceutical Industry, Clinical Trials, Troubleshooting, Aseptic Processing, Quality System, Clinical Development, CAPA, Facilities Management, V&V, GxP, 21 CFR Part 11, GLP, Computer System..., Biopharmaceuticals, Electronics, GAMP, Testing, Technology Transfer, Medical Devices, SOP
Education
Community College of the Air Force 1990 — 1995
Bachelor of Science eq. in Electronics Engineering Technology, Metrology and Electronics Engineering
Genzyme, a Sanofi company July 2013 - Present
Genzyme December 2011 - July 2013
Genzyme October 2009 - December 2011
ImmunoGen, Inc. 2009 - 2009
Biopure Corporation 2006 - 2009
Biopure Corp. 2002 - 2006
Biopure Corp 1995 - 2002
Biopure 1990 - 1995
Skills
Manufacturing, Validation, GMP, FDA, Technology Transfer, Biotechnology, CAPA, Change Control, Facilities Engineering, Pharmaceutical Industry, GLP, Process Engineering, Lifesciences, Clinical Development, LIMS, Biopharmaceuticals, Process Simulation, Medical Devices, Computer System..., 21 CFR Part 11, Quality Assurance, Chromatography, Cell Culture, Aseptic Processing, Commercialization, Cleaning Validation, Filtration, Purification, Trackwise, FDA GMP, HPLC
Education
ASQ
Northeastern University
West Virginia University Institute of Technology
BS
Biologics Consulting Group 2010 - Present
Ariadne: Therapeutics Development Sciences September 2009 - 2010
Biopure 2005 - 2008
Biopure Corporation 2001 - 2005
Skills
Biotechnology, Biopharmaceuticals, Drugs, Medical Devices, Pharmacology, Toxicology Testing, Toxicology Study Design, GLP Evaluation, Toxicological Risk..., Biocompatibility Testing, ISO 10993 Testing, CRO Testing Management, Nonclinical Testing..., Pharmacokinetics, Translational..., Clinical Pharmacology, Regulatory Submissions, INDs, ANDAs, NDAs, BLAs, Vaccines, Recombinant Proteins, Blood Substitues, Oncology Drugs, Biosimilars, Monoclonal Antibodies, FDA, Clinical Trials, Clinical Development, Oncology, Pharmaceutical Industry, GCP, Clinical Research, Nanotechnology, Biologics, Biocompatibility, Drug Development, Drug Discovery, GLP, Lifesciences, Technology Transfer, CRO, Toxicology, IND, Regulatory Affairs, Validation, Life Sciences
Education
Harvard Medical School 1985 — 1987
Postdoc, Pharmacology
Yale University School of Medicine 1983 — 1985
Postdoc, Pharmacology
State University of New York College at Buffalo 1978 — 1983
Ph.D., Pharmacology
University of Massachusetts Boston 1974 — 1978
BA, Chemistry and Biology
Shire HGT January 2009 - Present
Biopure May 1985 - November 2008
Education
Tufts University 1983 — 1985
M.S., Chemical Engineering
Tufts University 1977 — 1982
B.S., Chemical Engineering
Regis High School 1973 — 1977
PP Manufacturing Corp. January 2011 - Present
QSI January 2009 - Present
Shire HGT 2010 - 2011
NNE Pharmaplan 2006 - 2009
Biopure 2006 - 2006
BioMetics 1997 - 2004
Oravax, Inc. 1995 - 1997
Repligen Corporation 1991 - 1995
Applied BioTechnoogy 1988 - 1991
Collaborative Research, Inc. 1987 - 1988
Education
University of Massachusetts Lowell 1987 — 2000
MS, Biological Sciences
University of Massachusetts Lowell 1983 — 1987
BS, Biological Sciences
Bank of America 2014 - Present
Bridgewater Associates April 2012 - November 2013
DC Energy September 2008 - April 2012
Maxiom Group June 2007 - August 2007
Biopure June 2003 - August 2003
Skills
PHP, R, MySQL, Microsoft Excel, PowerPoint, HTML, AJAX, Java, JavaScript, Matlab, Word, Perl, Financial Modeling, Time Series Analysis, FTR, Commodity Markets, Quantitative Analytics, Trading, Quantitative Finance, Trading Strategies
Education
Brown University 2004 — 2008
Sc.B., Applied Mathematics, Economics
Middlesex School
Shady Hill
Johnsons Immediate Solutions February 2013 - Present
Emergent BioSolutions October 2009 - February 2013
Hyaluron Contract Manufacturing May 2009 - October 2009
Biopure September 2004 - June 2008
Biopure March 2002 - September 2004
Collegenesis March 1998 - December 2001
Collagenesis September 1997 - March 1998
Skills
American Society of..., Gas Chromatography, ELISA, SEC reporting, cGMP, GMP, Validation, HPLC, Sop, Analytical Chemistry, GLP, Cleaning Validation, Wet Chemistry, Quality Control, Computer System..., Biotechnology, Aseptic Processing, Aseptic Technique, FDA, LIMS, 21 CFR Part 11, UV/Vis, Laboratory, Change Control, Quality Assurance, Biopharmaceuticals, GxP, Vaccines, Assay Development, Technology Transfer, Medical Devices, V&V, Clinical Trials, Formulation, Regulatory Requirements, Regulatory Affairs, Quality System, Pharmaceutical Industry, Microbiology, Pharmaceutics, Lifesciences, SOP, CAPA
Education
North Shore Community College 1996 — 1997
Biotechnology Applications
Florida Atlantic University 1974 — 1976
Marine Biology
University of Massachusetts Dartmouth 1969 — 1973
B.S., Marine Biology
Biopure February 1989 - November 2008
Biopure 1989 - 2008
Biopure 1989 - 2008
Fisons 1977 - 1989
Education
Middlesex Community College
Business Administration
Amgen May 2010 - Present
Biopure 1998 - 2008
Skills
FDA, Supply Chain, SOP, Plant, CAPA, Materials, cGMP, GMP, Pharmaceuticals, Biotechnology, Supply Chain Management, Clinical Trials, Operations Management, ERP, Lean Manufacturing, Materials Management, MRP, Production Planning, JIT, Life Sciences, Cost Reduction, Inventory Management, Supplier Management, Inventory Control, APICS
Education
University of Massachusetts Lowell 1987 — 1988
BS, Industrial Management
biopure 2000 - 2002
Education
Northeastern University 2002 — 2009
EthosEnergy Group PPS May 2014 - Present
TurboCare February 2011 - April 2014
TurboCare November 2008 - February 2011
Computer Sciences Corporation January 2000 - February 2002
Genzyme 1993 - 1999
Biopure June 1988 - December 1991
Skills
Energy, Six Sigma, Power Generation, Manufacturing, Project Engineering, Engineering
Education
D'Amore-McKim School of Business at Northeastern University 1997 — 1999
MBA, Business
University of New Hampshire 1988 — 1993
BSME, Mechanical Engineering
Astellas Pharma October 2011 - Present
Harvard Clinical Research Institute July 2011 - July 2012
Harvard Clinical Research Institute March 2008 - June 2011
Harvard Clinical Research Institute October 2007 - March 2008
Biopure 2005 - 2007
Boston Medical Center 2002 - 2005
Skills
Clinical Trials, GCP, CTMS, EDC, Clinical Research, Clinical Development, CRO, Clinical Monitoring, Oncology, FDA, Infectious Diseases, ICH-GCP, Pharmaceutical Industry, Biotechnology, Medical Devices, Regulatory Affairs, Protocol, 21 CFR Part 11, Project Management
Education
Boston University 2005 — 2007
Clinical Investigation
University of Vermont 1998 — 2002
Medical Lab Science
ACM Global Central Laboratory March 2015 - Present
ACM Global Central Laboratory November 2011 - February 2015
ACM Medical Laboratories March 2008 - November 2011
CooperVision 2006 - 2008
CooperVision 2004 - 2006
Amgen 2003 - 2004
Biopure 2001 - 2004
Bausch + Lomb 1999 - 2001
Bausch + Lomb 1995 - 1999
Skills
Clinical Research, Biotechnology, Clinical Trials, Clinical Development, CTMS, CRO, GCP, Life Sciences, Validation, Cross-functional Team..., FDA, SOP, Quality Assurance, Laboratory, Process Improvement, Pharmaceutical Industry
Education
State University of New York College at Oneonta 1989 — 1994
Bachelor's Degree, Biology
Shire Pharmaceuticals December 2013 - Present
Merck January 2011 - December 2013
Pfizer Pharmaceuticals 2009 - January 2011
Wyeth Biotech 2007 - 2009
Amylin Pharmaceuticals 2003 - 2007
Pharmaceutical Services Corporation 2002 - 2003
Formatech, Inc. December 2001 - May 2002
Alkermes 1995 - 2001
Biopure 1995 - 1995
Repligen Corporation 1993 - 1995
Skills
Manufacturing, SAP, Document Management, Microbiology, Regulatory Filings, Formulation, Filling, Bulk, Catridges, Technology Transfer, Biotechnology, Vaccines, Trackwise, Quality Control, Pharmaceutics, Validation, TrackWise, CAPA, FDA
Education
University of Massachusetts, Amherst 1989 — 1993
BS, Zoology
PAW BioScience Products 2004 - Present
Biopure 1997 - 2004
Skills
GMP, Process Engineering, Change Control, Biotechnology, HPLC, Commissioning, Validation, Engineering, Manufacturing, Protein Purification, Process Improvement, Quality Management, Product Design, Sterilization, Direct Sales, R&D, FDA, Technology Transfer
Education
Tufts University 2002 — 2004
Graduate Certificate, Manufacturing Engineering
Ithaca College 1993 — 1997
BA, Biology
Gentiva Health Services March 2013 - Present
Gentiva Health Services March 2012 - February 2013
RXi Pharmaceuticals Corp August 2010 - April 2011
Momenta Pharmaceuticals June 2010 - August 2010
Pfizer October 2009 - February 2010
Wyeth Research 2000 - 2009
Genetics Institute 1992 - 1998
Biopure 1988 - 1992
Skills
In Vivo, Pharmaceutical Industry, Animal Models, Pharmacology, Sop, Biotechnology, Clinical Trials, Pharmacokinetics, Validation, Clinical Research, Clinical Development, Veterinary Medicine, Animal Health, Animal Model Development, Data Management, Clinical Study Design, Project Coordination, Osteoarthritis, Study Design, Data Presentation, Supervisory Experience, Protocol Writing, Scheduling, Process Scheduler
Education
Mount Ida College
Bachelor, Liberal Studies, Animal Health Technology
Shionogi Inc November 2012 - May 2014
Aerie Pharmaceuticals February 2012 - July 2012
Mitsubishi Tanabe Pharma Corporation February 2011 - February 2012
Integra LifeSciences October 2007 - March 2010
Novo Nordisk A/S November 2005 - October 2007
Biopure June 2004 - July 2005
Wyeth Bio-Pharma April 2002 - April 2004
Bristol-Myers Squibb June 2001 - December 2001
Rutgers University August 1999 - August 2000
Skills
CTMS, CRO, Cross-functional Team..., Medical Devices, Therapeutic Areas, Rheumatoid Arthritis, Neurology, Regulatory Submissions, Clinical Research..., EDC
Education
Rutgers University-New Brunswick
MS, Microbiology and Molecular Genetics
New York University
BS, Neural Science
WGBH April 2010 - Present
Fish & Richardson P.C. June 2007 - August 2007
US Attorney's Office, Boston MA May 2006 - August 2006
Boston Scientific November 2003 - April 2005
PAREXEL January 2003 - October 2003
Dana-Farber Cancer Institute December 2001 - October 2002
Biopure December 2000 - August 2001
Harvard Medical School May 1999 - August 2000
Skills
Intellectual Property, Negotiation, Legal Research, Patents, Legal Writing, Licensing, Research, Patent Prosecution, Editing, Westlaw, Trade Secrets, Litigation, Community Outreach
Education
Boston College Law School 2005 — 2008
JD, cum laude
Smith College 1998 — 2002
BA, First Group Scholar (top 5% of class), Biology, Economics, Philosophy
Pembroke Elementary School September 2005 - Present
Biopure 1987 - 1991
Skills
Educational Leadership, Educational Technology, Classroom Instruction, Curriculum Development, Curriculum Design, Staff Development, Instructional Design, Classroom Management, Teaching, Instructional Technology, Mentoring, Literacy, Classroom, Educational Consulting, Technology Integration, Teacher Training, Higher Education
Education
Nova Southeastern University 2009 — 2014
Doctor of Education (Ed.D.), Educational Leadership and Administration, General
University of New England 2006 — 2008
Certificate of Advanced Graduate Studies, Educational Leadership
University of New England 2003 — 2005
Masters, Education
University of Maine 1983 — 1987
BA, Zoology
BioMarin April 2011 - Present
Biogen Idec 2008 - April 2011
Biogen Idec 2003 - 2008
Biopure 2001 - 2003
EMD Serono 1997 - 2001
Upjohn 1990 - 1997
University of Arkansas 1987 - 1990
Oregon State University 1983 - 1987
Skills
Clinical Trials, Oncology, Biostatistics, Clinical Development, Clinical Research, Statistics, Protocol Development, Study Design, Biotechnology, Clinical Study Design, FDA, Regulatory Submissions, GCP, CRO, Drug Development, Data Management, CDISC, Medical Writing, Immunology
Education
Western Michigan University
PhD, Statistics
Oregon State University
PhD, Fisheries
Brigham Young University
MS, Statistics
Ironwood Pharmaceuticals January 2013 - Present
Covidien 2010 - January 2013
Covidien 2008 - 2010
Innovex 2004 - 2007
Millennium Pharmaceuticals 2002 - 2004
Biopure 1998 - 2002
Skills
Registered Nurse, Clinical Trials, EDC
Education
Northeastern University 2011 — 2012
Master's degree (ongoing), Regulatory Affairs & Clinical Research
Boston College
Certificate Clinical Research Associate (CRA) and GCP
Massachusetts Bay Community College
Associate's degree, Registered Nursing/Registered Nurse
Northeastern University
Bachelor's degree, Nursing Science
Regis College
Certificate in Clinical Trial Managment/Regulatory Affairs
Toxikon Corporation April 2005 - Present
Biopure November 1998 - June 2005
Skills
Pharmaceutical Industry, Biotechnology, FDA, Microbiology, R&D, Medical Devices, Lifesciences, Validation
Education
Northeastern University
Medical Technology
AbbVie October 2011 - Present
Pfizer April 2005 - July 2011
Biopure May 2002 - October 2003
Skills
Chromatography, Sop, LIMS, Biotechnology, Pharmaceutical Industry, Purification, GMP, Biopharmaceuticals, FDA, Cell Culture, HPLC, Aseptic Processing, Change Control, Filtration, Manufacturing, Protein Purification
Education
Middlesex Community College 2002 — 2009
Certificate, Biotechnology
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
OPK Biotech, LLC October 2009 - Present
Biopure 2006 - 2009
Biopure 2006 - 2009
Biopure 2006 - 2009
Biopure August 2007 - September 2008
Computer Palace January 1988 - December 2006
Skills
Microsoft certified..., Microsoft Certified..., Web server host and..., Manufacture of Computer..., Sales and marketing..., Importing Computer..., Manufacturing of Custom..., Maintenance Work at OPK, Manufacture of..., Professional Auto..., Build and frame Houses, HPLC, Chromatography, Manufacturing, Automation, CompTIA A+ Certification, Microsoft Exchange, Purification, Testing, Sop, Laboratory, Technology Transfer, Validation
Education
Centeral New England 1981 — 1985
BS Computer Science and Engineering
Massachusetts Bay Community College 1981 — 1983
Associate's degree, Law Enforcement
Philips October 2013 - Present
Philips Healthcare September 2005 - Present
IDEXX Laboratories September 2004 - September 2005
Inotek Pharmaceuticals January 2004 - August 2005
Biopure August 2003 - December 2003
Lonza December 1999 - April 2003
Skills
Quality Assurance, Compliance, Document Management, Microsoft Office, Microsoft Excel, Microsoft Word, SAP, Trackwise, Amdocs Clarify, cGMP practices, GDP, Cross-functional Team..., Quality Control, Six Sigma
Education
University of Maine at Farmington 1995 — 1997
Bachelor of Business Administration (B.B.A.), Business Admin / Economics
SUNY Oneonta 1993 — 1994
N/A, Fashion Merchandising
Self-employed December 2011 - Present
Sonelgaz Algerie November 1984 - November 2011
BIOPURE January 2007 - May 2008
Education
Supelec 1977 — 1980
Ingénieur
Polytechnique d'Alger 1972 — 1976