Olympus Biotech
Industry: Biotech company
DescriptionFounded: 2010 Parent organization: Olympus Corporation
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Olympus Biotech Employees
Visterra Inc. October 2014 - Present
Genzyme June 2014 - October 2014
Olympus Biotech December 2012 - May 2014
Cerulean Pharma, Inc July 2012 - October 2012
DePuy Mitek (a Johnson & Johnson company) August 2010 - June 2012
EMD Serono, Inc. January 2010 - June 2010
Northeastern University May 2009 - December 2009
Skills
ELISA, Western Blotting, Mammalian Cell Culture, Assay Development, Cell-Based Assays, qPCR, SDS-PAGE, RNA isolation, Immunoassays, Transfection, High Throughput..., Purification, Cell, RT-PCR, Cell Culture, Cell Based Assays, Protein Expression, In Vitro, Biotechnology
Education
Northeastern University 2008 — 2010
MS, Biotechnology
Bangalore University 2005 — 2007
MS, Biotechnology
Nagpur University 2002 — 2005
BS, Biology
Novo Nordisk November 2014 - Present
Hypertherm Inc. August 2014 - September 2014
Olympus Biotech September 2011 - June 2014
Olympus Biotech January 2007 - August 2011
Stryker Biotech January 2005 - December 2006
Skills
Quality Assurance, CAPA, GMP, Manufacturing, Change Control, Quality System, ISO 13485, Validation, Sop, FDA, Root Cause Analysis
Education
Colby Sawyer College 2000 — 2004
BS, Community and Environmental Studies
Organogenesis Inc. March 2015 - Present
Alexion Pharmaceuticals, Inc. December 2014 - March 2015
Olympus Biotech February 2011 - May 2014
Stryker June 2007 - January 2011
Amgen May 2005 - May 2007
Perdue Farms September 2004 - March 2005
Baxter Transfusion Therapies August 2003 - December 2003
Skills
GMP, SOP, Microbiology, Training, Data Review, Aseptique Technique, Stability Testing, SDS-PAGE, HPLC, Quality Control, CAPA, Change Control, Quality Assurance, Biotechnology, Life Sciences, Scheduling, Investigations, FDA, GLP, Validation, Pharmaceutical Industry, 21 CFR Part 11
Education
University of Puerto Rico-Mayaguez
Bachelor of Science, Industrial Microbiology
University of Puerto Rico-Mayaguez
Bachelor of Science (B.S.), Biology
Millstone Medical Outsourcing April 2012 - Present
Olympus Biotech February 2011 - April 2012
Alexion Pharmaceuticals 2007 - 2010
Amgen 2004 - 2007
Dow Biopharmaceutical Contract Manufacturing 2000 - 2004
Copley Pharmaceuticals 1998 - 2000
Copley Pharmaceuticals 1995 - 1998
Springborn Laboratories 1994 - 1995
Springborn Laboratories 1992 - 1994
Education
Bridgewater State University 1990 — 1994
BS, Biology
TESARO May 2014 - Present
TESARO November 2012 - May 2014
Inspiration Biopharmaceuticals, Inc September 2011 - October 2012
Inspiration Biopharmaceuticals, Inc April 2011 - September 2011
Olympus Biotech February 2011 - April 2011
Stryker Biotech March 2010 - February 2011
Stryker Biotech August 2008 - March 2010
Stryker Biotech April 2006 - August 2008
Abbott Bioresearch Center April 2000 - September 2003
BASF Bioresearch Corporation March 1997 - April 2000
Skills
CAPA, FDA, GMP, GLP, Sop, Quality System, Biotechnology, Validation, 21 CFR Part 11, Pharmaceutical Industry, V&V, Change Control, Regulatory Affairs, ISO 13485, GxP, LIMS, Biopharmaceuticals, Medical Devices, Aseptic Processing, Lifesciences, Protein Purification, Quality Assurance, Computer System..., Quality Control, 21 CFR, Regulatory Submissions, Technology Transfer, IND, GCP, Quality Auditing, SOP
Education
University of Rhode Island 1992 — 1993
Bachelor of Science, Microbiology
University of Rhode Island 1986 — 1990
Bachelor of Science, Human Development, Counseling and Family Studies
New England College of Business May 2014 - Present
Rhodes Pharmaceuticals March 2015 - Present
Rhode Island Quality Institute February 2013 - March 2015
Olympus Biotech November 2011 - February 2013
Boston Medical Center October 2009 - November 2011
Healthdrive Medical and Dental Practices December 2008 - August 2009
Fresenius Medical Care August 2008 - November 2008
Office of the Massachusetts Attorney General May 2008 - August 2008
Halstrom Law Offices May 2007 - June 2008
Massachusetts Offices of Health and Human Services, Division of Medicaid - Board of Hearings January 2008 - May 2008
Skills
Medical Compliance, Health Law, Healthcare, Health Care Compliance, Contract Negotiation, Anti-Kickback Statute, Compliance, Legal Compliance, Process Improvement, Privacy Compliance, HIPAA, Analysis
Education
New England Law Boston 2006 — 2009
J.D., Law, Health Law
Penn State University 2002 — 2006
B.S., Criminal Justice, Business, International Studies, Labor and Industrial Relations
Ranney School
JDM Solutions and Technologies, LLC June 2014 - Present
Olympus Biotech October 2008 - May 2014
Smith & Nephew Orthopaedics September 2003 - September 2008
Mainline International September 2002 - September 2003
Merrill Lynch July 1995 - September 2002
Skills
Sales, Sales Operations, Sales Force Development, Product Launch, Surgeons, Management, Capital Equipment, Medical Devices, Training, Product Development, Operating Room, Orthopedic, Spine, Territory Development, Territory Expansion, Territory Account..., Sales Management, Sales Rep Training, National Sales Training, Relationship Management, Long-term Customer..., Orthopedics
Education
University of Florida 1991 — 1994
Bachelor of Science (B.S.), Public Relations
Hologic, Inc. July 2014 - Present
Olympus Biotech February 2011 - May 2014
Stryker Biotech September 2005 - February 2011
Commerce Insurance Company 2003 - 2005
Shaw's Supermarket 1993 - 2003
Skills
Customer Service, Account Management, Sales, Process Improvement, Sales Operations, Cross-functional Team..., Sales Management, Microsoft Office, Microsoft Excel, Negotiation, Healthcare, Sales Support Tools, Communication, Teamwork, Troubleshooting, Problem Solving, Close Attention to..., IRB, Accurate Record Keeping, Order Management, Consignment, Logistics, Account Reconciliation, Inventory Management, Research, Analysis, Business Objects, SugarCRM, GMP, FDA, Forecasting, Medical Devices, Biotechnology
Education
The New England Institute of Art
Associate's degree, Radio Broadcasting
Bentley University
Finance, General
Southern New Hampshire University 2015 - Present
Olympus Biotech 2012 - 2014
Olympus Biotech (formerly Stryker Biotech) 2008 - 2014
Procter & Gamble 1999 - 2008
Lockheed Martin (currently known as BAE Systems) 1993 - 1999
Lockheed Martin 1988 - 1993
Lockheed Martin 1983 - 1988
Skills
Manufacturing, FDA, CAPA, Validation, GMP, Building Automation, Mechanical Engineering, HVAC Controls, Facilities Management, Facilities Engineering, MEP Engineering, Project Management, Lean Manufacturing, Process Engineering, Maintenance Management, Product Launch, HAZWOPER, AutoCAD, Microsoft Office 2007, Fire Safety Management, New Product Launch, Engineering
Education
University of New Hampshire
Bachelor of Science (BS), Mechanical Engineering
Southern New Hampshire University
Completed five MBA related courses
The George Washington University
Associates Certificate, Project Management Institute
Vt Department of Health Laboratories August 2014 - Present
Seldon Technologies, Inc September 2012 - August 2014
Olympus Biotech January 2010 - August 2012
Olympus Biotech 2010 - 2011
Stryker Biotech May 2003 - July 2010
Skills
Biotechnology, CAPA, 21 CFR Part 11, GMP, FDA, ISO 13485, V&V, Lifesciences, Sop, Microbiology, Regulatory Affairs, Medical Devices, Validation, GLP, Biopharmaceuticals, Regulatory Submissions, Filtration, Laboratory, Aseptic Technique, Aseptic Processing, Quality Control, Change Control, Technology Transfer, Quality Assurance, Pharmaceutical Industry, Protein Purification, Cell Culture, HPLC, Quality System, GxP, Biochemistry, cGMP manufacturing, cGMP practices, Quality Auditing, Cleaning Validation, 21 CFR, Computer System..., SOP, Formulation, Root Cause Analysis, Design of Experiments, R, ASQ, FDA GMP, Life Sciences
Education
Norwich University 1989 — 1993
Bachelor of Science, Biology
Alexion Pharmaceuticals, Inc. June 2015 - Present
Synageva BioPharma Corp. November 2012 - Present
Blue Stream Laboratories August 2012 - November 2012
Olympus Biotech January 2012 - May 2012
Stryker Biotech April 2006 - October 2011
Formatech, Inc. August 2001 - March 2006
Skills
protein formulation, lyophilization..., stability studies, Preformulation, protein characterization, tangential flow..., Protein Characterization, HPLC, SDS-PAGE, Fill/Finish, Protein Purification, R&D, Isoelectric Focusing
Education
Boston University - School of Management 1998 — 2001
MBA, Business Administration
Boston University School of Medicine 1987 — 1992
Ph.D., Biochemistry
University of Rochester 1983 — 1987
B.S., Biochemistry
Novo Nordisk November 2014 - Present
Olympus Biotech February 2011 - August 2014
Stryker Biotech November 2001 - February 2011
Wausau Paper 1995 - 1999
Skills
V&V, Validation, FDA, GMP, CAPA, Change Control, Quality Assurance, Quality System, Biotechnology, Lifesciences, GxP, Aseptic Technique, Manufacturing, Pharmaceutical Industry, Biopharmaceuticals, Aseptic Processing, Cross-functional Team..., 21 CFR Part 11, Continuous Improvement, Regulatory Affairs, GLP, Sop, ISO 13485, Cell Culture, Root Cause Analysis, Medical Devices, Cleaning Validation, LIMS, Purification, cGMP practices, Technology Transfer, Trackwise, GAMP, Computer System..., SOP, Life Sciences
Education
Plymouth State University 1995 — 2000
Bachelor's Degree, Biology
Novo Nordisk December 2014 - Present
Olympus Biotech May 2013 - June 2014
Colby-Sawyer College January 2012 - May 2013
Colby-Sawyer College September 2010 - May 2013
Colby-Sawyer College May 2012 - September 2012
Pinegate Farm June 2005 - September 2009
Roger Williams Park Zoo May 2005 - September 2009
Skills
Cell Culture, Laboratory Safety, Academic Tutoring, Peer Tutoring, Supplemental Instruction, Protein Purification, Biotechnology, cGMP manufacturing, Aseptic Technique, Microsoft Office, Animal Husbandry, Horse Care, Horse Training, Purification, Gel Electrophoresis, HPLC
Education
Colby-Sawyer College 2009 — 2013
Bachelor of Arts (B.A.), Biology, General, 3.33
Olympus Biotech January 2011 - Present
Stryker Biotech November 1998 - January 2011
Creative BioMolecules December 1993 - November 1998
Skills
Cell Culture, CAPA, ISO 13485, FDA, V&V, GMP, Technology Transfer, Validation, Medical Devices, Quality System, Sop, Lean Manufacturing, Pharmaceutical Industry, GxP, 21 CFR Part 11, GLP, Change Control, Manufacturing, Cross-functional Team..., Quality Assurance, Biopharmaceuticals, Purification, Lifesciences, ISO, Root Cause Analysis, Design Control, Cleaning Validation, Aseptic Processing, Computer System..., Regulatory Affairs, Quality Auditing, Quality Control, Process Simulation, Regulatory Submissions, R&D, Trackwise, LIMS, SOP
Education
Plymouth State University 1998 — 2002
Masters, Business Administration
Norwich University 1988 — 1992
BS, Health Education - Minor: Biology
Novo Nordisk October 2014 - Present
Olympus Biotech February 2008 - Present
Momenta Pharmaceuticals September 2006 - January 2008
Acambis February 2003 - August 2006
Millennium Pharmaceuticals August 1998 - January 2003
Skills
Microbiology, Biotechnology, Cell Culture, Formulation, Cell Biology, Analytical Chemistry, Biopharmaceuticals, Protein Chemistry, ELISA, Cell, Process Simulation, Drug Development, Validation, Assay Development, Technology Transfer, Lifesciences, HPLC, Purification, Biochemistry, Protein Purification, GLP, GMP, Change Control, Molecular Biology, Sop, FDA, SDS-PAGE, Clinical Development, Life Sciences
Education
University of Massachusetts, Amherst
Master of Science degree, Food Science
University of Massachusetts Dartmouth
Bachelor of Science degree, Biology
Olympus Biotech February 2011 - Present
Harvard University March 1997 - June 1997
Skills
Biotechnology, Regulatory Affairs, FDA
Education
Harvard University 2006 — 2015
MLA, Biotechnology
McMaster University 1998 — 2001
BA, History
Dartmouth College August 2013 - Present
Olympus Biotech May 2011 - August 2013
Merck June 2006 - December 2010
GlycoFi August 2004 - December 2010
Agilix Corporation December 2002 - June 2004
Cornell University June 1996 - March 1997
Skills
Protein Chemistry, Protein Purification, Assay Development, ELISA, SDS-PAGE, Cell Culture, HPLC, Cell, Purification, Biochemistry, Isothermal Titration..., Cell Biology, Biotechnology, Proteomics, Drug Discovery, PCR, Laboratory, Life Sciences, Molecular Biology, Immunofluorescence, Characterization, Western Blotting
Education
Dartmouth College 2013 — 2018
Doctor of Philosophy (PhD), Biophysical Chemistry
Yale University 1997 — 2002
MS, Cell Biology
Cornell University 1992 — 1996
BA, Biochemistry
Agenus January 2015 - Present
Baxter International Inc. April 2014 - 2015
Olympus Biotech September 2012 - March 2014
UMass Boston September 2009 - August 2012
Blue Stream Laboratories June 2009 - September 2009
Boston Scientific 2004 - 2006
Skills
HPLC-MS, FPLC, Protein Purification, GC-MS, SDS -PAGE, UV/Vis, SEC, HPLC, NMR, Biotechnology, Mass Spectrometry, Chromatography, Purification, SDS-PAGE, Science, Chemistry, Life Sciences, Cell Culture, Protein Chemistry
Education
University of Massachusetts Boston 2009 — 2012
M.S., Analytical Chemistry ( RP-HPLC/ Mass Spectrometry)
University of Massachusetts Boston 2006 — 2009
Bachelor's Degree, Chemistry, Graduated With Honors
Alkermes July 2013 - Present
Molecular Insight Pharmaceuticals, Inc. November 2011 - February 2013
Olympus Biotech February 2011 - October 2011
Stryker Biotech September 2010 - January 2011
Stryker Biotech October 2005 - September 2010
Stryker Biotech April 1997 - September 2005
CIPR/MGH April 1992 - March 1997
Skills
Toxicology, GLP, Pharmacology, Biotechnology, Life Sciences, Toxicokinetics, Study Design, Regulatory Affairs, Study Monitoring, Pharmacokinetics, Animal Models, Data Analysis, Risk Assessment, Lifesciences, Assay Development, GMP, Oncology, Protocol, Pharmaceutics, Sop, Technology Transfer, Validation, Biomarkers, Biopharmaceuticals, Clinical Development, CRO, Biochemistry, Biologics, Drug Development, Drug Metabolism, FDA, IND, In Vivo, Medical Devices, Pharmaceutical Industry, R, Regulatory Submissions, SOP
Education
The Johns Hopkins University 2010 — 2012
MS, Bioscience Regulatory Affairs
University of Maine 1980 — 1984
BA, Zoology
New Hope, Inc. October 2011 - Present
Olympus Biotech April 2011 - October 2011
Boch Enterprises May 2010 - April 2011
Sullivan & Worcester LLP November 2007 - May 2010
Education
Roger Williams University 2003 — 2007
Bachelor of Science, Business Management, Psychology
Trestles Pain Specialists, LLC July 2014 - Present
Olympus Biotech May 2011 - May 2014
Innovative Medical June 2008 - May 2011
Team Surgical/IMED INC October 2005 - May 2011
Skills
Medical Devices, Operating Room, Capital Equipment, Orthopedic, Spine, Surgery, Market Development, Product Launch, Hospitals, Surgeons, Disposables, Neurosurgery, Sales Operations, Biologics, Surgical Instruments, Orthopedics, Sales Management
Education
California State University-Northridge 2000 — 2002
BA, Biomedical Physics
Novo Nordisk September 2014 - Present
Olympus Biotech February 2011 - August 2014
Stryker Biotech May 2008 - February 2011
Stryker Biotech November 1998 - May 2008
Creative BioMolecules March 1993 - November 1998
Verax Corporation January 1990 - March 1993
Skills
Quality Assurance, Training, 21 CFR Part 11, FDA, GMP, CAPA, ISO 13485, Document Management, Outlook, Visio, Quality Management, Pilgrim, Gallup Strengths, AutoCAD, Adobe Professional, ASQ, 21 CFR Part 820, Sop, Change Control, GxP, Biopharmaceuticals, Biotechnology, Quality Control, Cross-functional Team..., Quality System, 21 CFR, Software Documentation, Medical Devices, V&V, GLP, LIMS, Cleaning Validation, Quality Auditing, Design Control, Validation, Aseptic Processing, GAMP, Trackwise, Pharmaceutical Industry, Regulatory Affairs, Computer System..., HPLC, Regulatory Submissions, SOP
Education
Lyndon State College
Business Management
Hartford High School
College Preparation
Chiltern (previously Theorem Clinical Research) October 2014 - Present
Olympus Biotech July 2013 - May 2014
Weetabix North America September 2012 - June 2013
Sunovion Pharmaceuticals Inc. (formerly Sepracor) September 2009 - December 2011
Sepracor Pharmaceuticals October 2005 - August 2009
Boston Scientific October 2004 - October 2005
Synarc June 2004 - September 2004
PAREXEL International January 2000 - January 2003
Catholic Medical Center January 1997 - January 2000
U.S. Coast Guard January 1991 - January 1995
Skills
Pharmacovigilance, Drug Safety, MedDRA, Clinical Trials, GCP, Pharmaceutical Industry, Oncology, Clinical Development, CRO, Clinical Research, EDC, Therapeutic Areas, Adverse Event Reporting, Clinical Data Management, FDA, Respiratory Products, Federal & State..., EMEA, Oracle Clinical, Oracle AERS, Mentoring New Hires, SAE Reconciliation, FDA Audits, CNS disorders, Cardiovascular, Phase IIIb/IV, ARISg, Medical Information
Education
Framingham State University 1996 — 2000
Bachelor of Science, Dietetics/Biology
Novo Nordisk August 2014 - Present
Olympus Biotech February 2011 - August 2014
Stryker September 2002 - February 2011
Skills
Protein Purification, buffer formulations, Clean Rooms, Column Chromatography, Column Packing, HPLC, Viral Clearance, Microfiltration, cGMP manufacturing, cGMP practices, SIP, CIP systems, Aseptic Technique, Biotechnology, GMP
Education
Castleton State College 1997 — 2002
Bachelor of Science (BS), Natural Sciences
LSNE Contract Manufacturing July 2014 - November 2014
Olympus Biotech America January 2012 - June 2014
Olympus Biotech December 2007 - January 2012
ClearSource Bottled Water Company June 2006 - December 2007
Wyeth September 1987 - June 2006
Pfizer 1987 - 2006
Skills
GMP, CAPA, Validation, Sop, Biotechnology, Quality Assurance, 21 CFR Part 11, FDA, Cleaning Validation, Aseptic Processing, V&V, ISO 13485, Medical Devices, GLP, Biopharmaceuticals, Change Management, Auditing, Quality Auditing, Computer System..., Regulatory Affairs, cGMP manufacturing, cGMP practices, GxP, HPLC, Root Cause Analysis
Education
Clinton Community College 1985 — 1987
Associate of Science (AS), Medical Lab Technology
State University of New York College at Plattsburgh 1984 — 1985
Behavioral Sciences
University of Phoenix
Olympus Biotech February 2011 - September 2014
Stryker Biotech September 2009 - February 2011
Stryker Biotech January 2008 - September 2009
Stryker Biotech September 1998 - January 2008
Stryker Biotech September 1996 - September 1998
CR Bard June 1981 - September 1996
Skills
FDA, Quality Management, CAPA, Packaging, Quality System, GMP, Logistics, ISO 13485, Continuous Improvement, 21 CFR Part 11, Medical Devices, Change Control, Validation, Warehousing, Design Control, Process Improvement, Biotechnology, Cross-functional Team..., Quality Assurance, Materials Management, Product Distribution, Sop, Capital Equipment, Change Management, Team Building, Regulatory Affairs, Operational Excellence, Supply Chain Management, Lean Manufacturing, Supplier Audits, Strategic Planning, Distribution, Supply Chain
Education
Northeastern University
Business Administration
Olympus Biotech October 2008 - Present
UTC September 2001 - September 2008
Liquid Metronics 1987 - 2008
Skills
Manufacturing, Engineering, Process Improvement, Value Stream Mapping, Lean Manufacturing, Manufacturing..., Root Cause Analysis, Continuous Improvement, Kaizen, Automotive, SPC, DMAIC
Education
University of Massachusetts at Lowell 1997 — 2001
Bachelor of Science (B.Sc.), Industrial Technology
Northern Essex Community College 1983 — 1986
Associate of Science (AS), Engineering Science
St. Jude Medical November 2014 - Present
NeuroTherm, Inc. June 2013 - Present
ACell, Inc. January 2012 - June 2013
Olympus Biotech September 2010 - December 2011
Synthes May 2002 - December 2010
Osbon Medical Systems January 1996 - April 2001
Skills
Orthopedic, Capital Equipment, Medical Devices, Surgery, Pain Management, Disposables, Hospitals, Spine, Sales Operations, Selling, Surgeons, Market Development, Orthopedics, Product Launch, Sales, Surgical Instruments, Operating Room
Education
University of Northern Iowa 1991 — 1996
Bachelor of Arts (BA), Business Management
University of Northern Iowa
Bachelor of Business Administration (B.B.A.), Business Administration and Management, General
KARL STORZ Endovision April 2014 - Present
Karl Storz Endovision November 2011 - April 2014
Boston Biomedical Associates June 2011 - November 2011
Olympus Biotech January 2011 - June 2011
Stryker Biotech 2008 - January 2011
Stryker Biotech July 2006 - April 2008
Skills
Quality System..., Training, ISO 13485, ISO 9001, ISO 14001, Auditing, CAPA, GMP, Quality Assurance, Clinical Development, Third Party Inspection, 21 CFR Part 11, Document Management, Project Management
Education
Plymouth State University 1991 — 1995
Bachelor of Arts (B.A.), Medieval and Renaissance Studies
Batavia Biosciences August 2014 - Present
Olympus Biotech April 2009 - April 2014
Stryker 2006 - 2009
Stryker Biotech October 2002 - October 2006
Dow Biopharmaceutical Contract 2000 - 2002
BASF Bioresearch Corp. April 1996 - October 2000
EMD Serono, Inc. 1996 - 1996
Skills
CAPA, GLP, FDA, Validation, Sop, 21 CFR Part 11, Biotechnology, HPLC, ELISA, Quality System, SDS-PAGE, Quality Control
Education
Norwich University 1989 — 1993
Bachelor of Science (BS), Biology, General
Olympus Biotech 2011 - September 2014
Stryker Biotech 2008 - 2011
Stryker Biotech 2002 - 2008
Fischer Scientific International 1999 - 2000
United States Surgical Corporation 1987 - 1998
Skills
Medical Devices, FDA, Capital Equipment, Biotechnology, ISO 13485, GMP, Market Development, CAPA, GCP, Manufacturing, Change Control, Validation, Regulatory Affairs, Clinical Research, Product Launch, Quality System, 21 CFR Part 11, Technology Transfer, V&V, Cross-functional Team..., Lifesciences, Sop, Product Development, Commercialization, Pharmaceutical Industry, Clinical Trials, Regulatory Requirements, Cardiology, Clinical Development, R&D, Regulatory Submissions, Design Control, GLP, Operating Room, SOP, Management, Strategy, Sales Operations, Strategic Planning, Process Improvement, Sales, Life Sciences, Mergers & Acquisitions, Leadership
Education
Lyndon State College
Bachelor of Arts (B.A.), Behavioral Science
Harvard Business School
Executive Leadership Program
Hyun Kim Consulting May 2010 - Present
Olympus Biotech February 2012 - August 2014
Virdante Pharmaceuticals November 2009 - April 2010
Transport Pharmaceuticals November 2006 - October 2009
Anika Therapeutics October 2005 - November 2006
Wyeth Research October 1997 - October 2005
Skills
Regulatory Affairs, Clinical Research, Infectious Diseases, Formulation, Tissue Engineering, Regenerative Medicine, Project Management, Dermatology, Medical Affairs, Inflammation, Research, Central Nervous System, Biotechnology, Biomaterials, GMP, Cell Culture, Sop, R&D, Medical Devices, Drug Development, Clinical Development
Education
Brown University 1993 — 1997
PhD, Medical Science
Brown University 1991 — 1992
ScM, Biomedical Engineering
Brown University 1987 — 1991
ScB, Biomedical Engineering
Safety Partners, Inc. October 2014 - Present
Olympus Biotech July 2012 - August 2014
Olympus Biotech March 2010 - July 2012
Stryker Biotech April 2000 - February 2011
Skills
GMP, Biotechnology, Sop, GLP, Lifesciences, FDA, Quality System, CAPA, R&D, Medical Devices, Pharmaceutical Industry, RCRA, EHS Program Development, Biosafety, OSHA, EHS, Hazardous Waste..., Quality Assurance, 21 CFR Part 11, ISO 13485, Troubleshooting, Environmental Awareness, Change Control, Cross-functional Team..., SOP
Education
University of Massachusetts at Lowell 1997 — 2000
Bachelor of Science (BS), Environmental Science
Middlesex Community College 1995 — 1997
Associates Degree, Environmental Technology
Novo Nordisk September 2014 - Present
Olympus Biotech February 2012 - August 2014
Olympus Biotech October 2008 - February 2012
Stryker Biotech February 2006 - October 2008
Pfizer Pharmaceuticals February 2002 - February 2006
Pfizer Pharmaceuticals July 1999 - February 2002
Skills
Lean Manufacturing, Technology Transfer, Root Cause Analysis, Operational Excellence, Process Engineering, cGMP, PMP, Project Management, Project Portfolio..., Manufacturing, GMP, Process Improvement, Validation, Continuous Improvement, Six Sigma, Medical Devices, Biopharmaceuticals, Cross-functional Team...
Education
University of New Haven 2002 — 2004
MS, Engineering Management
University of Rochester 1995 — 1999
BS, Chemical Engineering
Alexion Pharmaceuticals, Inc. January 2015 - Present
Alexion Pharmaceuticals January 2012 - Present
Olympus Biotech February 2011 - January 2012
Stryker Biotech December 2007 - February 2011
Stryker Biotech October 2006 - December 2007
Stryker Biotech May 2005 - October 2006
AstraZeneca December 2001 - May 2005
Education
University of Rhode Island - College of Business Administration 2008 — 2010
MBA
University of Rhode Island 2007 — 2009
Masters, Biotechnology
Villanova University 1997 — 2001
Bachelors, Chemical Engineering
Mammotome, a Division of Devicor Medical Products, Inc. May 2014 - Present
Olympus Biotech January 2008 - February 2014
Skills
Surgeons, Orthopedic, Spine, Surgery, Market Development, Biotechnology, Healthcare, Sales, New Business Development, Account Management, Marketing, Product Launch, Orthopedics, Medical Devices, Capital Equipment
Education
Assumption College 1999 — 2003
Olympus Biotech April 2011 - Present
TJX August 2010 - February 2011
TJX May 2004 - August 2010
TJX November 2000 - May 2004
TJX February 1998 - November 2000
Skills
Cpr Certified, First Aid, iata, Excel, GMP, Distribution, Cold Chain, Word, Dangerous Goods Training, Training, Microsoft Excel, Microsoft Word, Transportation, Warehousing, IATA, Supply Chain, Management, Shipping, Process Improvement
Education
Dean College 1984 — 1986
Associates, Business Managment
Olympus Biotech February 2011 - July 2012
Stryker Biotech December 2004 - February 2011
Advocates, Inc. April 2002 - May 2004
KForce December 2001 - April 2002
Informa Financial, Inc September 1998 - November 2001
Accountemps February 1997 - September 1998
Reflection Technology, Inc. February 1993 - June 1996
Skills
Financial Reporting, Fixed Assets, Journal Entries, General Ledger, Auditing, Monthly Reporting, Account Reconciliation, Intercompany Processing, Payroll Processing, Organization Skills, Meeting Deadlines, SOX Documentation
Education
Northeastern University
Bachelors, Accounting
GlaxoSmithKline April 2013 - Present
Olympus Biotech May 2011 - July 2012
FMC October 2010 - May 2011
Bristol-Myers Squibb March 1990 - October 2010
Sirrine Environmental Consultants May 1987 - March 1990
Skills
Engineering, GMP, Biopharmaceuticals, Project Management, Equipment Qualification, Environmental..., Facilities Management, Chemical Engineering, Validation, FDA, Biotechnology, 21 CFR Part 11, Cross-functional Team..., Commissioning, Manufacturing, Filtration, Aseptic Processing, Chromatography, Computer System..., Technology Transfer, Instrumentation, Change Control, Process Simulation, CAPA
Education
University of Wisconsin-Madison 1982 — 1984
BS, Chemical Engineering
Clemson University 1984 — 1987
MS, Environmental Engineering
Olympus Biotech August 2013 - Present
Olympus Biotech September 2011 - August 2013
Olympus Biotech December 2006 - September 2011
Stryker Biotech December 2006 - January 2011
Ethicon Endo-Surgery March 2005 - January 2007
Osteotech September 2001 - March 2005
Skills
Medical Devices, Orthopedic, Oncology, Surgeons, Disposables, Neurology, Capital Equipment, Operating Room, Market Development, Urology, Surgical Instruments, Biotechnology, Pharmaceutical Industry, Spine, Cross-functional Team..., Account Management, Sales Management, New Business Development, Neurosurgery, FDA, Product Launch
Education
Penn State University
BS, Business
FUJIFILM Dimatix, Inc. April 2014 - Present
Olympus Biotech July 2012 - April 2014
Applied Research Associates, Inc. October 2002 - July 2012
Naval Surface Warfare Center, Carderock Division, U.S.Navy June 1999 - October 2002
Education
University of Delaware 1996 — 1999
Masters Electrical Engineering (MEE)
Middlebury College 1991 — 1995
BA, Physics
Wilmington Friends School 1988 — 1990
International School of Geneva, Switzerland 1984 — 1988
ImmuNext December 2013 - Present
Olympus Biotech February 2011 - November 2013
Stryker Biotech 2007 - February 2011
Department of Biochemistry at Dartmouth Medical School 2004 - 2007
Skills
Biotechnology, Bioreactor, R&D, Process Simulation, Fermentation, Protein Purification, Cell Culture, Cell, Protein Chemistry, Purification, Assay Development, Molecular Cloning, Chromatography, GMP, FDA, Sop, V&V, Flow Cytometry, Biopharmaceuticals, Western Blotting, Stem Cells, ELISA, GLP, DNA
Education
The University of Freiburg
Ph.D, Cell Biology
Peking Union Medical College 1995 — 1998
MS, Cancer Biology
Tongji Medical College 1987 — 1992
MD, Medicine
Dartmouth Hitchcock Medical Center July 2012 - Present
Olympus Biotech July 2009 - July 2012
Stryker Biotech July 2009 - January 2011
Stryker Biotech 2008 - 2009
Stryker Biotech 2005 - 2008
Skills
21 CFR Part 11, Automation, CAPA, Calibration, Change Control, Computer System..., Continuous Improvement, Engineering, Biotechnology, FDA, GMP, GxP, ISO 13485, Lifesciences, Manufacturing, Medical Devices, Microsoft Office, Pharmaceutical Industry, Process Engineering, Process Improvement, Project Management, Quality Assurance, Quality System, Root Cause Analysis, Sop, Testing, Troubleshooting, V, Validation, Windows
Education
River Valley Community College 2012 — 2014
Practical Nursing, Vocational Nursing and Nursing Assistants
Regis University 2007 — 2009
MBA, General Business
Vermont Technical College 2002 — 2006
BS, Electro-Mechanical Engineering
GE Healthcare September 2014 - Present
Olympus Biotech April 2011 - May 2014
Charles River Laboratories May 2001 - April 2011
Charles River Laboratories January 1998 - May 2001
Charles River Laboratories April 1994 - January 1998
Charles River Laboratories May 1988 - April 1994
Skills
GLP, FDA, Sop, Biotechnology, 21 CFR Part 11, CAPA, GMP, Quality Assurance, Change Control, Validation, Biopharmaceuticals, LIMS, Lifesciences, Medical Devices, Toxicology, SOP
Education
Anna Maria College 1992 — 1995
Master's Degree, Biological Sciences
Worcester State University 1988 — 1992
Bachelor's Degree, Biology/Biological Sciences, General
Becker College 1986 — 1988
Associate's Degree, Veterinary/Animal Health Technology/Technician and Veterinary Assistant
Amy Dingley Consulting September 2014 - Present
Olympus Biotech June 2011 - Present
Olympus Biotech America April 2011 - Present
Olympus Biotech 2011 - 2011
Skills
Biopharmaceuticals, CAPA, 21 CFR Part 11, GMP, Change Control, FDA, Validation, Analytical Methods..., Medical Devices, Pharmaceutical Industry, Life Sciences, SOP, GLP, Biotechnology, Technology Transfer, Quality System, V&V
Education
Oberlin College
Brandeis University
Ph.D., Chemistry
Harvard Medical School
Postdoctoral Fellow
National Field Representatives June 2012 - Present
Olympus Biotech 2010 - June 2012
Topflight Corporation June 2002 - December 2003
Adhesives Research, Inc. 1996 - 2002
BD 1985 - 1995
Analytab Products (API) 1980 - 1984
Skills
Quality System, Teaching, Learning Management..., Biopharmaceuticals, Document Management, GxP, Management, Employee Training, Computer System..., Outlook, Visio, Curriculum Design, Project Planning, CAPA
Education
Saint John's University 1978 — 1980
BS, Medical Technology
SUNY Stony Brook
Shire August 2015 - Present
Shire Pharmaceuticals September 2013 - August 2015
Genzyme Biosurgery July 2011 - September 2013
Olympus Biotech July 2010 - July 2011
Stryker July 2006 - July 2010
Stryker August 2003 - July 2006
Skills
ASQ Internal Auditing..., CAPA, Sop, Cell Culture, Internal Audit, Change Control, FDA, ASQ, GMP, Quality Assurance, Quality Auditing, Lifesciences, Formulation, Manufacturing, GLP, V&V, Root Cause Analysis, Medical Devices, Regulatory Affairs, 21 CFR, HPLC, Aseptic Processing, Validation, 21 CFR Part 11, Computer System..., Pharmaceutical Industry, ISO 13485, Biotechnology, Biopharmaceuticals, Quality System, LIMS, GxP, Document Management, Quality Control, Cleaning Validation, Software Documentation, Technology Transfer, GAMP, Regulatory Submissions, Laboratory, Trackwise, Calibration, SOP, Life Sciences, Quality Management
Education
Franklin Pierce College 2004 — 2006
Master of Business Administration (M.B.A.), Organizational Leadership
Franklin Pierce College 1999 — 2003
Bachelor of Science (BS), Biology/Biological Sciences, General
ASQ Courses