Stryker Biotech
Industry: Biotech company
DescriptionFounded: 2003 Parent organization: Stryker Corporation
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Stryker Biotech Employees
AstraZeneca February 2014 - Present
Bristol-Myers Squibb August 2012 - February 2014
Amylin Pharmaceuticals February 2008 - August 2012
Stryker Biotech April 1999 - February 2008
Clear Channel Communications September 2004 - April 2007
United States Army Reserve July 1992 - June 1997
Skills
FDA, Medical Devices, Validation, GMP, Change Control, Quality Assurance, Process Improvement, Six Sigma, Leadership, CAPA, Root Cause Analysis, Quality Auditing, Troubleshooting, Technology Transfer, Biotechnology, Continuous Improvement, Lifesciences, Aseptic Processing, ISO 13485, Quality System, Quality Control, 21 CFR Part 11, Biopharmaceuticals, Process Simulation, Operational Excellence, V&V
Education
Bexley Seabury
Working towards a Master of Divinity (M.Div.), Divinity/Ministry, Junior
Norwich University 2002 — 2004
MBA
Plymouth State University
BA, History
Suneva Medical March 2014 - Present
Kythera Biopharmaceuticals August 2007 - March 2014
Allergan (Alleran Medical) March 2006 - August 2007
Allergan (Alleran Medical) September 2004 - March 2006
Ipsen Ltd. February 2002 - September 2004
Stryker Biotech November 1999 - February 2002
Ranbaxy April 1994 - May 1997
Skills
Oncology, Neurology, Endocrinology, EMEA, Regulatory Affairs, Regulatory Submissions, FDA, Pharmaceutical Industry, IND, Medical Devices, Biotechnology, Clinical Development, NDA, Regulatory Requirements, Therapeutic Areas, Validation, CMC, Biopharmaceuticals, Clinical Trials, Pharmaceutics, GMP, SOP, Life Sciences
Education
College of Pharmacy 1997 — 2001
B. Pharmacy
California State University-Dominguez Hills 1997 — 1999
MBA, International Business
Jamia Hamdard 1991 — 1993
M. Pharm, Pharmaceutics
Berhampur University 1987 — 1991
B. Pharmacy, Pharmaceutics and Drug Design
Pharmacy 1987 — 1991
B. Pharmacy
Keurig Green Mountain, Inc. January 2011 - Present
Stryker, Biotech Division January 2006 - January 2010
Stryker Biotech January 2006 - January 2008
American Superconductor July 2001 - December 2005
APW Wright Line January 1997 - March 2001
MHPG, INC July 1995 - January 1997
Galileo Electro-Optics Corp November 1987 - July 1995
Skills
Purchasing, Lean Manufacturing, Supply Chain, Inventory Control, Strategic Sourcing, Negotiation, Sales Management, Supply Management, Project Management, Procurement, Vendor Management, Materials Management, Global Sourcing, Product Development, Contract Negotiation, Manufacturing, Leadership, Project Planning, Kaizen, Management, Medical Devices, Sourcing, Forecasting, Contract Management, ISO, Cross-functional Team..., MRP, Supply Chain Management, Continuous Improvement
Education
Worcester State University 1991 — 1994
Business
Becker College 1984 — 1986
Becker Junior College
Associate Degree of Science
Quaboag HS
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
Enable Injections 2014 - Present
Pharmacuetical and Medical Device Clients February 2014 - Present
Bristol-Myers Squibb 2010 - 2013
Amylin Pharmaceuticals 2007 - 2010
Stryker Biotech 2004 - 2007
Stryker 1999 - 2004
Skills
CAPA, Validation, Medical Devices, ISO 13485, GMP, Commercialization, FDA, V&V, Process Engineering, 21 CFR Part 11, Program Management, Project Management, Design Control, Continuous Improvement, Quality System, Biotechnology, Technology Transfer, R&D, Engineering, Start-ups, Manufacturing, Change Management, Pharmaceutical Industry, Sop, Change Control, Operational Excellence, Process Improvement, Cross-functional Team..., Contract Manufacturing, Root Cause Analysis, Quality Control, Quality Assurance, Lifesciences, Strategy, Engineering Management, Aseptic Processing, Process Simulation, Biopharmaceuticals, Design of Experiments
Education
Dartmouth College, Thayer School of Engineering & Tuck School of Business 1994 — 1998
Masters, Engineering Management
Drexel University 1986 — 1991
Bachelor of Science (B.S.), Civil Engineering
Alexion Pharmaceuticals, Inc. October 2013 - Present
A10 Clinical Solutions July 2013 - October 2013
A10 Clinical Solutions March 2012 - November 2012
Amgen August 2004 - August 2011
Regeneron Pharmaceuticals July 2002 - August 2004
Stryker Biotech February 2001 - June 2002
Regeneron Pharmaceuticals May 1999 - February 2001
DMV International Nutritionals June 1998 - April 1999
Skills
GMP, Quality Assurance, Quality System, Change Control, Quality Control, CAPA, FDA, Sop, Manufacturing, Validation, 21 CFR Part 11, LIMS, Aseptic Processing, Biopharmaceuticals, Biotechnology, GLP, Supplier Quality, SOP
Education
State University of New York at Albany 1996 — 1997
Bachelor of Science (BS), Biology, General
Albany College of Pharmacy of Union University 1993 — 1995
66 credits, Pharmacy
Shire July 2015 - Present
Pfizer February 2014 - Present
CISBIO Bioassays, Member of the IBA Group March 2007 - February 2014
Stryker Biotech September 2004 - February 2007
Repair Connection Inc. 1997 - 2001
Mantis Computer Inc. 1994 - 2001
J.P.'s Tuxedos 1985 - 1991
Skills
Biotechnology, Life Sciences, GMP, Aseptic Technique, HPLC, Clinical, Clinical Trials, Technology Transfer, Protein Chemistry, Protein Purification, Clinical Research, Cell Culture, Process Development, Diagnostics, Monoclonal Antibodies, Clinical Development, Purification, Assay Development, Biochemistry, Cell, Drug Discovery, ELISA, Lifesciences, Medical Devices, Molecular Biology, Process Simulation, Pharmaceutical Industry
Education
Boston University 2007 — 2015
Bachelor of Science (B.S.) Biomedical Laboratory and Clinical Sciences, Biomedical Laboratory and Clinical Sciences
Boston University 2007 — 2013
Awarded Certificate in Clinical Research 2013, Biomedical Laboratory and Clinical Research
Middlesex Community College 2004 — 2005
A.S., Biotechnology
Vermont Technical College 1982 — 1984
Associates of Science, Agribusiness
Organogenesis Inc. February 2013 - February 2014
Organogenesis July 2012 - January 2013
Organogenesis 2007 - June 2012
Stryker Biotech 2005 - 2007
DePuy Spine 2003 - 2005
Skills
Medical Devices, Clinical Research, Clinical Operations, Biotechnology, Clinical Trials, Clinical Development, FDA, Wound Care, Pharmaceutical Industry, Advisory Boards, Regulatory Affairs, Lifesciences, Life Sciences, Orthopedic, Medical Writing, Orthopedics, Periodontal Disease
Education
Bucknell University
BA, Biology
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
GW Plastics August 2014 - Present
Olympus Biotech America February 2011 - June 2014
Stryker Biotech April 2008 - February 2011
Stryker Biotech January 2005 - April 2008
Stryker Biotech November 2002 - January 2005
Stryker Biotech July 1999 - November 2002
Stryker Biotech and Creative Biomolecules, Inc. December 1996 - July 1999
Skills
FDA, Regulatory Affairs, Validation, Regulatory Submissions, Biotechnology, Cross-functional Team..., Regulatory Requirements, V&V, CTD, TGA, EMA, Strategic Planning, Electronic Submissions, Customer Service, GMP, Compliance, Project Management
Education
Hamilton College 1992 — 1996
Bachelor of Arts (B.A.), Biology
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
Global Atlantic Financial Group Limited September 2014 - Present
Olympus Biotech America February 2011 - August 2014
Stryker Biotech February 2007 - January 2011
Covidien February 2004 - February 2007
Skills
Employee Benefits, Benefits Administration, Benefits Negotiation, Qualified Retirement..., Human Resources, Program Management, New Hire Orientations, HR Policies, Employee Handbooks, Policy, HRIS, Personnel Management, FMLA, Performance Management, Training, Leadership, Compensation & Benefit, Employee Engagement, Workers Compensation, Management, Strategic HR, Succession Planning, HR Consulting, Job Descriptions, Workforce Planning, Exit Interviews, Employment Law, Employee Training, Job Analysis, Labor Relations, Temporary Placement, Resume Writing, Organizational Design, Legal Compliance, Organizational..., COBRA, Salary, Employee Relations, Affirmative Action, Recruiting, Screening Resumes, Hiring, Internet Recruiting, Behavioral Interviewing, Interviews, Screening, Compensation & Benefits
Education
Assumption College
MBA, Human Resources
Nichols College
BSBA, Human Resources
Stryker Biotech January 2011 - October 2011
Stryker Biotech March 2006 - January 2011
UMass Medical School 2005 - 2006
Invitrogen, Inc 2003 - 2004
Sequitur Inc October 2000 - December 2003
Genome Therapeutics 1987 - 2000
Boston University Medical School 1985 - 1987
Skills
qPCR, Cell Based Assays, Molecular Biology, Cell Culture, ELISA, RNA isolation, RNAi, Stem Cells, recombinant DNA..., Reporter Gene Assays, Electroporation, Cell, Cell Biology, Laboratory, Protein Chemistry, HPLC, Biotechnology, Validation, Assay Development
Education
California Polytechnic State University-San Luis Obispo
Anatomy Physiology minor in Mathematics
Meso Scale Discovery August 2012 - Present
GE Healthcare March 2010 - August 2012
GE Healthcare 2007 - March 2010
Millennium Pharmaceuticals 2004 - 2007
Stryker Biotech 2000 - 2001
Skills
CRM, Leadership, Business Acumen, Biotechnology, Selling Skills, Cross-functional Team..., Six Sigma, GMP, Chemistry, Protein Purification, Chromatography, Immunoassays, Proteomics, Sop, Cell, Lifesciences, Cell Culture, Purification, Laboratory, Drug Discovery, Pharmaceutical Industry, ELISA, FDA, Life Sciences, SOP
Education
University of North Carolina at Wilmington 2001 — 2003
MS, Chemistry
Keene State College 1996 — 2000
BA, Chemistry
Barnstable High School 1992 — 1996
Science
Green Mountain Human Resources Association (GMHRA) January 2014 - Present
College of St. Joseph in Vermont July 2012 - Present
Heritage Family FCU February 2007 - Present
Stryker Biotech June 2002 - October 2006
Twincraft Soap August 1986 - July 2000
Skills
Employee Relations, Onboarding, HRIS, Employee Benefits, Talent Management, Human Resources, Deferred Compensation, Workforce Planning, Recruiting, Benefits Administration, Organizational..., Performance Management, Employee Engagement, HR Consulting, Talent Acquisition, Job Descriptions, HR Policies, Personnel Management, Organizational..., Coaching, FMLA, Strategic HR, Career Development, Employee Handbooks, Succession Planning, New Hire Orientations, Organizational Design, Applicant Tracking..., Employment Law, Interviews, Hiring, Labor Relations, Leadership Development, Resume Writing, Executive Pay, Payroll, Conflict Resolution, Executive Coaching, College Recruiting, Employee Training, Training, Policy, Temporary Staffing, Leadership, Workers Compensation, Compensation & Benefit, Staff Development, Workshop Facilitation
Education
Trinity College, Burlington VT 1988 — 1993
Bachelor's degree, Business Administration and Management, General
Champlain College 1986 — 1988
Associate's degree, Office Management and Supervision
Shire HGT February 2013 - Present
Biogen Idec July 2012 - December 2012
Percivia February 2011 - April 2012
Stryker Biotech July 2008 - February 2011
Microbiology Research Associates September 2007 - June 2008
Biovest International January 2006 - September 2007
Cetek Corporation March 2002 - June 2005
Cetek Corporation December 2000 - March 2002
Skills
GMP, Quality Control, ELISA, Problem Solving, Aseptic Technique, Bioassay, Analytical Biochemistry, Microbiology, Improvisational Comedy
Education
Penn State University 1996 — 2000
Bachelor of Science (BS), Biotechnology
Improv Asylum 2011 — 2012
Certificate of Completion, Improvisation
Boston Scientific April 2014 - Present
Consultant April 2011 - Present
STDMed August 2012 - March 2014
Stryker Development January 2005 - March 2011
CIBOR 2008 - 2011
Stryker Biotech May 2003 - April 2005
Stryker Leibinger/Instruments January 2000 - January 2003
Johnson & Johnson June 1990 - April 2000
Skills
Medical Devices, Biomaterials, Biomedical Engineering, R&D, Product Development, Design Control, Orthopedics, Cross-functional Team..., Strategic Planning, Biotechnology, Patents, Surgery, 510 K
Education
Michigan State University College of Human Medicine 1988 — 1990
MS, Biomechanics
Michigan State University 1984 — 1988
BS, Mechanical Engineering and Biomedical Engineering
Hastings High
Barry-Wehmiller Design Group April 2013 - Present
PharmEng Technology October 2012 - April 2013
Integrated Commissioning & Qualification, Corp. December 2009 - November 2012
Stryker Biotech May 2008 - December 2009
Validation Technologies, Inc. January 2006 - May 2008
Wyeth BioPharma October 2000 - January 2006
Nashua Corp 1997 - 2000
Skills
Process Validation, Validation, cGMP, Biotechnology, GMP, Process Engineering, Metrology, Delta V, V&V, Biopharmaceuticals, Manufacturing, Commissioning, FDA, 21 CFR Part 11, Change Control, Pharmaceutical Industry, Computer System..., GAMP, GxP, Quality System, Sop, Quality Assurance, Troubleshooting, CAPA, Medical Devices, Software Documentation, Regulatory Affairs, ISO 13485, GLP, Process Simulation, LIMS, Calibration, Testing, Technology Transfer, Cleaning Validation, Engineering, Quality Auditing, Aseptic Processing, Root Cause Analysis, Regulatory Requirements, Quality Management, Lifesciences, HPLC, Pharmaceutics, PLC, Sterilization, Chromatography, Cell Culture, Regulatory Submissions, R&D
Education
Merrimack College 1992 — 1995
Electrical and Electronics Engineering
Millennium Pharmaceuticals November 2013 - Present
Genzyme February 2012 - November 2013
Genzyme August 2011 - February 2012
Biogen Idec July 2006 - July 2011
Biogen Idec June 2004 - July 2006
Biogen Idec April 2002 - June 2004
Biogen Idec May 2001 - April 2002
Biogen Idec December 1999 - May 2001
Lonza Biologics February 1999 - December 1999
Stryker Biotech April 1998 - February 1999
Skills
GMP, Quality System, Quality Assurance, Sop, Technology Transfer, Cell Culture, 21 CFR Part 11, Change Control, Trackwise, Chromatography, Validation, Biopharmaceuticals, GxP, Biotechnology, Deviations, Aseptic Technique, CAPA, Continuous Improvement, FDA, Filtration, Quality Auditing, Quality Control, Quality Management, Aseptic Processing, LIMS, Manufacturing, V&V, Pharmaceutical Industry, Cleaning Validation, Fermentation, GLP, Computer System..., Regulatory Affairs, Software Documentation, Regulatory Submissions, SOP, TrackWise
Education
Maine Maritime Academy 1991 — 1995
BS, Ocean Studies
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
Stryker Spine January 2011 - Present
ApaTech, Inc. October 2008 - December 2010
Stryker Spine May 2005 - October 2008
Stryker Biotech April 2001 - April 2005
Education
Northeastern University 1983 — 1988
Bachelor of Science (BS), Organizational Communication, General, 3.14159265359
Novo Nordisk December 2014 - Present
Olympus Biotech America March 2013 - August 2014
Olympus Biotech America February 2010 - March 2013
Stryker Biotech September 2008 - February 2010
Skills
Aseptic Technique, Isolator Operations, GMP training, Microsoft Office, Microsoft Excel, Microsoft Word, Teamwork, GMP, Chemistry, Biology, Microbiology, Aseptic Processing
Education
Norwich University 2004 — 2009
Bachelor's degree, Biology, General
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
Novartis March 2007 - Present
Stryker Biotech September 2004 - March 2007
Skills
Forecasting, Process Improvement, Cross-functional Team..., Sarbanes-Oxley Act, Business Planning, Financial Analysis, Mergers & Acquisitions, Leadership, Finance, Financial Modeling, Budgets, Strategic Financial..., Internal Controls, Managerial Finance, Strategy, Variance Analysis, Financial Reporting, Due Diligence, SAP, Capital Budgeting, Pharmaceutical Industry, Change Management, Accounting, Business Process..., Strategic Planning
Education
Southern Connecticut State University 1999 — 2001
MBA
Quinnipiac University 1988 — 1992
BS, Accounting
Olympus March 2013 - Present
Covidien May 2012 - February 2013
Lantheus Medical Imaging April 2011 - May 2012
Lantheus Medical Imaging June 2009 - April 2011
Straumann USA, LLC June 2007 - May 2008
Straumann, LLC June 2007 - November 2007
Boston Scientific November 2005 - February 2007
Stryker Biotech January 2002 - October 2005
Stryker January 2002 - October 2005
Skills
Medical Devices, Orthopedic, Selling, Product Launch, Sales Process, CRM, Sales Management, Sales Operations, Selling Skills, Training, Marketing, Business Planning, Organizational..., Sales Force Development, Sales Presentations, Learning Quickly, Sales, Pharmaceutical Sales, Management, Urology, Surgeons, Market Development, Sales Effectiveness, Cardiology
Education
D'Amore-McKim School of Business at Northeastern University 1998 — 1999
MBA, Hightech MBA
Syracuse University 1989 — 1993
BS, Premed-Biochemistry
Lake Lehman HighSchool 1986 — 1989
Agilux Laboratories July 2015 - Present
AbbVie September 2014 - July 2015
Vivopath LLC October 2012 - June 2014
Stryker Biotech January 2010 - November 2011
Stryker Biotech October 2007 - January 2010
Stryker Biotech January 2005 - October 2007
TKT March 2002 - March 2003
Curis Inc June 1999 - February 2002
Skills
Cell Based Assays, GLP, Clinical Development, Toxicology, ELISA, Molecular Biology, Cell Culture, SOP, Western Blotting, Validation, SDS-PAGE, Clinical Trials, Aseptic Technique, Research, LIMS, Quality Systems, Immunoassays, Purification, In Vitro, Clinical Research
Education
Ohio University 1990 — 1997
Bachelor of Science, Wildlife Biology
Pequannock Township High School Pompton 1986 — 1990
High School Diploma
Retired April 2014 - Present
Millennium Pharmaceuticals January 2011 - March 2014
ARIAD Pharmaceuticals, Inc. May 2007 - January 2011
Stryker Biotech December 2005 - May 2007
Biogen Idec April 2005 - December 2005
V.I. Technologeis, Inc. August 2000 - April 2005
Biovest International 2005 - 2005
V.I. Technologies, Inc. (Vitex) 2000 - 2005
VI Technologies Inc. 2000 - 2005
Vitex 2000 - 2004
Skills
EDC, FDA, Regulatory Affairs, Biotechnology, IND, GCP, Pharmaceutical Industry, Regulatory Submissions, CTMS, Quality Assurance, Technology Transfer, Drug Development, Oncology, Clinical Development, Clinical Trials, ISO 13485, Regulations, GMP, 21 CFR Part 11, CAPA, Biopharmaceuticals, CRO, Sop, Regulatory Requirements, eCTD, Validation, Change Control, GLP, Lifesciences, Pharmacovigilance, Biologics, CMC, Computer System..., Vaccines, Drug Discovery, Medical Devices, Protocol, GxP, V&V, Medical Writing, Therapeutic Areas, ICH-GCP, Pharmaceutics, PMA, Design Control, Regulatory Strategy..., Aseptic Processing, Clinical Operations, Quality System, Drug Safety
Education
Boston University 1990 — 1992
Master of Business Administration, General
Rensselaer Polytechnic Institute 1983 — 1985
Master of Engineering, Biomedical Engineering
Rensselaer Polytechnic Institute 1979 — 1983
Bachelor of Science, Biomedical Engineering
NewLink Genetics January 2015 - Present
Oxford Corp September 2014 - December 2014
Oxford Corp March 2014 - June 2014
Ironwood Pharmaceuticals December 2011 - January 2014
Philips Healthcare October 2010 - December 2011
Stryker Biotech April 2005 - July 2009
Genzyme Corp 2002 - 2005
Sycamore Networks 2000 - 2001
Digi International 1995 - 2000
Bytex 1981 - 1994
Skills
Business Process..., Release Management, Technical Support, Team Building, 21 CFR Part 11, Cross-functional Team..., Design Control, Quality System, Computer System..., Change Control, Process Improvement, GAMP, Validation, CAPA, Medical Devices, Continuous Improvement, FDA, Software Documentation, Quality Management, Document Management, ISO 13485, Root Cause Analysis, ISO 14971, GxP, Quality Assurance, Quality Control, Manufacturing, Sop, V&V, Quality Auditing, Iso 9000, GMP, Biotechnology
Education
Boston College 1981 — 1984
BA, Mathematics
Novartis March 2012 - Present
Stryker Biotech April 2011 - March 2012
Skills
Microbiology, Biopharmaceuticals, R&D, GMP, Drug Delivery, Medical Devices, Technology Transfer, Cell Culture, Biotechnology, HPLC, Protein Chemistry, V&V, Formulation, Lifesciences, SDS-PAGE, CAPA, Pharmaceutical Industry, Validation, FDA, GLP, Chromatography, Molecular Biology, Cell, Purification, Western Blotting, Transfection, ELISA, Laboratory, LIMS, Assay Development, Protein Purification, Biochemistry, Sop, Life Sciences
Education
Massachusetts College of Pharmacy and Health Sciences 1996 — 2002
Pharmacy
Cayuga Consulting January 2004 - Present
Independent Consultant January 2002 - Present
Vital Diagnostics February 2011 - August 2011
AdvanDx January 2008 - February 2010
Surface Logix January 2007 - January 2008
Aspect Medical Systems 2000 - 2002
Davol 2000 - 2001
DePuy Mitek 1998 - 2000
Johnson and Johnson Professional (Now Depuy) 1997 - 1998
Stryker Biotech 1995 - 1997
Skills
PMA, Medical Devices, IND, Clinical Development, NDA, Clinical Research, CMC, MDR, Technical Files, CTD, IDE, Pharmacovigilance, Orthopedic, FDA, CAPA, ISO 13485, Regulatory Affairs, Regulatory Submissions, GMP, Validation, Sop, Quality Assurance, Clinical Trials, Biopharmaceuticals, GCP, Drug Development, Quality System, Regulatory Requirements, Infectious Diseases, Commercialization, Medical Writing, Chromatography, eCTD, Hardware Diagnostics, GxP, Pharmaceutics
Education
Boston University 1992 — 1997
MPH, Public Health -Environmental Health
Wheaton College 1978 — 1983
BA, Biology
MKS Instruments May 2014 - Present
Coaching Training & Consulting January 2014 - May 2014
Boston Medical Center March 2011 - November 2013
Stryker Biotech January 2005 - July 2009
Lightbridge, Inc. June 2000 - July 2003
Bose Corp 1998 - 2000
Skills
MBTI, Certified DDI..., Staff Development, Team Building, Training, Cross-functional Team..., Leadership Development, Coaching, Organizational..., Performance Management, Employee Relations, Change Management, Project Management, Public Speaking, Onboarding, Strategic Planning, Leadership, Meeting Facilitation -..., Substitute Teacher -..., Human Resources, Management, Conflict Resolution, Employee Engagement, Employee Training, Workshop Facilitation, Instructional Design, Program Management, Personnel Management, Organizational..., Career Development, Training Delivery
Education
iPEC 2009 — 2010
Certificate, Professional Life/Business Core Energy Coaching
Anna Maria College
Masters Degree, Education
Bates College
Bachelor of Arts, English
Gilead Sciences April 2014 - October 2014
MedImmune, an AstraZeneca Company 2005 - 2014
Stryker Biotech 2004 - 2005
Millipore 2001 - 2004
Fred Hutchinson Cancer Research Center 1999 - 2001
Dana-Farber Cancer Institute 1998 - 1999
Harvard Medical School 1998 - 1999
Seragen, Inc. 1985 - 1990
Skills
Medical Affairs, Infectious Diseases, Health Economics, Vaccines, Clinical Development, Cross-functional Team..., Immunology, Product Launch, Strategic Leadership, Outcomes Research, Strategic Planning, Health Policy, Patient Outcomes, Virology, Oncology, Public Heatlh, Antibodies, Monoclonal Antibodies, Clinical Trials, Public Health, FDA, Protein Chemistry, Pediatrics, Biotechnology, Biopharmaceuticals, R&D, Assay Development, Therapeutic Areas, Technology Transfer, Medical Devices, Regulatory Affairs
Education
Massachusetts Institute of Technology - Sloan School of Management
Executive Certificate in Management and Leadership
University of Arizona College of Pharmacy
Training Program in Health Outcomes & PharmacoEconomic Research
Harvard Medical School
Postdoctoral Fellow, Virology
Dana-Farber Cancer Institute
Postdoctoral Fellow, Virology
University of Massachusetts Medical School
Ph.D., Virology and Immunology
Johns Hopkins Bloomberg School of Public Health
MPH, Public Health
Celestica February 2013 - 2015
Celestica April 2009 - February 2013
Acusphere, Inc. October 2008 - April 2009
Confidential June 2008 - October 2008
Histogenics April 2007 - October 2008
Stryker Biotech 2006 - 2007
Alkermes 2001 - 2006
Armstrong Pharmaceuticals 1997 - 2002
ATC Associates 1993 - 1997
Skills
Strong technical and..., Working knowledge of..., Advanced knowledge of..., FDA, GMP, Iso 9000, Management, Budgets, Conflict Management, Forging, GCPs, Validation, ISO 13485, Laboratory, Team Building, Regulations, Manufacturing, Quality System, Strategy, Quality Auditing, Process Improvement, CAPA, Biotechnology, Cross-functional Team..., Six Sigma, Medical Devices, Quality Assurance, Supplier Quality, Pharmaceutical Industry
Education
University of Massachusetts Lowell 2003 — 2005
MS, Chemistry
Franklin Pierce University 2002 — 2005
MBA, Leadership
University of Massachusetts Lowell 1989 — 1994
BA; BS, Modern Languages; Chemistry
Dartmouth College 2012 - Present
Millennium Pharmaceuticals May 2012 - January 2013
Amgen May 2011 - August 2011
National Cancer Institute June 2009 - August 2010
National Cancer Institute June 2008 - August 2008
United Therapeutics July 2005 - August 2007
Cambrex July 2004 - July 2005
Stryker Biotech May 2002 - August 2002
Skills
Cancer, Epidemiology, Biostatistics, Biotechnology, Data Analysis, SAS, Protein Purification, Process Development, R, Lifesciences, Science, Cell Culture, Molecular Biology, Statistics, Process Simulation, Scientific Writing, Genetics, Biochemistry, Infectious Diseases
Education
Harvard University School of Public Health 2010 — 2015
Doctor of Science (Sc.D.)
Harvard University School of Public Health 2010 — 2012
Master of Science (S.M.)
Columbia University Mailman School of Public Health 2007 — 2009
Master of Science (M.S.)
McGill University 1999 — 2004
Bachelor of Engineering (B.Eng.)
Stryker Biotech June 2007 - Present
international power 2006 - 2008
MFS 2002 - 2006
MFS Investment Management 2002 - 2006
Aspen Technology June 1998 - July 2002
Education
Bentley University 1997 — 2000
MBA/MIS
Colby College 1989 — 1993
BA
CVS Caremark Corporation October 2012 - Present
Boston Biomedical Associates May 2011 - October 2012
Aptiv Solutions February 2010 - May 2011
Oxford Immunotec September 2008 - January 2010
Hologic, Inc. (formerly Cytyc Corp.) July 2007 - September 2008
Stryker Biotech July 2005 - June 2007
Davol November 2002 - July 2005
Skills
Medical Devices, FDA, Regulatory Affairs, GCP, ISO 13485, Clinical Trials, Pharmaceutical Industry, Regulatory Submissions, PMA, IND, CAPA, 21 CFR Part 11, Sop, Biotechnology, Clinical Research, CTMS, Lifesciences, Validation, GMP, Post Market Surveillance, Quality Auditing, ISO 14971, Software Documentation, Quality Assurance, Clinical Development, Regulatory Requirements, Pharmacovigilance, Cross-functional Team...
Education
University of Massachusetts, Amherst 2000 — 2002
MPH, Epidemiology
Clark University 1995 — 1999
BA, Biology/Microbiology
Biogen Idec July 2014 - Present
Biogen Idec February 2012 - July 2014
Stryker Regenerative Medicine January 2007 - October 2011
Stryker Biotech 2002 - 2007
Repromedix Corporation 2000 - 2002
Skills
Western Blotting, Aseptic Technique, qPCR, Tissue Culture, ELISA, Molecular Biology, Cell Based Assays, In Vitro, Immunoassays, Biotechnology, GMP, GLP, Biopharmaceuticals, cGMP, Immunology, Technology Transfer, SOP, PCR, Pharmacology, Pharmaceuticals, Biochemistry, Microbiology, Gel Electrophoresis, Science, Diagnostics, Sop, Laboratory, Cell, Pharmaceutical Industry, In Vivo, Clinical Development, Validation, FDA, Regulatory Affairs
Education
Framingham State University
Bachelor of Science (B.S.), Biology, General
Northeastern University
Graduate Certificate, Regulatory Affairs
Worcester State University
Master of Science (M.S.), Biotechnology
Biogen November 2014 - Present
Biogen Idec September 2013 - November 2014
Biogen Idec March 2012 - September 2013
Biogen Idec October 2010 - March 2012
Biogen Idec October 2006 - October 2010
Stryker Biotech February 2004 - October 2006
Akzo Nobel May 2002 - February 2004
Skills
Process Improvement, Cross-functional Team..., Quality Assurance, GMP, Biotechnology, FDA, Project Management, Engineering, Medical Devices, Validation, Pharmaceutical Industry, CAPA, Process Engineering, Process Simulation, Troubleshooting, Manufacturing, Strategy
Education
Bentley College - Elkin B. McCallum Graduate School of Business 2008 — 2010
MBA, Management
Dartmouth College 2000 — 2002
MEM, Engineering Management
Dartmouth College - The Tuck School of Business at Dartmouth 2000 — 2002
Master, Engineering Management
Bucknell University 1996 — 2000
BS, Chemical Engineering, Minor in Being Awesome
Sanofi Pasteur June 2006 - Present
Institute of Validation Technology 2010 - 2011
Lonza January 2005 - June 2006
Stryker Biotech August 2004 - January 2005
Skills
Nuclear Engineering, Evironmental Engineer, Maintenance Engineering
Education
Florida Institute of Technology 1991 — 1995
MBA, Personnel Management
University of Pittsburgh 1988 — 1991
BS, Chemistry, Biology, Math
Medtronic Vascular November 2009 - Present
IDEV March 2009 - November 2009
Cardiovascular Systems, Inc. January 2008 - March 2009
Stryker Biotech February 2003 - October 2004
Ethicon Endo-Surgery June 1999 - February 2003
Skills
Medical Devices, Interventional..., Cath Lab, Cardiology, Vascular Surgery, Peripheral Vascular, Disposables, Radiology, Sales Operations, Stents, Operating Room, Capital Equipment, Interventional Radiology, Surgeons, Vascular
Education
Ohio University 1995 — 1999
Bachelor of Science, Marketing
RCMT Technologies assigned to Atrium Medical September 2013 - Present
Genzyme August 2012 - November 2012
QD Vision, Inc. March 2012 - June 2012
Johnson & Matthey Pharma Services January 2011 - March 2012
Lonza July 2009 - June 2010
Abbott Bioresearch Center October 2008 - March 2009
Stryker Biotech April 2003 - October 2008
Skills
HPLC, GMP, Purification, Quality Assurance, Sop, Technical Writing, Deviations, GLP, Aseptic Technique, CAPA, Batch Records, Software Documentation, Change Control, Protein Purification, Aseptic Processing, Biotechnology, LIMS, FDA, SOP
Education
Middlesex Community College 2000 — 2013
Associate of Science, Biotechnology
Amgen July 2011 - Present
Very Merry Dickens Carolers August 2004 - Present
GTC Biotherapeutics August 2007 - June 2010
GTC Biotherapeutics 2007 - 2010
Stryker Biotech 2003 - 2007
Skills
Biotechnology, Technology Transfer, Biopharmaceuticals, Sop, Microbiology, Medical Devices, GLP, Validation, V&V, Pharmaceutical Industry, CAPA, GMP, FDA, Research, HPLC, Quality Assurance, Start-ups, Healthcare, Lifesciences, Regulatory Affairs, Life Sciences
Education
Oral Roberts University 1996 — 2000
BS
ImmuNext February 2011 - Present
ImmuRx Inc. 2005 - 2011
Millennium Pharmaceuticals, Inc. 2001 - 2003
Stryker Biotech 1998 - 1999
Verax, Creative Biomolecules 1985 - 1999
Verax 1985 - 1997
Education
Massachusetts Institute of Technology
M.S.
Dartmouth College
BA, Engineering Sciences
Biogen Idec July 2012 - Present
Biogen Idec February 2012 - July 2012
Biogen Idec February 2011 - February 2012
Biogen Idec October 2008 - February 2011
Genzyme March 2008 - September 2008
Alkermes April 2007 - March 2008
Alkermes June 2006 - April 2007
Stryker Biotech May 2005 - August 2005
Accutest June 2004 - July 2004
Alkermes May 1999 - August 1999
Skills
Validation, LIMS, CAPA, GLP, GMP, Risk Assessment, Compliance, Operations Management, Project Management, Operational Planning, Biotechnology Industry, SCADA, Technical Writing, Auditing, Recalls, Archives, Work Orders, Change Control, GAMP, Quality Assurance, Quality Control, Line Clearance, Trackwise, eDocs, Livelink, ISOtrain, Batch Records, Alarm Management, Contract Negotiation, Periodic Review, Crystal Reports, GxP, Biotechnology, Computer System..., Pharmaceutical Industry, Biopharmaceuticals, Analytical Chemistry, FDA, Protein Chemistry
Education
Tufts University 2004 — 2005
M.S., Biotechnology
Worcester Polytechnic Institute 2002 — 2004
M.S., Molecular Biology
Tufts University 1998 — 2002
B.S., Biology, Environmental Studies
Boston University 1998 — 1998
N/A, Sustainable Development
Franklin Pierce Law Center
J.D., N/A
Johnson & Johnson - Consumer September 2014 - Present
Johnson & Johnson - Medical Devices & Diagnostics March 2011 - August 2014
Johnson & Johnson - Medical Devices & Diagnostics March 2007 - March 2011
Stryker Biotech January 2004 - March 2007
Johnson & Johnson May 2001 - September 2003
Skills
Validation, Quality Systems, Medical Devices, Quality Assurance, Design Control, Regulatory Affairs, 510 K, FDA, GMP, Process Validation, International Project..., International..., Quality System, R&D, ISO 13485, V&V, CAPA, Program Management, Sop, Risk Management, Change Control, Cross-functional Team..., Project Planning, Manufacturing, Management, Biotechnology, Clinical Trials, 21 CFR Part 11, Pharmaceutical Industry, Continuous Improvement, Strategy, Regulatory Submissions, Technology Transfer, Business Process..., Product Launch, Product Development, Project Management, Quality Auditing, Quality Management, ISO 14971, GxP, ISO, Commercialization, DMAIC, Computer System..., Process Engineering, Root Cause Analysis
Education
Escola Politécnica da USP
Bachelor’s Degree, Chemical Engineering
Stevens Institute of Technology
Masters of Engineering, Chemical Engineering
Boston Scientific June 2013 - Present
Sirtris Pharmaceuticals November 2012 - May 2013
Ingenuity Systems June 2010 - October 2012
Stryker Biotech September 2005 - July 2009
Invitrogen November 2003 - November 2004
Sequitur Inc. April 2001 - November 2003
Boston University School of Medicine 1992 - 1994
Skills
Biochemistry, Assay Development, Protein Chemistry, Cell, Fluorescence, Biomarker Discovery, Transfection, Biotechnology, Lifesciences, Cell Culture, Molecular Biology, Cell Biology, Drug Development, Drug Discovery, In Vitro, Stem Cells, Laboratory, R&D
Education
Penn State University 1994 — 2001
Ph.D., Physiology
Smith College 1989 — 1992
B.A., Biology
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
Hillsboro School District June 2014 - Present
Seacoast United June 2011 - Present
Trinity High School April 2013 - June 2014
Express Soccer Club September 2010 - June 2012
St. Paul's School September 2005 - July 2011
Brewster Academy September 2003 - June 2004
Kearsarge Regional High School September 1999 - June 2003
Stryker Biotech June 1998 - June 1999
Creative Biomolecules June 1997 - June 1998
Immunomedics June 1995 - June 1997
Skills
Teaching, Curriculum Development, Curriculum Design, Classroom, Staff Development, Educational Leadership, Educational Technology, Public Speaking, K-12, Teacher Training, Coaching, Community Outreach, Lesson Planning, PowerPoint, Program Management, Classroom Management, Microsoft Office, Differentiated..., Instructional Design, Educational Consulting, Strategic Planning, Technology Integration, E-Learning, Leadership Development, Program Development, Professional..., Leadership, Education Reform, Team Building, Instructional Technology, Grant Writing, Research
Education
Norwich University 2009 — 2011
MS, Organizational Leadership
Norwich University 1990 — 1995
BS, Biomedical Technology
Eisai May 2012 - Present
Eisai May 2009 - May 2012
Eisai Pharmaceuticals 2005 - May 2009
Stryker Biotech 2002 - 2005
bioMerieux 2001 - 2002
Organon Teknika 2001 - 2002
Catalytica Pharmaceuticals 1999 - 2001
DSM 1999 - 2001
Skills
Serialization, Cross-functional Team..., Management, Project Management, Packaging, GMP, Validation, Medical Devices, Change Control, 21 CFR Part 11, Quality System, Biotechnology, Manufacturing, Technology Transfer, Quality Assurance, ISO 13485, Process Improvement, Aseptic Processing, Product Development, FDA, R&D, Continuous Improvement, Regulatory Affairs, CAPA, Troubleshooting
Education
Michigan State University 1995 — 2000
BS, Packaging
Exoxemis / Excited States, LLC September 2012 - Present
Sunovion Pharmaceuticals Inc. April 2011 - May 2012
Stryker Biotech May 2010 - May 2011
Johnson & Johnson April 2006 - May 2010
Ipsen 2004 - 2006
Impath Predictive Oncology 2002 - 2004
Beth Israel Deaconess Medical Center 2000 - 2002
Skills
Clinical Research, Protocol, CRO, Clinical Trials, Oncology, GCP, Pharmaceutical Industry, CTMS, Vendor Management, Clinical Operations, Neurology, Phase I, Clinical Development, ICH-GCP, Clinical Monitoring, FDA, Clinical Trial..., Protocol Development, Medical Devices, Biotechnology, Project Management
Education
Boston College 2000 — 2001
Continuing Education
Slippery Rock University of Pennsylvania 1991 — 1995
BS
Olympus Biotech America January 2011 - Present
Stryker Biotech November 1998 - December 2010
Creative Biomolecules April 1993 - November 1998
Verax March 1991 - March 1993
Skills
GMP, FDA, CAPA, Validation, Cross-functional Team..., Biopharmaceuticals, ISO 13485, Medical Devices, Purification, Quality System, Biotechnology, GLP, Change Control, Lean Manufacturing, 21 CFR Part 11, Root Cause Analysis, Aseptic Processing, Quality Assurance, V&V, Manufacturing, Lifesciences, HPLC, Sop, GxP, Pharmaceutical Industry, Chromatography, Cell Culture, Column Packing, Column Chromatography, Protein Purification, Filtration
Education
New England College
B.A. Biology
DepuySynthes CMF October 2011 - Present
Stryker Biotech March 2005 - April 2010
EBI Medical Systems May 2000 - May 2002
Education
East Tennessee State University
University of Tennessee-Knoxville
FORUM Pharmaceuticals (formerly Envivo Pharmaceuticals) March 2015 - Present
FORUM Pharmaceuticals (formerly Envivo Pharmaceuticals) April 2013 - March 2015
Inspiration Biopharmaceuticals, Inc. November 2011 - April 2013
Boston Scientific August 2009 - November 2011
Stryker Biotech August 2008 - August 2009
PAREXEL March 2007 - August 2008
GxP Quality Consulting December 2006 - March 2007
Transport Pharmaceuticals 2004 - 2006
Shire Pharmaceuticals 2002 - 2004
Cubist Pharmaceuticals 2001 - 2002
Education
Harvard University
Bachelor of Liberal Arts (ALB), Concentration in The History of Science, and a minor in Psychology
Harvard University
Master of Liberal Arts (ALM), Concentration in History (Candidate)
Marshfield High School
Diploma
Dartmouth-Hitchcock September 2014 - Present
Olympus Biotech America June 2012 - September 2014
Olympus Biotech America (formerly Stryker Biotech) January 2009 - June 2012
PPD June 2007 - December 2008
Stryker Biotech January 2005 - May 2007
Skills
FDA, Sop, CAPA, Regulatory Affairs, 21 CFR Part 11, Project Coordination, Change Control, GxP, Regulatory Requirements, Regulatory Submissions, Clinical Development, Project Management, Quality System, Data Management, Quality Control, Microbiology, Quality Assurance, cGMP, GMP, Pharmaceutical Industry, Biotechnology, Biopharmaceuticals, Medical Devices, Biologics, Combination Products, eCTD, EMA, TGA, Validation, Health Promotion, Training Delivery, GCP, Aseptic Processing, Cleaning Validation, Learning Management..., Development Of..., Labels, SOP
Education
Southern New Hampshire University 2012 — 2015
Masters, Business Administration, GPA 3.9
Castleton State College 2002 — 2004
Bachelors, major in Biology, minor in Chemistry
Food and Drug Administration January 2011 - Present
Cephalon (via acquisition of Ception Therapeutics) -- now Teva Pharmaceutical Industries Ltd. February 2009 - January 2011
Seattle Genetics December 2007 - January 2009
Amgen 2007 - 2007
Stryker Biotech December 2000 - 2007
Abraxis BioScience April 1998 - December 2000
Skills
Technology Transfer, Formulation, Commercialization, Monoclonal Antibodies, Lyophilization, Chemistry,..., Small Molecules and..., Regulatory, Protein Chemistry, CMC, Biotechnology, GMP, FDA, Clinical Trials, Chemistry, Biologics, Manufacturing, Biopharmaceuticals, Regulations, Pharmaceutics, 21 CFR Part 11, Change Control, Regulatory Affairs, Medical Devices, Clinical Development, IND, Process Simulation, Validation, GLP
Education
Clark University 2002 — 2005
MBA, Management
Washington University in St. Louis 1994 — 1998
MS, PhD, Chemical Engineering
Indian Institute of Technology, Bombay 1990 — 1994
Bachelor's Degree in Chemical Engineering
AstraZeneca August 2015 - Present
Uno Chicago Grill April 2000 - Present
AstraZeneca April 2009 - August 2015
AstraZeneca June 2006 - April 2009
AstraZeneca February 2006 - June 2006
Bose Corporation November 2005 - February 2006
Bose Corporation 2005 - 2006
Stryker Biotech June 2004 - August 2004
Skills
Bartending, Microbiology, Validation, Environmental Monitoring, Restaurants, Manufacturing, Testing, Food & Beverage, Lean Manufacturing, Pharmaceuticals, Food, Continuous Improvement, Supplier Management, GMP, Quality Control, LIMS, 21 CFR Part 11, Aseptic Technique, Change Control, Laboratory, Computer System..., GLP, Aseptic Processing, Trackwise, Quality Auditing, Cell Culture, Sop, Pharmaceutical Industry, FDA, CAPA, Sterilization, Supply Management, Biotechnology, SOP, HPLC, Quality System, Quality Assurance, Cross-functional Team..., Leadership, Life Sciences, Medical Devices, Technology Transfer, Regulatory Affairs, Biopharmaceuticals, Management, GxP, Chemistry, Chromatography, Sales, Customer Service
Education
Framingham State College 2000 — 2004
BS, Biology
Framingham State University 2000 — 2004
Bachelor of Science (BS), Biology
MarVista Entertainment March 2012 - Present
Explorica April 2008 - October 2011
Stryker Biotech May 2007 - April 2008
Eastman Kodak Company August 2006 - April 2007
Eastman Kodak Company March 2005 - August 2006
Cinesite, Inc June 2003 - February 2005
Eastman Kodak Company October 2002 - February 2005
Cinesite 2003 - January 2005
Eastman Kodak Company September 2001 - September 2002
Eastman Kodak Company July 1999 - September 2001
Skills
Forecasting, Financial Modeling, Strategy, Financial Analysis, Mergers & Acquisitions, Finance, Budgets, Financial Reporting, Corporate Finance, Strategic Planning, Process Improvement, Strategic Financial..., Managerial Finance, Business Planning, Management Consulting, Customer Service, Business Strategy, Business Development, International Business, Risk Management, Pricing Strategy, Mergers, Manufacturing, Management, FX Hedging, Goal Oriented, Human Resources, Strategic Partnerships, Marketing, Complex Analysis, Financial Planning, Treasury, Organizational..., Cash Management, Investor Relations, Delivering Results, Banking Relationships, Problem Solving, Board Reporting, Financial Management, Strategy Development, Remote Management, Manufacturing Finance, Quality, Decision Making Skills, Personnel Development, Executive Management, Leadership
Education
Syracuse University 1989 — 1991
MBA, Finance
Syracuse University - Martin J. Whitman School of Management 1989 — 1991
MBA, Finance
Clarkson University 1985 — 1989
BS, Finance
Fayetteville-Manlius 1981 — 1985
Regents Honors Diploma
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
Pecquet Goad Consulting LLC January 2010 - Present
Stryker Biotech January 2007 - October 2011
Peptimmune August 2004 - January 2007
Wyeth January 2000 - March 2004
LSU School of Veterinary Medicine June 1996 - January 2000
ETEX 1995 - 1996
Arthur D Little November 1990 - August 1995
EG&G Mason Laboratories 1987 - 1990
Skills
Veterinary Pathology, Toxicology, Laboratory Animal..., Toxicologic Pathology, Animal Models, Veterinary Mediicne, IND Strategies, Preclinical Pharmacology, Toxicokinetics, Safety Pharmacology, Nonclinical/Preclinical..., Efficacy Studies, Protein Drug Development, Small Molecule Drug..., Surgical Models, Device Development, GLP, Veterinary, Pathology, IND, Regulatory Submissions, Vaccines, Surgery, Pharmacology, Biotechnology, Pharmaceuticals, Oncology, Medical Devices, Drug Discovery, Immunohistochemistry, Protocol, Pharmaceutical Industry, Drug Development
Education
University of Tennessee-Knoxville 1982 — 1985
PhD, Comparative and Experimental Medicine
Louisiana State University and Agricultural and Mechanical College 1974 — 1981
DVM and BS, Veterinary Medicine and Zoology
EMD Serono, Inc. July 2014 - Present
Organogenesis January 2010 - February 2014
Stryker Biotech 2005 - 2009
Harvard Pilgrim Health Care February 2002 - October 2005
Gentiva Health Services February 1992 - November 2000
Skills
Data Analysis, Project Management, Management, Analysis, Customer Service, Leadership, Market Research, Presentations, Program Management, Product Management, Medical Devices, Account Management, Survey Research, Budgets, Pharmaceutical Industry, Biotechnology, Strategy, Biopharmaceuticals, Market Analysis
Education
Babson College - Franklin W. Olin Graduate School of Business
Master of Business Administration (MBA)
Brandeis University
B.A., Biology
Flory Consulting, LLC December 2011 - Present
Stryker Biotech August 2006 - November 2011
Pfizer Pharmaceuticals September 1993 - August 2006
Department of Pathology, University of Michigan Medical School August 1991 - August 1993
Trudeau Institute July 1988 - July 1991
Skills
Pharmacology, Drug Discovery, Drug development, Biomarkers, PK/PD, Toxicology, Small molecules and..., Immunology, Translational medicine, Autoimmune diseases, Osteoarthritis, Inflammation, Devices, Regulatory Submissions, In Vivo, Biomarker Discovery, Translational Medicine, Autoimmune Diseases, Small Molecules, Medical Devices, Pharmaceutics, R&D, IND, Cell, Drug Development, Biologics, Biotechnology, FDA
Education
Oregon State University 1982 — 1988
Ph.D., Immunology, Zoology
University of Michigan 1976 — 1980
B.S., Zoology
Elmore Patent Law Group July 2008 - Present
Stryker Biotech July 2005 - July 2008
Praecis Pharmaceuticals 2000 - 2005
Hamilton, brook, Smith & Reynolds, PC 1995 - 2000
Tufts University 1990 - 1995
Education
Harvard University 1983 — 1989
Ph.D., Chemistry
Davidson College 1979 — 1983
BS, Chemistry
ARIAD Pharmaceuticals, Inc. January 2015 - Present
ARIAD Pharmaceuticals, Inc. January 2013 - January 2015
ARIAD Pharmaceuticals, Inc. February 2011 - January 2013
Prometrika June 2008 - January 2011
Stryker Biotech January 2008 - June 2008
Stryker biotech April 2007 - December 2007
Averion International August 2004 - April 2007
Skills
Clinical Development, Clinical Research..., CRO, Pharmaceutical Industry, CTMS, Clinical Operations, Clinical Research, Clinical Trials, GCP, Medical Writing, FDA, EDC, Clinical Monitoring, Biotechnology
Education
MGH Institute of Health Professions 2008 — 2010
Masters, Clinical Investigation
Holliston High School
Saint Anselm College
All Chores Considered October 2013 - Present
Perioperative Consulting & Surgical Services LLC June 2013 - Present
RAPID-5 MRS, Inc. June 2013 - Present
Stryker Performance Solutions February 2011 - March 2013
Genzyme Corporation January 2007 - February 2011
Stryker Biotech 2002 - 2007
Shipley / Rohm & Haas April 2000 - March 2002
Nova Biomedical March 1986 - March 2000
Skills
Supply Chain, Logistics, Sales Operations, Project Planning, Customer Service, International Trade, International Sales, Medical Devices, Cross-functional Team..., Capital Equipment, Product Launch, Orthopedic, Export, Biotechnology, FDA, Process Improvement, Pharmaceutical Industry, Commercialization, Forecasting, Lifesciences, Hospital..., Quality System, ISO 13485, Market Development, Operating Room, Quality Assurance, Management, Biopharmaceuticals, Six Sigma, Leadership, 21 CFR Part 11, CAPA, Training, CRM, Acquisition Integration, Quality Management, Sales, Continuous Improvement, Integration, International Logistics
Education
Northeastern University
Quincy College
Genzyme April 2012 - Present
Infinity Pharmaceuticals March 2009 - April 2012
Stryker Biotech May 2006 - March 2009
Wyeth 2001 - 2006
Education
Cornell University 1989 — 1995
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
Rueger Consulting January 2008 - Present
Stryker Biotech 1998 - 2008
Creative BioMolecules, Inc 1990 - 1998
Education
Duke University 1971 — 1976
PhD, Biochemistry
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
EPIRUS Biopharmaceuticals December 2014 - Present
Olympus Biotech America October 2010 - May 2014
Stryker Biotech 2005 - December 2010
Wyeth BioPharma 2003 - 2005
Biogen 2001 - 2003
Biogen 1995 - 2001
Biogen 1989 - 1995
Skills
Validation, Quality System, CAPA, 21 CFR Part 11, FDA, Biopharmaceuticals, Change Control, GxP, Biotechnology, Manufacturing, GMP, Computer System..., Tech Transfer, Manufacturing Technical..., Process Validation, Project Management, Process Development, Process Simulation, V&V, Technology Transfer, GLP, Chromatography, Cell Culture, Fermentation, Pharmaceutical Industry, Protein Chemistry
Education
Boston College
MS with distinction, Biochemistry
Syracuse University
BS, cum laude, ESF-Biology
MacroGenics May 2011 - January 2014
Genzyme Corporation January 2010 - September 2010
Ascent Therapeutics September 2009 - December 2009
Human Genome Sciences October 2007 - March 2009
Stryker Biotech June 2005 - October 2007
Altus Pharmaceuticals June 2004 - June 2005
Wyeth Biotech January 1998 - June 2004
Education
University of Massachusetts Lowell 2003 — 2005
MS, Biological Sciences
Gettysburg College 1994 — 1998
BS, Biology
Genzyme October 2014 - Present
Olympus Biotech America (previously known as Stryker Biotech) July 2012 - March 2014
Olympus Biotech America (previously known as Stryker Biotech) 2011 - July 2012
Stryker Biotech 2008 - 2011
Stryker Biotech 2005 - 2008
Stryker Biotech 2003 - 2005
ViaCell 2001 - 2003
UMass Medical School 1999 - 2001
UMass Medical School 1997 - 1999
Alpha-Beta Technology 1996 - 1997
Skills
ELISA, GMP, Cell Culture, Cell Based Assays, Goal-oriented..., Bioassay, Analytical Method..., Change Management, Technology Transfer, Deviations, SOP authoring, Regulatory Submissions, Microsoft Excel, Project Management, PowerPoint, SlimStat, Stability, Presentations, Reviews, Risk Assessment, Personnel Management, Report Writing, 21 CFR Part 11, Annual Reports, Slope Stability Analysis, Trend Analysis, Purchase Contracts, Forecasting, Cross-functional Team..., Cross-functional..., OOS, co-validation, Troubleshooting, Method Development and..., Biotechnology, Cell, Chromatography, SDS-PAGE, Aseptic Technique, FDA, Immunoassays, Research, Pharmaceutical Industry, Cell Biology, Assay Development, Lifesciences, CAPA, Validation, Life Sciences
Education
Merrimack College 1991 — 1995
BA in Biology, with minor in Chemistry
Olympus Gyrus ACMI November 2010 - Present
Nova Biomedical August 2009 - November 2010
Stryker Biotech April 2008 - July 2009
Boston Scientific May 2004 - March 2008
Skills
510 K, FDA, Medical Devices, Regulatory Affairs, IEC 60601 3rd Edition, ISO 13485, Technical File, ISO 14971
Education
Assumption College 2006 — 2009
MBA, Business
Johnson and Wales University 1999 — 2004
B.A., Business Management
CPM Facilities Services, LLC July 2014 - Present
Genzyme November 2011 - June 2014
Genzyme July 2008 - November 2011
Stryker Biotech January 2008 - July 2008
Amgen January 2003 - January 2008
Kokusai Semiconductor Equipment Corporation October 2000 - January 2003
US Navy April 1992 - September 2000
Skills
Validation, Technology Transfer, Sop, Regulatory Submissions, Regulatory Affairs, Quality Control, Quality Assurance, Purification, Project Management, Process Simulation, Process Improvement, Process Engineering, Pharmaceutical Industry, Medical Devices, Manufacturing, Lifesciences, GxP, GMP, GLP, GAMP, Filtration, Fermentation, FDA, Engineering, Drug Development, Cleaning Validation, Change Control, Cell Culture, CAPA, Biotechnology, Biopharmaceuticals, 21 CFR Part 11, Aseptic Processing, Life Sciences, SOP
Education
East Carolina University
USN Nuclear Power Program
Lantos Technologies January 2014 - Present
Lantos Technologies June 2013 - January 2014
Lantos Technologies September 2012 - June 2013
Cochlear November 2011 - September 2012
Cochlear March 2010 - February 2012
GSK March 2008 - March 2010
GSK 2005 - 2008
Stryker Biotech 2004 - 2005
GMP Companies 2001 - 2004
Eli Lilly 1996 - 2001
Skills
Pharmaceutical Industry, Clinical Development, Biotechnology, Program Management, Immunology, Strategy, Neuroscience, Regulatory Affairs, Marketing, Medical Devices, Cross-functional Team..., FDA, Product Launch, Business Development, Biopharmaceuticals, Oncology, Commercialization
Education
The Johns Hopkins University 1984 — 1988
Indiana University - Kelley School of Business
MBA
Highlander Analytics December 2012 - Present
AMAG Pharmaceuticals August 2008 - June 2012
BattelleCRO February 2002 - June 2008
Summit Technology September 1998 - January 2001
Stryker Biotech October 1994 - January 1998
Astra Pharmaceuticals 1998 - 1998
Gynecologic Oncology Group September 1992 - September 1994
PAREXEL 1987 - 1992
Education
State University of New York College at Buffalo 1995 — 1996
MS, Epidemiology
Framingham State University 1988 — 1992
Sunovion Pharmaceuticals Inc. October 2014 - Present
Olympus Biotech Corporation May 2013 - August 2014
Olympus Biotech America March 2011 - April 2013
Stryker Biotech May 2010 - February 2011
Stryker Biotech 2007 - 2010
Stryker Biotech 2006 - 2007
Stryker Biotech 2000 - 2005
Skills
Financial Reporting, Forecasting, Sarbanes-Oxley Act, Product Costing, Cross-functional Team..., Auditing, Budgets, Accounting, Medical Devices, Financial Analysis, General Ledger, Biotechnology, Internal Audit, Finance, Process Improvement, Manufacturing, Managerial Finance, Management, Pharmaceutical Industry, Strategic Financial..., Strategic Planning
Education
University of Phoenix 2004 — 2006
MBA coursework, 3.92
Bentley College - Elkin B. McCallum Graduate School of Business 2002 — 2004
Graduate Accounting and Finance Coursework
East Stroudsburg University of Pennsylvania
Bachelor of Science (B.S.), Business Management, cum laude
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
Parsons March 2007 - Present
Amylin Pharmaceuticals March 2007 - Present
Stryker Biotech July 2003 - March 2007
Merck July 2000 - November 2001
Merck July 1998 - June 2000
Education
Northwestern University 1993 — 1998
Shire Pharmaceuticals March 2015 - Present
Boston Scientific April 2005 - March 2015
Stryker Biotech 2004 - 2005
Clinical Assistance Programs 2003 - 2004
Averion 2000 - 2003
Skills
Clinical Trials, CTMS, Medical Devices, Clinical Research, FDA, Budgets, GCP, Project Management, Protocol, Strategic Planning
Education
Providence College 1996 — 2000
B.A., English
Providence College 1996 — 2000
Bachelor's degree
Johnson and Johnson Wound Management, a business unit of Ethicon Inc August 2011 - Present
Johnson & Johnson May 2003 - August 2011
Smith College Executive Education for Biopharma 2011 - 2011
Boston University School of Medicine May 2007 - July 2008
Stryker Biotech June 1998 - April 2003
United States Surgical Corporation June 1996 - June 1998
Yale University School of Medicine October 1995 - June 1996
Skills
Medical Devices, IND, Regulatory Affairs, PMA, Regulatory Requirements, Clinical Trials, Validation, FDA, Pharmaceutical Industry, GMP, Clinical Development, Regulatory Submissions, Lifesciences, Biotechnology, CAPA, Pharmacovigilance, Medical Affairs, Pharmacology, GCP, Biologics, Biopharmaceuticals, CRO, Drug Development, Clinical Research, Cell, Sop, 21 CFR Part 11, Therapeutic Areas, Technology Transfer, Oncology, Design Control, GLP, Commercialization, ISO 13485, Immunology, V&V, Drug Discovery, R&D, ISO 14971, CE marking, Infectious Diseases, Life Sciences, SOP
Education
Massachusetts College of Pharmacy and Health Sciences 1999 — 2001
MS, Drug Regulatory Affairs and Health Policy
Fairfield University 1991 — 1995
BS, Biology
Smith College
Women in Biotechnology
Covidien November 2013 - Present
Covidien August 2012 - November 2013
Covidien February 2012 - September 2012
Covidien June 2010 - February 2012
Covidien October 2007 - June 2010
Confluent Surgical / Covidien December 2004 - October 2007
Confluent Surgical December 2003 - December 2004
Confluent Surgical October 2002 - December 2003
Stryker Biotech October 2001 - October 2002
Skills
Design Control, Medical Devices, FDA, Regulatory Affairs, CAPA, Lifesciences, Quality System, ISO 13485, Cross-functional Team..., Interventional..., Clinical Trials, Product Development, CTMS, Clinical Development, CE marking, Clinical Research, IDE, PMA, Surgical Devices
Education
Massachusetts College of Pharmacy and Health Sciences 2002 — 2004
Master of Science (M.S.), Drug Regulatory Affairs and Health Policy
St. Bonaventure University 1996 — 2000
Bachelor of Science (B.S.), Biochemistry
GTC Biotherapeutics September 1999 - Present
Stryker Biotech 1997 - 1999
BioTransplant 1995 - 1999
Creative Biomolecules 1994 - 1997
Oravax 1994 - 1997
Centocor 1990 - 1994
Seragen 1986 - 1990
Charm 1984 - 1987
Education
Bentley University 1986 — 1990
MBA, Marketing
University of New Hampshire 1978 — 1982
BS, Biochemistry, molecular biology
Novo Nordisk January 2015 - Present
Rutland Regional Medical Center June 2012 - Present
Rutland Regional Medical Center February 2011 - June 2012
Rutland Regional Medical Center July 2009 - February 2011
Stryker Biotech April 2007 - July 2009
Stryker Biotech January 2002 - April 2007
Rutland Northeast Supervisory Union February 2002 - February 2005
Rutland Regional Medical Center 1995 - 2002
United States Marine Corps July 1988 - April 1995
Skills
ISO 13485, Supply Chain Management, Manufacturing, FDA, Medical Devices, Microsoft Office, Cross-functional Team..., Project Management, Sop, Strategic Planning, 21 CFR Part 11, GMP, CAPA, Six Sigma, Budgets, MRP, Process Improvement, Analysis, Change Management, Supply Chain, EMR, Healthcare, Outlook, Healthcare Information..., EHR, Hospitals, Data Analysis, HIPAA, Cerner, Revenue Cycle, Visio, Medical Terminology, Management, Physicians, Software Documentation
Education
Norwich University 2010 — 2012
Master of Business Administration (MBA), Project Management
Castleton University 1997 — 2001
BA, Biology (minor - Chemistry)
Symmetry Medical November 2011 - Present
Medrobotics Corporation January 2011 - November 2011
Keystone Dental 2009 - 2011
Keystone Dental Inc. 2007 - 2009
Accellent 2005 - 2007
Stryker Biotech 1998 - 2004
Stryker Biotech 1997 - 1998
Stryker Orthopaedics 1996 - 1997
Stryker Orthopaedics 1994 - 1996
Education
Harvard Business School 1989 — 1991
MBA, Business- focus on Industrial Marketing and Operations
Union College 1982 — 1986
BS, Mechanical Engineering
Biogen Idec April 2007 - Present
Stryker Biotech November 2005 - April 2007
Education
University of Massachusetts Dartmouth 1999 — 2001
Nankai University
Excited States, LLC August 2013 - July 2014
Biogen Idec August 2012 - January 2013
Stryker Biotech August 2010 - January 2012
Alkermes, Inc. March 2009 - June 2010
Alkermes, Inc. July 2008 - March 2009
PROMETRIKA, LLC February 2007 - April 2008
Nucryst Pharmaceuticals November 2003 - February 2007
Unither Pharmaceuticals, Inc. August 2002 - November 2003
Macrochem Corporation March 2000 - August 2002
Alkermes 1999 - 2000
Skills
Clinical Trials, Clinical Development, CRO, Oncology, Regulatory Submissions, FDA, Clinical Research, Protocol, Medical Devices, Clinical Study Design, Medical Affairs, IND, Phase I, Pharmaceutical Industry, Biotechnology, CTMS, CRF design, Clinical Monitoring, Sop
Education
Regis College
Bachelor of Arts (B.A.), Sociology/Biology, Graduated Cum Laude
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
Skydive New England June 1999 - August 2011
Stryker Biotech February 2000 - April 2008
Skydive New England 1999 - 2008
Synergy Codeworks January 2002 - May 2005
Vermont Skydiving Adventures 1997 - 2003
Skills
CAPA, Software Documentation, Troubleshooting, V&V, GMP, Microsoft Office, Manufacturing, FDA, Sales, Quality Control, Research, Marketing
Education
Castleton University 1996 — 2000
ImmunoGen, Inc. July 2007 - Present
Stryker Biotech January 2002 - June 2007
Skills
ELISA, Bioassays, Tissue Culture, GMP, GLP, LIMS, Cell Based Assays, Immunoassays, Bioassay, SDS-PAGE, Biotechnology, Assay Development, Validation, Cell, Biopharmaceuticals
Education
Illinois Institute of Technology 1997 — 2000
MS, Biology
Drake University 1987 — 1992
BA, Biology, Psychology
U of C Lab School
Takeda Pharmaceuticals February 2013 - Present
Baxter Healthcare July 2008 - February 2013
Stryker Biotech January 2007 - July 2008
Eastman Chemical Company November 2004 - January 2007
I*Logic July 2002 - November 2004
Hollingsworth Packaging Solutions December 2001 - May 2002
Alcoa January 2000 - July 2000
Skills
Packaging, Packaging Engineering, Cold Chain Packaging, Medical Packaging, Project Management, Product Development, Lean Manufacturing, Plastics, Medical Devices, Manufacturing, Pharmaceutical Packaging, Validation, GMP, FDA, CAPA, R&D, Quality System, V&V, ISO 13485, Change Control, Design of Experiments, Minitab, Design Control, Cross-functional Team..., DMAIC, 21 CFR Part 11
Education
Northwestern University 2011 — 2014
Master of Engineering Management (MEM), McCormick School of Engineering
Michigan State University 1997 — 2001
Bachelor of Science (BS), School of Packaging
AbbVie November 2013 - Present
AstraZeneca R&D Boston June 2010 - November 2013
AstraZeneca R&D Boston June 2007 - June 2010
Stryker Biotech June 2003 - June 2007
Skills
Drug Discovery, GMP, Lifesciences, GLP, Assay Development, Biotechnology, In Vitro, ELISA, Drug Development, Cell, Biomarkers, Monoclonal Antibodies, Protein Chemistry, Immunoassays, Purification
Education
Worcester State University 2004 — 2006
M.S, Biotechnology/Biology
Norwich University 1999 — 2003
B.S, Biology
Actavis (fomerly Forest) January 2015 - Present
Forest Pharmaceuticals November 2012 - Present
Pleasanton Cavaliers Rugby 2011 - Present
Syneron Candela February 2012 - November 2012
Baxano March 2010 - April 2011
Stryker Biotech June 2006 - March 2010
Medi-Flex Hospital August 2005 - June 2006
OSTEOCARE INC July 2004 - July 2005
ADP October 2002 - July 2004
DATA PROCESSING (ADP) October 1999 - October 2002
Skills
Surgeons, Medical Devices, Operating Room, Orthopedic, Spine, Sales, Surgery, Strategic Planning, Cold Calling, Disposables, Capital Equipment, Neurosurgery, Outsourcing, Marketing, Sales Operations, Sales Management
Education
Occidental College 1992 — 1996
B.A., Political Science
Amador High
GE Healthcare February 2015 - Present
Xcellerex A GE Healthcare Life Science Company April 2013 - Present
Xcellerex A GE Healthcare Life Sciences Company October 2009 - April 2013
Stryker Biotech June 2004 - June 2009
Skills
Technology Transfer, Process Development, Problem Solving, Protein Purification, Biotechnology, GMP
Education
Birmingham-Southern College 1997 — 2000
BS, Biology
MassBiologics July 2014 - Present
Complya Consulting Group, LLC August 2012 - July 2014
Experienced Program, Project and Operations Mgt. Leader November 2011 - August 2012
Stryker Biotech February 2011 - October 2011
Stryker Biotech October 2009 - February 2011
Stryker Biotech July 2008 - October 2009
Stryker Biotech January 2003 - July 2008
Creative Biomolecules 1998 - 2002
Copley Pharma 1995 - 1998
Anika Therapeutics (Medchem Products) 1982 - 1995
Skills
Biotechnology, Operations Management, Project Management, Supply Chain, Medical Devices, Technology Transfer, Leadership, Program Management, Management, Budgets, Quality Assurance, Software Documentation, ISO 13485, Change Control, Strategic Planning, Pharmaceutical Industry, 21 CFR Part 11, Risk Assessment, Manufacturing, Quality System, Product Launch, GMP, Cross-functional Team..., Start-ups, Sop, Regulations, GCP, FDA, Clinical Development, Pharmaceutics, GLP, CAPA, SDLC, V&V, Biopharmaceuticals, GxP, Regulatory Affairs, Validation, Regulatory Submissions, Lifesciences, Computer System..., R&D, GAMP, Clinical Trials, Life Sciences, SOP
Education
Bridgewater State College 1975 — 1979
BS -, Biology, minor chemistry
Ironwood Pharmaceuticals July 2015 - Present
Ironwood Pharmaceuticals June 2014 - July 2015
Ironwood Pharmaceuticals June 2012 - June 2014
Ironwood Pharmaceuticals February 2011 - June 2012
Genzyme Biosurgery January 2010 - February 2011
Genzyme Biosurgery October 2008 - January 2010
Genzyme Biosurgery July 2007 - October 2008
Stryker Spine 2004 - 2007
Stryker Biotech 2001 - 2004
Education
Boston College 1998 — 2001
BS, Marketing
GE Healthcare April 2011 - Present
Genzyme December 2010 - April 2011
Athena September 2009 - December 2010
Charles River Laboratories January 2007 - February 2009
Millipore October 2004 - December 2006
Charles River Laboratories 2000 - 2004
Stryker Biotech February 2000 - April 2000
Unisyn Technologies May 1997 - April 1999
Opta Food Ingredients 1993 - 1997
Skills
HPLC, GLP, GMP, Validation, LC-MS, UV/Vis, Sop, Quality Control, Life Sciences
Education
Framingham State University
BS, Food Science
Bristol-Myers Squibb June 2014 - Present
Bristol-Myers Squibb, Inc. 2010 - November 2014
Medarex May 1999 - April 2010
Medarex 1999 - 2009
Merck Serono June 2002 - 2006
Stryker Biotech August 1996 - May 1999
Skills
Technology Transfer, Drug Discovery, Manufacturing, Biopharmaceuticals, GMP, Aseptic Processing, Sop, LIMS, HPLC, Cell Culture, Biotechnology, Chromatography, Process Simulation, CAPA, FDA, Pharmaceutical Industry, Management, Assay Development, Purification, GLP, Validation, 21 CFR Part 11, Microbiology, Monoclonal Antibodies, Lifesciences, IND, Protein Chemistry, Protein Purification, Clinical Development, Drug Development, Fermentation, ELISA, Change Control, Analytical Chemistry, Aseptic Technique, Cell, Oncology
Education
University of New Hampshire 1989 — 1992
Master's degree, Chemistry
Messiah College 1983 — 1987
BS, Chemistry, Biology
Putney, Inc. January 2012 - Present
Covidien February 2010 - January 2012
Wyeth September 2008 - March 2010
Johnson & Johnson 2005 - 2008
Stryker Biotech May 2001 - April 2005
Skills
FDA, Regulatory Affairs, IND, GMP, Regulatory Submissions, Pharmaceutical Industry, CAPA, Biotechnology, GLP, Sop, Biopharmaceuticals, Lifesciences, 21 CFR Part 11, Change Control, Medical Devices, Protocol, Clinical Development, Drug Development, Life Sciences
Education
Northeastern University 2006 — 2007
MS, Regulatory
Lake Forest College 1997 — 2001
BA, Biology
Waters Corporation May 2015 - Present
CONMED Corporation September 2013 - March 2015
Coldwell Banker Real Estate April 2013 - July 2013
Massachusetts Medical Society April 2012 - January 2013
Sidera Networks July 2008 - February 2012
PFPC May 2007 - May 2008
Stryker Biotech June 2007 - September 2007
Staples September 2005 - November 2005
IDC July 2004 - September 2004
Fidelity Investments June 1998 - May 2004
Skills
Regulatory Affairs, Marketing Support, Legal Support, Office Administrator, Operations Specialist, 510(k), Calendars, Multi Tasking, Planning and scheduling, Customer Service, Purchase Requisitions, Quality Oriented, Close Attention to..., Exceptional organization, Confidential Documents, Typing, 401k Rollovers, Roth IRA, 403 b, Work Ethic, Dependable Team Player, Events, Records Management, Data Entry, Invoice Processing, Notary Public, Lotus Notes, Microsoft Office, Worldox, SharePoint, ScanSnap iX500, SAP, Sametime
Education
Lyndon State College 1979 — 1980
Administrative Assistant and Secretarial Science, General
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
LabCentral May 2015 - Present
LabCentral November 2013 - May 2015
InVivo Therapeutics Corporation January 2012 - October 2013
Pervasis Therapeutics November 2005 - November 2011
Stryker Biotech September 2003 - November 2005
Forticell Bioscience Inc. (formerly Ortec International Inc.) October 1998 - August 2003
Wyeth Pharmaceuticals March 1994 - October 1998
Skills
Cell Culture, R&D, Cell Based Assays, GLP, cGMP, Technology Transfer, Biotechnology, Validation, Tissue Engineering, Process Development, Cross-functional Team..., Troubleshooting, Problem Solving, ELISA, Biomedical Engineering, In Vitro, PowerPoint, Excel, Word, GMP, Cell
Education
Cornell University 1989 — 1993
BS, Bioengineering
Thermo Fisher Scientific January 2014 - Present
Marion DuPontt Scott Equine Center, Virginia Tech April 2013 - September 2013
Intrexon Corporation July 2011 - March 2013
Intrexon Corporation July 2010 - July 2011
Intrexon Corporation May 2009 - February 2011
Intrexon Corporation November 2007 - May 2009
Stryker Biotech 1999 - 2001
Aventis Behring 1998 - 1999
Skills
Molecular Biology, Biotechnology, Protein Chemistry, Stem Cell Technology, Pharmacology, Laboratory, Assay Development, Lifesciences, Drug Discovery, Microbiology, Genomics, Biopharmaceuticals, Aseptic manufacturing, FDA GMP, Analytical Method..., Vascular Biology, Mammalian Cell Culture, Technology Transfer, Synthetic Biology, Toxicology, Sop, Cell, GLP, DNA, GMP, Cell Culture, FDA, R, Cell Biology, PCR, Pharmaceutical Industry, Biochemistry, Medical Devices, Drug Development
Education
Geisel School of Medicine at Dartmouth 2006 — 2008
PostDoc, Biochemistry
Dartmouth College 2001 — 2006
PhD, Pharmacology
Western Illinois University 1994 — 1998
Bachelor of Science (BS), Microbiology, General
Hypertherm, Inc. May 2012 - Present
Hypertherm, Inc. May 2011 - May 2012
Pompanoosuc Mills October 2010 - February 2011
Co-Op Foodstores October 2009 - September 2010
AtPar Inc October 2008 - October 2009
Duke University Medical IT Department March 2008 - June 2008
Stryker Biotech June 2005 - October 2007
Skills
Troubleshooting, Technical Support, Outlook, Servers, Active Directory, Testing, Process Improvement, Access, Manufacturing, Project Management, Windows 7, Problem Solving, Windows, Computer Hardware, Change Management, Team Leadership, Team Building, Microsoft Office, Training, Help Desk Support, Visio, Software Documentation, Program Management, Management, Quality Assurance, Operating Systems, Computer Repair, Information Technology, Cross-functional Team..., Hardware
Education
Champlain College 2012 — 2016
Master of Business Administration (M.B.A.), Business Administration and Management, General
Columbia Southern University 2008 — 2011
BA/BS, Information Technology
Vertex Pharmaceuticals February 2010 - Present
Vertex Pharmaceuticals January 2010 - February 2015
Vertex Pharmaceuticals January 2008 - January 2010
Stryker Biotech August 2005 - January 2008
Biogen Idec August 2001 - August 2005
Organogenesis September 2000 - August 2001
ICSL Clinical Studies September 1999 - September 2000
Skills
Patient Safety, Clinical Trials, Biotechnology, Pharmaceutical Industry, Clinical Research, Pharmacovigilance, Clinical Development, Medical Devices, Drug Safety, Oncology, Validation, Vendor Management, GCP, CAPA, Medical Writing, Regulatory Affairs, Quality Assurance, 21 CFR Part 11, Clinical Monitoring, Regulatory Submissions, FDA
Education
University of Massachusetts Dartmouth 1996 — 1999
BSN, Nursing
Bristol Community College 1995 — 1996
ASN, Nursing
Bridgewater State University 1983 — 1988
BS, Management Science
Stryker September 2014 - Present
Stryker Orthopaedics January 2012 - September 2014
Stryker Orthopaedics July 2008 - January 2012
Stryker Biotech June 2006 - July 2008
Pfizer July 2004 - June 2006
Skills
Research, Biomedical Engineering, Design Control, R&D, Medical Devices, Biomaterials, HPLC, Mechanical Testing, FDA, ISO 13485, Biomechanics, Biotechnology, Cross-functional Team..., Design of Experiments, Life Sciences, Product Development, Product Launch
Education
Columbia University - Fu Foundation School of Engineering and Applied Science
MS, Mechanical Engineering
Rensselaer Polytechnic Institute
BS, Biomedical Engineering
Celldex Therapeutics April 2015 - Present
NPS Pharmaceuticals May 2011 - April 2015
MannKind Corporation August 2008 - April 2011
NC BioNetwork August 2006 - August 2008
Biolex 2003 - 2006
Stryker Biotech 2002 - 2003
Covance Biotechnologies 1999 - 2000
Sanofi Pasteur 1991 - 1999
Skills
CAPA, GMP, Technology Transfer, Manufacturing, FDA, Lifesciences, Purification, Biopharmaceuticals, Product Development, Validation, Biotechnology, Sop, LIMS, GLP, Change Control, Quality System, 21 CFR Part 11
Education
East Stroudsburg University of Pennsylvania 1987 — 1991
Bachelor of Science (BS), biology, marine science
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
Biogen Idec August 2014 - Present
MedImmune December 2012 - Present
MedImmune September 2009 - December 2012
Stryker Biotech 2001 - 2003
Skills
Protein Purification, Protein Expression, Biochemistry, Molecular Biology, Protein Chemistry, Molecular Cloning, ELISA, Manufacturing Operations, Technology Transfer
Education
Yale University 2003 — 2009
PhD, Molecular Biophysics and Biochemistry
Clark University 2000 — 2003
BA, Biochemistry and Molecular Biology
Nipmuc 1995 — 1999
Colby-Sawyer College August 2010 - Present
Colby-Sawyer College August 2010 - Present
Dartmouth College July 2007 - September 2010
Plymouth State University September 2006 - January 2007
University of New Hampshire January 2000 - June 2000
Stryker Biotech May 1999 - May 2000
Skills
Protein Chemistry, Fermentation, Environmental Awareness, Genetic Engineering, Teaching, Medical Research, Environmental Issues, Curriculum Design, Cell Biology, PCR, Training, Protein Expression, Immunohistochemistry, Protein Purification, Animal Models, Genetics
Education
Dartmouth College 2000 — 2007
Ph.D., Physiology
University of New Hampshire 1996 — 2000
B.S., Zoology
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
Genzyme February 2014 - Present
Genzyme August 2011 - February 2014
Genzyme March 2007 - August 2011
Stryker Biotech September 2006 - February 2007
Skills
Biotechnology, Clinical Research, Sop, CAPA, Pharmaceutical Industry, Quality Auditing, FDA, SOP, Regulatory Affairs, GMP, Quality Assurance, Clinical Trials
Education
MGH Institute of Health Professions 2007 — 2009
Masters, Clinical Investigation
Quinnipiac University 2002 — 2006
Bachelors, Biomedical Sciences
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
Alnylam Pharmaceuticals 2014 - 2015
Acetylon Pharmaceuticals, Inc. 2010 - 2014
Stryker Biotech 2007 - 2010
Biogen Idec 1998 - 2007
Education
Curry College 1993 — 1996
BSN, Nursing
Cell Signaling Technology (CST) February 2015 - Present
Cell Signaling Technology (CST) February 2013 - January 2015
Cell Signaling Technology (CST) September 2010 - January 2013
Boston Biochem July 2009 - August 2010
Stryker Biotech June 2008 - August 2008
Skills
Cell Culture, ELISA, PCR, Protein Purification, SDS-PAGE, Western Blotting, Tissue Culture, Biochemistry, Cell Biology, Purification
Education
Endicott College 2014 — 2016
Master of Business Administration (M.B.A.)
Plymouth State University
B.S., Biotechnology
Norwich University Office of Strategic Partnerships September 2010 - Present
Stryker Biotech May 2010 - August 2010
NUARI June 2009 - May 2010
Norwich University Office of Strategic Partnerships January 2008 - May 2010
Education
Norwich University 2007 — 2011
BS, Mechanical Engineering
Nature Cures Naturopathic Clinic 2013 - Present
Stryker Biotech February 2011 - November 2011
Stryker Biotech January 2008 - January 2011
Stryker Biotech December 1999 - December 2007
Skills
Medical Devices, Orthopedic, FDA, Payroll, Leadership, Quality Assurance, Software Documentation, Biotechnology, Management, Process Scheduler, Sop, Accounts Payable, Cross-functional Team..., Validation, Pharmaceutical Industry, Quality Control, Quality System, Administrative..., Administrative...
Education
Community College of Rhode Island 1977 — 1979
Assoicates Degree, Retail Management
Bridgewater Associates August 2013 - Present
Dartmouth College September 2008 - Present
New Energy Capital June 2009 - September 2009
Stryker Biotech 2008 - 2009
Skills
C, C++, Matlab, R, Minitab, Machine Learning, Option Pricing, Optimization, Stochastic Processes, Stochastic Calculus, Monte C, Game Theory, Data-driven Decision..., Probability Theory, Numerical Analysis, Linux, Windows, Excel, JMP, SPC, Six Sigma, Economic Modeling, Statistics, Time Series Analysis, Financial Modeling, Algorithms, Microsoft Excel, SAS
Education
Dartmouth College 2009 — 2013
Doctor of Philosophy (Ph.D.), Energy Economy and Environment
McCormick LifeScience Consultants, LLC January 2012 - Present
Stryker Biotech June 2008 - October 2011
ViviSource Labs July 2006 - June 2008
Azopax Therapeutics October 2005 - June 2006
Phylogix, Inc. August 2004 - September 2005
Skills
ELISA, In Vivo, Non-clinical, Pharmacology, Pre-clinical Studies, Scientific Writing, Editing, Biotechnology, Regulatory Submissions, Regulatory Documentation, DMPK, Animal Work, Laboratory, Data Analysis, CRO, Animal Husbandry, In Vitro, Toxicology, Surgery, Microbiology, Drug Delivery
Education
Franklin Pierce College 1996 — 2000
BA, Anthropology
Olympus Biotech (formerly Stryker Biotech) 2011 - 2014
Stryker Biotech 2000 - 2011
State of New Hampshire DOT 1988 - 2000
Skills
Troubleshooting, Certified Master..., Level I Certified..., Predictive Maintenance..., Certified Level 1..., Predictive Maintenance, Quality Assurance, Process Improvement, Manufacturing, Root Cause Analysis, Thermal Imaging, Continuous Improvement, Maintenance & Repair, Maintenance Management, Supervisory Skills, Ultrasound, FDA, GMP
Education
NH Technical College
Associate's degree, Applied Science
Benjamin Franklin Institute of Technology
Two Year Certificate, Automotive Technology
Aspen Aerogels April 2015 - Present
Olympus Biotech (formerly Stryker Biotech) February 2011 - August 2014
Stryker Biotech April 2005 - January 2011
Stryker Biotech April 2000 - March 2005
Skills
Accounts Payable, Account Reconciliation, Accounting, Journal Entries, Accruals, Invoicing, Finance, Teamwork, General Ledger, Auditing, Sarbanes-Oxley Act, Accounts Receivable, Bank Reconciliation, Sarbanes-Oxley, Microsoft Excel, Pharmaceutical Industry, 1099 Preparation, Procedures Documentation
Education
Quinsigamond Community College
Accounting