Anika Therapeutics
Industry: Company
DescriptionHeadquarters: Bedford, MA Founded: 1983 Subsidiaries: Anika Therapeutics Srl, Anika Securities Corp.
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Anika Therapeutics Employees
Maquet Getinge Group February 2015 - Present
LeMaitre Vascular May 2013 - February 2015
Genzyme December 2011 - April 2013
Pharmalucence June 2011 - December 2011
Anika Therapeutics September 2010 - June 2011
Bristol-Myers Squibb, Devens, MA November 2009 - June 2010
Aushon BioSystems August 2009 - November 2009
Oxford Immunotec April 2009 - August 2009
Linkage, Inc. May 2005 - March 2009
Skills
Aseptic Technique, Aseptic Processing, Quality Assurance, Quality Control, Bioburden, Endotoxin, Environmental..., Microbiology, Sterility Assurance, Sterilization, GDP, cGMP practices, cGMP manufacturing, ISO 13485, Biotechnology, Medical Devices
Education
Indiana University Bloomington 2004 — 2008
Bachelors of Science, Biology, General
Indiana University Bloomington 2004 — 2008
Bachelor of Science (BS), Psychology
Corbus Pharmaceuticals April 2014 - Present
InVivo Therapeutics 2010 - 2013
Celsion Corporation 2008 - 2010
Transport Pharmaceuticals 2006 - 2008
Echo Therapeutics 2002 - 2006
Satcon Technology Corporation 2000 - 2002
Anika Therapeutics March 1993 - 2000
Skills
Capital Raising, M&A experience, Lifesciences, Profit Maximization, Investor Relations..., Managing Rapid Growth, Board of Directors, Budgeting, Medical Devices, SEC filings, Strategic Planning, Business Strategy, IPO, Public Equity Offerings, Commercialize technology, SEC Financial Reporting, Financial Accounting, Pharmaceutical Industry, Reverse Mergers, P&L Management, Strategic Leadership, Thought Leadership, Business Planning, Debt & Equity Financing, Licensing Negotiations, Legal Compliance, Real Estate Transactions, CPA, MBA, Intellectual property, Clinical Trials, GMP manufacturing, Human resources, Board communications, Emerging Technologies, Cash flow management, working capital..., Investor Relations, Venture Capital, Investment banking, Product aquistions, Public relations, Product development, Commercialization, Regulatory affairs, Drug/device combinations, Team Building, Turn Around Management, International Business, Biotech
Education
Babson College - Franklin W. Olin Graduate School of Business 1986 — 1990
Master of Business Administration (MBA), Finance
Babson College 1976 — 1980
Bachelor of Science, Accounting
Anika Therapeutics August 2008 - Present
Anika Therapeutics January 2008 - Present
Amerifit pharma July 2001 - June 2008
Amerifit Brands Inc January 2001 - January 2006
Copley Pharmaceutical Inc January 1998 - January 2000
Copley Pharmaceutical Inc January 1993 - January 1996
Skills
Validation, GMP, Sop, ISO, Manufacturing, Biotechnology, Software Documentation, CAPA, Aseptic Processing, FDA, 21 CFR Part 11, Change Control, Quality System, V&V, ISO 13485, LIMS, Medical Devices, Purification, GLP, Sterilization, Troubleshooting, Quality Assurance, Design Control, Clean Rooms, Pharmaceutical Industry, Process Simulation, Computer System..., Filtration, Environmental Monitoring, Lifesciences, Technology Transfer, Trackwise, FDA GMP, Life Sciences, SOP
Education
Middlesex Community College 1993 — 1994
Computer Technology
Massachusetts Bay Community College 1989 — 1993
General Studies (High School Diploma)
2007Nit co Northland Industrial Truck Co. Inc
Middlesx Community College
LeMaitre Vascular November 2014 - Present
Hyde Engineering + Consulting May 2014 - November 2014
IntelligentMDx June 2013 - January 2014
Anika Therapeutics April 2012 - May 2013
EMD Millipore October 2010 - April 2012
Sanofi Pasteur 2008 - 2010
Biopure 2006 - 2008
Proteome Systems May 2004 - June 2006
Air Products and Chemicals May 2002 - May 2004
Skills
GMP, Validation, Biotechnology, Chromatography, Technology Transfer, CAPA, Sop, FDA, Purification, Aseptic Technique, Protein Purification, Filtration, Vaccines, Cleaning Validation, Chemical Engineering, Process Engineering, Biopharmaceuticals, Change Control, Design of Experiments, Aseptic Processing, R&D, V&V, Quality Assurance, Fermentation, 21 CFR Part 11, Cell Culture, LIMS, Molecular Biology, ELISA, Root Cause Analysis, GLP, Quality System, Pharmaceutical Industry, SOP
Education
Northeastern University 2005 — 2007
MS, Biotechnology
Penn State University 1997 — 2002
BS, Chemical Engineering
CMC Biologics May 2015 - Present
Shire Pharmaceuticals September 2013 - April 2015
Anika Therapeutics May 2013 - September 2013
Cytovance Biologics October 2011 - April 2013
Cytovance Biologics August 2010 - October 2011
Skills
Biopharmaceuticals, Biotechnology, GMP, Sop, Technology Transfer, Validation, GLP, Purification, Lifesciences, Monoclonal Antibodies, Fermentation, V&V, Manufacturing, Protein Purification, Microbiology
Education
Oklahoma State University 2007 — 2010
Bachelor's degree, Chemical Engineering
Complya Consulting Group 2010 - Present
TMQ Consulting 2001 - Present
PrimeraDX, Inc. February 2011 - October 2013
Anika Therapeutics 2005 - 2008
Avecia Biotechnology 2003 - 2005
Organogenesis 1999 - 2001
Genzyme Biosurgery 1993 - 1999
Skills
CAPA, FDA, GMP, Medical Devices, ISO 13485, Validation, Quality System, Biotechnology, 21 CFR Part 11, Change Control, V&V, Pharmaceutical Industry, Regulatory Affairs, Technology Transfer, Sop, Manufacturing, R&D, Continuous Improvement, Quality Assurance, Quality Auditing, Lifesciences, Biopharmaceuticals, Computer System..., Design Control, GxP, GLP, Regulatory Requirements, Commercialization, Six Sigma, ISO 14971, Quality Control, Regulatory Submissions, Testing, Aseptic Processing, ISO, Clinical Trials, LIMS, Contract Manufacturing, 21 CFR, Biologics, GCP, SOP, Life Sciences
Education
Boston University - School of Management
MBA, Business
Kettering University
BSME, Mechanical Engneering
Smith & Nephew June 2015 - Present
Anika Therapeutics May 2013 - May 2015
Misfit Wearables August 2012 - December 2012
DePuy Spine, A Johnson & Johnson Company May 2011 - August 2011
AgaMatrix September 2008 - August 2010
AgaMatrix January 2006 - August 2008
AgaMatrix January 2005 - December 2005
Skills
Medical Devices, Product Launch, Cross-functional Team..., Product Management, Product Development, Start-ups, Business Strategy, Healthcare, Negotiation, Strategy, New Business Development, Business Development, Microsoft Office, FDA, Market Research, Integrated Marketing, Product Marketing, Sales, Business Planning, Global Marketing, Management, Pharmaceutical Industry, Customer Service, Marketing Strategy, YouTube, Strategic Planning, Program Management, Product Design, Forecasting, Analysis, Competitive Analysis, Market Analysis, Entrepreneurship, Strategic Partnerships, Face, Marketing, Commercialization, Crowdfunding, Channel Partners, Crowdsourcing, Sales Channel...
Education
Babson College - Franklin W. Olin Graduate School of Business
MBA, Marketing & Entrepreneurship
Tufts University
BSME, Mechanical & Biomedical Engineerig
University College London, U. of London
BSME, Mechanical & Biomedical Engineering, Junior Year Abroad
United Nations International School
International Baccalaureate, Economics
Anika Therapeutics June 2011 - Present
Formatech, Inc. May 2001 - May 2011
Biovest International (formerly Unisyn Technologies) August 2000 - May 2001
Wyeth Pharmaceuticals (formerly Genetics Institute) August 1996 - August 2000
Raytheon Missile Systems April 1982 - June 1996
Skills
Management, CAPA, Organization, Spreadsheets, Oral & Written..., Time Management, Sop, GMP, Quality System, GxP, Pharmaceutical Industry, HPLC, Training, Quality Control, Change Control, Aseptic Processing, 21 CFR Part 11, Trackwise, LIMS, GLP, V&V, Quality Auditing, Biotechnology, Validation, Quality Assurance, Analytical Chemistry, ISO 13485, SOP, FDA, Medical Devices, Laboratory, Root Cause Analysis
Education
Middlesex Community College 1995 — 1996
Certificate, Biotechnology Technician
Fitchburg State University 1987 — 1991
AS, Electronics Engineering Technology
Deirdre Rakus Photography October 2010 - Present
Unidine Corporation April 2010 - October 2010
Energy Federation Incorporated February 2008 - December 2009
Silverscape October 2006 - February 2008
University of Massachusetts Dartmouth September 2005 - May 2006
SnapChef 2006 - 2006
Anika Therapeutics June 2005 - August 2005
Skills
Social Media Marketing, Social Media, Marketing, Advertising, Salesforce.com, PowerPoint, Marketing Strategy, Market Research, Marketing Communications, Email Marketing, Customer Service, Business Development, Event Planning, New Business Development, Social Networking
Education
University of Massachusetts Dartmouth 2005 — 2006
MBA
University of Massachusetts Dartmouth 2001 — 2005
Bachelor of Science, Marketing
Bellerophon Therapeutics May 2015 - Present
Wombat Capital March 2015 - Present
Bruder Consulting International, LLC November 2014 - Present
Case Western Reserve University 1998 - Present
Stryker Corporation January 2013 - October 2014
Becton, Dickinson and Company September 2007 - October 2012
Johnson & Johnson 2005 - 2007
DePuy, Inc., a Johnson & Johnson Company 2000 - 2005
Anika Therapeutics 1998 - 2000
Osiris Therapeutics 1994 - 1998
Skills
Biotechnology, Medical Devices, Lifesciences, Biomedical Engineering, FDA, Commercialization, Technology Transfer, Biomaterials, Cell, Orthopedic, Clinical Trials, R&D, Regenerative Medicine, Clinical Research, Product Development, Stem Cells, Hardware Diagnostics, Strategy, Healthcare, Research, Surgery, Regulatory Affairs, Innovation Management, Medical Diagnostics, Pharmaceutical Industry, Molecular Biology, Cell Culture, ELISA, ISO 13485, Advisory Boards, Tissue Engineering, Protein Chemistry, Board Level, Biochemistry, Immunology, Genomics, In Vitro, Portfolio Management, Biomechanics, Cell Biology, Drug Delivery, Medicine, Flow Cytometry, Immunoassays, R&D planning, Ophthalmology, Life Sciences, Orthopedics, Business Strategy
Education
Brown University 1980 — 1984
Bachelor of Science (ScB), Biological Sciences, General
Case Western Reserve University 1985 — 1990
Doctor of Philosophy (Ph.D.), Cell/Cellular and Molecular Biology
Case Western Reserve University 1985 — 1992
Doctor of Medicine (M.D.)
ConforMIS, Inc. November 2014 - January 2015
VWR August 2008 - January 2014
Alkermes April 2006 - March 2007
UMass Biologics February 2005 - April 2006
Massachusetts General Hospital January 1998 - February 2005
Genzyme December 2000 - September 2003
TEI Biosciences Inc September 2000 - December 2000
Anika Therapeutics May 1999 - September 2000
Skills
Microsoft Office, Management, Microsoft Excel, Microsoft Word, Research, PowerPoint, Leadership, Training, Manufacturing, Quality Control, FDA, Laboratory, SOP, Testing, R&D, Documentation, Biotechnology, Purification, Protein Purification, Life Sciences
Education
Boston University 2012 — 2014
Bachelor Degree, Biomedical Laboratory and Clinical Science
Middlesex Community College 2007 — 2010
Associate Degree, Biotechnology
Toxikon Corporation January 2015 - Present
Anika Therapeutics November 2012 - September 2014
Alpha Analytical,Inc. 2005 - 2012
Toxikon Corporation July 2001 - November 2005
Skills
ICP-OES, Atomic Absorption, X-ray fluoresence, LECO Instrumentation, Wet Chemistry, Ion Chromatography, GMP, Laboratory, Analytical Chemistry, Quality Control, LIMS, UV/Vis, Chemistry, HPLC, Chromatography, GLP, Biotechnology, Validation, FDA, SOP
Education
Niagara University
Bachelor of Science, Chemistry
Genzyme sanofi October 2012 - Present
Genzyme June 2007 - November 2012
Wyeth Biotech August 2005 - June 2007
Boston Analytical June 2000 - August 2005
Anika Therapeutics June 1998 - June 2000
US Air Force May 1992 - November 1996
Skills
LIMS, GMP, Root Cause Analysis, Troubleshooting, Aseptic Technique, Cell Culture, Aseptic Processing, Trackwise, MFG-Pro, Leadership, Delta V, Biotechnology
Education
Northern Essex Community College 1997 — 1999
Biotechnology Certificate
Cambridge Isotope Laboratories October 2011 - Present
Northeastern University January 2011 - Present
CBC S.A. January 2011 - October 2011
Medtronic Vascular September 2010 - December 2010
Medtronic Vascular June 2010 - September 2010
Anika Therapeutics 2008 - March 2010
Anika therapeutics October 2008 - July 2009
GlaxoSmithKline 2006 - 2008
Skills
Quality Assurance, FDA, GMP, Medical Devices, Regulatory Affairs, Auditing, CAPA, ISO 13485, Manufacturing, Quality Control, Sop, Validation, 21 CFR Part 11, Quality System
Education
Northeastern University 2009 — 2010
M.S., Regulatory Affairs
Université de Montréal 2002 — 2006
B.S, Chemistry
Anika Therapeutics October 2013 - Present
Anika Therapeutics September 2013 - September 2013
Sekisui Diagnostics, LLC September 2012 - January 2013
Skills
ELISA, Gel Electrophoresis, Centrifugation, Microfiltration, HPLC, Gas Chromatography, Protein Purification, Tissue Culture, Media Preparation, Buffer, Aseptic Technique, Microsoft Office, PowerPoint, Molecular & Cellular..., PCR, Clean Rooms, Manufacturing, ISO 13485, CAPA, FDA, GMP, Validation
Education
Worcester State University 2010 — 2012
Bachelor's degree, Biotechnology
Bunker Hill Community College 2006 — 2009
Associate in Biotechnology
Dusa Pharmaceuticals May 2011 - Present
Anika Therapeutics April 2008 - May 2011
Acusphere June 2005 - April 2008
Duracell June 2004 - June 2005
Skills
Validation, Project Management, CAPA, Automation, Process Control, Sop, Commissioning, Technology Transfer, FDA, Process Engineering, Biotechnology, Process Simulation, Quality System, Manufacturing, GMP, Pharmaceutical Industry, V&V, SOP
Education
University of Massachusetts, Amherst 2000 — 2004
B.S., Chemical Engineering
Sanofi Pasteur November 2009 - Present
EMD Serono March 2009 - December 2009
Shire HGT 2006 - 2009
Transkaryotic Therapies, Inc. 2002 - 2006
Organogenesis, Inc. 2000 - 2002
Anika Therapeutics 1998 - 2000
Genzyme Corporation 1992 - 1998
Education
University of New Hampshire 1988 — 1992
BS, Chemical Engineering
Pharmaceuticals and Medical Devices July 2013 - Present
Anika Therapeutics March 2013 - Present
BioBridges, LLC March 2012 - March 2013
Interleukin Genetics December 2007 - February 2012
Skills
Clinical Trials, Clinical Research, Regulatory Affairs, Clinical Development, Clinical Trial..., Regulatory Submissions, FDA, Genetics, Clinical Project..., Life Sciences, Nuclear Medicine, Cardiology, Inflammation, CRO Management, Infectious Diseases, GMP, Oncology, IND, Lifesciences, Biotechnology, CTMS, Neurology
Education
The University of Texas at Austin
Validant January 2015 - Present
Drug Development Resources September 2012 - Present
Compass Pharma Consulting, LLC September 2011 - Present
Anika Therapeutics July 2014 - January 2015
NextPharma July 2013 - April 2014
Complya Consulting Group January 2011 - April 2014
Ebewe Pharma December 2011 - December 2012
The Quantic Group, Ltd August 2011 - December 2012
AVEO Pharmaceuticals January 2011 - August 2011
Biogen Idec August 2007 - December 2010
Skills
Investigations, Compliance, Validation, Process Improvement, Process Optimization, Medical Devices, Regulatory Submissions, Continuous Improvement, Troubleshooting, Quality Assurance, Quality Management, Contract Manufacturing, GxP, Change Management, FDA, Quality Systems, Quality Auditing, Pharmaceuticals, Root Cause Analysis, Biotechnology, Operational Excellence, Problem Solving, Technology Transfer, Supplier Management, ISO 13485, GMP, Auditing, GCP, Clinical Trials, Regulatory Requirements, Quality System, Pharmaceutical Industry, 21 CFR Part 11, V&V, CAPA, Change Control, Biopharmaceuticals, Supply Management, Regulatory Affairs, Pharmaceutics, Computer System..., Sop, Clinical Development, GLP, Process Simulation, Manufacturing, LIMS, Aseptic Processing, Drug Development, R&D
Education
Northwestern University 2004 — 2006
Masters of Science, Product Development
University of Münster 1981 — 1990
Dr. rer. nat. (Ph.D.), Chemistry
CIRCOR International, Inc. 2010 - Present
TEAM Industries January 2005 - November 2009
Anika Therapeutics 2001 - 2005
Agion Technologies 1999 - 2001
Integrated Logistics Solutions January 1997 - January 1999
Eaton Corporation January 1988 - January 1997
Skills
Supply Chain Management, Manufacturing, Supply Chain, Value Stream Mapping, Continuous Improvement, Project Management, Lean Manufacturing, Management, Kaizen, Kanban, Logistics, 5S, Product Development, Six Sigma, Process Improvement, MRP, Cross-functional Team..., Global Sourcing, Manufacturing..., JIT, New Business Development, Process Engineering, Operational Excellence, Toyota Production System, TPM, Black Belt, Quality Management, FMEA, Manufacturing..., Supply Management, Strategic Sourcing, Root Cause Analysis, Business Process..., Inventory Management, Production Planning, ISO, Materials Management, SPC, DMAIC, SMED, Change Management, Supplier Quality, APQP
Education
Baldwin Wallace University
Bachelors of Arts
Cleveland State University / Electronic Technical Institute
Associates Degree
University of Pennsylvania - The Wharton School
EMD Millipore February 2015 - Present
Anika Therapeutics December 2007 - August 2014
Lonza June 2006 - November 2007
Vertex Pharmaceuticals 2005 - 2006
Chemic Laboratories Inc. April 2001 - December 2004
AstraZeneca June 2000 - April 2001
Skills
FDA, GMP, Validation, CAPA, Chemistry, Change Control, OOS Investigations, Chromatography, 21 CFR Part 11, HPLC, Sop, Technology Transfer, Risk Assessment, Quality System, Auditing, Analytical Chemistry, Quality Control, UV/Vis, Pharmaceutical Industry, LC-MS, Audits, SOP
Education
Rose-Hulman Institute of Technology 1996 — 2000
BS, Chemistry
Newport Corporation December 2008 - Present
Abiomed, Inc November 2000 - September 2008
Anika Therapeutics September 1995 - October 2000
Dade Lytening Systems (formerly Baxter Lytening Systems, Amdev) 1984 - 1995
Skills
SAP, Import Compliance, Lean Manufacturing, Medical Devices, Six Sigma, Manufacturing, Supply Chain Management, Cross-functional Team..., Supply Management, Continuous Improvement, Supply Chain, ISO, Production Planning, Process Improvement, ERP, Product Development, FDA, Purchasing, Procurement, Management
Education
Northern Essex Community College 1989 — 1994
Associates, Business Management
Complya Consulting Group Independent ConsultantQuality Executive Partners, IncJune 2014 - June 2015
Anika Therapeutics September 2012 - March 2014
Pfizer June 2011 - July 2012
Pfizer (formerly Wyeth Biotech) September 2005 - June 2011
Boston Analytical 1992 - September 2005
Skills
GMP, Quality System, Pharmaceutical Industry, Biotechnology, Medical Devices, Quality System..., CAPA, FDA, Validation, Technology Transfer, Continuous Improvement, Quality Remediation, V&V, Quality Assurance, Sop, Aseptic Processing, ISO 13485, Quality Control, Clinical Trials, Cleaning Validation, Method validaiton, ICH guidelines, cGMPs, Trackwise, Testing, Laboratory, Quality Control..., Dispositon, Change Control, SOP
Education
State University of New York at Buffalo
BA, Chemisty
Benefitfocus August 2013 - Present
Empowered Benefits February 2011 - June 2012
Cardinal Health March 2008 - May 2009
Fresenius Medical Care October 2005 - June 2007
Anika Therapeutics April 2001 - October 2005
Franklin Pierce Temporaries April 2000 - March 2001
Skills
Recruiting, HRIS, Human Resources, Succession Planning, Employee Benefits, Employee Relations, Onboarding, Performance Management, Coaching, Process Improvement, FMLA, Team Building, Strategic Planning, Organizational..., Six Sigma, Leadership Development, Employee Training, Talent Management, Deferred Compensation, Training, Sourcing, Employee Engagement, Applicant Tracking..., Benefits Administration, Personnel Management, Hiring, New Hire Orientations, Leadership, Interviews, Management, Payroll, Strategy
Education
Suffolk University 1996 — 2000
Bachelor of Science
Harvard University July 2012 - Present
Harvard University June 2012 - July 2012
Whitehead Institute November 2011 - June 2012
Anika Therapeutics December 2010 - November 2011
Synta Pharmaceuticals Corp. (Boston) May 2008 - December 2010
Synta Pharmaceuticals May 2008 - December 2010
Draper Laboratory January 2007 - May 2008
Triumvirate Environmental April 2002 - October 2006
Skills
Hazardous Waste..., RCRA, Department of..., IATA, EHS, Environmental Compliance, EPA, Industrial Hygiene, Hazardous Materials..., HAZWOPER, Hazardous Materials, Chemistry, Waste, Environmental Awareness, Waste Management
Education
College of Oceanerring 1999 — 2000
Commercial diving
Boston University 1994 — 1997
BA, Archaeology
UCL 1995 — 1996
Medieval Archaeology
University of Massachusetts, Amherst 1993 — 1994
Chemistry
Biogen Idec September 2014 - Present
Integrated Project Services (IPS) January 2012 - December 2012
Shire July 2011 - December 2011
Teleflex Medical January 2011 - July 2011
Bristol-Myers Squibb October 2010 - December 2010
AMAG Pharmaceuticals May 2010 - October 2010
Genzyme Corporation Allston Landing February 2008 - November 2009
Wyeth Biotech June 2005 - February 2008
Wyeth Biotech December 2000 - June 2005
Anika Therapeutics June 1998 - November 2000
Skills
GMP, Validation, Quality Assurance, Biotechnology, Manufacturing, CAPA, Engineering, Sop, Change Control, Microsoft Office, Process Scheduler, FDA, Regulatory Affairs, Technology Transfer, LEED AP, V&V, Software Documentation, Aseptic Processing, Computer System..., GxP, Biopharmaceuticals, Quality System, ISO 13485, LIMS, GLP, Pharmaceutical Industry, Quality Control, Process Simulation, Continuous Improvement, 21 CFR Part 11, Trackwise, Deviation Management, Troubleshooting, Microsoft Certified..., Regulatory Requirements, Scheduling, SOP
Education
Everblue Training Institute 2009 — 2009
LEED AP, Green Building Professional
North Shore Community College 1970 — 1973
Associates, Business and General Studies
Harris Real Estate School
Mass Real Estate Sales Education, Residential Real Estate, Passed State Exam
Amgen September 2012 - Present
U.S. Validation Services, Inc. May 2009 - Present
R & C Consulting Group LLC May 2015 - June 2015
IQS Integrated Quality Solutions November 2013 - February 2014
Boston Scientific May 2012 - August 2012
Anika Therapeutics November 2011 - May 2012
Metro Logics, Inc. November 2010 - January 2012
Boston Scientific February 2011 - October 2011
Anika Therapeutics March 2009 - June 2011
Organogenesis January 2011 - March 2011
Skills
Validation, Computer System..., CAPA, Risk Assessment, ISO 13485, 21 CFR Part 11, GAMP, 21 CFR, SDLC, Change Control, Medical Devices, GxP, Quality System, Root Cause Analysis, GMP, Quality Assurance, Automation, Sop, LIMS, Quality Auditing, Biotechnology, Quality Control, Software Documentation, Lifesciences, V&V, Calibration, GLP, FDA, Testing, SOP
Education
Saint Petersburg University of Telecommunications
MS, Electrical Engineering
Anika Therapeutics September 2013 - November 2014
Boston Scientific September 2011 - September 2013
Bausch & Lomb July 2008 - April 2011
HOYA Surgical Optics April 2007 - July 2008
Johnson and Johnson, ETHICON 2003 - 2007
Alcon March 1994 - December 2002
Johnson & Johnson, IOLAB Corporation 1988 - 1994
Skills
Product Development, R&D, Medical Devices, Biotechnology, FDA, Pharmaceutical Industry, Innovation, Clinical Development, Team Leadership, Technology, Product Launch, Leadership, Management, Quality Assurance, Healthcare, Commercialization, Design Control, GLP, Entrepreneurship, Product Marketing, Cross-functional Team..., Market Development, Lifesciences, Regulatory Affairs, V&V, Regulatory Submissions, Strategy, Process Improvement, Biomedical Engineering, Clinical Trials, Validation, Medical Imaging, Continuous Improvement, Competitive Analysis, GMP, Six Sigma, Technology Transfer, 21 CFR Part 11, Sop, ISO 13485, Capital Equipment, Strategic Thinking, Clinical Research, Patents, Manufacturing, Consulting, CAPA, Design of Experiments, Cardiology, Medical Device R&D
Education
University of Florida
Bachelor of Science (B.S.), Zoology
University of Florida
Doctor of Philosophy (Ph.D.), Materials Science and Engineering
Harvard Business School
Program for Management Development
Stanford Biodesign Executive Education
Managing Innovation
Engle Strategic Solutions January 2012 - Present
Thermogenesis April 2009 - January 2012
Raydiance, Inc. May 2008 - September 2008
DEY L.P. January 2002 - December 2007
Anika Therapeutics September 1996 - December 2001
Allergan Pharmaceuticals November 1980 - September 1994
Skills
Board Leadership, Community Development, Team Management, Strategic Planning, Medical Devices, Pharmaceutical Industry, CEOs, Audit Committee, Board of Director..., Compensation & Benefit, International Sales, Negotiation, Board Governance, Non-profit Board..., Leadership, Board of Directors, Biotechnology, Forecasting, Mergers & Acquisitions, Business Strategy, Management, Strategy, Acquisition Integration, Business Development, Cross-functional Team..., Lifesciences, Executive Management, FDA, New Business Development, Product Development, Contract Negotiation, Entrepreneurship, Team Building, Due Diligence, Business Planning, Marketing, Product Launch, Commercialization, Start-ups, Healthcare, Market Analysis, Management Consulting, Sales, Manufacturing, Product Marketing, Coaching, Process Improvement, Competitive Analysis, Venture Capital, Consulting
Education
University of Southern California - Marshall School of Business 1981 — 1983
MBA, Finance
University of Colorado Boulder 1968 — 1972
BS, Accounting
Anika Therapeutics June 2015 - Present
Berkshire Group L.L.C. March 2014 - May 2015
The TJX Companies, Inc. July 2010 - February 2014
Sharon Merrill Associates January 2007 - July 2010
Compton Consulting Group January 2006 - December 2006
Skills
Corporate Communications, Investor Relations, Media Relations, Crisis Communications, Proxy Contests, Public Relations, Event Planning, Copywriting, Leadership, Messaging, Speech Writing, Strategic Planning, Thought Leadership, Strategy, Reputation Management, Strategic Communications, Internal Communications
Education
Babson College - Franklin W. Olin Graduate School of Business 2012 — 2015
Master of Business Administration (MBA)
McGill University 2001 — 2006
B.Com.
Lexington High School
Albany Molecular Research February 2006 - January 2011
Anika Therapeutics October 1995 - February 2006
Anika Therapeutics June 1991 - October 1995
Copley Pharmaceutical January 1990 - June 1991
Fisons Corporation 1977 - 1989
Skills
Aseptic Processing, Sterilization, Lyophilization, Environmental Monitoring, Contamination Control, Clean Rooms, Biotechnology, GMP, Trackwise, Purification, Filtration, Downstream Processing, CAPA, FDA, 21 CFR Part 11, Sop, Validation, Pharmaceutical Industry, Change Control, Quality Auditing, Formulation, Manufacturing, Quality Control, Technology Transfer, Biopharmaceuticals, ISO, GLP, V&V, Cleaning Validation, Microbiology, LIMS, Continuous Improvement, GxP, Computer System..., Quality Management, Quality System, FDA GMP, ISO 13485, Chromatography, Regulatory Affairs, Manufacturing Operations, Contract Manufacturing, SOP, TrackWise
Education
University of Massachusetts Lowell
Business Management
Eliassen Group November 2013 - Present
Commissioning Agents Inc. 2009 - November 2013
Amgen 2011 - 2012
Biogen Idec 2010 - 2011
Genzyme 2010 - 2010
Bristol-Myers Squibb 2010 - 2010
Anika Therapeutics 2009 - 2009
Abbott Vascular 2009 - 2009
E/ M Associates 2008 - 2009
Acusphere Inc. 2008 - 2009
Education
University of Massachusetts, Amherst 2005 — 2007
BA, Geology/ Chemistry
University of Maine 2003 — 2005
Geology-Chemistry; Fine Art
Oracle November 2014 - Present
Oracle October 2010 - October 2014
Anika Therapeutics May 2010 - April 2011
Lowell House, Inc October 2008 - August 2009
Margolis & Bloom November 2007 - September 2008
Doubletree Hotel September 1999 - October 2007
Skills
Outlook, PowerPoint, Microsoft Excel, Microsoft Word, Customer Service, Customer Satisfaction, File Management, Marketing, Leadership, Materials Management, Grant Writing, System Administration, Estate Planning, Data Entry
Education
Elon University 2004 — 2007
BA, Sociology
Salem State College 2002 — 2004
Bachelor of Science (BS), Sociology
AgaMatrix April 2015 - Present
AgaMatrix October 2013 - April 2015
Anika Therapeutics March 2013 - October 2013
Seaside Therapeutics October 2012 - March 2013
Genzyme September 2011 - October 2012
Shire HGT January 2011 - September 2011
Shire HGT August 2009 - January 2011
Shire HGT May 2008 - August 2009
Wyeth Biotech September 2003 - May 2008
Wyeth Biotech 2001 - 2003
Skills
Microsoft Word, Microsoft Excel, Visual D Base, Access 97 & 98, Windows NT Explorer, Adobe Professional, PowerPoint, Windows 98 & 2000, Office XP, Oracle, Vista, MAXIMO, AGILE PLM, TagLink, SAP, Drawing Document..., TrackWise, Microsoft Visio, DataStream (Infor), TrueView, File Maker Pro, Maximo, Access, Document Management, Visio, FDA, GMP, Change Control, Trackwise, Software Documentation, Biotechnology, Pharmaceutical Industry, Sop, CAPA, Product Lifecycle..., Quality System, Microsoft Office Xp, GLP, FileMaker, SOP, Quality Assurance, Validation, Microsoft Office, Windows Vista
Education
Northern Essex Community College
Associates, Business Management with Computer Applications Option
Salem High School
University of Phoenix
Masters, Management
University of Phoenix
Bachelors, Management
Anika Therapeutics April 2010 - Present
Anika Therapeutics April 2009 - May 2009
Acusphere, Inc. February 2008 - February 2009
Distinction in the Field May 2006 - May 2007
McLean Hospital November 2006 - April 2007
Skills
GMP, CAPA, Microbiology, Sop, FDA, Quality Assurance, GLP, Aseptic Processing, Laboratory, Biotechnology, Environmental Monitoring, GxP, SOP, Quality System
Education
Emmanuel College 2003 — 2007
B.A., Psychology
FORUM Pharmaceuticals (formerly Envivo Pharmaceuticals) June 2014 - Present
Vertex Pharmaceuticals February 2011 - June 2014
Johnson and Johnson July 2003 - February 2011
Cubist Pharmaceuticals September 2000 - July 2003
Anika Therapeutics February 1999 - September 2000
Genetics Institute 1992 - 1999
Skills
Cross-functional Team...
Education
Massachusetts College of Pharmacy and Health Sciences
Master’s Degree, Drug Regulatory Affairs and Health Policy
Somerset High School
Diploma
University of Massachusetts Boston
Bachelors of Science, Biology
Bruker Daltonics February 2015 - Present
St. Jude Medical February 2012 - October 2014
Anika Therapeutics March 2009 - February 2012
Aved Electronics August 2006 - September 2008
Rad Technologies November 2004 - July 2006
Skills
Inventory Management, Manufacturing, Customer Service, Data Entry, Outlook, Word, Exel, Forklift Operator, Shipping, Receiving, Material Handling, Bilingual-Spanish, Warehousing, Materials Management, Medical Devices, GMP, Sop, Cross-functional Team..., Logistics, Inventory Accuracy, SAP Warehouse Management, ISO 13485, Software Documentation, Microsoft Excel, Microsoft Word, SOP
Education
ITT Technical Institute-Wilmington 2011 — 2011
Some courses completed, Information Technology
Miguel M. Muñoz High School in Cayey, PR 2001 — 2004
Diploma
Anika Therapeutics April 2013 - Present
Anika Therapeutics October 2005 - March 2013
Transkaroytic Therapies, Inc. 2003 - 2005
Transkaryotic Therapies, Inc. 2000 - 2003
PwC 1995 - 2000
Skills
Medical Devices, Biotechnology, Cross-functional Team..., Lifesciences, Change Control, Acquisition Integration, Regulatory Submissions, Orthopedic, Process Improvement, Strategic Planning, Clinical Research, Financial Reporting, Sarbanes-Oxley Act
Education
Boston University 2001 — 2003
Master of Business Administration (MBA)
University of Massachusetts, Amherst 1993 — 1995
Bachelor of Business Administration (BBA), Accounting
HBS FSE
Rimini Street December 2014 - Present
Accretive Solutions April 2014 - December 2014
Hardinge Inc December 2013 - February 2014
Bauer Hockey, Inc May 2013 - November 2013
MKS Instruments September 2012 - February 2013
State Street March 2012 - July 2012
Exa Corporation May 2011 - September 2011
Momentive Performance Materials December 2010 - April 2011
Anika Therapeutics August 2010 - October 2010
American Superconductor February 2007 - June 2010
Skills
SOX, Internal Controls, Financial Reporting, SEC reporting, US GAAP, Sarbanes-Oxley Act, SEC filings, Sarbanes-Oxley, Managerial Finance, External Audit, Financial Statements, Finance, Auditing, Internal Audit, IPO, Analysis, CPA, Risk Assessment, Accounting, Financial Analysis, Financial Accounting, IFRS, Cost Accounting, Financial Modeling, Financial Audits, GAAP, Forecasting, Business Process..., Management, Enterprise Risk..., Budgets, Process Improvement, IT Audit, Acquisition Integration, Financial Risk, SOX 404, ERP, Executive Management, Tax, SAP, SAS70, COSO, General Ledger, Account Reconciliation, Mergers & Acquisitions, Risk Management, Corporate Governance, Cash Management, Cash Flow, Due Diligence
Education
Isenberg School of Management, UMass Amherst 1990 — 1993
BBA, Accounting and Information Systems
Weymouth North High School
Barry-Wehmiller Design Group October 2011 - Present
Novartis April 2009 - September 2011
Anika Therapeutics October 2006 - April 2009
Protein Forest, Inc. June 2004 - August 2004
Skills
Process Engineering, Technology Transfer, Root Cause Analysis, FDA, GMP, Change Control, Validation, Quality System, Design of Experiments, Lean Manufacturing, Firewood
Education
Massachusetts Institute of Technology 2001 — 2005
B.S., Mechanical Engineering
Anika Therapeutics May 2010 - Present
Anika Therapeutics October 2005 - April 2009
Natgun Corporation 2004 - 2005
Aggregate Industries 2002 - 2004
Wakefield Materials Corporation 1996 - 2002
West Lynn Creamery 1988 - 1991
Skills
Employee Relations, Hiring, Manufacturing, HRIS, Performance Management, Compensation, Employee Benefits, Deferred Compensation, Recruiting, Human Resources, Coaching, Onboarding, Talent Management, Personnel Management, Training, Sourcing, Applicant Tracking...
Education
Mount Saint Mary College
BS, Business Adminstration
State University of New York College of Agriculture and Technology at Morrisville
AS, Liberal Arts
BIND Therapeutics September 2015 - Present
Anika Therapeutics June 2015 - August 2015
University of Massachusetts Lowell August 2012 - May 2015
Atrium Medical/Maquet Getinge Group December 2013 - January 2014
Semprus BioSciences July 2013 - December 2013
Off Broadway Players UMASS Lowell May 2012 - May 2013
Middleton Department of Public Works June 2009 - August 2012
Vicor Corporation January 2012 - June 2012
Market Basket September 2007 - August 2011
Skills
Minitab, Matlab, Engineering, Six Sigma, Process Engineering, Manufacturing, Design of Experiments, Lean Manufacturing, Research, Materials, Continuous Improvement, Materials Science, SPC, Testing, Quality Control, Root Cause Analysis, Validation, Chemistry, Management, Product Development, Program Management, Software Documentation, PowerPoint, Chemical Engineering, Polymers, UV/Vis
Education
University of Massachusetts at Lowell 2009 — 2015
B.S, Chemical Engineering
Masconomet Regional HS 2005 — 2009
Regulatory Affairs Program, Northeastern University September 2007 - Present
tJun 17 Life Sciences, LLC, a Global Market Access Organization - Regulatory, Reimbursement, HEOR January 2010 - Present
BioSignostix, Inc. September 2013 - Present
Medical Development Group July 2014 - Present
Association of Graduate Regulatory Educators (AGRE) September 2013 - Present
Bridgehead International Ltd January 2011 - February 2012
MeniGen Technologies March 2010 - April 2011
Anika Therapeutics January 2007 - January 2010
Smith & Nephew Endoscopy April 2000 - January 2007
Visible Genetics 1997 - March 2000
Skills
Commercialization, Marketing Strategy, Market Research, New Business Development, Marketing Management, Regulatory Affairs, Healthcare Reimbursement, Pricing Strategy, Health Economics, Biotechnology, Medical Devices, Product Development, Product Launch, Strategy, Lifesciences, Market Development, Start-ups, Pharmaceutical Industry, FDA, Clinical Trials, Global Marketing, Oncology, Clinical Development, Cross-functional Team..., Competitive Analysis, Management, Regulatory Submissions, Infectious Diseases, Technology Transfer, Clinical Research, Healthcare, Market Access, Orthopedic, Business Development, Biopharmaceuticals, Biochemistry, Biomedical Engineering, Drug Development, Pharmaceutics, Microbiology, Molecular Biology, ISO 13485, Immunology, Diabetes, Hardware Diagnostics, Pharmacovigilance, Validation, Regulatory Requirements, Competitive Intelligence, Entrepreneurship
Education
Boston College - Wallace E. Carroll Graduate School of Management 1999 — 2000
MBA, Marketing
Boston College 1993 — 1997
PhD, Molecular and Cellular Biology
Harvard University 1986 — 1990
AB, Biochemical Sciences
Malden Catholic High School 1982 — 1986
HS Diploma
Quality Systems Integration August 2014 - Present
Massachusetts Army National Guard May 2014 - Present
Anika Therapeutics October 2011 - March 2014
Embryotech Labs October 2008 - September 2011
Cubist Pharmaceuticals September 2007 - September 2008
Biogen Idec February 2007 - September 2007
TransMolecular June 2006 - February 2007
Skills
Change Control, Validation, Medical Devices, 21 CFR Part 11, FDA, Pharmaceutical Industry, Biotechnology, Quality Assurance, V&V, ISO 13485, Quality System, Quality Auditing, Supplier Quality, Regulatory Affairs, FDA GMP, Aseptic Processing, GMP, CAPA
Education
Norwich University 2002 — 2006
Biology
Genzyme June 2010 - Present
Anika Therapeutics April 2010 - June 2010
Eisai November 2008 - April 2009
Discovery Laboratories November 2007 - October 2008
Merck March 2007 - October 2007
VaxInnate Corporation November 2005 - February 2007
Pfizer January 2005 - October 2005
Skills
Six Sigma, DMAIC, TQM, GMP, FDA, Validation, CAPA, Quality System, Quality Control, Quality Assurance, GLP, Chromatography, V&V, Biotechnology, LC-MS, HPLC, LIMS, Biopharmaceuticals, Analytical Chemistry, SOP
Education
Vanderbilt University 2001 — 2004
Masters of Science, Chemistry
University of Massachusetts, Amherst 1997 — 2001
Bachelors of Science, Biochemistry and Molecular Biology
Burlington High School
Burlington High School
Siemens Healthcare Diagnostics, Inc. March 2013 - Present
Anika Therapeutics September 2007 - July 2012
Anika Therapeutics January 2006 - September 2007
Oscient Pharmaceuticals June 2004 - January 2006
Abbott Diagnostics/Abbott Diabetes Care 1988 - 2004
Skills
Materials Management, Supply Chain Management, Manufacturing..., Contract Negotiation, Strategic Planning, Process Improvement, Clinical Research, Continuous Improvement, Supplier Quality, Change Control, FDA GMP, Cross-functional Team..., Regulatory Submissions, Purchase Management, Inventory Management, Demand Forecasting, Project Management, Organizational..., Medical Devices, Manufacturing Operations
Education
Indiana University Bloomington 1983 — 1987
Bachelor's degree, Chemistry
Bemis Associates June 2010 - Present
IntegraTECH Solutions October 2007 - July 2010
Vitasoy USA Inc. February 2005 - October 2006
Amphenol 2000 - 2005
Anika Therapeutics 1998 - 2000
Skills
Supply Management, Supply Chain Management, Manufacturing, Lean Manufacturing, Plastics, Production Planning, MRP, Materials Management, Supply Chain, Continuous Improvement, Materials, Purchasing, Cross-functional Team..., Inventory Management, Adhesives, Product Development, Pricing, Process Improvement, Injection Molding, Six Sigma, Contract Negotiation, Procurement, Forecasting, Manufacturing..., Microsoft Office
Education
Pace University - Lubin School of Business 2012 — 2014
Bachelor's Degree, BBA - Internal Auditing, 3.53 - Honors
Middlesex Community College 1994 — 2011
Assoc, BUSINESS TRANSFER
Nova Biomedical March 2011 - Present
TYRX, Inc. January 2009 - February 2010
Anika Therapeutics May 2008 - August 2008
Intact Medical October 2001 - October 2006
Primedica Corporation January 1998 - October 2001
Genzyme August 1991 - September 1998
Skills
Medical Devices, Biotechnology, Product Launch, Product Development, Disposables, Lifesciences, Commercialization, Market Development, Product Management, Product Marketing, FDA, Medical Diagnostics, Capital Equipment, Cardiology, Hardware Diagnostics, Pharmaceutical Industry, Cross-functional Team..., Management, Life Sciences
Education
Bentley College - Elkin B. McCallum Graduate School of Business 1992 — 1997
MBA, Marketing
University of Rochester 1987 — 1991
BS, Microbiology
Anika Therapeutics October 2014 - Present
MIT Enterprise Forum of Cambridge June 2013 - Present
Medical Capital Advisors July 2012 - October 2014
Harvard University - School of Engineering and Applied Sciences January 2012 - May 2013
MIT Enterprise Forum of Cambridge May 2011 - May 2013
Pioneer Surgical Technology November 2008 - June 2012
MIT Enterprise Forum of Cambridge May 2009 - May 2011
MIT Enterprise Forum of Cambridge May 2009 - May 2011
Pioneer Surgical Orthobiologics October 2007 - November 2008
Angstrom Medica, Inc October 2006 - October 2007
Skills
Medical Devices, Biotechnology, Venture Capital, Start-ups, Commercialization, Regenerative Medicine, Cell Therapy, M&A experience, Lifesciences, R&D, Surgery, Market Development, FDA, Product Launch, Spine, Orthopedic, Product Development, Entrepreneurship, Biomedical Engineering, Biomaterials, Strategic Partnerships, Oncology, Mergers & Acquisitions, Cardiology, Patents, Clinical Trials, Clinical Development, Technology Transfer, Nanotechnology, Pharmaceutical Industry, Stem Cells, Business Development, ISO 13485, Strategy, Market Analysis, Characterization, Business Planning, Protein Chemistry, Cross-functional Team..., Hardware Diagnostics, Corporate Development, Regulatory Affairs, Science, Validation, Global Marketing, V&V, Drug Delivery, Technology Evaluation, Biopharmaceuticals, Design Control
Education
Massachusetts Institute of Technology
PhD, Chemical Engineering
Massachusetts Institute of Technology
M.S., Chemical Engineering Practice
Stanford University
B.S., Chemical Engineering
Phillips Academy
Teleflex; ARROW Vascular Access Division 2013 - 2014
Spinal Kinetics 2011 - 2013
Cutera 2010 - 2010
Anika Therapeutics 2007 - 2010
Roche Diagnostics 2002 - 2004
Packard BioChip 2001 - 2001
MJ Research 1996 - 2000
Skills
Medical Devices, Biotechnology, Market Development, Lifesciences, Product Development, Cross-functional Team..., Product Launch, Commercialization, FDA, Product Management, Product Marketing, Clinical Trials, Marketing Strategy, Strategy, Cell Culture, Marketing Management, Start-ups, Marketing, Design Control, Management, Vascular, Global Marketing
Education
Babson College - Franklin W. Olin Graduate School of Business 2005 — 2007
MBA
University of Massachusetts Medical School 1993 — 1996
MS
Kite Pharma, Inc. July 2015 - Present
Roche Diagnostics May 2014 - June 2015
Biogen Idec May 2013 - May 2014
Belvaros Group November 2011 - May 2013
Amgen April 2007 - November 2011
QP Group Americas November 2004 - April 2007
Novartis Institutes for BioMedical Research July 2004 - November 2004
Wyeth Pharmaceuticals January 2002 - July 2004
Anika Therapeutics January 2001 - December 2001
Skills
Category Management, Negotiation, Data Research, Strategic Sourcing, Sourcing Compliance, B2B eCommerce, Stakeholder Management, Team Leadership, Change Management, Business Transformation, Business Process..., Supplier Management, Sourcing, Contract Negotiation, Procurement, Spend Analysis, Cross-functional Team..., Strategy Development, Process Improvement, Supply Management, Compliance, B2B, Management, Strategy, Outsourcing, Vendor Management, Supply Chain, Consulting, P&L Management, Global Sourcing, Six Sigma, Executive Management, E-commerce, International Business, Management Consulting, Business Strategy, Competitive Analysis, Forecasting, Contract Management, Purchasing, Operational Excellence, Program Management, Leadership, Product Development, E-procurement, Pharmaceutical Industry, eSourcing, Business Planning, Product Launch
Education
Babson College - Franklin W. Olin Graduate School of Business 2000 — 2005
MBA
University of San Diego 1996 — 1999
Bachelors
Smith & Nephew July 2014 - Present
Volcano Corporation December 2012 - March 2014
Teleflex Medical (Arrow International) June 2010 - December 2012
Anika Therapeutics October 2009 - June 2010
BD Medical - Ophthalmic Systems December 2006 - July 2009
Terumo Cardiovascular Systems November 2005 - November 2006
Raytheon Integrated Defense Systems November 2003 - October 2005
United States Postal Service - Springfield Bulk Mail Center May 2002 - September 2002
Skills
Internal Audit, Mechanical Engineering, Business Analysis, Quality System, 21 CFR Part 11, Iso 9000, Validation, FDA, Medical Devices, Six Sigma, Root Cause Analysis, Quality Assurance, ISO 13485, Design Control, Minitab, SPC, CAPA, ISO 9000, Manufacturing
Education
Bentley College - Elkin B. McCallum Graduate School of Business
MBA
University of Massachusetts, Amherst 1999 — 2003
B.S., Industrial Engineering and Operations Research
Hvitfeldtska Gymnasiet 1996 — 1999
International Baccalaureate
Grand River Aseptic Manufacturing February 2015 - Present
Anika Therapeutics May 2014 - February 2015
Pfizer November 2012 - May 2014
Pfizer July 2007 - December 2012
Pfizer January 2004 - July 2007
Pfizer January 2002 - January 2004
King Pharmaceuticals October 2001 - January 2002
King Pharmaceuticals March 1999 - October 2001
Skills
Technology Transfer, Sop, GMP, Aseptic Processing, Biopharmaceuticals, Pharmaceutical Industry, FDA, Quality Assurance, Formulation, Pharmaceutics, CAPA, Quality Control, SOP
Education
Oakland University 1995 — 1998
Biology
Terumo September 2012 - Present
Novartis/Sandoz January 2012 - Present
SAINT JUDE MEDICAL CORPORATION September 2011 - Present
Anika Therapeutics June 2011 - Present
St. Jude Medical 2010 - Present
Compliance Partners, LLC January 2012 - August 2012
Medtronic Spine & Biologics June 2009 - December 2009
Boston Scientific June 2006 - March 2009
Arrow Internationl/Teleflex April 2008 - October 2008
Allergan August 2005 - June 2006
Skills
CAPA, GMP, Validation, FDA, V&V, Process Simulation, ISO 13485, Iso 9000, Quality Management, ISO, Biotechnology, LIMS, Software Documentation, Change Control, Quality System, Medical Devices, Computer System..., GxP, Sterilization, Testing, Quality Auditing, Pharmaceutical Industry, Manufacturing, Regulatory Affairs, Design Control, Six Sigma, Quality Assurance, Automation, Sop, Pharmaceutics, 21 CFR Part 11, Cleaning Validation, Minitab, Design of Experiments, HPLC, GAMP, Quality Control, Root Cause Analysis, Calibration, Regulatory Requirements, Aseptic Processing, GLP, ISO 14971, FDA GMP, Equipment Qualification, R&D, Technology Transfer, Biopharmaceuticals, Regulatory Submissions, Laboratory
Education
Illinois Institute of Technology 1993 — 1994
BS, Chemical Engineering
Molaison Law Firm July 2010 - Present
Molaisongs 1996 - Present
Sensory Overload Productions 2007 - Present
FLAG Marketing 2004 - April 2013
Frontier Science June 2009 - July 2010
(Wilmark exec. staffing firm) 2004 - 2008
Anika Therapeutics August 2007 - December 2007
Virgin Megastore January 2003 - July 2007
Idenix January 2007 - June 2007
Genomics Collaborative August 2006 - December 2006
Skills
Entertainment, Music, Legal Research, Legal Writing, Estate Planning, Successions, Succession Planning, Trademarks, Estate Administration, Copyright Law, Westlaw, Music Industry, Marketing, Singing, Songwriting, Guitar, Data Entry, Litigation, Concerts, Music Production, Recording, Editing
Education
New England School of Law 2006 — 2010
Juris Doctor, Law
Berklee College of Music 2000 — 2005
B.F.A, Songwriting and Music Business and Management
Barry-Wehmiller Design Group October 2013 - Present
Anika Therapeutics June 2011 - October 2013
Etex Corporation November 2007 - June 2011
Anika Therapeutics 2005 - 2006
Spherics 2003 - 2005
Skills
Design Control, Medical Devices, Biomaterials, FDA, CAPA, Biomedical Engineering, ISO 13485, Process Simulation, Validation, SOP, Quality System, R&D, V&V, Technology Transfer, Orthopedic, Biotechnology, Design of Experiments, GMP, Commercialization, Product Launch, Pharmaceutical Industry, Regulatory Affairs, Manufacturing, Lifesciences, ISO 14971, Product Development
Education
University of Oxford 2006 — 2007
M.Sc., Pharmacology
Cornell University 1999 — 2003
B.S., Chemical Engineering
Selecta Biosciences July 2011 - Present
Ocular Therapeutix April 2008 - September 2010
Xcellerex September 2007 - April 2008
Caliper Life Sciences November 2006 - July 2007
Anika Therapeutics April 2004 - October 2006
Avecia Biotechnology January 2004 - February 2004
AstraZeneca March 2002 - November 2002
Millennium Pharmaceuticals June 1999 - February 2000
Skills
HPLC, Protein Chemistry, PCR, Fluorescence, Chromatography, Biotechnology, UV/Vis, Validation, GMP, UV, SDS-PAGE, Sop, Gel Electrophoresis, DNA extraction, DNA sequencing
Education
American International College 1994 — 1999
Mincom, inc. October 2000 - Present
Anika Therapeutics 1996 - 1997
Education
Queens College 1976 — 1977
European Motorsport LLC , Boston Ma April 2015 - Present
Minot Motorworks October 2014 - April 2015
DDC April 2014 - October 2014
Alpha 1 flight services December 2013 - April 2014
WALDORF HIGH SCHOOL OF MASSACHUSETTS BAY September 2011 - March 2012
CARIGNAN HOME IMPROVEMENTS September 2010 - September 2011
Anika Therapeutics February 2008 - April 2009
Skills
Biotechnology, Validation, Aircraft Maintenance, Budgets, Public Speaking, Sales, Construction, Education, Automotive Repair, Automotive Electronics, Quality Control, Teaching, Customer Service, Project Management, Life Sciences, Microsoft Office
Education
National Aviation Academy of New England 2012 — 2013
AVIATION MAINTENANCE TECHNICIAN PROGRAM, AVIATION MAINTENANCE, 97.95%
University of Massachusetts, Amherst 2002 — 2005
B.S. PLANT SOIL AND INSECT SCIENCES, MINOR MICROBIOLOGY, 3.27 GPA
WALDORF HIGH SCHOOL OF MASSACHUSETTS BAY 1997 — 2001
Anika Therapeutics May 2009 - Present
Bionostics October 2007 - May 2009
Anika Therapeutics Inc September 1999 - September 2007
AAC Consulting Group 1998 - 1999
Education
Lehigh University 1986 — 1990
Anika Therapeutics November 2005 - Present
Lonza 2000 - 2004
Education
University of New Hampshire 1993 — 1997
St Jude Medical April 2010 - Present
Onel Technologies Inc. July 1995 - Present
Boston Scientific 2009 - 2010
Boston Scientific 2009 - 2009
PharmEng Technology Inc. 2008 - 2009
Anika Therapeutics 2008 - 2008
SNC Lavalin Pharma July 2001 - October 2002
Bayer Diagnostics January 2000 - August 2001
Apotex Inc. 1999 - 2000
GlaxoWellcome 1995 - 1999
Skills
Validation, GxP, Manufacturing, GMP, Technology Transfer, Medical Devices, Start-ups, GAMP, CAPA, FDA, Testing, Biopharmaceuticals, Commissioning, R&D, Biotechnology, ISO 13485, Process Simulation, Quality System, Regulatory Affairs, Quality Assurance, Pharmaceutical Industry, Sop, Lifesciences, 21 CFR Part 11, Cross-functional Team..., V&V, ISO, Root Cause Analysis, Quality Control, Quality Management, Quality Auditing, Process Engineering, Commercialization, Change Control, Product Launch, Six Sigma, SOP, Life Sciences
Education
University of Cape Town 1986 — 1991
E.E.
University of Cape Town 1986 — 1989
Berkshire Sterile Manufacturing February 2014 - Present
Kinney Consulting October 2010 - February 2014
Hyaluron October 1999 - October 2010
Anika Therapeutics September 1996 - September 1999
Anika Therapeutics September 1995 - September 1996
Wyeth Ayerst September 1988 - September 1991
Waters Corporation September 1985 - September 1988
Skills
Validation, Pharmaceutical Industry, Aseptic Processing, Biotechnology, Formulation, Drug Delivery, Lyophilization, Parenteral, Management, Strategic Planning, Technology Transfer, GMP, Lifesciences, Biopharmaceuticals, FDA
Education
University of Massachusetts, Amherst 1991 — 1995
PhD., Analytical Chemistry
Northeastern University 1983 — 1986
Masters, Medicinal Chemistry
Southeastern University 1978 — 1982
Bachelor of Applied Science (B.A.Sc.), Chemistry
iRobot Corporation February 2008 - Present
Anika Therapeutics 2006 - 2008
EMD Millipore December 2002 - February 2006
Select Appointments 2003 - 2005
Skills
Accounting, Process Improvement, Accounts Payable, Project Management, Revenue Recognition, Team Building, Oracle E-Business Suite, Continuous Improvement, Team Leadership, Auditing, Microsoft Excel, Analysis, Microsoft Office, PowerPoint, Cross-functional Team..., Microsoft Word, Customer Service, Payroll, Purchasing, Manufacturing, Financial Analysis, Financial Reporting, Outlook
Education
University of Massachusetts Lowell 1995 — 1999
Genzyme January 2014 - Present
Genzyme May 2011 - January 2014
Anika Therapeutics April 2007 - May 2011
Genzyme June 2003 - March 2007
Education
Tufts University 2010 — 2012
MSEM, Engineering Management
Tufts University 2005 — 2009
ME, Biotechnology Engineering
Northeastern University 1998 — 2003
BS, Chemical Engineering
Biogen Idec January 2013 - Present
Genzyme November 2011 - January 2013
Genzyme December 2009 - November 2011
Anika Therapeutics September 2006 - December 2009
Nutramax January 2006 - September 2006
Centro January 1999 - October 2001
RSU July 1990 - April 1996
Skills
21 CFR Part 11, FDA, Pharmaceutical Industry, GMP, Biotechnology, Validation, Medical Devices, CAPA
Education
Doctor Harisingh Gour Vishwavidyalaya
Master's degree, Microbiology
Pandit Ravishankar Shukla University
Master of Philosophy (M.Phil.), Life Sciences
Syracuse University
Computer and Information Sciences and Support Services
Dassault Systemes August 2014 - Present
Amadeus, North America May 2013 - July 2014
Mevion Medical Systems July 2012 - April 2013
ikaSystems July 2010 - June 2012
Anika Therapeutics April 2010 - May 2010
BAE Systems, Advanced Information Technology May 2007 - May 2009
Boston Scientific 2005 - 2006
Raytheon 2004 - 2005
MIT Lincoln Laboratory 2004 - 2005
CDI Corporation 2001 - 2004
Skills
Generic Special..., Reading Certification, K-8, Sourcing, Recruiting, Employee Relations, Human Resources, Employment Law, Employee Benefits, Management, Talent Acquisition, Technical Recruiting, Onboarding, Applicant Tracking..., Friendly Personality, HR Policies, Keen Listener, Temporary Placement, Interviews, Deferred Compensation, Screening, Internet Recruiting, Hiring, Healthcare, Temporary Staffing, Start-ups, Consulting, Personnel Management, Leadership, Process Improvement, Executive Search, Training, Talent Management, Contract Recruitment
Education
Fitchburg State College 1990 — 1994
M.S. Management, Business, Cum Laude
Framingham State College
Graduate Coursework, Generic Special Education, Cum Laude
Lesley University
B.A. Education, Special Education; Child Psychology, Cum Laude
Genentech 2013 - Present
Anika Therapeutics 2011 - 2013
Shire HGT 2005 - 2009
Amgen 2004 - 2005
Novo Nordisk 2001 - 2003
Skills
Biopharmaceuticals, Validation, GMP, Process Development, Purification, Technology Transfer, Commissioning, FDA, Process Control, Project Managenment, Manufacturing Support, Design of Experiments, SPC, Process Engineering, Quality by Design, Protein Purification, Cell Culture, Manufacturing, Biotechnology, Process Simulation
Education
The University of British Columbia 1994 — 1997
Masters of Applied Science, Chemical and Biological Engineering
Nanjing University of Technology
scPharmaceuticals May 2015 - Present
Anika Therapeutics November 2013 - April 2015
Thoratec Corporation July 2002 - October 2013
St. Jude Medical December 1999 - June 2002
Baxter International Cardiovascular Group 1997 - 1999
Skills
Regulatory Affairs, FDA, Medical Devices, ISO 13485, Design Control, Clinical Trials, CAPA, Regulatory Submissions, PMA, Biomedical Engineering, Quality System, ISO 14971, Biotechnology, Validation, CE marking, Lifesciences, Combination Products, Class III Medical..., International..., Life Sciences
Education
University of California, San Diego
BS, Biology
University of Utah
MPH, Public Health
Julia Therapeutics January 2006 - Present
Anika Therapeutics 2005 - 2006
Smith & Nephew Endoscopy January 2002 - 2005
Summit Technology 1990 - 2000
Education
Columbia Law School
Anika Therapeutics February 2012 - Present
Praxis Advisors February 2009 - March 2012
Nucryst Pharmaceuticals June 2007 - December 2008
Anika Therapeutics 1998 - 2007
AnikaTherapeutics 1998 - 2007
Immulogic Pharmaceuticals 1995 - 1997
Biogen Idec 1991 - 1994
Alpha Therapeutics 1988 - 1991
Lederle Labs 1984 - 1988
New England Deaconess Hospital 1978 - 1984
Skills
Lifesciences, Pharmaceutical Industry, Licensing, Medical Devices, New Business Development, Product Development, Corporate Development, Biopharmaceuticals, Biotechnology, Business Development, Commercialization, Cross-functional Team..., FDA, Life Sciences, Marketing, Oncology, Product Launch, Technology Transfer
Education
Massachusetts College of Pharmacy and Health Sciences 1974 — 1979
BS, MS
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
Anika Therapeutics June 1997 - Present
Skills
Team Building, Disaster Recovery, Outsourcing Management, Active Directory, Virtualization, IT Management, Problem Solving, Change Control, Troubleshooting, Strategic Planning, IT Strategy, Microsoft Technologies, System Administration, GMP, Software Documentation, Validation, Process Simulation, Process Improvement, Cross-functional Team...
Education
Northeastern University
Skyworks Solutions, Inc. October 2014 - Present
BioConcept Laboratories, Inc. May 2014 - August 2014
Anika Therapeutics 2009 - May 2014
Exiqon June 2008 - December 2009
Wyeth December 2001 - November 2007
Skills
GxP, 21 CFR Part 11, Pharmaceutical Industry, CAPA, GMP, Sop, Validation, Change Control, FDA, Computer System..., LIMS, Quality System, Quality Control, Technology Transfer, SOP, V
Education
University of Maine 1989 — 1996
Master of Science (MS), Microbiology
FDA November 2014 - Present
Anika Therapeutics August 2011 - November 2014
Pfizer/Wyeth July 2007 - August 2011
US Army Research Institute of Environmental Medicine (USARIEM) March 1993 - April 1994
US Army Environmental Hygiene Agency (USAEHA) July 1990 - March 1993
Skills
GMP, Sop, Validation, Aseptic Processing, CAPA, FDA, GLP, Biotechnology, 21 CFR Part 11, Change Control, Trackwise, V, Biopharmaceuticals, LIMS, SOP, Environmental Compliance, V&V
Education
Gordon College 1986 — 1989
BS, Biology
Ocular Therapeutix, Inc. March 2015 - Present
Acusphere, Inc., Watertown, MA 2006 - February 2015
Macrochem Products 2004 - 2005
AltaRex 2001 - 2003
Anika Therapeutics 1991 - 2000
Skills
Pharmaceutical Industry, SEC filings, Biotechnology, Clinical Trials, Financial Analysis, Internal Controls, Revenue Recognition, Sop, Financial Reporting, Compliance, Sarbanes-Oxley Act, Medical Devices, Auditing, Mergers, Accounting, Lifesciences, US GAAP, FDA, Budgets, Sarbanes-Oxley, GAAP, Due Diligence, Mergers & Acquisitions
Education
Merrimack College 1984 — 1989
Bachelor, Accounting
Suffolk University - Sawyer Business School
Masters, Business Administration with Concentration in Organizational Behavior
Histogenics Corporation July 2015 - Present
Genzyme June 2014 - December 2014
Anika Therapeutics June 2014 - June 2014
Eisai March 2013 - November 2013
Repligen Corporation November 2010 - November 2012
Joule Biotechnologies September 2008 - October 2010
Avecia Biotechnologies June 2005 - June 2008
Skills
Quality Control, Analytical Chemistry, Biotechnology, Chromatography, Pharmaceutical Industry, HPLC, GLP, Validation, GMP, FDA, Life Sciences, UV/Vis, LIMS, 21 CFR Part 11, CAPA
Education
University of Massachusetts Lowell 1998 — 2000
Masters, Clinincal lab Sciences
Shire August 2012 - Present
Genentech March 2012 - July 2012
Allergan Medical (formerly Serica Technologies) 2010 - 2012
Serica Technologies 2008 - 2010
Anika Therapeutics 2006 - 2008
Lonza Biologics 2002 - 2006
Lonza Biologics 2001 - 2002
Lonza Biologics 2000 - 2001
Wyeth Biopharma (formerly Genetics Institute) 1998 - 2000
Millipore 1995 - 1998
Skills
GMP, CAPA, Validation, FDA, Quality System, Quality Assurance, Biopharmaceuticals, Quality Control, Six Sigma, Medical Devices, Microbiology, ISO, Manufacturing, Continuous Improvement, Lean Manufacturing, Deviations, Cell Culture, Software Documentation, Environmental Monitoring, Trackwise, 21 CFR Part 11, Aseptic Processing
Education
University of Massachusetts at Lowell 1996 — 1998
Graduate Certificate, Biotechnology
University of New Hampshire 1987 — 1991
BA, Microbiology
LighTouch Medical April 2014 - Present
BTA June 2004 - Present
Anika Therapeutics 2003 - 2004
Immunogen 2001 - 2002
Ciba-Corning 1982 - 2000
Ciba Geigy 1968 - 1982
Skills
Business Development, Marketing, Strategic Planning, Healthcare, Negotiation, Licensing, Business Planning, Pharmaceutical Industry, Brand Development, Medical Devices, Sales
Education
St. John's University School of Law 1971 — 1975
JD, Law
Saint John's University 1969 — 1971
MBA, Exec Mgt
Fordham University 1963 — 1967
BS, Biology
Advanced Cell Technology 2010 - March 2011
Anika Therapeutics April 2009 - December 2009
pharmalucence October 2008 - April 2009
Toxikon January 2008 - September 2008
Medical discovery partners LLC October 2004 - March 2006
Boston medical center May 2004 - October 2004
museum of science April 2003 - May 2004
Skills
Microbiology, SDS-PAGE, Molecular Biology, Biopharmaceuticals, Validation, GMP, FDA, Biotechnology, CAPA, LIMS, Lifesciences, Pharmaceutical Industry, Cell Culture, Laboratory, Technology Transfer, Microscopy, Quality Control, Testing, Environmental Monitoring, V&V, Aseptic Processing, Aseptic Technique, Sop, Medical Devices, GLP, ELISA, qPCR, DNA extraction, Life Sciences
Education
University of Madras 1998 — 2000
Master's degree, Microbiology
M.S microbiology
Anika Therapeutics September 2014 - Present
Lampire Biological Laboratories August 2012 - May 2014
Bioresource Technology Inc. September 2003 - March 2012
Serologicals (prev. Intergen, now Seracare) June 1999 - March 2003
Bayer Diagnostics (prev. Chiron, now Siemens Healthcare) February 1993 - May 1999
Chiron Corporation (prev. Novartis) March 1995 - May 1996
Novartis ( prev. Ciba Corning) February 1993 - March 1995
Skills
GMP, Validation, FDA, CAPA, Biotechnology, Technology Transfer, Quality Assurance, Manufacturing, Pharmaceutical Industry, Medical Devices, ISO 13485, V&V, GLP, R&D, Process Engineering, Design of Experiments, Quality Control, Lean Manufacturing, Product Development, Process Improvement, Change Control, Chromatography
Education
University of Rhode Island 1996 — 1998
EMBA, College of Business Administration
University of Rhode Island
Bachelor of Science (B.S.), Chemical Engineering
Anika Therapeutics June 2008 - Present
Epic Therapeutics June 2006 - October 2007
MA department of public health 2001 - 2006
Education
University of Massachusetts, Amherst 1996 — 2000
BS, Microbiology
Allergan Medical January 2010 - Present
Serica Technologies, Inc. May 2007 - January 2010
Anika Therapeutics 2006 - 2007
Miltenyi Biotec 2002 - 2006
Eligix/Biotransplant 1998 - 2002
Beckman Coulter 1984 - 1998
Skills
Regulatory Affairs, Class III Medical..., Biopharmaceuticals, Quality Assurance, Biotechnology, Regulatory Requirements, Product Development, V&V, FDA, Clinical Development, Clinical Research, GLP, Validation, IND, Lifesciences, 21 CFR Part 11, Pharmaceutical Industry, Sop, GCP, Drug Development, SOP, Quality System
Education
Barry University 1991 — 1994
Master of Business Administration (MBA)
Doane College 1980 — 1982
BA, Natural Sciences
Anika Therapeutics October 2012 - Present
Skills
GMP, Quality Control, SOP, HPLC, Quality System, Validation, FDA, UV/Vis, Analytical Chemistry, Chromatography, Chemistry, GC-FID
Education
Eastern Kentucky University 2007 — 2009
Chemistry
Kennesaw State University 2001 — 2003
BS, Chemistry
Central Dauphin 1994 — 1996
Sirtex Wilmington LLC July 2010 - Present
Anika Therapeutics June 2009 - July 2010
Verax Biomedical, Inc. June 2006 - May 2008
Biovest International June 2005 - August 2005
MGI Pharma February 2005 - April 2005
Alkermes January 2002 - June 2004
Organogenesis January 2000 - November 2001
Genzyme Biosurgery October 1995 - January 2000
Biogen September 1986 - November 1991
Skills
FDA, Assay Development, Molecular Biology, Biotechnology, ELISA, CAPA, Aseptic Technique, Cell, Quality Assurance, Laboratory, GMP, Cell Culture, Quality Control
Education
Northeastern University 1978 — 1983
B.S., Biology
Genzyme October 2009 - Present
Anika Therapeutics December 2007 - February 2009
BD Biosciences July 2002 - December 2007
Graphique de France March 2000 - May 2002
DS GRAPHICS, INC 1997 - 2000
Skills
Materials Management, Analysis, Product Development, Procurement, Supply Chain, Purchasing, MRP, Manufacturing, Cross-functional Team..., Contract Negotiation, Process Improvement, Inventory Management, Logistics, Negotiation, Supply Chain Management, Strategic Sourcing, Lean Manufacturing, SAP, APICS
Education
Northeastern University 2003 — 2004
Certificate, Supply Chain Management
Northeastern University 1998 — 2002
BS/BA, Business Management
ST JOSEPH'S HIGH--LOWELL
Tufts Medical Center April 2011 - Present
Anika Therapeutics June 2008 - April 2011
Wyeth 2007 - 2008
Bauchi specialist hospital March 1998 - February 1999
Skills
Biotechnology, Healthcare, Sop, FDA, 21 CFR Part 11, GMP, Medical Devices, Pharmaceutical Industry, SOP
Education
University of Massachusetts Lowell 2008 — 2009
MS, Clinical research
University of Benin 1990 — 1997
OD, Doctor of Optometry
Merrimack Pharmateuticals, Inc. July 2014 - Present
Anika Therapeutics September 2010 - July 2014
Candela Corporation January 2007 - September 2010
Parametric Technology Corporation January 2005 - January 2007
3Com 2004 - 2004
American Tower 1999 - 2004
Leydon & Gallagher, 1989 - 1998
Price Waterhouse 1988 - 1989
Skills
SEC filings, Accounting, General Ledger, Auditing, Tax, Management, Accounts Payable, Internal Audit, Payroll, Financial Reporting, Consolidation, SEC Filings, Forecasting, Financial Statements, Sarbanes-Oxley Act
Education
Bentley University 1991 — 1996
MS, Taxation
Bentley University 1987 — 1988
BS, Accountancy
University of Massachusetts, Amherst
Genzyme Corporation July 2009 - Present
Anika Therapeutics July 2007 - July 2009
Education
Regis College 2005 — 2006
MS, Health Product Regulation
Blend Therapeutics June 2015 - Present
Acusphere, Inc. December 2010 - February 2015
Anika Therapeutics May 2009 - November 2010
Acusphere, Inc. 2008 - 2009
Acusphere, Inc. 2003 - 2008
Skills
CMO Management, Manufacturing..., Technology Transfer, GMP, Aseptic Processing, Engineering Management, Validation, Process Development, GxP, LIMS, CMO management, Filtration, Biopharmaceuticals, Aseptic Technique, Regulatory Submissions, Deviations, Cleaning Validation, Sterilization, Purification, Formulation, Drug Development, Manufacturing, Clinical Trials, Cross-functional Team..., Fermentation, Process Simulation
Education
Northeastern University 1997 — 2002
Bachelors, Chemical Engineering
Genzyme Biosurgery April 2011 - Present
Genzyme June 2009 - April 2011
Anika Therapeutics October 2006 - March 2009
Anika Therapeutics April 1997 - October 2006
Thermo Electron June 1994 - May 1995
Education
University of Massachusetts, Amherst 1991 — 1994
MS, Analytical Chemistry
Shire Pharmaceuticals March 2014 - Present
Shire HGT May 2011 - March 2014
Anika Therapeutics August 2009 - May 2011
Azonix Corporation October 2007 - April 2009
Kontron August 2006 - September 2007
CardioDynamics November 2004 - August 2006
Thermo Fisher Scientific August 2005 - September 2005
Autosplice December 1996 - November 2004
KLA-Tencor June 2000 - November 2000
Skills
Cross-functional Team..., Supply Chain, Manufacturing, Lean Manufacturing, Kaizen, MRP, Supply Management, Process Improvement, Product Development, Forecasting, Biotechnology, Logistics, Medical Devices, Management, Continuous Improvement, Six Sigma, Quality System, Materials Management, Supply Chain Management, ISO, Production Planning, Project Planning, GMP, Root Cause Analysis, CAPA, Quality Assurance, FDA
Education
Bethel Theological Seminary 1997 — 1999
Master of Arts, Theology
Fuller Theological Seminary 1994 — 1996
Work towards MA, Theology
Point Loma Nazarene University 1992 — 1994
Bachelor of Arts, Religion, Theology, Philosophy
San Diego State University-California State University 1991 — 1992
Work towards undergrad degree, Geology, Sociology
Palomar College 1987 — 1991
Work towards undergrad degree, Geology, Anthropology, Astronomy
San Pasqual High School
Sensitech August 2012 - Present
Exemplar Pharma, LLC, August 2011 - August 2012
Proventys, Inc, June 2010 - May 2011
Anika Therapeutics June 2009 - May 2010
Kraft Foods February 2009 - April 2009
Teleflex Medical August 2008 - January 2009
Analog Devices August 2007 - August 2008
NFPA November 2006 - August 2007
Shire HGT November 2003 - November 2006
Skills
Software Documentation, Technical Writing, Validation, GMP, Quality System, FDA, Document Management, Change Control, Training, V&V, Medical Devices, SDLC
Education
Providence College 1994 — 1998
Bachelor of Arts, English/Writing
Bristol-Myers Squibb May 2011 - Present
Bio-Concept Laboratories January 2011 - May 2011
Anika Therapeutics September 1998 - October 2010
Skills
CAPA, FDA, 21 CFR Part 11, Cell Culture, Filtration, Manufacturing, Clean Rooms, GMP, Sop, Validation, Biotechnology, Quality Assurance, Pharmaceutical Industry, Technology Transfer, Quality Control, V&V, Quality System, Aseptic Processing
Education
Manhattan College 1983 — 1984
MS, Civil Engineering
Anika Therapeutics August 2005 - August 2010
Genzyme January 1994 - July 2003
Education
Boston University School of Medicine 1999 — 2002
Bachelor of Science in Biomedical Laboratory and Clinical Sciences
inVentiv Health Clinical November 2012 - Present
inVentiv Health Clinical 2012 - 2015
inVentiv Health Clinical 2012 - 2015
Execupharm 2010 - 2012
H&E Clinical Consulting, LLC May 2010 - February 2011
Pfizer 2011 - 2011
Genzyme 2010 - 2011
Anika Therapeutics February 2009 - March 2010
EyeGate Pharmaceuticals July 2007 - April 2008
Biosphere Medical, Inc. 2006 - 2007
Skills
Clinical Research, Pharmaceutical Industry, Medical Devices, Biotechnology, Clinical Trials
Education
Heidelberg University 1976 — 1980
BS, Psychology/Sociology
St. Edward High school 1972 — 1976
Abbott May 2015 - Present
Ortho Clinical Diagnostics November 2010 - April 2015
Anika Therapeutics April 2010 - September 2010
Lonza Biologics February 2007 - March 2010
Pfizer October 2006 - December 2006
University of New Hampshire January 2003 - August 2006
Skills
GMP, Validation, Sop, LIMS, Microbiology, CAPA, Environmental Monitoring, Lifesciences, Biotechnology, FDA, Change Control, Cell Culture, Pharmaceutical Industry, 21 CFR Part 11, Medical Devices, GLP, ISO 13485, Quality Assurance, V&V, Quality Control, SOP, Life Sciences
Education
Temple University 2014 — 2017
Master's Degree, Quality Assurance and Regulatory Affairs
University of New Hampshire 2002 — 2006
Bachelor's degree, Biology, General
Temple University
Quality Assurance/Regulatory Affairs
TMC Ametek January 2015 - Present
L-3 Communications June 2005 - July 2013
L-3 Communications June 2002 - January 2005
Anika Therapeutics 2001 - 2002
Anika Therapeutics 2001 - 2002
Ametek Aerospace 1998 - 2000
Ametek Aerospace 1995 - 1998
Honeywell Bull 1987 - 1989
Skills
Macola, ERP, Process Improvement, Internal Audit, Risk Management, Leadership, Cost Accounting, Variance Analysis
Education
Merrimack College
BS, Accounting
University of Dayton 1978 — 1980
Mechanical Engineering
Quanterix August 2015 - Present
Americanbio, Inc. July 2011 - August 2015
Anika Therapeutics February 2010 - June 2011
Boston Biomedica 1992 - 2003
Skills
CAPA, GMP, FDA, Change Control, GxP, Quality Assurance, Biotechnology, Validation, Commercialization, 21 CFR Part 11, Sop, Quality Control, Team Leadership, PowerPoint, Strategic Planning, GLP, Aseptic Processing, Lifesciences
Education
Stonehill College
Bachelor of Science (BS), Biology/Chemistry
highschool
Anika Therapeutics March 2009 - Present
Contract Manufacturing December 2007 - January 2009
Stryker Biotech May 2004 - December 2007
Bristol-Myers Squibb / Dupont Pharmaceuticals March 1997 - May 2004
Biosurface/Genzyme Biosurgery January 1990 - July 1996
Skills
CAPA, Purification, Change Control, FDA, V&V, Troubleshooting, Validation, Manufacturing, Medical Devices, Lifesciences, Pharmaceutical Industry, Technology Transfer, 21 CFR Part 11, Cell, GMP, LIMS, Process Improvement, Formulation, Quality System, Automation, Sop, Biopharmaceuticals, Aseptic Processing, Training, Management, Quality Assurance, Biotechnology, Quality Control, Cleaning Validation, ISO 13485, Process Simulation, Chromatography, Aseptic Technique, Root Cause Analysis, Cell Culture, Sterilization, Cross-functional Team..., Filtration, Continuous Improvement, Environmental Monitoring, CIP, Quality Auditing, Clean Rooms, Lean Manufacturing, Drug Delivery, Lyophilization, Contract Manufacturing, cGMP manufacturing, Downstream Processing, cGMP practices
Education
University of Massachusetts Lowell
Biology
Austin Prep 1982 — 1986
Diploma, College Prep Studies
Bob Tellis and Associates January 2001 - Present
Anika Therapeutics 2002 - 2003
NitroMed June 1999 - September 2000
ImmunoGen, Inc. June 1998 - June 1999
Ciba-Corning Diagnostics June 1986 - June 1994
Ciba Geigy Pharma 1981 - 1990
Education
St. John's University School of Law 1971 — 1975
JD, contract law
Saint John's University 1969 — 1971
MBA, exec. management
Fordham University 1963 — 1967
BS, biology, philosophy
School name:
Courtagen Life Sciences, Inc. September 2015 - Present
Allergan February 2014 - June 2015
Allergan July 2011 - February 2014
Allergan December 2010 - July 2011
Anika Therapeutics June 2007 - June 2010
Skills
CAPA, FDA, ISO 13485, Validation, GMP, Sop, Change Control, Medical Devices, Quality System, Biotechnology, Biomaterials, Materials Management, Manufacturing, Environmental Monitoring, Pharmaceutical Industry, SOP, Quality Control, 21 CFR Part 11, Design Control, Cross-functional Team..., Six Sigma, V&V
Education
University of Massachusetts at Lowell 2000 — 2006
Bachelors, Mechanical Engineering Technology, Cum Laude
Smiths Medical February 2014 - Present
Anika Therapeutics March 2010 - January 2014
J-PAC, LLC June 2008 - November 2009
AMERIFIT PHARMA, INC November 2007 - June 2008
LAUREATE PHARMA, INC June 2005 - April 2006
Johnson Matthey November 2003 - June 2005
XYLOS CORPORATION May 2003 - August 2003
BIOMIRA, INC February 2000 - October 2002
Skills
GMP, Product Development, Batch Records, Batch Release, Quality Control, FDA GMP, Aseptic Processing, FDA, Process Simulation, Manufacturing, Testing, Quality System, Deviations, Quality Assurance
Education
Drexel University 2003 — 2005
BS, Management
Mercer County Community College
AS Degree, Biology
Tepha, Inc. July 2015 - Present
DENTSPLY IH November 2013 - June 2015
Integra LifeSciences October 2010 - November 2013
Candela Corporation July 2010 - September 2010
Anika Therapeutics January 2009 - February 2010
Laser Services August 2007 - February 2009
Skills
GMP, Medical Devices, CAPA, Quality System, FDA, ISO 13485
Education
University of Massachusetts, Amherst 2002 — 2007
BS, Physics, Mathematics
Anika Therapeutics September 2007 - February 2010
IBM May 2006 - September 2007
Education
Lesley University
Masters, Business Management
Ogletree, Deakins, Nash, Smoak & Stewart, P.C October 2011 - Present
Ogletree Deakins March 2009 - October 2011
Eze Castle Integration July 2007 - February 2008
Anika Therapeutics July 2006 - July 2007
Filene's August 2002 - May 2006
Skills
Litigation, Legal Research, Microsoft Office, Legal Writing, Microsoft Excel, Research, Customer Service, Microsoft Word, Legal Assistance, PowerPoint, Outlook, Retail, Data Entry, Event Planning, Social Media
Education
Fisher College 2002 — 2005
Bachelor's degree, Business Management
Fisher College 1999 — 2001
Associate's degree, Paralegal Studies
Crosspoint Engineering July 2005 - Present
Shire HGT August 2009 - October 2012
Anika Therapeutics August 2007 - August 2009
AspenTech July 2000 - May 2003
Honeywell Process Solutions 1996 - 2000
Skills
Validation, GMP, Engineering, Process Engineering, Troubleshooting, Process Improvement, Manufacturing, Programming, Documentation, cGMP, Automation, Problem Solving, PLC, Instrumentation, Commissioning, Requirements Analysis, Change Management, User Interface, Technical Writing
Education
University of South Florida 1988 — 1993
BSChE, Engineering
Novartis Institutes for BioMedical Research December 2012 - Present
Aushon BioSystems December 2010 - December 2012
Aerotek Contract September 2010 - December 2010
Genzyme Genetics January 2009 - September 2010
Genzyme Biosurgery July 2005 - December 2008
Anika Therapeutics September 2004 - June 2005
Skills
Protein Chemistry, Assay Development, Protocol, Biotechnology, Cell Culture, Lifesciences, ELISA, Gel Electrophoresis, PCR, GMP, Molecular Biology, qtPCR, biomakers multiplexing, Protein-protein..., Protein Assays, Immunoassay development..., Soluble Protein...
Education
Northeastern University 2012 — 2014
Master of Science (M.Sc.), Project Management (Clinical Trial Design)
Boston University 2005 — 2007
B.Sc Biomedical and Clinical Research
Middlesex Community College 2003 — 2005
A.S, Biotechnology
Anika Therapeutics
Skills
Biotechnology, CAPA, Cross-functional Team..., FDA, GMP, ISO 13485, Medical Devices, Pharmaceutical Industry, Quality System, Technology Transfer, Validation
Education
University of Massachusetts, Amherst 1994 — 1999
B.S., Chemical Engineering
GE Healthcare April 2015 - Present
Anika Therapeutics December 2013 - April 2015
Anika Therapeutics October 2011 - December 2013
Life Technologies May 2011 - September 2011
Zapp Lab, Umass Medical School May 2010 - May 2011
Zapp Lab, UMass Medical School May 2009 - May 2010
Bath and Body Works August 2006 - March 2009
Skills
Gel Electrophoresis, Biotechnology, Chromatography, FDA, Laboratory, Protein Expression, Western Blotting, DNA, GMP, Sop, Manufacturing, Validation, HPLC, LIMS, Purification, SOP, CAPA, Microbiology
Education
Framingham State University
Bachelor of Science, Chemistry
Hudson High School
High School Diploma
TJX August 1999 - 2011
The TJX Companies 1999 - 2010
Celerity Solutions, Dedham, MA 1996 - 1999
Anika Therapeutics 1993 - 1996
Medical Devices Company, Kiev, Ukraine 1977 - 1992
Education
Ukrainian State Chemical Technology University, Dnipropetrovsk
Bachelor of Science Degree, Math and Chemistry
Lancaster Laboratories March 2014 - Present
Amgen March 2014 - Present
University of Massachusetts September 2012 - December 2013
Anika Therapeutics January 2012 - September 2012
Skills
Biotechnology, Cell Culture, Lifesciences, Technical Transfers, Biomedical Engineering, Formulation Fill Finish, Peristaltic Pump..., Validation
Education
University of Massachusetts Lowell 2012 — 2013
Master's Degree, Biomedical Engineering & Biotechnology
University of New Hampshire 2007 — 2011
University of New Hampshire 2007 — 2011
Bachelor of Science (BS), Chemical Engineering, Energy Option
Kavaliro/Disney April 2014 - Present
Self Employed PersonalTax January 2008 - Present
Genzyme October 2006 - May 2007
MICROFINANCIAL, INC 2005 - 2006
CRITICAL THERAPEUTICS INC 2005 - 2005
DELOITTE & TOUCHE, LLP 2003 - 2004
Anika Therapeutics January 2001 - January 2003
Skills
Journal Entries, Account Reconciliation, GAAP, Accounting, Internal Controls, SEC Financial Reporting, Tax, Financial Analysis, Financial Reporting, Tax Returns, Tax Accounting, Financial Statements, Sarbanes-Oxley Act, Finance, Auditing, SEC filings, Forecasting, Budgets, Sales Tax, Accruals
Education
Northeastern University 1997 — 2000
Master's degree, Taxation, 3.5
Northeastern University 1997 — 2000
Master of Science Degree, Taxation
Northeastern University 1985 — 1987
Bachelor of Science Degree, Business Administration; Accounting. Accounting
Anika Therapeutics January 2008 - Present
Biogenidec January 2004 - November 2007
Pfizer January 2001 - January 2004
Lucent Technologies January 1999 - January 2001
A.E.P Industries January 1989 - January 1999
Skills
Validation, Aseptic Processing, V&V, Filtration, Manufacturing, Medical Devices, HPLC, Sterilization, Root Cause Analysis, CAPA, Change Control, GMP, 21 CFR Part 11, Environmental Monitoring, Troubleshooting, Quality System, Aseptic Technique, FDA, LIMS, Chromatography, Biotechnology, Autoclave, ISO 13485, Pharmaceutical Industry, Cell Culture, Deviations, Formulation, Sop
Education
Northern Essex Community College
Anika Therapeutics August 2009 - Present
Omya June 2008 - March 2009
Amerifit Brands February 2007 - November 2007
Bionostics April 2001 - January 2007
Army National Guard November 1994 - November 2003
Skills
CAPA, Quality System, FDA, Quality Control, Sop, Quality Assurance, Product Development, GMP, Change Control, GLP, Validation, LIMS, ISO 13485
Education
Norwich University
Organogenesis QC Analyst
Ipsen September 2011 - March 2012
Anika Therapeutics March 2010 - July 2010
Associates of Cape Cod 2000 - 2009
Skills
Pharmaceutical Industry, Biotechnology, Quality System, GMP, Sop, Aseptic Processing, CAPA, Quality Assurance, Quality Control, Validation
Education
Salve Regina University 1993 — 1997
Bachelor of Science (BS), Microbiology, General
Advansource Biomaterials September 2007 - Present
Healthcare Automation June 2006 - December 2007
Anika Therapeutics February 1991 - July 2005
Skills
GMP, Quality Assurance, Sop, ISO, Quality System, Calibration, Document Management, FDA, GxP, Quality Control, CAPA, Validation, 21 CFR Part 11, Design Control, Regulatory Affairs, GLP, ISO 13485
Education
The Salter School-Tewksbury Campus 2006 — 2006
certificate, medical billing
Syneron/Candela Corporation September 2011 - Present
Anika Therapeutics June 2011 - September 2011
Anika Therapeutics February 2005 - September 2010
Genzyme Corporation January 1994 - December 2002
Education
Boston University 1998 — 2002
Bachelor of Science, Biomedical Laboratory and Clinical Sciences
AMRI October 2011 - Present
Anika Therapeutics July 2011 - October 2011
Pharmalucence June 2005 - March 2011
Diatide Laboratoies July 2002 - June 2005
DuPont Pharmaceutical Company May 1995 - December 2002
DuPont Pharmaceutical Company August 1993 - May 1995
Skills
Experienced in GC and..., Experienced with UV/VIS..., Experience in EPA Lab..., Experience with both...
Education
UMass Lowell
Bachelor of Science (BS), Environmental Science
Augmenix, Inc. August 2013 - August 2015
Anika Therapeutics May 2013 - August 2013
Massachusetts General Hospital January 2012 - August 2012
Genzyme January 2011 - July 2011
Genzyme January 2010 - July 2010
Draper Laboratory May 2009 - September 2009
Skills
Matlab, R&D, AutoCAD, Biotechnology, SolidWorks, Engineering, LabVIEW, Medical Devices, Chemical Engineering, FDA, CNC Mill
Education
Illinois Institute of Technology 2015 — 2017
Master of Science (M.S.), Biomedical Engineering
Northeastern University 2008 — 2013
Bachelor's degree, Chemical Engineering / Biochemical Engineering
Anika Therapeutics 2015 - Present
Skills
Regulatory Affairs, FDA, Medical Devices, Design Control, Regulatory Submissions, Regulatory Requirements, CE marking, 21 CFR Part 11, Validation, ISO 14971, Clinical Trials, Change Control, PMA, Leadership
Education
Northeastern University
Master of Science (MS), Regulatory Affairs
Northeastern University
Graduate Certificate in Biopharmaceutical International Regulatory Affairs
Stonehill College
Bachelor of Arts (BA), Criminology
Stonehill College
Paralegal Certification
Anika Therapeutics June 2015 - September 2015
Collins-Crochiere Construction Services May 2014 - January 2015
Skills
Microsoft Office, Microsoft Excel, Microsoft Word
Education
University of Massachusetts, Amherst 2012 — 2016
Bachelor’s Degree, Biochemistry and Molecular Biology, 3.7
Minnechaug Regional High School 2008 — 2012
GPA 3.9/4.0