Control Delivery Systems
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Control Delivery Systems Employees
Lantheus Medical Imaging December 2012 - February 2014
AMAG Pharmaceuticals December 2006 - November 2012
Fresenius Biotech GmbH July 2005 - December 2006
Able Laboratories January 2005 - June 2005
The Gillete Company February 2004 - January 2005
Control Delivery Systems June 2003 - June 2003
Alkermes May 2002 - August 2002
PAREXEL May 1997 - May 2002
Genetics Institute 1995 - 1997
Genetics Institute 1992 - 1995
Skills
Clinical Development, Regulatory Affairs, Pharmacovigilance, Clinical Trials, Sop, Pharmaceutical Industry, Oncology, CRO, Biotechnology, Immunology, CTMS, IND, Microbiology, Biochemistry, FDA, Quality Assurance, Regulatory Submissions
Education
Ohio University 1982 — 1985
M.Sc, Microbiology & Immunology
St. Xavier's College 1978 — 1981
Bachelor of Science (B.Sc.), Microbiology & Biochemistry
Self-Employed September 2015 - Present
Health Decisions January 2015 - Present
ICON plc May 2013 - January 2015
Execupharm July 2010 - November 2012
MedFocus/inVentiv Clinical Solutions June 2007 - July 2010
Kelly Services September 2005 - September 2006
Wyeth Research September 2003 - September 2005
Control Delivery Systems January 2001 - September 2003
Brigham and Women's Hospital June 2000 - January 2001
Education
Boston University - School of Management 2002 — 2004
MBA
Penn State University 1996 — 2000
BS, Biobehavioral Health
Bridgemedica September 2011 - Present
Commodore Builders August 2006 - September 2011
Tissue Regeneration, Inc October 2005 - February 2006
Boston Scientific October 2004 - November 2005
Control Delivery Systems February 2002 - July 2003
Biolink Corporation February 1998 - February 2002
Cytotherapeutics, Inc. April 1996 - February 1998
DePuy Mitek January 1992 - April 1996
The Hospital for Special Surgery July 1987 - July 1989
Skills
Medical Devices, Design Control, ISO 13485, R&D, FDA, Biomedical Engineering, Product Development, Design for Manufacturing, V&V, Project Management, Prototype, Biomechanics
Education
University of Michigan 1989 — 1991
M.S., BioEngineering
Stanford University 1986 — 1987
M.S., Mechanical Engineering
University of Massachusetts, Amherst 1982 — 1986
B.S., Mechanical Engineering
pSivida Corp. 2008 - Present
pSivida 2006 - 2008
Control Delivery Systems 1992 - 2005
New England Eye Center 1995 - 2000
University of Kentucky 1988 - 1994
Roche 1983 - 1984
Skills
Ophthalmology, Biotechnology, Pharmaceutics, Drug Delivery, Life Sciences
Education
University of Southern California 1987 — 1988
Post Doctoral Fellowship
University of Wales, Cardiff 1984 — 1987
Doctor of Philosophy (Ph.D.), Pharmaceutical Sciences
Durham University 1979 — 1982
Bachelor’s Degree, B.Sc. Chemistry, Honors
NH Department of Health and Human Services, Division of Public Health Services May 2013 - Present
Self-Employed February 2012 - May 2013
Biogen Idec April 2011 - February 2012
New England Research Institutes June 2002 - April 2011
Control Delivery Systems 2001 - 2002
Medical Scientists, Inc., 2000 - 2001
Brigham & Women’s Hospital September 1997 - May 2000
Massachusetts Eye & Ear Infirmary 1993 - 2000
The Health Institute 1992 - 1993
Abt Associates 1988 - 1991
Skills
Clinical Development, Clinical Study Design, CRO, EDC, Biotechnology, Clinical Monitoring, ICH-GCP, Clinical Data Management, Protocol, Large Budget Management, Time Management, Vendor Management, Cross-functional Team..., Manuscript Development, Data Analysis, Clinical Research, Outcomes Research, Hepatitis C, Multiple Sclerosis, Macular Degeneration, Hepatology, Public Health, Project Management, IRB, CRF design, Clinical Operations, Grant Writing, SAS, Infectious Diseases, Sop, FDA, Clinical Trials, Biostatistics, Data Management, Management, Pharmaceutical Industry, GCP, Research, Statistics, SOP
Education
Harvard T.H. Chan School of Public Health 1995 — 2000
Sc.D.
Harvard T.H. Chan School of Public Health 1990 — 1993
M.Sc.
Dartmouth College 1984 — 1988
AB
St. Paul's School ASP 1983 — 1983
Complya Consulting Group September 2010 - Present
Concert Pharmaceuticals May 2008 - September 2010
Oscient Pharmaceuticals September 2006 - May 2008
Wyeth Pharmaceuticals 2003 - 2006
Control Delivery Systems 2002 - 2003
Bristol-Myers Squibb 1995 - 2002
Skills
GMP, GxP, 21 CFR Part 11, Auditing, CAPA
Education
Saint Joseph's College 1991 — 1995
Bachelors, Biology and Chemistry
INVO Bioscience March 2004 - Present
real estate 2003 - 2010
Medelle Corporation January 2004 - October 2006
Control Delivery Systems March 2000 - January 2004
Boston Scientific March 1984 - February 1998
Boston Scientific 1985 - 1998
Skills
ISO 13485, FDA, Quality Assurance, R&D, Regulatory Affairs, Quality System, Medical Devices, Clinical Trials, Product Development, Entrepreneurship, Start-ups
Education
Montana State University-Bozeman 1975 — 1979
Ziopharm Oncology September 2015 - Present
Synageva BioPharma Corp. June 2013 - September 2015
ZIOPHARM June 2012 - June 2013
Ziopharm Oncology May 2011 - June 2012
ZIOPHARM July 2006 - May 2011
Averion Inc. 2004 - 2006
Millennium Pharmaceuticals, Inc. 2003 - 2004
Control Delivery Systems 2000 - 2003
Skills
Clinical Operations, Oncology, Pharmaceutical Industry, CTMS, Clinical Research, Clinical Trials, CRO, Clinical Development, Vaccines, Drug Development, Biotechnology, EDC, Management, GCP
Education
Boston College 1993 — 1997
Groton School
pSivida, Inc. 2005 - Present
Control Delivery Systems 2001 - 2005
Boston Scientific 1997 - 2001
Nova Biomedical 1991 - 1997
Education
Bentley University 1985 — 1989
Boston Scientific March 2009 - Present
Sepracor Inc. March 2008 - February 2009
Boston Scientific September 2003 - March 2008
Control Delivery Systems 2001 - 2003
Biochem Pharma (Acquired by Shire Pharma) 2001 - 2001
PAREXEL 1998 - 2001
Brigham and Women’s Hospital/ Harvard Medical School 1997 - 1998
Skills
CTMS, Clinical Trials, Clinical Research, Clinical Development, Clinical Monitoring, CRO, GCP, EDC, Medical Devices, Clinical Data Management, FDA, Oncology, ICH-GCP, Biotechnology, Stents, Drug Eluting Stents
Education
Stonehill College 1992 — 1996
BS, Pre-Med/Biology
Genzyme March 2013 - Present
Lonza June 2007 - March 2013
Alkermes 2004 - 2006
Control Delivery Systems 2001 - 2004
Skills
GMP, Quality Assurance, CAPA, Aseptic Processing, FDA, LIMS, Cross-functional Team..., Biopharmaceuticals, Biotechnology, Validation, 21 CFR Part 11, Sop, Quality Control, Change Control, Technology Transfer, Six Sigma, GLP, Quality System, Aseptic Technique, Fermentation, Cleaning Validation, GxP, V&V, Lifesciences, Purification, Contract Manufacturing, Microbiology, Cell Culture, Life Sciences, Computer System..., TrackWise, Pharmaceutical Industry, Strategic Planning, Business Process..., Operations Management
Education
Harvard Extension School 2014 — 2014
Executive Strategy and Communication
New York Institute of Technology-Old Westbury 2006 — 2008
M.B.A., Leadership
St. Joseph's College 2000 — 2004
B.S., Biology
Harvard Extension School
Boston Scientific September 2013 - Present
Boston Scientific August 2010 - September 2013
Boston Scientific July 2009 - August 2010
Covidien March 2007 - July 2009
Covidien 2003 - 2007
Control Delivery Systems September 2001 - September 2003
Control Delivery Systems September 2001 - September 2002
Bioheart Inc September 2000 - September 2001
Skills
Medical Devices, CAPA, FDA, R&D, Sop, Product Management, Cross-functional Team..., Wound Care, Clinical Trials, Validation, Project Planning, ISO 13485, PMP, Product Development, Clinical Research, Drug Delivery, Six Sigma, GMP, Design Control, Clinical Development, Management, Leadership
Education
Boston College 1995 — 1998
MS, Biochemistry
Smith College 1991 — 1995
Bachelor of Arts (B.A.), Biology and Chemistry
Pentax Medical Company February 2010 - Present
OmniSonics Medical Technologies August 2007 - January 2009
Boston Scientific 2003 - 2007
Control Delivery Systems 2001 - 2003
Education
Harvard Extension School
University of Massachusetts Boston
Presidio Pharmaceuticals January 2010 - Present
Alnylam Pharmaceuticals 2008 - January 2010
Vertex Pharmaceuticals 2003 - 2008
Control Delivery Systems 2002 - 2003
Vertex Pharmaceuticals 1996 - 2002
Mallinckrodt Veterinary 1995 - 1996
Food and Drug Administration 1987 - 1995
Skills
Pharmaceuticals, Regulatory Affairs, Lifesciences, Biopharmaceuticals, Veterinary, Pharmaceutical Industry, Drug Development, IND, Technology Transfer, Quality System, Clinical Development, Drug Discovery, Biotechnology, Validation, Regulatory Submissions, CAPA, FDA, Change Control, GMP, Oncology, Sop, Medical Devices, CRO, Intellectual Property, Clinical Trials, GLP, 21 CFR Part 11, CMC, NDA, CMC Regulatory Affairs, eCTD, Vaccines, GCP, SOP, Life Sciences
Education
University of California, Berkeley 1984 — 1986
M.S., Organic Chemistry
Harvard University 1977 — 1981
B.A., Chemistry
DataXu January 2011 - Present
OATSystems, a division of Checkpoint Systems April 2007 - January 2011
Lonza: A Global Leader In Life Sciences April 2004 - April 2007
Control Delivery Systems April 2002 - April 2004
Alliant Medical May 2001 - April 2002
C-bridge Internet Solutions July 1997 - May 2001
Cambridge Technology Group July 1997 - May 1999
Thinking Machines Corporation October 1990 - July 1997
Skills
Accounting, Financial Analysis, Financial Modeling, Revenue Recognition, Global Consolidation, Forecasting, Start-ups, Process Improvement, Budgets, Mergers & Acquisitions, Onboarding, Microsoft Office, SAP, Oracle, Intacct, Solium, ADP Payroll, Adaptive Insights, IPO, Financial Controlling, Employee Stock Options, Business Strategy, Equity Management, US GAAP, Internal Controls, Sarbanes-Oxley, International Operations, ERP Implementations, Contract Management, Contract Negotiation, Management, Sarbanes-Oxley Act, Financial Reporting, Auditing, Financial Statements, GAAP, Consolidation, Finance, General Ledger, Fixed Assets, Cash Management, Tax, Corporate Finance, Cash Flow Forecasting, Budgeting, Financial Planning, Due Diligence, Management Accounting, ERP, SaaS
Education
State University of New York at Albany
Bachelor's Degree, Accounting, economics, managment, finance
pSivida Corp. November 2009 - Present
pSivida Inc. October 2000 - October 2009
Control Delivery Systems October 2000 - January 2006
Boston Scientific January 1988 - October 2000
Skills
FDA, Medical Devices, Manufacturing, GMP, Biotechnology, Leadership, Pharmaceutical Industry, Design Control, Lifesciences, Technology Transfer, ISO 13485, CAPA, Clinical Development, Quality System, Regulatory Affairs, Life Sciences
Education
Suffolk University 1984 — 1987
BS
Archbishop Williams High School 1980 — 1983
Halloran Consulting Group, Inc. May 2015 - Present
Halloran Consulting Group, Inc. November 2014 - May 2015
Quintiles Consulting November 2013 - November 2014
Avarent Consulting LLC March 2013 - November 2014
Baxter Healthcare November 2007 - March 2013
Boston Scientific 2004 - 2007
Control Delivery Systems 2001 - 2004
Skills
Medical Devices, Pharmaceutical Industry, FDA, Clinical Development, Clinical Trials, Validation, Regulatory Affairs, CAPA, Cross-functional Team..., GCP, Biotechnology, Clinical Research, Product Launch, Regulatory Submissions, Pharmacovigilance, Lifesciences, Medical Device Marketing, Voice of the Customer, Key Opinion Leaders, Product Requirements, V&V
Education
Lake Forest Graduate School of Management 2011 — 2013
Master of Business Administration (MBA), Organizational Behavior Studies, Graduated with High Honors
Thomas Jefferson University
Master of Science (M.S.), Medical Microbiology and Bacteriology
Mount Holyoke College
Biology/Biological Sciences, General
Taaneh, Inc. January 2015 - Present
Celator Pharmaceuticals July 2004 - January 2015
Control Delivery Systems 2002 - 2004
Elan Pharmaceuticals 1999 - 2001
Skills
Pharmaceutical Industry, Biotechnology, Technology Transfer, GMP, Clinical Development, GLP, Drug Development, Lifesciences, Pharmaceutical..., global CMC Regulatory, Nanotechnology, Supply Chain, scale up, Compliance, pharmaceutical...
Education
Boston University
PhD, biochemistry, biophysics
Brandeis University
PostDoctoral Fellowship, Stuctural Biology
Takeda Pharmaceuticals May 2014 - Present
Quality Assurance Consultant September 2013 - May 2014
AVEO Pharmaceuticals July 2011 - June 2013
Vertex Pharmaceuticals April 2008 - June 2011
Critical Therapeutics, Inc. June 2004 - April 2008
Theseus Imaging, Inc. August 2003 - June 2004
Control Delivery Systems August 2002 - June 2003
AstraZeneca February 1992 - August 2002
Skills
GMP, Pharmaceutical Industry, FDA, 21 CFR Part 11, Validation, Regulatory Affairs, Technology Transfer, Change Control, Sop, V&V, Document Management, Document Review, Product Development, GxP, CAPA, GLP, Computer System..., Biopharmaceuticals, IND, Regulatory Submissions, LIMS, Quality System, Regulatory Requirements, Trackwise, Aseptic Processing, CMC, Cleaning Validation, Quality Assurance, SOP, TrackWise
Education
University of Massachusetts Lowell 1983 — 1987
B.S., Chemistry, Chemical Engineering
Zata Pharmaceuticals January 2014 - Present
Veterans Health Administration July 2008 - Present
Not Applicable January 2007 - June 2008
Palomar Medical Technologies, Inc. December 2005 - December 2006
Perceptive Informatics; PAREXEL September 2004 - November 2005
Not Applicable July 2003 - August 2004
Control Delivery Systems May 2001 - June 2003
Argose May 2000 - January 2001
Molecular Geodesics July 1999 - April 2000
Geltex April 1998 - August 1998
Skills
Program Evaluation, Software Validation, Product Development, Project Planning, Project Portfolio..., Program Management, Clinical Trial..., Clinical Research, Drug Delivery, Drug Discovery, Drug Development, Medical Devices, Risk Assessment, Risk Analysis, Risk Mitigation, Risk Management, Quantitative Analysis, Technology Evaluation, Patent Analysis, Literature Reviews, Requirements Analysis, Software Design, Diabetes, Oncology, Orthopedics, Dermatology, Pain Management, Biomarkers, Biomaterials, Molecular Biology, Medical Imaging, Analytical Chemistry, Contract Negotiation, GAMP, 21 CFR Part 11, Medical Lasers, Bio-Polymers, ISO 9001, SOP Development, eDC Design and..., Opthamology, Urology, Market Analysis, Quality Management, Financial Modeling, Statistical Modeling, Designs, SOP development, Management, Clinical Trials
Education
Columbia University Mailman School of Public Health 1998 — 1999
Master of Public Health (M.P.H.), Environmental Health Sciences; Gene/Environment Interactions
Northeastern University 1996 — 1997
Biomedical Sciences, General
Northeastern University 1993 — 1996
Bachelor of Science (B.S.), Biology / Biochemistry
Bentley University 1990 — 1991
Computer Information Systems/ Finance
Everett High School 1986 — 1990
Manco Trading LLC 2000 - Present
Control Delivery Systems 1990 - 1999
Medricon 1985 - 1994
Skills
Mergers & Acquisitions, Management, Restructuring, Finance, Consulting, Funding, Licensing, Strategic Planning, Business Strategy, Strategy, Due Diligence, Investments, Negotiation, Business Planning, Business Development, Leadership, Entrepreneurship, New Business Development, Private Equity, Acquisitions, Team Building, Valuation, Budgets, Financial Analysis, Marketing, Small Business, Sales, Asset Management
Education
Claremont Graduate University - Peter F. Drucker and Masatoshi Ito Graduate School of Management 1982 — 1987
Master of Business Administration (MBA), Accounting / Healthcare Finance
California State University-Fullerton 1977 — 1982
Master of Arts (M.A.), Organic Chemistry
University of California, Irvine 1973 — 1977
Bachelor of Arts (B.A.), Chemistry, Deans List