Transkaryotic Therapies Inc.
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Transkaryotic Therapies Inc. Employees
CMC Biologics June 2014 - Present
Puget Sound Blood Center November 2013 - June 2014
Bulletproof Documentation, Inc. 2012 - March 2013
Genentech March 2007 - March 2010
Genentech April 2004 - March 2007
Transkaryotic Therapies, Inc. May 2000 - June 2003
Skills
cGMP manufacturing, Purification, Technical Writing, Protein Purification, Academic Writing, Academic Research, Laboratory Skills, Clean Rooms, Laboratory Equipment, Sampling, Safety, Hazardous Areas, Employee Training, Technical Training, Change Control, CAPA, Cleaning Validation, Research
Education
University of New Hampshire
Bachelor of Arts (B.A.), Philosophy
AMC Consulting, LLC July 2012 - Present
Suffolk University, Sawyer Business School July 2011 - Present
Ziopharm Oncology January 2014 - April 2015
Shire January 2009 - December 2010
Shire 2007 - 2009
Shire 2005 - 2007
Transkaryotic Therapies Inc 2003 - 2005
Transkaryotic Therapies Inc 2001 - 2003
Tufts Medical Center 1994 - 2001
Tufts Medical Center 1984 - 1994
Skills
Clinical Development, Clinical Trials, Drug Development, Pharmaceutical Industry, Oncology, Biotechnology, Clinical Research, CRO, Biopharmaceuticals, FDA, CTMS, Lifesciences, Pharmacology, Regulatory Affairs, Regulatory Submissions, Medical Devices, GCP, Healthcare Management, Clinical Operations, Medical Affairs, Vaccines, Infectious Diseases, Immunology, Neurology, Life Sciences
Education
Boston University
BS, Nursing
Suffolk University
MHA, Health Administration
Shire Pharmaceuticals July 2006 - October 2014
Transkaryotic Therapies Inc June 2002 - July 2006
Organogenesis Inc. March 1996 - May 2002
Elan Pharmaceuticals June 1995 - September 1995
ABB March 1991 - April 1995
Skills
FMEA, CAPA, 21 CFR Part 11, FDA GMP, CIP systems, SIP, Cell Culture, Purification, Chromatography, LIMS, Bioreactor perfusion..., GE - Kaye 2000..., Analytical Instrument..., SCADA, PLC Ladder Logic, TrackWise, PIDs, Loop Tuning, Process Automation, Test & Measurement..., ISO-14644, Certified Electrician, Change Control, Deviation Management, Valgenesis, Pilgrim, Motor Control
Education
Dublin Institute of Technology
Electrical and Electronics Engineering
Takeda Pharmaceuticals Director, R&D ITBiogen Idec2010 - 2014
Merck Research Laboratories 2004 - 2010
BioIT Solutions 2002 - 2003
CombinatoRx, Inc. 2000 - 2002
Cereon Genomics LLC 1998 - 2000
Monsanto/Cereon 1998 - 2000
Genome Therapeutics Corporation 1997 - 1998
Transkaryotic Therapies Inc 1992 - 1997
Howard Hughes Medical Institute 1991 - 1992
BioTechnica International 1985 - 1991
Skills
Drug Discovery, Leadership, Databases, Biotechnology, Lifesciences, Pharmaceutical Industry, Molecular Biology, High Throughput..., Cell Culture, Validation, Bioinformatics, Biochemistry, Technology Transfer, Clinical Trials, R&D, Start-ups, Drug Development, Clinical Development, Vaccines, Operations Management, Project Management, Biomarker Discovery, Strategy, Biopharmaceuticals, Life Sciences
Education
Northeastern University 2003 — 2006
M.S., Regulatory Affairs
Harvard University 1978 — 1982
A.B., Classics
Idera Pharmaceuticals May 2014 - Present
Sarepta Therapeutics January 2013 - May 2014
Shire Pharmaceuticals - HGT March 2009 - December 2012
Shire Pharmaceuticals - HGT January 2006 - March 2009
Transkaryotic Therapies, Inc October 2003 - January 2006
Therion Biologics November 2002 - October 2003
Vertex Pharmaceuticals 1998 - 2002
Massachusetts General Hospital - Dept of Psychiatry 1994 - 1998
Skills
Clinical Development, Clinical Research, Medical Affairs, Clinical Operations, Clinical Trials, Biotechnology, Pharmaceutical Industry, GCP, Oncology, CRO, CTMS, Drug Development, Pharmacovigilance, Orphan Drugs
Education
Hartwick College 1989 — 1993
BA, Psychology
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
Lonza March 2015 - Present
Lonza August 2011 - Present
Baxter Pharmaceutical Solutions LLC June 2010 - August 2011
Baxter BioPharma Solutions LLC February 2008 - June 2010
Xanthus Pharmaceuticals 2006 - 2007
Oscient Pharmaceuticals, Inc. 2006 - 2006
Cubist Pharmaceuticals, Inc. 2004 - 2006
Transkaryotic Therapies, Inc. 2001 - 2004
Skills
Certified Project..., Cross-functional Team..., Pharmaceutical Industry, Project Management, FDA, Design of Experiments, Business Process Mapping, Change Control, ISO, Program Management, Business Process, Change Management, Process Simulation, Supply Chain, Leadership, Biopharmaceuticals, Biotechnology, GMP, Manufacturing
Education
Indiana University Bloomington 1993 — 1997
Bachelors, Biology, Spanish
Harvard University August 2014 - Present
Neotropical Grassland Conservancy January 2004 - Present
Transkaryotic Therapies, Inc. 2000 - 2003
Skills
DNA sequencing, Phylogenetics, Genomics, R, Python, Microsoft Office
Education
Boston University 2007 — 2014
Doctor of Philosophy (Ph.D.), Biology
University of Nevada-Las Vegas 2003 — 2006
Master of Science (M.Sc.), Biology
University of Massachusetts, Amherst 1994 — 1998
Bachelor of Science (B.Sc.), Biology, General
Boehringer Ingelheim November 2013 - Present
Boehringer Ingelheim February 2012 - October 2013
University of Connecticut Health Center August 2009 - January 2011
Pfizer October 2007 - October 2008
Optos November 2005 - April 2006
Wyeth January 2005 - June 2005
Johnson & Johnson November 2004 - January 2005
Transkaryotic Therapies, Inc. August 2004 - October 2004
Boston Scientific March 2004 - July 2004
Provided Upon Request 1998 - 2004
Skills
Flexibility, Ability to wear many..., Close Attention to...
Education
The University of Connecticut
Bachelor of Science (B.S.), Health Systems Management
The University of Connecticut
Bachelor of Arts (B.A.), Economics
The University of Connecticut
Master of Public Health Certificate Program, Epidemiology and Public Health
Novartis Institutes for BioMedical Research (NIBR) June 2015 - Present
UMass Medical School July 2013 - January 2014
Integrated Genetics, formerly Genzyme Genetics April 2010 - September 2012
sanofi-aventis September 2008 - December 2009
Harvard Medical School 2006 - 2008
Bauer Center for Genomics Research, Harvard University 2001 - 2006
Transkaryotic Therapies, Inc 1994 - 1998
Skills
Genetics, Molelcular Cloning, DNA Sequencing, Transcription Profiling, DNA microarray, DNA extraction, RNA isolation, DNA ligation, Vector Design, Vector Cloning, Luminex, Agarose Gel..., Library construction, Mammalian Cell Culture, Restriction Mapping, PCR primer design, Biotechnology, Molecular Biology, PCR, Lifesciences, Assay Development, Biochemistry, Cell Culture, Genomics, DNA, real-time PCR, Microarray, Purification, Laboratory, LIMS, Genotyping, Gene Expression, Life Sciences, RNA Isolation, qPCR, DNA Extraction
Education
Stephen F. Austin State University
B.S., Biology
Shire Pharmaceuticals February 2014 - Present
Shire HGT February 2012 - February 2014
Shire HGT 2011 - 2012
Shire HGT 2006 - 2011
Transkaryotic Therapies, Inc 1992 - 2006
New England Biolabs January 1990 - June 1992
Institute of Basic Medical Sciences (IBMS) of Chinese Academy of Medical Sciences (CAMS) July 1988 - October 1989
Skills
Protein Chemistry, Protein Purification, Biotechnology, Drug Discovery, Lifesciences, Purification, Biochemistry, Assay Development, Chromatography, Cell Culture, Cell, Biopharmaceuticals, Drug Development, HPLC, ELISA, Technology Transfer, Life Sciences
Education
Peking Union Medical College 1980 — 1988
Doctor of Medicine (M.D.)
Peking University 1980 — 1982
Pre-Medicine/Pre-Medical Studies
Thermo Fisher Scientific January 2015 - Present
DPS Engineering November 2014 - December 2014
Safety Partners, Inc. July 2011 - October 2014
Shire Pharmaceuticals June 2004 - March 2011
Transkaryotic Therapies Inc June 2004 - July 2005
Antigenics Inc June 2003 - June 2004
Pratt & Whitney January 2002 - August 2002
Skills
Ergonomics, Biosafety, Training, Industrial Hygiene, GMP, EHS, Pharmaceutical Industry, Biotechnology, Risk Assessment, Laboratory, Root Cause Analysis, Safety Management..., Quality System, Hazardous Waste..., Safety Training, ISO 14001, Radiation Safety, Environmental Compliance, Inspection, Occupational Health, Environmental Health, Environmental Auditing, CAPA, Hazard Analysis, Environmental..., Hazard Recognition, Incident Investigation, EPA, Industrial Safety, Hazardous Materials, Workplace Safety, Environmental Awareness, Waste Management
Education
University of Massachusetts, Amherst 2000 — 2003
Master of Science (MS), Environmental Health/Industrial Hygiene
University of Massachusetts, Amherst 1996 — 2000
Bachelor of Science (BS), Environmental Science
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
Colorado State University August 2010 - Present
MountainWest Pain Relief Center October 2007 - Present
Music 2012 - 2014
Music 2012 - 2014
EMD Lexigen Research Center 2004 - 2006
Transkaryotic Therapies, Inc. July 2000 - August 2003
Skills
Pain Management, Therapeutic Massage, Rehabilitation, Strength Training, Craniosacral Therapy, Neuromuscular Therapy, Bodywork, Wellness Coaching, Injury Prevention, Wellness, Fitness, Functional Training, Personal Training, Injury, Egoscue Certified..., Supported Employment, Job Coaching
Education
University of Massachusetts, Amherst 1995 — 1999
B.S., Biology
WA 1991 — 1995
Colorado State University
Master of Business Administration (MBA), Business Administration and Management, General, 3.5
Geisel School of Medicine at Dartmouth College September 2013 - Present
University of California, San Diego 2004 - 2009
Massachusetts General Hospital 2002 - 2004
Transkaryotic Therapies Inc 1999 - 2000
Massachusetts General Hospital 1997 - 1999
Skills
Research, Statistics, Cancer, Clinical Research, Public Health, Biostatistics, Epidemiology, Data Analysis, Grant Writing, Qualitative Research, Literature Reviews, Clinical Trials, Program Evaluation
Education
University of California, San Diego 2009 — 2013
Doctor of Philosophy (Ph.D.), Public Health, Health Behavior
University of Massachusetts Lowell 2000 — 2002
Master's Degree, Mathematics - Statistics
University of Massachusetts, Amherst 1993 — 1997
Bachelor's Degree, Public Health
Bottomline Technologies October 2014 - Present
Icarus Rising Computer Studio September 1982 - Present
Randstad Technologies US February 2014 - October 2014
American Holt Corp. March 2013 - February 2014
Cramer Fabrics December 2011 - February 2014
Catalano Brothers Trucking Company November 2011 - September 2013
Framingham State University September 1998 - June 2009
Kayem Foods Inc. August 1999 - March 2003
Transkaryotic Therapies, Inc. February 2001 - February 2001
Manulife Financial May 2000 - January 2001
Skills
Access, Microsoft Office, Database Development, Architecture, Documentation, Databases, Programming, VBA, VB.NET, Visual Studio, .NET, Visual Basic, Software Development, Application Development, Database Design, ADO.NET, SDLC, Software Engineering, Software Design, Writing Skills, Software Documentation, T-SQL, XML, Web Applications, IIS, ASP.NET, Web Development, WCF, Testing, JavaScript
Education
Northeastern University 1973 — 1974
English
University of Massachusetts Boston 1969 — 1972
B.A., English
Preclinical Solutions February 2010 - Present
C.A.P.T.S. March 2012 - Present
Shire Human Genetic Therapies, inc. July 2009 - February 2010
Shire Human Genetic Therapies 2005 - February 2010
Shire HGT 2005 - 2010
Transkaryotic Therapies, Inc 2000 - 2005
TKT 2000 - 2005
Hybridon 1996 - 2000
Biodevelopment Laboratories 1995 - 1996
Arthur D. Little 1987 - 1995
Skills
Biotechnology, Toxicology, Pharmacokinetics, Pharmacology, Pharmaceutical Industry, Lifesciences, Protocol, Drug Development, Clinical Development, IND, Drug Discovery, Regulatory Submissions, Drug Delivery, Assay Development, In Vitro, Biopharmaceuticals, Protein Chemistry, Clinical Trials, FDA, Clinical Research, Immunology, Oncology, CRO, Biomarkers, Immunoassays, Bioanalysis, Translational Medicine, GLP, In Vivo, Cell Culture, GCP, Biologics, HPLC, Infectious Diseases, Laboratory, Quality Assurance, ADME, Validation, Technology Transfer, Sop, Drug Metabolism, Vaccines, Regulatory Affairs, Pharmaceutics, 21 CFR Part 11, GMP, Biochemistry, Clinical Study Design, Life Sciences, SOP
Education
Marblehead High 1979 — 1982
Bridgewater State University
Biology
Salem State University
Biology
Dicerna Pharmaceuticals, Inc. September 2015 - Present
TESARO February 2014 - September 2015
Ironwood Pharmaceuticals April 2012 - January 2014
Millennium Pharmaceuticals July 2011 - April 2012
Prometheus January 2009 - February 2011
Amylin Pharmaceuticals, Inc. April 2008 - January 2009
Amylin Pharmaceuticals, Inc. April 2003 - April 2008
Transkaryotic Therapies, Inc. June 2001 - March 2003
Transkaryotic Therapies, Inc. August 2000 - June 2001
Genetics Institute (Wyeth) July 1998 - August 2000
Skills
Regulatory Affairs, FDA, Compliance, Clinical Trials, IND, Clinical, Biotechnology, cGMP, Pharmaceuticals, Clinical Development, Regulatory Submissions, Pharmacovigilance, Oncology, Quality Assurance, EU, Regulatory Strategy, Documentation, Clinical Research, Drug Development, GMP, Medical Affairs, Pharmaceutical Industry, Pharmaceutics, Strategy
Education
Boston College - Wallace E. Carroll Graduate School of Management 1998 — 2002
MBA, International Business
Dickinson College 1989 — 1993
HealthWyse April 2015 - Present
Gamma Sigma Sigma National Service Sorority June 2005 - Present
HealthWyse February 2013 - April 2015
McKesson August 2003 - February 2013
Security Source, Inc 2002 - 2003
Transkaryotic Therapies, Inc 2001 - 2002
Digital Goods / aka SoftLock.com 2000 - 2001
Skills
Healthcare Industry, HL7, Web Applications, Web Services, Customer Service, Customer Satisfaction, Customer Retention, Customer Oriented, Team Leadership, Teamwork, Self-starter, Goal Oriented, Goal-oriented..., Internet Services, Healthcare Consulting, HIPAA, Healthcare Information..., Healthcare, Time Management, Managed Care, Sales, Troubleshooting, Hospitals, Leadership, Medicare, Process Improvement
Education
New England College 2007 — 2011
Candidate, Master of Science in Management, Health Care Administration, 3.8
Memorial City General Hospital (now Hermann) 1986 — 1987
LVN/LPN, Licensed Vocational Nursing, A
Fitchburg State University 1976 — 1980
BA, English, Journalism
Tekla Capital Management March 2015 - Present
Sabby Capital, LLC September 2011 - February 2015
Cowen Asset Management, LLC April 2008 - September 2011
Andesite Capital, LLC November 2006 - April 2008
Putnam Associates, Inc. July 2005 - November 2006
Transkaryotic Therapies Inc 2004 - 2005
Decision Resources 2001 - 2003
Education
Massachusetts Institute of Technology - Sloan School of Management 2003 — 2005
MBA
University of California, Los Angeles
Ph.D.
Swarthmore College 1992 — 1996
BA
University of Pennsylvania 1996 — 1999
Master’s Degree
Shire Pharmaceuticals February 2013 - Present
Shire Pharmaceuticals July 2005 - February 2013
Transkaryotic Therapies, Inc. September 2004 - July 2005
Ropes & Gray LLP 1999 - 2004
Skills
Licensing, Compliance, Pharmaceuticals, Biotechnology, Life Sciences, Lifesciences, Pharmaceutical Industry, FDA, Technology Transfer, Patents, Due Diligence, Regulatory Affairs, Intellectual Property, Biopharmaceuticals, Clinical Trials, Clinical Development, Regulatory Requirements, Drug Development
Education
Boston College Law School
J.D.
Boston University School of Medicine
M.A.
Brown University
A.B., English and American Literature
NxStage Medical September 2012 - Present
PerkinElmer, Inc December 2007 - September 2012
PerkinElmer, Inc November 2006 - November 2007
PerkinElmer, Inc September 2003 - October 2006
Transkaryotic Therapies, Inc. March 2002 - September 2003
R&D Specialist September 2001 - February 2002
Eastern Cooperative Oncology Group July 2000 - September 2001
Skills
Microsoft Office, Microsoft CRM, Adobe Creative Suite, QuarkXPress, SharePoint, Documentum, FileMaker, Business Objects, EndNote, Project Management, Digital Photography, Marketing Communications, Marketing Management, Relationship Management, Print Management, Account Management, Technical Presentations, Process Improvement, Website Updating, Informatics, Presentations, Enterprise Software, Drug Discovery, Knowledge Management, Lifesciences, Biotechnology, Pharmaceutical Industry, Product Development, Commercialization, Chemistry, Medical Devices, Software Documentation
Education
University of Rochester 1995 — 1999
B.A, Biology
Biogen Idec January 2009 - Present
Biogen Idec March 2007 - December 2008
Shire HGT (Formerly known as Transkaryotic Therapies, Inc.) August 2005 - February 2007
Transkaryotic Therapies, Inc. November 2002 - August 2005
National City Bank December 1999 - September 2002
Education
University of California, Irvine 1989 — 1994
BA, Politics and Society
Pfizer September 2015 - Present
Hospira July 2013 - Present
Hospira March 2013 - July 2013
Merck August 2011 - September 2012
Xcellerex, Inc August 2009 - July 2011
Alkermes, Inc April 2006 - February 2009
GenVec, Inc November 2003 - June 2005
Transkaryotic Therapies, Inc January 2001 - January 2003
Skills
Quality Assurance, Sop, Software Documentation, Quality Control, Validation, Technical Editing, Protocol, GMP, FDA, CAPA, Change Control, GLP, Biotechnology, Trackwise, Pharmaceutical Industry, Biopharmaceuticals, 21 CFR Part 11, Quality System, Cell Culture, LIMS, Aseptic Processing, Document Management, Quality Auditing, Aseptic Technique, Regulatory Requirements, Raw Materials, Cleaning Validation, Regulations, Cross-functional Team..., Root Cause Analysis, Technical Writing, FDA GMP, Medical Devices, Manufacturing, GxP, Technology Transfer
Education
University of Phoenix 2012 — 2015
Bachelor of Science, Health/Health Care Administration/Management
Berklee College of Music 1998 — 2001
Valsource LLC October 2014 - Present
Manufacturing Associate Genzyme May 2011 - April 2014
Amgen Rhode Island January 2006 - October 2010
Biovest International February 2005 - December 2005
Transkaryotic Therapies, Inc November 2001 - December 2003
Altus Biologics September 1999 - November 2001
Skills
Biotechnology, Aseptic Technique, GMP, Biopharmaceuticals, Sop, LIMS, Purification, Pharmaceutical Industry, Validation, FDA, Chromatography, Cleaning Validation, Protein Purification, CAPA, Filtration, Protein Chemistry, SOP
Education
Western New England College 1992 — 1996
Bachelor of Science, General Biology; Biology
Boston University
Western New England College 1992 — 1996
Bachelor of Science (BS), Biology/Biological Sciences, General
Cubist Pharmaceuticals August 2013 - Present
Cubist Pharmaceuticals January 2011 - July 2013
Cubist Pharmaceuticals April 2009 - December 2010
Cubist Pharmaceuticals June 2007 - March 2009
Shire Human Genetic Therapies Inc September 2005 - June 2007
Transkaryotic Therapies Inc September 2004 - September 2005
Baxter BioScience 2002 - 2004
Skills
Biotechnology, Pharmaceutical Industry, Strategy, Drug Development, Monte Carlo Simulation, Mergers, Lifesciences, Biopharmaceuticals, Change Management, Life Sciences, Financial Analysis, Management
Education
University of Massachusetts at Amherst - Isenberg School of Management
Master of Business Administration (MBA)
University of Massachusetts, Amherst
Bachelor of Business Administration (BBA)
Vertex Pharmaceuticals May 2014 - Present
Shire Pharmaceuticals February 2007 - May 2014
Shire Human Genetic Therapies August 2005 - January 2007
Transkaryotic Therapies Inc. September 2001 - July 2005
Rhodia ChiRex June 1999 - September 2001
Serono July 1997 - June 1999
Arthur Andersen LLP September 1993 - July 1997
Skills
Pharmaceutical Industry, Biotechnology, Investor Relations, Cross-functional Team..., Lifesciences, Product Launch, Strategy, Global Marketing, Finance Operations, Relationship Management, Finance, Customer Oriented, Financial Analysis, Biopharmaceuticals, Financial Reporting, Life Sciences
Education
University of Notre Dame 1989 — 1993
Bachelor of Business Administration, Accounting
Shire Pharmaceuticals April 2005 - Present
Transkaryotic Therapies, Inc September 1995 - April 2005
Repligen Corporation June 1986 - February 1995
Skills
Purification, Biotechnology, Protein Chemistry, Chromatography, Biopharmaceuticals, Assay Development, Drug Discovery, HPLC, Technology Transfer, LC-MS, GLP
Education
Massachusetts Institute of Technology 1982 — 1986
Proskauer Rose LLP August 2012 - Present
NetBio, Inc. 2005 - August 2012
The Jackson Laboratory 1999 - 2010
Transkaryotic Therapies, Inc September 2001 - July 2004
Howrey LLP January 2000 - September 2001
Jackson Laboratory 1997 - 2000
Jackson Laboratory 1997 - 2000
Lyon July 1987 - December 1999
Skills
Commercialization, Patents, Intellectual Property, Litigation, Licensing, Trade Secrets, Patent Prosecution, Patentability, Patent Litigation, Lifesciences, Copyright Law, Trademarks, Biotechnology, Technology Transfer, Due Diligence, Life Sciences
Education
University of Southern California - Marshall School of Business 1990 — 1992
MBA, Finance, International Business
DePaul University College of Law 1980 — 1983
JD, Law
Purdue University 1976 — 1980
B.S., Biology
St Luke
St Luke
Concert Pharmaceuticals, Inc. March 2008 - Present
NIRI Boston 2009 - 2010
ViaCell September 2005 - November 2007
Transkaryotic Therapies, Inc. April 1999 - July 2005
Vertex Pharmaceuticals June 1995 - April 1999
Skills
Biotechnology, Corporate Communications, Investor Relations, Crisis Communications, Internal Communications, Media Relations, Public Relations, Reputation Management, Start-ups, Communication Training, Strategy, Pharmaceutical Industry, Life Sciences, Strategic Communications
Education
Northeastern University 1990 — 1995
BS, Business Administration
Scioderm Pharmaceuticals October 2013 - Present
Edimer Pharmaceuticals April 2013 - Present
Ultragenyx Pharmaceuticals January 2011 - Present
Foldrx Pharmaceuticals June 2009 - February 2011
Simon Kucher Partners 2008 - 2009
Biomarin Europe December 2005 - January 2008
BioMarin Pharmaceutical Inc. 2006 - 2008
Shire HGT 2005 - 2005
Transkaryotic Therapies, Inc. 1999 - 2005
Transkaryotic Therapies (Shire Pharmaceuticals) 1999 - 2005
Skills
Pharmaceuticals, Biotechnology, Life Sciences, Pricing and Health Care..., Clinical Development, Clinical Research, Technology Transfer, Regulatory Affairs, Medical Devices, Infectious Diseases, Business Development, Biochemistry, Pharmaceutical Industry, Healthcare, Drug Development, Market Access, Lifesciences, Biopharmaceuticals, Sop
Education
Harvard University, John F. Kennedy School of Government 1986 — 1987
MPA, Public Policy
Boston College 1965 — 1969
Bachelor of Science (BS), Economics
Banyan Biomarkers, Inc. September 2010 - Present
NFDM September 2010 - April 2011
Oragenics, Inc. January 2004 - May 2006
BioFlorida, Inc. December 1999 - January 2004
USBiomaterials Corp July 1997 - November 1999
Transkaryotic Therapies, Inc. January 1991 - June 1997
Ernst & Young February 1984 - September 1991
Education
Bryant University 1993 — 1996
MS, Taxation
Bryant University 1979 — 1982
MBS, Management
Bryant University 1975 — 1977
BS, Accounting
Bryant University 1968 — 1972
BS, Business Education
Non-profit Animal Welfare January 2006 - Present
Langston Consulting August 2012 - January 2013
Transkaryotic Therapies, Inc 1999 - 2003
GENZYME 1992 - 1995
Skills
Bilingual English/..., Extensive experience..., Work experience in..., Seven years in..., International Sales, Product Management, Biotechnology, Rare Diseases, Dog Training, Animal Behavior, Spanish, Training, International Marketing
Education
Thunderbird School of Global Management 1983 — 1984
MIM, International Finance
St. Lawrence University 1976 — 1980
BS, BA, BS, Psychology. BA, Spanish.
Shire HGT May 2010 - Present
Shire HGT January 2007 - May 2010
Transkaryotic therapies, Inc January 2001 - January 2004
Transkaryotic Therapies, Inc June 1998 - December 2001
Education
Boston University School of Medicine 2000 — 2003
Certificate, Regulatory and Clinical Affairs
University of New Hampshire 1994 — 1998
BS, Microbiology
Shire October 2013 - Present
Shire August 2013 - October 2013
Shire May 2011 - August 2013
Shire December 2005 - May 2011
Antigenics September 2005 - November 2005
Antigenics September 2004 - September 2005
Antigenics September 2003 - September 2004
Transkaryotic Therapies Inc November 2000 - September 2003
Skills
Biotechnology, Sop, GMP, Biopharmaceuticals, CAPA, FDA, SOP, Change Control, Validation
Education
Salem State University 1995 — 2000
Bachelor of Science (B.S.), Biology/Biological Sciences, General
Memorial Sloan-Kettering Cancer Center December 2013 - Present
Shire HGT 2001 - 2013
Shire HGT 2001 - 2013
Shire Human Genetic Therapies February 2009 - 2012
Shire Human Genetic Therapies July 2006 - February 2009
Transkaryotic Therapies, Inc February 2005 - July 2006
Transkaryotic Therapies, Inc February 2003 - February 2005
Transkaryotic Therapies, Inc July 2001 - February 2003
Taconic Biotechnology October 1999 - July 2001
Skills
cGMP, Excel, Word, PowerPoint, Cell Culture, Process Development, GMP, Biotechnology, Deviations, Change Control, CAPA, Trackwise, Technology Transfer, Validation, SOP development, Regulatory Requirements, Regulatory Submissions, ICH guidelines, 21 CFR, Quality Assurance, TrackWise
Education
University at Albany, SUNY 1997 — 1999
BS, Biology
State University of New York at Cobleskill 1995 — 1997
A.A.S, Biological Technology
Bristol-Myers Squibb June 2011 - Present
Bristol-Myers Squibb June 2010 - June 2011
Bristol-Myers Squibb November 2007 - June 2010
Wyeth Biotech April 2005 - November 2007
EMD Pharmaceuticals January 2003 - April 2005
EMD Pharmaceuticals October 2001 - January 2003
Alkermes April 2001 - October 2001
Transkaryotic Therapies Inc. September 1999 - April 2001
Skills
GMP, Biotechnology, Pharmaceutical Industry, Quality Control, SOP, FDA, Validation, 21 CFR Part 11, CAPA, Change Control
Education
University of Massachusetts at Lowell 1999 — 2001
Graduate Certificate, Bioprocessing/Engineering
Salem State College 1995 — 1999
Bachelors, Biology
Eleven Biotherapeutics January 2011 - October 2012
Acceleron Pharma July 2004 - October 2010
CytoCure, LLC January 2003 - July 2004
Transkaryotic Therapies, Inc. September 2002 - December 2002
Boston Medical Center June 2000 - August 2002
Skills
Molecular Biology, qPCR, Protein Expression, Protein Purification, Affinity Chromatography, Assay Development, ELISA, Cell Culture, yeast cell culture, Multi-color Flow..., FACS analysis, Pharmacokinetics, Western analysis, RT-PCR, Vector Cloning, DNA extraction, RNA isolation, Electroporation, Transfection, Mammalian Cell Culture, Primary Cells, bacteria cell culture, AKTA, LAL, BCA Protein Assay, Silver Staining, Reporter Gene Assays, SPR
Education
Boston University School of Medicine
M.A., Pharmacology
Providence College
B.S., Biology
Bridgewater-Raynham Regional High School