Acambis Company
Industry: Commercial company
DescriptionHeadquarters: Cambridge, MA Founded: 1990 Parent organization: Sanofi
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Acambis Employees
Abbvie Bioreasearch Center April 2008 - Present
Abbvie Bioreasearch May 2007 - Present
Acambis May 2004 - April 2008
Skills
GMP, Validation, CAPA, Change Control, FDA, Sop, V&V, Computer System..., Medical Devices, Clean Rooms, GxP, Biopharmaceuticals, Aseptic Processing, Cleaning Validation, GLP, GAMP
Education
Quinsigamond Community College
Worcester State University
Goodman Advisory Group, LLC May 2007 - Present
Acambis September 2005 - May 2007
Boston Scientific Corp September 2001 - September 2005
Arthur Andersen LLP September 1998 - September 2001
Education
Babson College - Franklin W. Olin Graduate School of Business 2003 — 2006
MBA
University of Pennsylvania - The Wharton School 1994 — 1998
BS Economics
Deloitte February 2015 - Present
International Resources Group August 2012 - January 2015
International Business & Technical Consultants, Inc. September 2011 - August 2012
Population Services International August 2010 - December 2010
JMR Portfolio Intelligence January 2010 - May 2010
Asia Cause Lawyer Network / Lawyers Collective October 2007 - April 2008
South Asian Human Rights Documentation Center 2008 - 2008
Acambis June 2007 - October 2007
Nevell White January 2007 - June 2007
Skills
Proposal development..., Project management for..., Experience living &..., Proposal Writing, Project Management
Education
University of Denver 2009 — 2011
Master of Arts, Global Finance Trade Economic Integration, Global Health, International Development
University of California, Irvine 2004 — 2007
Bachelor of Arts, International Studies & Political Science
Vertex Pharmaceuticals September 2013 - Present
Genzyme April 2011 - September 2013
Genzyme July 2010 - April 2011
Genzyme February 2005 - July 2010
Amgen February 2003 - February 2005
Acambis November 2002 - February 2003
Abbott Bioresearch Center (formerly BASF Bioresearch Corp.) March 1998 - November 2002
Genzyme October 1994 - March 1998
Clean Harbors August 1992 - September 1994
Biogen 1991 - 1991
Skills
Lean Manufacturing, CAPA, GMP, Validation, Quality Control, LIMS, FDA, Sop, Quality Assurance, GDP, Compliance, Continuous Improvement, Trackwise, Process Improvement, Analytical Chemistry, Deviation Management, GxP, 21 CFR Part 11, Quality System, V&V, Change Control
Education
Framingham State University 1997 — 2001
MA, Business Administration
University of Massachusetts Boston 1987 — 1991
BS, Biology
hingham high
Blue Lamb Furnishings December 2012 - Present
Blue Lamb Design Group 2008 - Present
Parker Village Productions 2008 - Present
The New England Institute of Art September 2010 - November 2010
Sirtris Pharmaceuticals October 2009 - April 2010
My New England Contractor 2009 - 2010
Momenta Pharmaceuticals 2007 - 2009
Acambis 2006 - 2007
American Repertory Theatre 2003 - 2005
Wheelock Family Theatre 2003 - 2005
Skills
Editing, Photography, Painting, Drawing, Rendering, Photoshop, Research, Microsoft Office, Interior Design, Space planning, Furniture, Furnishings, Renovation, Organization, Writing, Mac, Quality Assurance, Voice Over
Education
New England Institute of Art 2008 — 2009
Certificate, Residential Interior Decorating
Simmons College 1999 — 2001
BA, Art
Elon University 1997 — 1999
French & Art
Genzyme August 2014 - Present
Amgen September 2012 - December 2013
Genzyme April 2011 - August 2012
Pfizer Pharmaceuticals May 2007 - August 2010
wyeth February 2007 - May 2007
Acambis August 2006 - December 2006
LeMaitre Vascular April 2006 - July 2006
Wyeth December 2005 - April 2006
Out of Industry Experience July 2004 - October 2005
Biogen Idec June 2002 - June 2004
Skills
CAPA, Investigation, Deviations, Quality Assurance, Technical Writing, Project Management, People-oriented, Assertiveness, Highly Ambitious, Highly detail oriented, Communication Skills, Trackwise, GMP, 21 CFR Part 11
Education
Endicott College
BS, Business
Lonza March 2015 - Present
MassBiologics June 2006 - February 2015
MassBiologics April 2004 - June 2006
Acambis 2002 - 2004
Alkermes December 2001 - September 2002
Collagenesis 1999 - 2001
Skills
Aseptic Processing, Biopharmaceuticals, Biotechnology, CAPA, Change Control, FDA, GMP, GxP, Quality Assurance, Quality Control, Quality System, Sop, Technology Transfer, Validation
Education
Arizona State University 1991 — 1995
Bachelor of Science (BS), Human Nutrition/Biology
Novo Nordisk October 2014 - Present
Olympus Biotech February 2008 - Present
Momenta Pharmaceuticals September 2006 - January 2008
Acambis February 2003 - August 2006
Millennium Pharmaceuticals August 1998 - January 2003
Skills
Microbiology, Biotechnology, Cell Culture, Formulation, Cell Biology, Analytical Chemistry, Biopharmaceuticals, Protein Chemistry, ELISA, Cell, Process Simulation, Drug Development, Validation, Assay Development, Technology Transfer, Lifesciences, HPLC, Purification, Biochemistry, Protein Purification, GLP, GMP, Change Control, Molecular Biology, Sop, FDA, SDS-PAGE, Clinical Development, Life Sciences
Education
University of Massachusetts, Amherst
Master of Science degree, Food Science
University of Massachusetts Dartmouth
Bachelor of Science degree, Biology
Agenus April 2013 - Present
Bristol-Myers Squibb, Devens, MA October 2010 - March 2013
BioVEX October 2007 - August 2010
Repligen Corporation April 2007 - September 2007
Acambis September 2001 - March 2007
Genzyme 1997 - 1998
AutoImmune 1996 - 1997
Astra Pharmaceuticals 1992 - 1995
Skills
GMP, Validation, FDA, CAPA, Biopharmaceuticals, Biotechnology, Sop, 21 CFR Part 11, Pharmaceutical Industry, Technology Transfer, LIMS, Change Control, Vaccines, UV/Vis, Protein Chemistry, ELISA, Assay Development, HPLC, Quality Control
Education
University of Massachusetts Lowell 1998 — 1999
M.Ed.
Clark University 1988 — 1992
BA
doTERRA December 2013 - Present
Acambis May 2005 - September 2005
Bio-Tissue January 2003 - January 2005
Imugen 1999 - 2003
Millennium Pharmaceuticals May 2001 - September 2001
Skills
Teaching, Microsoft Office, Research, Curriculum Development, PowerPoint, Higher Education, Microsoft Word
Education
Boston University 2000 — 2002
Master's degree, Neurobiology and Neurosciences
Regis College 1998 — 2000
Bachelor of Arts (B.A.), Biology, General
Worcester Polytechnic Institute 1996 — 1998
Biology, General
Acceleron Pharma January 2015 - Present
Acceleron Pharma January 2012 - December 2014
sanofi pasteur September 2008 - January 2012
Acambis July 2001 - September 2008
Genzyme Tissue Repair 1995 - 2001
Skills
Project Management, Biotechnology, Auditing, GMP, NCMR, Quality System..., Quality Systems Design, FDA GMP, Deviation Management, CAPAs, CMO management, Clinical Manufacturing, GLP, Quality Assurance, Clinical Trials, Pharmaceutical Industry, IND, CAPA, Quality System, GxP, GCP, Regulatory Affairs
Education
Cornell University 1982 — 1986
Bachelor of Science (BS), Industrial and Labor Relations
Sanofi Pasteur Biologics, Inc. February 2010 - Present
Acambis February 2001 - September 2008
Skills
Biologics Manufacturing..., Department Head, Large-scale Cell Culture, Biopharmaceuticals, Vaccines, Process Simulation, Process Improvement, Biologics, Pharmaceutical Industry, Cell Culture, Technology Transfer, Biotechnology, Clinical Trials, Clinical Development, Process Engineering, Protein Chemistry, Lifesciences, Viruses
Education
University of California, San Diego 1972 — 1994
BA, MS, PhD, Biology, Chemistry, Biochemistry, Pharmacology
MVG Consulting Services, Inc. August 1998 - Present
Acambis September 2003 - 2008
MannKind Corporation 2003 - 2004
Cubist Pharmaceuticals 1999 - 2003
Serono 1998 - 2002
Nitinol Medical Technologies 1997 - 1998
Vertex Pharmaceuticals 1995 - 1997
Copley Pharmaceuticals 1995 - 1995
Repligen Corporation 1992 - 1995
PAREXEL 1989 - 1992
Skills
Biotechnology, GCP, Clinical Development, Clinical Trials, Pharmaceutical Industry, Medical Writing, Oncology
Education
Lesley University 1994 — 1996
MS, Business Management
Boston State College 1976 — 1981
BS, Biology
Hull High School
Pfizer June 2015 - Present
Vishay Intertechnology, Inc. October 2014 - June 2015
Amgen May 2005 - August 2013
Amgen October 2004 - April 2005
Dow BCMS January 2001 - January 2004
Acambis January 2001 - March 2001
Wyeth Biopharma formerly Genetics Institute January 1998 - January 2000
Alkermes November 1997 - January 1998
Whitehead Institute January 1995 - January 1997
Skills
Biotechnology, Cell Culture, SOP, Production, Documentation, Validation, Fermentation, Testing, Chemistry, Clean Rooms, Aseptic Technique, Manufacturing Operations, Raw Materials, HPLC, Operational Excellence, Contract Manufacturing, CAPA, Aseptic Processing, Software Documentation, FDA, Protein Chemistry, Quality Assurance, Quality Control, Quality System, 21 CFR Part 11
Education
Northeastern University 1997 — 1998
Biotechnology
Bunker Hill Community College 1994 — 1994
Biomedical Certification, Biomedical Careers
Exempla Healthcare October 2013 - Present
Exempla Healthcare May 2007 - October 2013
Hallmark Healthcare June 2003 - April 2007
Acambis February 2001 - May 2002
Skills
Hematology, Laboratory, Blood Bank, Microbiology, Urinalysis, Hospitals, Clinical Research, Clinical Microbiology, Medical Technology, Meditech, Medical Terminology, Laboratory Safety, Laboratory Equipment, Medical Microbiology, CLIA, Clinical, Healthcare, Problem Solving, Troubleshooting, Clinical Development, Laboratory Skills, Laboratory Automation, Laboratory Technicians, Bloodborne Pathogens, Blood Transfusion, Analytical Chemistry, Medicinal Chemistry, Microscopy, Sunquest
Education
University of Massachusetts at Lowell 1996 — 2000
Bachelor, Medical Technology
Stiefel, a GSK company August 2015 - Present
Duke University Medical Center August 2014 - August 2015
University of Southern California August 2008 - May 2014
Acambis February 2008 - August 2008
Wyeth May 2006 - August 2007
Biogen Idec May 2004 - August 2005
Skills
Molecular Biology, Cellular Biology, Neuroscience, Molecular Cloning, DNA extraction, RNA isolation, PCR, RT-PCR, qPCR, Microarray, Western Blotting, Southern Blotting, ELISA, Immunohistochemistry, Metabolism, Glucose Testing, Insulin Testing, Mammalian Cell Culture, Transfection, Calcium Imaging, Viral plaque assay, Transgenic mouse..., Mouse Husbandry, Mouse Breeding, Assay Development, Confocal Microscopy, Virology
Education
University of Southern California 2008 — 2013
PhD, Molecular Biology
Wake Forest University 2003 — 2007
BS, Biology
Reading Memorial High School 1999 — 2003
BIOTRONIK November 2011 - Present
Repligen Corporation May 2006 - August 2010
Acambis 2005 - 2006
Skills
Microsoft Office, Microsoft Excel, Microsoft Word, PowerPoint, English, Windows, Research, Teaching, Public Speaking, Strategic Planning
Education
PrepMD 2010 — 2011
Certificate, Cardiac Rhythm Management
Boston University 2005 — 2006
Graduate Certificate, Project Management
Clark University 2001 — 2005
Bachelors, Biology/Pre-Med
Genzyme August 2011 - Present
Xcellerex April 2009 - August 2011
Acambis April 2006 - August 2008
TKT 2005 - 2006
Lonza 2002 - 2003
Wyeth 1997 - 2002
Genetics Institute 1997 - 2002
Skills
Cell Culture, Validation, Lifesciences, Sop, Protein Purification, ELISA, Biopharmaceuticals, Biotechnology, GLP, Protein Chemistry, GMP, Purification, Chromatography, Cell, Vaccines, Technology Transfer, Monoclonal Antibodies, Fermentation, Process Simulation, LIMS, Assay Development, Aseptic Processing, HPLC, Drug Discovery, FDA, V&V
Education
NGH
Certified Consulting Hypnotist
Salem State University
MSW
University of Massachusetts Lowell
BS, Chemistry
other
Commercial Pilot
The Jesup Library August 2015 - Present
The Jesup Library August 2015 - Present
self-employed 2010 - Present
Ellsworth Public Library November 2014 - May 2015
The Jackson Laboratory 2007 - 2009
Peptimmune 2004 - 2007
Altus (biotechnology) 2003 - 2004
Therion Biologics 2003 - 2003
Summers and Summers 2002 - 2003
Acambis 2002 - 2002
Skills
Operations Management, Project Management, Quality Assurance, Regulatory Affairs, Writing, Editing, Teaching, Training, Office Administration, Strategic Planning, Social Media
Education
University of California, Santa Barbara 1994 — 1997
BA with honors, English
Phillips Academy 1991 — 1992
Suffolk University Law School
Genzyme, a Sanofi Company July 2007 - Present
Acambis July 2005 - July 2007
Education
Assumption College 2001 — 2005
Bachelor's degree, Environmental Science
VolPal January 2015 - Present
Michael Overton Consulting November 2013 - December 2014
NNE Pharmaplan January 2010 - October 2013
Drug Development Resources April 2007 - January 2010
Acambis 2003 - 2007
Wyeth 2000 - 2003
Biogen 1988 - 2000
Skills
Biotechnology, GMP, Validation, Technology Transfer, Lifesciences, FDA, Pharmaceutical Industry, Vaccines, Microbiology, Regulatory Affairs, Medical Devices, CAPA, Manufacturing, 21 CFR Part 11, Change Control, Biopharmaceuticals, V&V, GxP
Education
Central Michigan University
MS, Administration
Boston University
BA, Biology
KBI Biopharma July 2015 - Present
Novartis June 2012 - June 2015
Sanofi Pasteur August 2004 - July 2012
Acambis 2004 - 2007
Skills
GMP, Cell Culture, Aseptic Processing, Cleaning Validation, Vaccines, Aseptic Technique, Trackwise, Chromatography, Validation, 21 CFR Part 11, Sop, HPLC, CAPA, GLP, LIMS, SOP
Education
Emmanuel College 1995 — 2000
Bachelor of Science (BS), Biology, General
Merrimack Pharmaceuticals June 2011 - February 2014
Genocea Biosciences April 2010 - June 2011
sanofi pasteur 2007 - April 2010
Acambis 2007 - April 2010
Skills
GMP, R&D, Vaccines, FDA, Strategy, Quality Assurance, Pharmaceutical Industry, Quality System, Life Sciences, Biotechnology, Clinical Development, GLP, GCP, Continuous Improvement
Education
Massachusetts College of Pharmacy and Health Sciences 2004 — 2006
Master's Degree, Drug Regulatory Affairs and Health Policy
Albany Medical Center July 2011 - Present
Biogen Idec 2004 - 2007
Acambis 2002 - 2004
Queen's University 1995 - 2000
Education
Albany Medical College 2007 — 2011
Doctor of Medicine (MD)
Harvard University 2004 — 2009
Master's of Liberal Arts
Queen's University 1995 — 2000
Bachelor of Applied Science (B.A.Sc.)
Sarepta Therapeutics (formerly AVI BioPharma) December 2011 - Present
Apex CMC Advisors, LLC January 2011 - January 2012
GSK January 2010 - November 2010
Enobia Pharma June 2008 - January 2010
Acambis February 2006 - May 2008
Wyeth October 2003 - February 2006
Diosynth 2000 - 2003
Roche Diagnostics 1996 - 2000
Skills
Technology Transfer, Scale Up, FDA, Oligonucleotides, Biotechnology, Vaccines, Commercialization, Pharmaceutical Industry, Lifesciences, Business Process..., Project Portfolio..., Earned Value Management, Government Contracting
Education
University of North Carolina at Chapel Hill - Kenan-Flagler Business School 2001 — 2003
MBA, Strategy, finance, marketing
The Ohio State University 1987 — 1992
Ph. D., Molecular biology, fermentation technology, downstream processing
King George HS, Bombay
King George HS, Bombay
Federal Reserve Bank of Boston August 2011 - Present
David Nicklas Consulting August 2011 - Present
US Navy Reserves June 2008 - Present
Blitz Connects October 2010 - August 2011
Chestnut Hill Realty June 2007 - June 2010
Acambis May 2006 - August 2006
Skills
Security, Network Security, Computer Security, Troubleshooting, Microsoft Office, Network Administration, Hardware, Microsoft Excel, CISSP, Help Desk Support, Computer Forensics, Customer Service, Leadership, Security Clearance, PowerPoint, Project Management, SharePoint, Vulnerability Assessment, Symantec Endpoint..., Active TS/SCI Clearance, Networking, Help Desk Management, BigFix, SCCM, Active Directory, Symantec BindView, IP 360, Information Security, Information Technology, VMware, Windows Server, Analysis, Windows 7, Computer Hardware, System Administration, Disaster Recovery, Information Assurance, Military, Enterprise Software, Linux, Servers, Technical Support, Public Speaking
Education
Norwich University 2005 — 2010
Bachelor of Science, Computer Security and Information Assurance
Xaverian Brothers High School 2001 — 2005
Pfenex Inc November 2012 - Present
Laureate Biopharmaceutical Services May 2011 - November 2012
Crucell October 2009 - May 2011
Crucell October 2006 - December 2009
Acambis 2004 - 2006
Joslin Diabetes Center 2003 - 2004
Beth Israel Deaconess Medical Center 1999 - 2003
American Red Cross 1996 - 1999
American Red Cross 1996 - 1999
Skills
Biopharmaceuticals, Biotechnology, Technology Transfer, Contract Management, Lifesciences, Strategy, Vaccines, Immunology, Cell Culture, Cell Biology, Cell, Commercialization, Molecular Biology, ELISA, Drug Development, Protein Chemistry, Monoclonal Antibodies, R&D, Pharmaceutical Industry, Genomics, Assay Development, CRM, Virology, Microbiology, GMP, Biochemistry, Drug Discovery, Antibodies, Clinical Development
Education
Harvard University 2000 — 2003
Master of Science (M.S.), Virology
Syracuse University 1992 — 1996
BS, Biology
Citeline, Inc. June 2015 - Present
Citeline, Inc. January 2013 - June 2015
Citeline, Inc. June 2008 - January 2013
Citeline, Inc. June 2007 - June 2008
Citeline, Inc. January 2006 - June 2007
Acambis March 2003 - August 2005
American Institutes for Research September 2000 - March 2003
OraVax January 2000 - September 2000
Skills
Clinical Trials, Drug Development, Lifesciences, Biotechnology, Pharmaceutical Industry, Competitive Intelligence, R&D, Biopharmaceuticals, Clinical Development, Pharmaceutics, CRO, Regulatory Affairs, Medical Writing, Cell Biology, Molecular Biology, Vaccines, Life Sciences
Education
Baylor College of Medicine 1997 — 1999
graduate work, Virology
College of the Holy Cross 1993 — 1997
BA, Biology
Covidien December 2008 - Present
Covidien December 2007 - January 2012
Boston Scientific 2000 - 2008
Acambis December 2005 - December 2007
Biogen 2001 - 2004
Boston Scientific November 1986 - May 2001
Skills
Team Building, Public Speaking, Medical Devices, Quality System, GMP, Training, Instructional Design, Training Delivery, Instructor-led Training, Quality Auditing, Learning Management..., Root Cause Analysis, Lean Manufacturing, Process Improvement, CAPA, Cross-functional Team..., Manufacturing, Quality Assurance, FDA, Continuous Improvement, Software Documentation, Operational Excellence, Communication Skills, Sop, Validation, Six Sigma, SOP
Education
Lesley University 1998 — 2003
Masters, Management
Wayland Baptist University 1991 — 1994
B.S., Corporate Training and Development
Chesapeake College 1982 — 1986
A.S, criminal Justice
PRO Unlimited September 2014 - Present
Sanofi Pasteur March 2009 - May 2011
Acambis / Sanofi Pasteur May 2007 - February 2009
Acambis September 2006 - April 2007
California National Primate Research Center, UC Davis February 2003 - June 2006
Skills
Vaccines, Immunology, Cell, Assay Development, Biopharmaceuticals, Clinical Research, Clinical Development, Animal Work, Biotechnology, Cell Biology, Cell Culture, ELISA, Infectious Diseases, Monoclonal Antibodies, Virology
Education
University of California, Davis - Graduate School of Management 2005 — 2006
University of California, Davis 1997 — 2002
PhD
The University of Kiel 1993 — 1997
Diplom Biologist
Renee Cameron Photography September 2010 - Present
Sirtex Medical Limited March 2012 - April 2014
Tetraphase Pharmaceuticals March 2011 - September 2011
Sirtris Pharmaceuticals April 2010 - January 2011
Shire HGT January 2009 - January 2010
EPIX Pharmaceuticals March 2008 - December 2008
Acambis November 2005 - October 2007
Massachusetts General Hospital April 2003 - November 2005
Skills
Photography, Digital Photography, Portrait Photography, Adobe Creative Suite, Photoshop, Fine Art Printing, Travel Photography, Event Photography, Fine Art Photography, Digital Media, Clinical Trials, Clinical Research, CRO, Regulatory Affairs, Sop, Clinical Operations, CTMS, GCP, Clinical Development, Pharmaceutical Industry, Oncology, Biotechnology, Cardiology, Clinical, FDA, Lifesciences, Clinical Study Design
Education
Center for Digital Imaging Arts (Boston University 2009 — 2011
Certificate, Professional Photography, Photography
MGH Institute of Health Professions 2001 — 2003
MS, Clinical Research
University of Cincinnati 1990 — 1995
BS, Psychology/Biology
Vertex Pharmaceuticals February 2015 - Present
Vertex Pharmaceuticals October 2011 - Present
Vertex Pharmaceuticals August 2010 - October 2011
Vertex Pharmaceuticals July 2008 - August 2010
Genzyme September 2006 - July 2008
Acambis 2002 - 2007
Skills
Regulatory Affairs, Regulatory Submissions, FDA, IND, Pharmaceutical Industry, Biotechnology, 21 CFR Part 11, eCTD, Vaccines, GMP, Sop, Regulatory Requirements, Computer System..., GxP, Regulatory Operations, Regulations, SOP
Education
The University of Connecticut 1988 — 1992
Bachelor of Arts, English
State University of New York College at Cortland
BS, Exercise Physiology
Pfizer June 2008 - Present
Acambis November 2004 - May 2008
Genzyme October 1999 - November 2004
Roche Molecular Systems August 1996 - September 1999
Education
The College of New Jersey 1992 — 1996
BS, Biology
high school
NIH March 2007 - Present
Acambis 2001 - 2007
Skills
Vaccines, Clinical Research, Clinical Trials, Biotechnology, Regulatory Requirements, Lifesciences, Program Management, Regulatory Affairs, Project Management, IND, Infectious Diseases, Public Health, Drug Development, Immunology, Clinical Development, GLP, Microbiology, GCP, FDA, Life Sciences
Education
University of Maryland College Park 1991 — 1993
M.S., Nutritional Biochemistry
Montclair State University 1985 — 1989
B.S., Biology major/ Chemistry minor
Sanofi Pasteur Biologics January 2009 - Present
Acambis April 2002 - December 2008
Organogenesis 1998 - 2001
Education
College of the Holy Cross 1991 — 1995
BA, Chemistry
Massachusetts Biologic Laboratories 2005 - Present
Acambis 2001 - 2005
Oravax 1996 - 2001
Repligen Corporation 1993 - 1996
Skills
GMP
Education
University of New Hampshire 1988 — 1992
Fresenius Medical Care July 2015 - Present
Alkermes, Inc. 2007 - Present
ARIAD Pharmaceuticals, Inc. 2005 - 2007
Acambis 2000 - 2005
Genzyme 1996 - 2000
Skills
FDA, Regulatory Affairs, Biopharmaceuticals, Drug Development, IND, Regulatory Submissions, Clinical Development, Regulatory Affairs..., Biotechnology, Regulatory Strategy, Vaccines, Pharmaceutical Industry, NDA, MAA, DMF, CTA, PMC, PMR, FDA GMP, GCP, CMC, R&D, Regulatory Requirements
Education
Lesley University
Bachelor of Science (BS), Business Management
Marian Court College
Associate of Science (AS), Business Administration
Northeastern University
Completing Master of Regulatory Affairs
InterSystems March 2009 - Present
InterSystems February 2007 - February 2009
Acambis October 2005 - February 2007
Acambis August 2002 - October 2005
Haley & Aldrich 1997 - 2002
Education
Harvard University Extension School 2000 — 2004
CAS, Software Engineering
Cornell University 1995 — 1997
MS, Civil Engineering
Northeastern University 1990 — 1995
BS, Civil Engineering
Genzyme November 2012 - Present
DAC Engineering June 1993 - Present
Vacuum Process Technology LLC (VPT) February 2012 - November 2012
Lonza October 2009 - February 2012
Applied Control Engineering February 2008 - September 2009
Acambis March 2002 - January 2008
Skills
Metrology, PLC, Automation, Instrumentation, Process Control, Validation, Manufacturing, Commissioning, GMP, Engineering, DCS, SCADA, Troubleshooting, Biotechnology, HVAC, Visual Basic, FDA, HPLC, DeltaV, ControlLogix, Change Control, Fermentation, Beer, Tubes, Cleaning Validation, Electrical Engineering, Calibration, Computer System..., Control Systems Design, Process Engineering, WebDAV, Allen Bradley, Control Logic, 21 CFR Part 11, Tube, Wonderware, Electronics, Electricians
Education
Boston University 2004 — 2006
B.Sc
Northeastern University 1996 — 2002
Computer Engineering Technology
Sanofi Pasteur January 2002 - Present
acambis 2002 - 2009
Genetics Institute 1990 - 1994
Education
Nova Southeastern University 1996 — 1998
MS, Education
Repligen Corporation July 2015 - Present
Amgen March 2008 - Present
BioVex, Inc. March 2008 - March 2012
ArQule, Inc. February 2006 - March 2008
Acambis 2005 - 2006
Biogen Idec October 2004 - September 2005
Biogen Idec 2003 - 2005
Biogen Idec 2001 - 2003
Biogen Idec 2000 - 2001
Skills
Biotechnology, FDA, GMP, Sop, Pharmaceutical Industry, CAPA, GLP, Clinical Trials, 21 CFR Part 11, GCP, Biopharmaceuticals, GxP, Quality System, Software Documentation, Quality Assurance, SOP
Education
Cambridge College 2004 — 2010
RCM Technologies April 2013 - Present
ISPE Boston Area Chapter 2015 - 2015
Eliassen Group February 2013 - April 2013
Pharmaceutical Validation Solutions, Inc. May 2005 - February 2013
Fluor 2002 - 2005
Acambis 2002 - 2003
DuPont Pharmaceuticals 1990 - 2000
Skills
Validation, Change Control, GMP, Sop, FDA, Biotechnology, Technology Transfer, Quality System, 21 CFR Part 11, Aseptic Processing, Pharmaceutical Industry, Medical Devices, Cleaning Validation, CIP, Biologics, Quality Assurance, Document Management, Quality Control, Deviations, Analytical Chemistry, Manufacturing, Equipment Qualification, Consent Decree, Deviation Management, LIMS, Purification, GxP, Lifesciences, Process Improvement, R&D, Biopharmaceuticals, Calibration, Autoclave, Clinical Trials, HPLC, Root Cause Analysis, GLP, Biotechnology Industry, Process Simulation, Lyophilization, Pharmaceutics, Testing, Oncology, Chromatography, Trackwise, Regulatory Submissions, GAMP, Sterilization, Regulatory Affairs, Vaccines
Education
University of Massachusetts Lowell 1990 — 1996
St Johns Prep
St Johns Prep
Pfizer October 2009 - Present
Wyeth August 2006 - October 2009
Wyeth Biotech August 2006 - October 2009
Acambis January 2006 - August 2006
Acambis January 2003 - December 2005
Acambis February 2002 - December 2003
Genzyme October 2000 - February 2002
Pavonis September 1998 - September 2000
Massachusetts General Hospital July 1997 - September 1998
Education
Bates College 1994 — 1997
B.S., Biochemistry
Allergan January 2014 - Present
ImmunoGen, Inc. October 2012 - January 2014
Advanced Technologies and Regenerative Medicine July 2007 - June 2012
Stryker Biotech May 2005 - July 2007
Amgen October 2003 - May 2005
Acambis February 2003 - September 2003
Stryker Biotech September 1999 - January 2003
Hybridon September 1998 - September 1999
Serono Labs August 1992 - 1998
Skills
Quality Control..., Stability managment, Method Development, HPLC, CE, SDS-PAGE, Western Blotting, IEF, BIOASSAY, CELL CULTURE, Data Review / Approval, OOS investigations, GMP, Cell Culture, Quality Assurance, Medical Devices, Chemistry, Laboratory, Bioassay, Protein Chemistry, CAPA, GLP, ELISA, LIMS, Biopharmaceuticals, FDA, Immunoassays, Quality Control
Education
University of Massachusetts Dartmouth 1985 — 1989
BS, Biology
Sanofi Pasteur (Acambis Campus) August 2014 - Present
Sanofi Pasteur (Acambis campus) December 2005 - August 2014
BioTech Studio LLC 2003 - 2005
Fraunhofer USA August 2001 - June 2003
Hercules Inc. (bought by Ashland in 2008) November 1998 - August 2001
Acambis April 1996 - October 1998
Skills
Infectious Diseases, Biotechnology, Vaccines, Antibodies, R&D, Virology, Protein Chemistry, Biochemistry, Technical Project..., Entrepreneurship, Team Leadership, Assay Development, Protein Engineering, FDA, Biopharmaceuticals, Pharmaceutical Industry, Monoclonal Antibodies, High Throughput..., Chemistry
Education
Massachusetts Institute of Technology 1991 — 1995
Ph.D., Biological Chemistry
McGill University 1988 — 1991
B.Sc., Biochemistry
University of California - Riverside January 2012 - Present
Riverside Parks and Recreation 2012 - Present
Santa Ana College 2011 - Present
Ace Wireless Group June 2010 - November 2011
METABOLIX INC April 2007 - March 2009
Quinsigamond Community College April 2004 - June 2006
Acambis March 2002 - April 2004
BURLE INDUSTRIES August 1999 - February 2002
LUXTEC CORPORATION May 1996 - August 1999
THE HOPE GROUP September 1991 - May 1996
Skills
Documentations, Process Improvement, Project Management, Microsoft Office, Quality Assurance, Software Documentation, Training, Integration, Cross-functional Team..., Management, Disaster Recovery, Leadership, Analysis, Microsoft SQL Server, Networking, Windows Server, ERP, Start-ups, Team Leadership, Business Development, Telecommunications, Technical Support, Software Development, Budgets, Data Center, Enterprise Software, Security, Network Administration, Information Technology, Troubleshooting, Network Security, Microsoft Exchange, Program Management, Access, SharePoint, Visio, Databases, System Administration, Project Planning, Windows, Vendor Management, IT Management, Data Analysis, CRM, Team Building, E-commerce, Requirements Analysis, Business Analysis, SDLC, Business Intelligence
Education
California University Llano 2014 — 2014
Doctor of Ministry, Theology and Religious Vocations, 4.0
Eastern Nazarene College 2001 — 2003
MSM, Business
Eastern Nazarene College 1999 — 2001
BSBA, Business Admin
Sanofi Pasteur December 2008 - April 2011
Acambis July 2008 - December 2008
Schering Plough February 2008 - July 2008
Organon April 2006 - February 2008
Boston University Medical School July 2004 - April 2006
Skills
Cell Culture, Biotechnology, ELISA, Lifesciences, FDA, Research, Molecular Biology, Immunology, Validation, PCR, Biochemistry, GLP, Infectious Diseases, Western Blotting, Life Sciences, Assay Development
Education
Boston College 2000 — 2004
Jennison Associates March 2014 - Present
Arrowstreet Capital March 2010 - March 2014
Express Gourmet September 2006 - October 2009
Acambis November 2000 - June 2006
The Wang Center for the Performing Arts July 2000 - October 2000
Skills
•High Level Customer..., •Training..., •Evaluation and..., Training, Customer Service, Servers, Process Improvement, Security, Troubleshooting, Business Services, Microsoft Exchange, Networking, Project Management, Microsoft Office, Hardware, VMware, SharePoint, Microsoft SQL Server, Enterprise Architecture, Databases, WAN, Disaster Recovery, Visio, Technical Support, Windows, Routers, Active Directory, VMware Infrastructure, Software Documentation, VMware ESX, Management, Windows Server, Quality Assurance
Education
Boston University 2004 — 2005
Graduate Certificate, Project Management
Clark University 1999 — 1999
Certificate, Windows NT Administrator
Suffolk University 1994 — 1998
Bachelor of Arts, Paralegal Studies
Alnylam Pharmaceuticals February 2010 - January 2012
Sanofi Pasteur September 2008 - February 2010
Acambis 2005 - September 2008
Millipore September 2001 - August 2005
Skills
Lipid transfection, Fluorescent antibody..., Centrifugation,..., Mixing and mass..., Viral titer assays -..., Virus propagation,..., Mammalian cell culture..., Bioreactor, Mammalian Cell Culture, Transfection, Assay Development, Purification, Biotechnology, Cell Culture, Fluorescence, Chromatography
Education
Worcester Polytechnic Institute 1996 — 2001
Bachelor of Science, Chemical Engineering
Northeastern University
Sanofi Pasteur 2008 - Present
Acambis September 1997 - September 2008
Skills
Assay Development, Biochemistry, Biopharmaceuticals, Biotechnology, Cell Culture, Clinical Development, Clinical Trials, Drug Development, Drug Discovery, ELISA, FDA, GLP, GMP, Immunology, Infectious Diseases, Life Sciences, Lifesciences, Molecular Biology, Pharmaceutical Industry, R, Research, Team Building, Technology Transfer, Vaccines
Education
University of London 1988 — 1993
Amgen March 2006 - Present
Acambis August 2002 - March 2006
American Power Conversion July 1999 - August 2002
Scoletti's Italian Gourmet Deli 1999 - 2002
Skills
Quality System, Pharmaceutical Industry, Quality Assurance, GMP, CAPA, Computer System..., Change Control, GxP, 21 CFR Part 11, FDA, Biotechnology, Validation, Sop, Technology Transfer, Vaccines, GLP, Biopharmaceuticals
Education
Keene State College
Novartis April 2007 - Present
Acambis February 2003 - March 2007
Skills
Immunology, Virology, Ophthalmology, Drug Development, Cell Culture, Vaccines, Biotechnology, Infectious Diseases, ELISA, Biochemistry, In Vivo, Molecular Biology, Pharmacology
Education
Harvard University 1999 — 2002
Masters, Immunology
University of Pennsylvania 1995 — 1999
Bachelors, Biology
Genzyme August 2013 - Present
Genzyme September 2011 - Present
Mass Histology Services April 2010 - March 2012
Veroscience April 2007 - May 2008
Acambis November 2005 - October 2006
amgen May 2003 - November 2005
AVANT Immunotherapeutics 2002 - 2003
Education
University of Rhode Island 2000 — 2002
Keryx Biopharmaceuticals July 2015 - Present
Alkermes March 2008 - July 2015
Aeris Therapeutics, Inc. May 2007 - February 2008
ViaCell, Inc 2004 - 2007
Nucryst Pharmaceuticals 2003 - 2004
Acambis 2001 - 2003
Education
Salem State University 1998 — 2003
Acambis Clinical Trial ManagerCubist2003 - 2005
Education
Boston College 1984 — 1988
Sanofi Pasteur September 2007 - Present
Acambis 2007 - 2008
Shire HGT 2006 - 2007
Shire Human Genetic Therapies 2004 - 2007
TKT (Shire Human Genetic Therapies) 2004 - 2006
Vertex Pharmaceuticals 1998 - 2004
Transcend Therapeutics 1997 - 1998
Alpha Beta Technology 1996 - 1997
Hoffman La Roche 1993 - 1996
Norwalk Hospital 1990 - 1993
Skills
Clinical Trials, Pharmaceutical Industry, Vaccines, CTMS, Clinical Development, Clinical Monitoring, CRO, GCP, Regulatory Submissions, Clinical Research, Oncology, Lifesciences, Biotechnology, Infectious Diseases, Drug Development, EDC, Clinical Data Management, ICH-GCP, Therapeutic Areas, Sop, Biopharmaceuticals, Regulatory Affairs, Protocol, FDA, Medical Affairs, Pharmacovigilance, 21 CFR Part 11, Immunology, GLP, Neurology, Medical Writing, Endocrinology, SOP, Life Sciences
Education
Columbia University in the City of New York 1989 — 1991
Master of Arts (M.A.), Human Physiology
Wichita State University 1984 — 1987
Bachelor's Degree, Health Services/Allied Health/Health Sciences, General
BioProtection Systems / NewLink Genetics Corp. March 2015 - Present
Vaccinologist October 2010 - Present
CBR International Corp. November 2013 - February 2015
PharmAthene February 2008 - September 2010
Acambis 2004 - 2008
Baxter BioScience 2000 - 2004
North American Vaccine 1991 - 2001
University of Pittsurgh 1978 - 1987
Skills
Biotechnology, Technology Transfer, Vaccines, Life Sciences, GMP, CAPA, Aseptic Processing, Lifesciences, Biopharmaceuticals, Quality System, Pharmaceutical Industry, Commercialization, 21 CFR Part 11, Clinical Development, Oncology, FDA, Regulatory Affairs, Validation
Education
University of Pittsburgh
Ph.D., Microbiology/Biological Sciences
Enumeral Biomedical Corp November 2012 - Present
Enumeral Biomedical Corp June 2011 - November 2012
Tolerx, Inc. May 2008 - March 2011
Acambis June 2006 - May 2008
Houghton Mifflin October 2005 - May 2006
Massachusetts Institute of Technology August 2002 - September 2005
Skills
ELISA, Assay Development, Cell, Immunology, In Vitro, In Vivo, Flow Cytometry, Cell Biology, FACS, Antibodies, Monoclonal Antibodies, Virology, Mammalian Cell Culture, Vaccines, Biotechnology
Education
Massachusetts Institute of Technology 2002 — 2005
M.S., Biology
University of Arizona 1998 — 2002
B.S., Molecular and Cell Biology
Paratek Pharmaceuticals, Inc. March 2009 - Present
Momenta Pharmaceuticals January 2007 - March 2009
Acambis November 2005 - January 2007
Millennium Pharmaceuticals February 2000 - January 2005
Education
Boston University 2006 — 2009
MS, Project Management
Michigan State University 1992 — 1997
BS, Dietetics
InventivHealth Clinical March 2014 - Present
Novartis Institute for BioMedical Research April 2010 - March 2014
Artisan Pharma September 2008 - February 2010
EPIX Pharmaceuticals August 2007 - October 2008
Altus Pharmaceuticals August 2006 - August 2007
Acambis March 2006 - August 2006
Stryker 2003 - 2006
Biopure 2001 - 2002
Skills
Biotechnology, Clinical Research, Clinical Development, Project Management, Medical Writing, Clinical Trials, Oncology, Data Management, CRO, CTMS, GCP, EDC, Drug Development, Clinical Monitoring
Education
University of Oklahoma 1987 — 1991
BS, Physiology
Portsmouth HS 1978 — 1991
Diploma
high school 1981 — 1981
diploma
Acambis Associate Director Business DevelopmentDyaxSeptember 2001 - April 2005
Admetric BioChem Inc. October 1998 - September 2001
Education
Simmons College - Simmons School of Management 2002 — 2004
MBA, Business Administration
Purdue University 1996 — 2000
PhD, Medicinal Chemistry
East Stroudsburg University of Pennsylvania 1992 — 1996
BS, Chemistry
Committee for Public Counsel Services July 2012 - Present
Smithers Viscient April 2005 - August 2013
Acambis July 2004 - December 2004
Avecia 2002 - 2004
Skills
Research, PowerPoint, Microsoft Office, Legal Research, Microsoft Excel
Education
Roger Williams University School of Law 2004 — 2008
JD, Law
University of Massachusetts Dartmouth 1998 — 2002
BS, Biology
Sanofi Pasteur Biologics, LCC August 2009 - Present
sanofi pasteur 2009 - Present
Acambis October 2005 - August 2009
Skills
GMP, Validation, SOP, FDA, Pharmaceutical Industry, CAPA, Change Control, Biotechnology, GLP, Biopharmaceuticals, 21 CFR Part 11
Education
Universidad de San Carlos de Guatemala 1980 — 1985
BS in Chemical Engineering, Fluids Dynamic
PharmArete Consulting Services February 2010 - Present
AVEO Pharmaceuticals August 2010 - May 2012
Sanofi Pasteur 2009 - 2010
Acambis 2008 - 2009
UCB 2004 - 2008
Celltech North America Inc. 2001 - 2004
Medeva Americas Inc. 1996 - 2001
Hoechst Roussel Pharmaceuticals/Hoechst Marion Roussel Inc. 1991 - 1996
Marion Laboratories/Marion Merrell Dow 1988 - 1991
Lederele Laboratories Division/Medical Research Division of the American Cyanamid Company 1984 - 1988
Skills
Operations Management, FDA, GMP, Clinical Trials, Technology Transfer, Strategy, Manufacturing, Validation, Product Development, Biopharmaceuticals, Quality System, Sop, Start-ups, Pharmaceutical Industry, 21 CFR Part 11
Education
Grand Valley State University
BSc, Chemistry
Purdue University
PhD, Analytical Chemistry
Pfizer May 2013 - Present
New York City Department of Health and Mental Hygiene 2011 - May 2013
New York City Department of Health and Mental Hygiene January 2006 - August 2007
Acambis 2001 - 2006
Skills
Vaccines, Infectious Diseases, GCP, Microbiology, Biotechnology, Clinical Trials, Pharmaceutical Industry, Epidemiology, EDC, Clinical Research, Regulatory Affairs, Global Health, CTMS, 21 CFR Part 11, Clinical Development, Lifesciences, FDA, Oncology, Public Health, CRO, Validation, Drug Development, Sop, Biostatistics
Education
University of Pittsburgh Graduate School of Public Health 2007 — 2011
PhD, Epidemiology
Harvard T.H. Chan School of Public Health 2001 — 2004
Sc.M., Epidemiology
The Johns Hopkins School of Pubilc Healh 1998 — 2000
Sc.M., Molecular Microbiology and Immunology
Repligen Corporation May 2007 - Present
REPLIGEN CORP May 2007 - Present
Acambis November 2005 - March 2007
ACAMBIS, INC November 2005 - March 2007
Clark University January 2001 - January 2002
Education
Clark University 2001 — 2005
BA, Biology
Boston University
Graduate Certificate, Project Management
Clark University
B.A, Biology
Infinity Pharmaceuticals January 2014 - Present
Sanofi Pasteur July 2010 - January 2014
Sanofi Pasteur September 2008 - July 2010
Acambis May 2007 - September 2008
BioEngine, Inc. December 2006 - April 2007
Pacific Nutritional, Inc. February 2005 - October 2006
Education
Northeastern University 2012 — 2014
Master of Business Administration (M.B.A.), High Technology
Northeastern University 2000 — 2004
BS, Biology
ImmunoGen, Inc. December 2011 - Present
ImmunoGen, Inc. December 2006 - December 2011
Acambis July 2004 - December 2006
Wyeth BioPharma January 2001 - June 2004
Education
University of Phoenix 2002 — 2004
Master of Business Administration (MBA), Technology Management
Northeastern University 1995 — 1999
Bachelor of Science (B.S.), Biochemistry
Genzyme 2006 - 2012
Nephros Therapeutics (RenaMed) 2004 - 2006
Acambis 2002 - 2004
Q-One Biotech 2001 - 2002
AstraZeneca 1998 - 2000
Biogen 1994 - 1998
Skills
GMP, Validation, GLP, Sop, Pharmaceutical Industry, FDA
Education
University of Massachusetts, Amherst 1985 — 1989
BS, Animal Science
sanofi-aventis January 2011 - Present
Sanofi Pasteur January 2009 - December 2010
Acambis April 2005 - December 2008
Nova Biomedical November 2000 - April 2005
Barry Controls July 1992 - November 2000
Skills
Vaccines, GMP, Life Sciences, R&D, Manufacturing, Product Development, Lean Manufacturing, Supply Chain, Procurement, Strategic Sourcing, Purchasing, Pharmaceuticals, Supplier Management, SAP
Education
Northeastern University 1996 — 1997
Bachelor of Business Administration (B.B.A.), Logistics, Materials, and Supply Chain Management
Bunker Hill Community College 1992 — 1994
Associate's degree, Business Administration and Management, General
Mastrogiovanni & Denehy, P.C. 2006 - Present
Panacos Pharmaceuticals 2004 - 2006
Acambis 2002 - 2004
Telephotonics Inc. 2000 - 2002
Moody, Famiglietti & Andronico, LLP 2000 - 2000
Gamesville.com 1999 - 2000
Arthur Andersen LLP 1997 - 1999
Skills
Sarbanes-Oxley Act, Internal Controls, Financial Reporting, Financial Analysis, Auditing, Due Diligence, Financial Modeling, Budgets, Revenue Recognition, US GAAP, FASB, Sales & Use Tax
Education
Northeastern University 1995 — 1997
BSBA, Accounting
University of Massachusetts, Amherst 1992 — 1994
Woburn High School 1989 — 1991
Baxter BioScience Department SpecialistBaxter BioScienceNovember 2007 - August 2010
Baxter BioScience July 2000 - November 2007
acambis 2002 - 2003
Skills
GMP
Education
University of Maryland Eastern Shore 1996 — 2000
BS, Biology
Biogen Idec July 2012 - Present
Biogen Idec July 2007 - May 2012
Acambis January 2004 - June 2007
Schwartz Communications October 2000 - December 2003
Skills
Biotechnology, Lifesciences, Biopharmaceuticals, Product Launch, Internal Communications, Product Communication, Cross-functional..., Corporate Communications, Crisis Communications, Life Sciences, Strategic Communications, Marketing, Public Affairs
Education
Butler University
Bachelor of Arts (BA), Public and Corporate Communications
Citra Labs - a Biomet Biologics Company April 2011 - January 2014
Alexion Pharmaceuticals 2007 - 2011
Acambis 2002 - 2007
Skills
Quality Assurance, GMP, CAPA, Biopharmaceuticals, FDA, 21 CFR Part 11, Validation, Sop, Change Control, Aseptic Processing, Biotechnology, GLP, LIMS, Pharmaceutical Industry, Vaccines, Quality System, Regulatory Affairs, Lifesciences, Microbiology, Clinical Development
Education
The Johns Hopkins University
MS, Regulatory Affairs
Rutgers University-New Brunswick
BS, Animal Science, Microbiology
Alexion Pharmaceuticals December 2009 - Present
Alexion Pharmaceuticals, Inc. April 2007 - December 2009
Acambis December 2002 - April 2007
Acambis April 2002 - December 2002
Massachusetts Biologic Laboratories July 1999 - April 2002
Massachusetts Biologic Laboratories June 1996 - July 1999
Massachusetts Biologic Laboratories June 1993 - June 1996
Skills
Quality Assurance, GMP, Validation, Biotechnology, FDA, Sop, Quality System, CAPA, Pharmaceutical Industry, Lifesciences, Change Control, Manufacturing...
Education
University of Massachusetts Dartmouth 1989 — 1993
Bachelor's Degree, Biology, General
Boston Area December 2012 - Present
Belmont Day School January 2003 - June 2012
Acambis July 1998 - May 2001
Skills
Curriculum Design, Teaching, Curriculum Development, Tutoring, Educational Technology, Community Outreach, Program Development, Non-profits, Higher Education, Editing, Research, Public Speaking, Staff Development, Grant Writing
Education
Lesley University 2001 — 2003
M. Ed., Elementary Education/Creative Arts in Learning
Wesleyan University 1994 — 1998
BA, Psychology
Novartis Consumer Health April 2005 - Present
Acambis 1997 - 2005
Education
North Shore Community College
Associate of Science (A.S.), BioTechnology