Wyeth Biotech
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Wyeth Biotech Employees
Fujifilm Diosynth Biotechnologies February 2013 - Present
Fujifilm Diosynth Biotechnologies August 2011 - February 2013
Fujifilm Diosynth Biotechnologies January 2011 - August 2011
Fujifilm Diosynth Biotechnologies April 2008 - January 2011
Wyeth Biotech 2004 - 2008
Abbott Laboratories 1999 - 2004
Skills
GMP, Quality Control, Chemistry, LIMS, Validation, Testing, Technology Transfer, Chromatography, Sop, V&V, Biotechnology, CAPA, GLP, 21 CFR Part 11, Quality System, Lifesciences, Change Control, Software Documentation, FDA, Cleaning Validation, HPLC, Biopharmaceuticals, SOP
Education
Indiana University Bloomington 1995 — 1999
B.S., Biochemistry, Math, Spanish
Jim Dezieck, Leadership and Organization Development Consultant 2013 - Present
Pfizer Biotech Andover 2009 - 2013
International AIDS Society 2011 - 2011
Wyeth Biotech 2004 - October 2009
Massachusetts Institute of Technology July 1997 - July 2004
Harvard University September 1981 - July 1991
Skills
Leadership Development, Executive Coaching, MBTI, Organizational..., Organizational..., Coaching, Succession Planning, Organizational Design, Strategy, Culture Change, Emotional Intelligence, Team Building, Human Resources, 360 Feedback, Instructional Design, Program Management, Performance Management, Change Management, Leadership, Training Delivery, Workshop Facilitation, Team Leadership, Employee Engagement, Cross-functional Team..., Strategic Planning, Management Development, Project Planning, Personal Development, Facilitators, Career Development, Talent Management, Training, Process Improvement
Education
Harvard University
EdM, Counseling and Consulting Psychology
The University of Connecticut
Bachelor of Science (BS), Education
Parkway Middle School September 2010 - Present
Bellalago Academy School April 2005 - June 2010
Discovery Intermediate School September 2002 - April 2005
EMD Millipore June 2000 - June 2002
Wyeth BioTech March 1998 - May 2000
Wyeth Biotech (Genetics Institute) June 1988 - March 1998
Skills
Teaching, Microsoft Office, Public Speaking, Research, Curriculum Design, Customer Service, Curriculum Development, Microsoft Excel, PowerPoint, Higher Education, Strategic Planning, Microsoft Word, Classroom, Educational Technology, Teacher Training
Education
Southern New Hampshire University 1998 — 2000
Master in Business Education, Concentration in Training and Development, 4.0
Southern New Hampshire University 1996 — 1998
BS in Business Studies, Concentration in Business Administration, Summa cum laude
Fleming College 1980 — 1982
Forestry Techician, Forestry
John Hancock Investments March 2015 - Present
Fidelity Investments February 2013 - December 2014
EMD Millipore October 2011 - July 2012
Health Dialog August 2007 - September 2011
Fidelity Investments 2006 - 2007
Wyeth Biotech 2005 - 2007
YBP Library Services 2004 - 2005
Manulife Financial 2003 - 2004
Putnam Investments 2000 - 2002
John Hancock Financial Services 1999 - 2000
Skills
Project Management, Change Management, SDLC, Program Management, Business Analysis, Process Improvement, Cross-functional Team..., IT Strategy, Integration, Software Documentation, Strategy, PMO, Budgets, Agile Methodologies, Management, Requirements Analysis, Vendor Management, PMP, Leadership, Quality Assurance, Software Project..., SharePoint, Team Leadership, Business Intelligence, MS Project, Visio, Risk Management, Software Development
Education
Providence College 1991 — 1993
MBA, International Business
Georgetown University 1984 — 1987
Bachelor of Science (B.S.), International Politics
Hopkins School
Pfizer July 2008 - Present
Wyeth August 2005 - June 2008
Wyeth Biotech May 2004 - July 2005
Genetics Institute October 2000 - July 2005
Genzyme November 1998 - September 2000
Skills
Trackwise, Chromatography, Gel Electrophoresis, Empower, Citrix, Outlook, Windows, 5S, Analytical Method..., Qualification Testing, Method 1, ICH guidelines, LIMS, FDA, Process Improvement, Change Control, 21 CFR Part 11, Software Documentation, Pharmaceutical Industry, Quality Control, Biotechnology, Biopharmaceuticals, Testing, Regulatory Affairs, GMP, Validation, GLP, GxP, Analytical Chemistry, Technology Transfer, Sop, HPLC, SOP development, CAPA, Assay Development, V&V, SDS-PAGE, Equipment Qualification, SOP authoring, Cross-functional Team..., Laboratory, IND, ELISA, UV/Vis, Wet Chemistry, Regulatory Submissions
Education
Massachusetts College of Pharmacy and Health Sciences 2013 — 2014
Graduate Certificate, Regulatory Affairs
Georgia Southern University 1993 — 1997
Bachelor of Science (BS), Biology, General
Genzyme February 2012 - Present
Ernest Engineered Solutions, Inc. December 2005 - January 2012
Pfizer July 2010 - October 2011
Pfizer 2006 - July 2010
Wyeth Biotech March 2006 - October 2009
WorldSyncPlus (dba Parataxsys) 2002 - 2006
Osram Sylvania 1995 - 2004
Bechtel, Savannah River Site January 1990 - May 1995
Anolg Devices, Advanced Development Group June 1986 - January 1987
Skills
Object Oriented..., JAVA, Visual Basic, C/C++, Win32 API, TCL/TK, Assembler, PERL, MATLAB, Windows, UNIX (SCO), Linux RH5.5, Apple Macintosh, AS/400, Oracle, TOAD, MS-SQL 2000, MSDE, Access, ADO, OLE, ODBC, JDBC, SQL, WebSphere TX, DataStage TX, WebSphere MQ, MSMQ, J-Builder, Eclipse, MS-Office / Project /..., VSS, eInfotree-STAC, Honeywell POMS..., Delta Tau Motion Control, Eurotherm Controls, SAP ECC, SAP BI, ARIS BPM, MES, HMI, SCADA, OPC, COM / DCOM, ActiveX Controls, Swing, HTML, XML, ETL, CSV
Education
Georgia Institute of Technology 1992 — 1994
MS, Controls / Communication Systems
University of Maine 1984 — 1989
BS, Electrical Engineering, Control Systems, and Computing
Aquaro Biosystems January 2014 - Present
Technology Insights January 2014 - Present
3D Biomatrix July 2010 - December 2013
University of Michigan September 2004 - July 2010
University of Michigan January 2009 - April 2009
Wyeth Biotech May 2006 - August 2006
Boehringer Ingelheim Pharmaceuticals June 2002 - August 2002
Skills
Cell Culture, Pharmaceutical Industry, Stem Cells, Product Development, Biotechnology, Lifesciences, Molecular Biology, Technology Transfer, Managing Distribution..., Product Marketing, Product Launch, Commercialization, Science
Education
University of Michigan 2004 — 2010
PhD, Chemical Engineering
University of Michigan 2004 — 2005
MS, Chemical Engineering
Cornell University 2003 — 2004
MEng, Chemical Engineering
Cornell University 1999 — 2003
BS, Chemical Engineering
Dendreon March 2011 - Present
Pfizer Pharmaceuticals April 2008 - December 2010
Wyeth Biotech December 2006 - April 2008
Wyeth Biotech May 2003 - December 2006
Barr Laboratories January 2001 - May 2003
Barr Laboratories July 1998 - January 2001
Barr Laboratories October 1997 - July 1998
Education
Cornell University 2001 — 2004
bs, Animal Science
Rockland Community College
Charles River Laboratories April 2013 - January 2014
Liberty Mutual Insurance January 2012 - March 2013
Biogen Idec January 2011 - December 2011
Biogen Idec January 2008 - June 2010
CIBER October 2007 - January 2008
Wyeth Biotech September 2003 - October 2007
iBasis, Inc September 2000 - January 2002
NSTAR 1997 - June 2000
NSTAR 1983 - 1997
US Department of Transportation January 1979 - January 1983
Skills
Software Documentation, Process Improvement, SharePoint, Change Control, Team Building, Workshop Facilitation, Budgets, ITIL Implementation, Quality Assurance, Business Process, Project Management, PMP, Change Management, Program Management, Business Analysis, Data Center, Vendor Management, Training, Management, Requirements Analysis, Testing, Project Portfolio..., Software Development, Analysis, Databases, SDLC
Education
D'Amore-McKim School of Business at Northeastern University
MBA
Project Management Institute
Project Management Professional
Tufts University
Ph.D.
State University of New York at Stony Brook
BS
Biogen January 2010 - Present
Wyeth Biotech October 1997 - October 2009
TAP Pharmaceuticals August 1992 - September 1997
Skills
Biopharmaceuticals, Oncology, Pharmaceutical Industry, Biotechnology, Neurology, Pharmaceutical Sales, Hematology, Immunology, Rheumatology, Gastroenterology, Cancer, Medical Devices, Biologics, Urology, Hospital Sales, Buy & Bill, Sales Effectiveness, Product Launch, OB/GYN, Orthopedic, Hospitals, Injectable, Commercialization, KOL development
Education
Cleveland State University
BA & S, Science, Marketing, Communication
Pfizer, Speciality Care/Biotechnology April 2011 - Present
Pfizer's Global Manufacturing (PGM) Specialty/Biotechnology Operating Unit April 2008 - April 2011
Wyeth Biotech October 2005 - April 2008
Wyeth Biotech July 2003 - September 2005
Wyeth Biotech September 2001 - June 2003
Chembio Diagnostics System, Inc. April 1999 - September 2001
Skills
Vaccines, LIMS, Technology Transfer, Biotechnology, V&V, Change Control, FDA, Quality Assurance, Validation, CAPA, Regulatory Submissions, Analytical Chemistry, Lifesciences, Sop, Quality Control, GMP, Regulatory Requirements, Aseptic Processing, Program Management, Cross-functional Team..., Manufacturing, Process Validation, Quality System, Strategic Planning, Continuous Improvement
Education
College of Medicine, University of Saskatchewan, Canada 1989 — 1999
Post-Doctoral Research Fellow
Guru Nanak Dev University, India 1989 — 1995
Ph.D., Biochemistry
University of Saskatchewan, Canada 1991 — 1993
M.S., Clinical Pathology
Guru Nanak Dev University 1987 — 1989
M.Phil, Biology
Guru Nanak Dev University 1986 — 1987
M.Sc. (Hons.), Biology
Guru Nanak Dev University 1983 — 1986
B.Sc. (Hons.), Biology
Amgen (formerly BioVex) March 2011 - Present
BioVex July 2010 - March 2011
Pfizer (formerly Wyeth) January 2009 - July 2010
Wyeth Biotech October 2006 - January 2009
Bayer Diagnostics February 1995 - October 2006
Bayer Diagnostics 1995 - 2006
Siemens Medical Solutions (formerly Bayer) 1995 - 2006
Skills
Quality Systems, GMP, Quality Assurance, Biotechnology, Biochemistry, CAPA, FDA, Validation, GLP, Sop, 21 CFR Part 11, Regulatory Affairs, V&V, Technology Transfer, GxP, ISO 13485, Pharmaceutical Industry, GCP, Regulatory Submissions, Clinical Trials, Medical Devices, Change Control, Lifesciences, Microbiology, Biopharmaceuticals, Aseptic Processing, Quality Control
Education
Harvard School of Public Health 1999 — 2004
Masters Certificate, Public Health
Wheaton College (MA) 1990 — 1994
Bachelor of Arts, BioChemistry
NSF-DBA June 2013 - Present
Pfizer Network Performance Group 2010 - June 2013
Wyeth Biotech 2005 - 2010
Wyeth Biotech 2003 - 2005
Genetics Institute 1996 - 2002
Nutramax 1995 - 1996
Nutramax 1995 - 1996
US Navy 1975 - 1995
Skills
Operational Excellence, Validation, Six Sigma, Pharmaceutical Industry, Change Control, GMP, 21 CFR Part 11, Sop, Lean Manufacturing, FDA, Computer System..., CAPA, Process Improvement, Manufacturing, Software Documentation, Business Transformation, Automation, Quality System, Continuous Improvement, Project Management, Program Management, Human Error, Biotechnology, Strategy, Change Management, LIMS, Biopharmaceuticals, V&V, GxP, Aseptic Processing, Technology Transfer, GAMP, Cross-functional Team..., Process Simulation, Value Stream Mapping, Black Belt, Regulatory Requirements, Regulatory Affairs, Root Cause Analysis, Quality Auditing, Regulatory Submissions, Manufacturing Operations, Quality Management, ISO 13485, GLP, Vaccines, Cleaning Validation, Quality Control, Medical Devices, SOP
Education
Endicott College 2013 — 2014
Bachelor's Degree, Business Administration, Management and Operations, 4.0
Excelsior College 1984 — 1986
AS, Associates of Science
Roche Diagnostics Hematology October 2013 - Present
Bioscale, Inc October 2011 - July 2013
Helicos Biosciences March 2008 - November 2011
Wyeth Biotech November 2006 - 2007
Lonza Biologics January 2005 - November 2006
Peace Corps June 2000 - August 2002
Skills
Assay Development, Validation, R&D, Fluorescence Microscopy, Fluorescence, DNA, GLP, Biotechnology, Lifesciences, Molecular Biology, Biochemistry, Technology Transfer, Genomics, FDA, Protein Chemistry, Sequencing, Proteomics
Education
Harvard University 2011 — 2016
M.L.A. Degree Candidate, Biotechonology
Rensselaer Polytechnic Institute 1995 — 1999
Bachelor of Science
Pfizer July 1998 - Present
Community Music Center of Boston 2007 - 2010
Wyeth Biotech 2005 - 2008
Wyeth Biotech 2002 - 2005
Wyeth Biotech 1998 - 2002
Harvard Medical School 1994 - 1998
Schepens Eye Research Institue, Boston, MA 1984 - 1989
Skills
Biotechnology, Molecular Biology, Protein Chemistry, Biochemistry, Cell, Immunology, Biopharmaceuticals, Cell Biology, Drug Development, Cross-functional Team..., Clinical Development, Genetics, Product Development, Life Sciences, Pharmaceutical Industry, Technology Transfer
Education
Harvard University 1988 — 1994
Ph.D., Molecular Cell Biology; RNA structure and function
Northeastern University
M.S., Biology
Muhlenberg College 1976 — 1980
B.S., Biology
CSCS Corp. Construction Division June 2010 - Present
NE Chapter ISPE August 2009 - Present
CSCS Corp. February 2010 - June 2010
Alexion Pharmaceuticals January 2007 - February 2010
Wyeth Biotech February 2003 - January 2007
Wyeth Pharmaceuticals January 1999 - February 2003
Serono Laboratories March 1993 - September 1998
BW Manufacturing March 1992 - March 1993
Skills
Microsoft Excel, GMP, Sop, Validation, Pharmaceutical Industry, Biopharmaceuticals, Technology Transfer, Biotechnology, FDA, Manufacturing, Chromatography, R&D, Lifesciences, Change Control, Process Simulation, 21 CFR Part 11, CAPA, Quality System, Analytical Chemistry, Commercialization, Chemistry, Drug Development, Regulatory Affairs, GLP, V&V, Regulatory Submissions, Vaccines, Clinical Development, Medical Devices, Pharmaceutics, Regulatory Requirements, Quality Control, Drug Discovery, SOP
Education
Community College of Rhode Island 2000 — 2002
Parsons October 2011 - Present
Parsons June 2011 - October 2011
Parsons April 2010 - June 2011
Bristol Myers Squibb February 2007 - April 2010
Parsons Corp December 2006 - April 2010
Wyeth Biotech December 2005 - December 2006
Lonza Biologics October 2001 - December 2005
Skills
Construction, Quality Assurance, cGMP, GMP, Contract Negotiation, Compliance, Document Management, Procurement, Validation, Quality Systems, Supervisory Skills, Biotechnology, Process Improvement, Problem Solving, Manufacturing, Life Sciences, Microsoft Office, Plant Commissioning, Commissioning, Quality System, Contract Management, Proposal Writing
Education
Franklin Pierce University 2002 — 2005
MBA, Leadership
Franklin Pierce University 2000 — 2002
BS, International Business
Karlstad University 1994 — 1996
BS, Education
Novartis Animal Health April 2014 - Present
Novartis Animal Health August 2013 - Present
Novartis Animal Health January 2008 - July 2013
Novartis Animal Health November 2002 - March 2008
Wyeth Biotech 2000 - 2002
Warner Lambert 1993 - 1998
US Army 1985 - 1988
Skills
Pharmaceutical Industry, GMP, FDA, Validation, V&V, Sop, Change Control, CAPA, Regulatory Affairs, Supply Chain, 21 CFR Part 11, SOP, Biopharmaceuticals, Strategy, Supply Chain Management, Technology Transfer
Education
Eastern University 1996 — 1998
MBA, Business Management
North Carolina Central University 1980 — 1984
BA, History
Pfizer January 2013 - Present
Pfizer June 2011 - January 2013
Pfizer December 2009 - May 2011
Wyeth Pharmaceuticals 2006 - 2009
Wyeth Biotech 2004 - 2006
Wyeth Biotech 2003 - 2004
Penna Consulting 2000 - 2003
Skills
Talent Acquisition, Talent Management, HR Generalst, Change Management, Recruiting, Performance Management, Succession Planning, Employee Relations, Employer Branding, Organizational Design, Employee Engagement, Workforce Planning, Deferred Compensation, HRIS, HR Consulting
Education
Dublin City University 2003 — 2005
Master Business Studies, HR Strategy
University of Birmngham 1994 — 1997
Law, LLB Honours, Law
Pfizer October 2010 - Present
Pfizer October 2009 - September 2010
Wyeth Biotech October 2008 - September 2009
Wyeth 2005 - September 2008
Green Mountain Technology Inc May 2003 - March 2005
Cimcon Software September 2001 - May 2003
Capital Consultancy (UK) Ltd February 2002 - July 2002
Skills
Computer System..., 21 CFR Part 11, SDLC, Validation, Change Control, Oracle, Requirements Analysis, Microsoft SQL Server, MES, Pharmaceutical Industry, SQL, Business Analysis, Quality Assurance, Automation, Documentum
Education
Gujarat University 1985 — 1987
M.Sc, Chemistry
St. Xavier's College 1985 — 1986
Business Application Certification, Computer Science
C.U.Shah Science College 1982 — 1985
B.Sc, Chemistry
St. Xavier's High School - Jamnagar 1970 — 1982
School
Pfizer 2013 - Present
Pfizer 2012 - 2013
Pfizer 2010 - 2012
Pfizer 2008 - 2010
Wyeth Pharmaceuticals 2007 - 2008
Wyeth Pharmaceuticals 2005 - 2006
Wyeth Pharmaceuticals 2004 - 2005
Wyeth Biotech 2001 - 2004
Wyeth Pharmaceuticals 1998 - 2001
Wyeth Research 1995 - 1998
Skills
Pharmaceutical Sales, Product Launch, Project Management, Budgets, Relationship Marketing, Science, Pharmaceutical Industry, Rheumatology, Biotechnology, Integrated..., Sales Effectiveness, Hospital Sales, Market Access, Cross-functional Team..., Market Research, Product Marketing, Global Marketing, Dermatology, Strategy
Education
Temple University 1993 — 1998
MBA, Marketing
Cornell University 1987 — 1991
BA, Chemistry
Bronx High School of Science 1983 — 1987
Pfizer August 2014 - Present
Pfizer November 2008 - August 2014
Wyeth Biotech February 2006 - November 2008
Wyeth Pharmaceuticals December 2006 - March 2007
Wyeth Biotech August 2005 - February 2006
Wyeth Consumer Health March 2004 - July 2005
Kraft Foods North America May 2001 - September 2001
Skills
PMP, Biotechnology, Aseptic Technique, Environmental Monitoring, GMP, Sop, Validation, FDA, Pharmaceutical Industry, CAPA, Change Control, Quality System, V&V, Technology Transfer, Six Sigma, LIMS, Quality Assurance, 21 CFR Part 11, Process Simulation, Cross-functional Team..., Continuous Improvement, Process Optimization, Lean Manufacturing, Process Engineering, SAP, GLP, Biopharmaceuticals, Manufacturing, Analytical Chemistry, R, Quality Control, Quality Auditing, R&D, SOP, Aseptic Processing, Management, Operational Excellence, GxP, Computer System..., Leadership
Education
Iona College 2003 — 2008
MBA
The Cooper Union for the Advancement of Science and Art 2002 — 2004
Masters in Engineering
The Cooper Union for the Advancement of Science and Art 1998 — 2002
Bachelor of Engineering
Archbishop Molloy 1995 — 1998
High school diploma
Tenax Therapeutics, Inc. (formerly Oxygen Biotherapeutics, Inc.) June 2012 - Present
Clinical Research Management June 2011 - February 2012
SAIC January 2009 - June 2011
BWA Consulting, LLC December 2008 - December 2009
Tunnell Consulting, Inc. May 2008 - December 2008
Lonza Walkersville, Inc. August 2004 - January 2008
USP Chapter <1046> ad hock Advisory Panel 2007 - 2008
Argos Therapeutics March 2001 - July 2004
Diosynth January 1996 - June 2001
Wyeth Biotech June 1991 - January 1996
Skills
FDA, GMP, GLP, GCP, Clinical Trials, Validation, Technology Transfer, Biotechnology, Quality Control, Quality Assurance, CAPA, Sop, Purification, Protein Chemistry, Lifesciences, Microbiology, Vaccines, Life Sciences, Regulatory Submissions, Biopharmaceuticals, Pharmaceutical Industry, Cell, R&D, Quality System, V&V, Computer System..., CMC, Regulatory Complicane, Fermentation Process..., Project Management, IND & CTD
Education
Hood College 1978 — 1980
BA, Biology
Genzyme, a sanofi company August 2014 - Present
Genzyme June 2012 - August 2014
Pfizer October 2009 - June 2012
Wyeth Biotech June 2008 - October 2009
Wyeth BioPharma February 2006 - June 2008
Biogen Idec November 2000 - February 2006
U.S. Food and Drug Administration August 1997 - November 2000
U.S. Food and Drug Administration January 1992 - August 2000
Skills
Regulatory Affairs, Clinical Development, Biopharmaceuticals, Online Communications, Vaccines, Pharmaceutical Industry, FDA, Regulatory Requirements, Formulation, Oncology, Biologics, GMP, Pharmaceutics, Medical Devices, CMC, Clinical Research, Regulatory Submissions, Drug Development, NDA, Microbiology, GLP, 21 CFR Part 11, Sop, Biotechnology
Education
University of Massachusetts Lowell 1994 — 1996
MS, Biology
University of Massachusetts, Amherst 1989 — 1992
BS, Microbiology
University of Southern California
DRSc, Regulatory Science
Florida Institute of Technology
Boehringer Ingelheim July 2011 - Present
sanofi-aventis November 2004 - 2011
Bracco Diagnostics August 2003 - November 2004
Elan October 2001 - September 2003
Wyeth Biotech 1998 - 2001
Skills
Cardiology, Pharmaceutical Sales, Oncology, Diagnostics, Nuclear Medicine, Neurology, Rheumatology, Sales Operations, Hospital Sales, Medical Devices, Nephrology, Psychiatry
Education
The University of Tennessee at Chattanooga 2000 — 2005
MPA, Public Policy/Administration
Converse College 1990 — 1994
B.A., English, Communications
Procept Partners, LLC January 2009 - Present
Sullivan University College of Pharmacy June 2010 - October 2011
Stiefel Laboratories November 2006 - December 2008
Baxter Healthcare July 2005 - November 2006
DSM Pharmaceuticals August 2004 - July 2005
DSM Pharmaceuticals December 2002 - August 2004
Wyeth Biotech December 2001 - December 2002
Wyeth Biotech May 1999 - December 2001
Skills
Product Development, Process Improvement, Aseptic Processing, Regulatory Submissions, GxP, Project Portfolio..., Stage-Gate, Process Excellence, Six Sigma, Value Stream Mapping, Activity Based..., Multivariate Statistics, Quality by Design, SAS, R (statistics), C, Python, Linux, CAPA, Cross-functional Team..., FDA, Formulation, GMP, Pharmaceutical Industry, Quality Assurance, Quality System, Technology Transfer, V, Validation
Education
Elon University - Martha and Spencer Love School of Business 2008 — 2010
MBA
Indiana University - Kelley School of Business 2009 — 2010
Management Consulting
Purdue University 1995 — 1999
PhD, Industrial Pharmacy / Pharmaceutics
University of Louisville 1988 — 1993
B.S., Chemical Engineering
Siemens Healthcare May 2015 - Present
Vital Signs, Inc. / CareFusion September 2010 - May 2015
Validant June 2010 - September 2010
Pfizer October 2009 - November 2009
Wyeth November 2008 - October 2009
Wyeth Biotech May 2005 - November 2008
Wyeth January 2005 - April 2005
Wyeth October 2002 - December 2004
Wyeth March 2002 - September 2002
Vertek Corporation June 2000 - August 2001
Skills
Change Control, FDA, Validation, GMP, Sop, Pharmaceutical Industry, 21 CFR Part 11, CAPA, Quality System, Quality Assurance, Medical Devices, Six Sigma, Process Improvement, Cross-functional Team..., GxP, Testing, Manufacturing, Software Documentation, Technical Writing, SDLC, Root Cause Analysis, Quality Management, Regulatory Affairs, Quality Control, ISO 13485, Engineering, V&V, Lean Manufacturing, SOP
Education
Rutgers, The State University of New Jersey-New Brunswick
Bachelor of Science, Mechanical/Aerospace Engineering
Fairleigh Dickinson University
MBA, Management
DPS Engineering September 2015 - Present
EGS Consulting Ltd January 2013 - August 2015
Emerson October 2010 - December 2012
Merck Sharp & Dohme February 2010 - October 2010
Jacobs Engineering November 2009 - February 2010
Emerson Process Management May 2008 - November 2009
Jacobs Engineering May 2006 - May 2008
PM Group September 2003 - May 2006
Wyeth Biotech March 2003 - September 2003
Flextronics September 2002 - March 2003
Skills
Instrumentation, Validation, Commissioning, Automation, Calibration, PLC, GAMP, Engineering, DCS, Project Engineering, Process Automation, GMP, Control Systems Design, Electricians, Process Engineering, Electrical Engineering, Manufacturing, Foundation Fieldbus, Procurement, Electronics
Education
Cork Institute of Technology 1998 — 2002
BSc, Applied Physics & Instrumentation
Terence MacSwiney
Biogen Idec April 2014 - Present
Biogen Idec June 2008 - April 2014
Biogen Idec November 2013 - March 2014
Biogen Idec 2010 - 2011
University of New Hampshire September 2008 - December 2008
Wyeth Biotech May 2007 - August 2007
University of New Hampshire August 2006 - May 2007
Wyeth Biotech May 2006 - August 2006
Charles River Laboratories June 2005 - August 2005
Skills
Cell Culture, Cell, Molecular Biology, Assay Development, PCR, Tissue Culture, Protein Expression, Molecular Cloning, In Vitro, GMP, DNA, Validation, In Vivo, Virology, FDA, Biopharmaceuticals, Laboratory
Education
Tufts University 2012 — 2015
Master of Science (M.S.), Biology (Concentration in Developmental Biology)
Harvard University 2009 — 2011
Continuing Graduate Education, Biology
University of New Hampshire 2004 — 2008
BS, Biology, General
Pfizer, Inc. (formerly Wyeth Biotech) December 2008 - Present
Wyeth Biotech September 2005 - December 2008
Talecris Biotherapeutics 1999 - 2005
Skills
Biotechnology, GMP, cGMP, GLP, Coaching, Life Sciences, 21 CFR Part 11, Sop, Lifesciences, Microsoft Office, LIMS, Project Management, E-Learning, Quality Control, Environmental Monitoring, Change Control, Microbiology, Chemistry, CAPA, FDA, Pharmaceutical Industry, SOP, Validation
Education
Elizabeth City State University 1992 — 1996
B.S., Biology
University of Phoenix
MHA, Informatics
Pfizer May 2011 - Present
Pfizer October 2009 - May 2011
Wyeth Biotech 2002 - September 2009
GlaxoSmithKline 1996 - 2002
Novartis Animal Vaccines, UK 1994 - 1996
Skills
Biopharmaceutical..., Vaccine and protein..., Management and..., Biopharmaceuticals, Vaccines, Process Development, Product Development, Protein Chemistry, Bioprocessing, Process Simulation, Chromatography, Purification, Monoclonal Antibodies, Technology Transfer, V&V, Fermentation, GMP, Biotechnology, Validation, Sop, GLP, Lifesciences, Drug Development, Pharmaceutical Industry, Change Control, Aseptic Processing, Quality by Design, IND, Antibodies, Life Sciences, SOP
Education
IE (Instituto de Empresa) 2010 — 2011
MBA
Swansea University 1991 — 1994
PhD, Biochemical Engineering
Dublin City University 1987 — 1991
BSc, Biotechnology (Mammalian Cell Culture Technology & Biochemical Engineering), First Class Hons
Noven Pharmaceuticals September 2011 - Present
Pfizer - Biotech March 2010 - September 2011
Wyeth Biotech December 2006 - March 2010
Wyeth Consumer Healthcare March 2003 - November 2006
Wyeth Consumer Healthcare October 2001 - March 2003
Skills
CAPA, Trackwise, Project Management, English, MRP, Polish, Cross-functional Team..., Sop, GMP, FDA, Pharmaceutical Industry, Change Control, Validation, GxP, LIMS, GLP, 21 CFR Part 11, Regulatory Affairs, Quality System, Computer System..., Manufacturing, Quality Control, Aseptic Processing, Root Cause Analysis, Quality Assurance, Quality Management, Technology Transfer, Biopharmaceuticals, Biotechnology, Manufacturing Quality..., Risk Assessment, Leadership, Transdermal, CMMS, Product Launch, Disposition, Deviations, Vaccines, Regulatory Requirements, SOP development, GCP, SOP, TrackWise
Education
Iona College
MBA
Hofstra University 1997 — 2001
BS, Chemistry
Genentech June 2015 - Present
Pacira Pharmaceuticals, Inc. May 2014 - May 2015
Amylin Pharmaceuticals 2011 - 2014
Novartis Vaccines and Diagnostics 2010 - 2010
Wyeth Biotech 2007 - 2009
Eli Lilly and Company 2006 - 2007
Eli Lilly and Company 2006 - 2006
Eli Lilly and Company 2003 - 2006
Skills
Six Sigma, Root Cause Analysis, Strategic Planning, Chromatography, Automation, Supply Chain, Forecasting, Troubleshooting, PLC, Process Design, Ultrafiltration, Allen Bradley, Biotechnology, Pharmaceutical Industry, GMP, Validation, Technology Transfer, Cross-functional Team..., Capacity Planning, Change Control, Lifesciences, 21 CFR Part 11, Product Development, Quality Assurance, Vaccines, CAPA, Chemical Engineering, FDA, Competitive Analysis, Process Engineering, Manufacturing, Biopharmaceuticals, Strategy, Operational Excellence, Computer System..., Project Management, GxP, Operations Management
Education
Duke University - The Fuqua School of Business 2009 — 2011
MBA, Health Sector Management, Operations Management
University of Michigan 1999 — 2003
BSE, Chemical Engineering
Family Leave March 2014 - Present
INC Research September 2006 - February 2014
INC Research September 2005 - October 2006
PPD May 2003 - August 2005
BioTranplant March 2000 - December 2002
Wyeth Biotech April 1997 - March 2000
EMD Serono, Inc. (formerly Serono Laboratories) May 1994 - April 1997
ImmunoGen, Inc. December 1993 - May 1994
GSK October 1991 - December 1993
Duke University Health System January 1985 - December 1993
Skills
Clinical Development, CRO, Oncology, Clinical Research, Biotechnology, Quality Assurance, Data Management, Regulatory Affairs, Medicine, GCP, Medical Devices, Hematologic Malignancies, Clinical Pathology, Laboratory Medicine, Oncology Clinical..., Clinical Monitoring, EDC, Clinical Trials, CTMS
Education
Massachusetts General Hospital Institute Of Health Professions 2000 — 2003
MS, Clinical Investigation
Duke University School of Medicine 1984 — 1985
MT (ASCP), Medical Technology
Pfeiffer University 1979 — 1984
BS, Biology, Medical Technology
Pfizer October 2009 - Present
Wyeth Biotech January 2007 - November 2009
Wyeth Biotech January 1997 - December 2006
Genetics Institute January 1992 - December 1996
Arthur D. Little January 1980 - December 1991
Partners HealthCare January 1977 - November 1980
Skills
Pharmaceuticals, Biotechnology, Operational Excellence, Process Improvement, Continuous Improvement
Education
University of Massachusetts Boston 1973 — 1977
BA, Biology
D'Amore-McKim School of Business at Northeastern University
MBA, Business
SAU90 School District August 2012 - Present
Boston Analytical October 2007 - 2010
Wyeth Biotech June 1999 - October 2007
Skills
Microbiology, Lifesciences, Cell Culture, Biotechnology, LIMS, GMP, Sop, Science, Validation, Laboratory, GLP, FDA, Pharmaceutical Industry, CAPA
Education
Franklin Pierce College 2009 — 2011
MEd, Biology Education
BS Biology 1995 — 1999
Bachelor of Science (BS), Biology, General
Sterilmed (Johnson & Johnson) August 2015 - Present
Lifecore Biomedical July 2014 - August 2015
Urologix September 2012 - June 2014
WuXi AppTec April 2011 - September 2012
Boston Scientific Inc April 2007 - March 2011
Upsher-Smith Laboratories July 2006 - March 2007
Wyeth Biotech March 2003 - June 2006
GlaxoSmithkline 1998 - 2003
Skills
CAPA, FDA, GMP, Medical Devices, Quality System, Quality Control, ISO 13485, Quality Assurance, Quality Auditing, Regulatory Affairs, Iso 9000, Training, Quality Management, ISO 17025, Complaint Management, Change Control, 21 CFR, Management Review, Recalls, Class III Medical..., Supplier Quality..., V&V, Supplier Quality, GLP, FDA GMP, Manufacturing, GMPs, ISO 9001, AATB, Class II Medical Devices
Education
East Carolina University 1995 — 1997
BS, Environmental Health
TESARO 2014 - Present
Sunovion Pharmaceuticals Inc. 2011 - 2013
Pfizer 2009 - 2011
Pfizer/Wyeth 2009 - 2011
Wyeth Biotech November 2002 - October 2009
Wyeth Biotech (Genetics Institute) January 1996 - November 2002
Genetics Institute November 1989 - January 1996
Skills
Clinical Trials, Biotechnology, Clinical Development, Clinical Research, Supply Chain Management, Pharmaceutical Industry, Cross-functional Team..., Regulatory Affairs, Project Management, Biopharmaceuticals, Oncology, Infectious Diseases, Vendor Relationship..., GLP, ICH-GCP, FDA GMP, Manufacturing
Education
Daniel Webster College
BS, Business Managment
University of New Hampshire 1986 — 1988
AS, Business Managment
Pronutria Biosciences August 2015 - Present
Pronutria August 2014 - August 2015
Pronutria July 2011 - July 2014
Virdante Pharmaceuticals December 2008 - May 2011
Wyeth Biotech December 2005 - October 2008
Wyeth Biotech July 2003 - December 2005
Wyeth Biotech June 2002 - June 2003
Wyeth Biotech May 2001 - August 2001
Millipore May 2000 - August 2000
Skills
Chromatography, Biotechnology, Purification, Protein Purification, Protein Chemistry, Technology Transfer, Process Development, Molecular Biology, Process Engineering, Filtration, Depth Filtration, Ultrafiltration, Process Simulation, Process Optimization, R&D, HPLC, Characterization, Chemical Engineering, Design of Experiments, SDS-PAGE, Pharmaceutical Industry, Biopharmaceuticals, Validation, Fermentation, GMP, Change Control, FDA, Cell Culture, CAPA, V&V, Downstream Processing, Aseptic Processing, AKTA, Pharmaceuticals, cGMP, Data Analysis, Microfiltration, CMO management, Process Design, Mass & Energy Balance, Start-ups, Biotechnology Industry, Pilot Plant, FDA GMP, Protein Production, Batch Records, Product Innovation, Entrepreneurship
Education
Tufts University 2002 — 2003
Master of Science (MS), Chemical & Biotechnology Engineering
Tufts University 1998 — 2002
Bachelor of Science (BS), Chemical Engineering
Deerfield Academy 1995 — 1998
High School
The MITRE Corporation January 2011 - Present
Pfizer (formerly Wyeth) 2006 - July 2010
Wyeth Biotech 2000 - 2005
Genetics Institute/Wyeth 1993 - 1999
Horizons Technology, Inc. 1992 - 1993
Skills
ITIL, Software Documentation, PMP, Data Center, IT Service Management, IT Management, IT Operations, GMP, Change Management, Program Management, Business Analysis, Vendor Management, Active Directory, CRM, Information Technology, Disaster Recovery, Quality Assurance, SDLC, IT Strategy, Outsourcing, Management, Enterprise Architecture, SharePoint, Networking, Project Portfolio..., PMO, Requirements Analysis, Process Improvement, Project Delivery, Team Leadership, Customer Service, Training, Cross-functional Team..., Visio, Integration, Technical Support, Business Process, Software Project..., MS Project, Project Management
Education
New England College 2009 — 2012
MS, Management, GPA: 4.0
Emmanuel College 2003 — 2008
BS, Business Administration, GPA: 3.92
MedImmune August 2012 - Present
Novartis Vaccines and Diagnostics February 2011 - August 2012
Pfizer October 2009 - March 2011
Wyeth Biotech August 2001 - April 2009
Wyeth Pharmaceuticals 2004 - 2006
Wyeth Pharmaceuticals August 2001 - December 2003
Skills
Biotechnology, Management, Strategy, Project Planning, Vaccines, Clinical Development, Pharmaceutical Industry, Biopharmaceuticals, Leadership, Analysis, Technology Transfer, Cross-functional Team..., R&D, Commercialization, FDA, Drug Development, GMP, Life Sciences
Education
Cornell University - Johnson Graduate School of Management 1999 — 2002
Cornell University 1990 — 1994
BS
Lonza Biologics July 2007 - Present
Wyeth Biotech November 1993 - July 2007
Digital Equipment Corporation August 1988 - November 1993
Skills
Manufacturing, Software Documentation, Validation, Integration, GMP, MES, Automation, 21 CFR Part 11, Biotechnology, CAPA, Change Control, Quality Assurance, Computer System..., Engineering, FDA, GAMP, Java, Perl, Pharmaceutical Industry, Troubleshooting, Visio, Oracle, Quality System, SQL, System Administration, Windows Server, Visual Basic, Linux, Process Engineering, Programming, Sop, Six Sigma
Education
Franklin Pierce College 2002 — 2005
Bachelor of Science (B.S.), Computer Science
Home January 2015 - Present
PMI 2009 - 2015
Self-Employed July 2009 - August 2009
Self-Employed April 2008 - March 2009
Catalent Pharma Solutions (formerly Cardinal Health) 2007 - 2008
Cardinal Health, SPS 2005 - 2007
Wyeth Biotech 2004 - 2005
DSM Pharmaceuticals 1998 - 2004
Schein 1993 - 1998
ZLB Bioplasma 1992 - 1993
Skills
Validation, FDA, Pharmaceutical Industry, Sterilization, Vaccines, Sop, GMP, Regulatory Requirements, 21 CFR Part 11, Technology Transfer, V&V, Change Control, Quality Control, Manufacturing, CAPA, Aseptic Processing
Education
Illinois Institute of Technology
MS, Microbiology
Michigan State University
BS, Microbiology
ERT May 2015 - Present
PHT Corporation March 2014 - May 2015
Oracle Health Sciences September 2012 - February 2014
Oracle Health Sciences September 2011 - September 2012
Oracle Health Sciences October 2010 - August 2011
Phase Forward May 2008 - September 2010
Wyeth Biotech February 2007 - April 2008
Wyeth Biotech December 2006 - February 2007
Skills
21 CFR Part 11, Computer System..., GxP, FDA, Validation, Quality Assurance, CRO, Lifesciences, GCP, Pharmaceutical Industry, Document Management, Sop, SaaS, SDLC, EDC, Data Management, Clinical Trials, CTMS, Clinical Data Management, Pharmacovigilance, Biotechnology, Change Control, Life Sciences, SOP
Education
Gettysburg College 2002 — 2006
BS, Biology, Neuroscience
DIS - Danish Institute for Study Abroad 2004 — 2004
Copenhagen, Denmark, Medical Practice and Policy Program
Actavis April 2014 - Present
Actavis February 2012 - Present
Pfizer Pharmaceuticals October 2009 - February 2012
Wyeth Biotech May 2007 - October 2009
Glatt Air Techniques August 2004 - May 2007
The Multitech Group March 2001 - August 2004
ROIUp.com - Pre-startup February 2000 - March 2002
Glatt Air Techniques March 1996 - March 2001
Sandvik Sorting Systems March 1991 - March 1996
Skills
SCADA, PLC, Electrical Engineering, Kaizen, Automation, GMP, cGMP, Validation, Six Sigma, Manufacturing, Lean Manufacturing, Continuous Improvement, Engineering, Process Engineering, Integration, Troubleshooting, MES, Commissioning, 21 CFR Part 11, Microsoft Office, AutoCAD, Project Engineering, Access, Excel, Root Cause Analysis, Process Improvement, Problem Solving, Word, Program Management, Pharmaceuticals, Pharmaceutical Industry, Microsoft Excel, Technology Transfer, Biotechnology, Computer System..., Sop, Project Management, Quality System, FDA, V&V, Change Control, Software Documentation, Cross-functional Team..., CAPA, LIMS, Quality Assurance, Process Simulation, GxP, GAMP, R&D
Education
Iona College 2007 — 2011
MBA, Finance, Honors
SetFocus 2007 — 2007
Microsoft Official Curriculum
Solartech 2000 — 2000
-Microsoft Official Curriculum, Solution Developer Track
New Jersey Institute of Technology 1991 — 1995
BS, Electrical Engineering
Murphy Energy July 2013 - Present
The NORDAM Group March 2010 - July 2013
Nortel June 2007 - March 2010
Wyeth Biotech 2004 - 2007
Skills
FCPA, Compliance, Licensing, Ethics, Investigations, Federal contracting, HIPPA, Contract Management, Corporate Law, Corporate Governance, Due Diligence, Employment Law, Export Controls, Fraud, HIPAA, ITAR, Intellectual Property, Legal Compliance, Mergers, Privacy Law, Private Investigations, Risk Assessment
Education
The John Marshall Law School 1999 — 2000
LL.M, Intellectual Property
Thomas M. Cooley Law School 1996 — 1999
JD, Law
Greensboro College 1989 — 1993
BS, Business and Economics
Drug Quality Assurance, LLC May 2008 - Present
Virdante Pharmaceuticals 2010 - 2011
Intercell AG 2009 - 2010
Wyeth Biotech 2006 - 2008
Drug Quality Assurance, LLC 2004 - 2006
Cambridge Isotope Laboratories 2001 - 2004
Biogen Idec 1998 - 2001
Genzyme 1996 - 1998
Skills
Quality Assurance, FDA, Process Validation, Technology Transfer, Medical Devices, Compliance, Vaccines, Auditing, GMP, Quality Systems, Pharmaceuticals, Biotechnology, GLP, SOP, Validation, CAPA, cGMP, QC, Change Control, Regulatory Affairs, HPLC, Biopharmaceuticals, 21 CFR Part 11, GxP, GCP, Cleaning Validation, Quality Management, Quality Auditing, Regulatory Requirements, Change Management, Drug Development, Pharmaceutical Industry, Quality System, Global Regulatory...
Education
D'Amore-McKim School of Business at Northeastern University 1981 — 1985
MBA, Business
University of Guelph 1978 — 1980
MS, Food Chemistry and Processing
Fundtech Corp. January 2014 - Present
Fundtech Corp. April 2011 - December 2013
Fundtech Corp. October 2007 - April 2011
Fundtech Corp. February 2007 - October 2007
Wyeth Biotech March 2005 - February 2007
Wyeth Biotech June 2002 - March 2005
Fundtech August 2000 - June 2002
Artis Corporation February 2000 - August 2000
Malden Mills Industries, Inc. October 1996 - February 2000
Interwave Technology, Inc. November 1995 - October 1996
Education
Cornell University 1977 — 1981
BA, Mathematics
University of Massachusetts Lowell 1997 — 1997
Introduction to Visual Basic
Penn State University 1994 — 1994
C++ Programming
Delaware County Community College 1990 — 1990
AC/DC Electrical Circuits
FirstEnergy January 2010 - Present
Wyeth Biotech 2006 - 2008
wyeth 2006 - 2008
On Assignment 2003 - 2006
Education
Georgetown University 2001 — 2002
Pfizer January 2008 - Present
Wyeth Biotech June 2006 - December 2007
Wyeth Biotech March 2004 - June 2006
Integrated Project Services May 2002 - March 2004
Diosynth Biotechnology December 2000 - May 2002
Skills
21 CFR Part 11, GMP, Validation, Change Control, Sop, CAPA, Aseptic Processing, FDA, Technical Writing, LIMS
Education
Temple University 2010 — 2013
MS, Quality Assurance and Regulatory Affairs
University of Phoenix 2004 — 2007
MBA
Elon University 1995 — 2000
BS, Biology
Mangan Inc. June 2011 - Present
Vantage Consulting Group October 2009 - 2011
BE&K BioPharm 2007 - 2008
PharmEng July 2005 - January 2007
Wyeth Biotech 2004 - 2006
AMEC BioPharmaceuticals 2004 - 2005
Merck 2000 - 2005
Merck 2003 - 2004
Merck 2003 - 2004
Merck 2002 - 2004
Skills
Validation, Computer System..., Quality Control, 21 CFR Part 11, CAPA, GMP, Biotechnology, Leadership, Sop, GAMP, V&V, Quality Assurance, FDA, Pharmaceutical Industry, Business Development, GxP, Change Control, Process Engineering, Quality System, SOP
Education
Nash Community College 1995 — 1998
Ass. Science, Information Systems
East Carolina University
B.S., Industrial Technology
Accertify, Inc. March 2012 - Present
IDBS March 2008 - March 2012
Wyeth Biotech February 2007 - March 2008
University of Illinois June 2004 - December 2005
Skills
Java
Education
Illinois Institute of Technology 2000 — 2004
B.S, Chemistry
AGM Quality GMP Audits 2011 - Present
Pfizer PGM, SCBU/BioTherapeutics 2007 - 2010
Wyeth Biotech 2001 - 2007
Wyeth 1998 - 2001
cGMP Validation 1997 - 1998
Solvay Pharmaceuticals 1992 - 1997
Burroughs Wellcome 1986 - 1992
Education
Fairleigh Dickinson University
MBA, Pharnaceuticals
Marietta College
BS, Chemistry
Cognizant Technology Solutions December 2013 - Present
Ofni Systems January 2007 - December 2013
Wyeth Biotech May 2006 - January 2007
Talecris Biotherapeutics August 2001 - May 2006
Skills
21 CFR Part 11, Validation, Change Control, FDA, Sop, V&V, Quality Auditing, Quality Assurance, Computer System..., GMP, GxP, LIMS, Quality System, GLP, Software Documentation, GAMP
Education
Guilford College 1990 — 1994
B.S., Physics
Bioarray Therapeutics Inc. June 2014 - September 2014
Verastem May 2011 - June 2014
AstraZeneca 2008 - 2010
Wyeth Biotech 2007 - 2007
Education
State University of New York Upstate Medical University 1998 — 2006
Ph.D., Immunology
LIU Brooklyn 1996 — 1998
M.S., Biology / Medical Microbiology
Fairfield University 1992 — 1996
B.S., Biology
MacroGenics May 2011 - January 2014
Genzyme Corporation January 2010 - September 2010
Ascent Therapeutics September 2009 - December 2009
Human Genome Sciences October 2007 - March 2009
Stryker Biotech June 2005 - October 2007
Altus Pharmaceuticals June 2004 - June 2005
Wyeth Biotech January 1998 - June 2004
Education
University of Massachusetts Lowell 2003 — 2005
MS, Biological Sciences
Gettysburg College 1994 — 1998
BS, Biology
Asepsis Consulting International LLC 2012 - Present
Hospira Inc 2012 - 2013
Hospira Inc 2012 - 2013
Bausch and Lomb June 2005 - January 2012
Wyeth Biotech 2003 - 2004
Baxter Healthcare November 2001 - June 2003
Millipore Corporation September 1996 - January 2000
Skills
Aseptic Processing, Sterilization, Microbiology, Validation, Pharmaceutical Industry, Environmental Monitoring, Quality Assurance, HPLC, Biopharmaceuticals, Vaccines, Six Sigma, R&D, Quality Control, FDA, GMP, CAPA, Medical Devices, Quality System, V&V, 21 CFR Part 11, Laboratory, Operational Excellence, Technology Transfer, Change Control, Sop, GLP, Biotechnology, Regulatory Affairs, Quality Auditing, Pharmaceutics, Lifesciences, ISO 13485, Protocol Design, Cleaning Validation, LIMS, Instrument Validation, Computer System..., Commercialization, Analytical Chemistry, GxP, Regulatory Requirements, SOP, Life Sciences
Education
University of Rochester - William E. Simon Graduate School of Business Administration 2008 — 2010
MBA, MBA
Cornell University 1985 — 1989
Ph. D., Environmental Microbiology
Punjab Agricultural University 1980 — 1983
M. Sc, Microbiology
Celgene November 2014 - Present
Celgene August 2011 - Present
Pfizer November 2008 - July 2011
Wyeth Biotech November 2005 - November 2008
Wyeth Pharmaceuticals April 2001 - November 2005
Fuji Electric Corp of America April 1989 - October 2000
Skills
Pharmaceutical Industry, Change Control, GMP, Sop, Vendor Management, Process Improvement, Project Management, FDA, Project Planning, 21 CFR Part 11, Cross-functional Team..., Biotechnology, Team Leadership, Facilities Management, Talent Management, Talent Acquisition, Quality Assurance, Training, Management, Recruiting, Budgets, Strategic Planning, SAP, Leadership, Program Management, Team Building, Biopharmaceuticals, Performance Management, PMP, GxP, Continuous Improvement, Manufacturing, Quality Control, Pharmaceutics, Process Engineering, Project Portfolio..., Change Management, Procurement, Business Process..., Quality Management, Vaccines, LIMS, SOP
Education
DeVry University 2006 — 2007
Project Management
University of Phoenix 2001 — 2003
Bachelors, Business
Alexion Pharmaceuticals June 2013 - Present
Kadmon Pharmaceuticals January 2008 - June 2013
Valeant Pharmaceuticals January 2006 - December 2007
InterMune September 2004 - December 2005
Wyeth Biotech January 2001 - August 2004
Skills
Leadership Development, Training, Pharmaceutical Sales, Strategy, Selling Skills, Sales Management, Pharmaceutical Industry, Coaching, Biotechnology, Marketing, Sales Effectiveness, Situational Leadership, Healthcare, Marketing Strategy, Product Launch, Sales Force Development, Public Speaking, Salesforce Training, Secondary Education, Adult Education, Hepatitis C
Education
Indiana University Bloomington 1996 — 1997
MS, Secondary Education
Grove City College 1989 — 1993
BA, Marketing & Economics
Celgene August 2014 - Present
Particle Sciences, Inc. August 2012 - July 2014
McNeil Consumer Healthcare April 2012 - August 2012
Biokinetics March 2008 - March 2012
Foster Wheeler/Biokinetics March 2008 - March 2012
Wyeth Biotech November 2006 - March 2008
Wyeth Biotech November 2006 - March 2008
Wyeth Biotech November 2006 - March 2008
Best Sweet, Inc March 2006 - November 2006
Wyeth Vaccines September 2004 - March 2006
Skills
Validation, Change Control, CAPA, GMP, V&V, Protocol, Sop, Document Management, Cleaning Validation, Quality System, Aseptic Processing, Quality Assurance, GxP, Trackwise, FDA, Vaccines, Pharmaceutical Industry, Process Simulation, Biotechnology, Software Documentation, Computer System..., Quality Control, Chromatography, GAMP, GLP, Pharmaceutics, LIMS, Biopharmaceuticals, SOP
Education
Fairleigh Dickinson University
East Stroudsburg University
B.A; B.S, English Literature and Secondary Education; Engineering Technology
Blair Academy
Wyeth Biotech November 2007 - Present
Merck 2004 - 2007
Education
Columbia University in the City of New York 2002 — 2004
MS, Chemical Engineering
University of Maine 1998 — 2002
BS, Chemical Engineering
Covaris October 2008 - Present
Genzyme January 2008 - October 2008
Wyeth Biotech February 2006 - February 2008
baxter 2001 - 2005
Skills
Software Documentation, Testing, Validation, GMP, FDA, Sop, Quality System, Quality Control, CAPA, Medical Devices, V&V, 21 CFR Part 11, ISO 13485, R&D, Root Cause Analysis, Computer System..., Manufacturing, HPLC, Change Control, Biopharmaceuticals, Biotechnology, Pharmaceutical Industry, GLP
Education
Emmanuel College 2001 — 2005
Northern Essex Community College 2001 — 2004
SAFC Biosciences March 2010 - Present
Wyeth Biotech November 2006 - September 2011
University of Illinois at Chicago 2001 - 2007
Skills
Cell, Protein Chemistry, Molecular Biology, Antibodies, Drug Discovery, HPLC, Biotechnology, Cell Culture, Drug Delivery, Chromatography, Formulation, Technology Transfer, Pharmaceutical Industry, Lifesciences, Drug Development, GMP, Biopharmaceuticals, Assay Development, Biochemistry, GLP
Education
University of Illinois at Chicago 2001 — 2006
PhD, Pharmaceutics
Gujarat University 1995 — 2000
M.Pharm, Pharmacy
Wyeth Biotech Manager, validation and Technical ComplianceMarkenMay 2013 - Present
Pfizer 2002 - Present
marken 2012 - 2014
Wyeth 2002 - 2008
Skills
Validation, Pharmaceuticals, Process Validation, GMP, Cell, Technology Transfer, Computer System..., 21 CFR Part 11, Vaccines, SOP, Documentation, Microbiology, Medical Devices, Cell Culture
Education
Florida State University 1990 — 1995
TechnoPro Solutions January 2011 - Present
Sanofi Pasteur 2011 - Present
GlaxoSmithKline 2012 - 2013
Pfizer 1984 - 2010
Wyeth Biotech 2005 - 2009
Wyeth Biotech 2004 - 2005
Wyeth Biotech 2001 - 2004
Wyeth Pharmaceuticals 1994 - 2001
Skills
Project Management, Engineering, Validation, FDA, Automation & Controls, Manufacturing, GxP, Biotechnology, Facilities Management, GMP, HVAC, Process Simulation, Pharmaceutical Industry, Technology Transfer, Process Engineering, Computer System..., 21 CFR Part 11, Change Control, Quality Systems, R&D, Project Planning
Education
Indian Institute of Technology, Bombay 1979 — 1981
M.S.
Wyeth Biotech Production SupervisorWyeth2004 - Present
Pfizer 2004 - Present
Pfizer (previously Wyeth) 2004 - Present
Skills
CAPA, Aseptic Processing, GMP, Sop, FDA, 21 CFR Part 11, V&V, Cleaning Validation, Validation, Technology Transfer, Pharmaceutical Industry, Biopharmaceuticals, Quality System, Manufacturing, Biotechnology, SOP
Education
East Carolina University 1986 — 1989
Pfizer March 2013 - Present
Pfizer October 2011 - March 2013
Pfizer 2009 - October 2011
Wyeth Biotech May 2005 - October 2009
Inotek Pharmaceuticals August 2004 - May 2005
iBasis 2001 - 2002
Skills
HPLC, LIMS, Analytical Chemistry, GMP, Sop, Technology Transfer, Validation, UV/Vis, Biotechnology, Pharmaceutical Industry, Lifesciences, Chromatography
Education
Gordon College 1999 — 2003
BS, Chemistry
Gordon College 1999 — 2003
Bachelor of Science (B.S.), Chemistry
R-Pharm U.S. LLC August 2014 - Present
Bristol-Myers Squibb 2013 - 2014
Pfizer 2009 - 2012
Wyeth Biotech 2007 - 2009
Endo Pharmaceuticals 2005 - 2007
Endo Pharmaceuticals 2003 - 2005
Merck 2001 - 2003
Merck 2000 - 2001
Merck 1998 - 1999
The Wharton Econometrics Forecasting Associates 1991 - 1994
Skills
Oncology, Business Intelligence, Pharmaceutical Industry, Market Access, Market Research, Pharmaceutical Sales, Leadership, Sales Effectiveness, Product Launch, Analytics, Biopharmaceuticals, Biotechnology, Cardiology, Commercialization, Competitive Analysis, Competitive Intelligence, Cross-functional Team..., Dermatology, Endocrinology, Forecasting, Global Marketing, Hospital Sales, Lifesciences, Managed Care, Management, Market Analysis, Neurology, OB/GYN, P, Product Development, Rheumatoid Arthritis, Rheumatology, Therapeutic Areas, Vaccines
Education
Duke University - The Fuqua School of Business 1994 — 1996
MBA
Villanova University 1987 — 1991
BA, Economics
Hospira August 2010 - Present
Pfizer (formerly Wyeth) January 2008 - August 2010
Wyeth Biotech January 2008 - January 2009
Bristol-Myers Squibb January 2003 - December 2007
Enzon Pharmaceuticals (formerly Elan) 2000 - 2003
MedImmune April 1998 - August 2000
Mallinckrodt August 1992 - April 1998
Estee Lauder September 1980 - August 1991
Skills
V&V, Quality Assurance, Validation, GMP, FDA, Quality Control, CAPA, Microbiology, Aseptic Technique, Quality System, Sterilization, GxP, Change Control, Technology Transfer, Biopharmaceuticals, GAMP, Biotechnology, Cleaning Validation, Aseptic Processing, Pharmaceutical Industry, Computer System...
Education
State University of New York Empire State College 1989 — 1990
BS, Science & Technology
State University of New York at Stony Brook 1978 — 1980
Molecular Biology
Farmingdale State College 1975 — 1977
AAS, Medical Laboratory Technology
Farmingdale State College 1975 — 1977
aas, laboratory technology
Central Carolina Community College January 2011 - Present
Pfizer, PGM - Specialty/Biotechnology Unit October 2009 - January 2011
Wyeth Biotech March 2002 - October 2009
Wake County Government 1999 - March 2002
Givaudan - Roure 1995 - 1998
Skills
Physical Security, Executive Protection, Risk Assessment, Event Management, Investigations, Security Audits, Security Management, Security Operations, Emergency Management, Access Control, CCTV, Surveillance, Investigation, Private Investigations, Enforcement, Police, Corporate Security, Leadership, Protection, Security Training, Crisis Management, Internal Investigations
Education
ASIS 1984 — 2015
Security Management
Cuyahoga Community College 1971 — 1973
AAS, Law Enforcement
American Society for Industrial Security, International
CPP, Security Management
Siemens Healthcare April 2013 - Present
Infosoft November 2012 - April 2013
Dendreon August 2010 - November 2012
Pfizer (former Wyeth) January 2009 - August 2010
Wyeth January 2005 - January 2009
Wyeth Biotech 2002 - 2005
Datascope 1993 - 2002
Centronix 1990 - 1993
Skills
Quality Assurance, Validation, 21 CFR Part 11, Change Control, Computer System..., GMP, FDA, Sop, Software Documentation, IQ, CAPA, Quality Control, Testing, Troubleshooting, GAMP, Pharmaceutical Industry, GxP, Problem Solving, Project Planning, V&V, Automation, Electronics Repair, Root Cause Analysis, Quality System, Quality Auditing, Configuration Management, SDLC, Consent Decree, Medical Devices, cGMP, Risk Management, Manual Testing, Technical Training, Requirements Analysis, Requirements..., Process Improvement, Project Management, ISO 13485, Trackwise, Technical Communication, OQ, PQ, UAT coordination, URS, LIMS, FCC General..., Electronics..., Defect Tracking, SQA, Software Quality...
Education
Rutgers University-New Brunswick 2015 — 2015
Thomas Edison State College 2009 — 2010
BA
County College of Morris 1990 — 1996
AAS
William Paterson University of New Jersey 1983 — 1985
BA
County College of Morris 1981 — 1983
AA
Wyeth Biotech Sr. Validation Lunch ConsultantWyeth2008 - Present
Education
East Stroudsburg University of Pennsylvania 1983 — 1987
Piramal Critical Care, Inc August 2014 - Present
The FlexPro Group December 2013 - Present
Bausch and Lomb September 2010 - August 2013
Teva Pharmaceuticals USA April 2007 - September 2010
Wyeth Biotech April 2004 - April 2007
DSM Catalytica Pharmaceuticals December 2001 - December 2003
DSM Catalytica Pharmaceuticals December 1999 - December 2001
National Starch and Chemical September 1991 - November 1999
Skills
Project Management, Program Management, Project Portfolio..., Manufacturing, GMP, V&V, Validation, Quality Assurance, Technology Transfer, Process Improvement, Product Development, Project Planning, Regulatory Affairs, Regulatory Submissions, Product Management, Process Simulation, Pharmaceutical Industry, 21 CFR Part 11, Cross-functional Team..., Sop, CAPA, Change Control, FDA, Six Sigma, Chemistry, Drug Development, Clinical Trials, CRO, Biotechnology, Quality System, LIMS, Pharmaceutics, R&D, Medical Devices, Computer System..., ISO 13485, GLP, Vaccines, Regulatory Requirements, Process Engineering, Quality Control, GxP, Biopharmaceuticals, Continuous Improvement, Clinical Development, Quality Auditing, Commercialization, GCP, Contract Manufacturing, Analytical Chemistry
Education
Lehigh University - College of Business and Economics 2009 — 2012
MBA, General
Rutgers University-New Brunswick 1987 — 1991
PhD, Chemical & Biochemical Engineering
Cornell University 1982 — 1987
Bachelor of Science, Chemical Engineering
Shire - Human Genetic Therapies April 2008 - Present
Shire Pharmaceuticals 2008 - 2015
Shire Pharmaceuticals 2008 - 2015
Shire Pharmaceuticals 2008 - 2015
Shire HGT 2008 - 2013
Wyeth Biotech 2008 - 2009
WYETH 2006 - 2007
Wyeth Biotech 1999 - 2007
Skills
GMP, Sop, Validation, Change Control, 21 CFR Part 11, FDA, Manufacturing, Technology Transfer, CAPA, Quality Assurance, Biopharmaceuticals, Aseptic Processing, Trackwise, GxP, Pharmaceutical Industry, Computer System..., V&V, GLP, Biotechnology, SOP
Education
Green Mountain College 1987 — 1991
Biogen Idec January 2015 - Present
Biogen Idec January 2014 - December 2014
Biogen Idec July 2009 - December 2013
Millennium Pharmaceuticals October 2008 - June 2009
Wyeth Biotech 2001 - 2008
Wyeth BioPharma 1995 - 2001
Genetics Institute 1989 - 1995
Genetics Institute 1986 - 1989
Dana-Farber Cancer Institute 1984 - 1986
Skills
21 CFR Part 11, Validation, FDA, Quality Control, Immunoassays, Laboratory, Biotechnology, CAPA, Software Documentation, GMP, LIMS
Education
Worcester Polytechnic Institute 2014 — 2017
Master of Science (MS), Bioscience Administration
Northeastern University - Graduate School of Business Administration 1988 — 1992
Master of Business Administration (M.B.A.)
Dartmouth College 1980 — 1984
BA, Biology
Genzyme September 2009 - Present
Invensys Validation Technologies September 1997 - September 2009
Wyeth Biotech 2004 - 2008
Wyeth Biopharma 2004 - 2008
Education
D'Amore-McKim School of Business at Northeastern University 1999 — 2004
Northeastern University 1992 — 1997
BSSEE, Electrical Engineering
Bristol-Myers Squibb November 2012 - Present
Pfizer October 2011 - November 2012
Pfizer September 2008 - September 2011
Wyeth Biotech March 2005 - September 2008
Wyeth Biotech May 2001 - September 2003
Skills
LIMS, FDA, Pharmaceutical Industry, Technology Transfer, Biotechnology, Protein Purification, Sop, GMP, 21 CFR Part 11
Education
Harvard University
ALM, Biology
University of Massachusetts, Amherst
B.S., Biology
Pfizer October 2009 - Present
Wyeth Biotech October 2007 - October 2009
Wyeth BioPharma June 1998 - September 2007
Skills
Process Development, Cell Culture, Fermentation Technology, Vaccines, Protein Expression, Protein Purification, Biotechnology, Technology Transfer, Biopharmaceuticals, Fermentation, Monoclonal Antibodies
Education
Eidgenössische Technische Hochschule Zürich 1995 — 1998
Post-doc, Biotechnology
Massachusetts Institute of Technology 1988 — 1995
PhD, Chemical Engineering
Rice University 1982 — 1986
BS, Chemical Engineering/Biochemistry
Pfizer 2010 - Present
Wyeth Biotech 2008 - 2010
Wyeth February 2001 - 2008
Skills
Aseptic Processing, 21 CFR Part 11, Change Control, GMP, Validation, Chemistry Instruments, Microbiology Instruments, HPLC, UPLC, FPLC, MALDI-TOF, SEC-MALLS, Micro ID systems, Fit For Purpose, Biolog, Raman, Skalar, TOC
Education
East Carolina University 1990 — 1995
Bachelor of Arts (B.A.), Chemistry
Wyeth Biotech Operations ManagerWyeth Biotech2003 - Present
Wyeth Biotech 2003 - Present
Circe Biomedical 1987 - 2003
Circe Biomedical (WR GRACE) 1988 - 1992
Education
Connecticut College 1974 — 1978
Wyeth Biotech Sr. Process EngineerWyeth Vaccines1992 - Present
Wyeth Pharmaceuticals 1992 - Present
Wyeth 1992 - Present
Pfizer (formerly Wyeth Biotech) 1992 - Present
Pfizer 1992 - Present
Education
East Carolina University 1984 — 1992
BS & MS, Industrial Technology
Garner High School
Allergan September 2014 - Present
Allergan December 2011 - Present
Allergan May 2008 - December 2011
Millennium Pharmaceuticals November 2004 - May 2008
Sepracor Pharmaceuticals 2002 - 2004
Sepracor 2002 - 2004
Wyeth Biotech 2000 - 2002
GlaxoSmithKline January 1990 - January 1999
Glaxo Inc. 1990 - 1999
Skills
Regulatory Affairs, CMC Regulatory Affairs, Regulatory Submissions, IND, FDA, eCTD, Pharmaceutical Industry, Drug Development, Clinical Development, GMP, CMC, Regulatory Requirements
Education
Guilford College 1985 — 1989
Bachelor of Science (BS), Chemistry
Shire Pharmaceuticals Director, Global Regulatory Affairs CMCShire Human Genetic Therapies2008 - 2014
Wyeth Biotech 2003 - 2008
Vical Inc. 2002 - 2003
Skills
Protein Chemistry, IND, Regulatory Affairs, Monoclonal Antibodies, CMC, Clinical Development, Drug Development, Clinical Research, Clinical Trials, Vaccines, Technology Transfer, Quality by Design, Biotechnology, Regulatory Submissions, Biopharmaceuticals
Education
Harvard Medical School
Postdoctoral Fellow, Bacterial Pathogenesis (Anthrax Toxin)
Peking Union Medical College (PUMC)
Medicine
University of California, Irvine
PhD, Biochemistry and Molecular Biology
New England Biolabs June 2012 - Present
Genzyme sanofi July 2011 - June 2012
Shire Pharmaceuticals October 2010 - June 2011
Shire Pharmaceuticals November 2008 - October 2010
Tufts University September 2006 - 2010
Wyeth Biotech July 2008 - October 2008
Wyeth Biotech May 2005 - July 2008
Wyeth BioPharma January 2004 - May 2005
Genetics Institute October 2001 - January 2004
Formatech, Inc. March 2001 - September 2001
Skills
Validation, Protein Chemistry, GMP, Assay Development, HPLC, Biotechnology, LIMS, SDS-PAGE, Western Blotting, Protein Purification, UV/Vis, Analytical Chemistry, Technology Transfer, Biopharmaceuticals, Cell
Education
Quality & Productivity Solutions, Inc 2010 — 2010
Lean Six Sigma Green Belt
Curry College
University of Massachusetts Lowell
Biogen November 2010 - Present
Pfizer April 2004 - November 2010
Wyeth Biotech April 2004 - September 2009
CRB Consulting Engineers October 2001 - April 2004
ABB Automation Inc August 1997 - October 2001
Morrison Knudsen Corporation September 1991 - August 1997
Skills
DeltaV, Process Control, DCS, Automation, Process Automation, PLC, Commissioning, Instrumentation, Foundation Fieldbus, Allen Bradley, SCADA, Project Engineering, Profibus, Control System Design, Engineering, Process Engineering, Validation, WebDAV, P&ID, Control Systems Design, Technology Transfer
Education
Professional Engineering License 1993 — 2010
Professional Engineering (PE) License, Control Systems
Cleveland State University 1988 — 1992
Masters Business Adminstration (MBA), Concentration in Finance
Geneva College 1981 — 1985
BS Chemical Engineering, Major Chemistry, Minor Mathematics
Bristol-Myers Squibb October 2011 - Present
Pfizer 2006 - Present
Wyeth Biotech March 2006 - October 2011
Wyeth Biotech July 2002 - February 2006
Wyeth Biotech November 2000 - June 2002
Pharmeco Laboratories October 1998 - November 2000
ChemDesign Corporation February 1998 - November 1998
Education
Gordon College
Biogen Idec, Inc. January 2011 - Present
Biogen November 2011 - June 2013
Biogen September 2010 - January 2011
Novartis Vaccines and Diagnostics May 2009 - September 2010
Wyeth Biotech 2004 - 2008
Wyeth Biotech (now Pfizer) 2002 - 2004
Wyeth Biotech (now Pfizer) 2000 - 2002
Catalytica Pharmaceuticals (Formerly Glaxo Wellcome) 1998 - 2000
Glaxo Wellcome Company (Formerly Burroughs Wellcome) 1991 - 1998
Skills
Change Control, GMP, SOP, FDA, Pharmaceutical Industry, Biotechnology, Validation, CAPA, 21 CFR Part 11, Quality Assurance, Quality System, Technology Transfer, Biopharmaceuticals, Quality Control, Aseptic Processing, Start-ups, Delta V, Preventive Maintenance, Metrology, Internal Audit, External Audit, Training, P&ID
Education
East Carolina University 1985 — 1990
B.S., Environmetal Health, Industrial Hygiene
Pfizer March 2012 - Present
Pfizer January 2010 - March 2012
Pfizer October 2009 - January 2010
Wyeth Biotech 2003 - October 2009
Wyeth Research 2000 - 2003
Skills
Technology Transfer, GMP, Validation, Biopharmaceuticals, Pharmaceutical Industry, Biotechnology, 21 CFR Part 11, Change Control, Vaccines, Sop, FDA, LIMS, Drug Discovery, GLP, Purification, Chromatography, CAPA, Lifesciences, Protein Chemistry, Drug Development, HPLC
Education
Duke University 1995 — 2000
Ph.D., Organic Chemistry
Georgia Institute of Technology 1991 — 1995
BS, Chemistry
Wyeth Biotech August 1993 - May 2008
Education
Franklin Pierce University 1994 — 1997
none, Computer Science
TEC Regulatory Consulting April 2011 - Present
Enzon Pharmaceuticals. Inc. November 2005 - April 2011
Immunomedics Inc November 2002 - November 2005
Savient (BioTechnology General Corp) May 2000 - November 2002
Wyeth Biotech April 1987 - May 2000
Skills
Biopharmaceuticals, Regulatory Affairs, Biotechnology, Drug Discovery, Oncology, FDA, Vaccines, CRO, Pharmaceutical Industry, Regulatory Submissions, Clinical Development, GCP, Drug Safety, Sop, Lifesciences, Clinical Trials, Validation, Drug Development, Regulatory Requirements, Immunology, GMP, Technology Transfer
Education
1969 — 1973
Dr.sc.nat.
Wyeth Biotech April 2002 - May 2008
Coty, Inc. 2000 - 2002
Closure Medical 1998 - 2000
Education
Fairleigh Dickinson University
MBA Finance
Hampton University
BS, Mathematics, Industrial Engineering, Electrical Engineering
Pfizer 2011 - Present
Pfizer 2008 - 2011
Wyeth 2006 - 2008
Wyeth BioPharma 2005 - 2007
Wyeth Biotech 2001 - 2004
Skills
Cross-functional Team..., Strategy, Product Development, Product Management, Leadership, Strategic Planning, Marketing Strategy
Education
Cornell University - S.C. Johnson Graduate School of Management 1999 — 2001
MBA
United States Naval Academy
BS
Pfizer October 2009 - Present
wyeth biotech 2006 - 2008
Alpharma/Purepac/Actavis 2001 - 2006
Skills
Project Management, Lean Six Sigma Green..., Cleaning Validation, Equipment Qualification, Process Improvement, Process Verification, Aseptic Processing, CAPA, FMEA, Continuous Improvement, Quality Management, Six Sigma, Trackwise, Validation, GMP, LIMS, FDA, Vaccines, Pharmaceutical Industry, Sop, Biotechnology, Change Control, Quality System, V&V, GxP, Computer System..., Technology Transfer, GLP, Biopharmaceuticals, SOP, TrackWise, 21 CFR Part 11, Quality Auditing, Management, Regulatory Requirements
Education
Iona College
Master of Business Administration (MBA), Management and Finance
Villanova University 2008 — 2009
Master Certificate, Project Management
DeWitt Clinton HS, Bronx, NY
Pre-med - MACY Science Honors Program
Pace University
Bio/Chem, Biology-Preprofessional
bluebird bio December 2014 - Present
Shire Pharmaceuticals (Oxford Corp.) June 2014 - November 2014
Amgen (Sunrise Systems) August 2012 - June 2014
Boston Analytical June 2009 - June 2012
Bosotn Analytical 2007 - 2009
Wyeth Biotech 2000 - 2007
Wyeth Biotech 1994 - 2007
Genetics & IVF Institute 1988 - 2007
Skills
Calibration, Microsoft Excel, Sop, LIMS, GMP, Validation, Pharmaceutical Industry, Quality System, 21 CFR Part 11, FDA, Change Control, Biotechnology, Quality Assurance, Document Management, CAPA, HPLC, V&V, Quality Auditing, Software Documentation, Quality Control
Education
Daniel Webster College 2000 — 2002
Bachelor Science, Organizational Management
Northern Essex Community College 1982 — 1986
Associates Degree, Office Management
BD April 2009 - Present
United States December 2008 - Present
Wyeth Biotech 1992 - 2008
American Cyanamid, Lederle-Praxis Biologicals 1992 - 1994
Brookhaven National Laboratory February 1991 - August 1992
Loral Electronic Systems 1989 - 1991
Education
Duke University - The Fuqua School of Business 1993 — 1995
MBA, General Business
New York Institute of Technology 1983 — 1987
B.S., Business Administration
Smithtown High School East 1974 — 1977
Suffolk County Community College
Eisai February 2013 - Present
Wyeth Biotech March 2005 - March 2010
Education
Elizabeth City State University 1989 — 1994
Bachelor of Science (BS), Industrial Engineering
Bristol-Myers Squibb June 2014 - Present
Protein Sciences Corporation 2012 - June 2014
Pfizer 2009 - 2012
Wyeth Biotech 2006 - 2009
Wyeth Biotech 2003 - 2006
Wyeth Consumer Healthcare 2001 - 2003
Skills
UV/Vis, Technology Transfer, Six Sigma, Quality Assurance, Process Improvement, GMP, Biotechnology
Education
Iona College
MBA, General Management
S.N.D.T University
MS, Analytical and Medicinal Chemistry
University of Mumbai
BS, Chemistry
temple university
Certification in QA/ RA in Drug Development
Wyeth Biotech March 2004 - December 2008
Nortel September 1978 - September 2002
Education
North Central College 1984 — 1986
East Tennessee State University 1966 — 1967
General Engineering
US Coast Guard Academy 1965 — 1966
Marine Engineering
Scrub Source January 2010 - Present
Wyeth Biotech May 2004 - November 2008
Wyeth Biotech April 2001 - May 2004
BASF Health & Nutrition January 1999 - March 2001
BASF Health & Nutrition March 1996 - January 1999
BASF Health & Nutrition March 1994 - March 1996
BASF Health & Nutrition April 1988 - March 1994
Education
Eastern Michigan University 1996 — 1999
Quality Engineering
University of Michigan-Dearborn 1982 — 1987
BS, Chemistry
Pfizer November 2013 - Present
Pfizer June 2011 - Present
Pfizer Pharmaceuticals March 2006 - May 2011
Wyeth Biotech February 2004 - March 2006
Schering-Plough Research Institute January 2003 - February 2004
Wyeth Research 2001 - 2002
Wyeth Research 1998 - 2001
Skills
Sop, Pharmaceutical Industry, Biotechnology, Quality System, Lifesciences, Aseptic Processing, LIMS, CAPA, Quality Assurance, Trackwise, Quality Auditing, Pharmaceutics, Vaccines, Clinical Research, FDA, R&D, Stability, Manufacturing, Trending Analysis, Root Cause Analysis, SAP
Education
Fairleigh Dickinson University 2000 — 2005
MBA, Pharmaceutical Studies
Seton Hall University 1996 — 1998
MS, Biology
Montclair State University 1992 — 1996
BS, Biology
Stryker March 2012 - Present
Stryker Endoscopy June 2010 - March 2012
Genzyme January 2008 - June 2010
Wyeth Biotech August 2005 - January 2008
Wyeth Biotech, Andover, Ma 2005 - 2008
Skills
Microbiology, Quality Control, CAPA, GMP, FDA, GLP, Validation, V&V, Aseptic Processing, LIMS
Education
Fairfield University 2001 — 2005
Bachleors Degree, Biology
Amgen (Formerly BioVex, Inc.) August 2010 - Present
Lonza June 2010 - August 2010
Wyeth Biotech May 2009 - August 2009
Wyeth Biotech June 2008 - August 2008
Skills
Cell Culture, Biotechnology, GMP, Technology Transfer, Biopharmaceuticals, Biochemistry, Molecular Biology, Validation
Education
Georgia Institute of Technology 2006 — 2010
Bachelor of Science (B.S.), Biomedical/Medical Engineering
Pfizer October 2010 - Present
Wyeth Biotech 1987 - June 2011
Education
Drexel University 1984 — 1987
MS, Biochemical Engineering
uniQure August 2014 - Present
Shire (Contractor) April 2014 - August 2014
Lonza May 2013 - March 2014
Lonza August 2009 - May 2013
DECCO Process Solutions July 2008 - August 2009
Kelly Engineering Resources August 2006 - July 2008
Wyeth Biotech 2003 - 2008
Intergrated Process Technologies January 2002 - August 2006
Skills
Process Simulation, Technology Transfer, Purification, Process Engineering, FDA, Chemical Engineering, GMP, Validation, Fermentation, Biotechnology, CAPA, V&V, Biopharmaceuticals, Remediation Engineering, Commissioning, Engineering Design, Decommissioning, Project Management, Filtration, Aseptic Processing
Education
Georgia Institute of Technology 1997 — 2001
BS, Chemical Engineering
Westford Academy 1993 — 1997
HS Diploma
Tufts University
Biotechnology Engineering
Pfizer March 2015 - Present
Pfizer July 2014 - February 2015
Pfizer March 2012 - July 2014
Pfizer August 2011 - March 2012
Wyeth Biotech June 2007 - December 2009
Genentech (formerly Tanox Inc) March 2006 - June 2007
Agribiotics Inc / EMD Merck March 2002 - February 2006
Nagarjuna University March 1998 - December 2001
Safe Pharmaceuticals (P) Limited 1998 - 2001
Skills
Cell Culture, GMP, Technology Transfer, Fermentation, Biopharmaceuticals, LIMS, Aseptic Processing, Validation, CAPA, Change Control, FDA, Continuous Improvement, Manufacturing Scale-up, Protein Purification, Column Packing, Process Validation, Downstream Processing, Bioreactor..., Management, Investigation, Process Equipment Design, Depth Filtration, SAP, Column Chromatography, Biotechnology, Profusion Bioreactor..., Pharmaceutical Industry
Education
Indian Institute of Technology (Banaras Hindu University), Varanasi 1996 — 1998
Master's Degree, Biochemical engineering, A
Nagarjuna University 1994 — 1996
Master of Science, Biotechnology, B
Wyeth Pharmaceuticals (acquired by Pfizer Pharmaceuticals) 2009 - Present
Wyeth Biotech 1992 - Present
Pfizer 1992 - Present
Kearfott Guidance & Navigation 1986 - 1992
Skills
Validation, GMP, Change Control, 21 CFR Part 11, Sop, LIMS, Trackwise
Education
Fairleigh Dickinson University
BSEET, Electrical Engineering Technology, Graduated Summa Cum Laude
Lonza Biologics 2007 - 2010
Wyeth Biotech 1991 - 2007
Education
Fitchburg State University
Bachelor of Science, Biology
Shire Pharmaceuticals August 2012 - Present
Shire Pharmaceuticals April 2011 - August 2012
Pfizer Pharmaceuticals April 2010 - May 2011
Wyeth Biotech January 2006 - March 2010
Wyeth Pharmaceuticals Rouses Point 2004 - 2006
Wyeth Pharmaceuticals 1998 - 2000
Wyeth Research 1993 - 1998
Skills
Aseptic Processing, Quality System, GMP, R&D, Change Control, Manufacturing, Laboratory, Quality Assurance, HPLC, Computer System..., Clinical Trials, GLP, Pharmaceutical Industry, Biotechnology, Validation, Management, Auditing, CRO, Cleaning Validation, FDA, Six Sigma, Clinical Development, LIMS, Sop, CAPA, Internal Audit, Regulatory Submissions, GCP, 21 CFR Part 11, V&V, Deviations, Leadership, DEA, Lifesciences, Regulatory Requirements, Inspection, Chromatography, Quality Management, Cross-functional Team..., Human Resources, Continuous Improvement, Technology Transfer, Regulatory Affairs, Quality Auditing, GxP, Contract Manufacturing, Analytical Chemistry, Quality Control, Project Management, Trackwise
Education
University of Pittsburgh 1989 — 1991
MS, Organic Chemistry
Hartwick College 1983 — 1987
BS, Chemistry, Bilogy
DaVita June 2007 - Present
Wyeth Biotech July 2004 - June 2007
Merck & Company, Inc January 1993 - January 2003
Skills
Employee Relations, Performance Management
Education
Eastern Mennonite University
Bachelor of Science, Management and Organizational Development
James Madison University
Graduate work, Human Resource Development
Meredith College
Biogen Idec October 1999 - Present
Wyeth Biotech November 1996 - October 1999
Industrial Systems Design January 1996 - November 1996
Biogen February 1990 - January 1996
Skills
Automation, Control Systems Design, Biotechnology, Engineering, GAMP, FDA, GMP, Process Control, Manufacturing, Validation, Computer System..., Sop, 21 CFR Part 11, CAPA, Instrumentation, Technology Transfer, WebDAV
Education
Grantham University
Associate of Science (A.S.), Computer Software Engineering
Pfizer Consumer Health October 2013 - Present
Novartis Consumer Health August 2011 - October 2013
Prestige Brands, Inc. May 2008 - August 2011
Wyeth Biotech 2004 - 2008
Opus, Inc. 1999 - 2004
Skills
Change Control, CAPA, Management, Labels, Regulatory Affairs, 21 CFR, Drug Product, Annual Reports, Promotions, Advertising, Proofreading, FDA, GxP, Validation, Vaccines, GLP, Quality System, 21 CFR Part 11, R&D, GCP, Strategy, Product Launch, Consumer Healthcare, Competitive Analysis, Drug Development, Global Marketing, Regulatory Submissions, Regulatory Requirements, Pharmacovigilance, Technology Transfer, Pharmaceutics
Education
Iona College 2008 — 2011
MBA, Marketing, E-commerce
College of Mount Saint Vincent 1998 — 2001
BA, Psychology
Pfizer November 2012 - Present
Pfizer August 2010 - November 2012
Pfizer October 2009 - August 2010
Wyeth Biotech May 2007 - October 2009
Wyeth Biotech September 2002 - May 2007
Skills
Forecasting, Sop, SAP, Process Improvement, Financial Analysis, SAP R/3, Financial Modeling, Financial Reporting, Variance Analysis, SAP BW, Managerial Finance, Budget, Sarbanes-Oxley Act, Business Analysis, Cost Accounting, Pricing, Strategic Planning, Accounting, Business Process..., Accruals, Microsoft Excel, Budgets, Strategic Financial..., OnePager Express, Cross-functional Team..., SOP
Education
Endicott College 2013 — 2015
Master of Business Administration (M.B.A.), Project Management
Salem State University 2007 — 2010
Bachelors, Business Administration
Northern Essex Community College 2000 — 2006
Associates, Business
Maine Medical Center October 2007 - Present
Wentworth Douglass Hospital September 2004 - April 2007
Wyeth Biotech May 2002 - March 2004
Hallmark Health System, Inc. May 2000 - May 2002
McLarens Toplis North America, Inc. April 1998 - April 2000
Education
Fisher College 1994 — 1996
Associates, Paralegal Studies
Pfizer Scientist IIIWyeth BiotechMay 2007 - October 2009
Wyeth Biotech March 2004 - October 2009
Hester Biosciences Limited November 2001 - October 2003
Skills
LIMS, Validation, Sop, GMP, GLP, Aseptic Processing, Microbiology, Vaccines, CAPA, V&V, Change Control, Technology Transfer, Biopharmaceuticals, Cleaning Validation, SOP, Pharmaceutical Industry
Education
Gujarat University 1999 — 2001
Master’s of Science, Life Sciences
Gujarat University 1996 — 1999
Bachelors of Science, Microbiology
Sanofi Pasteur Biologics March 2011 - Present
Pfizer (formerly Wyeth Biotech) 2003 - 2010
Wyeth Biotech 2003 - 2009
Circe Biomedical 1988 - 2003
Skills
Technology Transfer, Training, Start-ups, Private Investigations, Internal Audit, Internal Communications, Biotechnology, GMP, Pharmaceutical Industry, Biopharmaceuticals, Change Control, LIMS, FDA, Cell Culture, Trackwise, Purification, CAPA
Education
Connecticut College
BA, zoology
bluebird bio August 2014 - Present
Moderna Therapeutics December 2012 - July 2014
Agenus June 2012 - December 2012
Percivia December 2010 - April 2012
Acceleron Pharma July 2008 - October 2010
Wyeth Biotech January 2005 - June 2008
Skills
Ultrafiltration, Diafiltration, Clarification, Flocculation, Viral Clearance, Virus filtration, Affinity Chromatography, Ion Exchange, HIC, Mixed Mode, Size Exclusion, SDS-PAGE, TFF, Design of Experiments, High throughput..., AKTA, Papain digestion, LAL and Endotoxin, Sterile Technique, Depth Filtration, Centrifugation, Protein Purification, cGMP manufacturing, Western Blot, Filtration, Membrane Chromatography, High Thoughput DoE, Microfiltration, Precipitation, Column Packing, Batch Record and SOP..., Process Development, Unicorn, HPLC, Purification, Hydrophobic Interaction..., Chromatography, Biotechnology, Process Simulation, LC-MS, Western Blotting, Aseptic Technique
Education
Connecticut College 2000 — 2004
B.A., Biochemistry, Cellular and Molecular Biology
Milton Academy
US Navy June 2011 - Present
University of New England August 2008 - June 2009
Wyeth Biotech June 2006 - August 2007
Skills
Family Medicine, Hypertension, Diabetes, Obstetrics, Gynecology, Geriatrics, Pediatrics, Works well with a team, Works well individually, Highly motivated..., Professional..., Analytic Problem Solving
Education
University of New England 2007 — 2011
D.O., Doctor of Osteopathy
Elmira College 2002 — 2006
Bachelor of Science (B.S.), Biochemistry