Taratec Development Corporation
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Taratec Development Corporation Employees
DuPont 2014 - Present
DuPont 2012 - 2014
DuPont 2008 - 2012
Cardinal Health 2004 - 2008
ACLARA BioSciences, Inc. 2002 - 2003
Taratec Development Corporation 2001 - 2002
SciQuest.com 2000 - 2001
Skills
Biotechnology, Medical Devices, Business Development, Six Sigma, Negotiation, Sales, Marketing, Training, Voice of the Customer, New Business Development, Key Account Management, Product Development, Lifesciences, Cross-functional Team..., Capital Equipment, Leadership, Sales Management, Pricing, Pharmaceutical Industry, B2B, Salesforce.com, Forecasting, Management, Strategic Planning, Sales Process, Market Development, Sales Operations, Product Launch, Product Marketing, Team Building, Direct Sales, Market Analysis, Selling, Sales Presentations, Channel Partners, Industrial Safety, disposables
Education
University of Minnesota - Carlson School of Management 2001 — 2004
MBA
University of Minnesota-Twin Cities 1988 — 1993
BS
International Safety Equipment Association (ISEA)
QSSP Designation & 30 hour OSHA card
DuPont Protection Technologies
Green Belt
CSols Inc. May 2014 - Present
Apex Scientific Solutions 2013 - Present
Labwell 2011 - 2012
Ocimum Biosolutions 2008 - 2010
CSols Inc. 2007 - 2008
Thermo Fisher Scientific 2005 - 2007
Thermo Electron Corp 2002 - 2005
Thermo Informatics 2000 - 2002
Taratec Development Corporation 1997 - 2000
Skills
Strategy, Business Development, LIMS, CRM, Competitive Analysis, Sales Management, Management, Account Management, Negotiation, Business Strategy, Project Planning, Process Improvement, Microsoft Office, Training, Enterprise Software, SaaS, Solution Selling, Selling, Project Management, Marketing, Software Development, Customer Service, Budgets, Market Research, Team Leadership, Sales Operations, Outsourcing, Sales & Marketing..., Relationship Management, Target Marketing, Account Planning, AES, Entrepreneurship, Key/Corporate Account..., CTMS, ERP, Electronic Lab Notebooks, Software Development..., Budget Management, CDS, Clinical Data Management, Presentation Skills, P&L / Financial..., FTIR, EDC, SFDC, Distributor / Vendor..., SDMS, 21 CFR Part 11, MES
Education
Duke University
Ph.D., Analytical Chemistry
Brandeis University
BA (Cum Laude with Honors in Chemistry), Chemistry
Compliance and Technololgy Consulting, LLC April 2015 - Present
BIOVIA July 2014 - March 2015
HESTIA Affordable Development September 2012 - October 2014
Avance Consulting September 2013 - July 2014
Noven Pharmaceuticals August 2010 - August 2013
Noven Pharmaceuticals July 2009 - August 2010
RCM Technologies December 2006 - March 2009
Joule May 2006 - December 2006
Taratec Development Corporation November 2003 - April 2006
TFS May 2002 - October 2003
Skills
SDLC, Program Management, Vendor Management, Software Quality, Compliance, Management, Cross-functional Team..., FDA, Project Management, Team Leadership, PMO, Validation, Quality Assurance, Business Process..., Process Improvement, ITIL, Computer System..., 21 CFR Part 11, Change Control, Software Documentation, GxP, GAMP, Medical Devices, Quality System, GMP, V&V, CAPA, Leadership, Regulatory Requirements, Testing, Six Sigma, Process Engineering, Process Simulation, Quality Management, Pharmaceutical Industry, Quality Auditing, LIMS, Consulting, Information Technology
Education
Florida International University 2012 — 2013
Master of Business Administration (MBA), Business Administration and Management, General
Universidad de Puerto Rico 1988 — 1996
BS, General Science
Weil Group, Inc. June 2010 - Present
Stelex August 2008 - May 2010
Patni Lifesciences and Taratec Development Corp. February 2004 - July 2008
Taratec Development Corporation October 2002 - January 2004
Baxter International Inc. August 1992 - May 2002
United States Air Force January 1984 - June 1992
Skills
21 CFR Part 11, Computer System..., FDA, Validation, CAPA, MES, SDLC, GMP, Change Control, V&V, Software Documentation, LIMS, Sop, Cross-functional..., Cross Functional Team..., System Testing, Quality System, Quality Assurance, GAMP, Systems Analysis, SOP
Education
University of Puerto Rico-Mayaguez 1978 — 1983
Bachelor of Science (BS), Biology, General
University of Puerto Rico-Mayaguez 1978 — 1983
BS, Biology, General
Transcat July 2015 - Present
Lonza: A Global Leader In Life Sciences November 2013 - June 2015
SAIC February 2010 - September 2013
MedImmune January 2009 - February 2010
NASA October 2006 - December 2008
Taratec Development Corporation January 2004 - July 2006
Skills
GAMP, Computer System..., Quality System, Validation, GMP, FDA, CAPA, Quality Assurance, Sop, Calibration, Quality Control, Manufacturing, Testing, Pharmaceutical Industry, Change Control, Instrumentation, V&V, 21 CFR Part 11, GxP, LIMS, Quality Auditing, Root Cause Analysis, ISO, Software Documentation, Laboratory, Medical Devices, Engineering, Document Management, Automation, GLP, R&D, ISO 13485, Design of Experiments, SOP
Education
Inter American University 1996 — 2001
Bachellor, Electronic Engineering Technology
Inter American University of Puerto Rico-Aguadilla 1996 — 2001
Bachelor of Science (BS), Electronic Engineering Technology
Sanofi Pasteur April 2008 - Present
Schering-Plough Research Institute March 2004 - February 2007
Taratec Development Corporation January 1999 - April 2004
Skills
Change Control, 21 CFR Part 11, Quality System, Validation, Project Management, Pharmaceutical Industry, Computer System..., GxP, GMP
Education
Temple University 2006 — 2007
Drug Development Certificate, Clinical and Industrial Drug Development
State University of New York at Stonybrook 1981 — 1983
Bachelor of Science (BS), Biochemistry
DMH Consulting Group January 2012 - Present
The Parent TRAIN 2009 - 2011
Taratec Development Corporation May 2005 - September 2005
Taratec Development Corporation 2001 - 2005
INNOVEXX December 1999 - 2001
Omni Logistics Inc 1993 - 1999
Skills
Regulatory Documentation, Validation, Iso 9000, Project Management, Audit Reports, Remediation, Documentation Practices, Quality Auditing, FDA, Sample Management, PDMA, 21 CFR Part 11, Pharmaceutical Industry, Computer System..., Change Control, Vendor Management, Lifesciences, GMP, Quality Assurance, Process Improvement, CAPA, Cross-functional Team..., Management
Education
Rutgers, The State University of New Jersey-Newark 1985 — 1989
BS, Marketing
Grom Associates, Inc. May 2011 - Present
Grom Associates January 2010 - April 2011
Medical Marketing Studies US, Inc. February 2009 - December 2009
TeamLink Corporation October 2002 - February 2009
Taratec Development Corporation 2000 - 2002
APAC Customer Services 1993 - 2000
Square D Company 1983 - 1992
Harnischfeger 1979 - 1983
Skills
Recruiting, Technical Recruiting, Sourcing, Vendor Management, Outsourcing, Management, Contract Recruitment, Process Improvement, Talent Acquisition, Account Management, SAP, Sales, CRM, ERP, Change Management, Resource Management, Business Process..., Human Resources, Leadership, Strategy
Education
Thomas Jefferson High School 1968 — 1975
Kentucky-Western University
Human Resources Management
Kirkwood Community College
Business
Raritan Valley Community College
Human Resources
BitTitan September 2015 - Present
Microsoft March 2012 - July 2015
AT&T Mobility April 2005 - March 2012
Colegio de Abogados de Puerto Rico 2009 - 2011
Taratec Development Corporation April 2004 - April 2005
Spherion June 2001 - April 2004
Research Analysis and Maintenance September 2000 - May 2001
Southern Point, Inc January 1998 - September 2000
Integrated Systems June 1997 - December 1997
University of Puerto Rico August 1996 - May 1997
Skills
IT Management, Program Management, Data Center, Project Management, IT Strategy, System Administration, Disaster Recovery, IT Operations, Team Building, Enterprise Software, Networking, Testing, Teamwork, Management, Security, Servers, Operating Systems, Negotiation, ITIL, Change Management, Conflict Resolution, Legal Advice, Telecommunications, Cloud Computing, System Deployment, Infrastructure, Intellectual Property, Team Management, System Architecture, IT Service Management, People Management, Photography, Legal Research, Copyright Law, Leadership, Integration, Project Planning, Process Improvement, Strategy, Outsourcing, Spontaneity, Mentoring New Hires, Quick Witted, Trade Secrets, Copyrights, Legal Compliance, Agile Methodologies, SDLC, Agile Project Management, Software Project...
Education
University of Puerto Rico 2004 — 2008
JD, Law
University of Puerto Rico
BS, Computer Science
Independent Consulting November 2012 - Present
Y-Prime, LLC October 2012 - November 2012
Raritan Inc. August 2010 - September 2012
Glemser Technologies November 2007 - April 2010
First Consulting Group March 2006 - November 2006
Taratec Development Corporation February 2005 - February 2006
Computer Horizons August 2004 - January 2005
PSCI July 1997 - March 2003
Air Products 1987 - 1997
Skills
Agile Methodologies, Project Management, Program Management, Business Process..., Software Development, Change Management, PMP, Quality Assurance, PMO, Management Consulting
Education
PMI 2011 — 2011
PMP
Villanova University 2010 — 2010
Certificate
DeSales University 1991 — 1999
B.S.
Garden Living Designs, LLC May 2007 - Present
BNI - West Central Florida 2009 - March 2014
David Conner & Associates September 2004 - May 2007
Taratec Development Corporation 1999 - 2004
Exxon Research & Engineering 1991 - 1999
Structure Tone 1987 - 1991
Exxon Research & Engineering 1980 - 1986
Skills
Project Estimation, Project Management, Value Engineering, Communication Skills, Analysis, Organization, Dedicated Professional, Landscape Design, Listener, Supportive, Business Networking, Social Media, Budgets, Team Building, Leadership, Small Business, Training, Management, Construction, Marketing, CRM, Consulting, Networking, Contractors, Business, Entrepreneurship, Social Networking, Customer Satisfaction, Renovation, Residential Homes, Decks, Project Planning, Referrals
Education
Lafayette College 1976 — 1980
BS, Mechanical Engineering
EMC 2014 - Present
Dell August 2011 - February 2014
Turin Networks (renamed Force10 Networks) February 2001 - August 2011
IronBridge Networks October 1999 - February 2001
Harris and Jefferies 1997 - 1999
Sun Microsystems 1992 - 1997
Praxsys Technologies 1990 - 1992
Phoenix Technologies 1988 - 1990
Taratec Development Corporation 1985 - 1987
Burroughs 1980 - 1985
Education
Columbia University in the City of New York 1976 — 1980
BS, Computer Science
Core Web Solutions June 2003 - Present
Taratec Development Corporation November 2001 - June 2003
Nextel Communications January 1998 - June 2001
Skills
IT Service Management, Web Design, Website Development, Telecommunications, Technical Writing, Technical Support, Technical Product...
Education
State University of New York College of Agriculture and Technology at Morrisville 1991 — 1993
Associate of Arts (AA), Liberal Arts and Humanities
New York Military Academy 1987 — 1990
High School Diploma, High School/Secondary Diplomas and Certificates
The Learning House January 2012 - Present
Hanover College January 2006 - Present
Taratec Development Corporation 2005 - 2006
First Consulting Group 2004 - 2005
Lloyd's Register Serentec, Inc. 2002 - 2004
Perot Systems 2000 - 2002
Keane 1996 - 2000
International Business Machines 1995 - 1996
Keane 1992 - 1995
Electronic Data Systems 1988 - 1992
Skills
Sales Management, Teaching, Educational Technology, Higher Education, Compliance, Engagement, Business Management, Public Speaking, Writing, Management, E-Learning, Student Affairs, Curriculum Development, Research, Strategy, Project Management, Time Management, Data Analysis, Social Media, Marketing, Staff Development, Fundraising, Leadership Development, Community Outreach
Education
University of Louisville 1992 — 1995
MBA
Hanover College 1983 — 1987
BA, Political Science & Business Administration
SCIEX March 2012 - Present
PerkinElmer LAS March 2009 - March 2012
Taratec Development Corporation 2006 - 2008
Waters Corp 1997 - 2006
Memorial Sloan-Kettering Cancer Center 1987 - 1996
University of Puerto Rico-Cayey 1985 - 1987
Skills
Technical Training, Training Services, Instructor-led Training, Instrumentation, CDS, Web Based Training, Training, HPLC, Validation, Pharmaceutical Industry, Chromatography, Biotechnology, Lifesciences, Mass Spectrometry, Leadership, Troubleshooting, LC-MS, Sop, Gas Chromatography, R&D, Analytical Chemistry, Laboratory Automation, V&V, LIMS, Chemistry, 21 CFR Part 11, GMP, FDA, GLP, Quality Assurance, Laboratory, CAPA, Hardware Diagnostics, Technology Transfer, Purification, GxP, Biopharmaceuticals, Change Control, Medical Devices, Quality System, Calibration, Drug Discovery, Microbiology, Genomics, Protein Chemistry, DNA sequencing, ELISA, E-Learning, HPLC-MS, Life Sciences
Education
City University of New York City College 1988 — 1991
Biochemistry and Molecular Biology
Universidad de Puerto Rico 1981 — 1985
BS, Science
Esc Sup Francisco Morales
Deloitte Consulting LLC March 2010 - Present
Trioh and Serac Solutions March 2007 - Present
Trioh Consulting Group, Inc March 2007 - Present
Serac Solutions, LLC March 2007 - Present
Merck 2006 - Present
Taratec Development Corporation June 2005 - March 2007
Honeywell Process Solutions 1996 - 2006
HoneyWell-Poms September 1996 - June 2005
Skills
Management, Oracle, SDLC, Testing, Databases, Integration, PL/SQL, Process Improvement, Validation, Software Project..., Project Management
Education
Illinois Institute of Technology
BS, Mechanical Engineer
GlaxoSmithKline Biologicals March 2008 - Present
AstraZeneca March 2003 - September 2007
Encorium October 2001 - March 2003
Mentor Technologies April 2000 - September 2001
Taratec Development Corporation September 1998 - April 2000
AstraMerck August 1995 - September 1998
Skills
Vaccines, CRO, Clinical Development, Clinical Operations, CTMS, Pharmaceutical Industry, Clinical Trials, GCP, Biologics, Clinical Research..., Clinical Monitoring, ICH-GCP, Therapeutic Areas, Clinical Research
Education
University of Colorado Boulder 1989 — 1994
EPOB/BS, Molecular Biology, Oncology, Chemistry
Strand Genomics - Genetic Testing startup February 2015 - Present
Daiichi Sankyo Pharmaceutical January 2011 - January 2014
Covance - Drug Development/Biotech/Healthcare CRO January 2010 - January 2011
Schering-Plough Research Institute January 2005 - January 2010
Aventis Pharmaceutical January 2002 - January 2005
Taratec Development Corporation January 1998 - January 2002
Skills
Computer System..., GxP, CRO, Pharmaceutical Industry, Quality Assurance, CAPA, Medical Devices, FDA, 21 CFR Part 11, Change Control, SOP Development, SDLC, Testing, Laboratory Quality, ISO 151289, CAP Accreditation, CLIA, Quality Systems
Education
Stevens Institute of Technology
Graduate Masters Certificate, Pharmaceutical Manufacturing Practices
Autism Home Support Services, Inc January 2014 - Present
West Suburban Angels, Inc May 2013 - Present
Autism Home Support Services, Inc September 2009 - December 2013
City of Naperville May 2005 - April 2013
Miller & Company 1997 - 2009
Ombudsman Educational Services 2001 - 2003
Taratec Development Corporation 2001 - 2003
Alamar Biosciences 1989 - 1997
Baxter October 1985 - October 1989
Baxter Healthcare/ American Hospital Supply Corp 1967 - 1989
Skills
Community Development, Non-profits, Interim Management, Business Development, Marketing, Fundraising, Strategic Planning, Public Speaking, Public Relations, Customer Service, Event Planning, Healthcare, Marketing Strategy, Marketing Communications, Community Outreach, Event Management, Team Building, Leadership Development, Media Relations, Social Media, Microsoft Office, Crisis Communications, Editing, Project Management, Social Media Marketing, Research
Education
Lake Forest Graduate School of Management 1980 — 1982
MBA, Marketing
University of Iowa 1963 — 1967
BS, General Science, Pre-Medical Studies
Erie High School 1959 — 1963
Diploma
PerkinElmer January 2015 - Present
PerkinElmer August 2012 - December 2014
Celgene October 2011 - August 2012
Centerline Partners June 2011 - October 2011
LabAnswer June 2009 - June 2011
Patni Life Science (formerly Taratec Development) September 2007 - May 2009
Taratec Development Corporation August 2005 - August 2007
Purdue Pharma 1997 - 2005
PepsiCo - Pepsi Beverages Company November 1995 - February 1997
SmithKline Beecham January 1991 - November 1995
Skills
Laboratory informatics, Project Management, Requirements Gathering, Requirements Management, Requirements..., Business Analysis, Computer System..., IT Strategy, Client Relationship..., Scientific Computing, LIMS, CDS, ELN, SDMS, GxP, Process Mapping, Workflow Analysis, Lab IT Support, Training Skills, 21 CFR Part 11, Management Consulting, Vendor Relations, Crystal Reports, Requirement...
Education
Stevens Institute of Technology - Project Management 1999 — 2000
Project Management
NYU Stern School of Business 1995 — 1996
Management / Finance
Stevens Institute of Technology - MS Chemistry 1994 — 1995
Master of Science (MS), Analytical Chemistry
New York University 1986 — 1990
Bachelor of Arts (BA), Chemistry
RE/MAX Marketing Specialists March 2011 - Present
Women's Council of Realtors 2008 - 2009
Taratec Development Corporation January 1997 - December 1998
Johnson & Johnson January 1975 - December 1996
Skills
Referrals, Short Sales, Buyers, Relocation, Home Staging, Real Estate, Listings, Sellers, Senior Real Estate, REO, Residential Homes, ABR, National Association of..., First Time Home Buyers, New Home Sales, SFR, Single Family Homes, Buyer Representation, Foreclosures
Education
The College of New Jersey 1971 — 1974
BS, Business, Accounting
Safis Solutions, LLC September 2015 - Present
Beckman Coulter August 2013 - Present
Navigant July 2013 - August 2013
Anson Group October 2010 - July 2013
Eli Lilly May 2002 - September 2010
Taratec Development Corporation December 1998 - March 2002
Bio-Reg Associates May 1996 - June 1997
Skills
Quality Auditing, Process Auditing, Computer System..., Medical Devices, FDA, Change Control, Validation, Quality Systems, Pharmaceuticals, CAPA, GMP, Quality Assurance, Process Improvement, Pharmaceutical Industry, 21 CFR Part 11, GxP, Regulatory Affairs, V&V, ISO 13485, Quality System, IT Infrastructure..., Lifesciences, Sop, Strategy, Regulatory Requirements, Biotechnology, GLP, Technology Transfer, Regulatory Submissions, Clinical Trials, Software Documentation, Commercialization, Quality Control, Clinical Development, GCP, LIMS, R&D, Cross-functional Team..., Business Process, Biopharmaceuticals, Manufacturing, Quality Management, Hardware Diagnostics, Design Control, Oncology, Process Simulation, SharePoint, Clinical Research, ISO, GAMP
Education
Indiana University - Kelley School of Business 2008 — 2013
MBA, General Management
University of Maryland College Park 1994 — 1998
M.S., Bioengineering
Allahabad Agricultural Institute 1984 — 1988
Bachelor of Technology, Agricultural Engineering
Tri-Ultra Media, Brielle NJ January 2009 - Present
Kaplan EduNeering/RedHawk Communications January 2008 - January 2009
Taratec Development Corporation January 2006 - August 2007
Prous Science January 2003 - January 2006
Skills
Social Media Marketing, Social Media, Online Marketing, Facebook, Video SEO, Mobile Marketing, Market Positioning &..., Local Search..., SEO, Online Advertising, Analytics, Positioning, Research, Marketing, Marketing Strategy, Email Marketing, Account Management, Web Marketing, Brand Development, Business Development, YouTube, Marketing Communications, Social Marketing, Web Analytics, E-commerce, Creative Direction, Digital Marketing, Direct Marketing, Lead Generation, Google Analytics, Corporate Communications, Marketing Management, Entrepreneurship, Strategic Partnerships, Digital Media, Website Development, B2B, Product Marketing, Digital Strategy, Strategy, PPC, Facebook ads, Google Adwords, Viral Marketing, Social Networking, Integrated Marketing, Blogging, Content Strategy, Relationship Marketing, Brand Awareness
Education
University of Massachusetts, Amherst 1991 — 1995
B.S., Exercise Physiology
Allergan June 2011 - Present
Eli Lilly and Company 2008 - 2010
Wyeth June 2007 - December 2007
GSK 2006 - 2007
Taratec Development Corporation 2004 - 2006
Ivax Pharmaceuticals 2002 - 2004
Baxter International Inc. 1991 - 2002
Skills
Validation, Computer System..., People Skills, 21 CFR Part 11, Cross-functional..., Cross-functional Team..., Quality Assurance, Process Improvement, Ethylene Oxide..., Wet Chemistry, Raw Materials, CSV, UV/Vis, SOP development, Root Cause Analysis, Research, FDA GMP, Outlook, Microsoft Office, Microsoft Excel, English, Windows, PowerPoint, Microsoft Word, Medical Devices, Customer Service, Teaching, SOP Development, LIMS
Education
Universidad de Puerto Rico 1985 — 1990
Bachelor of Science (BS), Chemistry, Cum Laude
Genzyme March 2015 - Present
Genzyme January 2014 - Present
Sanofi Pasteur March 2011 - December 2013
Sanofi Pasteur January 2009 - March 2011
Patni Life Sciences, Inc. July 2007 - January 2009
Taratec Development Corporation February 2005 - July 2007
Taratec Development Corporation April 2003 - February 2005
Taratec Development Corporation July 1999 - April 2003
Taratec Development Corporation January 1997 - July 1999
Skills
21 CFR Part 11, Validation, Computer System..., LIMS, GMP, Pharmaceutical Industry, GAMP, Quality Assurance, GxP, Quality System, GLP, FDA, Project Management, Biotechnology, Lifesciences, Change Control, Software Documentation, Requirements Analysis, SDLC, Pharmaceutics, Laboratory, Regulatory Affairs, Software Project..., Business Process..., Strategy, Informatics, Integration, Quality Control, Regulatory Submissions, CAPA, Electronic Lab Notebooks, Sop, Quality Management, Program Management, V&V, Document Management, Testing, Business Process, Regulatory Requirements, Project Portfolio..., R&D, Biopharmaceuticals, Documentum, Data Management, Technology Transfer, Vaccines, IT Strategy, LIMS & Lab Informatics, Pharmaceutical Quality..., HOPE
Education
McMaster University 1989 — 1992
MSc, Geology
McMaster University 1982 — 1987
BSc, Geology
Phillips Pet Food & Supplies March 2015 - Present
Pet-a-cure July 2009 - March 2015
Avantor Performance Materials, Inc. March 2013 - July 2013
PETCO Animal Supplies, Inc. November 2011 - 2013
Sanofi April 2011 - July 2011
Sanofi April 2011 - July 2011
Grom Associates February 2011 - April 2011
ADESA December 2010 - January 2011
Realogy Holdings Corp. September 2007 - November 2008
Taratec Development Corporation November 2006 - July 2007
Skills
Talent Acquisition, Applicant Tracking..., Recruiting, Onboarding, Sourcing, Human Resources, Interviews, Temporary Placement, CRM, Screening, Training, Business Development, Management, Organizational..., Hiring, Deferred Compensation, Time Management, Leadership, Team Building, College Recruiting, Job Descriptions, Networking, Sales, Talent Management, Taleo, Employee Relations, Internet Recruiting, Consulting, Strategy
Education
St. Leo University 2002 — 2003
HR & Business Management
North Plainfield High School 1984 — 1988
Diploma
Penn State University
Penn State University
Simon Property Group 2014 - Present
WP GLIMCHER 2014 - 2015
WP GLIMCHER 2014 - 2015
Elanco March 2014 - October 2014
Unison Resource Company October 2012 - March 2014
DuPont Pioneer February 2006 - September 2012
Equity Office Properties 2003 - 2005
Taratec Development Corporation 2000 - 2003
Skills
Administrative..., Travel Arrangements, Office Management, Outlook, Calendaring, Spreadsheets, Lotus Notes, PowerPoint, Event Planning, Confidentiality, Microsoft Excel, Microsoft Office, Administrative...
Education
Ball State University 1997 — 2000
Business Administration, Management and Operations
Highland High School 1994 — 1997
English/Journalism
Sanofi December 2010 - Present
sanofi-aventis October 2009 - December 2010
sanofi-aventis May 2006 - October 2009
Integrated Project Services February 2005 - April 2006
Integrated Project Services April 2004 - February 2005
Taratec Development Corporation June 2001 - April 2004
Colorcon 1992 - 1998
Skills
Validation, Quality Systems, Quality Assurance, 21 CFR Part 11, Computer System..., GMP, MES, Pharmaceuticals, cGMP, Quality Auditing, Document Management, Business Process..., SOP, SDLC, Coaching, Compliance, Software Validation, Change Control, Testing, Quality System, Sop, GxP, Pharmaceutical Industry, FDA, Medical Devices, Biotechnology, Clinical Trials, Biopharmaceuticals
Education
University of Pittsburgh 1982 — 1986
Bachelor of Science, Chemistry
Retired September 2015 - Present
Novartis Institutes for BioMedical Research November 2001 - September 2015
Novartis Institutes for BioMedical Research January 1999 - November 2001
Novartis Pharmaceuticals January 1997 - December 1998
Ciba-Geigy Pharmaceuticals 1987 - 1997
Taratec Development Corporation October 1984 - September 1987
Merck & Co., Inc November 1980 - October 1984
Skills
Drug Discovery, Drug Design, Cheminformatics, Pharmaceutical Industry, Oncology, Computational Chemistry, Molecular Modeling, Bioinformatics, Structural Biology, Biochemistry, Computational Biology, Protein Chemistry, Protein-protein..., Structural..., Technology Transfer, Scientific Computing, Target Identification, Microbiology, Life Sciences, Drug Development
Education
Massachusetts Institute of Technology 1970 — 1977
PhD, Biological Oceanography
Rutgers University-New Brunswick 1993 — 1996
MLS, Library & information science
Rensselaer Polytechnic Institute 1966 — 1970
BS, Biology
School District of Philadelphia September 2009 - Present
Royal Gramma LLC September 2008 - September 2009
CRF Inc July 2007 - August 2008
Integic a Northrop Grumman Corp. October 2005 - January 2007
IntraLinks, Inc. August 2002 - September 2005
Phase Forward 2001 - 2002
Clinsoft 1998 - 2002
Domain Pharma 1998 - 2001
Taratec 1997 - 1998
Taratec Development Corporation 1997 - 1998
Education
Delaware Valley College 2009 — 2010
Teacher Certification
Temple University
BBA
Connolly, LLC July 2015 - Present
ATG Learning Academy 2006 - Present
Paragon 2013 - July 2015
Almac Clinical Technologies 2008 - 2012
Centocor R&D, Inc. 2003 - 2007
Taratec Development Corporation 2002 - 2003
CB Technologies, Inc. 2000 - 2002
Base 10 Systems 1995 - 2000
Base Ten Systems 1995 - 2000
Skills
Certified Project..., Root Cause Analysis, Computer System..., Validation, Clinical Trials, GxP, FDA, 21 CFR Part 11, Project Management, Pharmaceutical Industry, SDLC, Program Management, Software Documentation, CRM, Process Improvement, Biotechnology, Regulatory Affairs, Leadership, Quality Assurance, Team Leadership, Cross-functional Team..., Enterprise Software, ERP, Project Planning, Change Control, Resource Management, Project Portfolio..., Six Sigma, Business Process..., IT Strategy, PMO, Strategy
Education
United States Naval War College
College of Command Staff
Drexel University
MS, Engineering Management
Villanova University
BS, Physics
Taratec Development Corporation October 2005 - Present
Software Professionals/VirtusPartners May 2005 - September 2005
Enzon Pharmaceuticals, Inc. May 2003 - April 2005
Taratec Development Corporation September 2002 - January 2003
Impact Systems, Inc. June 2002 - September 2002
TMP Worldwide/DuPont Pharmaceuticals April 2000 - January 2002
CSC/DuPont May 1997 - April 2000
FannieMae March 1990 - March 1997
Honeywell, Inc. February 1988 - January 1990
CIGNA Corporation June 1986 - December 1988
Education
Drexel University 1983 — 1985
M.S.
Bangalore University 1969 — 1971
M.Sc.
Bangalore University 1966 — 1969
B.Sc. (Hons)
iGATE 2011 - Present
Patni Computer Systems 2007 - 2011
Taratec Development Corporation 1988 - 2007
Skills
21 CFR Part 11, Computer System..., Validation, FDA, Change Control, Quality System, SDLC, Quality Assurance, Pharmaceutical Industry, Quality Auditing, Medical Devices, GxP, Business Analysis, Program Management, Testing, V&V, GAMP, Lifesciences, Sop, Clinical Trials, LIMS, Process Improvement, GMP, Software Documentation, Quality Management, Cross-functional Team..., New Business Development, Pharmacovigilance
Education
University of Maryland College Park
BS Comp Sci
IGATE (formerly Patni) 2011 - Present
Patni (formerly Taratec) 2007 - 2011
Taratec Development Corporation 2004 - 2007
Abbott Laboratories 2003 - 2003
Abbott Laboratories 2001 - 2003
Abbott Laboratories 1999 - 2001
Skills
21 CFR Part 11, Software, Computer System..., Validation, CAPA, FDA, Change Control, GxP, GMP, Quality System, V&V, Quality Assurance, LIMS, Medical Devices, Pharmaceutical Industry, Quality Auditing, Software Quality..., Testing, GAMP, Software Documentation, Document Management
Education
Northwestern University 2007 — 2012
MS, Quality Assurance and Regulatory Science
Illinois Institute of Technology 1997 — 1999
BS, Chemical Engineering (minor in BioMedical Engineering)
College of the Bahamas 1996 — 1997
AA, Engineering
College of the Bahamas 1994 — 1996
AA, Biology & Chemistry
GHS, Nassau 1991 — 1994
QC, Georgetown 1988 — 1991
PPD October 2012 - Present
ESD 6 2011 - Present
PPD October 2013 - November 2014
PPD March 2010 - November 2012
PPD October 2007 - February 2010
Memory Pharmaceuticals August 2005 - October 2007
Memory Pharmaceuticals November 2002 - July 2006
Alteon, Inc January 2002 - November 2002
Taratec Development Corporation July 2000 - January 2002
Organon July 1991 - July 2000
Skills
Computer System..., 21 CFR Part 11, GCP, Document Management, EDC, Help Desk Support, Firewalls, Trial Management, Network Development, IT Management, Pharmaceutical Industry, Validation, Biotechnology, Data Management, Project Management, Program Management, Clinical Trials, Change Control, FDA, Lifesciences, Clinical Development, CTMS, Protocol, Clinical Research, Sop, Software Documentation, Neuroscience, Drug Discovery, LIMS, Outsourcing, Neurology, Line Management, Pharmaceutics, Start-ups, ICH-GCP
Education
New Jersey Institute of Technology 1993 — 1995
MS
California State University-East Bay 1985 — 1988
BS
Florida State University 1981 — 1985
Pfizer Research November 2007 - Present
Howard Systems May 2007 - November 2007
Taratec Development Corporation July 2005 - May 2007
Wyeth June 2003 - July 2005
DCSS June 2001 - June 2003
Beckman Coulter LAO July 1990 - September 2001
AM Varityper June 1981 - July 1990
Skills
Computer System..., 21 CFR Part 11, LIMS, Change Control, Validation, GxP, FDA, SDLC, GMP, Quality Assurance, Requirements Analysis, Sop, Software Documentation, Business Analysis, Quality System, Crystal Reports, Oracle, Laboratory, Databases
Education
Ramapo College of New Jersey 1995 — 2006
BS, Information Technology
DeVry Institute of technology 1979 — 1981
ET, Electronics
AbbVie August 2013 - Present
Abbott Laboratories April 2011 - January 2013
Abbott Laboratories March 2008 - April 2011
Abbott Laboratories May 2006 - February 2008
Taratec Development Corporation July 2002 - May 2006
Skills
Change Control, Validation, FDA, Pharmaceutical Industry, 21 CFR Part 11, GMP, Computer System..., Quality Assurance, Sop, Medical Devices, Biotechnology, GxP
Education
Northeastern Illinois University 1998 — 2000
Masters, Computer Science
Northeastern Illinois University 1995 — 1997
Bachlor, Biology
Medidata Solutions December 2006 - Present
Taratec Development Corporation September 2003 - December 2006
Pfizer March 1999 - July 2003
CSC May 1998 - February 1999
Oracle August 1993 - May 1998
Digital Equipment Corporation May 1992 - July 1993
Apoloco Systems Limited May 1987 - May 1992
Sterling Winthrop Research Institute July 1981 - April 1987
Ciba-Geigy August 1977 - June 1981
Merck August 1974 - August 1977
Skills
21 CFR Part 11, Clinical Trials, Pharmacovigilance, Pharmaceutical Industry, CRO, Program Management, Quality Assurance, CTMS, FDA, Data Management, EDC, Clinical Data Management, Validation, GCP, Regulatory Affairs, Clinical Development, Project Management, SDLC, Biotechnology, Software Documentation, Cross-functional Team..., Lifesciences, Quality System, Process Improvement, Change Management, Life Sciences
Education
Saint Joseph's University 1992 — 1994
Master of Business Administration (MBA), Pharmaceutical Marketing
State University of New York Downstate Medical Center College of Medicine 1972 — 1974
Bachelor of Science (BS), Medical Computer Science
Nassau Community College 1970 — 1972
AS, math and science
Inspectorate March 2012 - Present
Amylin Pharmaceuticals February 2007 - June 2012
Taratec Development Corporation January 2006 - June 2006
Bayer MaterialScience August 1998 - December 2005
Education
University of Houston-Clear Lake 2001 — 2005
M.S., Software Engineering
University of Puerto Rico 1984 — 1989
B.S., Chemistry
Day & Zimmermann January 2012 - Present
Comcast Cable June 2003 - January 2012
Comcast June 2003 - January 2012
Comcast June 2003 - January 2012
Comcast Cable June 2003 - January 2012
Comcast June 2003 - January 2012
Taratec Development Corporation September 1997 - April 2003
TRW June 1996 - September 1997
Skills
C#, Oracle, SDLC, Microsoft SQL Server, SharePoint, .NET, Integration, SQL, Requirements Analysis, ASP.NET, Databases
Education
Drexel University 1993 — 1996
B.S., Computer Engineering
Office of Management and Budget from the Commonwealth of Puerto Rico April 2001 - Present
Goverment of Puerto Rico March 2001 - Present
Puerto Rico State Homeland Security August 2010 - May 2011
Oficina de Gerencia y Presupuesto April 2001 - October 2010
Taratec Development Corporation 2000 - 2001
FEMA 1995 - 1997
Skills
Project Management, Microsoft Technologies, Windows Server, MS Exchange Server 2003, MS Exchange Server 2010, MS ISA, Windows Server 2008, Risk Assessment, SQL Server, Ubuntu, Windows server 2008 R2, Network Administration, ITIL, Virtualization, TMG, VMware Workstation, VMware, VMware ESX, Microsoft Exchange, Microsoft SQL Server, Disaster Recovery, 2008 R2, Networking, SQL, Network Security, SharePoint, IT Management, Security, DNS, windows 2012, DHCP, Firewalls, Computer Security, Active Directory, System Administration, VPN, XP, Servers, Windows 7, Windows XP, Group Policy, Data Center, IIS, Hyper-V, Cisco Technologies, Citrix, Information Security, IT Service Management
Education
Universidad de Puerto Rico 1986 — 2000
BBA, Computer Information System
Colegio San Jose 1980 — 1986
HS, High school
Gilead Sciences February 2013 - Present
Gilead Sciences February 2009 - January 2013
Gilead Sciences May 2006 - February 2009
College of Lake County September 2005 - May 2006
RCV Consultants, Inc. September 2004 - May 2006
PharmTech, Inc. August 2001 - January 2004
Taratec Development Corporation September 1998 - March 2001
Abbott Laboratories May 1977 - January 1998
Skills
21 CFR Part 11, Pharmaceutical Industry, GMP, GCP, Validation, Sop, Biotechnology, GLP, FDA, Quality System, Computer System..., V&V, Regulatory Submissions, CAPA, LIMS, Clinical Trials, Change Control, Quality Auditing, Cross-functional Team..., Regulatory Requirements, Technology Transfer, IND, EDC, Biopharmaceuticals, CRO, Analytical Chemistry, Medical Devices, Chromatography, HPLC, SOP, Regulatory Affairs, CTMS, ISO 13485, GxP, Pharmaceutics, Pharmacovigilance, GAMP, Lifesciences, R&D, ICH-GCP, Clinical Development, Drug Development, Aseptic Processing, Cleaning Validation, Oncology, eCTD
Education
Northeastern University 1974 — 1978
M.S., Organic Chemistry
Houghton College 1970 — 1974
B.S., Chemistry
PATNI LIFE Sciences Computer Compliance SpecialistDePuy Synthes companies of J&JJune 2011 - Present
Bristol-Myers Squibb/ consultant 2006 - Present
Taratec Development Corporation 2005 - Present
Saint Jude Medical Device 2008 - 2010
Skills
Validation, 21 CFR Part 11, FDA, Change Control, Computer System..., GxP, V&V, Sop, LIMS, GAMP, CAPA, GMP, Medical Devices
Education
Temple University 1980 — 1985
MBA, Computers and Informational Sciences
Rutgers, The State University of New Jersey-Newark 1968 — 1973
Independent September 2011 - Present
Fisher Clinical Services May 2007 - July 2011
Covex LLC July 2006 - May 2007
Johnson & Johnson, Centocor 2004 - 2007
CimQuest, Inc. November 2002 - July 2006
Taratec Development Corporation March 1999 - November 2002
Colorcon March 1991 - March 1999
Pecora Corporation 1988 - 1991
Pecora Corporation 1988 - 1991
Skills
Records Management, Validation, LIMS, Computer System..., Document Management, FDA, Change Control, Plateau, GMP, GLP, 21 CFR Part 11, cGMP, SOP, GxP, GAMP, UV, Learning Management, Quality Systems, CAPA, CTMS, Clinical Development, Clinical Trials, Pharmaceutical Industry, Quality Auditing, Quality Control, Quality System, V&V
Education
Goshen College 1983 — 1988
Bachelor of Arts (B.A.), Psychology
URS Corporation October 2007 - July 2012
Siemens Energy & Automation November 2004 - October 2007
Taratec Development Corporation 2002 - 2003
Taratec Development Corporation 2002 - 2003
Instrumentation Technical Services 1994 - 1995
Fisher-Rosemount 1985 - 1994
Fisher-Rosemount 1985 - 1994
The Ahmedabd Electricity Company Limited (Now Torrent -Power Group) October 1981 - March 1985
Petrofils Coperative Limited 1979 - 1981
Skills
Project Management, Start-ups, Instrumentation, Control Theory, DCS, Commissioning, Process Control, PLC, Electricians, Engineering, SCADA, Power Plants, Project Engineering, EPC, Petrochemical, Process Automation, Power Generation, Energy, Control Systems Design, Nuclear, Proposal Writing, Engineering Management, Contract Management, Project Planning, Procurement, Validation, Compliance, Gas, Automation, Turbines, Boilers, Troubleshooting, Integration, Manufacturing, Process Engineering, Factory, Electrical Engineering, Engineering Design, FEED, Refinery, P&ID, Project Control, Project Estimation, Gas Turbines, Refineries, Power Distribution, HAZOP, Oil/Gas, Engineers, Water Treatment
Education
Gujarat University 1971 — 1977
Bachelor in Engineering, Instrumentation & Control
Quintiles August 2012 - Present
RTI Health Solutions November 2010 - August 2012
RTI Health Solutions October 2009 - November 2010
NTG Consulting October 2007 - October 2009
Pfizer Inc 2007 - October 2009
Barr Labs 2004 - 2008
Relsys 2002 - 2003
Taratec Development Corporation 1996 - 2002
Abbott Laboratories 1993 - 1996
Skills
21 CFR Part 11, Pharmacovigilance, Computer System..., Pharmaceutical Industry, Validation, Clinical Trials, FDA, Change Control, Quality Assurance, GCP, Regulatory Affairs, SDLC, Sop, Lifesciences, GxP
Education
McGill University
EMC January 2008 - August 2008
BusinessEdge Solutions November 2004 - December 2007
Fujitsu Consulting 2004 - 2004
Taratec Development Corporation 1999 - 2004
Education
Marist College 2001 — 2005
MBA, Business
California State University-Fullerton 1991 — 1997
Black Diamond Networks April 2015 - July 2015
IGATE August 2014 - March 2015
Black Diamond Networks March 2013 - September 2013
Oxford Global Resources January 2012 - December 2012
Experis Technology Group February 2011 - November 2011
Intel June 2008 - March 2009
Taratec Development Corporation May 2007 - February 2008
Pfizer September 2005 - April 2006
Skills
FDA, Validation, Requirements Analysis, Documentation, GMP, Medical Devices, 21 CFR Part 11, Pharmaceuticals, Quality Assurance, SDLC, Change Management, Quality Systems, Process Mapping, Business Analysis, Analysis, Life Sciences, Computer System..., Requirements Gathering, Visio, Business Requirements, Systems Analysis, GAMP, Pharmaceutical Industry, Software Documentation, GLP, Quality System, Quality Auditing, Change Control, Quality Management, Lifesciences, Business Process Mapping
Education
Brandeis University 1978 — 1980
Master of Arts (M.A.), Psychology
Merck 2012 - Present
Merck September 2009 - 2012
Schering-Plough Research Institute 2005 - 2009
Taratec Development Corporation September 2003 - September 2005
Merck 2003 - 2003
Prudential Financial September 2000 - November 2002
Skills
Computer System..., Validation, Change Control, 21 CFR Part 11, Technology Transfer, Project Management, Clinical Trials, Sop, Pharmaceutical Industry, GxP, FDA, GMP, Regulatory Affairs, Quality Auditing, Quality System, V&V, LIMS, Quality Assurance, CAPA, FDA Inspections, Compliance, Risk Management, Internal Audit, External Audit, Regulatory Agencies, Regulatory Readiness, GLP, SOP
Education
Stevens Institute of Technology 2006 — 2008
MS, Project Management
New Jersey Institute of Technology 1995 — 1999
BS, Management Information Systems
Tema Secondary School 1991 — 1992
High School Diploma
Achimota School 1985 — 1990
Diploma, Arts
Morning Star School 1978 — 1984
Elementary
Quest Diagnostics February 2008 - Present
Fidelity Information Services July 2000 - February 2008
Taratec Development Corporation September 1996 - May 2000
Skills
JavaScript, Integration, Microsoft SQL Server, COBOL, Unix, Business Analysis, Process Improvement, HL7, Databases, SQL, C#, Business Intelligence, SharePoint, ETL
Education
Drexel University
Penn State University
Master, Engineering Science
Patni Life Sciences Sr. SpecialistPatni Life Sciences
Taratec Development Corporation May 1988 - July 2007
Bactomatic 1987 - 1988
Skills
21 CFR Part 11, Computer System..., GAMP, GxP, Validation, Change Control, Sop, FDA, Pharmaceutical Industry, V&V, GMP, Quality Assurance, Pharmacovigilance, Lifesciences, Life Sciences
Education
Southern Illinois University, Edwardsville 1967 — 1976
BA, Chemistry, Math, Biology
GSK Consumer Healthcare March 2015 - Present
Novartis Consumer Health June 2012 - March 2015
Actavis April 2009 - June 2012
King Pharmaceutical (now Pfizer) December 2007 - March 2009
Becton Dickinson 2006 - 2007
CH2M HILL - Lockwood Greene 2003 - 2006
Taratec Development Corporation 2001 - 2003
Wyeth-Lederle (now Pfizer) 1999 - 2001
Schering-Plough Research Institute 1982 - 1999
Skills
21 CFR Part 11, Computer System..., V&V, Validation, CAPA, GMP, FDA, Change Control, Pharmaceutical Industry, Sop, Quality System, Quality Assurance, Technology Transfer, Business Process, Project Management, Medical Devices, Manufacturing..., R&D Operations, Fermentation Technology, Biotechnology, ISO 13485, GAMP, Quality Auditing, GxP, Chromatography, Cleaning Validation, R&D, Quality Control, Manufacturing, Trackwise, HPLC, Regulatory Affairs, Cross-functional Team..., GLP, Aseptic Processing, Analytical Chemistry, Biopharmaceuticals, LIMS, Pharmaceutics, Process Simulation, FDA GMP, Regulatory Requirements, Regulatory Submissions, Quality Management, Lifesciences, SOP
Education
University of Puerto Rico-Mayaguez
Bachelor’s Degree
UC Berkeley 1981 — 1982
Inter-American University of Puerto Rico-Metropolitan Campus 1994 — 1998
Baptist Health July 2014 - Present
HighPoint Solutions July 2012 - April 2014
Alliance Life Sciences Consulting Group, Inc April 2008 - July 2012
RCM Technologies October 2007 - April 2008
QA Edge Inc. April 2007 - October 2007
Nth Tier Solutions October 2006 - April 2007
HighPoint Solutions August 2006 - October 2006
J&R Consulting, Inc. February 2005 - August 2006
Idea Integration August 2004 - February 2005
Taratec Development Corporation 2002 - 2004
Skills
Quality Assurance, Software Documentation, SDLC, 21 CFR Part 11, Testing, Computer System..., Validation, Business Process, User Acceptance Testing, Requirements Analysis, Business Analysis, GxP, Quality Management, GMP, Document Management, Project Management, Documentation, Process Improvement, Change Control, LIMS, Change Management, Compliance, Integration, Pharmaceuticals, FDA, Pharmaceutical Industry, Data Warehousing, Business Process Mapping, Process Engineering, Quality Systems, ERP, Master Data Management, Contract Management, Managed Market Analytics, Agile & Waterfall..., Management, Consulting
Education
Kutztown University of Pennsylvania 1992 — 1996
BA, English Professional Writing w/ a Minor in Telecommunications
Collins College 2000 — 2001
AA, Visual Communications Multimedia Design
Impax Laboratories August 2013 - Present
Johnson & Johnson March 2012 - August 2013
Novartis Institutes for Biomedical Research (NIBR) January 2011 - February 2012
Catalent Inc October 2010 - February 2011
SDLC Consulting Inc April 2008 - February 2011
Pfizer May 2008 - May 2009
CSSC March 2006 - April 2008
Taratec Development Corporation October 1998 - March 2006
Skills
Validation, GxP, Computer System..., FDA, V&V, 21 CFR Part 11, Sop
Education
Mendeleyev University of Chemical Technology of Russia 1986 — 1986
MS, Chemical Technology
Moscow State University of Food Production (MGUPP) 1978 — 1983
Patni Life Sciences, Inc. 2007 - Present
Taratec Development Corporation 1993 - 2007
Education
Bloomsburg University of Pennsylvania 1978 — 1982
BS, Management
Fairleigh Dickinson University
MBA, Marketing
AbbVie April 2015 - Present
AbbVie August 2013 - April 2015
Abbott Laboratories January 2013 - August 2013
AbbVie January 2013 - August 2013
Taratec Development Corporation 2002 - 2006
Skills
Computer System..., 21 CFR Part 11, Project Management, Validation, Manage Multiple, CAPA, Quality Assurance, FDA, Change Control, LIMS, Pharmaceutical Industry, GxP, GMP, Quality System, Sop, Biotechnology, GAMP, GLP, V&V, Software Documentation, SOP
Education
Northeastern Illinois University 1998 — 2000
Master's degree, Computer Science
Northeastern Illinois University 1995 — 1997
Bachelor's degree, Biology, General
PepsiCo January 2013 - Present
PepsiCo May 2010 - March 2013
Pepsico September 2007 - April 2010
PepsiCo May 2007 - April 2010
Bearing Point Inc September 2006 - May 2007
BearingPoint September 2006 - April 2007
Thermo Fisher Scientific May 2005 - September 2006
Thermo Fisher Scientific May 2005 - September 2006
Thermo Fischer Scientific May 2005 - September 2006
Taratec Development Corporation January 2004 - May 2005
Skills
Project Management, Strategy, Program Management, SDLC, Change Management, PMO, Requirements Gathering, Management, Analysis
Education
University of Pittsburgh 1999 — 2003
Bachelors of Science, Chemical and Petroleum Engineering
University of Pittsburgh
Bachelor of Science, Chemical and Petroleum Engineering
Bank of America Merrill Lynch 2005 - Present
Spot Buying Solutions November 2001 - July 2005
Provato April 2000 - August 2001
Blackberry Technologies Corp November 1999 - April 2000
Taratec Development Corporation 1996 - 1999
HarperCollins Publishers 1994 - 1996
Dendrite 1993 - 1995
Datronics April 1990 - August 1993
Conoco (UK) 1983 - 1989
ZR Computers August 1982 - March 1983
Education
University of Portsmouth 1980 — 1982
BSc, Computer Science
Lincoln College of Technology 1976 — 1980
O levels, A levels, City & Guilds
Reeds School 1969 — 1977
'O' levels
Infotech Aerospace Services April 2007 - Present
Pfizer Pharmaceuticals 2004 - 2007
Taratec Development Corporation 2004 - 2007
MELLEX Software Solutions July 1996 - 2004
Allied Signal 1996 - 2004
Tucson Embedded Systems Inc. 1996 - 2004
Securaplane, LLC 1996 - 2004
Honeywell Aerospace 1996 - 2004
Skills
Computer System..., Software Development, Validation, Embedded Systems, Systems Engineering, UML, Software Design, Testing, Requirements Analysis, Troubleshooting
Education
State University of New York at Binghamton
MSAT, Software Engineering
EMC October 2009 - Present
Short Road Consulting November 2001 - October 2009
Taratec Development Corporation 2000 - 2001
Arbour Group July 1995 - October 2000
Johnson & Johnson, Ethicon July 1985 - July 1995
Skills
Project Management, IT Strategy, SDLC, Computer System..., Requirements Analysis, ERP, Validation, Software Development, ITIL, Cloud Applications, Business Intelligence, Cross-functional Team..., Business Process, Analysis, System Testing, Process Improvement, Business Analysis, Program Management, HP Quality Center, GAMP5
Education
Penn State University
BS, Industrial Engineering
Acorda Therapeutics, Inc. April 2013 - Present
Pfizer Pharmaceuticals May 2006 - December 2012
Taratec Development Corporation December 2001 - May 2006
EON Laboratories November 2000 - November 2001
BioSpecifics Technologies Corp August 2000 - November 2000
Skills
Computer System..., GMP, Software Documentation, Laboratory, LIMS, 21 CFR Part 11, GxP, Sop, Validation, Change Control, CAPA, FDA, V&V, Quality System, Pharmaceutical Industry, Biotechnology, Quality Assurance, GLP, HPLC, Quality Auditing
Education
Rutgers University-New Brunswick 1996 — 1999
BS, Biotechnology
Miami Dade College 1993 — 1996
AA, Pre Bachelors of Arts
Naturobotics Systems June 2009 - Present
Ramsey Yunan Enterprises 2001 - Present
Silent Dragon Kung Fu and Tai Chi 2001 - Present
Taratec Development Corporation 1998 - 2001
DMR Consulting (for UPS) 1997 - 1998
University of New Haven 1995 - 1995
Carbone-Lorraine North America 1988 - 1992
Teledyne Brown Engineering 1986 - 1988
Skills
Program Management, Databases, Engineering, Testing, Integration, Microsoft SQL Server, Software Development, Oracle, Analysis, Leadership, Manufacturing, Software Documentation
Education
Rutgers University-New Brunswick 2004 — 2010
PhD, Mechanical Engineering
University of New Haven 1992 — 1994
MSME, Mechanical Engineering
University of New Haven 1984 — 1986
BSME, Mechanical Engineering
County College of Morris 1982 — 1984
AS, Engineering Science
MedAvante 2013 - Present
EMC Consulting & BusinessEdge Solutions 2002 - 2013
PPD Informatics 2001 - 2002
Taratec Development Corporation 1997 - 2001
Clinarium 1997 - 1997
Doney & Associates 1993 - 1997
Bristol-Myers Squibb 1989 - 1993
ER Squibb & Sons 1982 - 1989
AMAX Zinc Company 1976 - 1982
Skills
Clinical Trials, EDC, CTMS, Pharmaceutical Industry, 21 CFR Part 11, Pharmacovigilance, Clinical Data Management, CRO, GCP, Clinical Research, Regulatory Submissions
Education
Rider University
MBA
Saint Louis University
A.B., Chemistry
LabAnswer July 2009 - Present
Patni Computer Systems 2006 - April 2009
Patni Life Sciences, Inc. 2006 - April 2009
Taratec Development Corporation 2006 - 2007
Canadian Food Inspection Agency June 2005 - June 2006
CGI January 2002 - June 2005
Cognicase October 1999 - January 2002
EDS Canada 1996 - 1999
Cablecom International Network Cabling Inc. April 1994 - September 1995
InGenius Engineering 1993 - 1994
Skills
Microsoft SQL Server, Oracle, LIMS, Integration, Databases, .NET, SDLC, Requirements Analysis, Lifesciences, Software Project..., Computer System..., Crystal Reports, Business Analysis
Education
City University of New York 2006 — 2006
BS, Information Science
CDI 1982 — 1983
Computer Technology
Algonquin College of Applied Arts and Technology 1978 — 1980
Computer Science
Deloitte April 2014 - Present
CTG March 2006 - Present
Taratec Development Corporation November 2003 - March 2006
Mead Johnson Nutritionals 2005 - 2006
Powerway 1998 - 2001
Skills
SDLC, Quality Assurance, Requirements Analysis, Business Analysis, Process Improvement, Software Documentation
Education
Indiana University Bloomington 1998 — 2001
Masters, Information Science
AstraZeneca July 2014 - Present
AstraZeneca April 2012 - June 2014
AstraZeneca R&D March 2011 - April 2012
AstraZeneca March 2001 - April 2011
Taratec Development Corporation September 1997 - April 2001
Abbott September 1990 - September 1997
Institut Pasteur 1987 - 1990
Skills
Regulatory Submissions, FDA, Drug Discovery, Cross-functional Team..., Regulatory Affairs, Pharmaceutical Industry, GLP, GMP, Regulatory Requirements, R&D, Quality System, Clinical Development, Strategy, Clinical Research, Quality Assurance, Clinical Trials, Document Management, Validation, GxP, Change Control, Drug Development, Computer System..., GCP, Pharmaceutics, Sop, 21 CFR Part 11, Biotechnology, SOP, eCTD
Education
University of Ottawa
Master of Business Administration (M.B.A.), Project Management
University of Ottawa
Bachelor of Applied Science (BASc), Chemical Engineering
University of Ottawa
Bachelor of Science (BSc), Biochemistry, A
University of Ottawa
Masters in Engineering Management, Engineering
RCM Technologies October 2004 - Present
Taratec Development Corporation September 2002 - May 2004
Applix March 2000 - November 2001
PricewaterhouseCoopers February 1998 - February 2000
CompUSA January 1995 - January 1998
Skills
Process Improvement, Account Management, Project Management, Document Management, Solution Selling, New Business Development, Validation, Business Development, Vendor Management, SaaS
Education
George Mason University 1994 — 1996
MS, Information Systems
Pontifical Catholic University 1981 — 1985
BBA, Business Administration
The Hun School of Pricenton 1976 — 1978
HS
Pfizer 2010 - Present
Wyeth 2001 - 2010
Wyeth 1996 - 2001
Taratec Development Corporation 1995 - 1996
American Cyanamid 1987 - 1995
Technicon Instruments 1981 - 1987
Rochester General Hospital, Rochester, NY and Beth Abraham Hospital, Bronx, NY 1975 - 1980
Skills
Medical Writing, IND, IB, Technical Writing, Regulatory Submissions, eCTD, Pharmacovigilance, GLP, Writing, Validation, Clinical Trials, Clinical Development, Pharmaceutical Industry, Toxicology, Computer System..., Vaccines, Pharmacokinetics, Infectious Diseases
Education
New York University - Polytechnic School of Engineering 1982 — 1984
MS, Computer Science
State University of New York College at Plattsburgh 1977 — 1980
BS, Medical Technology
Faber Consulting, LLC October 2007 - Present
BusinessEdge Solutions October 2004 - September 2007
Taratec Development Corporation October 2002 - September 2004
Glemser Technologies November 2001 - October 2002
The Cutter Comapnies June 1996 - September 2001
Johnson & Johnson September 1982 - June 1996
Education
Penn State University
MA, Economics
Rutgers College
BA, Economics / Computer Science
CSA-Soliance April 2013 - Present
Abbott Laboratories March 2008 - January 2012
Taratec Development Corporation October 2003 - November 2007
Performance Validation August 2000 - June 2003
Helena Laboratories August 1988 - January 1992
Education
Lamar University
B.S., Biology/Biological Sciences, General
The University of Texas at Austin
B.S., Chemical Engineering
Merck December 2012 - Present
VibrAlign January 2009 - December 2012
IVC Technologies 2003 - 2008
Taratec Development Corporation 2006 - 2006
International Paper 2000 - 2003
Duke Engineering & Services 1998 - 2000
Skills
Alignment, IR, Reliability, Engineering, Manufacturing, Production, Vendor, Energy, Microsoft Office, Problem Solving, Thermal, RCFA, Pharmaceutical Industry, Preventive Maintenance, Predictive Maintenance, Paper Industry
Education
North Carolina State University 1991 — 1996
BS, Mechanical Engineering
Enterprise System Partners Limited September 2014 - Present
Endeavor Consulting Group, LLC August 2013 - September 2014
Enterprise System Partners Limited August 2011 - July 2013
Weilgroup November 2010 - August 2011
Cordis 2006 - 2011
ALpharma Integrated Solutions August 2008 - October 2010
Taratec Development Corporation January 2005 - August 2008
ISS Corp November 2001 - January 2005
Cellular One (Former AT&T) December 1998 - May 2001
Skills
Camstar InSite MES, Camstar Business..., Network, System and..., Network and System..., Virtual Environment..., CSV Validation, 21 CFR Part 11, Windows Server, Visio, MS Project, MES, Validation, Troubleshooting, GMP, Sop, Computer System..., FDA, Software Documentation, Manufacturing, SDLC, GAMP, Testing, Medical Devices, V&V, Quality System, Change Control, CAPA, ISO 13485, FMEA, GxP, Design Control, Six Sigma, Root Cause Analysis, Quality Assurance, Quality Control, Process Simulation, Automation, Project Management Plan, Quality Auditing, Engineering, Project Management, ISO, DMAIC, FDA GMP, Cross-functional Team..., Management Consulting, Quality Management, Cross Functional Team...
Education
Universidad Politécnica de Puerto Rico 1996 — 2002
Bachelor, EE
MESO SCALE DIAGNOSTICS August 2014 - Present
St. Jude Medical (IESD) June 2013 - August 2014
Maquet Cardiovascular September 2011 - June 2013
Maquet Cardiovascular January 2007 - August 2011
Schering-Plough Pharmaceuticals 2003 - 2006
Taratec Development Corporation 2003 - 2003
Baxter Healthcare 2002 - 2003
Skills
CAPA, Quality Systems, FDA, ISO 13485, Minitab, Medical Devices, 21 CFR Part 820, 21 CFR Part 210 & 211, Auditing, Quality Auditing, CQA, CMQ/OE, Lead Auditor, Supplier Management, Design Control, Internal Audit, Validation, ASQ, Sop, Quality System, FMEA, Quality Control, Quality Assurance, Quality Management, Supplier Quality, GMP, ISO, FDA GMP, 21 CFR, DMAIC, Supply Management, Root Cause Analysis, Change Control, ISO 14971, Injection Molding, Lean Manufacturing
Education
Universidad de Puerto Rico 1996 — 2002
BSIE, Industrial Engineering
PLI 2015 - Present
PLI 2011 - 2015
SAIC 2004 - 2010
Taratec Development Corporation 2001 - 2004
Ocular Sciences Incorporated 1997 - 2001
Aquila Technologies 1994 - 1997
Skills
Quality System, FDA, Validation, Change Control, Pharmaceutical Industry, 21 CFR Part 11, CAPA, Sop, GLP, Quality Assurance, GxP, LIMS, V&V, GMP, SOP
Education
University of California, San Diego
Systems Engineering Certification
University of New Mexico, Albuquerque
Bachelor of Science (B.S.) Mathematics (Applied) & Biology (Microbiology)
Direct Energy January 2014 - Present
Hess Corporation September 2005 - December 2013
Taratec Development Corporation November 2002 - September 2005
KPMG US January 2000 - October 2002
Skills
Financial Analysis, Accounting, Financial Reporting, Variance Analysis, General Ledger, Internal Controls, Financial Modeling, SAP, Forecasting, Account Reconciliation, Sarbanes-Oxley Act, Microsoft Excel
Education
Montclair State University
Bachelor's Degree, Business Administration-Concentration in Accounting