Shire Laboratories, Inc
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Shire Laboratories, Inc Employees
Employee
Years
Job
Industry
John DelaCruz John DelaCruz's Shire Laboratories, Inc Experience 2002 - 2005
Job Sr. Analytical Chemist at Rhodes Pharmaceuticals
Industry Pharmaceuticals
Experience
Rhodes Pharmaceuticals July 2015 - Present
Allergan March 2012 - June 2015
Patheon 2007 - March 2012
Patheon Pharmaceuticals May 2007 - February 2012
Shire Pharmaceuticals 2006 - 2007
Supernus Pharmaceuticals, Inc. 2005 - 2006
Shire Laboratories, Inc. 2002 - 2005
Skills
HPLC, cGMP, Validation, GMP, Pharmaceuticals, GLP, Sop, UV/Vis, Analytical Chemistry, Gas Chromatography, Pharmaceutical Industry, Chemistry, FDA, Dissolution, Technology Transfer, Biotechnology, Chromatography, Drug Development, R&D, Regulatory Affairs, Life Sciences, CAPA, LIMS, Laboratory, V&V, Change Control, Pharmaceutics, 21 CFR Part 11, Regulatory Submissions, SOP
Education
Michigan State University 1997 — 2002
Ph.D., Chemistry
University of Michigan-Dearborn 1992 — 1997
BS, Chemistry
Rhodes Pharmaceuticals July 2015 - Present
Allergan March 2012 - June 2015
Patheon 2007 - March 2012
Patheon Pharmaceuticals May 2007 - February 2012
Shire Pharmaceuticals 2006 - 2007
Supernus Pharmaceuticals, Inc. 2005 - 2006
Shire Laboratories, Inc. 2002 - 2005
Skills
HPLC, cGMP, Validation, GMP, Pharmaceuticals, GLP, Sop, UV/Vis, Analytical Chemistry, Gas Chromatography, Pharmaceutical Industry, Chemistry, FDA, Dissolution, Technology Transfer, Biotechnology, Chromatography, Drug Development, R&D, Regulatory Affairs, Life Sciences, CAPA, LIMS, Laboratory, V&V, Change Control, Pharmaceutics, 21 CFR Part 11, Regulatory Submissions, SOP
Education
Michigan State University 1997 — 2002
Ph.D., Chemistry
University of Michigan-Dearborn 1992 — 1997
BS, Chemistry
Maria Pittaras, PMP Maria Pittaras, PMP's Shire Laboratories, Inc Experience 2002 - 2005
Job Director, Portfolio Management at Supernus Pharmaceuticals, Inc.
Industry Pharmaceuticals
Experience
Supernus Pharmaceuticals, Inc. March 2014 - Present
Supernus Pharmaceuticals, Inc. December 2007 - March 2014
Supernus Pharmaceuticals, Inc. December 2005 - 2007
Shire Laboratories, Inc. 2002 - 2005
MDS Pharma Services, Inc. 2001 - 2002
Bausch & Lomb Pharmaceuticals 1996 - 2001
Skills
Strategic Planning, Cross-functional Team..., PMP, Program Management, Portfolio Management, Project Planning, Pharmaceuticals, Product Development, R&D, Pharmaceutical Industry, Drug Development, GMP, Validation, Clinical Trials, FDA
Education
University of South Florida 1991 — 1996
BS
University of South Florida 1991 — 1996
BA
Supernus Pharmaceuticals, Inc. March 2014 - Present
Supernus Pharmaceuticals, Inc. December 2007 - March 2014
Supernus Pharmaceuticals, Inc. December 2005 - 2007
Shire Laboratories, Inc. 2002 - 2005
MDS Pharma Services, Inc. 2001 - 2002
Bausch & Lomb Pharmaceuticals 1996 - 2001
Skills
Strategic Planning, Cross-functional Team..., PMP, Program Management, Portfolio Management, Project Planning, Pharmaceuticals, Product Development, R&D, Pharmaceutical Industry, Drug Development, GMP, Validation, Clinical Trials, FDA
Education
University of South Florida 1991 — 1996
BS
University of South Florida 1991 — 1996
BA
Cindy Shekailo Cindy Shekailo's Shire Laboratories, Inc Experience January 2002 - March 2004
Job Director of Operations, AMGA's Anceta Collaborative
Industry Hospital & Health Care
Experience
Eurofins Medinet January 2009 - November 2011
Eurofins Medinet April 2008 - January 2009
Eurofins Medinet October 2005 - April 2008
Otsuka America Pharmaceutical, Inc April 2004 - October 2005
Shire Laboratories Inc January 2002 - March 2004
R.W. Johnson Pharmaceutical Research Institute October 1998 - December 2001
Skills
Validation, Vendor Management, Process Improvement, Clinical Trials, Cross-functional Team..., Project Management, Change Management, Management, Analysis, Leadership, Six Sigma, Healthcare, Drug Development, Requirements Analysis, Integration
Education
Syracuse University 1994 — 1998
BS, Bioengineering
Eurofins Medinet January 2009 - November 2011
Eurofins Medinet April 2008 - January 2009
Eurofins Medinet October 2005 - April 2008
Otsuka America Pharmaceutical, Inc April 2004 - October 2005
Shire Laboratories Inc January 2002 - March 2004
R.W. Johnson Pharmaceutical Research Institute October 1998 - December 2001
Skills
Validation, Vendor Management, Process Improvement, Clinical Trials, Cross-functional Team..., Project Management, Change Management, Management, Analysis, Leadership, Six Sigma, Healthcare, Drug Development, Requirements Analysis, Integration
Education
Syracuse University 1994 — 1998
BS, Bioengineering
Patrick Barber Patrick Barber's Shire Laboratories, Inc Experience February 2004 - April 2005
Job Technical Lead at Intrexon Corporation
Industry Information Services
Experience
Intrexon Corporation July 2015 - Present
Dovel Technologies September 2014 - July 2015
The Henry M. Jackson Foundation for the Advancement of Military Medicine December 2011 - September 2014
Clovis December 2012 - June 2014
Booz Allen Hamilton July 2011 - December 2011
Otsuka America Pharmaceutical, Inc. October 2005 - July 2011
SAIC May 2005 - October 2005
Shire Laboratories, Inc. February 2004 - April 2005
Mylan Pharmaceuticals June 2001 - May 2003
Skills
Crystal Reports, Visio, Lotus, Adobe Acrobat, Millennium, SQL Server, MS Project, Excel, 21 CFR Part 11, LIMS, Process Validation, Validation, GMP, Data Management, Computer System..., GAMP, GxP, cGMP, FDA, CAPA, Software Validation, GLP, SOP, QSR, Change Control, Chemstation, CDISC, Laboratory Automation, Technology Transfer, Quality Systems, Clinical Data Management, Oracle Clinical, Validations, Data Quality, Data Governance, Dissolution, Aseptic Processing, Data Analysis, Master Data Management, Software Documentation, Analytical Chemistry, HPLC, Databases, SharePoint, Technical Writing, Project Management, Assay Development, Requirements Analysis, Business Intelligence, Business Analysis
Education
University of Maryland University College 2007 — 2010
MS, IT
West Virginia University 1996 — 2001
BS, MA, Chemistry
Intrexon Corporation July 2015 - Present
Dovel Technologies September 2014 - July 2015
The Henry M. Jackson Foundation for the Advancement of Military Medicine December 2011 - September 2014
Clovis December 2012 - June 2014
Booz Allen Hamilton July 2011 - December 2011
Otsuka America Pharmaceutical, Inc. October 2005 - July 2011
SAIC May 2005 - October 2005
Shire Laboratories, Inc. February 2004 - April 2005
Mylan Pharmaceuticals June 2001 - May 2003
Skills
Crystal Reports, Visio, Lotus, Adobe Acrobat, Millennium, SQL Server, MS Project, Excel, 21 CFR Part 11, LIMS, Process Validation, Validation, GMP, Data Management, Computer System..., GAMP, GxP, cGMP, FDA, CAPA, Software Validation, GLP, SOP, QSR, Change Control, Chemstation, CDISC, Laboratory Automation, Technology Transfer, Quality Systems, Clinical Data Management, Oracle Clinical, Validations, Data Quality, Data Governance, Dissolution, Aseptic Processing, Data Analysis, Master Data Management, Software Documentation, Analytical Chemistry, HPLC, Databases, SharePoint, Technical Writing, Project Management, Assay Development, Requirements Analysis, Business Intelligence, Business Analysis
Education
University of Maryland University College 2007 — 2010
MS, IT
West Virginia University 1996 — 2001
BS, MA, Chemistry
Tracy Tucker Tracy Tucker's Shire Laboratories, Inc Experience June 2001 - May 2005
Job Project Manager at U.S. Food and Drug Adminstration
Industry Government Administration
Experience
CNI Technical Services, LLC June 2013 - Present
Hester Group, LLC/U.S. Food and Drug Administration July 2012 - June 2013
Prince George's County Public Schools November 2011 - June 2012
Delta Sigma Theta Sorority, Inc. Prince George's County Alumnae Chapter August 2008 - June 2012
BOWIE STATE UNIVERSITY PRE-COLLEGE SCIENCE SCHOLARS PROGRAM June 2011 - July 2011
HARRINGTON MORAN AND BARKSDALE, INC. July 2009 - December 2010
Prince George's County Public Schools January 2008 - June 2009
Long & Foster Real Estate, Inc. January 2006 - January 2008
Shire Laboratories, Inc. June 2001 - May 2005
Shire Laboratories, Inc. January 2001 - June 2001
Skills
GMP, FDA, SOP development, Quality Assurance, Sop, Validation, Analysis, Deviations, Microsoft Office, Quality Control, Pharmaceutical Industry
Education
University of Maryland University College 2011 — 2013
MS, Project Management
University of Maryland University College 2011 — 2012
Certification, Project Management
Lincoln University 1980 — 1984
BA, Biology
CNI Technical Services, LLC June 2013 - Present
Hester Group, LLC/U.S. Food and Drug Administration July 2012 - June 2013
Prince George's County Public Schools November 2011 - June 2012
Delta Sigma Theta Sorority, Inc. Prince George's County Alumnae Chapter August 2008 - June 2012
BOWIE STATE UNIVERSITY PRE-COLLEGE SCIENCE SCHOLARS PROGRAM June 2011 - July 2011
HARRINGTON MORAN AND BARKSDALE, INC. July 2009 - December 2010
Prince George's County Public Schools January 2008 - June 2009
Long & Foster Real Estate, Inc. January 2006 - January 2008
Shire Laboratories, Inc. June 2001 - May 2005
Shire Laboratories, Inc. January 2001 - June 2001
Skills
GMP, FDA, SOP development, Quality Assurance, Sop, Validation, Analysis, Deviations, Microsoft Office, Quality Control, Pharmaceutical Industry
Education
University of Maryland University College 2011 — 2013
MS, Project Management
University of Maryland University College 2011 — 2012
Certification, Project Management
Lincoln University 1980 — 1984
BA, Biology
Arkadi Doubintchik Arkadi Doubintchik's Shire Laboratories, Inc Experience December 1996 - February 1998
Job Technical Project Manager
Industry Information Technology and Services
Experience
National Center for Biotechnology Information (NCBI) August 2012 - Present
WIATECH September 2008 - April 2011
Lockheed Martin August 2000 - September 2008
Turner, Harper, and Associates December 1999 - August 2000
Kaiser Permanente February 1998 - December 1999
Shire Laboratories, Inc December 1996 - February 1998
Mars December 1993 - April 1996
Institute of Oxygen Industry September 1987 - May 1992
Skills
Federal Contracts, Financial management, Change management, Risk management: risk..., Team Management, Stakeholder management, Project planning and..., Customer relations, Development..., Business analysis, Technical Documentation, Requirements Management, Security, Quality assurance, Database analysis and..., Web system architecture..., MS Visual Studio, MS Visual Source Safe, MS SharePoint, MS SQL Server, Adobe Dreamweaver, Adobe Fireworks, Adobe Photoshop, IBM Rational Suite, MS .NET, MS ASP, JAVA, SAS, ORACLE, Erwin, TOAD, XML tools, JIRA, MS Project, MS Visio, MS Office, CMMI, SDLC, Waterfall, Agile, Scrum, PMI, WBS, XML Schema, Function Point Analysis, Requirements..., Use Cases, Test Cases, Russian, Audio Engineering
Education
Московский Государственный Университет Инженерной Экологии (МГУИЭ) 1982 — 1987
M.S., Management Science/Operations Research
Moscow Mathematical School #91 1979 — 1982
High School Diploma, Math and Science, Computer Programming
National Center for Biotechnology Information (NCBI) August 2012 - Present
WIATECH September 2008 - April 2011
Lockheed Martin August 2000 - September 2008
Turner, Harper, and Associates December 1999 - August 2000
Kaiser Permanente February 1998 - December 1999
Shire Laboratories, Inc December 1996 - February 1998
Mars December 1993 - April 1996
Institute of Oxygen Industry September 1987 - May 1992
Skills
Federal Contracts, Financial management, Change management, Risk management: risk..., Team Management, Stakeholder management, Project planning and..., Customer relations, Development..., Business analysis, Technical Documentation, Requirements Management, Security, Quality assurance, Database analysis and..., Web system architecture..., MS Visual Studio, MS Visual Source Safe, MS SharePoint, MS SQL Server, Adobe Dreamweaver, Adobe Fireworks, Adobe Photoshop, IBM Rational Suite, MS .NET, MS ASP, JAVA, SAS, ORACLE, Erwin, TOAD, XML tools, JIRA, MS Project, MS Visio, MS Office, CMMI, SDLC, Waterfall, Agile, Scrum, PMI, WBS, XML Schema, Function Point Analysis, Requirements..., Use Cases, Test Cases, Russian, Audio Engineering
Education
Московский Государственный Университет Инженерной Экологии (МГУИЭ) 1982 — 1987
M.S., Management Science/Operations Research
Moscow Mathematical School #91 1979 — 1982
High School Diploma, Math and Science, Computer Programming
Sharon M. de Guzman Sharon M. de Guzman's Shire Laboratories, Inc Experience 2000 - 2006
Job Clinical Trial Manager at Medpace
Industry Pharmaceuticals
Experience
Medpace August 2015 - Present
MedImmune November 2011 - January 2015
Supernus Pharmaceuticals, Inc. July 2007 - November 2011
Advancis Pharmaceutical Corporation 2006 - 2007
Shire Laboratories, Inc. 2000 - 2006
Georgetown University Medical Center 1998 - 2000
Skills
GMP, FDA, Cross-functional Team..., Project Management, Analysis, Pharmaceutical Industry, Bioanalysis, Biotechnology, Drug Development, GLP, Budgets, Oncology, Leadership, R&D, Analytical Chemistry, Management
Education
The Johns Hopkins University 2002 — 2005
M.S., Biotechnology
Virginia Commonwealth University 1993 — 1997
B.S., Chemistry
Medpace August 2015 - Present
MedImmune November 2011 - January 2015
Supernus Pharmaceuticals, Inc. July 2007 - November 2011
Advancis Pharmaceutical Corporation 2006 - 2007
Shire Laboratories, Inc. 2000 - 2006
Georgetown University Medical Center 1998 - 2000
Skills
GMP, FDA, Cross-functional Team..., Project Management, Analysis, Pharmaceutical Industry, Bioanalysis, Biotechnology, Drug Development, GLP, Budgets, Oncology, Leadership, R&D, Analytical Chemistry, Management
Education
The Johns Hopkins University 2002 — 2005
M.S., Biotechnology
Virginia Commonwealth University 1993 — 1997
B.S., Chemistry
David S. Schappelle, MS, PHR's Shire Laboratories, Inc Experience 2001 - 2005
Job Human Resources (generalist and recruiter) for DoD/IC, Aerospace, IT/Software/HighTech, Pharma/Biotech, and much more!!
Industry Human Resources
Experience
Cornell Technical Services October 2014 - Present
Emergent Space Technologies, Inc. June 2012 - October 2014
QSSI April 2010 - June 2012
Lockheed Martin IS&GS-Civil (NISC Team) 2009 - June 2010
Supernus Pharmaceuticals, Inc. December 2005 - February 2009
Shire Laboratories Inc. 2001 - 2005
Shire Labs Inc 2001 - 2005
US Office Products 2000 - 2001
Skills
HR management, HRIS, Benefits, Employee Relations, Compensation plan design, Labor Categories, Proposal Support, EEO compliance, Affirmative Action, Performance Management, Managing HR team, Strategic Planning, Strategic Partnerships, Corporate Communications, Internal Communications, Charity Events, Corporate Events, Human Resources, Personnel Management, Management, Employee Benefits, Organizational..., Training, Temporary Placement, Hiring, Compensation Structures, Recruiting, Talent Management, Leadership, HR Policies, Strategy
Education
University of Maryland University College 2004 — 2006
MS - Management, Human Resources
University of Maryland College Park 1995 — 2000
Bachelor of Arts (B.A.), History
Quince Orchard 1991 — 1995
High School Diploma, General Studies
Cornell Technical Services October 2014 - Present
Emergent Space Technologies, Inc. June 2012 - October 2014
QSSI April 2010 - June 2012
Lockheed Martin IS&GS-Civil (NISC Team) 2009 - June 2010
Supernus Pharmaceuticals, Inc. December 2005 - February 2009
Shire Laboratories Inc. 2001 - 2005
Shire Labs Inc 2001 - 2005
US Office Products 2000 - 2001
Skills
HR management, HRIS, Benefits, Employee Relations, Compensation plan design, Labor Categories, Proposal Support, EEO compliance, Affirmative Action, Performance Management, Managing HR team, Strategic Planning, Strategic Partnerships, Corporate Communications, Internal Communications, Charity Events, Corporate Events, Human Resources, Personnel Management, Management, Employee Benefits, Organizational..., Training, Temporary Placement, Hiring, Compensation Structures, Recruiting, Talent Management, Leadership, HR Policies, Strategy
Education
University of Maryland University College 2004 — 2006
MS - Management, Human Resources
University of Maryland College Park 1995 — 2000
Bachelor of Arts (B.A.), History
Quince Orchard 1991 — 1995
High School Diploma, General Studies
Krystyna Belendiuk, PhD, MBA's Shire Laboratories, Inc Experience 1997 - 2000
Job President at Potomac Consultants
Industry Biotechnology
Experience
Potomac Consultants July 2000 - Present
Aptus Pharmaceuticals 2001 - 2002
Shire Laboratories, Inc. 1997 - 2000
Shire Pharmaceuticals 1996 - 2000
Pharmavene, Inc. 1990 - 1996
University of Chicago (Psychiatry) 1976 - 1983
Skills
Licensing, Due Diligence, Strategy Development, Pharmaceuticals, Start-ups, Biotechnology, Business Strategy, Product Development, Financial Modeling, Strategic Planning, Competitive Analysis, Writing, Technology Evaluation, Pharmaceutical Industry, Strategy, Leadership, Program Management, Venture Capital, Clinical Trials, Commercialization, Clinical Research, Biopharmaceuticals
Education
University of Chicago 1973 — 1976
Ph.D./MBA, Biological Sciences/Marketing, Economics
McGill University 1969 — 1972
B.Sc., Biochemistry
Potomac Consultants July 2000 - Present
Aptus Pharmaceuticals 2001 - 2002
Shire Laboratories, Inc. 1997 - 2000
Shire Pharmaceuticals 1996 - 2000
Pharmavene, Inc. 1990 - 1996
University of Chicago (Psychiatry) 1976 - 1983
Skills
Licensing, Due Diligence, Strategy Development, Pharmaceuticals, Start-ups, Biotechnology, Business Strategy, Product Development, Financial Modeling, Strategic Planning, Competitive Analysis, Writing, Technology Evaluation, Pharmaceutical Industry, Strategy, Leadership, Program Management, Venture Capital, Clinical Trials, Commercialization, Clinical Research, Biopharmaceuticals
Education
University of Chicago 1973 — 1976
Ph.D./MBA, Biological Sciences/Marketing, Economics
McGill University 1969 — 1972
B.Sc., Biochemistry
Kathryn Mallari, PMP's Shire Laboratories, Inc Experience May 2001 - December 2005
Job
Industry Biotechnology
Experience
AstraZeneca August 2015 - Present
MedImmune February 2006 - August 2015
Supernus Pharmaceuticals, Inc. December 2005 - February 2006
Shire Laboratories Inc May 2001 - December 2005
PRTM March 2000 - May 2001
Alexion Pharmaceuticals January 1998 - February 2000
Interferon Sciences Inc August 1988 - January 1998
Skills
Technology Transfer, Biopharmaceuticals, FDA, Sop, Biotechnology, GMP, Change Control, Pharmaceutical Industry, Drug Development, 21 CFR Part 11, Quality Assurance, GxP, Cross-functional Team..., Regulatory Affairs, CAPA, Validation, GLP, Computer System..., LIMS, Vaccines
Education
GenEdge Alliance 2011 — 2011
Lean Six Sigma Black Belt trained
Rutgers, The State University of New Jersey-New Brunswick 1994 — 1998
MBA
Virginia Polytechnic Institute and State University 1984 — 1988
BS
AstraZeneca August 2015 - Present
MedImmune February 2006 - August 2015
Supernus Pharmaceuticals, Inc. December 2005 - February 2006
Shire Laboratories Inc May 2001 - December 2005
PRTM March 2000 - May 2001
Alexion Pharmaceuticals January 1998 - February 2000
Interferon Sciences Inc August 1988 - January 1998
Skills
Technology Transfer, Biopharmaceuticals, FDA, Sop, Biotechnology, GMP, Change Control, Pharmaceutical Industry, Drug Development, 21 CFR Part 11, Quality Assurance, GxP, Cross-functional Team..., Regulatory Affairs, CAPA, Validation, GLP, Computer System..., LIMS, Vaccines
Education
GenEdge Alliance 2011 — 2011
Lean Six Sigma Black Belt trained
Rutgers, The State University of New Jersey-New Brunswick 1994 — 1998
MBA
Virginia Polytechnic Institute and State University 1984 — 1988
BS
Erika (Van Loon) Panico's Shire Laboratories, Inc Experience August 2004 - August 2005
Job Regulatory Affairs Director at AstraZeneca
Industry Pharmaceuticals
Experience
AstraZeneca July 2015 - Present
Chiesi Pharmaceuticals Inc. April 2010 - June 2015
Chiesi Pharmaceuticals Inc. September 2005 - March 2010
Shire Laboratories Inc. August 2004 - August 2005
Shire Laboratories Inc. August 2002 - July 2004
Shire Laboratories Inc. March 1995 - July 2002
Zynaxis Inc. October 1993 - October 1994
Skills
FDA, IND, Regulatory Affairs, Regulatory Submissions, Pharmaceutical Industry, eCTD, Clinical Development, Drug Development, R&D, Regulatory Strategy..., Cross-functional Team..., Management, Innovation, Virtual Teams, Due Diligence, Clinical Research, Clinical Trials, Life Sciences
Education
Hood College 2004 — 2006
Certificate, Regulatory Affairs
Wittenberg University 1989 — 1993
Bachelor of Arts (B.A.), Chemistry
Webster High School 1986 — 1989
AstraZeneca July 2015 - Present
Chiesi Pharmaceuticals Inc. April 2010 - June 2015
Chiesi Pharmaceuticals Inc. September 2005 - March 2010
Shire Laboratories Inc. August 2004 - August 2005
Shire Laboratories Inc. August 2002 - July 2004
Shire Laboratories Inc. March 1995 - July 2002
Zynaxis Inc. October 1993 - October 1994
Skills
FDA, IND, Regulatory Affairs, Regulatory Submissions, Pharmaceutical Industry, eCTD, Clinical Development, Drug Development, R&D, Regulatory Strategy..., Cross-functional Team..., Management, Innovation, Virtual Teams, Due Diligence, Clinical Research, Clinical Trials, Life Sciences
Education
Hood College 2004 — 2006
Certificate, Regulatory Affairs
Wittenberg University 1989 — 1993
Bachelor of Arts (B.A.), Chemistry
Webster High School 1986 — 1989
Elaine Grief's Shire Laboratories, Inc Experience 1996 - 2004
Job Analytical, Stability and Regulatory CMC Support
Industry Pharmaceuticals
Experience
Shire Pharmaceuticals/ Kelly Services 2010 - Present
Shire Pharmaceuticals 2004 - 2010
Shire Laboratories Inc 1996 - 2004
Magellan Laboratories 1995 - 1996
Syntex/ Roche Laboratories 1994 - 1996
Skills
Pharmaceutical Industry, Drug Development, Sop, Clinical Development, GMP, Validation
Education
University of California, Berkeley
Bachelor's Degree, Nutritional Sciences and Food Chemistry
Shire Pharmaceuticals/ Kelly Services 2010 - Present
Shire Pharmaceuticals 2004 - 2010
Shire Laboratories Inc 1996 - 2004
Magellan Laboratories 1995 - 1996
Syntex/ Roche Laboratories 1994 - 1996
Skills
Pharmaceutical Industry, Drug Development, Sop, Clinical Development, GMP, Validation
Education
University of California, Berkeley
Bachelor's Degree, Nutritional Sciences and Food Chemistry
Frank Harper's Shire Laboratories, Inc Experience September 2001 - December 2005
Job Exchange/AD/Quest Migration Lead Engineer
Industry Computer Networking
Experience
Aerstone September 2012 - Present
Quest Consultants LLC February 2010 - September 2012
NASA / GSFC March 2006 - January 2010
Shire Laboratories, Inc. September 2001 - December 2005
Shire Pharmaceuticals 2001 - 2005
Orange Technical Institute January 1999 - August 2001
Skills
Quest Migration Manager, Microsoft Exchange, Virtualization, Active Directory, CCNA, VPN, Networking, Firewalls, Network Design, Routers, Cisco Technologies, XP, Cisco IOS, CCNP, Windows XP, A+, Network+, Certified Novell..., Disaster Recovery, Network Security, Systems Engineering
Education
Prince Georges Community College 1983 — 1985
Aerstone September 2012 - Present
Quest Consultants LLC February 2010 - September 2012
NASA / GSFC March 2006 - January 2010
Shire Laboratories, Inc. September 2001 - December 2005
Shire Pharmaceuticals 2001 - 2005
Orange Technical Institute January 1999 - August 2001
Skills
Quest Migration Manager, Microsoft Exchange, Virtualization, Active Directory, CCNA, VPN, Networking, Firewalls, Network Design, Routers, Cisco Technologies, XP, Cisco IOS, CCNP, Windows XP, A+, Network+, Certified Novell..., Disaster Recovery, Network Security, Systems Engineering
Education
Prince Georges Community College 1983 — 1985
Justin Meadows's Shire Laboratories, Inc Experience November 2001 - September 2004
Job Manufacturing Process Engineer at Sandoz
Industry Pharmaceuticals
Experience
Sandoz 2012 - Present
Purdue Pharma September 2009 - July 2012
Covidien October 2004 - August 2009
Shire Laboratories Inc November 2001 - September 2004
Wyeth Consumer Healthcare May 2000 - April 2001
Skills
Clinical Trials, Formulation, Clinical Research, GLP, GMP, Validation, Sop, Analytical Chemistry, HPLC, Chromatography, Pharmaceutical Industry, Chemistry, UV
Education
James Madison University 1996 — 2000
Bachelor's degree, Chemistry
Sandoz 2012 - Present
Purdue Pharma September 2009 - July 2012
Covidien October 2004 - August 2009
Shire Laboratories Inc November 2001 - September 2004
Wyeth Consumer Healthcare May 2000 - April 2001
Skills
Clinical Trials, Formulation, Clinical Research, GLP, GMP, Validation, Sop, Analytical Chemistry, HPLC, Chromatography, Pharmaceutical Industry, Chemistry, UV
Education
James Madison University 1996 — 2000
Bachelor's degree, Chemistry
Erika Wambolt's Shire Laboratories, Inc Experience 2003 - 2005
Job Director Technical Operations External Manufacturing at McNeil Consumer Healthcare
Industry Pharmaceuticals
Experience
McNeil Consumer Healthcare February 2015 - Present
Actavis plc September 2013 - January 2015
Shire Pharmaceuticals December 2008 - September 2013
Shire Pharmaceuticals February 2005 - November 2008
Shire Laboratories, Inc. 2003 - 2005
Schering-Plough 1996 - 2003
Procter & Gamble Pharmaceuticals 1994 - 1996
Richardson-Vicks Research Center 1985 - 1989
Skills
Technology Transfer, Validation, Manufacturing, Process Improvement, Topical Medication, Tablets, Pharmaceutics, Formulation, Quality Assurance, Pharmaceutical Industry, Quality by Design, GMP, DEA, GxP, CMC, Dissolution, Sop, CAPA, FDA, Regulatory Affairs, Regulatory Submissions, Drug Development, Cleaning Validation, Clinical Development, SOP, Biopharmaceuticals, GLP
Education
University of Cincinnati 1989 — 1994
Ph.D., Pharmaceutics
University of Connecticut 1982 — 1987
B.S., Pharmacy
McNeil Consumer Healthcare February 2015 - Present
Actavis plc September 2013 - January 2015
Shire Pharmaceuticals December 2008 - September 2013
Shire Pharmaceuticals February 2005 - November 2008
Shire Laboratories, Inc. 2003 - 2005
Schering-Plough 1996 - 2003
Procter & Gamble Pharmaceuticals 1994 - 1996
Richardson-Vicks Research Center 1985 - 1989
Skills
Technology Transfer, Validation, Manufacturing, Process Improvement, Topical Medication, Tablets, Pharmaceutics, Formulation, Quality Assurance, Pharmaceutical Industry, Quality by Design, GMP, DEA, GxP, CMC, Dissolution, Sop, CAPA, FDA, Regulatory Affairs, Regulatory Submissions, Drug Development, Cleaning Validation, Clinical Development, SOP, Biopharmaceuticals, GLP
Education
University of Cincinnati 1989 — 1994
Ph.D., Pharmaceutics
University of Connecticut 1982 — 1987
B.S., Pharmacy
Jeff Uhal's Shire Laboratories, Inc Experience May 2000 - February 2006
Job Associate Research Scientist III at Actavis
Industry Pharmaceuticals
Rebecca Gilpin's Shire Laboratories, Inc Experience 2000 - 2001
Job QA Lead (Associate Director) at Shire Pharmaceuticals
Industry Pharmaceuticals
Experience
Shire Pharmaceuticals 2009 - Present
Shire 2006 - 2009
Shire September 2004 - April 2006
Shire 2003 - 2004
Shire 2002 - 2003
Shire 2001 - 2002
Shire Laboratories Inc. 2000 - 2001
Shire Laboratories Inc. 1998 - 2000
Skills
Auditor (internal and..., Quality Assurance, Supplier Management for...
Education
St. Mary's College of Maryland 1996 — 2000
Bachelor of Arts, Biology and Chemistry
Shire Pharmaceuticals 2009 - Present
Shire 2006 - 2009
Shire September 2004 - April 2006
Shire 2003 - 2004
Shire 2002 - 2003
Shire 2001 - 2002
Shire Laboratories Inc. 2000 - 2001
Shire Laboratories Inc. 1998 - 2000
Skills
Auditor (internal and..., Quality Assurance, Supplier Management for...
Education
St. Mary's College of Maryland 1996 — 2000
Bachelor of Arts, Biology and Chemistry
Todd Lipman's Shire Laboratories, Inc Experience 2002 - 2004
Job Sr. Applications Administrator at Biogen
Industry Pharmaceuticals
Experience
Biogen July 2015 - Present
CSols Inc September 2009 - July 2015
Patni Life Sciences January 2008 - September 2009
Sapphire Technologies October 2006 - January 2008
Biogen Idec October 2006 - January 2008
Boston Scientific 2004 - 2006
Shire Laboratories, Inc 2002 - 2004
Shire Laboratories November 1999 - December 2002
Magellan Labs 1997 - 1998
United States Marine Corps 1990 - 1994
Education
North Carolina State University 1996 — 1997
Inorganic Chemistry
Campbell University 1993 — 1996
BS, Chemistry
Wakefield High School 1986 — 1990
Biogen July 2015 - Present
CSols Inc September 2009 - July 2015
Patni Life Sciences January 2008 - September 2009
Sapphire Technologies October 2006 - January 2008
Biogen Idec October 2006 - January 2008
Boston Scientific 2004 - 2006
Shire Laboratories, Inc 2002 - 2004
Shire Laboratories November 1999 - December 2002
Magellan Labs 1997 - 1998
United States Marine Corps 1990 - 1994
Education
North Carolina State University 1996 — 1997
Inorganic Chemistry
Campbell University 1993 — 1996
BS, Chemistry
Wakefield High School 1986 — 1990
Padmanabh P. Bhatt's Shire Laboratories, Inc Experience January 2003 - December 2005
Job Chief Scientific Officer & Senior VP, Intellectual Property
Industry Pharmaceuticals
Experience
Supernus Pharmaceuticals, Inc. December 2005 - Present
Shire Laboratories, Inc. January 2003 - December 2005
POINT Biomedical Corporation 2001 - 2003
ALZA Corporation 1996 - 2001
Skills
Executive Management, Drug Delivery, Product Development, Intellectual Property, Pipeline Development, R&D, Pharmaceutical Industry, Drug Development, Biotechnology, Regulatory Affairs, SOP, Validation, Biopharmaceuticals, FDA
Education
The University of Kansas
Ph.D., Pharmaceutical Chemistry
The University of Kansas
M.S., Pharmaceutical Chemistry
University of Mumbai
M.Pharm., Bombay College of Pharmacy
University of Mumbai
B.Pharm., Bombay College of Pharmacy
Supernus Pharmaceuticals, Inc. December 2005 - Present
Shire Laboratories, Inc. January 2003 - December 2005
POINT Biomedical Corporation 2001 - 2003
ALZA Corporation 1996 - 2001
Skills
Executive Management, Drug Delivery, Product Development, Intellectual Property, Pipeline Development, R&D, Pharmaceutical Industry, Drug Development, Biotechnology, Regulatory Affairs, SOP, Validation, Biopharmaceuticals, FDA
Education
The University of Kansas
Ph.D., Pharmaceutical Chemistry
The University of Kansas
M.S., Pharmaceutical Chemistry
University of Mumbai
M.Pharm., Bombay College of Pharmacy
University of Mumbai
B.Pharm., Bombay College of Pharmacy
Erika Roers's Shire Laboratories, Inc Experience February 2003 - March 2005
Job Senior Manager at Supernus Pharmaceuticals, Inc.
Industry Pharmaceuticals
Experience
Supernus Pharmaceuticals, Inc. November 2014 - Present
Supernus Pharmaceuticals, Inc. August 2014 - October 2014
Supernus Pharmaceuticals, Inc. January 2012 - July 2014
Supernus Pharmaceuticals, Inc. June 2008 - December 2011
Supernus Pharmaceuticals, Inc. March 2005 - May 2008
Shire Laboratories Inc. February 2003 - March 2005
Shire Laboratories, Inc. February 2001 - January 2003
Skills
HPLC, Analytical Chemistry, Leadership, Chromatography, Bioanalysis, GLP, Drug Development
Education
University of Maryland College Park 1997 — 2000
B.S., Chemistry
Supernus Pharmaceuticals, Inc. November 2014 - Present
Supernus Pharmaceuticals, Inc. August 2014 - October 2014
Supernus Pharmaceuticals, Inc. January 2012 - July 2014
Supernus Pharmaceuticals, Inc. June 2008 - December 2011
Supernus Pharmaceuticals, Inc. March 2005 - May 2008
Shire Laboratories Inc. February 2003 - March 2005
Shire Laboratories, Inc. February 2001 - January 2003
Skills
HPLC, Analytical Chemistry, Leadership, Chromatography, Bioanalysis, GLP, Drug Development
Education
University of Maryland College Park 1997 — 2000
B.S., Chemistry
Robert Pete Pullen, Ph.D.'s Shire Laboratories, Inc Experience 1997 - 2004
Job Owner at Robert "Pete" Pullen, Ph.D., Analytical Consulting
Industry Pharmaceuticals
Experience
Robert "Pete" Pullen, Ph.D., ANALYTICAL CONSULTING Analytical DevelopmentTech TransferStability January 2012 - Present
Shire Pharmaceuticals January 2011 - January 2012
Shire Pharmaceuticals January 2007 - December 2010
Shire Pharmaceuticals November 2004 - December 2006
Shire Laboratories Inc 1997 - 2004
Solvay Pharmaceuticals 1990 - 1997
Skills
Analytical Development, CMC Submissions, Stability, Technology Transfer, Laboratory Operations, Program Management, Validation, Analytical Chemistry, Laboratory, CMC, GMP, FDA, Regulatory Affairs, LIMS, Pharmaceutical Industry, 21 CFR Part 11, Chemistry, Quality Control, IND, CRO, Sop, Regulatory Submissions, Contract Manufacturing, Quality System, Drug Development
Education
Georgia State University
Ph.D., Analytical Chemistry
Oglethorpe University
BS, Biology, Chemistry
Western Michigan University
Master of Arts (M.A.), Chemistry
Robert "Pete" Pullen, Ph.D., ANALYTICAL CONSULTING Analytical DevelopmentTech TransferStability January 2012 - Present
Shire Pharmaceuticals January 2011 - January 2012
Shire Pharmaceuticals January 2007 - December 2010
Shire Pharmaceuticals November 2004 - December 2006
Shire Laboratories Inc 1997 - 2004
Solvay Pharmaceuticals 1990 - 1997
Skills
Analytical Development, CMC Submissions, Stability, Technology Transfer, Laboratory Operations, Program Management, Validation, Analytical Chemistry, Laboratory, CMC, GMP, FDA, Regulatory Affairs, LIMS, Pharmaceutical Industry, 21 CFR Part 11, Chemistry, Quality Control, IND, CRO, Sop, Regulatory Submissions, Contract Manufacturing, Quality System, Drug Development
Education
Georgia State University
Ph.D., Analytical Chemistry
Oglethorpe University
BS, Biology, Chemistry
Western Michigan University
Master of Arts (M.A.), Chemistry
Luke Shannon's Shire Laboratories, Inc Experience 2002 - 2003
Job Associate at Rakoczy Molino Mazzochi Siwik LLP
Industry Law Practice
Experience
Rakoczy Molino Mazzochi Siwik LLP November 2010 - Present
Schiff Hardin September 2007 - November 2010
United States District Court for the Northern District of Illinois August 2006 - September 2007
Shire Laboratories Inc. 2002 - 2003
Brookhaven National Laboratory June 2001 - August 2001
University of Nevada Reno June 2000 - August 2000
Skills
Registered Patent..., Patent Litigation, Intellectual Property, Litigation, Patents, Commercial Litigation, Client Counseling, Hatch-Waxman litigation
Education
Chicago-Kent College of Law, Illinois Institute of Technology 2003 — 2006
J.D.
Dordt College 1998 — 2002
B.A., Chemistry
Rakoczy Molino Mazzochi Siwik LLP November 2010 - Present
Schiff Hardin September 2007 - November 2010
United States District Court for the Northern District of Illinois August 2006 - September 2007
Shire Laboratories Inc. 2002 - 2003
Brookhaven National Laboratory June 2001 - August 2001
University of Nevada Reno June 2000 - August 2000
Skills
Registered Patent..., Patent Litigation, Intellectual Property, Litigation, Patents, Commercial Litigation, Client Counseling, Hatch-Waxman litigation
Education
Chicago-Kent College of Law, Illinois Institute of Technology 2003 — 2006
J.D.
Dordt College 1998 — 2002
B.A., Chemistry
Angela Wehr's Shire Laboratories, Inc Experience March 2001 - September 2005
Job Scientist at Biogen Idec
Industry Pharmaceuticals
Experience
Biogen Idec July 2011 - Present
University of Pennsylvania June 2006 - July 2011
Biogen Idec June 2010 - August 2010
SHIRE LABORATORIES, INC March 2001 - September 2005
Shire Laboratories, Inc May 1998 - March 2001
Virginia Tech August 1997 - May 1998
Skills
Mass Spectrometry, HPLC, Biotransformation, Proteomics, Drug Metabolism, Bioanalysis, LC-MS, In Vitro, Chromatography, Assay Development, Analytical Chemistry
Education
University of Pennsylvania School of Medicine 2005 — 2011
PhD, Pharmacology
VIRGINIA TECH 1995 — 1998
BS, Biochemistry
Biogen Idec July 2011 - Present
University of Pennsylvania June 2006 - July 2011
Biogen Idec June 2010 - August 2010
SHIRE LABORATORIES, INC March 2001 - September 2005
Shire Laboratories, Inc May 1998 - March 2001
Virginia Tech August 1997 - May 1998
Skills
Mass Spectrometry, HPLC, Biotransformation, Proteomics, Drug Metabolism, Bioanalysis, LC-MS, In Vitro, Chromatography, Assay Development, Analytical Chemistry
Education
University of Pennsylvania School of Medicine 2005 — 2011
PhD, Pharmacology
VIRGINIA TECH 1995 — 1998
BS, Biochemistry