Magellan Laboratories
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Magellan Laboratories Employees
PAREXEL June 2015 - Present
Market Sense, Inc. January 2015 - April 2015
INC Research July 2013 - January 2015
PharmaNet Development Group, Inc. October 2010 - November 2012
Covance Clinical Pharmacology August 2009 - September 2010
MDS Pharma Services, Inc. July 2001 - August 2009
Huntingdon Life Sciences 1999 - 2001
Magellan Laboratories 1995 - 2000
DPT Laboratories 1993 - 1994
Skills
Biotechnology, Clinical Trials, Clinical Research, Bioanalysis, CRO, Life Sciences, Clinical Development, Strategic Partnerships, Lifesciences, Oncology, Drug Development, GLP, Pharmaceutical Industry, Sop, Drug Discovery, GCP, Regulatory Submissions, Regulatory Affairs, Medical Devices, CTMS, Business Development, Pharmaceutics, FDA, IND, Biopharmaceuticals, 21 CFR Part 11, Infectious Diseases, EDC, Therapeutic Areas, Technology Transfer, Pharmacology, Clinical Pharmacology, Immunology, Clinical Data Management, Pharmacovigilance, Validation, Protocol, Toxicology, Medical Writing, GMP, Commercialization, SOP
Education
Texas A&M University 1984 — 1987
MS, Chemistry
Texas A&M University 1984 — 1987
MS, Chemistry
University of the Incarnate Word 1980 — 1984
Bachelor of Science (BS), Biochemistry
Seattle Genetics March 2015 - Present
Seattle Genetics, Inc. June 2010 - Present
Dendreon April 2005 - May 2010
AllStar Fitness November 2007 - March 2009
Amgen September 1996 - December 2004
Magellan Laboratories September 1994 - September 1996
Skills
Biotechnology, QC, GMP, Quality Systems, Compliance, FDA, LIMS, Quality Control, 21 CFR Part 11, Quality System, Validation, Sop, Protein Chemistry, Change Control, CAPA, Biopharmaceuticals, GLP
Education
University of North Carolina at Wilmington 1990 — 1994
BA, Biology/ Chemistry
Agilent Technologies June 2006 - October 2013
Synthon Pharmaceuticals February 2005 - June 2006
Wyeth Vaccines September 1999 - November 2004
Closure Medical Corporation April 1998 - July 1999
Magellan Laboratories May 1996 - April 1998
Skills
Validation, GMP, GLP, Quality Control, HPLC, UV, Analytical Chemistry, 21 CFR Part 11, Laboratory, R&D, CAPA, Protein Chemistry, Instrumentation, Pharmaceutical Industry, Chemistry, Chromatography, Change Control, LIMS, Technology Transfer, Western Blotting, SDS-PAGE, GC-FID, 1H NMR
Education
North Carolina State University
Bachelor of Science (B.S.), Chemistry
Military
US Navy, Honorable Discharge
Red Hat January 2012 - Present
MedThink Communications November 2005 - December 2011
Cardinal Health 2002 - 2005
Magellan Laboratories 1997 - 2002
Skills
Email Marketing, Marketing Communications, Marketing, Advertising, Strategic Communications, Integrated Marketing, Digital Strategy, Social Media Marketing, SEM, Media Planning, Direct Mail, Leadership, Direct Marketing, Interactive Marketing, Online Marketing, Online Advertising, Lead Generation
Education
North Carolina State University 1993 — 1997
Bachelor's degree, English
College of Wooster 1992 — 1993
GSK September 2001 - Present
Glaxo Wellcome Inc September 1999 - September 2001
Magellan Laboratories December 1995 - September 1999
Fisons Instruments (VG Masslab) October 1993 - December 1995
Roche Biomedical Laboratories June 1988 - October 1993
Research and Analytical Laboratories April 1988 - June 1988
Industrial and Environmental Analysts August 1986 - April 1988
Skills
Chromatography, Analytical Chemistry, Spectroscopy, Gas Chromatography, Chemistry, Pharmaceutical Industry, Six Sigma, LC-MS, Dissolution, Mass Spectrometry, HPLC, GLP, GMP, Drug Discovery, UV/Vis, Technology Transfer, Validation, Biotechnology, Lifesciences, CRO, LIMS, Drug Development, FDA, Laboratory, 21 CFR Part 11, Sop, Formulation, Cleaning Validation, GxP, Life Sciences, SOP, CAPA, GC-MS
Education
Purdue University 1982 — 1986
BS, Chemistry
Covance August 2015 - Present
GSK January 2013 - August 2015
GSK September 2010 - December 2012
Gilead Sciences April 2006 - August 2010
Metabolon July 2003 - February 2006
Paradigm Genetics February 2002 - July 2003
Magellan Laboratories November 1998 - February 2002
Skills
BioSciences Management, Pharmacology, Data Analysis, Pharmacokinetic Analysis, ADME, Metabolomics, Assay Development and..., Mass Spectrometry, Automation, Robotics, Bioanalysis, Instrument Repair, Validation, Regulatory Requirements, Laboratory Construction, Biotechnology, Drug Metabolism, Structural Chemistry, Project Management, Process Optimization, Data Visualization, Drug Discovery, Laboratory, HPLC, Assay Development, GLP, Chemistry, Chromatography, Life Sciences, LC-MS, Analytical Chemistry, Biology, Pharmacokinetics, CRO, Pharmaceutical Industry
Education
North Carolina State University - College of Management 2009 — 2012
MBA, Biosciences Management
University of Maryland College Park 1995 — 1998
Master of Science (MS), Analytical & Environmental Chemistry
North Carolina State University 1990 — 1995
BS Chemistry, Chemistry
Pharmatek Laboratories, Inc. March 2009 - Present
Banner Pharmacaps March 2008 - March 2009
Pharmatek 2003 - 2008
Cardinal Health 1996 - 2003
Magellan Laboratories 1996 - 2002
Skills
Analytical Chemistry, GMP, HPLC, Drug Development, Formulation, Contract Manufacturing, CMC, Clinical Trials, Technology Transfer, GLP, Clinical Development, Validation, Chemistry, Biotechnology, FDA, Chromatography, Pharmaceutics, Laboratory, Pharmaceutical Industry, Drug Discovery, CRO, Lifesciences, Regulatory Affairs, Sop, Biopharmaceuticals, LIMS, V&V, UV/Vis, SOP
Education
East Carolina University
Bachelor of Arts (B.A.), Chemistry
Becton Dickinson January 2014 - Present
Catalent Pharma Solutions March 2009 - December 2013
OpAns November 2007 - February 2009
Cardinal Health 1999 - 2007
Magellan Laboratories 1999 - 2002
Ohio University 1988 - 1992
Skills
HPLC, Analytical Chemistry, Validation, Chemistry, Mass Spectrometry, Gas Chromatography, Pharmaceutical Industry, Drug Delivery, GC-MS, Laboratory, Characterization, Method Development, Pharmaceutics, Science, CMC, Organic Chemistry, GMP, Pharmaceutical Packaging, LC-MS
Education
Colorado School of Mines 1992 — 1998
Ph.D., Chemistry
Ohio University 1988 — 1992
B.S., Chemistry
Novartis Vaccines February 2012 - March 2015
Catalent Pharma Solutions June 2010 - February 2012
Novo Nordisk March 2010 - July 2010
AlphaVax October 2008 - February 2010
PharmaDirections August 2006 - October 2008
PharmaDirections 2005 - 2006
Magellan Laboratories 1999 - 2005
Cardinal Health 1997 - 2005
Magellan Laboratories 1997 - 1999
Entropy, Inc. April 1994 - 1997
Skills
GMP, Pharmaceutical Industry, Validation, Six Sigma, Sop, Drug Development, Strategy, Training, CAPA, FDA, Process Improvement, Biotechnology, Leadership, Change Control, Technology Transfer, 21 CFR Part 11, Program Management, Cross-functional Team..., Analytical Chemistry, Management, PMP, CRO, Project Management, Pharmaceutics, Product Development, Manufacturing
Education
North Carolina State University - College of Management 1999 — 2002
MBA, New Product Development
University of North Carolina at Chapel Hill 1990 — 1994
BS, Biology
Fujifilm Diosynth Biotechnologies May 2013 - Present
Fujifilm Diosynth Biotechnologies October 2009 - May 2013
Diosynth October 2007 - October 2009
Catalent April 2007 - October 2007
Cardinal Health 2004 - 2007
Magellan Laboratories 1998 - 2004
O'Brien & Gere April 1989 - July 1998
Nanco Laboratories 1987 - 1989
Skills
FDA, Biotechnology, Software Documentation, Cleaning Validation, GMP, Validation, Medical Devices, Quality System, Quality Assurance, 21 CFR Part 11, Pharmaceutical Industry, Sop, HPLC, CAPA, GLP, V&V, Change Control, Biopharmaceuticals, Technology Transfer, Analytical Chemistry, Quality Auditing, Chemistry, Process Improvement, LIMS
Education
State University of New York College at Geneseo 1983 — 1987
BA, Mathematics
InstantGMP, Inc. January 2004 - Present
PharmaDirections, Inc. May 2003 - Present
Nobex Corporation August 2000 - March 2003
Magellan Laboratories 1997 - 2000
AAI 1995 - 1997
SmithKline Beecham 1993 - 1995
Johnson & Johnson 1991 - 1993
Berlax Laboratories 1983 - 1990
Ciba-Geigy (now Novartis) 1967 - 1983
Skills
Drug Development, PK, Pharmaceutical Industry, Biotechnology, Clinical Development, Lifesciences, Technology Transfer, GMP, FDA, Regulatory Affairs, Biopharmaceuticals, Analytical Chemistry, Formulation, Pharmaceutics, Validation, GLP, Commercialization, Strategy, 21 CFR Part 11, Drug Delivery, R&D, Drug Discovery, CRO, Toxicology, Manufacturing, Sop, Protein Chemistry, Regulatory Submissions, IND, Clinical Trials, SOP, Life Sciences, HPLC
Education
Rutgers, The State University of New Jersey-Newark 1979 — 1982
Ph.D., Physical Chemistry
Rutgers, The State University of New Jersey-Newark 1977 — 1979
M.S., Chemistry
Ramapo College of New Jersey 1973 — 1976
B.S., Chemistry
Mylan January 2014 - Present
Putney, Inc. June 2008 - January 2014
Catalent Pharma Solutions March 2001 - June 2008
Cardinal Health February 2001 - April 2007
Magellan Laboratories March 2001 - February 2002
West Pharmaceutical Services March 1995 - March 2001
Sartomer August 1994 - March 1995
Harwick Chemical Corporation July 1992 - August 1994
Skills
Negotiation, Pharmaceutical Industry, Strategy, Product Development, Organizational..., Positioning, Business Development, Technology Transfer, Drug Delivery, Forecasting, Supply Chain, Manufacturing, Cross-functional Team..., Management, Entrepreneurship, Sales Operations, Leadership, Contract Manufacturing, Strategic Planning, GMP, Biopharmaceuticals, Formulation, Business Planning, Medical Devices, FDA, Regulatory Affairs, Biotechnology, Validation, Drug Development, Sop, IND, Pharmaceutics, 21 CFR Part 11, Generic Programming, Change Control, CAPA, Aseptic Processing, Clinical Development, GLP, Regulatory Submissions, V&V, Analytical Chemistry, GxP, Lifesciences, HPLC, CRO, Life Sciences, SOP
Education
Hiram College 1988 — 1992
BA, Chemistry, Communications
ESK Consulting, Inc. January 2006 - Present
PharmaDirections 2005 - 2012
Cardinal Health Pharmaceutical Development January 2002 - January 2005
Magellan Laboratories April 1998 - January 2002
Hospira 1997 - 2000
Skills
Vendor Management, Pharmaceutical Industry, GMP, FDA, Validation, Technology Transfer, Sop, Biotechnology, CAPA, CRO, Change Control, 21 CFR Part 11, Clinical Development, Lifesciences, Clinical Trials
Education
North Carolina State University 1992 — 1996
BS, Biology, Nutrition
AstraZeneca September 2015 - Present
Watts Water Technologies February 2015 - September 2015
Pure Encapsulations 2013 - 2015
Diebold, Inc. 2009 - 2013
Wilmington University and Northeastern University 2002 - 2008
Magellan Laboratories 1998 - 2001
Omni-Circuits, Inc. 1995 - 1998
Skills
Employee Relations, Performance Management, Human Resources, Succession Planning, Recruiting, Organizational..., Management, Personnel Management, Employee Benefits, Deferred Compensation, Leadership, Talent Management, Onboarding, Strategic Planning, Change Management, HRIS, Training, Sourcing, Occupational Health, Human Resource..., HR Policies, Interviews, Talent Acquisition, Coaching, Process Improvement, Employee Training, Taleo, New Hire Orientations, Workforce Planning, Employee Engagement, HR Consulting, Strategic HR, HR Transformation, Oracle HR, HR Management, HR Strategy, HR Project Management, SPHR, SHRM, Strategic Human..., Engaged Cultures, Mergers & Acquisitions, Legal Compliance, Project Management, Lean Six Sigma, Organizational Design, Strategy, Hiring
Education
University of Wisconsin-Madison
Bachelor of Arts (BA)
Cardinal Stritch University
Master of Science (MS)
Purdue University
Lean Six Sigma Certification
INC Research October 2013 - Present
Community Service January 2012 - September 2013
GlaxoSmithKline October 2010 - December 2011
Synthon January 2010 - September 2010
GlaxoSmithKline 2002 - 2010
Magellan Laboratories January 2002 - July 2002
Bausch + Lomb 2000 - 2002
Bausch + Lomb 2000 - 2000
Bausch + Lomb 1997 - 1999
Skills
Project Management, Team Building, Collaborative Problem..., Cross-functional Team..., CMC Regulatory Affairs, Regulatory Strategy..., FDA, EMEA, Quality by Design, DMF
Education
University of Rochester - William E. Simon Graduate School of Business Administration
MBA, Marketing, Strategy
University of Rochester
Ph.D., Physical Organic Chemistry
Rutgers, The State University of New Jersey-New Brunswick
B.S., Chemistry
Catalent Pharma Solutions January 2015 - Present
Catalent Pharma Solutions September 2011 - January 2015
Catalent Pharma Solutions February 2011 - September 2011
Catalent Pharma Solutions July 2010 - September 2011
Catalent Pharma Solutions 2006 - 2011
Catalent Pharma Solutions August 1998 - 2011
Catalent Pharma Solutions August 1998 - July 2010
Magellan Laboratories 1998 - 2010
Cardinal Health 2002 - 2006
Magellan Laboratories (acquired in 2002 by Cardinal Health) 1998 - April 2002
Skills
Budgets, GMP, Sop, Validation, Technology Transfer, FDA, Pharmaceutical Industry, GLP, 21 CFR Part 11, V&V, Analytical Chemistry, CAPA, GxP, CRM Integration, Change Control, Drug Development, Data Integration, HPLC, CRO, Biopharmaceuticals, Biotechnology, Chromatography, Formulation
Education
University of Tennessee-Knoxville 1986 — 1990
Chemistry
Pfeiffer University 1982 — 1986
BS, 1986
Pfizer March 2010 - September 2011
Pfizer BioTherapeutics R&D December 2009 - March 2010
Pfizer BioTherapeutics R&D October 2009 - December 2009
Wyeth Research October 2006 - October 2009
Catalent 2001 - 2006
Cardinal Health 2001 - 2006
Cardinal Health, PTS (formerly Magellan Laboratories) 2001 - 2006
Magellan Laboratories 2000 - 2001
Skills
CA Claris PM Software, SAP, Ariba, MS Project, Vendor Management, Contract Negotiations, Manufacturing, Vaccines, cGMP, Budgeting, Validation, Pharmaceuticals, Analytical Chemistry, 21 CFR Part 11, Cross-functional Team..., Documentation, Change Management, Project Planning, Visio, HP Quality Center V10, Software Documentation
Education
Southern Illinois University, Carbondale 1991 — 1996
PhD, Chemistry
Truman State University 1986 — 1991
BS, Chemistry
BD June 2000 - Present
GlaxoWellcome 1999 - 2000
Magellan Laboratories 1998 - 1999
National Specialty Gases 1996 - 1998
Skills
Analytical Chemistry, HPLC, GLP, Drug Delivery, GMP, R&D, Biotechnology, Chemistry, FDA, Biomaterials, Protein Chemistry, Formulation, ELISA, Pharmaceutical Industry, Validation, Chromatography, UV/Vis, Assay Development
Education
Radford University 1991 — 1996
BS, Chemistry
LCMS Services, LLC September 2012 - Present
EAG Life Sciences February 2012 - September 2012
LCMS Services, LLC October 2007 - February 2012
Atlantic Analytical Laboratory April 2004 - September 2007
UPM Pharmaceuticals October 2002 - August 2003
Damocles10 December 1996 - September 2002
Magellan Laboratories February 1998 - August 1999
Roche Biomedical Labs June 1990 - August 1996
LDC/Milton Roy 1983 - 1990
Skills
Chromatography, New Business Development, LC-MS, CRO, Clinical Trials, Biotechnology, Analytical Chemistry, HPLC, Life Sciences, GLP, Technology Transfer, Product Development, cGMP, Drug Discovery, Bioanalysis, GMP, Lifesciences, Pharmaceutics, Pharmaceutical Industry, Sop, Chemistry, Drug Development, FDA, Validation, Mass Spectrometry, Clinical Development, Polymers, Computer System..., GxP, Clinical Research, Regulatory Submissions, LIMS, Oncology, Biopharmaceuticals, Organic Chemistry, 21 CFR Part 11, Commercialization, Regulatory Affairs, Formulation, R&D, Laboratory, Marketing Strategy, Protein Chemistry, V&V, Purification
Education
Northeastern University
PhD
University of Massachusetts, Amherst
MS
Syracuse University
BS
Avomeen Analytical Services January 2015 - Present
Avomeen Analytical Services April 2012 - December 2014
Intertek August 2010 - February 2012
Ciba Expert Services November 2009 - August 2010
Velcera, Inc. August 2007 - January 2009
Cardinal Health August 2001 - July 2007
Magellan Laboratories 2001 - 2002
Honeywell August 1998 - December 2000
DSM Copolymer September 1995 - August 1997
Skills
Analytical Chemistry, GMP, Chemistry, Product Development, R&D, Six Sigma, LC-MS, IR, Spectroscopy, Drug Development, Pharmaceutical Industry, Validation, Program Management, NMR, FTIR, FDA, Pharmaceutical..., SOP, GLP, HPLC
Education
University of California, Berkeley
Postdoc, Chemistry
Massachusetts Institute of Technology 1984 — 1990
PhD, Physical Chemistry
Stevens Institute of Technology 1999 — 2001
M.T.M., Technology Management
The University of Chicago 1980 — 1984
B.Sc., Chemistry
Allergan 2015 - Present
Haemonetics 2000 - 2014
Haemonetics 1999 - 2000
Magellan Laboratories 1997 - 1999
Bausch + Lomb 1984 - 1997
Skills
Quality Management, Quality Assurance, Pharmaceutical Industry, Analytical Chemistry, FDA GMP, Sterility Assurance, Validation, Calibration, CAPA, Pharmaceutical..., Sterilization, Documentation, ISO 13485, ISO 14971, SOP, Medical Devices, GMP, Laboratory, FDA
Education
Furman University
Bachelor of Science (BS), Chemistry
Rho January 2014 - Present
Rho September 2010 - December 2013
Rho, Inc. September 2007 - August 2010
Rho, Inc. September 2007 - April 2009
Catalent Pharma Solutions February 2007 - September 2007
Cardinal Health 2003 - February 2007
Magellan Laboratories 2001 - 2002
Medical University of South Carolina July 2000 - August 2001
Skills
Software Documentation, Clinical Trials, Cross-functional Team..., Validation, Analysis, Sop, Clinical Research, Budgets, Pharmaceutical Industry, Vendor Management, CRO, Training, Leadership, Management, Project Management, CTMS, Drug Development, Clinical Data Management, GCP, Biotechnology, EDC, Clinical Development, 21 CFR Part 11, FDA
Education
University of North Carolina at Chapel Hill 1996 — 2000
B.S., Chemistry
Biogen March 2011 - Present
Catalent Pharma Solutions March 2010 - March 2011
Catalent Pharma Solutions 2001 - August 2010
Magellan Laboratories 1998 - 2001
Battelle Memorial Institute 1995 - 1998
Skills
GLP, Microbiology, Laboratory, Biopharmaceuticals, Purification, Vaccines, Aseptic Technique, Chemistry, Virology, Quality Control, DNA, Environmental Monitoring, GMP, Sop, Validation, FDA, Testing, CAPA, 21 CFR Part 11, Biotechnology, SOP
Education
University of Mount Union 1984 — 1988
BS, Biology
The Ohio State University
Ph.D., Medical Microbiology and Immunology
Eisai August 2012 - Present
KBI BioPharma February 2009 - September 2011
Cardinal Health April 2004 - October 2006
Magellan Laboratories April 2000 - April 2004
Skills
HPLC, Chromatography, Analytical Chemistry, GMP, UV/Vis, GLP, Technology Transfer, Validation, Sop, Biotechnology, Biopharmaceuticals, Protein Purification, SDS-PAGE, ELISA, Assay Development, Aseptic Technique, Biochemistry, Chemistry, V, Cleaning Validation, Western Blotting, Change Control, Chemstation, Dissolution, UV, USP, Analytical Method..., Wet Chemistry, Capillary..., IR, Quality Control
Education
North Carolina Central University 1996 — 2000
Chemistry
Gilead Sciences December 2014 - Present
Validant April 2014 - November 2014
Catalent Pharma Solutions January 2002 - February 2014
Magellan Laboratories October 1996 - January 2002
Bristol Myers Product May 1991 - October 1996
Skills
Analytical Chemistry, GMP, Dissolution, HPLC, LC-MS, Drug Development, Sop, Validation, V&V, GLP, Chemistry, Chromatography, Change Control, Technology Transfer, FDA, LIMS, Formulation, 21 CFR Part 11, UV/Vis, UV, Drug Delivery, Gas Chromatography, Cleaning Validation, Analytical Method..., CAPA, Biopharmaceuticals, USP, GxP, Mass Spectrometry, Trackwise, Method Development, CRO, Aseptic Processing, Drug Discovery, Wet Chemistry, Project Management, SOP
Education
North Carolina State University 1986 — 1990
BS, Chemistry
North Carolina State University 1986 — 1990
BS, Chemistry
Hillsboro High School
Global Knowledge Training May 2011 - Present
MindWorks Multimedia, Inc. October 2010 - April 2011
CONAGRA FOODS, INC November 2008 - March 2010
GlaxoSmithKline July 2003 - August 2008
GlaxoSmithKline April 2001 - July 2003
GlaxoSmithKline November 1996 - April 2001
Magellan Laboratories 1994 - 1996
Skills
Project Management, Six Sigma, Training, Instructional Design, Quality Control, GMP, Workshop Facilitation, Project Planning, Software Documentation, Leadership, Budgets, Process Engineering, Quality Assurance, E-Learning, Cross-functional Team..., Management, Program Management, Manufacturing, PMP, Lean Manufacturing, Risk Management, Testing, Process Improvement, Change Management, Business Process..., Employee Training, Team Leadership, Quality System, Quality Management, Business Process, Team Building, Project Portfolio..., Vendor Management, Organizational..., Strategy, Sales Operations, Captivate, Continuous Improvement, General Awesomeness, Technical Training, Performance Management, Training Delivery, Operational Excellence, Management Consulting, Customer Satisfaction
Education
Wake Technical Community College 1992 — 1994
AAS, Industrial Pharmaceutical Technology
The George Washington University
Master's Certificate, Project Management
Wesleyan College
Bachelor of Science, Business Management
Actavis January 2014 - Present
Shire Pharmaceuticals August 2010 - May 2013
Shire Pharmaceuticals 2008 - 2010
Shire Pharmaceuticals 2006 - 2008
Shire Pharmaceuticals 2005 - 2006
Barr Labs 2004 - 2005
Barr Laboratories 2002 - 2004
TMD Friction 2000 - 2002
VA/SC Department of Labor 1998 - 2000
Magellan Laboratories 1996 - 1998
Skills
GMP, Quality Control, LIMS, Cross-functional Team..., Pharmaceutics, Validation, 21 CFR Part 11, Quality System, Technology Transfer, Pharmaceutical Industry, Regulatory Affairs, Quality Assurance, Sop, Six Sigma, Continuous Improvement, FDA, CAPA, Process Improvement, Root Cause Analysis, HPLC, Supply Chain, Manufacturing Operations, Leadership..., Product Strategies, Change Control, Computer System..., Strategic Planning, Global Operations, Regulatory Submissions, GLP, Trackwise, Manufacturing, V&V, Dissolution, Drug Development, GxP, Product Launch, eCTD, SOP
Education
Radford University 1991 — 1996
BS, Chemistry
University of Maryland Baltimore 2007 — 2009
GlaxoSmithKline September 2011 - Present
Adherex Technologies February 2004 - April 2009
BioStratum Inc. July 2000 - March 2003
Magellan Laboratories August 1998 - April 2000
Magellan Laboratories July 1997 - August 1998
Pralex Corporation July 1994 - August 1995
Skills
Project Management, Management, Quality Assurance
Education
North Carolina Agricultural and Technical State University 1995 — 1997
MS, Organic Chemistry
St. Augustine's College 1990 — 1994
BS, Chemistry
BioMarin Pharmaceutical February 2007 - Present
Biogen Idec April 2001 - February 2007
Magellan Laboratories May 2000 - April 2001
Allermed Laboratories October 1997 - May 2000
McGhan Medical September 1992 - August 1997
Skills
IND, Regulatory Affairs, Regulatory Submissions, FDA
Education
San Diego State University-California State University 2001 — 2004
MS, Regulatory Affairs
San Diego State University-California State University 1997 — 1999
MS, Biology
UC Santa Barbara 1987 — 1992
BA, Biology
Halo Pharmaceutical, Inc. August 2013 - Present
Sandoz 2008 - 2013
MicroDose Technologies 2008 - 2008
Kos Pharmaceuticals 2001 - 2007
Magellan Laboratories 1999 - 2001
Skills
Project Management, Pharmaceutical Industry, GMP, Formulation, FDA, R&D, Drug Development, Pharmaceutics, Regulatory Submissions, Technology Transfer, Quality by Design, Drug Delivery, GLP, ANDA, HPLC, Analytical Chemistry, Dry Powder Inhalers, Validation, Biotechnology, Chromatography
Education
University of North Carolina at Chapel Hill
Master of Science (MS), Biomedical Engineering
University of Dayton
Bachelor of Science (BS), Bio-Engineering Technology
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
Catalent Pharma Solutions July 2007 - Present
Cardinal Health PTS March 2007 - July 2007
Cardinal Health 2003 - March 2007
Magellan Laboratories 2000 - 2003
Magellan Laboratories 1997 - 2000
Skills
Validation, Analytical Chemistry, 21 CFR Part 11, HPLC, GMP, Chromatography, FDA, Sop, GLP, Pharmaceutical Industry, Dissolution, Biotechnology, Software Documentation, Drug Development, Quality Assurance, Computer System..., Quality System, CAPA, GxP, LIMS, Change Control, UV/Vis, GAMP, SOP development, Lifesciences, Regulatory Requirements, Gas Chromatography, Technology Transfer
Education
University of North Carolina at Chapel Hill 1994 — 1997
MS, Chemistry
Luther College 1990 — 1994
BA, Chemistry
Pearl Therapeutics January 2008 - Present
Inhalation Solutions, LLC January 2005 - January 2008
Magellan Labs/Cardinal Health 2001 - 2004
Magellan Laboratories 1992 - 2001
MDRI 1988 - 1992
Skills
Pharmaceutical Industry, Technology Transfer, Project Management, Inhalation, Formulation, Analytical Chemistry, Manufacturing, Quality Assurance, GMP, Commercialization, FDA, Validation
Education
Purdue University
PhD, Analytical Chemistry
Bradley University 1976 — 1980
Bachelor of Science (BS), Chemisty
Patheon March 2013 - Present
Patheon Pharmaceuticals, Inc. September 2012 - March 2013
Liquidia Technologies, Inc. 2007 - September 2009
Techlytic Consulting, Inc. December 2004 - June 2007
Cardinal Health 2002 - 2004
Magellan Laboratories 1995 - 2004
Burroughs Wellcome Co. 1986 - 1995
Skills
GLP, Technology Transfer, FDA, Drug Development, Biotechnology, Validation, Lifesciences, HPLC, Regulatory Affairs, Chemistry, Laboratory, Sop, Analytical Chemistry, CMC, Product Development, Clinical Development, Pharmaceutics, Chromatography, CRO, CAPA, Pharmaceutical Industry
Education
Purdue University 1980 — 1986
Doctor of Philosophy (Ph.D.), Analytical Chemistry
William & Mary 1976 — 1980
BS, Chemistry
Atherogenics Inc VPCardinal HealthOctober 1998 - January 2005
Magellan Laboratories 1998 - 2002
LAB 1997 - 1998
Phoenix international 1995 - 1997
phoenix international 1994 - 1997
glaxo research and development 1981 - 1995
glaxo 1981 - 1995
Education
University of East Anglia 1979 — 1981
bachelors, chemistry
Catalent Pharma Solutions June 2011 - Present
Merck (legacy Inspire) 2008 - June 2011
Inspire Pharmaceuticals September 2007 - June 2011
Catalent 2006 - 2007
Cardinal Health 2002 - 2006
Magellan Laboratories 1999 - 2001
Magellan Labs 1997 - 1999
Smithkline Beecham 1993 - 1997
Delphi 1991 - 1992
Skills
FDA, GMP, GLP, Technology Transfer, Analysis, Inhalation Toxicology, GCP, Pharmaceutical Industry, Sop, Validation, CAPA, Analytical Chemistry, Regulatory Submissions, Drug Delivery, CRO, Clinical Development, Aseptic Processing, Pharmaceutics, Drug Discovery, Regulatory Affairs, Biotechnology, HPLC, Drug Development, Clinical Trials, R&D
Education
UWIST 1979 — 1984
PhD, Microbiology
Aberystwyth University 1976 — 1979
BSc, Microbiology
PPD 2010 - Present
Pharmaceutical Product Development May 2005 - 2010
Magellan Laboratories 1998 - 2002
Skills
CRO, Pharmaceutical Industry
Education
University of North Carolina at Chapel Hill 1999 — 2002
North Carolina State University 1989 — 1996
BS, Master's, Organic Chemistry
Beyond Chinatown March 2013 - Present
Ropes & Gray LLP October 2008 - Present
Ropes & Gray LLP July 2007 - October 2008
Magellan Laboratories 2000 - 2000
Skills
Patent Prosecution, Patent preparation, Patents, Chemistry, Patentability, Intellectual Property, Prosecution, Legal Research
Education
Benjamin N. Cardozo School of Law, Yeshiva University 2001 — 2004
JD, Intellectual Property Law
The Ohio State University 1994 — 1999
BA, Chemistry
American International Biotechnology Services October 2010 - April 2013
IRIX Pharmaceuticals November 2008 - June 2010
Cayman Chemical December 2005 - September 2007
Pfizer 2001 - 2005
Pfizer - Pharmacia - Monsanto 2001 - 2005
Magellan Laboratories (acquired in 2002 by Cardinal Health) October 1998 - December 2001
Magellan Laboratories 1998 - 2001
Bristol-Myers Squibb 1990 - 1991
Ciba-Geigy 1988 - 1990
Skills
Biotechnology, Pharmaceutical Industry, Lifesciences, Chromatography, Chemistry, HPLC, GLP, Analytical Chemistry, Technology Transfer, FDA, Sop, Drug Discovery, LC-MS, Clinical Trials, ELISA, Organic Synthesis, Validation, Organic Chemistry, Regulatory Affairs, Drug Development
Education
North Carolina State University 1996 — 1998
Post Doc, Natual Product Synthesis
Dartmouth College 1993 — 1996
Ph.D., Organic Chemistry
Florida State University 1985 — 1989
chemistry
Clark University 1981 — 1985
B.A., Chemistry
Vermont Academy 1978 — 1981
East Lyme High School
Tergus Pharma June 2013 - Present
The Clorox Company June 2008 - June 2013
PharmaDirections Inc August 2007 - May 2008
Leiner Health Products January 2005 - June 2007
Cardinal Health November 2001 - June 2004
Raylo Chemical Co. January 1999 - July 2001
Magellan Laboratories 1991 - 1996
Upjohn June 1974 - September 1987
Skills
GMP, SOP, GLP, cGMP, Validation, Change Control, Pharmaceuticals, HPLC, QC, Packaging, Quality Auditing, Analytical Chemistry, Quality Assurance, Sop, Pharmaceutical Industry, 21 CFR Part 11, Quality Control, CAPA, Continuous Improvement, FDA, Quality System, Pharmaceutics, Manufacturing, Raw Materials, Clinical Trials, Laboratory, Training, V&V, Technology Transfer, Software Documentation, GxP
Education
Wake Technical Community College 1988 — 1990
Multiple Courses Completed, Liberal Arts and Sciences/Liberal Studies, 3.0
Kalamazoo Valley Community College 1974 — 1976
Multiple Courses, Liberal Arts and Sciences/Liberal Studies, 3.0
Spring Arbor University 1971 — 1973
Liberal Arts
Orexigen Therapeutics April 2015 - Present
Allergan May 2013 - December 2014
Allergan October 2006 - May 2013
Cardinal Health 2004 - 2006
Cardinal Health 2002 - 2004
Magellan Laboratories 1999 - 2002
Cabrillo Laboratories 1998 - 1999
Amylin Pharmaceuticals 1996 - 1998
University of California, Riverside 1990 - 1996
National Science Foundation 1989 - 1990
Skills
Biotechnology, Analytical Chemistry, Quality by Design, Lean Six Sigma, CMC development, HPLC, Computer System..., GLP, LC-MS, Chemistry, GMP, 21 CFR Part 11, Six Sigma, Regulatory Submissions, Mass Spectrometry, Validation, Formulation, Biopharmaceuticals, Drug Development, Technology Transfer, Chromatography, FDA
Education
Indiana University Bloomington 1984 — 1989
Ph.D., Chemistry
University of Missouri-Columbia 1982 — 1984
M.S., Chemistry
University of Missouri-Columbia 1978 — 1982
B.S., Biochemistry
Inspire Pharmaceuticals Inc June 2010 - March 2011
Catalent Pharma Solutions July 2007 - May 2009
Cardinal Health 2003 - 2007
Magellan Laboratories 1997 - 2002
Education
North Carolina State University 2001 — 2004
MA, Organizational Leadership
University of North Carolina at Chapel Hill 1991 — 1995
BA, Chemistry
North Carolina Agricultural and Technical State University
Doctoral Student, Leadership Studies
KBI Biopharma September 2013 - Present
United Therapeutics August 2011 - August 2013
LabCorp November 2010 - August 2011
Duke University Health System April 2008 - October 2010
Parion Sciences October 2007 - April 2008
Trimeris, Inc. October 2001 - October 2007
ChemCodes, Inc May 2000 - October 2001
Leiner Health Products June 1999 - April 2000
Magellan Laboratories January 1999 - June 1999
Duke University Medical Center August 1997 - January 1999
Skills
Pharmaceutical Industry, Molecular Biology, Biotechnology, HPLC, Lifesciences, Multi-color Flow..., Dissolution, IC, Karl Fisher, GMP, GLP, GCP, SOP Writing, Inventory Management, Equipment Management, FTIR, Monoclonal Antibodies, Cell Culture, Chemistry, Sop, Research, Microsoft Office, Problem Solving, Chromatography, Drug Discovery, Analytical Chemistry, Infectious Diseases, Vaccines, Small Molecules, Peptides, Drug Development, ELISA, Immunology, Biochemistry, In Vitro, Validation, Life Sciences, SOP
Education
Johnson C. Smith University - JCSU 1993 — 1996
B.S., Chemistry
Warren Wilson College 1991 — 1993
Chemistry/Biology
Catalent Pharma Solutions September 2007 - Present
Cardinal health / Catalent Pharma Solutions 2004 - Present
Mikart, Inc. 2000 - 2003
Magellan Laboratories 1998 - 2000
Skills
GMP, Validation, LIMS, GLP, Dissolution, FDA, Pharmaceutical Industry, Sop, UV/Vis, HPLC, Analytical Chemistry, Chromatography
Education
Cumberland College 1992 — 1996
Bachelor's Degree, Chemistry and Mathematics
Rae Kushner Hebrew Academy August 2009 - Present
MicroDose Technologies July 2006 - October 2008
MicroDose Therapeutx 2006 - 2008
NovaDel Pharma Inc. November 2004 - March 2006
Schering-Plough 2001 - 2005
Schering-Plough Research Institute 2001 - 2004
Magellan Laboratories 1999 - 2000
Magellan Labs 1999 - 2000
Guilford Pharmaceuticals 1996 - 1999
Skills
Analytical Chemistry, HPLC, GMP, Technology Transfer, Pharmaceutical Industry, GLP, Drug Delivery, Formulation, Validation, R&D, Sop, UV/Vis, Chromatography, FDA, Lifesciences
Education
Illinois State University 1990 — 1992
Teaching Certification, Secondary Education; Chemistry; Physics
Illinois State University 1987 — 1989
Bachelor's, Chemistry
Catalent Pharma Solutions September 2004 - Present
Cardinal Health May 2002 - September 2004
Magellan Laboratories 1999 - 2002
BASF April 1997 - February 1999
Sandoz January 1992 - March 1997
Skills
New Product..., Pharmaceutical..., GLP and GMP for..., Project Budget..., Team Facilitation for..., Leadership by Influence, Risk Assessment,..., Lessons Learned,..., Contract and Customer..., Negotiation and..., Lean Six..., Project Management..., MS Office Suite and..., Working across...
Education
North Carolina State University 1988 — 1991
Doctor of Philosophy (Ph.D.), Crop Science/Soil Science
North Carolina State University 1986 — 1988
Master of Science (M.S.), Weed Science
Purdue University 1981 — 1985
BS, Agronomy
Salix Pharmaceuticals April 2007 - Present
EMD Pharmaceuticals January 2006 - March 2007
Inspire Pharmaceuticals March 2001 - September 2005
Magellan Laboratories 1993 - 2001
Magellan Labs/Cardinal Health 1993 - 2001
Skills
GMP, GCP, QA, QC, GMP, Pharmaceutical Industry, Quality Assurance, CAPA, FDA, Clinical Trials, Quality Auditing, 21 CFR Part 11, Clinical Research, GCP, Sop, Regulatory Affairs, Clinical Development, SOP, CRO, Validation
Education
Appalachian State University
Catalent April 2007 - Present
Cardinal Health 2002 - 2007
Magellan Laboratories 2001 - 2002
AAIPharma 1998 - 2001
Labcorp 1990 - 1998
Skills
Pharmaceutical Industry, GMP, Sop, Laboratory, Software Documentation, Quality Control, GLP, Analytical Chemistry, V&V, HPLC, CRO, UV/Vis, Validation, FDA, Biotechnology, Chromatography
Education
North Carolina State University 1984 — 1989
BS, Biological Sciences
BD April 2014 - Present
Becton Dickinson July 2012 - April 2014
BD May 2009 - July 2012
OpAns, LLC July 2007 - March 2009
Catalent January 2007 - July 2007
Cardinal Health April 2002 - January 2007
Magellan Laboratories December 1998 - April 2002
Education
University of North Carolina at Chapel Hill 1992 — 1998
PhD, Analytical Chemistry, Mass Spectrometry
Formex February 2014 - Present
Boston Analytical April 2013 - January 2014
Catalent Pharma Solutions 2012 - January 2013
Aptuit December 2010 - March 2012
Frontage Laboratories September 2008 - January 2011
ABC Labs August 2007 - September 2008
AAIPharma 2006 - 2007
MDS Pharma Services 2001 - 2005
Magellan Laboratories 2000 - 2001
IBAH Pharm Services 1997 - 2000
Skills
CRO, Technology Transfer, Pharmaceutical Industry, Pharmaceutical Sales, Business Development, New Business Development, Brand Awareness, Sales Process, Territory Management, Drug Development, Contract Negotiation, Sales
Education
Temple University
BS, Chemistry
Vintage Pharmaceuticals R&D ChemistQualitest Pharmaceuticals2008 - Present
Nektar Therapeutics 2002 - 2007
Vintage Pharmaceuticals January 2001 - November 2002
Magellan Laboratories September 1997 - December 2000
Education
University of Southern California 1993 — 1997
Hewlett-Packard May 2013 - Present
Hewlett-Packard November 2010 - June 2013
Hewlett-Packard (EDS) March 2001 - November 2010
Magellan Laboratories 1999 - 2001
Cardinal Health 1999 - 2001
Magellan Labs 1999 - 2001
Skills
Business Analysis, Process Improvement, Software Documentation, Medicaid, HIPAA, Requirements Gathering, SDLC, Requirements Analysis, Business Requirements, User Acceptance Testing, PMP, Business Process, Analysis, Vendor Management, Project Management, Visio, Change Management, SharePoint, Program Management, Call Centers
Education
University of Montana 1996 — 1999
C-Level Management Solutions LLC July 2012 - Present
BASi Inc December 2008 - July 2012
ATHEROGENICS July 2006 - 2008
Cardinal Health, SPS April 2002 - January 2005
Magellan Laboratories 1998 - 2003
Phoenix International 1995 - 1998
Glaxo Smith Kline (GGR) 1981 - 1995
Skills
Analytical Chemistry, Drug Development, Clinical Trials, GMP, Drug Discovery, Technology Transfer, Sop, HPLC, Medical Devices, Chemistry, Clinical Research, R&D, Pharmacology, Oncology, GLP, Corporate Development, Mentoring Of Staff, Change Management, Strategic Planning, Executive Management, CRO, Product Development, Biopharmaceuticals, Regulatory Affairs
Education
University of Hertfordshire 1988 — 1993
PhD, Analytical Chemistry
University of East Anglia 1979 — 1981
BSc Hons, Chemistry
ICON plc (formerly Aptiv Solutions and Fulcrum) September 2010 - Present
PPD October 1998 - September 2010
Magellan Laboratories 1992 - 1998
United-Guardian 1986 - 1992
Skills
CMC Regulatory Affairs, eCTD, Regulatory Submissions, Regulatory Affairs, Pharmaceuticals, FDA, Regulatory Strategy, GMP, CMC, Drug Development, Pharmaceutical Industry, Strategy, IND
Education
Carnegie Mellon University 1982 — 1986
BS, Chemistry
Hitachi Data Systems January 2013 - Present
Hewlett-Packard October 2000 - December 2012
eTesting 1998 - 2000
Magellan Laboratories 1996 - 1998
Skills
HP, Program Management, Agile Methodologies, PMP, Software Project..., Cross-functional Team..., Product Lifecycle..., Storage, Product Management, Cloud Computing, Enterprise Software, Quality Assurance, Data Center, Integration, Storage Area Networks, SAN, Virtualization
Education
Campbell University 1991 — 1995
BS, Biology
Eisai Inc April 2012 - Present
Eisai Inc June 2011 - April 2012
Eisai Inc October 1998 - June 2011
Magellan Laboratories July 1994 - October 1998
Bioanalytika Laboratories, Inc. May 1993 - July 1994
Skills
Formulation, Analytical Chemistry, Chromatography, HPLC, GLP, Technology Transfer, GMP, Pharmaceutical Industry, Validation, LC-MS, CRO, FDA, Chemistry, UV/Vis, Dissolution, Drug Development, Pharmaceutics
Education
North Carolina State University
B.S., Chemistry
Catalent Pharma Solutions July 2014 - Present
Catalent 2007 - June 2014
Cardinal Health, SPS 2002 - 2006
Magellan Laboratories 1998 - 2002
IEA 1987 - 1998
Skills
Sop, Pharmaceutical Industry, GMP, Validation, Purchasing, Six Sigma, Cross-functional Team..., Process Improvement
Education
University of Pittsburgh 1984 — 1986
BS, Elem Educ
Ligonier Valley Senior High School 1980 — 1982
Magellan Health Services March 2011 - Present
Boehringer Ingelheim Chemicals January 2007 - March 2011
Boehringer Ingelheim Chemicals March 2005 - January 2007
Boehringer Ingelheim Chemicals December 2002 - March 2005
Insmed August 2001 - September 2002
Magellan Laboratories August 1996 - August 2001
Skills
Six Sigma, Lean Tools, Project Management, Change Management, Quality Management, GMP, FDA, Pharmaceutical Industry, Change Control, Technology Transfer, GLP, Quality System, Quality Assurance, Regulatory Affairs, Process Improvement, Training, Cross-functional Team..., Lean Manufacturing, Management, Continuous Improvement, Software Documentation, 21 CFR Part 11, Operational Excellence, Quality Control, Program Management, Root Cause Analysis, Strategy, Business Process, Leadership
Education
University of Richmond - Robins School of Business 2005 — 2008
MBA
University of North Carolina at Chapel Hill 1994 — 1996
MS, Analytical Chemistry
William & Mary 1990 — 1994
BS, Chemistry
Enco Pharmaceutical Development, Inc. February 2009 - Present
Aradigm Corporation September 2004 - February 2006
Azopharma Contract Pharmaceutical Services 2004 - 2006
Cardinal Health September 1998 - August 2004
Magellan Laboratories September 1998 - May 2002
Skills
Drug Delivery, Pharmaceutical Industry, FDA, Technology Transfer, GMP, Inhalation, Validation, Analytical Chemistry, Sop, Pharmaceutics, Regulatory Affairs, Biopharmaceuticals, Clinical Development, GLP, Medical Devices, Biotechnology, 21 CFR Part 11, Drug Development, Drug Discovery, Nasal, CAPA, Formulation, CRO, R&D, HPLC, Life Sciences
Education
University of North Carolina at Greensboro 1987 — 1989
Bachelors, Chemistry/Biology
University of Minnesota-Twin Cities
Ph.D., MedChem
Eisai, Inc March 1998 - Present
Magellan Laboratories January 1997 - March 1998
Novo Nordisk June 1996 - January 1997
Skills
GMP, Auditing, Quality System, Sop, Quality Auditing, Pharmaceutical Industry, CAPA, Change Control, SOP, 21 CFR Part 11, Validation, Regulatory Affairs, Quality Assurance, Technology Transfer, FDA, Aseptic Processing
Education
North Carolina State University 1991 — 1993
BS, Life Sciences
Monogram Biosciences August 2011 - Present
Monogram Biosciences November 2002 - July 2011
Agouron/Pfizer 1998 - 2001
Magellan Laboratories 1998 - 2000
Skills
Personalized Medicine, Infectious Diseases, Biotechnology, Oncology, Virology, Genomics, Cardiology, Molecular Biology, Pharmaceutical Sales, Managed Care
Education
South Carolina State University 1987 — 1991
BS, Biology Minor Chemistry
Guilford County Emergency Services March 2003 - July 2008
Guilford County Emergency Services February 2000 - July 2008
Guilford County Emergency Services January 2003 - December 2007
Magellan Laboratories January 1999 - February 2000
Universal Organics, LLC January 1998 - January 1999
Education
University of North Carolina at Chapel Hill 1993 — 1997
M.S., Organic Chemistry
West Virginia University 1988 — 1993
B.S., Chemistry
Grifols January 2012 - Present
Grifols August 2009 - January 2012
Talecris Biotherapeutics, Inc. May 2005 - August 2009
Cardinal Health June 2002 - October 2004
Magellan Laboratories November 1998 - June 2002
Skills
Pharmaceutical Industry, Customer Service, GMP, Biotechnology, Cross-functional Team..., Quality Assurance, Process Improvement, Training, Healthcare, Validation
Education
Penn State University 1987 — 1991
Bachelor's Degree, Chemistry