AAIPharma Company
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AAIPharma Employees
Quintiles December 2014 - Present
Quintiles November 2013 - November 2014
Drug Safety Alliance, a United Drug Company April 2011 - November 2013
PAREXEL December 2009 - April 2011
PAREXEL January 2008 - December 2009
AAIPharma June 2007 - January 2008
Teva Pharmaceuticasl-( Formerly-Ivax) 2005 - 2007
Cleveland Clinic Florida 1997 - 2004
Skills
Pharmacovigilance, ICH-GCP, Global Management, Global Strategy, Cross-cultural Teams, Clinical Research, Team Leadership, Mentoring, Clinical Development, Clinical Trials, CRO, GCP, Drug Safety, Diabetes, Neurology, Oncology, Medical Writing, Pharmaceutical Industry, Regulatory Submissions, Medical Affairs, EDC, Clinical Monitoring, Infectious Diseases, Regulatory Affairs, Clinical Data Management, MedDRA, Drug Development
Education
Universidad de Buenos Aires 1982 — 1988
MD, Doctor of Medicine
Lower Cape Fear Hospice February 2011 - Present
UNCW School of Social Work August 2011 - May 2013
Coastal Horizons Center, Inc. January 2012 - April 2013
PPD October 2005 - July 2011
AAIPharma August 1990 - October 2005
Skills
Clinical Research, Clinical Trials, Biotechnology, GMP, Research, Community Outreach, Quality Assurance, Microsoft Excel, Chemistry, Microsoft Office, Pharmaceutical Industry, Mental Health, Individual Counselling, Group Therapy, Family Therapy, Grant Writing, Healthcare, Public Speaking, PowerPoint, Training
Education
University of North Carolina at Wilmington 2011 — 2013
Master of Social Work (MSW), Social Work
University of North Carolina at Wilmington 2005 — 2007
Bachelor of Science; 2011, Clinical Research
Wofford College 1986 — 1990
Bachelor of Science, Biology
SynteractHCR May 2015 - Present
Pharm-Olam International January 2013 - April 2015
Pharm-Olam International April 2010 - January 2013
ZeeCRO Inc. 2008 - May 2010
AAIPharma Services Corp. June 2009 - November 2009
AAIPharma January 2007 - June 2009
Cvitkovic & Associes Consultants March 2003 - January 2007
Consulat General de France a Houston 2001 - 2002
Skills
CRO, EDC, GCP, Clinical Trials, CTMS, Clinical Development, Oncology, ICH-GCP, Clinical Monitoring, Clinical Research, Regulatory Submissions, Neurology, Clinical Data Management, Sop, Drug Development, Infectious Diseases, Medical Writing, Vaccines, Protocol, Therapeutic Areas, SOP
Education
Tulane University 1997 — 2000
Bachelor of Science, Cell Biology
Awty international school 1994 — 1997
Baccalaureat, Biology, General
Formulation Hause LLC April 2009 - Present
King Pharmaceuticals September 2002 - February 2009
AAIPharma May 1991 - August 2002
Skills
Drug Delivery, Drug Development, CRO, Pharmaceutical Industry, Clinical Development, Analytical Chemistry, GMP, Formulation, Technology Transfer, HPLC, Sop, Pharmaceutics, ANDA, IND, CMC, Regulatory Submissions, Validation, FDA, CAPA, Change Control, Quality by Design, Chromatography, Laboratory, Drug Discovery, GLP, NDA, Dissolution, 21 CFR Part 11, Bioanalysis, Biopharmaceuticals, Regulatory Affairs, Pharmacokinetics, Protocol, LIMS, LC-MS, Clinical Trials, SOP
Education
University of North Carolina at Chapel Hill 1986 — 1991
RxPlus Pharmacies September 2014 - Present
Bottle & Bottega Denver Metro February 2012 - September 2014
Marken May 2011 - January 2012
Ben Venue Laboratories April 2009 - May 2011
Adventrx May 2007 - January 2009
AAIPharma 2003 - 2007
Skills
Pharmaceutical Industry, Lifesciences, Oncology, Biotechnology, Medical Devices, Clinical Trials, Commercialization, Technology Transfer, Market Research, Pharmaceutics, Management, Business Development, Life Sciences, Sop, FDA, Cross-functional Team..., Clinical Development, Regulatory Affairs, Strategy, SOP, Business Networking
Education
Tri-State University 1998 — 2002
BS, Biology
Lowe's Companies, Inc. September 2014 - Present
Static Control Components Inc. September 2013 - September 2014
ASAP Solutions, LLC 2012 - 2013
Director Business Process Management Technology, PPD January 2012 - July 2012
PPD October 2010 - July 2012
PPD January 2010 - October 2010
PPD July 2007 - December 2009
AAIPharma October 2005 - July 2007
Duke University - Clinical Research Institute (DCRI) August 2004 - April 2005
Siebel Systems May 1998 - March 2004
Skills
Enterprise Architecture, SDLC, Siebel, IT Strategy, SOA, Integration, Business Intelligence, Business Analysis, Information Technology, ESB, Architecture, Solution Architecture, Project Management, Data Warehousing, Databases, PMP, Cross-functional Team..., Consulting, EAI, Requirements Analysis, Software Project..., Agile Methodologies, Visio, Web Services, Business Process, CTMS, 21 CFR Part 11, Software Development, Middleware, Governance, PL/SQL, Data Modeling, CRO, Spanish, Microsoft SQL Server, Mobile Applications, Management, Identity Management, XML, Business Requirements, Testing, Mobile Technology, Agile, Application Development, Regulatory Requirements, PLM Tools, Maturity Models, Technology Roadmapping, Strategic Roadmaps, TOGAF
Education
Universidad de La Salle
MBA, Master of Business Administration
Universidad de Los Andes 1986 — 1986
B.S., Systems and Computer Engineering
Gimnasio Iragua
Halloran Consulting Group, Inc. May 2010 - Present
Boston Scientific January 2007 - April 2010
aaiPharma 2000 - 2006
Brigham and Women's Hospital 1997 - 2000
Skills
Diabetes, Cardiology, Sop, CTMS, GCP, Quality System, Clinical Development, Clinical Trials, Line Management, FDA, Clinical Data Management, EDC, Oncology, Clinical Monitoring, Regulatory Affairs, Clinical Operations, Regulatory Submissions, Protocol, 21 CFR Part 11, Pharmaceutical Industry, CAPA, Therapeutic Areas, SOP
Education
University of New Hampshire 1982 — 1986
Bachelor of Science (BS), Nursing
Pharmaceutical Partners, LLC August 2007 - Present
AAIPharma 2005 - 2007
AAIPharma 2001 - 2005
AAIPharma 1994 - 2004
AAIPharma 1980 - 2001
Skills
Pharmaceutical Industry, GMP, FDA, Technology Transfer, CRO, Validation, Sop, Clinical Development, LIMS, Cross-functional Team..., Medical Devices, Biotechnology, Regulatory Submissions, Drug Development, GLP, Quality Management, Laboratory, Clinical Trials, Regulatory Affairs, Software Documentation, Pharmaceutics, SOP, Chemistry, Lifesciences, Oncology, Manufacturing, R&D, GCP, Quality System, Quality Assurance, 21 CFR Part 11
Education
University of North Carolina at Wilmington 1971 — 1975
BS, Biology, Chemistry
Schwartz & Kramer Search Corp August 2015 - Present
Genentech September 2013 - May 2015
TalentWave June 2010 - September 2013
RemX Scientific September 2009 - June 2010
I3 Pharma Resourcing January 2008 - May 2009
Schwartz & Stevens Search 2002 - 2007
MRI 1999 - 2002
PPD 1997 - 1999
AAIPharma 1995 - 1996
MCV Toxicology 1990 - 1993
Skills
Executive Search, Biotechnology, Lifesciences, Recruiting, Medical Devices, Clinical Research, Pharmaceutical Industry, Clinical Development, CRO, Pharmaceutics, Drug Development, Temporary Placement, Human Resources, R&D, Oncology, Clinical Trials, Data Management, GCP, Regulatory Submissions, Regulatory Affairs, CTMS, Infectious Diseases, Talent Acquisition, FDA, Biopharmaceuticals, Internet Recruiting, Applicant Tracking..., Life Sciences
Education
Virginia Polytechnic Institute and State University 1984 — 1988
BS, Biology
University of North Carolina at Wilmington 1995 — 1996
graduate studies, Environmental Sciences
Boldt Clan June 2013 - Present
St. Jude Children's Research Hospital August 2012 - June 2013
Merck February 2005 - August 2012
aaiPharma 1998 - 2005
Takeda Chemical Products June 1994 - August 1996
Skills
Trackwise, LIMS, Empower, SAP, Microsoft Word, Clarity, GMP, Validation, Microsoft Excel, GLP, HPLC, Chemistry, Analytical Chemistry, R&D, Biotechnology, IR, Chromatography, V&V, Pharmaceutical Industry, SOP, TrackWise
Education
University of North Carolina at Wilmington 1994 — 1998
BS, Chemistry
Cape Fear Community College 1992 — 1994
Associate of Applied Science, Chemical Technology
Darwin Chambers Company January 2012 - Present
LabCorp February 2011 - January 2012
AAIPharma March 2008 - February 2011
Covance May 2003 - March 2008
Prevalere Life Sciences June 2003 - May 2004
ABC Laboratories January 1999 - May 2003
Sigma Aldrich 1997 - 1998
Sigma Chemical 1990 - 1997
Skills
Sales, Manufacturing, Negotiation, Formulation, Laboratory, Oncology, Biopharmaceuticals, GLP, Leadership, Sales Management, Business Development, Regulatory Affairs, Management, Business Strategy, Strategy, Contract Negotiation
Education
Truman State University 1988 — 1991
B.S., Biology, Chemistry
PPD October 2011 - Present
PharPoint Research, Inc. January 2011 - September 2011
i3 Statprobe July 2010 - January 2011
AAIPharma December 2006 - August 2009
Inveresk Research September 2004 - September 2005
Skills
Clinical Trials, Microsoft Word, Biostatistics, Microsoft Excel, Clinical Data Management, SAS, Pharmaceutical Industry, Clinical Research, GCP, Regulatory Submissions
Education
University of North Carolina at Wilmington 2000 — 2005
Masters, Applied Mathematics
Chiltern June 2015 - Present
Biostudy Solutions, LLC November 2009 - June 2015
Self Employed April 2007 - November 2009
AAIPharma October 2004 - August 2009
Skills
Pharmaceutical Industry, CRO, FDA, SOP, Clinical Trials, GCP, Clinical Development, Validation, Clinical Research, Protocol, SAS Programming
Education
University of North Carolina at Wilmington 2003 — 2005
B.S, Statistics
UPM Pharmaceuticals, Inc. August 2012 - Present
AAIPharma Services October 2010 - October 2011
AAIPharma January 2009 - October 2011
AAIPharma Services Corp. 2009 - October 2011
Gene Express, Inc. October 2007 - December 2008
AAIPharma 1990 - 2007
Skills
CRO, GMP, Sop, Pharmaceutical Industry, FDA, Validation, Technology Transfer, Drug Development, 21 CFR Part 11, GLP, Change Control, Leadership, Biopharmaceuticals, Quality Assurance, Clinical Development, Regulatory Affairs, CAPA, GCP, Project Management, Chromatography, Analytical Chemistry, Biotechnology, HPLC, Pharmaceutics, V&V, LIMS
Education
University of North Carolina at Wilmington 2003 — 2006
MBA, Business Administration and Management, General
University of North Carolina at Pembroke 1988 — 1990
B.S., Chemistry
Quality Chemical Laboratories September 2014 - Present
Osmotica Pharmaceutical April 2008 - August 2014
Leiner Health Products April 2005 - March 2008
aaiPharma April 1995 - March 2005
Skills
GMP, Technology Transfer, Validation, Process Transfer, Pharmaceutical Industry, Process Optimization, Pharmaceutics, 21 CFR Part 11, Biotechnology, GLP, Formulation, Sop, HPLC, V&V, Change Control, FDA, Quality System, Aseptic Processing, R&D, Biopharmaceuticals, Regulatory Affairs, CAPA, Cleaning Validation, Drug Development
Education
University of South Carolina-Columbia
BS, Chemical Engineering
PPD January 2009 - Present
Inclinix, Inc. October 2007 - January 2009
AAIPharma December 2006 - October 2007
AAI Pharma September 1997 - December 2006
Armstrong Pharmaceuticals July 1995 - September 1997
Skills
GCP, Validation, Clinical Trials, Pharmaceutical Industry, CRO, Oncology, Formulation, R
Education
University of North Carolina at Wilmington 2004 — 2006
MBA, Business
Worcester State University 1990 — 1995
BS, Chemistry
Quintiles April 2013 - Present
Quintiles February 2012 - Present
Quintiles October 2010 - Present
AAIPHARMA May 1990 - October 2010
AAIPHARMA February 2007 - April 2008
AAIPHARMA August 2005 - February 2007
AAIPHARMA February 1999 - August 2005
AAIPHARMA March 1996 - February 1999
AAIPHARMA September 1992 - March 1996
AAIPHARMA March 1992 - September 1992
Skills
Clinical, Generics, Clinical Pharmacology, ANDA, FDA, Clinical Research, GCP, SOP, CRO, Pharmaceuticals
Education
PROJECT MANAGEMENT PROFESSIONAL 2008 — 2009
PMP CERTIFICATION, PROJECT MANAGEMENT
Webster University 1993 — 1996
Masters, BUSINESS
Stony Brook University 1981 — 1985
BS, PHYSICS
Leaders in the VP Marketing Business Development Arena in the Greater Chicago Area 2012 - Present
Mylan Institutional 2010 - Present
-Principal October 2009 - Present
AAIPharma May 2008 - October 2009
Draxis Pharma April 2007 - November 2007
Sandoz March 2004 - April 2005
Cardinal Health May 2001 - June 2002
American Pharmaceutical Partners June 1998 - April 2001
LyphoMed Inc. (now APP) 1989 - 2001
Fujisawa 1989 - 1998
Skills
Marketing Strategy, Expert relationship..., Expansion Strategies, Management Consulting, Sales Management, Product Management, Business Strategy, Medical Devices, Business Development, Product Development, Entrepreneurship, Leadership, Marketing, Pharmaceutical Industry, Management, Proactive self-starter, Sales, Cross-functional Team..., FDA, Sop, Pharmaceutical Sales, Product Launch, CAPA, Change Control, Healthcare, GMP, Biopharmaceuticals, 21 CFR Part 11, Validation, Biotechnology, Commercialization, Regulatory Affairs, Quality System, Regulatory Submissions, Clinical Development, Oncology, Technology Transfer, GxP, Clinical Trials, Pharmaceutics, Lifesciences, Drug Development, CRO, Regulatory Requirements, V&V, Sales Effectiveness, Vaccines, Pharmacovigilance, LIMS
Education
University of Illinois at Urbana-Champaign 1973 — 1978
B.S., Biology
NC Department of Revenue December 2014 - Present
State of North Carolina October 2012 - September 2014
Quanta Technology, LLC February 2010 - November 2011
NCHICA- NC Health Information & Communication Alliance May 2008 - November 2009
AAIPharma January 2008 - March 2008
SpecComm International September 1989 - September 2007
Skills
Customer Relations, Event Planning, Publishing, Proposal Writing, Outlook, Customer Service, Excel, Word, PowerPoint, Event Management, Trade Shows, Newsletters, Administration, Marketing Communications, Promotions, Email Marketing, Salesforce.com, Media Relations, Direct Marketing, Market Research, Market Planning, Microsoft Office, Budgeting, International Logistics, Logistics, Bookkeeping, Tax Preparation, QuickBooks, Budgets, Microsoft Excel, Program Management, Microsoft Word, Training, Marketing
Education
The University of Georgia 1967 — 1970
BA, Economics
Newcomb of Tulane
BA, Economics
Wake Technical Community College
Par Pharmaceutical 2014 - Present
UnitedHealth Group 2013 - 2014
Teva Pharmaceuticals 2009 - 2013
Teva Pharmaceuticals 2002 - 2009
Access Pharmaceuticals, Inc. 2000 - 2002
AAIPharma 1998 - 2000
Skills
Analytical Chemistry, Biotechnology, Sop, GMP, Pharmaceutical Industry, FDA, HPLC, Validation, CAPA, 21 CFR Part 11, Six Sigma, Lean Manufacturing, Kaizen, 5S, Waste Reduction, Change Management, SPC, Minitab, Operational Excellence, Process Improvement, Poka Yoke, Cost Reduction..., Statistical Tools, Mistake Proofing, FMEA, Risk Management, DMAIC, Design of Experiments, Quality Assurance, Quality System, Compliance, Quality Auditing, Value Stream Mapping, Trackwise, LIMS, Change Control
Education
University of North Carolina at Chapel Hill 1994 — 1998
BA, Chemistry
Pinecrest High School 1990 — 1994
Cody Creek, The Depot January 2013 - Present
Meridien Marketing & Logistics, Inc June 2012 - Present
The Harrelson Company July 2007 - January 2012
CAMS March 2006 - July 2007
Prudential Real Estate April 2005 - April 2006
AAIPharma November 2005 - March 2006
Intracoastal Rentals April 2004 - March 2005
Bert Croom, LLC Private Investigations May 2003 - June 2004
MOVIES 1990 - 1991
Skills
Team Building, Sales Management, Customer Satisfaction, Strategic Thinking, Team Leadership, Decision Making Skills, Real Estate Development, Property Marketing, Media Events, Trade Show..., Industry Networking, Marketing, Customer Service, Business Development, New Business Development, Sales, Management, Networking, Sellers, Negotiation, CRM, Time Management, Real Estate, Program Management, Event Planning, Microsoft Excel, Strategic Planning, Account Management, Leadership, Event Management
Education
University of North Carolina at Wilmington 1989 — 1991
Brixey & Meyer May 2014 - Present
Brixey & Meyer, Inc. August 2013 - Present
Brixey & Meyer, Inc. January 2012 - August 2013
Christopher's Restaurant & Catering September 2009 - January 2012
AAIPharma June 2008 - September 2008
Cameron School of Business Student Services August 2007 - December 2007
Bluewater Grill April 2007 - September 2007
The Oceanic Restaurant August 2005 - October 2006
Skills
Microsoft Excel, PowerPoint, Microsoft Word, Customer Service, Microsoft Office, Event Planning, Financial Analysis, Finance, Financial Reporting, Budgets, Auditing, Accounting
Education
International Business School Alliance ~ UNCW & Euromed Marseille 2007 — 2008
IMBA & MSc of Mgt, Non-profit Management & Economic Development
University of North Carolina at Wilmington 2002 — 2007
Bachelor of Business Administration (BBA), Accounting
Brooke Army Medical Center May 2014 - Present
Northeast Baptist Hospital July 2012 - May 2014
University Hospital April 2011 - June 2012
University of the Incarnate Word January 2009 - May 2012
SURGICAL SPECIALTY INSTRUMENTS August 2007 - December 2009
CV Therapeutics June 2005 - February 2007
NPS Pharmaceuticals January 2005 - June 2005
Ventiv Pharmaceutical Services January 2005 - June 2005
AAIPharma September 2002 - June 2004
ROCHE LABORATORIES November 1999 - June 2001
Skills
Sales, Cardiology, Diabetes, Oncology, Neurology, Pharmaceutical Industry, Gastroenterology, Pharmaceutical Sales, Biotechnology, Endocrinology, Rheumatology, Infectious Diseases, Healthcare, Hematology, Hospitals, Critical Thinking, Critical Care, Medicine, Surgery, Medical Devices
Education
University of the Incarnate Word 2009 — 2012
BSN, second degree
The University of Texas at Austin 1995 — 1997
Master's, Communications
The University of Texas at Austin 1976 — 1978
BA, Biology/Chemistry
The University of Texas at Austin 1974 — 1978
BA, Biology
Gilead Sciences July 2015 - Present
Gilead Sciences January 2014 - July 2015
Gilead Sciences February 2012 - January 2014
Gilead Sciences (formerly CV Therapeutics) April 2009 - February 2012
CV Therapeutics 2005 - 2009
Corixa 2003 - 2005
AAIPharma 2000 - 2003
Skills
Clinical Data Management, GCP, CDISC, EDC, Clinical Trials, Medidata Rave
Education
University of Minnesota-Twin Cities 1997 — 2000
Bachelor of Arts, German
CloudWyze, Inc. January 2012 - Present
AcoustiCreations, Inc. January 2004 - Present
OPTEREX June 2007 - December 2012
Olsen Enterprises, Inc. March 2002 - December 2012
BBXComputers January 2002 - December 2012
AAIPharma March 1998 - March 2001
Skills
Problem Solving, Technical Leadership, Technology Management, Customer Satisfaction, Customer Service, IT Management, IT Strategy, IT Outsourcing, Network Security, Wireless Broadband, Troubleshooting, Information Technology, Crestron, Polycom Video..., Polycom, Entrepreneurship, Data Center, Leadership, Networking, Outsourcing
Education
University of North Carolina at Wilmington 1998 — 2002
BA, Information Systems
S/V Dragon's Dance 2011 - Present
Global Clinical Research Solutions,LLC September 2009 - Present
AAIPharma 2007 - 2009
Southeastern Research Group, Inc 2005 - 2007
MDS 2003 - 2006
DNA Sciences 2001 - 2003
GSK 1985 - 2001
GlaxoSmithKline 1985 - 2001
Skills
Bioanalysis, CRO, Clinical Development, Drug Development, Clinical Trials, Drug Discovery, Oncology, Pharmaceutical Industry, Pharmacology, Biotechnology, Pharmacokinetics, Sop, Clinical Research, Drug Metabolism, Therapeutic Areas, Clinical Operations, Protocol, GCP, R&D, Phase I, FDA, Vaccines, GLP, Regulatory Affairs, Regulatory Submissions, Validation, Clinical Pharmacology, Pharmaceutics, CTMS, Neuroscience, Commercialization, Biopharmaceuticals, Neurology, Clinical Data Management, EDC, Diabetes, Infectious Diseases, Lifesciences, Medical Writing, Genomics, Laboratory, Cancer, Immunology, Pharmacovigilance, Cardiology, GMP, Technology Transfer, Genetics
Education
University of North Carolina at Wilmington 1971 — 1974
BS, Biology
Jenn The Teacher August 2010 - Present
Glynne's Soaps, Inc October 2008 - Present
AAI Pharma August 2007 - July 2010
AAIPharma May 2005 - August 2007
AAIPharma May 2000 - May 2005
Waccamaw Academy August 1998 - May 2000
Valley Christian High School 1995 - 1998
Skills
Science Education, Mathematics Education, Education, Tutoring, Teaching, Chemistry, Biology, Science, Analytical Chemistry, Lifesciences, Pharmaceutical Industry, Sop, Clinical Trials, Validation, CRO, Biotechnology, FDA, GLP, Clinical Development, HPLC, Technology Transfer, Clinical Research, LIMS, LC-MS, GMP
Education
University of North Carolina at Wilmington 2001 — 2007
MS, Chemistry
The Master's College 1989 — 1993
BS, Biological Sciences
Merck 2006 - Present
Schering Plough 2003 - 2006
GSK 2000 - 2003
Teva Pharmaceuticals 1999 - 2000
AAIPharma 1994 - 1999
Skills
Validation, Technology Transfer, Pharmaceutical Industry, GMP, Cross-functional Team..., Quality Assurance, Regulatory Submissions, Change Control, Cleaning Validation, Manufacturing Scale-up, Technical Project..., Continuous Improvement
Education
Syracuse University
MBA
Syracuse University
BS, Chemical Engineering
Doe & Ingalls, a Thermo Fisher Scientific Brand May 2014 - Present
Kberg Consultants April 2010 - Present
Biotest AG November 2007 - March 2010
Quality in BioPharma Group 2007 - 2009
AAIPharma August 2006 - August 2007
AstraZeneca Pharmaceuticals August 2000 - June 2006
Management Consultants April 1997 - July 2000
Ricoh Americas Corporation 1994 - 1997
ABC News September 1991 - March 1993
NBC News September 1988 - March 1989
Skills
R&D, New Business Development, Direct Sales, Customer Service, Technical Presentations, Cross-functional Team..., Product Marketing, Website Development, Contract Manufacturing, Biotechnology, Pharmaceutical Sales, Vaccines, Hospitals, Clinical Trials, Microbiology, Leadership, Lifesciences, Healthcare, Management, Pharmaceutical Industry, Sales Management, Sales Operations, Marketing, Medical Devices, Pharmaceutics, B2B, Employee Training, Military Logistics, Recruiting, Business Development, Biopharmaceuticals, CRM, Product Launch, Training, Entrepreneurship, Board Leadership, Logistics Planning, Training & Development, FDA, LIMS, Coaching, Aseptic Technique, Start-ups, Marketing Strategy, Cold Calling, Strategy, Drug Discovery, Selling, Budgets, 21 CFR Part 11
Education
State University of New York at Buffalo 1985 — 1990
B.A., Communication and Psychology, Public Relations & Advertising Minor
University at Buffalo 1985 — 1990
Bachelor's degree, Communication & Psychology
Putnam Investments January 2001 - April 2004
aaiPharma January 1996 - January 2001
Skills
Cisco Technologies, Disaster Recovery, VPN, Network Security, Windows Server, VMware, Troubleshooting, Active Directory, TCP/IP, Network Architecture, Virtualization, SQL, Firewalls, Team Leadership, Security, Servers, VoIP, Unix, Solaris, Project Management, WAN, Integration, Data Center, Networking, System Administration, Network Administration, Linux, Switches, IT Management
Education
University of Massachusetts Lowell 1998 — 2006
BSIT, Information Technology
Worcester Polytechnic Institute 1991 — 1994
Electrical Engineering
AAIPharma Services Corp. 2015 - Present
AAIPharma 2010 - Present
aaipharma 1997 - 2009
New Hanover Regional Medical Center 1991 - 1997
New Hanover Regional Medical Center 1991 - 1997
Skills
Pharmaceutical Industry, Software Documentation, 21 CFR Part 11, FDA, GMP, CRO, Clinical Trials, Validation, Biotechnology, CTMS, Change Control, Computer System..., GCP, Clinical Development, Management, SOP, Sop
Education
University of North Carolina at Wilmington 1999 — 2001
BS, Computer Science
University of Mount Olive 1995 — 1999
BS, Business Administration
Aurobindo Pharma USA, NC May 2015 - Present
Cirrus Pharmaceuticals, Inc., a Kemwell company July 2013 - April 2015
KEMWELL BIOPHARMA INC. November 2012 - April 2015
LUPIN Ltd., Pune, India October 2007 - November 2011
AAIPharma April 2006 - September 2007
Synta Pharmaceuticals June 2004 - December 2005
Magellan/Cardinal Health 2001 - 2004
Procter & Gamble Pharm. 1990 - 1994
Skills
* Pharmaceutical..., * Formulation..., Business Development, Team Leadership, Global Alliances, International Business..., Outsourcing Management, Licensing, Drug Delivery, R&D, GMP, Pharmaceutics, Product Development, Cross-functional Team..., FDA, Regulatory Submissions, Formulation, Contract Manufacturing, Biopharmaceuticals, Pharmaceutical Industry, Technology Transfer, Clinical Development, Regulatory Affairs, Drug Development, GLP, ANDA, Life Sciences, CRO, Strategy, Clinical Trials, Medical Devices
Education
University of South Carolina-Columbia 1984 — 1990
Doctor of Philosophy (PhD), Pharmaceutical Sciences
LMCP
B. Pharm. & M.Pharm., Pharmaceutical Sciences
Novella Clinical July 2015 - Present
Novella Clinical, Inc. April 2013 - August 2015
Novella Clinical, Inc. January 2011 - April 2013
Novella Clinical, Inc. May 2008 - December 2010
AAIPharma June 2007 - May 2008
PPD February 2006 - June 2007
University of North Carolina at Chapel Hill January 2004 - February 2006
Skills
Financial Reporting, Budgeting, Compliance, Forecasting, Data Analysis, Contract Management, Staff Management, Business Analysis, Project Finance, Deltek, Costpoint, EAC, Budgets, Leadership, Accounting, Clinical Trials, Financial Analysis, Auditing, Cost Accounting, Pharmaceutical Industry, Sarbanes-Oxley Act
Education
University of Alabama at Birmingham 1993 — 1997
Bachelor of Science (BS), Accounting
Proficient Learning, LLC October 2004 - Present
aaiPharma July 2003 - October 2004
UCB Pharma February 2000 - July 2003
Pfizer February 1995 - February 2000
The SEARLE Company Ltd. 1995 - 2000
Schwarz Pharma February 1993 - January 1995
Armstrong World Industries 1988 - 1993
Skills
Training, Pharmaceutical Sales, Selling Skills, Medical Devices, Sales, Biotechnology, Sales Force Development, Sales Management, Leadership Development, Hospitals, Product Launch, Learning Management, Sales Effectiveness, Cross-functional Team..., Instructor-led Training, Cardiology, Neurology, Sales Trainings
Education
Ohio State University 1983 — 1988
BS in Business Administration, Marketing & International Business
Medidata Solutions April 2015 - Present
Medidata Solutions December 2013 - April 2015
PPD August 2010 - December 2013
PPD August 2007 - July 2010
Rogers Corporation June 2005 - August 2007
Pfizer October 2004 - June 2005
aaipharma January 2003 - July 2004
AAIPharma Services Corp. January 2001 - January 2003
Skills
21 CFR Part 11, CRO, Oracle Clinical, EDC, Visio, Clinical Trials, Active Directory, Pharmaceutical Industry, Databases, ctms, Medidata, Oracle RDC, Inform, Data Management, CTMS, Clinical Data Management, Clinical Development, Software Documentation, GCP, Management, FDA, SOP
Education
University of North Carolina at Wilmington 1995 — 1999
Bachelor of Arts (B.A.), English
West Forsyth
Gilead Sciences January 2012 - Present
Pharmasset, Inc. March 2007 - January 2012
AAIPHARMA 2005 - 2007
GlaxoSmithKline 1999 - 2005
Quintiles 1997 - 1999
Skills
Clinical Development, Clinical Pharmacology, Clinical Trials, Transplant, CRO, Drug Development, EDC, GCP, Clinical Monitoring, Pharmaceutical Industry, Therapeutic Areas, Medical Writing, CTMS, Clinical Research, Regulatory Submissions, Infectious Diseases, Biotechnology, ICH-GCP, Regulatory Affairs, Pharmacovigilance
Education
UNC Chapel Hill
Master's degree
GE Energy March 2008 - Present
AAIPharma 2006 - 2008
AAI Pharma November 2000 - 2006
Skills
Chemistry, HPLC, Pharmaceutical Industry, Gas Chromatography, Laboratory, FDA, Analytical Chemistry, GMP, V&V, Chromatography, UV, Wet Chemistry
Education
University of South Florida 1988 — 1991
MAETRICS June 2015 - Present
inVentiv Health October 2009 - June 2015
Rules Based Medicine March 2008 - October 2009
AAIPharma October 2006 - October 2007
PRA International 2004 - 2006
Covance 2002 - 2004
Quest Diagnostics January 1990 - November 2001
Skills
Clinical Trials, CRO, Biotechnology, Clinical Development, Lifesciences, Oncology, Clinical Research, Pharmaceutical Industry, EDC, Drug Development, CTMS, Validation, Infectious Diseases, Biopharmaceuticals, GCP, Drug Discovery, Hardware Diagnostics, Clinical Data Management, Business Development, Vaccines, Regulatory Affairs, Neurology, Cardiology, Clinical Monitoring, ICH-GCP, Life Sciences, Commercialization, Pharmacovigilance, Business Strategy
Education
University of Scranton 1975 — 1979
BS
ABC Labs September 2007 - Present
MDS Pharma Services 2001 - Present
AAIPharma 2006 - 2007
Education
Temple University 1978 — 1983
IQ Consortium January 2013 - Present
Biogen Idec December 2009 - Present
IQ Consortium 2012 - 2012
Vertex Pharmaceuticals July 2006 - November 2009
Synta Pharmaceuticals 2005 - 2006
aaiPharma April 1999 - December 2005
Cygnus 1997 - 1999
Education
University of Miami 1995 — 1997
Post-Doctoral Fellow, Electrochemistry
University of Houston 1991 — 1995
Ph.D., Analytical Chemistry
Alexion Pharmaceuticals, Inc. May 2015 - Present
Amgen May 2006 - Present
Cardinal Health, SPS 2005 - 2006
AMEC BioPharmaceuticals 2001 - 2005
Day & Zimmermann 1999 - 2001
AAIPharma February 1997 - October 1999
Skills
Validation, Cleaning Validation, Project Management, Process Validation (PPQ), Quality Assurance, Regulatory Compliance, CAPA, Change Control, Biopharmaceuticals, 21 CFR Part 11, FDA, SOP, Technology Transfer
Education
University of North Carolina at Wilmington
U.S. Pharmacopeia September 2013 - Present
AAIPharma Services Corp. January 2009 - September 2013
AAIPharma Services Corp. October 2006 - January 2009
Fisher BioServices May 2004 - October 2006
AAC Consulting Group August 2000 - May 2004
AAIPharma July 1997 - August 2000
Skills
GMP, Validation, Pharmaceutical Industry, Change Control, Cleaning Validation, Quality System, Quality Assurance, CAPA, Technology Transfer, FDA
Education
University of North Carolina at Wilmington 1991 — 1996
Bachelor's degree, Chemistry
WuXi AppTec May 2014 - Present
AAIPharma Services Corp. January 2012 - June 2014
AAIPharma Services Corp. June 2009 - January 2012
The NutraSweet Company July 2008 - November 2008
AAIPharma July 2006 - June 2008
Holopack International July 2004 - July 2006
Skills
Manufacturing, GMP, Process Improvement, Validation, LIMS, Pharmaceutical Industry, FDA, HPLC, Software Documentation, Microbiology, SAP, Microsoft Excel, Project Management, V&V, Quality System, Quality Assurance, Sop, Biotechnology, Quality Control, SOP
Education
University of South Carolina-Columbia 1998 — 2003
Bachelor of Science (B.S.), Biology/Biological Sciences, General
Medtronic August 2011 - Present
Medtronic Spinal & Biologics January 2009 - March 2012
Medtronic 2007 - January 2009
Kelly Scientific Resources July 2006 - August 2007
National Eye Bank Center January 2006 - July 2006
Borghese Cosmetics 2005 - 2006
AAIPharma September 2001 - April 2005
Skills
Complaint Investigations, Product Complaints, Trend Analysis, Failure Modes, Root Cause Analysis, Spinal Implants, Interventional Spine, Spinal Decompression, Quality Assurance, Quality Improvement, Post Market Surveillance, Medical Devices, Medical Records, Product Knowledge, Microbiology, Pharmaceutical Sciences, Pharmaceutical..., Training & Development, Tissue Banking, FDA, Regulatory Requirements, Regulatory Guidelines, Microbiologists, CAPA, Corrective Actions, Preventive Actions, Auditing, External Audit, Internal Audit, Customer Relations, Quality Auditing, Requirements...
Education
University of North Carolina at Wilmington 1998 — 2002
Bachelor of Science, Biology
SDM Specialty Health Network October 2004 - Present
Shoppers Drug mart Specialty Health Network 2004 - Present
Shoppers Drug Mart Specialty Health Network 2004 - 2015
Shoppers Drug Mart Specialty Health Network 2004 - 2015
Shoppers Drug Mart Specialty Health Network 2004 - 2015
CALEA 2004 - 2008
AAIPharma Services Corp. 2001 - 2004
AAIPharma Services Corp. 2001 - 2004
AAIPharma Services Corp. 2001 - 2004
aaiPharma 2001 - 2003
Skills
Pharmaceutical Industry, Project Management, Strategic Planning, Team Leadership, Cross-functional Team..., Business Development, Change Management, Management, Leadership, Process Improvement, Microsoft Excel, Marketing, Strategy, Healthcare, New Business Development, Sales Management, Oncology, Contract Negotiation, Quality Assurance, Medical Devices, Operations Management
Education
University of Phoenix 2003 — 2008
BSc, MBA, Business Administration
Grifols Therapeutics, Inc. (Formerly Talecris) April 2011 - Present
Talecris Biotherapeutics, Inc. September 2009 - April 2011
Talecris May 2009 - September 2009
Wyeth 2008 - November 2008
Wyeth Biotech April 2005 - May 2008
Wyeth Biotech August 2001 - April 2005
AAIPharma 1998 - 2001
CompuChem January 1987 - August 1996
Triangle Laboratories July 1985 - December 1987
Skills
Microsoft Office, Documentum, Document Management, Supervisory Skills, Technical Writing, Training Delivery, Proofreading, Data Compilation, Data Quality, Analytical Chemistry, Data Collection, Sop, Quality Assurance, CAPA, GMP, HPLC, GLP, Quality System, Pharmaceutical Industry, Validation, Software Documentation, LIMS, GxP, Biotechnology, Change Control, FDA, Aseptic Processing, Computer System..., V&V, Quality Control, SOP, Trackwise, 21 CFR Part 11
Education
Temple University 2012 — 2016
MS Quality Assurance/Regulatory Affairs
University of North Carolina at Chapel Hill 1981 — 1985
BS, Chemistry
QCL -quality chem labs March 2015 - Present
Quality Chemical Laboratories February 2014 - March 2015
URL PHARMA January 2009 - May 2013
URL PHARMA July 2005 - January 2009
Elan 2003 - 2005
Protarga 2002 - 2003
AAIPharma 1996 - 2002
Skills
USP, Pharmaceutical Industry, Chromatography, GMP, Project Management, Validation, Technology Transfer, FDA, Formulation, Chemistry, 21 CFR Part 11, V&V, Organic Chemistry, HPLC, Sop, R&D, Change Control, Six Sigma, GLP, Cleaning Validation, CAPA, Regulatory Affairs, Drug Development, Pharmaceutics, Laboratory, SOP, LIMS, Quality System
Education
University of North Carolina at Wilmington 1993 — 1995
MS, Chemistry
University of North Carolina at Wilmington 1988 — 1993
BA, Chemistry, Environmental Studies, Teacher Certification
John T. Hoggard 1986 — 1988
HS
Education Management Systems, Inc. March 2005 - Present
AAIPharma March 2001 - July 2004
VisonAIR January 1998 - February 2001
Skills
Project Management, SQL, Leadership, Microsoft SQL Server, Active Directory, Visual Studio, Change Management, Integration, Visio, SAP R/3, Software Documentation, Databases, Hands-on Training, Testing, Quality Assurance
Education
University of North Carolina at Wilmington 1994 — 1999
BS, Computer Science
AAIPharma SAP AnalystAAI Pharma1999 - Present
AAIPharma Services Corp. 1999 - Present
AAI Development Services 1999 - Present
Applied Analytical Industries (AAI) 1985 - Present
Education
University of North Carolina at Wilmington 1979 — 1982
AAIPharma Senior Medical DirectorAAI Pharma2003 - Present
Evin H Sides, III, MD April 1978 - March 1998
US Army Reserve May 1968 - September 1969
Skills
Clinical Trials, Infectious Diseases, Clinical Research, GCP, Medicine, Clinical Development, Medical Affairs, Hospitals, Therapeutic Areas
Education
University of North Carolina at Chapel Hill School of Medicine 1961 — 1965
Wake Forest University 1954 — 1958
BS, Pre-Med
PPD October 2013 - Present
PPD April 2011 - October 2013
PPD November 2007 - March 2011
AAIPharma November 2004 - November 2007
Skills
Clinical Trials, Pharmaceutical Industry, Clinical Development, CRO, GCP
Education
University of North Carolina at Wilmington 2004 — 2006
MS, Mathematics with Statistics concentration
University of North Carolina at Wilmington 1999 — 2004
BS, Mathematics
University of North Carolina at Wilmington 1999 — 2004
BS, Statistics
PPD April 2014 - Present
PPD July 2008 - Present
AAIPharma October 1990 - July 2008
Skills
CRO, Pharmaceutical Industry, Clinical Trials, Clinical Research, Sop, Validation, Biotechnology, Change Control, Contract Negotiation, Process Improvement, CTMS, GCP, Budgets, Project Management, FDA, Analytical Chemistry
Education
University of North Carolina at Pembroke 1988 — 1990
Bachelor of Science (B.Sc.), Analytical Chemistry
AAIPharma July 2006 - Present
Yankee Candle Company November 2003 - Present
Education
University of North Carolina at Wilmington 2001 — 2005
AAI Pharma Services June 2013 - Present
Eli Lilly & Company December 2002 - May 2013
Insmed Incorporated September 2001 - September 2002
Wyeth April 1998 - August 2001
AAIPharma May 1996 - March 1998
Skills
Validation, Pharmaceutical Industry, GLP, GMP, FDA, Chemistry, Analytical Chemistry, Formulation, Pharmaceutics, Technology Transfer, Sop, HPLC, Drug Discovery, Drug Delivery, Biotechnology, Chromatography, R&D, Regulatory Submissions, Drug Development, V&V, Clinical Development, Change Control, Regulatory Affairs, Computer System..., CRO, CAPA, 21 CFR Part 11, Clinical Trials, Generic Programming, Quality System, Lifesciences, Dissolution, Cleaning Validation, LIMS, IND, Contract Manufacturing, CTMS, Quality Control, GCP, SOP
Education
University of South Carolina-Columbia 1990 — 1995
MS, Pharmacy
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
PPD 2002 - Present
AAIPharma 1989 - 1999
Skills
Pharmaceutical Industry, CRO, Drug Development, Biotechnology, Clinical Trials, Analytical Chemistry, Validation, Clinical Development, Drug Discovery, Lifesciences, GCP, FDA, Biopharmaceuticals, Oncology, Technology Transfer, CTMS, Business Development, GLP, Regulatory Affairs, Sop, EDC, Chromatography
Education
University of North Carolina at Wilmington 1998 — 2000
Quintiles April 2011 - Present
AAIPharma June 2006 - June 2010
Quintiles June 2003 - May 2006
Cazenove January 2001 - March 2003
PA Consulting 1998 - 2000
Skills
R&D, Management, FDA, CRO, Pharmaceutical Industry, GCP, Drug Development, Drug Discovery, Clinical Trials, Biotechnology, Oncology, Infectious Diseases, Medical Devices, Due Diligence, Clinical Development, Product Launch, Strategic Planning, Business Planning, Strategy, New Business Development, Cross-functional Team..., Clinical Data Management, Therapeutic Areas, Strategic Partnerships, Start-ups, Technology Transfer, Lifesciences, Corporate Development, Equities, Healthcare, Business Strategy, Business Development, Mergers & Acquisitions, Global Business..., Commercialization, Biopharmaceuticals, Market Access, Regulatory Affairs, CTMS, Clinical Operations, EDC, Clinical Research, Strategic Alliances
Education
The University of Glasgow 1994 — 1998
AAIPharma December 1993 - April 2013
Skills
Pharmaceutical Industry, CRO, GMP, Sop, FDA, Clinical Trials, Validation, Clinical Development, Biotechnology, Technology Transfer, 21 CFR Part 11, LIMS
Education
University of North Carolina at Wilmington 1989 — 1993
GO Race Productions March 2001 - Present
PPD April 2008 - October 2011
AAIPharma October 2005 - April 2008
AAIPharma Services Corp. May 2006 - December 2006
Skills
Sailing, Event Producing, Timing, Event Management, Events Coordination, Events Organisation, Triathlon, Running, Customer Service, EDC, Hematology, Oncology Clinical..., Leadership, Event Planning, Chemistry, Clinical Trials, Public Speaking
Education
University of North Carolina at Wilmington 2003 — 2005
Masters of Science, Inorganic Chemistry
University of North Carolina at Wilmington 1999 — 2003
Bachelor of Science, Marine Biology w/ Honors
University of North Carolina at Wilmington 1999 — 2003
Bachelor of Arts, Chemistry
Boston Scientific June 2014 - Present
Boston Scientific September 2009 - Present
Boston Scientific 2007 - 2009
AAIPharma 2002 - 2007
AAI Development Services, formerly MTRA 1998 - 2002
Skills
Clinical Trial..., EDC, Medical Devices, Clinical Trials, Clinical Research, Oncology, Biotechnology, Process Improvement, GCP, Oracle Clinical, Mentoring, SOP, Excel, Word, Cardiac, ICH-GCP, Visio, Cardiology, Microsoft Office, Pharmaceuticals, CRO, Clinical Monitoring, Protocol Development, 21 CFR Part 11, CTMS, FDA, Computer System..., Therapeutic Areas, Regulatory Submissions, Data Management, Drug Development, Regulatory Affairs, Lifesciences, Pharmaceutical Industry, Life Sciences
Education
Université de Technologie de Compiègne 1992 — 1997
Bachelor of Science (B.S.), Biomedical and Biomechanics Engineering
Catalent Pharma Solutions July 2014 - Present
Catalent Pharma Solutions January 2012 - July 2014
Catalent Pharma Solutions April 2007 - January 2012
Irvine Analytical Labs January 2005 - April 2007
aaiPharma 1997 - 2005
Skills
Account Management, Business Development, FDA, Cross-functional Team..., Pharmaceutical Industry, GMP, Lifesciences, Analytical Chemistry, CRM, Biopharmaceuticals, Sales, CRO, Validation, Technology Transfer, Biotechnology, CTMS, Key Account Management, GLP, Sop, Chromatography, Drug Development, New Business Development, Clinical Trials, HPLC, Regulatory Affairs, Clinical Development, Oncology, Vaccines, Medical Devices, Pharmaceutics, SOP
Education
University of North Carolina at Wilmington 1993 — 1997
BS, Chemistry
ICON plc May 2015 - Present
Quintiles Transnational March 2007 - May 2015
GlaxoSmithKline March 2005 - March 2007
Johnson Controls March 2004 - March 2005
Varian, Inc. July 2001 - March 2004
SciQuest 1999 - 2001
AAIPharma January 1997 - March 1999
LabCorp June 1996 - January 1997
Skills
Analytical Chemistry, CRO, Clinical Data Management, CTMS, Clinical Monitoring, Sop, Clinical Development, HPLC, Pharmaceutical Industry, ICH-GCP, GxP, GMP, EDC, Clinical Trials, GCP, SOP
Education
University of North Carolina at Greensboro 1992 — 1996
Bachelor of Science (BSc), Chemistry
Children's Mercy Hospital February 2011 - August 2011
Oncimmune June 2007 - February 2011
AAIPharma January 2006 - May 2007
University of Kansas Medical Center August 2005 - November 2005
University of Kansas August 2004 - August 2005
University of Kansas February 2003 - August 2004
Skills
Western Blotting, SDS-PAGE, Immunohistochemistry, H&E staining, Animal Surgery, Circular Dichroism, Fluorescence Microscopy, Fluorescence..., Spectrophotometry, Cell Culture, Cell Viability Assays, Nanoparticles, Immunofluorescence, Histology, Fixation, sectioning, ELISA, EIA, Protein Chemistry, Silver Staining, Luminex, Fluid Flow Shear Stress..., Immunostaining, Clinical Research, Clinical Assays, Dynamic Light...
Education
The University of Kansas 2000 — 2005
B.S. Cellular Biology, B.G.S. Psychology, Cellular Biology, Psychology, Chemistry
AAIPharma Services Corp. 2014 - Present
AAIPharma Services Corp. September 2007 - Present
AAIPharma September 2007 - July 2009
Del Laboratories, Inc. September 2006 - February 2007
Skills
Pharmaceutical Industry, Sop, 21 CFR Part 11, Technology Transfer, FDA, CTMS, GMP, CRO, Validation, Clinical Trials, Change Control, Drug Development, GCP, CAPA, Oncology, Regulatory Affairs, EDC, Clinical Development, GxP, Regulatory Submissions, ICH-GCP, Biopharmaceuticals, Pharmaceutics, Biotechnology
Education
University of North Carolina at Wilmington 2002 — 2006
Business, Economics
Afaxys, Inc. October 2012 - Present
PPD September 2011 - October 2012
AAIPharma August 1990 - January 2011
Skills
Drug Development, GMP, CRO, FDA, CTMS, Project Management, Clinical Development, Clinical Trials, Validation, Pharmaceutical Industry, Sop, Contract Manufacturing, Cross-functional Team..., Quality System, Quality Assurance
Education
University of Mount Olive
Associate's Degree, General Studies
Osmotica Pharmaceutical Corp June 2008 - Present
AAIPharma 2005 - 2008
PPD March 2004 - November 2006
Endeavor Pharmaceuticals October 2000 - January 2004
AAIPharma (AAI) 1991 - 2000
US Army October 1984 - October 1988
Skills
Clinical Research, Management, Drug Development, Lifesciences, Project Management, Program Management, Contract Management, Proposal Writing, Clinical Trials, Pharmaceutical Industry, CRO, Clinical Development, GLP, FDA, GMP, Technology Transfer, Strategy, Regulatory Affairs, R&D, Product Development, Sop, Biotechnology, Validation
Education
Defense Language Institute 1984 — 1984
diploma, German
University of North Carolina at Wilmington 1983 — 1984
MBA, business
AAIPharma Services Corp. May 2012 - Present
Coatings and Adhesives Corporation February 2011 - May 2012
Coty November 2008 - February 2011
Coty October 2007 - November 2008
Coty October 2004 - October 2007
Del Laboratories / Coty August 2003 - October 2004
AAIPharma September 2001 - August 2003
Skills
Supply Chain Management, Process Improvement, Supply Chain, Logistics, Inventory Management, Continuous Improvement, Operations Management, Lean Manufacturing, SAP, Cross-functional Team..., Purchasing, Six Sigma, Manufacturing, Forecasting, Team Building, Change Management, Management, Warehousing, Product Development, Project Management, Team Leadership, Project Planning, Warehouse Management, Process Engineering, Materials Management, Production Planning, 5S, Contract Negotiation, Supply Chain..., Quality Management, Demand Planning, Quality System, Quality Assurance, Inventory Control, Strategic Planning, Leadership, Logistics Management, GMP, Transportation, P&L Management
Education
University of North Carolina at Wilmington 2002 — 2004
MBA, Business Administration
University of North Carolina at Wilmington 1997 — 2001
BS, Operations Management
Aveta Business Solutions
Six Sigma Black Belt Certification
PPD March 2008 - Present
AAIPharma 1998 - 2008
Education
University of North Carolina at Chapel Hill 1984 — 1987
BA, Political Science
C.R. Bard December 2009 - Present
AAIPharma February 2009 - December 2009
PRA International April 2000 - December 2008
Education
University of Rhode Island 1993 — 1998
BS, Zoology
J. R. Cardinal Consulting, LLC September 2006 - Present
Andrx Phramaceuticals August 2001 - September 2005
Watson Pharmaceuticals 2001 - 2005
AAIPharma May 1999 - May 2001
Pfizer Global R&D 1982 - 1988
Skills
Sop, Formulation, Drug Delivery, R&D, Controlled Release, Clinical Research, FDA, Product Development, Drug Development, Pharmaceutics, Technology Transfer, Pharmaceutical Industry, GLP, GMP, CRO, Biotechnology, Manufacturing, V&V, Change Control, Validation, Regulatory Affairs, Regulatory Submissions, Biopharmaceuticals, CAPA, HPLC, Clinical Development, 21 CFR Part 11
Education
University of Wisconsin-Madison 1967 — 1973
Ph.D., Pharmaceutics
University of Michigan 1962 — 1967
BS, Pharmacy
Akorn Pharmaceuticals April 2015 - Present
Allergan October 2013 - April 2015
Teva Pharmaceuticals March 2007 - October 2013
Xanodyne Pharmaceuticals January 2005 - March 2007
AAIPharma March 2002 - February 2005
Geneva Pharmaceuticals December 1992 - August 2001
Skills
Managed Care, Pharmaceutical Sales, Pharmaceutical Industry, Medical Devices, Cardiology, Oncology
Education
The Ohio State University
PPD April 2012 - Present
PPD January 2008 - April 2012
PPD December 2006 - January 2008
PPD January 2006 - December 2006
PPD September 2004 - January 2006
AAIPharma 2003 - 2004
AAIPharma 1999 - 2003
AAIPharma 1998 - 1999
Skills
Clinical Trials, Oncology, CRO, Pharmaceutical Industry, Clinical Monitoring, CTMS, GCP, EDC, Clinical Development, Clinical Data Management, Sop, FDA, Clinical Research, Regulatory Affairs, Technology Transfer, Protocol, ICH-GCP, Therapeutic Areas, Regulatory Submissions, IND, 21 CFR Part 11, Drug Development, SOP
Education
University of North Carolina at Wilmington 2002 — 2004
MBA, Business
Wingate University 1989 — 1993
BS, Chemistry
Xerox Corporation December 2010 - August 2011
Xerox Global Services May 2009 - December 2010
Xerox Global Services March 2006 - February 2009
Time Warner Cable April 2003 - March 2006
ePlus Technology August 1999 - January 2002
Road Runner November 1998 - June 1999
AAIPharma May 1994 - November 1998
Interactive Control Technology May 1989 - May 1994
Skills
Outsourcing, Virtualization, VMware, Microsoft Exchange, Disaster Recovery, Cloud Computing, Storage, Data Center, Team Leadership, Business Process..., Vendor Management, Program Management, IT Service Management, IT Management, Pre-sales, Security, ITIL, Integration, Process Improvement, Testing, Business Analysis
Education
University of North Carolina at Wilmington 1996 — 1998
MBA, Mergers and Aquisitions
University of North Carolina at Wilmington 1984 — 1988
BS, Computer Science
aaipharma 1984 - 2007
Education
University of North Carolina at Wilmington 1987 — 1991
MBA
AAIPharma June 1997 - December 2007
Education
The University of Kansas 1992 — 1996
Bachelor of Science, Chemistry
AAIPharma 1996 - Present
Skills
CRO, Sop, GMP, Pharmaceutical Industry, HPLC, Analytical Chemistry, Validation, Drug Development, LIMS, Clinical Development, Technology Transfer, FDA, GLP, Chromatography, Gas Chromatography
Education
University of North Carolina at Wilmington 1989 — 1994
BS ('91) MS ('94), Marine Biology
AAIPharma October 1998 - Present
AAIPharma Services Corp. 1998 - 2014
Walt Disney World June 1986 - May 1997
Skills
Quality Assurance, Process Improvement, Outlook, Manufacturing, Pharmaceutical Industry, Microsoft Word, PowerPoint, English, Windows, Technical Writing, Training, Validation, Report Writing, Customer Service
Education
Texas Woman's University 1982 — 1986
Bachelor of Arts (BA), Psychology
Liberty Healthcare March 2011 - Present
AAIPharma November 1987 - March 2008
Skills
Deferred Compensation, Employee Relations, HRIS, Performance Management, Human Resources, Talent Management, Organizational..., Healthcare, Benefits Administration, Change Management, Training, Employee Training
Education
University of North Carolina at Wilmington 1995 — 1997
MBA
University of North Carolina at Wilmington 1982 — 1986
BS
PPD February 2014 - Present
PPD July 2012 - January 2014
PPD September 2010 - July 2012
PPD December 2007 - September 2010
AAIPharma 1996 - 2007
AAIPharma 1996 - 2007
AAIPharma Services Corp. 1996 - 2007
Skills
Pharmaceutical Industry, CRO, Clinical Development, Clinical Trials, Sop, Regulatory Affairs, Biotechnology, Oncology, GMP, FDA, Validation, GCP, CTMS, Regulatory Submissions, Biopharmaceuticals, ICH-GCP, Drug Development
Education
University of North Carolina at Wilmington 2003 — 2006
Master of Business Administration (MBA)
University of North Carolina at Wilmington 1990 — 1996
Bachelor's degree, Chemistry