AAIPharma Services Corp.
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AAIPharma Services Corp. Employees
AAIPharma Services Corp. February 2008 - February 2015
Strides Inc April 2007 - December 2007
Skills
Pharmaceutical Industry, SOP, GMP, Microsoft Office, GLP, Microsoft Word, PowerPoint
Education
Sanford-Brown Institute-Iselin 2010 — 2011
N/A, Medical/Clinical Assistant
Union County College 2007 — 2008
N/A, Marketing
AAIPharma Services Corp. September 2015 - Present
AAIPharma Services Corp. September 2013 - September 2015
Citi June 2012 - September 2013
AAIPharma Services Corp. September 2011 - June 2012
Wells Fargo Home Mortgage November 2007 - September 2011
Wachovia May 2006 - November 2007
Skills
Credit, Banking, Mortgage Lending, Loans, Finance, Customer Service, Training, Credit Analysis, Analysis, Business Analysis, Management
Education
Radford University 2000 — 2004
Bachelor of Science, Industrial/Organizational Psychology
Dynalabs April 2014 - Present
AAIPharma Services Corp. July 2008 - April 2014
Hospira February 2013 - August 2013
Celsis Analytical Services May 2006 - August 2007
Undergraduate Research August 2006 - May 2007
Saint Louis University Hospital May 2005 - May 2007
Skills
HPLC, IC, Dissolution, Wet Chemistry, Microsoft Excel, Microsoft Word, USP, Chemistry, LIMS, GLP, Laboratory, Analytical Chemistry, Chromatography, GMP, Pharmaceutical Industry, SOP
Education
Saint Louis University 2003 — 2007
Bachelor of Arts (B.A.), Chemistry
Catalent Pharma Solutions February 2012 - Present
Xcelience, LLC March 2011 - March 2012
AAIPharma Services Corp October 2007 - March 2011
AAIPharma September 2003 - October 2007
AAIPharma April 2001 - September 2003
AAIPharma February 1998 - April 2001
ACTS Testing Labs August 1994 - February 1998
Skills
Biotechnology, Clinical Trials, Microbiology, Clinical, Manufacturing, Strategic Partnerships, Technology Transfer, Packaging, Analytical Chemistry, Laboratory, Clinical Research, Clinical Development, Sop, HPLC, Chromatography, Sales, Drug Development, Business Development, GMP, New Business Development, SAP, Medical Devices, Formulation, Chemistry, Pharmaceutics, Gas Chromatography, Pharmaceutical Industry, FDA, Assay Development, Validation, Biopharmaceuticals, Regulatory Affairs, Quality Control, Lifesciences, GLP, Oncology, CRO, R&D, SOP, Life Sciences, Cross-functional Team..., 21 CFR Part 11, Regulatory Submissions, Management
Education
State University of New York College at Fredonia 1990 — 1994
Bachelors of Science, Chemistry, Biology, and Ecology
State University of New York College at Fredonia 1990 — 1994
BS, Biology, General
AAIPharma Services Corp. April 2013 - Present
DPT Laboratories, August 2012 - April 2013
Dendreon April 2010 - January 2012
Medarex 2004 - April 2010
Medarex 2002 - 2004
Medarex 1999 - 2002
Medarex 1998 - 1999
Medarex 1996 - 1998
Medarex 1994 - 1996
Cytogen Corporation April 1991 - April 1994
Skills
Microbiology, Immunology, cGMP, GMP, LIMS, SOP, Cell Based Assays, QC, Aseptic Processing, Biotechnology, Pharmaceuticals, Life Sciences, Quality Systems, Aseptic Technique, Cell Culture, Pharmaceutical Industry, Sop, Lifesciences, Biologics, Cell, Quality Control, HPLC, FDA, Validation, ELISA, GLP, Vaccines, 21 CFR Part 11, Assay Development, Laboratory, Monoclonal Antibodies, Technology Transfer, GxP, CAPA, Quality Assurance, Quality System, Biopharmaceuticals, V&V, Chromatography, Purification, Antibodies, Protein Chemistry, Clinical Development, R&D, Clinical Trials, Gel Electrophoresis, DNA, Trackwise, Change Control
Education
University of Phoenix 2003 — 2005
MBA, HR management
Rutgers University-New Brunswick 1979 — 1982
B.S., Animal Science (Cook College)
Wagner College 1979 — 1981
M.S., Microbiology
Tottenville High School 1975 — 1978
HS, Academic
AAIPharma Services Corp. March 1997 - Present
Parke-Davis Pharmaceutical Res Div. Warner-Lambert November 1992 - February 1997
Skills
Formulation Chemistry, Targeted Drug Delivery, Product Development, Technology Product..., Manufacturing Scale-up, Management, Bilingual-English/Spanis..., Department Budget..., Staff Oversight, Drug Development, Formulation, Drug Delivery, GMP, Biopharmaceuticals, CRO, Clinical Development, Validation, Pharmaceutical Industry, Technology Transfer, FDA, SOP
Education
The University of Connecticut 1987 — 1992
Doctor of Philosophy (Ph.D.), Pharmaceutical Sciences
University of Puerto Rico 1981 — 1986
Bachelor of Pharmacy (B.Pharm.), Pharmacy
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
ORC International February 2015 - Present
ORC International February 2014 - February 2015
AAIPharma Services Corp. September 2011 - February 2014
Johnson & Johnson February 2010 - February 2012
Skills
Sales, Customer Service, PowerPoint, Microsoft Excel, Access, Microsoft Word, Data Analysis, Word, Excel, New Business Development, Outside Sales, Project Management, Sales Management, Sales Presentations, Problem Solving, Proposal Writing, Salesforce.com, Prospecting Skills, Account Management
Education
Penn State University 2005 — 2009
BS, Biology
AAIPharma Services Corp. August 2015 - Present
G&W Laboratories June 2014 - July 2015
Actavis October 2006 - June 2014
Actavis October 2006 - June 2009
St. Alban Mental Institute May 2004 - October 2006
Skills
GMP, Pharmaceutical Industry, Raw Materials, FDA, Sop, Change Control, Strategic Sourcing, Supply Chain, CAPA, Supply Chain Management, Oracle, QAD
Education
Radford University 2002 — 2006
Bachelor's degree, Chemistry
Strayer University-North Carolina
Master of Business Administration (MBA), Business Administration and Management, General
Sancilio & Company August 2015 - Present
AAIPharma Services Corp. November 2014 - August 2015
AAIPharma Services Corp. April 2011 - November 2014
Wilmington Pharmaceuticals October 2007 - April 2011
AAIPharma December 2001 - September 2007
Applied Analytical Industries, Inc. April 2001 - December 2001
Applied Analytical Industries, Inc. July 2000 - March 2001
Applied Analytical Industries, Inc. October 1998 - July 2000
Applied Analytical Industries, Inc. June 1998 - October 1998
Roxane Laboratories May 1997 - May 1998
Skills
cGMP, Manufacturing, Validation, Product Development, Negotiation, Pharmaceuticals, Customer Relations, Pharmaceutical Industry, GMP, CRO, Formulation, Technology Transfer, FDA, Drug Development, Customer Service, Sop, 21 CFR Part 11, Regulatory Submissions, Biotechnology, Regulatory Affairs, Process Improvement, Lifesciences, Bioanalysis, V&V, Drug Delivery, Clinical Trials, Contract Manufacturing, GCP, Generic Programming, Biopharmaceuticals, Oncology, Pharmaceutics, GLP, Clinical Development, Infectious Diseases, Medical Devices, Drug Discovery, CAPA, R&D, EDC, Analytical Chemistry, Clinical Research, Cross-functional Team..., CTMS, HPLC, CMC, IND, Change Control, LC-MS, Pharmacokinetics
Education
Purdue University 1981 — 1988
BS Pharmacy, Pharmacy
QC Specialist at Patheon Pharmaceuticals QC SpecialistBanner PharmacapsJune 2007 - Present
AAIPharma Services Corp. June 1996 - June 2007
General Electric through Paradyme, Inc. contractors 1991 - 1994
Oxford Laboratories, Wilmington, NC 1986 - 1991
Skills
GLP, GMP, HPLC, V&V, Gas Chromatography, Chemistry, Method Development, Laboratory, Trackwise, Empower, LIMS, Validation, Wet Chemistry, Sop, Technology Transfer, Analytical Chemistry, UV, CAPA, FDA, Pharmaceutical Industry, Quality Control, 21 CFR Part 11, Dissolution, Quality Assurance, Cleaning Validation, GxP, Change Control, UV/Vis, Chromatography, USP, Computer System..., Formulation, LC-MS, SOP, TrackWise
Education
University of North Carolina at Wilmington 1992 — 1996
MS, Chemistry
Shippensburg University of Pennsylvania 1965 — 1968
B.S., Education-Chemistry
Mallinckrodt Pharmaceuticals ( Formerly Questcor) August 2014 - Present
Questcor Pharmaceuticals inc. February 2009 - August 2014
UCB Pharma 2007 - 2009
Schwarz Pharma 2005 - 2007
AAIPharma Services Corp. 2002 - 2005
Novartis 2001 - 2002
Verizon Wireless July 1994 - February 2001
Skills
Neurology, Biotechnology, Pharmaceutical Sales, Product Launch, Sales, Cardiology, Selling Skills, Diabetes, Oncology, Sales Effectiveness, Immunology, Selling, Rheumatology, Neuroscience, Managed Care, Pharmaceutical Industry, Gastroenterology, Medical Devices, Nephrology
Education
The University of Akron 1989 — 1993
Target January 2015 - February 2015
University of North Carolina at Chapel Hill January 2009 - May 2009
AAIPharma Services Corp. 2004 - 2007
Skills
Technical Support, Help Desk Support, System Administration, Cisco Routers, Nursing, Microsoft Office, Cisco Technologies, Software Installation, VMware ESX, Operating Systems, Network Administration, Computer Hardware, vSphere, Software Documentation
Education
University of Cebu 2009 — 2013
Bachelors, Nursing
Durham Technical Community College 2004 — 2009
Associate's degree, Networking Technology
Cebu Institute of Technology University 2001 — 2003
N/A, Computer Science
AAIPharma Services Corp. January 2005 - September 2008
Kelly Scientific Resources October 2002 - May 2004
UC San Diego Medical Center June 2001 - August 2002
Skills
FDA GMP, ELISA, SDS-PAGE, UV/Vis, GLP, Chromatography, Drug Development, Biotechnology, Lifesciences, Chemistry, Bioanalysis, Dissolution, Mass Spectrometry, Regulatory Affairs, Gas Chromatography, Immunology, Assay Development, Validation
Education
UCSD 2000 — 2002
Bachelor of Science (BS), Biochemistry
Victor Valley College 1998 — 2002
Associate of Science (A.S.), Scince
Mallinckrodt Pharmaceuticals February 2014 - Present
Mallinckrodt Pharmaceuticals May 2013 - February 2014
AAIPharma Services Corp. March 2013 - May 2013
EAG Life Sciences July 2010 - March 2013
Skills
GMP, Analytical Chemistry, HPLC, Wet Chemistry, UV/Vis, FTIR, GLP, Chemistry, Microsoft Office, Polarimeter, Dissolution, GC-FID, GC-MS, Karl Fisher, pH meter, extractables and...
Education
Truman State University 2006 — 2010
Bachelor of Science (BS), Chemistry
Republic Nation March 2014 - Present
Republic National Distributing Company May 2013 - Present
Medical University of South Carolina March 2012 - March 2014
AAI Pharma September 2011 - March 2012
AAIPharma Services Corp. January 2011 - September 2011
Skills
Pharmaceutical Industry, Sop, Manufacturing, FDA, Microsoft Office, GMP, Validation
Education
University of South Carolina Upstate 2008 — 2010
Bachelor of Science, Interdisciplinary Studies
Spartanburg Methodist College 2006 — 2008
Associate in Science
McKesson Health IT May 2014 - Present
MACIPA April 2010 - October 2013
AAIPharma Services Corp. January 2000 - February 2002
Skills
Microsoft Office, Project Management, Process Improvement, Salesforce.com, Customer Service, Outlook, Microsoft Excel, CRM, Management, Data Analysis, Database Administration, Microsoft Word, PowerPoint, Software Documentation, Windows 7, Active Directory, Troubleshooting, Healthcare Information..., Healthcare
Education
Lexington High School
St. Bonaventure University
Bachelor's Degree
Allergan, Inc. February 2014 - Present
Biotech CMQR Consulting, LLC June 2012 - December 2013
Teva Pharmaceuticals October 2011 - February 2012
Cephalon, Inc. May 2010 - October 2011
Ception Therapeutics, Inc. January 2007 - May 2010
Johnson & Johnson 2003 - 2007
AAIPharma Services Corp. 2001 - 2003
Aronex Pharmaceuticals 1996 - 2001
Alcon Laboratories, Inc. 1992 - 1996
Skills
GMP, Technology Transfer, Biotechnology, IND, CMC, Manufacturing, Contract Manufacturing, Product Development, Six Sigma, Life Sciences, Cell Culture, Lyophilization, Project Management, Business Development, NDA, eCTD, Recombinant Proteins, Budget Oversight, Staff Development, Antibody, Monoclonal Antibody MAB, Process Development, Upstream, Downstream Processing, Process Validation, Operations, CMO, Third Party..., Comparability studies, Biologicals, Formulation Development, Sterile Products, Small Molecule Drug..., Aseptic Manufacturing, Stability protocol, Drug Product, Methods Validation, Drug Substnace, CMC Regulatory..., BLA, MAA, QC, Quality Audit, Quality Agreements, Technical Support, Green Belt, Quality Systems, Protein Purification, Fermentation Process..., Management
Education
University of Arizona 1987 — 1992
PhD, Pharmaceutical Sciences
Villanova University 2012 — 2012
Six Sigma Green Belt
University of Mumbai 1984 — 1986
MS, Pharmacy, Pharmacology, Natural Products
University of Mumbai 1981 — 1984
BS, Pharmacy
AAIPharma Services Corp. April 2011 - Present
Petigru Properties January 2007 - August 2011
Inglese Law Office January 2006 - April 2011
Skills
CRO, Clinical Trials, Medical Devices, Life Sciences, GCP, Validation, Sop, Oncology, Biotechnology, Change Control, CAPA, GLP, Management, Sales
Education
College of Charleston
Bachelor of Science / Business Administration
Trident Technical College
Paralegal Studies
AAIPharma Services Corp. July 2014 - Present
Nesher Pharmaceuticals (USA) LLC December 2013 - May 2014
Sovereign Pharmaceuticals September 2013 - December 2013
Sovereign Pharmaceuticals March 2011 - September 2013
KV Pharmaceuticals August 2002 - March 2011
The Dial Corporation November 1999 - August 2002
LHB Industries November 1998 - November 1999
STERIS Corporation December 1997 - November 1998
quanterra environmental laboratories October 1997 - December 1997
Skills
cGMP, HPLC, FDA, Pharmaceuticals, Dissolution, GMP, Validation, CAPA, Quality Assurance, Quality Control, Analytical Chemistry, Gas Chromatography, Chromatography, Wet Chemistry, Sop, SOP, GLP, Pharmaceutical Industry
Education
Webster University 2008 — 2010
Master of Science, Science Management
Southern Illinois University, Carbondale 1993 — 1996
Bachelor of Science, Chemistry
AustarPharma, LLC January 2015 - Present
AustarPharma, LLC August 2012 - December 2014
AAIPharma Services Corp. August 2009 - August 2012
AAIPharma Services Corp. / Celsis Analytical Services November 2005 - August 2009
Anderol Inc February 2004 - July 2005
Stepan Company June 2000 - November 2003
Wyeth Ayerst Pharmaceuticals 1998 - 2000
Health Research Inc., Wadsworth Laboratories 1997 - 1998
Marine Biological Laboratory 1997 - 1997
Skills
CAPA, cGMP, Microbiology, SOP, GMP, Analytical Chemistry, HPLC, Quality Assurance, Compliance, Documentation, UV-Vis
Education
State University of New York at Stony Brook
Bachelors of Science Degree, Biology
Hostess Brands February 2012 - Present
Kobi Partners, LLC 2010 - Present
Indiana Live Casino and Indiana Downs Racetrack February 2011 - April 2012
The Great Atlantic & Pacific Tea Company January 2011 - April 2012
NYCOTB July 2010 - January 2011
Magna Entertainment Corp. March 2009 - May 2010
Muzak 2005 - 2006
AAIPharma Services Corp. 2004 - 2005
WorldCom 2003 - 2004
Sunterra 2002 - 2003
Skills
Mergers, Executive Management, Financial Analysis, Restructuring, Due Diligence, Strategic Planning
Education
University of Alabama 1980 — 1982
MA, Accounting
AAIPharma Services Corp. April 2003 - Present
Skills
Analytical Chemistry, Sop, Drug Development, Validation, Business Development, GMP, Manufacturing, Formulation, Customer Service, Pharmaceutical Industry, Quality Assurance, CAPA, FDA, Quality System, Change Control, SOP
Education
Southern New Hampshire University 2014 — 2017
Bachelor's Degree, Project Management
Oak Ridge National Laboratory February 2015 - Present
University of Tennessee August 2014 - Present
Durham County Government 2014 - 2014
AAIPharma Services Corp. December 2012 - 2013
Syngenta October 2011 - May 2012
North Carolina State University Theatre January 2010 - July 2011
Skills
Theatre, Time Management, Microbiology, Customer Service, Social Media Marketing, Information Science, Data Management, Publishing, HTML, Ebooks, Academic Libraries, Library Science
Education
University of Tennessee-Knoxville 2014 — 2016
Master's degree, School of Information Science
North Carolina State University 2009 — 2011
Bachelors of Science, Microbiology; Genetics
Haas PHARMTECH Consulting LLC June 2015 - Present
G&W Laboratories June 2014 - May 2015
Lachman Consultant Services 2015 - 2015
Lachman Consultant Services 2015 - 2015
Forest Laboratories March 2010 - March 2014
Schering Plough Merck 2001 - 2010
Hoffman-La Roche Ltd 2000 - 2001
AAIPharma Services Corp. 1998 - 2000
Novartis 1997 - 1998
Ciba-Geigy 1996 - 1997
Skills
Continuous Improvement, Product Development, Supply Chain Management, Process Improvement, cGMP, Pharmaceuticals, GMP, FDA, Technology Transfer, Validation, Cross-functional Team..., Process Validation, Operations Management, Team Building, Team Leadership, Packaging, 21 CFR Part 11, CAPA, Change Control, Clinical Trials, Formulation, Lifesciences, Manufacturing, Pharmaceutical Industry, Pharmaceutics, Quality System, R&D, Regulatory Affairs, Sop, Strategy, V&V, Biopharmaceuticals, Drug Development, GLP, EMEA, Organizational..., Life Sciences, SOP, Biotechnology, Coaching Baseball, Sports Coaching
Education
Universität Basel 1982 — 1985
Ph.D., Pharmaceutical Technology
Universität Basel 1976 — 1982
Master of Phamaceutics, Pharmacy Pharmaceutical Technology
AAIPharma Services Corp. May 2014 - Present
Southern Illinois University Edwardsville January 2012 - May 2014
Southern Illinois University Edwardsville August 2010 - May 2014
Skills
Leadership, Public Speaking, Chemistry, Sales, Inside Sales, Consoltative Selling, Analytical Chemistry, Salesforce.com, Microsoft Excel, USP-NF, Research, Data Analysis, GC, HPLC, PowerPoint, Microsoft Word, Statistics
Education
Southern Illinois University, Edwardsville 2010 — 2014
Bachelor of Arts (BA), Chemistry
Streator Township High School 2006 — 2010
Gruppo Campari September 2015 - Present
AAIPharma Services Corp. March 2015 - September 2015
Brown-Forman May 2014 - September 2014
Brown-Forman December 2012 - September 2013
Nealanders International Inc January 2012 - April 2012
Skills
Data Analysis, Statistics, SPSS, Research, Qualitative Research, Stata, R&D, Quantitative Research, Report Writing, Laboratory, Microbiology, Team Leadership
Education
University of Guelph 2010 — 2014
Honors Bachelor of Science (B.Sc.), Biochemistry, Business Administration
kaleo April 2013 - Present
MedImmune 2009 - 2013
MedImmune 2005 - 2008
MedImmune 2003 - 2005
SageNet/Spacenet January 2000 - January 2002
AAIPharma Services Corp. January 1999 - January 2000
AAIPharma Services Corp. January 1995 - January 1998
AAIPharma Services Corp. January 1994 - January 1995
Vought Aircraft January 1991 - January 1994
Vought Aircraft January 1988 - January 1991
Skills
Supply Chain Management, Supply Chain, Materials Management, SAP, Process Improvement, Procurement, FDA, Manufacturing, Validation, ERP, Sop, Forecasting, Logistics, Change Management, Project Management, SAP R/3, MRP, Project Planning, Inventory Management, Warehousing
Education
Texas A&M University 1979 — 1984
Bachelor of Science (B.S.), Industrial Engineering
University of North Carolina at Wilmington 1995 — 1997
MBA, Business Administration
AAIPharma Services Corp. October 2013 - Present
Boehringer Ingelheim September 2010 - September 2013
Walgreens October 2005 - August 2010
Skills
Parenteral..., Pharmaceutical Industry, GMP, Quality Assurance, Sop, FDA, USP, Compliance, 21 CFR, Regulatory Affairs, Quality Auditing, Manufacturing Operations, Aseptic Processing, Technology Transfer, Change Control, Product Complaints, Compounding, Formulation, Validation, CAPA, Master Control, ProCal, Trackwise, 21 CFR Part 11, Team Leadership, Cross-functional..., Problem Solving, Document Creation, Technical Documentation, ANDA, Quality System, Interpersonal Skill, Process Improvement, Supervision, Project Management, Laboratory, Cleaning Validation, ICH guidelines, Medical Terminology, GCP, GLP, Clinical Research, Microsoft Excel, Biotechnology, Medical Devices, HIPAA, Investigation, Clinical Trials, Regulatory Requirements
Education
Northeastern University 2011 — 2012
Master's Certificate, Biopharmaceutical International Regulatory Affairs
Old Dominion University 2007 — 2010
Bachelor of Science (BSc), Chemistry
Kent State University, The Center for Corporate and Professional Development
Introduction to Lean Sigma
Goodwin Biotechnology, Inc. 2015 - Present
AAIPharma Services Corp. July 2012 - March 2014
Goodwin Biotechnology, Inc. January 2012 - July 2012
Goodwin Biotechnology, Inc. January 2011 - January 2012
Goodwin Biotechnology, Inc. November 2009 - January 2011
Goodwin Biotechnology, Inc. November 2007 - November 2009
Eli Lilly and Company December 2005 - December 2006
O-I February 2005 - December 2005
Skills
Biotechnology, Validation, Biopharmaceuticals, GMP, Aseptic Processing, GLP, Sop, Software Documentation, CAPA, Lifesciences, Vaccines, FDA, Manufacturing, Clinical Trials, V&V, Technology Transfer, Change Control, Trackwise, LIMS, Purification, Chromatography, SOP, Life Sciences
Education
Universidad Metropolitana
BS, Environmental Sciences
AAIPharma Services Corp. April 2005 - Present
Celsis Analytical Services January 2002 - April 2005
Celsis Analytical Services October 1999 - April 2005
Washington University School of Medicine January 1999 - August 1999
Skills
Network Administration, Chromatography, Computer System..., Sop, HPLC, Database Administration, GMP, Laboratory, 21 CFR Part 11, Pharmaceutics, V, FDA, SOP, Technology Transfer, Validation, Pharmaceutical Industry
Education
Southeast Missouri State University 1994 — 1998
Bachelor's, Chemistry and Minor in Microbiology
AAIPharma Services Corp. June 2014 - Present
Boulder Brands December 2011 - June 2014
Becton Dickinson February 2008 - December 2011
Givaudan April 2009 - July 2009
L'Oréal October 2007 - February 2008
Skills
Quality Assurance, R&D, Microsoft Excel, Product Development, Microsoft Word, Troubleshooting, Chemistry, GMP, FDA, Excel, Word, Sales
Education
New Jersey City University 2003 — 2007
B.A., Biology
Sentio BioSciences February 2014 - June 2015
AAIPharma Services Corp. January 2012 - November 2013
Celsis Analytical Services October 2011 - January 2012
Celsis Analytical Services April 2008 - October 2011
Centocor Biologics, LLC June 2007 - April 2008
Celsis Laboratory Group September 2003 - June 2007
Celsis Laboratory Group March 1994 - September 2003
Ecolochem, Incorporated November 1993 - March 1994
Skills
cGMP, Microbiology, Validation, GMP, Sop, GLP, Biotechnology, FDA, Biopharmaceuticals, Technology Transfer, Lifesciences, Pharmaceutical Industry, CAPA, Analytical Chemistry, HPLC, 21 CFR Part 11, Drug Development, Chromatography, SOP, Life Sciences
Education
Southern Illinois University, Carbondale 1989 — 1993
B.A.- Biological Sciences, Biology, Chemistry
AAIPharma Services Corp. May 2015 - Present
AAIPharma Services Corp. June 2013 - May 2015
AAIPharma Services Corp. April 2012 - June 2013
International Technidyne Corporation July 2010 - April 2012
Skills
Sterility, Validation, Suitability, Clean Rooms, Antibiotic Resistance, Environmental Monitoring, Bioburden, Phlebotomy, GMP, GLP, Quality Control, FDA GMP, LAL, cGMP practices, OOS, Trackwise, USP, Quality Assurance, Change Control, Medical Devices, Raw Materials
Education
The College of New Jersey 2006 — 2010
Bachelor of Science (B.S.), Biology/Biological Sciences, General
Ontario Drug Policy and Research Network (ODPRN) June 2014 - Present
Private consulting July 2007 - Present
Institute for Clinical Evaluative Sciences June 2011 - June 2014
Princess Margaret Hospital May 2009 - June 2011
Centre for Excellence in HIV/AIDS July 2007 - March 2009
AAIPharma Services Corp. 2000 - 2005
Skills
Statistical Modeling, R, SAS, Epidemiology, Biostatistics, Statistics, Survival Analysis, Data Analysis, Public Health, Python, Logistic Regression, Canadian administrative..., SAS programming, Clinical Trials, Data Management, Time Series Analysis, Clinical Research, Predictive Modeling, Bioinformatics, Experimental Design, Linear Regression, Clinical Study Design, Literature Reviews, Statistical Programming, Multivariate Statistics, Statistical Computing, Statistical Consulting, SAS Programming
Education
The University of British Columbia 2005 — 2007
MSc, Statistics
University of Waterloo 2000 — 2005
BSc, Honours Bioinformatics, Minor Statistics
Roche Pharmaceuticals December 2011 - Present
i3 Research September 2010 - January 2012
GlaxoSmithKline July 2007 - September 2010
AAIPharma Services Corp. October 2005 - July 2007
AAIPharma Services Corp. February 2005 - October 2005
AAIPharma Services Corp. March 2004 - February 2005
Skills
21 CFR Part 11, CRO, Clinical Data, Clinical Data Management, Clinical Trials, EDC, CTMS, Oncology, Clinical Development, GCP, ICH-GCP, SOP, Data Management, Drug Development
Education
Queen's University 1999 — 2003
BScH, Life Sciences
PDI, Inc. 2015 - Present
The Phyllis Siperstein Tamarisk Assisted Living Residence 2012 - 2014
inVentiv Health 2010 - 2012
Boehringer Ingelheim Pharmaceuticals 2004 - 2009
AAIPharma Services Corp. 2003 - 2004
Schering-Plough Pharmaceuticals 1995 - 2002
Skills
Gastroenterology, Urology, Diabetes, Cardiology, Neurology, Rheumatology, Managed Care, Oncology, Territory Management, Pulmonology, Allergy, Dermatology, Pain Management, Infectious Diseases, Nephrology, Pharmaceutical Sales, Product Launch, Sales Operations, Internal Medicine, Hospital Sales, Capital Equipment, Medical Devices, Sales Effectiveness, Sales Force Development, Selling Skills, Hospitals, Sales
Education
Boston University
B.A., magna cum laude, Liberal Arts
Northeastern University
MBA, Marketing
The Law Offices Of J. Ghita Harris, PLLC May 2010 - Present
The Brown Law Firm, P.C. July 2008 - April 2010
Leiner Health Products November 2007 - April 2008
Purdue Pharma December 2002 - August 2004
DSM Pharmaceuticals August 2001 - December 2002
Varian January 2000 - August 2001
AAIPharma Services Corp. January 1997 - January 2000
Skills
Training, Regulatory Affairs, Pharmaceutical Industry, FDA, Technology Transfer, GMP, Civil Litigation, Public Speaking, Criminal Law, Quality Assurance, Legal Writing, Biotechnology, Validation, Intellectual Property, Patents, Trials
Education
North Carolina Central University School of Law 2004 — 2007
JD, Law
University of North Carolina at Chapel Hill
BA, Chemistry
PPD June 2013 - Present
ICON plc December 2011 - June 2013
Novella Clinical, Inc. January 2011 - December 2011
INC Research June 2009 - January 2011
AAIPharma Services Corp. June 2006 - August 2007
Skills
CTMS, GCP, CRO, ICH-GCP, EDC, Clinical Trials, Clinical Research, Oncology, Clinical Development, IVR, IWR, Women's Health, Central Nervous System, Validation, Inform, Data Management, Sop, 21 CFR Part 11, Oracle Clinical, FDA, Software Documentation, Therapeutic Areas, Clinical Monitoring, Protocol, Regulatory Submissions, Clinical Study Design, Infectious Diseases, Pharmaceutical Industry, Regulatory Affairs, Clinical Data Management, Drug Development, Regulatory Requirements, Medical Devices, Diabetes, Medidata, Regulatory Documentation, Trial Management, Document Management, Endocrinology, Cancer, Oncology Clinical..., Cross-functional Team..., Technical Support, GCPs, Clinical Operations, Biotechnology
Education
North Carolina Central University 2004 — 2009
Bachelor of Science, Public Health Education
Nypro, A Jabil Company June 2015 - Present
bioMerieux October 2014 - June 2015
AAIPharma Services Corp. March 2013 - October 2014
Qualicaps August 2010 - February 2013
ASQ 2012 - 2012
Banner Pharmacaps June 2009 - July 2010
Novartis Animal Health July 2005 - June 2009
Pharmagraphics May 2002 - June 2005
Abbott Laboratories June 1995 - May 2005
Skills
FDA, Quality System, CAPA, GMP, Sop, Quality Assurance, 21 CFR Part 11, Validation, Trackwise, Regulatory Affairs, Change Control, Analytical Chemistry, GLP, Formulation, ISO, HPLC, R&D, SOP, Lean Manufacturing, Biotechnology, Auditing, Technology Transfer, Pharmaceutical Industry, Quality Control, Computer System..., Manufacturing, GCP, Quality Auditing, Supplier Quality, GxP, ISO 13485, LIMS, Six Sigma, 21 CFR, Design Control, Quality Management, Biopharmaceuticals, FDA GMP, Cleaning Validation, Regulatory Submissions, Aseptic Processing, Medical Devices, Laboratory, Iso 9000, Regulatory Requirements, Root Cause Analysis, Continuous Improvement, Calibration, Pharmaceutics
Education
North Carolina Wesleyan 1991 — 1993
B.S Chemistry, Chemistry
North Carolina State University 1990 — 1991
Associate of Science (A.S.), Engineering
Halifax Community College 1988 — 1990
A.S Engineering, Engineering
University of North Carolina at Chapel Hill June 2008 - Present
Duke University June 2007 - June 2008
University of North Carolina at Chapel Hill February 2007 - June 2007
The Family Doctor February 2005 - June 2007
North Carolina State University August 2003 - May 2006
North Carolina State University January 2005 - May 2005
AAIPharma Services Corp. May 2003 - August 2003
North Carolina State University August 2001 - August 2003
AAIPharma Services Corp. May 2002 - August 2002
Skills
MRI, Microbiology, Wet Chemistry, Research, Biochemistry, Neuroscience, Laboratory, Neuroimaging, Cell Biology
Education
University of North Carolina at Chapel Hill 2008 — 2016
Doctor of Medicine (MD), Medicine
University of North Carolina at Chapel Hill 2008 — 2014
Doctor of Philosophy (PhD), Neurobiology
North Carolina State University 2001 — 2006
Bachelor of Science (BS), Bachelor of Science (BS), Bachelor of Art (BA), Biochemistry, Microbiology, & Psychology
NC State University August 2015 - Present
Summer hire via nextSource at BASF May 2015 - August 2015
NC State University August 2013 - May 2015
AAIPharma Services Corp. May 2013 - August 2013
Skills
PCR, Gel Electrophoresis, Cell Culture, SDS-PAGE, Biochemistry, Protein Purification, Western Blotting, Molecular Biology, Microbiology, Research, ELISA, Biotechnology, DNA extraction, Microscopy, Microsoft Office, PowerPoint, Genetics, Chromatography
Education
North Carolina State University 2015 — 2020
Doctor of Philosophy (PhD), Toxicology
North Carolina State University 2011 — 2015
Bachelor of Science (BS), Biochemistry
John T Hoggard
Mears Group, Inc. September 2014 - Present
AAIPharma Services Corp. June 2012 - March 2014
Metropolitan St. Louis Sewer District/Contract Assignment April 2011 - February 2012
Forfeiture Support Associates March 2007 - January 2011
National Children's Cancer Society June 2003 - September 2005
National Children's Cancer Society March 2001 - May 2003
Delmar Financial Company 1992 - 1993
Skills
Microsoft Office, Microsoft Excel, Microsoft Word, Customer Service, PowerPoint, English, Windows, Research, Outlook, Teaching, Photoshop, Strategic Planning, Budgets, Negotiation, Editing, Analysis, Management, Data Entry, Fundraising, Event Management, Event Planning, Training, Employee Relations, Newsletters, Administrative...
Education
Southern Illinois University, Edwardsville 1987 — 1991
Bachelor of Liberal Studies, Sociology, Spanish
AAIPharma Services Corp. May 2015 - Present
United States Army National Guard October 2013 - Present
Sovereign Pharmaceuticals February 2011 - February 2015
Tornier May 2008 - February 2011
Skills
GMP, FDA, Validation, CAPA, SOP, Quality System, GLP, V&V, HPLC, Quality Control
Education
Prairie View A&M University 1998 — 2003
Bachelor of Science (B.S.), Biology/Chemistry
Prairie View A&M University 1998 — 2002
Bachelor's Degree, Biology/Chemistry
AAIPharma Services Corp. April 2013 - Present
Celsis July 2010 - April 2013
Skills
GMP, Sop, UV/Vis, Chemistry, FDA, Pharmaceutical Industry, CAPA
Education
Southern Illinois University, Edwardsville
Bachelor of Science (BS), Biology/Chemistry
Baxalta August 2014 - Present
Baxalta, Inc (Baxter International Inc. spin-off) April 2014 - August 2014
AAIPharma Services Corp. February 2013 - March 2014
AAIPharma Services Corp. October 2011 - March 2013
AAIPharma Services Corp. April 2010 - October 2011
AAIPharma Services Corp. May 2008 - April 2010
Skills
Bi-lingual (Fluent..., Microsoft Office, Microsoft Excel, Microsoft Word, Microsoft Power Point, Microsoft Outlook, Adobe Acrobat, Adobe Photoshop, QuickBooks, LIMS, AX, SAP, Validation, Sop, GMP, Microbiology, Aseptic Technique, CAPA, Pharmaceutical Industry, Outlook, PowerPoint, GLP, USP, Environmental Monitoring, Cleaning Validation, Aseptic Processing, Quality Control, Pharmaceutics, Technology Transfer, 21 CFR Part 11, Method Development, Regulatory Requirements, Pharmaceutical..., Quality Assurance, Deviations, GxP, Lyophilization, Laboratory, SOP
Education
Pontificia Universidad Javeriana 1995 — 2000
Bachelor of Science (BS), Industrial Microbiology
Novartis October 2012 - Present
AAIPharma Services Corp. March 2007 - October 2012
United Financial Mortgage Corp August 2005 - March 2007
Public Works Commission August 2003 - May 2004
Skills
Wet Chemistry, Pharmaceutical Industry, Gas Chromatography, UV/Vis, GMP, HPLC, Dissolution, UV, Method Development, Atomic Absorption, Empower, Validation, SOP, Quality Control, GLP, CAPA, Chromatography, Analytical Chemistry, LIMS, 21 CFR Part 11, FDA
Education
Methodist College 1999 — 2004
Bachelor of Science (BS), Chemistry/Mathematics/Leadership
Acerta Pharma September 2013 - Present
Patheon Inc. September 2011 - September 2013
ARIAD Pharmaceuticals, Inc. September 2009 - September 2010
TetraPhase Pharmaceuticals July 2008 - April 2009
Repligen Corporation April 2007 - May 2008
University of South Carolina January 2006 - December 2006
Parenta Pharmaceuticals January 2005 - December 2006
AAIPharma Services Corp. December 2002 - June 2004
Skills
GMP, Chemistry, Validation, Formulation Development, Mass Spectrometry, Process Chemistry, HPLC, Product Development, Physical Chemistry, Pharmaceutical..., Drug Delivery, Analytical Chemistry, Formulation, Solid State..., ICH guidelines, Drug Development, Biotechnology, Pharmaceutics, Pharmaceutical Industry
Education
University of South Carolina-Columbia 2004 — 2006
BS, Chemistry
Trident Technical College 2002 — 2004
Associate of Arts (AA), Literature
PAREXEL May 2014 - Present
Reckitt Benckiser Pharmaceuticals October 2010 - May 2014
AAIPharma Services Corp. May 2000 - October 2010
St. Jude Children's Research Hospital May 1996 - August 1999
University of Tennessee, Memphis September 1990 - May 1996
Wyeth-Ayerst Laboritories January 1990 - June 1990
Skills
PMP, ClearTrial Software, Product Development, Contract Negotiation, Cross Functional Team..., Vendor Management, Program Management, Virtual Teams, Collaborative Problem..., Budget Monitoring, Proposal Generation, Competitive Analysis, Clinical Trials, Validation, Cross-functional Team..., Clinical Development, GMP, Regulatory Affairs, Management, Drug Development, Pharmaceutical Industry, Product Launch, Project Management, Sop, CRO, Medical Devices, Biotechnology, Clinical Research, SOP
Education
The Citadel 1999 — 2001
Master of Business Administration (MBA)
University of Tennessee-Health Science Center 1990 — 1996
Doctor of Philosophy (Ph.D.), Pharmacology
Pennsylvania State University 1985 — 1989
Bachelor of Science (B.S.), Biochemistry
AAIPharma Services Corp. March 2015 - Present
AAIPharma Services Corp. September 2012 - Present
AAIPharma Services Corp. November 2010 - September 2012
AAIPharma Services Corp. 2009 - November 2010
AAIPharma August 2003 - November 2010
AAIPharma Services Corp. January 1998 - August 2003
Skills
GMP, Pharmaceutical Industry, Validation, Analytical Chemistry, Sop, GLP, FDA, Biotechnology, HPLC, Technology Transfer, LIMS, Lifesciences, Clinical Development, Gas Chromatography, Drug Development, Pharmaceutics, Chemistry, Chromatography, Salesforce.com..., Analytics, Website Promotion, Digital Marketing
Education
University of North Carolina at Wilmington 1992 — 1996
Bachelor of Science
North Carolina State University 1992 — 1994
New Potato Technologies August 2012 - Present
AAIPharma Services Corp. May 2011 - August 2011
New Potato Technologies May 2008 - August 2010
Skills
3D Modeling, CAD, Manufacturing, Engineering, Photoshop, Machining, SolidWorks, Modeling, Injection Molding, Rendering, Electronics, Testing, Product Design, Rapid Prototyping, Inventor, 3D, Oracle Agile PLM, Autodesk Inventor, Product Development, Design for Manufacturing, Mechanical Engineering, AutoCAD, Microsoft Office, Metal Fabrication, Product Lifecycle..., Engineering Management
Education
Topsail High School 2005 — 2009
North Carolina State University
UNC Asheville
Engineering/Mechatronics
AAIPharma Services Corp. October 2013 - Present
Teva Pharmaceuticals October 2011 - October 2013
DeBaun Center for the Performing Arts August 2007 - May 2011
Glavy Laboratory, Stevens Institute of Technology 2009 - 2010
Skills
Solidworks, Labview, Simulink, AutoCAD, cGMP practices, FDA, 21 CFR Part 11, Validation, Investigation, CAPA, Technical Writing, Sop, Analytical Method..., Equipment Qualification, Cleaning Validation, Cell Culture, Data Analysis, Matlab, Microsoft Excel, Pharmaceutical Industry, PowerPoint, Engineering, Project Management, Microsoft Word, Microsoft Office
Education
Stevens Institute of Technology 2007 — 2011
Master of Science (MS), Chemical Biology, GPA 3.6
Stevens Institute of Technology 2007 — 2011
Bachelor of Engineering (BEng), Biomedical Engineering, GPA 3.6
Cape Henry Collegiate School 1997 — 2007
AAIPharma Services Corp. July 2015 - Present
AAIPharma Services Corp. May 2012 - July 2015
Patheon Inc. August 2010 - May 2012
Patheon December 2008 - August 2010
Pfizer August 2007 - December 2008
Pfizer February 2003 - August 2007
Pfizer January 2001 - February 2003
Skills
FDA, Validation, Drug Development, Pharmaceutical Industry, Technology Transfer, Quality Assurance, Generic Programming, Product Development
Education
Northern Arizona University 1996 — 2001
Zoology, Biology, Chemistry
Pearl Therapeutics September 2014 - Present
AAIPharma Services Corp. 2012 - 2014
Contract Client February 2013 - December 2013
Genzyme July 2005 - February 2012
United States Army Soldier Systems Center June 2004 - August 2004
Skills
Drug Discovery, Biotechnology, GLP, Assay Development, Lifesciences, R&D, Technology Transfer, Patents, FDA, CAPA, Laboratory, Regulatory Requirements, GMP, Pharmaceutical Industry, HPLC, Validation, SOP, Quality Auditing, Quality Assurance, Analytical Chemistry, Chromatography, Biopharmaceuticals
Education
Suffolk University Law School 2006 — 2010
JD, Intellectual Property
Stonehill College 2001 — 2005
B.S, Chemistry, Criminal Justice (minor)
AAIPharma Services Corp. January 2015 - Present
Qualitest Pharmaceuticals March 2010 - August 2014
Qualitest Pharmaceuticals April 2009 - March 2010
Qualitest Pharmaceuticals September 2007 - April 2009
Nektar Therapeutics February 2007 - May 2007
Nektar Therapeutics February 2002 - February 2007
Nektar Therapeutics September 2000 - February 2002
Skills
GMP, HPLC, Sop, Quality Control, GLP, Raw Materials, Change Control, Analytical Chemistry, 21 CFR Part 11, UV/Vis, Quality System, Gas Chromatography, IR, Regulatory Submissions, Wet Chemistry, Chemistry, Pharmaceutical Industry, USP, FDA GMP, GxP, ANDA, Titration, R&D, FDA, Validation
Education
University of Alabama in Huntsville 2010 — 2015
Master of Business Administration (MBA)
University of Alabama in Huntsville 1996 — 2000
Bachelor of Science, Chemistry
AAIPharma Services Corp. March 2015 - Present
Life Leadership: Know Yourself, Lead Your Life May 2014 - Present
AAIPharma Services Corp. October 2014 - March 2015
Mallinckrodt Pharmaceuticals January 2013 - October 2014
Covidien/Mallinckrodt, Inc July 2009 - January 2013
Mallinckrodt Pharmaceuticals June 2001 - January 2013
Skills
Online Marketing, Medical Devices, Six Sigma, Pharmaceutical Industry, Quality Assurance, Testing, Management, Process Improvement, Lean Manufacturing, Quality Control, Project Management, Change Management, Cross-functional Team..., GMP, Quality System, Root Cause Analysis, CAPA, Manufacturing, Quality Management, R&D, Process Engineering
Education
St. Louis Community College at Florissant Valley 1999 — 2001
Associates of Applied Science, Chemical Technology/Technician
Riverview Gardens Senior High School 1991 — 1995
High School Diploma
Southeast Missouri State University
Bachelor's degree, Technology Management, Junior
AAIPharma Services Corp. August 2015 - Present
Bayer HealthCare April 2005 - August 2015
Schering-Plough Pharmaceuticals ( Merck ) January 2005 - January 2011
Wyeth January 2002 - April 2005
Skills
Analytical Chemistry, Pharmaceutical Industry, GMP, HPLC, GLP, Quality Control, Drug Discovery, LC-MS, Technology Transfer, Validation, LIMS, Chromatography, FDA, Sop, Dissolution, R, SOP, Chemistry
Education
The University of New Mexico 1998 — 2001
AAIPharma Services Corp. July 2009 - Present
AAIPharma March 2008 - July 2009
AAIPharma May 2003 - March 2008
Corning Incorporated November 2001 - June 2002
Hoffmann-La Roche June 1996 - July 2000
Roche 1996 - 2000
Skills
Pharmaceutical Industry, Validation, Change Management, GMP, SDLC, V&V, Computer System..., Six Sigma, Chemistry, Process Improvement, Document Management, 21 CFR Part 11, FDA, Clinical Trials, Quality Assurance, Technology Transfer, SAP, Troubleshooting, LIMS, Change Control, Sop, Quality System, GxP, GLP, GAMP, Software Documentation, Biotechnology, CAPA, Pharmaceutics, SOP
Education
Seton Hall University 1987 — 1992
Clifton Senior High School 1983 — 1987
HS Diploma
B. Braun Medical September 2014 - Present
Nephron Pharmaceuticals July 2013 - September 2014
AAIPharma Services Corp. April 2012 - May 2013
Irvine Pharmaceutical Services January 2010 - April 2012
Quadrants Scientific, Inc January 2008 - October 2009
PacificGMP October 2006 - January 2008
Natural Alternatives International October 2005 - January 2008
Tanox West Inc April 2005 - October 2005
Biogen Idec January 2005 - April 2005
Guidant Cardiovascular April 2004 - January 2005
Skills
Microbiology, GLP, GMP, Biotechnology, Lifesciences, Validation, FDA, HPLC, Sop, ELISA, Environmental Monitoring, Spectrophotometry, PCR, CAPA, Laboratory, Life Sciences, Pharmaceutical Industry, Quality Control, SOP
Education
University of California, Riverside 2002 — 2003
Master of Science, Biochemistry and Molecular Biology
University of California, Riverside 1998 — 2002
Bachelor of Science, Biochemistry
Biogen Idec February 2013 - Present
Eisai Inc January 2009 - January 2013
Susan G. Komen 2010 - 2013
Eisai Inc. March 1999 - December 2008
AAIPharma Services Corp. 1997 - 1999
Skills
Validation, Sop, CAPA, FDA, GMP, Change Control, V&V, Chemistry, LIMS, 21 CFR Part 11, GxP, HPLC, Pharmaceutical Industry, Technology Transfer, GLP, SOP
Education
North Carolina State University 1994 — 1997
B.S, Biochemistry
Sturgill Consulting January 2014 - Present
AAIPharma Services Corp. January 2012 - November 2013
Celsis Analytical Services October 2008 - December 2011
Celsis Analytical Services January 2003 - October 2008
Celsis Analytical Services October 1997 - January 2003
Scientific Associates March 1993 - October 1997
Scientific Associates May 1990 - March 1993
Invitron July 1988 - May 1990
Scientific Associates July 1985 - July 1988
Skills
Microbiology, FDA, Sop, Biotechnology, GMP, CAPA, Pharmaceutical Industry, Biopharmaceuticals, Lifesciences, LIMS, Validation, GLP, Quality System
Education
Missouri State University 1980 — 1985
BS, Biology with an emphasis in Microbiology
Pharmaceutical Associates, Inc. March 2014 - Present
AAIPharma Services Corp. March 2013 - November 2013
AAIPharma Services Corp. December 2010 - March 2013
AAIPharma Services Corp. January 2007 - December 2010
Mallinckrodt October 1998 - January 2007
Lockwood Greene Engineers 1997 - 1998
Skills
Manufacturing Operations, Manufacturing, Biopharmaceuticals, GMP, Sop, Cleaning Validation, Change Control, Six Sigma, Contract Manufacturing, Pharmaceutical Industry, FDA, Lifesciences, CAPA, Technology Transfer, Quality System, Clinical Development, Validation, Root Cause Analysis, Lean Manufacturing
Education
Rutgers University-New Brunswick 1982 — 1987
BS, BA, Chemical Engineering, Economics
KCAS LLC December 2009 - Present
AAIPharma Services Corp. August 2005 - December 2009
IAL Biolytix July 2002 - July 2005
Education
Queen's University Belfast 1976 — 1980
MS and Ph.D., Analytical Chemistry
Merial, a Sanofi Company January 2013 - Present
Merial Limited December 2006 - January 2013
Pfizer September 2003 - December 2006
Pfizer January 2001 - September 2003
Lab Support, a division of On Assignment August 1999 - November 2000
AAIPharma Services Corp. July 1998 - August 1999
Skills
GMP, Pharmaceutical Industry, FDA, Regulatory Affairs, Regulatory Submissions, Sop, Validation, Technology Transfer, Vaccines, SOP, CAPA, GLP, Clinical Development, Cross-functional Team...
Education
Temple University 2001 — 2005
Masters, RA/ QA
University of North Carolina at Wilmington 1994 — 1998
Chemistry, BSc
Swan Clinical Supply Consulting LLC January 2012 - Present
AAIPharma Services Corp. 2007 - 2011
Voyager Pharmaceutical Corp 2005 - 2007
Cardinal Health 2003 - 2005
Trimeris 1995 - 2002
Skills
Pharmaceutical Industry, Clinical Trials, FDA, CRO, Clinical Supplies, Clinical Research, Strategy, Clinical Development, GMP, 21 CFR Part 11, Validation, Drug Development, GCP, Sop, GLP
Education
State University of New York Empire State College 1986 — 1989
Veristat September 2015 - Present
AAIPharma Services Corp. September 2012 - September 2015
Microtest Laboratories, Inc. July 2009 - April 2012
Microtest Laboratories, Inc. January 2008 - July 2009
Idenix Pharmaceuticals July 2006 - December 2007
Eisai, Inc. July 2004 - June 2006
Novartis Pharmaceuticals December 1994 - February 2004
By Gosh 1988 - 1992
Skills
Pharmaceutical Industry, Biotechnology, Lifesciences, Sop, Medical Devices, HPLC, Oncology, FDA, GMP, Validation, Pharmaceutical Sales, Chromatography, Clinical Trials, Analytical Chemistry, Chemistry, Biopharmaceuticals, GLP, Technology Transfer, Drug Development, Pharmaceutics, 21 CFR Part 11, Cardiology, CRO, Change Control, Clinical Development, Commercialization, Dermatology, Diabetes, Drug Discovery, Endocrinology, Immunology, Infectious Diseases, LIMS, Laboratory, Life Sciences, Microbiology, Neurology, Product Launch, Quality Control, Quality System, R, Regulatory Affairs, Regulatory Requirements, Regulatory Submissions, Rheumatology, SOP, Sales Effectiveness, Vaccines
Education
Saint Michael's College 1982 — 1986
Bachelor's degree
Saint Michael's College
Bachlor of Arts
Missouri Analytical Labs August 2014 - Present
AAIPharma Services Corp. July 2013 - March 2014
BestSweet October 2011 - January 2013
Harmony Labs Inc October 2004 - January 2011
Alpharma June 2001 - October 2004
Forest Pharmaceuticals September 1996 - May 2001
Beck Flavors December 1994 - September 1996
Skills
Quality Assurance, FDA, Quality Control, GMP, Sop, Validation, HPLC, Pharmaceutical Industry, Technology Transfer, Quality Auditing, CAPA, Wet Chemistry, Quality System, UV/Vis, Laboratory, Regulatory Affairs, LIMS, GLP, Trackwise, SOP
Education
University of Kansas 1990 — 1994
Bachelor of Arts (BA), Microbiology
Greater Lawrence Family Health Center October 2013 - Present
Greater Lawrence Family Health Center October 2010 - October 2013
AAIPharma Services Corp. 1993 - 2000
Skills
Clinical Research, Medicine, Healthcare, Medical Terminology, EMR, Treatment, Hospitals, Clinical Trials, HIPAA, Research, EHR, Data Entry, Medical Education, Patient Education, Public Health, Social Services, Nonprofits, Public Speaking, Social Media
Education
Wellesley College 1992 — 1998
Bachelor of Arts (B.A.), English Language and Literature, General, Biology
Universidad Iberomericana 2000 — 2006
Doctor of Medicine (M.D.)
Governor's academy
Celgene January 2007 - Present
Alpharma / Actavis 2003 - 2007
Purdue Pharma 2001 - 2003
Novo Nordisk May 1992 - May 2001
AAIPharma Services Corp. 1990 - 1992
Skills
Sop, GMP, CAPA, FDA, Analytical Chemistry, Pharmaceutical Industry, HPLC, Validation, GxP, GLP, LIMS, Quality Control, 21 CFR Part 11, Quality Assurance, Change Control, Technology Transfer, Pharmaceutics, Regulatory Submissions, V&V, Regulatory Affairs, Computer System..., Biotechnology, Chemistry, Cleaning Validation, Dissolution, Chromatography, Quality System, Quality by Design, Drug Development, Trackwise, Aseptic Processing, USP, Biopharmaceuticals, Quality Auditing, CRO, FDA GMP, GCP, Clinical Development, Clinical Trials, Regulatory Requirements
Education
University of Massachusetts at Lowell 1986 — 1995
Ph.D, Analytical Chemistry
Montclair State University 1981 — 1985
BS, Chemistry
Latticework Capital Management, LLC January 2015 - Present
American Capital March 2002 - December 2014
AAIPharma Services Corp. 2013 - 2014
Scientific Protein Labs LLC 2013 - 2014
Cambridge Major Laboratories, Inc. 2012 - 2014
Dynojet Research 2012 - 2014
ECA Medical Instruments 2009 - 2014
The Meadows of Wickenburg 2006 - 2014
Unwired Technology 2009 - 2013
Value Plastics, Inc. 2009 - 2011
Skills
Mergers & Acquisitions, Investment Banking, Investments, Portfolio Management, Equities, Finance, Private Equity, Due Diligence, Venture Capital, Corporate Development, Valuation, LBO, Financial Modeling, Corporate Finance, Medical Devices, Business Valuation, Healthcare, Mezzanine, M&A experience, Lifesciences, Leveraged Finance, Financial Analysis, Recapitalizations, Mergers, Private Placements, Strategy
Education
The University of Texas at Austin - The Red McCombs School of Business 1994 — 1999
BBA/MPA, Accounting
Trinity Valley School 1981 — 1994
High School
AAIPharma Services Corp. April 2015 - Present
AAIPharma Services Corp. July 2009 - Present
Skills
HTML, Software Documentation, Data Management, Microsoft SQL Server, Troubleshooting, Illustrator, MS Office, InfoPath, Dreamweaver, CSS, Microsoft Office, Twitter, Facebook, Google+, Pinterest, Tumblr, Training, Advertising, Adobe Acrobat, Management, Databases, Blogging, Social Media
Education
University of Cincinnati 1989 — 1992
MA, Arts Administration
Shenandoah University 1985 — 1989
BM, Music
AAIPharma Services Corp. May 2014 - Present
Catalent Pharma Solutions September 2011 - April 2014
Pfizer (formerly Wyeth) June 2005 - September 2011
GE Healthcare July 1999 - May 2005
UOP January 1991 - June 1999
Skills
Cross-functional Team..., GMP, Project Management, Validation, FDA, Change Control, Quality Assurance, 21 CFR Part 11, V&V, Manufacturing, Troubleshooting, Six Sigma, Project Engineering, Engineering, Contract Manufacturing, Aseptic Processing, Quality Management, Quality Auditing, Quality Control, Regulatory Requirements, Calibration, Design Control, CAPA, Technology Transfer, Regulatory Affairs, GAMP, Pharmaceutical Industry, Design of Experiments, Instrumentation, Computer System..., Chromatography, ISO 13485, Lifesciences, Fermentation, Quality System, Medical Devices, Process Improvement, Biotechnology, Lean Manufacturing, GLP, Vaccines, DMAIC, Biopharmaceuticals, Process Engineering, Root Cause Analysis, LIMS, Sop, R&D, Commissioning, Continuous Improvement
Education
University of Wisconsin-Madison - School of Business
Master Certificate, Project Management
North Carolina State University 1986 — 1990
BS, Chemical Engineering
Tergus Pharma October 2014 - Present
AAIPharma Services Corp. August 2013 - July 2014
Talecris July 2008 - March 2011
Analytical Solutions January 2006 - June 2008
Pier 1 Imports 2005 - 2007
Burleson Research Technologies 2003 - 2006
Skills
Biotechnology, GLP, GMP, Validation, HPLC, ELISA, Chromatography, Lifesciences, Chemistry, LIMS, Sop, FDA, Aseptic Technique, Data Analysis, SOP
Education
North Carolina State University 2003 — 2006
BS, Biological Sciences
North Carolina State University 2003 — 2006
bachelor of science, Biology
Southwestern Community College 2001 — 2003
Quintiles October 2012 - Present
Quintiles October 2010 - October 2012
Kendle International June 2008 - October 2010
AAIPharma Services Corp. January 2008 - June 2008
Duke University December 2006 - January 2008
PPD February 2004 - October 2006
Inveresk October 1999 - February 2004
Clintrials Reserch 1994 - 1999
Glaxo September 1992 - May 1994
American Cyanamid January 1990 - July 1992
Skills
Clinical Data Management, EDC, CRO, Oracle Clinical, Clinical Trials, GCP, CRF design, Inform, Data Management, ICH-GCP, Clinical Development, Oncology, Clinical Research
Education
The Ohio State University 1971 — 1975
BS, Microbiology
Neshaminy
LongueVue Capital, LLC April 2015 - Present
American Capital August 2004 - January 2015
AAIPharma Services Corp. 2013 - 2015
Cambridge Major Laboratories, Inc. 2012 - 2015
ECA Medical Instruments 2011 - 2015
The Meadows of Wickenburg 2006 - 2015
JP Morgan July 2001 - August 2004
Skills
Private Equity, LBO, Corporate Finance, Due Diligence, Valuation, Venture Capital, Investment Banking, Mergers & Acquisitions, Corporate Development, Financial Modeling, M&A experience, Capital Markets, Hedge Funds
Education
University of Pennsylvania - The Wharton School 2011 — 2013
MBA, Finance and Management
Southern Methodist University - Cox School of Business 1997 — 2001
BBA in Finance
AAIPharma Services Corp. March 2012 - Present
AAIPharma Services Corp. May 2008 - March 2012
Catalent Pharma Solutions June 2004 - May 2008
Procter and Gamble April 2003 - May 2004
Skills
GMP, CRO, Sop, Pharmaceutical Industry
Education
North Carolina State University - College of Management 2003 — 2006
MBA, Business Administration - Supply Chain Management
North Carolina State University 1983 — 1987
BS, Food Science
Southern Guilford High School 1979 — 1983
AAIPharma Services Corp. May 2014 - Present
AAIPharma Services Corp. November 2012 - May 2014
AAIPharma Services Corp. April 2012 - November 2012
Sapyence Management Group 2008 - 2012
Implicitech 2007 - 2012
Kadmus Pharmaceuticals, Inc. 2003 - 2007
Atairgin Technologies, Inc. 1997 - 2003
Education
University of California, San Francisco 1991 — 1997
Ph.D., Biomedical Sciences
Vanderbilt University 1986 — 1990
B.E., Biomedical and Electrical Engineering
Covington Latin School 1982 — 1986
AAIPharma Services Corp. 2009 - Present
Eastern Analytical Symposium 2004 - Present
Bristol-Myers Squibb 1997 - 2008
Hatco Corporation 1989 - 1997
Skills
Analytical Chemistry, HPLC, GMP, Chromatography, Chemistry, Pharmaceutical Industry, R&D, Validation, Gas Chromatography, Technology Transfer, Biotechnology, Organic Chemistry, Bioanalysis, Formulation, CRO, Regulatory Affairs, Laboratory, LIMS, Mass Spectrometry, V&V, LC-MS, FDA, Method Development, Sop, Drug Development, Quality Assurance, Assay Development, UV/Vis, 21 CFR Part 11, Raw Materials, GLP, Drug Discovery, Dissolution, UV, IR, Biopharmaceuticals, Purification
Education
Wesleyan University 1982 — 1988
Chemistry
University of Bridgeport 1977 — 1982
B.S., Chemistry
Research Pharmaceuticals Services, Inc. November 2011 - November 2014
Covance October 2010 - November 2011
Pharm-Olam International April 2010 - October 2010
Zeecro October 2009 - April 2010
AAIPharma Services Corp. September 2007 - October 2009
ResearchPoint September 2005 - September 2007
Assent Consulting December 2004 - June 2005
PPD July 1998 - November 2004
Chrysalis Clinical & Data Management Services September 1997 - May 1998
Education
University of Alaska Fairbanks 1992 — 1994
BA, Justice
Pikes Peak Community College 1990 — 1992
Political Science
Regeneron Pharmaceuticals November 2012 - Present
AMRI September 2002 - October 2012
AAIPharma Services Corp. September 1993 - September 2002
Education
Wesleyan University
Master of Arts (M.A.), Biochemistry and Molecular Biology
Rensselaer Polytechnic Institute
Bachelor of Science (BS), Chemistry
Boehringer Ingelheim November 2014 - Present
Amgen Inc May 2010 - October 2014
Watson Pharmaceuticals June 2007 - May 2010
AAIPharma Services Corp. October 2006 - June 2007
ApoPharma Inc. January 2003 - October 2006
Teva Canada November 1997 - January 2003
Novopharm August 1994 - November 1997
Beximco Ltd June 1990 - February 1992
Micro Industries Development Assistance and Services September 1987 - June 1990
Skills
FDA, Pharmaceutical Industry, GMP, Sop, CAPA, Validation, Technology Transfer, V&V, Change Control, Project Management, Regulatory Affairs, Cross-functional Team..., Clinical Trials, 21 CFR Part 11, Clinical Development, Manufacturing, GxP, LIMS, GCP, Drug Development, GLP, Regulatory Submissions, Computer System...
Education
University of Technology, Sydney 1992 — 1994
MBA, Business Administration
University of Technology, Sydney 1992 — 1994
Master of Business Administration (MBA), Finance and International Business
University of Calcutta 1982 — 1986
B.Sc.Tech., Engineering
Celgene March 2013 - Present
Celgene February 2010 - March 2013
Novartis October 2004 - February 2010
AAIPharma Services Corp. October 2001 - October 2004
Skills
PowerPoint, Microsoft Excel, Clinical Research, Customer Service, Budget, Oncology, Clinical Trials, GCP, CTMS, CRO, Clinical Development, Pharmaceutical Industry, Therapeutic Areas, Healthcare, Strategic Planning, Negotiation, Treatment, Biotechnology, ICH-GCP, Clinical Monitoring, EDC, Budgets
Education
Rutgers, The State University of New Jersey-Newark 2006 — 2009
Bachelor's degree in Science, Registered Nursing/Registered Nurse
Seton Hall University 2005 — 2006
AAIPharma Services Corp. October 2014 - Present
AAIPharma Services Corp. July 2012 - Present
AAIPharma Services August 2011 - July 2012
AAIPharma Services Corp. January 2008 - August 2011
AAIPharma Services Corp. January 2006 - January 2008
Kiel Laboratories 2003 - 2006
Skills
GMP, Pharmaceutical Industry, Pharmaceutics, Drug Development, Technical Transfers, ICP-MS, Thermal Analysis, FTIR, Particle Size Analysis, Formulation, Electronic Lab Notebooks
Education
The University of Georgia 2000 — 2003
PhD, Pharmaceutics
Virginia Tech 1993 — 1997
B.S., Chemical Engineering
Aprecia Pharmaceuticals February 2015 - Present
Teva Pharmaceuticals January 2012 - February 2015
Teva Pharmaceuticals ( formerly Barr Labs; Duramed Pharma. January 2010 - January 2012
Barr Laboratories March 2002 - December 2009
Duramed Pharmaceuticals February 2000 - March 2002
AAIPharma Services Corp. February 1999 - February 2000
Skills
GMP, Validation, FDA, Blister Packaging, Cleaning Validation, Process Validation, Change Control, Commissioning, Equipment Qualification, Maintenance Engineering, Equipment Installation, CAPA, Pharmaceutical..., Pharmaceutical..., SOP, Computer System..., 21 CFR Part 11, GxP, GAMP, Regulatory Requirements, Pharmaceutical Industry, Pharmaceutics, Trackwise, Quality by Design, Technology Transfer, TrackWise, V
Education
University of Cincinnati 2001 — 2004
BS, Chemistry
University of Toledo 1992 — 1994
AAS, Chemistry
Forest Laboratories December 2011 - Present
Pfizer Inc. 2010 - September 2011
Wyeth 2003 - 2010
AAIPharma Services Corp. 2001 - 2003
Education
New Jersey Institute of Technology
Ph. D., Environmental Science
Sichuan University
M.S., B.S., Chemistry
AAIPharma Services Corp. February 2015 - Present
The Mundy Companies May 2012 - February 2015
US Census Bureau November 2009 - September 2010
Chemical Specialities May 2005 - May 2006
Pfizer July 2001 - August 2004
Skills
HPLC, Wet Chemistry, FTIR, GC-FID, ICP, Quality Control, Supervisory Skills, Chemistry, Training, Microsoft Excel, GMP, Microsoft Office, Titration, PowerPoint, Access, Raw Materials, pH meter, Quality Assurance, UV-Vis, Conductivity, Analysis, Documentation, Troubleshooting, FDA, Problem Solving, LIMS, Analytical Chemistry, Excel, Pharmaceuticals, Instrumentation, SOP, Word, cGMP, Testing, Chromatography, Outlook, Gas Chromatography, TOC, Chemstation, Inorganic Chemistry, Column Chromatography, Organic Chemistry, USP, Analytical Techniques, Aseptic Technique, GLP, Particle Size Analysis, cGMP practices, Instrumental Analysis, UV/Vis
Education
The Ohio State University 1997 — 2000
Pursued MS degree in Food Science & Technology
North Carolina Agricultural and Technical State University 1992 — 1996
BS
CMC Biologics A/S January 2012 - Present
Greer Laboratories July 2011 - March 2012
APP Pharmaceuticals March 2011 - July 2011
AAIPharma Services Corp. January 2010 - February 2011
Amgen October 2006 - March 2008
Pfizer 1988 - 2004
Skills
Quality Assurance, Medical Devices, Human Resources, Sop, GLP, Biotechnology, Technology Transfer, Manufacturing, GMP, CAPA, Biopharmaceuticals, 21 CFR Part 11, Pharmaceutical Industry, Software Documentation, Aseptic Processing, Change Control, Validation, Quality System, FDA, LIMS, V&V, Regulatory Affairs, Cleaning Validation
Education
Southern Wesleyan University
B.S., Management
AAIPharma Services Corp. SupervisorAAIPharma ServicesNovember 2007 - June 2011
AAIPharma April 2005 - November 2007
Education
University of North Carolina at Wilmington 2003 — 2005
MS, Chemistry
Shippensburg University of Pennsylvania 1998 — 2002
BS, Chemistry
AAIPharma Services Corp. October 2014 - Present
Deibel Laboratories May 2014 - October 2014
Skills
Attention to detail, Microsoft Excel, Microsoft Word, Leadership, Communication, quick learner
Education
Park University 2010 — 2014
Bachelor's Degree, Biology, General, Graduated
Novella Clinical, Inc. July 2012 - Present
University of North Carolina at Wilmington May 2010 - May 2012
PPD January 2012 - April 2012
AAIPharma Services Corp. December 2006 - September 2007
University of North Carolina at Wilmington October 2005 - December 2006
Bayer HealthCare March 2000 - July 2005
UCSF October 1997 - December 1999
Chiron Corporation April 1997 - October 1997
Skills
Business Optimization, Global Strategy..., Strategic Planning, Market Research, Business Planning, Cross-functional Team..., PCR, Market Intelligence, Market Analysis, Global Drug Development, Data Analysis, Molecular Biology, Project Management, Statistics, Biotechnology, Cell Culture, Validation, Research, qPCR, Lifesciences, Infectious Diseases, Financial Analysis, FDA, Marketing, Life Sciences
Education
University of North Carolina Wilmington 2010 — 2012
MBA
Texas Woman's University 1994 — 1996
MS, Molecular Biology
University of Pune 1991 — 1993
MS, Microbiology
University of Pune 1988 — 1991
BS, Microbiology
AAIPharma Services Corp. April 2014 - Present
CSL Behring August 2012 - October 2013
JF Labs July 2010 - August 2012
Famous Footwear November 2008 - May 2010
Skills
Pharmaceutical Industry, GMP, Sop, Microbiology, Chemistry, Validation, Laboratory
Education
Millikin University 2006 — 2009
Bachelor of Science (B.S.), Biology, General
Fujifilm Diosynth Biotechnologies (formerly Merck) February 2008 - Present
Diosynth May 2003 - February 2008
Diosynth (formerly Covance) November 2000 - May 2003
Covance December 1999 - November 2000
AAIPharma Services Corp. April 1997 - December 1999
Skills
GMP, Management Development, Biotechnology, Pharmaceutical Industry, Quality Assurance, Software Documentation, Sop, Validation, Six Sigma, FDA, Cross-functional Team..., Training, Quality System, Lean Manufacturing, CAPA, Biopharmaceuticals, Quality Auditing
Education
North Carolina State University 1988 — 1994
BS, Chemical Engineering
INNO Clinical Outcomes LLC October 2013 - Present
Ockham November 2010 - September 2013
Abraxis BioScience June 2008 - May 2010
AAIPharma Services Corp. April 2007 - June 2008
Comprehensive Neuroscience, Inc January 2007 - April 2007
Duke Clinical Research Institute November 2006 - January 2007
PPD September 2004 - October 2006
Novella Clinical, Inc. November 2003 - August 2004
Inveresk Research March 1991 - October 2003
Skills
CRO, Data Management, FDA, Clinical Development, EDC, Therapeutic Areas, Regulatory Affairs, Clinical Trials, Clinical Data Management, Clinical Research, Sop, ICH-GCP, Pharmaceutical Industry, Infectious Diseases, Cardiology, Oncology, GCP, Biotechnology, Validation, Protocol, Drug Development, CTMS, Vaccines, Lifesciences, Regulatory Submissions
Education
University of Arkansas at Little Rock
Bachelor of Arts
Eli Lilly and Company April 2001 - Present
Greenwood Public Library 2011 - 2014
Banner Pharmacaps March 1999 - April 2001
AAIPharma Services Corp. April 1997 - March 1999
Lilly Ranbaxy Pharmaceuticals LLC April 1995 - April 1997
Geneva Pharmaceuticals Inc. February 1992 - April 1995
Duramed Pharmaceuticals Inc. March 1989 - February 1992
Skills
FDA, Regulatory Affairs, GMP, Pharmaceuticals, Regulatory Submissions, Regulatory Strategy, Cross-functional Team..., IND, Regulatory Requirements, ANDA, cGMP, Generics, Quality Auditing, Compliance, Small Molecule, NDA
Education
Miami University 1978 — 1982
Bachelor of Science, Mathematics and Statistics
AAIPharma Services Corp. November 2010 - Present
Schering-Plough Research Institute August 2000 - July 2008
Skills
Customer Service, PowerPoint, Microsoft Excel, Microsoft Word, Strategic Planning, Microsoft Office, Public Speaking, Budgets, Negotiation, Team Building, Pharmaceutical Industry, GMP, Validation, LIMS, 21 CFR Part 11, GLP
Education
Rider University 1996 — 2000
MS, Biology
Catalent Pharma Solutions June 2012 - Present
Catalent Pharma Solutions April 2011 - June 2012
MannKind Corporation April 2005 - April 2011
AAIPharma Services Corp. December 1996 - March 2005
Oneida Research Services June 1994 - November 1996
Skills
Chemistry, GMP, CRO, GLP, Pharmaceutical Industry, LIMS, Technology Transfer, Sop, HPLC, Cross-functional Team..., Formulation, Drug Development, FDA, Lifesciences, Biotechnology, 21 CFR Part 11, Validation, Analytical Chemistry, Clinical Development, R&D, Pharmaceutics, CAPA, Chromatography, Regulatory Affairs, Biopharmaceuticals, Regulatory Submissions, V&V, GxP, Change Control, Computer System..., Clinical Trials, Drug Discovery, Quality System, SOP, Life Sciences
Education
East Carolina University - College of Business 2011 — 2014
MBA
University of New Haven 2010 — 2011
MBA
University of North Carolina at Wilmington 1998 — 2001
MS, Chemistry
State University of New York College at Oneonta 1991 — 1994
BA, Chemistry
Utica College 1990 — 1991
Chemistry
AAIPharma Services Corp. July 2013 - Present
Euroifin Lancaster Laboratories, INC July 2011 - June 2013
Ohio University September 2009 - June 2011
Food and Drug Administration June 2010 - August 2010
Ohio University October 2008 - June 2009
Skills
HPLC, Microsoft Office, UV/Vis, Chemistry, Chromatography, Analytical Chemistry, Dissolution
Education
Ohio University 2007 — 2011
Bachelor of Science, Chemistry
PAREXEL April 2013 - Present
PPD March 2011 - April 2013
AAIPharma Services Corp. August 2006 - March 2011
Skills
CRO, Clinical Supplies, CTMS, Clinical Trials, GCP, Clinical Development, Sop, Pharmaceutical Industry, EDC, GMP, FDA, Drug Development, 21 CFR Part 11, Validation, Oncology, Regulatory Affairs, ICH-GCP, Clinical Monitoring, Biotechnology, Clinical Data Management, Technology Transfer, Therapeutic Areas
Education
The Ohio State University 1994 — 1999
B.S. Human Nutrition
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
AAIPharma Services Corp. April 2007 - Present
Education
The Ohio State University 2000 — 2005
Doctor of Philosophy (Ph.D.), Biochemistry
AAIPharma Services Corp. 2013 - Present
Environmental Chemists, Inc. 2011 - 2013
Wells Fargo Home Mortgage 2010 - 2011
Wells Fargo Home Mortgage 2009 - 2010
Wells Fargo Home Mortgage 2006 - 2009
Skills
Outstanding time..., Strong attention to..., Great analytical and..., Advocate Of Teamwork, Require minimum...
Education
Technical University of Lodz
Master of Science, Microbiology
Technical University of Lodz
Bachelor of Science, Biotechnology
PRA Health Sciences August 2014 - Present
PAREXEL June 2013 - August 2014
sanofi-aventis January 2003 - March 2013
AAIPharma Services Corp. 1997 - 2003
North Carolina Clinical Research 1994 - 1997
Skills
Clinical Development, Clinical Trials, ICH-GCP, CTMS, GCP, CRO, Clinical Research..., Infectious Diseases, Clinical Research, Therapeutic Areas, Clinical Monitoring, EDC, Pharmaceutical Industry, SOP, Oncology
Education
North Carolina State University 1988 — 1990
Bachelor of Science (B.S.), Zoology/Animal Biology
University of Florida 1984 — 1986
AAIPharma Services Corp. April 2013 - Present
AAIPharma Services Corp. April 2012 - April 2013
AAIPharma Services Corp. March 2011 - April 2012
AAIPharma Services Corp. February 2010 - March 2011
AAIPharma Services Corp. April 2008 - February 2010
GlaxoSmithKline March 2005 - March 2008
Skills
Quality Management, Quality Control, Sop, Process Improvement, Pharmaceutical Industry, Manufacturing, GLP, Quality System, GMP, Validation, SAP, FDA, 21 CFR Part 11, CAPA, Change Control, SOP, Medical Devices
Education
North Carolina State University
Bachelor's degree, Chemistry
Quality Chemical Laboratories October 2012 - Present
AAIPharma Services Corp. August 1985 - September 2012
Skills
GLP, HPLC, Dissolution, LIMS, Chemstation, LC-MS, Analytical Chemistry, GMP, Empower, Sop, USP, Chromatography, UV/Vis, Validation, FDA, Drug Development, SOP, Pharmaceutical Industry
Education
UNCW 1983 — 1986
Bachelor of Arts (BA), Chemistry
Peace College 1981 — 1983
Associate of Arts (AA)
AAIPharma Services Corp. Futureworld OperationsThe Walt Disney Company, EPCOTOctober 1986 - May 1997
Skills
Pharmaceutical Industry, FDA, Sop, Validation, GMP, Quality System, 21 CFR Part 11, Quality Auditing, Quality Control, SOP
Education
Texas Woman's University 1982 — 1986
Bachelor of Arts (B.A.), Psychology, A
Synthon February 2009 - Present
UCB Pharma March 2007 - December 2009
Schwarz Biosciences February 2006 - November 2007
AAIPharma Services Corp. 2002 - January 2006
DSM Pharmaceuticals 2000 - 2002
DSM Pharmaceuticals 1999 - 2000
Cato Research 1997 - 1999
Cato Research 1994 - 1997
Cato Research 1993 - 1994
Skills
Regulatory Submissions, Pharmaceuticals, GMP, Change Management, Strategic Planning, Product Development, Writing, Business Strategy, Negotiation, Biotechnology, Budgeting, Product Management, Team Leadership, Quality Assurance, Due Diligence, Compliance, Medical Devices, Research, Pharmaceutical Industry
Education
Meredith College 1988 — 1992
Bachelor of Science, Biology
Celgene March 2014 - Present
Linde Gas May 2013 - February 2014
AAIPharma Services Corp. August 2008 - February 2013
TestAmerica August 2007 - August 2008
Celsis May 2004 - August 2007
Skills
Wet Chemistry, Atomic Absorption, HPLC, Gas Chromatography, Analytical Chemistry, UV/Vis, Chromatography, GLP, LIMS, GMP, Validation, FDA, CAPA, Quality Assurance
Education
NJIT 2007 — 2010
Master of Science (MS), Chemistry
Rutgers, The State University of New Jersey-New Brunswick 2000 — 2004
Bachelor of Arts (B.A.), Chemistry
AAIPharma Services Corp. December 2014 - Present
AAIPharma Services Corp. May 2014 - December 2014
AAIPharma Services Corp. August 2012 - May 2014
Merck Sharp & Dohme May 2010 - August 2012
QC Laboratories November 2000 - May 2010
B. Braun Medical October 1998 - November 2000
Skills
GMP, GLP, Sterility testing, USP/EP/JP, USP <71>, USP<61>/<62>, USP<51>, USP<85>, Quality Assurance, CAPA, Microbiology, Deviation management, Validation, Sop, Aseptic Processing, Deviation Management, FDA, Aseptic Technique, SOP
Education
Penn State University 1993 — 1998
Bachelor of Science (BS), Biology, General
Sentio BioSciences April 2014 - Present
AAIPharma Services Corp. June 2011 - April 2014
Dynalabs November 2009 - June 2011
National Corn-to-Ethanol Research Center 2007 - November 2009
Skills
Pharmaceutical Industry, Validation, GMP, Sop, FDA, EDC, 21 CFR Part 11, Biotechnology, Clinical Data Management, Technology Transfer, Change Control, Data Management, Regulatory Affairs
Education
University of Illinois at Urbana-Champaign
Bachelor of Science (BS), Biology, General
BD Rx February 2010 - Present
Merck February 2006 - February 2010
Merck October 2004 - February 2006
Merck April 2001 - October 2004
GlaxoSmithKline January 2000 - April 2001
Eisai Pharmaceuticals December 1998 - January 2000
AAIPharma Services Corp. February 1997 - December 1998
Skills
GMP, Quality Assurance, FDA, GLP, Validation, 21 CFR Part 11, Analytical Chemistry, Biotechnology, Change Control, CAPA, GxP, Pharmaceutical Industry, Quality System, SOP, V, LIMS
Education
North Carolina State University 1991 — 1996
Bachelor of Science (BS), Biochemistry
North Carolina State University 1991 — 1996
Bachelor of Arts (BA), Chemistry
North Carolina State University 1991 — 1995
Bachelor of Science (BS), Biology
North Carolina State University 1991 — 1995
Minor, Genetics
AAIPharma Services Corp. January 2015 - Present
Euticals October 2012 - December 2014
Euticals October 2008 - September 2012
Skills
Quality Control, GMP, Quality Assurance, SOP, HPLC, Validation, Pharmaceutical Industry
Education
Missouri State University
Bachelor of Science (B.S.), Chemistry
AAIPharma Services Corp. May 2013 - August 2013
Skills
GMP, Problem Solving, Pharmaceutical..., Lean Manufacturing, Manufacturing, Pharmaceutical Industry
Education
North Carolina State University 2012 — 2016
Bachelor of Science (BS), Mechanical Engineering
Quality Chemical Laboratories, LLC May 2014 - Present
Quality Chemical Laboratories, LLC June 2012 - May 2014
Quality Chemical Laboratories, LLC March 2012 - June 2012
AAIPharma Services Corp. September 2007 - February 2012
AAIPharma Services Corp. July 2000 - September 2007
Smithfield Foods August 1997 - July 2000
Carolina Food Processors, Incorporated December 1994 - August 1997
BY-PROD Corporation February 1993 - December 1994
North/South Meat Packers Company November 1992 - February 1993
Skills
FDA, Quality Assurance, Pharmaceutical Industry, Validation, Aseptic Technique, 21 CFR Part 11, LIMS, Change Control, Microbiology, Food Processing, Food Manufacturing, Food Microbiology, GMP, GLPs, USDA, Food Safety, Food Industry, USP, SOP, Laboratory, Detail Oriented, Proofreading, Mistake Proofing, Grammar, Verbal Communication, Written Communication, Clerical Skills, Ph.Eur., Quality Auditing
Education
Miller-Motte College, Wilmington, NC 2009 — 2010
Associate's Degree, Criminal Justice, 4.0 GPA
North Carolina Agricultural and Technical State University 1986 — 1990
Bachelor's Degree, Professional Biology
AAIPharma Services Corp. June 2000 - Present
CompuChem Laboratories 1998 - 2000
American Environmental Network 1997 - 1998
Skills
Gas Chromatography, HPLC, Dissolution, UV, Empower 2, Method Development, Analytical Method..., Method Transfer, Microsoft Office, Karl Fisher, E-WorkBook (idbs), Sample Preparation, Report Writing, writing protocols, SOP, LIMS, UV/Vis, Analytical Chemistry, Validation, GMP
Education
State University of New York at Buffalo
Bachelor of Science (B.S.), Pharmacology
AAIPharma Services Corp. August 2007 - Present
Michael Foods June 2003 - December 2007
Silliker August 2000 - June 2003
Skills
GLP, GMP
Education
The Maharaja Sayajirao University of Baroda
Master of Science (MSc), Biology, General