AAIPharma Company
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AAIPharma Employees
Employee
Years
Job
Industry
Jonathan Anstett Jonathan Anstett's AAIPharma Experience September 2003 - October 2007
Job Account Director, Clinical Supply Services
Industry Pharmaceuticals
Experience
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
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
Bob Haldane Bob Haldane's AAIPharma Experience October 2003 - January 2008
Job Process Validation Consultant at VALIDANT, San Francisco, CA (Corporate Office Location, Home Owner in Naples, FL)
Industry Medical Devices
Experience
VALIDANT, San Francisco, CA March 2015 - Present
Self Employed December 2014 - Present
Visionare March 2014 - October 2014
Maetrics Consulting October 2013 - March 2014
Iconsoft August 2013 - October 2013
Self Employed May 2013 - July 2013
Arthrex November 2008 - April 2013
CAPSUGEL January 2008 - November 2008
AAIPHARMA October 2003 - January 2008
Skills
CAPA, Validation, FDA, Quality System, GMP, 21 CFR Part 11, ISO 13485, Change Control, Sop, Quality Assurance, Medical Devices
Education
Florida International University
Bachelor of Science (BS), Chemistry
Hialeah Miami Lakes High School
Hialeah Miami Lakes High School
Miami Dade College
Electronic Technology
VALIDANT, San Francisco, CA March 2015 - Present
Self Employed December 2014 - Present
Visionare March 2014 - October 2014
Maetrics Consulting October 2013 - March 2014
Iconsoft August 2013 - October 2013
Self Employed May 2013 - July 2013
Arthrex November 2008 - April 2013
CAPSUGEL January 2008 - November 2008
AAIPHARMA October 2003 - January 2008
Skills
CAPA, Validation, FDA, Quality System, GMP, 21 CFR Part 11, ISO 13485, Change Control, Sop, Quality Assurance, Medical Devices
Education
Florida International University
Bachelor of Science (BS), Chemistry
Hialeah Miami Lakes High School
Hialeah Miami Lakes High School
Miami Dade College
Electronic Technology
Mat Farris's AAIPharma Experience September 2003 - December 2004
Job Senior Regional Sales Director at Meda Pharma
Industry Pharmaceuticals
Experience
Meda Pharma January 2009 - Present
Meda Pharma December 2004 - December 2008
aaiPharma September 2003 - December 2004
Pharmacia 1991 - 2003
Skills
EBITDA Growth, Driving Results, Leading..., Leading Positive Change, Sales Management, Sales Force Development, Product Launch, Pharmaceutical Industry, Sales Effectiveness, Managed Care, Sales Operations, Sales, Pharmaceutical Sales, Hospital Sales, Management, Urology, Neurology, Rheumatology, Allergy
Education
Texas Christian University - M.J. Neeley School of Business 1987 — 1990
MBA, General Business
Kansas State University 1982 — 1986
BS, Business Administration
Meda Pharma January 2009 - Present
Meda Pharma December 2004 - December 2008
aaiPharma September 2003 - December 2004
Pharmacia 1991 - 2003
Skills
EBITDA Growth, Driving Results, Leading..., Leading Positive Change, Sales Management, Sales Force Development, Product Launch, Pharmaceutical Industry, Sales Effectiveness, Managed Care, Sales Operations, Sales, Pharmaceutical Sales, Hospital Sales, Management, Urology, Neurology, Rheumatology, Allergy
Education
Texas Christian University - M.J. Neeley School of Business 1987 — 1990
MBA, General Business
Kansas State University 1982 — 1986
BS, Business Administration
David Burns's AAIPharma Experience December 2001 - September 2007
Job
Industry Pharmaceuticals
Experience
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
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
Thomas McCray Harris Thomas McCray Harris's AAIPharma Experience 2007 - 2009
Job Medical Writer at AptivSolutions
Industry Pharmaceuticals
Experience
Aptiv Solutions July 2012 - Present
PAREXEL October 2010 - June 2012
The Biomedical Artisan November 2009 - November 2010
AAIPharma 2007 - 2009
GlaxoSmithKline 2004 - 2007
Becton Dickinson Technologies 2002 - 2004
Nobex Corporation 1996 - 2002
Burroughs Wellcome 1994 - 1995
Burroughs Wellcome 1991 - 1994
Burroughs Wellcome 1986 - 1991
Skills
Clinical Research, FDA, Medical Writing, Clinical Trials, Biotechnology, Pharmacology, Clinical Development, Infectious Diseases, Lifesciences, Medical Devices, Medical Terminology, Scientific Writing, ICH guidelines, Freelance Writing, Regulatory Requirements, EMEA, GLP, GCP, GMP, MHRA, Drug Delivery, Drug Development, Pre-clinical Studies, IACUC, Bloodborne Pathogens, Laboratory Animal..., Laboratory Safety, Editing, Peer Reviews, Protocol, ICF, CSRs, IND, Investigator Brochures, Narrative, Technical Presentations, Study Reports, Publications, CNS disorders, Cardiovascular Disease, Gastrointestinal..., Obstetrics, Pulmonary Diseases, Oncology, Autoimmune Diseases, Inflammation, Pain Management, Psychopharmacology, Research Design, Innovation
Education
East Carolina University 1978 — 1985
BS, Biology
Aptiv Solutions July 2012 - Present
PAREXEL October 2010 - June 2012
The Biomedical Artisan November 2009 - November 2010
AAIPharma 2007 - 2009
GlaxoSmithKline 2004 - 2007
Becton Dickinson Technologies 2002 - 2004
Nobex Corporation 1996 - 2002
Burroughs Wellcome 1994 - 1995
Burroughs Wellcome 1991 - 1994
Burroughs Wellcome 1986 - 1991
Skills
Clinical Research, FDA, Medical Writing, Clinical Trials, Biotechnology, Pharmacology, Clinical Development, Infectious Diseases, Lifesciences, Medical Devices, Medical Terminology, Scientific Writing, ICH guidelines, Freelance Writing, Regulatory Requirements, EMEA, GLP, GCP, GMP, MHRA, Drug Delivery, Drug Development, Pre-clinical Studies, IACUC, Bloodborne Pathogens, Laboratory Animal..., Laboratory Safety, Editing, Peer Reviews, Protocol, ICF, CSRs, IND, Investigator Brochures, Narrative, Technical Presentations, Study Reports, Publications, CNS disorders, Cardiovascular Disease, Gastrointestinal..., Obstetrics, Pulmonary Diseases, Oncology, Autoimmune Diseases, Inflammation, Pain Management, Psychopharmacology, Research Design, Innovation
Education
East Carolina University 1978 — 1985
BS, Biology
Afshin Safavi Afshin Safavi's AAIPharma Experience May 2007 - April 2008
Job Founder and Chief Scientific Officer at BioAgilytix Labs
Industry Pharmaceuticals
Experience
BioAgilytix Labs May 2008 - Present
AAIPharma May 2007 - April 2008
Talecris April 2001 - April 2007
Nobex Corporation April 2000 - April 2001
IGEN, Inc. (BioVeris) / GlaxoSmithKline Collaboration April 1999 - April 2000
Skills
Bioanalytical Operation, Immunoassay, CRO, Bioanalysis, GLP, Life Sciences, Clinical Development, ELISA, Drug Development, Immunoassays, Lifesciences, Drug Discovery, Pharmaceutical Industry, Assay Development, Biomarkers, Purification, Protein Chemistry, Clinical Trials, HPLC, GMP, Biotechnology, Validation, Biochemistry, Clinical Research, Cancer, Laboratory, Antibodies, Formulation, Sop, Cell, High Throughput..., In Vitro, Technology Transfer, Cell Culture, Immunology, Biopharmaceuticals, Molecular Biology, Protein Purification, Laboratory Automation, In Vivo, Chromatography, Cell Biology, Enzyme Assays, LC-MS, Western Blotting, PCR, Oncology, Mass Spectrometry, Monoclonal Antibodies, Proteomics
Education
Emory University 1997 — 1999
PostDoctoral, Biochemistry and Molecular Biology
University of Kentucky 1992 — 1997
Ph.D., Biochemistry
University of California, Los Angeles 1990 — 1992
BS, Biochemistry
BioAgilytix Labs May 2008 - Present
AAIPharma May 2007 - April 2008
Talecris April 2001 - April 2007
Nobex Corporation April 2000 - April 2001
IGEN, Inc. (BioVeris) / GlaxoSmithKline Collaboration April 1999 - April 2000
Skills
Bioanalytical Operation, Immunoassay, CRO, Bioanalysis, GLP, Life Sciences, Clinical Development, ELISA, Drug Development, Immunoassays, Lifesciences, Drug Discovery, Pharmaceutical Industry, Assay Development, Biomarkers, Purification, Protein Chemistry, Clinical Trials, HPLC, GMP, Biotechnology, Validation, Biochemistry, Clinical Research, Cancer, Laboratory, Antibodies, Formulation, Sop, Cell, High Throughput..., In Vitro, Technology Transfer, Cell Culture, Immunology, Biopharmaceuticals, Molecular Biology, Protein Purification, Laboratory Automation, In Vivo, Chromatography, Cell Biology, Enzyme Assays, LC-MS, Western Blotting, PCR, Oncology, Mass Spectrometry, Monoclonal Antibodies, Proteomics
Education
Emory University 1997 — 1999
PostDoctoral, Biochemistry and Molecular Biology
University of Kentucky 1992 — 1997
Ph.D., Biochemistry
University of California, Los Angeles 1990 — 1992
BS, Biochemistry
Kimbelyn Emory's AAIPharma Experience February 2004 - October 2012
Job Graphic Designer at Lower Cape Fear Hospice & LifeCareCenter
Industry Marketing and Advertising
Experience
Lower Cape Fear Hospice & LifeCareCenter February 2014 - Present
WhiteInk, LLC August 2013 - Present
AAIPharma February 2004 - October 2012
NC State University 2000 - 2004
Adstreet 1999 - 2000
Joseph C. Woodard Company 1996 - 1999
R.R. Donnelley & Sons 1993 - 1996
The Evening Telegram, Rocky Mount, NC 1992 - 1993
J.C. Penney 1992 - 1993
Skills
Microsoft Excel, Project Management, Adobe Acrobat, Dreamweaver, Packaging, PowerPoint, Marketing, Photoshop, Trade Shows, Microsoft Office, Graphic Design, Brochures, Advertising, Art Direction, Event Planning, Copywriting, Direct Mail, Marketing Strategy, Layout, Logo Design, Corporate Identity, Photography, Corporate Communications, Product Development, Budgets, Collateral, Email Marketing, Brand Development, Adobe Creative Suite, Illustrator, Marketing Communications, Social Media, HTML, Event Management, Facebook, Creative Direction, Training, Google Analytics, Google Adwords, LinkedIn, Management, Social Networking, Art, Editing, Corporate Branding, Integrated Marketing, WordPress, Web Design, Brand Management, Creative Strategy
Education
East Carolina University 1986 — 1991
BFA, Art
Enfield Academy, Whitakers, North Carolina
Lower Cape Fear Hospice & LifeCareCenter February 2014 - Present
WhiteInk, LLC August 2013 - Present
AAIPharma February 2004 - October 2012
NC State University 2000 - 2004
Adstreet 1999 - 2000
Joseph C. Woodard Company 1996 - 1999
R.R. Donnelley & Sons 1993 - 1996
The Evening Telegram, Rocky Mount, NC 1992 - 1993
J.C. Penney 1992 - 1993
Skills
Microsoft Excel, Project Management, Adobe Acrobat, Dreamweaver, Packaging, PowerPoint, Marketing, Photoshop, Trade Shows, Microsoft Office, Graphic Design, Brochures, Advertising, Art Direction, Event Planning, Copywriting, Direct Mail, Marketing Strategy, Layout, Logo Design, Corporate Identity, Photography, Corporate Communications, Product Development, Budgets, Collateral, Email Marketing, Brand Development, Adobe Creative Suite, Illustrator, Marketing Communications, Social Media, HTML, Event Management, Facebook, Creative Direction, Training, Google Analytics, Google Adwords, LinkedIn, Management, Social Networking, Art, Editing, Corporate Branding, Integrated Marketing, WordPress, Web Design, Brand Management, Creative Strategy
Education
East Carolina University 1986 — 1991
BFA, Art
Enfield Academy, Whitakers, North Carolina
Paula Gaio Paula Gaio's AAIPharma Experience April 2008 - October 2009
Job Sr CRA at PharmOlam International
Industry Research
Experience
Pharm-Olam International April 2010 - Present
ZeeCRO (formerly AAIPharma) October 2009 - April 2010
MDCI 2009 - 2010
AAIPharma April 2008 - October 2009
Dynavax Technologies 2007 - 2008
Monitoring Force USA, Inc 2004 - 2008
Clinical Research Consultant Group 2002 - 2006
CRCG 2000 - 2002
Skills
Clinical Monitoring, Clinical Trials, GCP, Clinical Operations, Leadership, Clinical Research..., CRO, Clinical Development, CTMS, EDC, Phase I, ICH-GCP, Management, Oncology, Clinical Data Management, Therapeutic Areas, Medical Devices, Patient Recruitment, Human Resources, Regulatory Submissions, Clinical Research, Sop, Pharmaceutical Industry
Education
McGill University
Bachelor's degree
Pharm-Olam International April 2010 - Present
ZeeCRO (formerly AAIPharma) October 2009 - April 2010
MDCI 2009 - 2010
AAIPharma April 2008 - October 2009
Dynavax Technologies 2007 - 2008
Monitoring Force USA, Inc 2004 - 2008
Clinical Research Consultant Group 2002 - 2006
CRCG 2000 - 2002
Skills
Clinical Monitoring, Clinical Trials, GCP, Clinical Operations, Leadership, Clinical Research..., CRO, Clinical Development, CTMS, EDC, Phase I, ICH-GCP, Management, Oncology, Clinical Data Management, Therapeutic Areas, Medical Devices, Patient Recruitment, Human Resources, Regulatory Submissions, Clinical Research, Sop, Pharmaceutical Industry
Education
McGill University
Bachelor's degree
Julie Ross Julie Ross's AAIPharma Experience 1997 - 1999
Job Director, Formulation Development at BioDelivery Sciences International
Industry Pharmaceuticals
Experience
BioDelivery Sciences International June 2012 - Present
Paw Pharma Services, LLC February 2012 - Present
Pfizer (formerly King Pharmaceuticals, Inc.) June 2009 - December 2011
King Pharmaceuticals July 2004 - June 2009
ViroPharma 2001 - 2004
Omnicare Pharmaceutics 1999 - 2001
AAIPharma 1997 - 1999
Skills
Team Coordination, Drug Development, Cross-functional..., Drug Delivery, Drug Manufacturing, Project Management, Formulation Development
Education
Medical University of South Carolina 1992 — 1996
PhD, Pharmaceutics
Clemson University 1988 — 1992
BS, Chemistry
BioDelivery Sciences International June 2012 - Present
Paw Pharma Services, LLC February 2012 - Present
Pfizer (formerly King Pharmaceuticals, Inc.) June 2009 - December 2011
King Pharmaceuticals July 2004 - June 2009
ViroPharma 2001 - 2004
Omnicare Pharmaceutics 1999 - 2001
AAIPharma 1997 - 1999
Skills
Team Coordination, Drug Development, Cross-functional..., Drug Delivery, Drug Manufacturing, Project Management, Formulation Development
Education
Medical University of South Carolina 1992 — 1996
PhD, Pharmaceutics
Clemson University 1988 — 1992
BS, Chemistry
Pete Megronigle Pete Megronigle's AAIPharma Experience 2005 - 2007
Job VP, Head NA Health Management Solutions at Quintiles
Industry Pharmaceuticals
Experience
Quintiles December 2011 - Present
Quintiles Commercial Solutions (Innovex) August 2009 - October 2012
Quest Diagnostics August 2007 - August 2009
AAIPHARMA 2005 - 2007
Innovex June 2003 - July 2005
Innovex (Quintiles) 1997 - 2005
Skills
Pharmaceutical Industry, Business Development, Clinical Trials, Oncology, Diabetes, Strategic Planning, CRO, Healthcare, Management, Marketing, Infectious Diseases, Neurology, Sales, Cross-functional Team..., Pharmaceutical Sales, Biotechnology, Cardiology, Clinical Development, Dermatology, Endocrinology, Gastroenterology, Managed Care, Medical Devices, Product Launch, Sales Effectiveness
Education
Rutgers University – Camden 1972 — 1977
BA, Biology
Quintiles December 2011 - Present
Quintiles Commercial Solutions (Innovex) August 2009 - October 2012
Quest Diagnostics August 2007 - August 2009
AAIPHARMA 2005 - 2007
Innovex June 2003 - July 2005
Innovex (Quintiles) 1997 - 2005
Skills
Pharmaceutical Industry, Business Development, Clinical Trials, Oncology, Diabetes, Strategic Planning, CRO, Healthcare, Management, Marketing, Infectious Diseases, Neurology, Sales, Cross-functional Team..., Pharmaceutical Sales, Biotechnology, Cardiology, Clinical Development, Dermatology, Endocrinology, Gastroenterology, Managed Care, Medical Devices, Product Launch, Sales Effectiveness
Education
Rutgers University – Camden 1972 — 1977
BA, Biology
Charlie Deignan's AAIPharma Experience 1994 - 1999
Job
Industry Biotechnology
Experience
Clearside Biomedical, Inc. 2012 - Present
Salutria Pharmaceuticals June 2009 - June 2012
AtheroGenics August 1999 - June 2009
Metastatix 2008 - 2008
AAIPharma 1994 - 1999
Schering-Plough Healthcare 1990 - 1994
Schering Plough 1988 - 1990
Education
Boston University Questrom School of Business 1982 — 1986
Clearside Biomedical, Inc. 2012 - Present
Salutria Pharmaceuticals June 2009 - June 2012
AtheroGenics August 1999 - June 2009
Metastatix 2008 - 2008
AAIPharma 1994 - 1999
Schering-Plough Healthcare 1990 - 1994
Schering Plough 1988 - 1990
Education
Boston University Questrom School of Business 1982 — 1986
E. Nicholas (Nick) Griffin, PhD, MBA, RPh E. Nicholas (Nick) Griffin, PhD, MBA, RPh's AAIPharma Experience December 2001 - December 2004
Job Senior Associate at Lachman Consulting Services Inc.
Industry Pharmaceuticals
Experience
Lachman Consulting Services Inc. June 2011 - Present
Shionogi Pharma (formerly Sciele Pharma) December 2004 - May 2011
AAIPharma December 2001 - December 2004
Schering-Plough Research Institute February 1998 - December 2001
Education
University of North Carolina at Wilmington 2003 — 2005
MBA
Medical University of South Carolina 1992 — 1998
PhD, Industrial Pharmacy
Medical University of South Carolina 1989 — 1992
BS, Pharmacy
Coastal Carolina University 1987 — 1989
Pre-pharmacy
Lachman Consulting Services Inc. June 2011 - Present
Shionogi Pharma (formerly Sciele Pharma) December 2004 - May 2011
AAIPharma December 2001 - December 2004
Schering-Plough Research Institute February 1998 - December 2001
Education
University of North Carolina at Wilmington 2003 — 2005
MBA
Medical University of South Carolina 1992 — 1998
PhD, Industrial Pharmacy
Medical University of South Carolina 1989 — 1992
BS, Pharmacy
Coastal Carolina University 1987 — 1989
Pre-pharmacy
Steve Harvey's AAIPharma Experience 1998 - 1999
Job Vice President of IT, Dole Packaged Foods, LLC
Industry Computer Software
Experience
Dole Packaged Foods, LLC July 2015 - Present
Dole Food Comany May 2010 - March 2013
THQ April 2005 - May 2010
Global Core Strategies 1998 - 2003
Intech February 2001 - February 2002
GCS, Condor Technologies (one of them) 1997 - 2001
Condor Technology Solutions June 1998 - January 2000
aaiPharma 1998 - 1999
CooperTools 1997 - 1999
Skills
ERP, SAP, SAP R/3, EDI, SAP ERP, SAP GRC Access Control, SAP CRM, SAP BW
Education
Monash University 1984 — 1987
Bachelor of Science (B.Sc.), Computer Science & Accounting
Dole Packaged Foods, LLC July 2015 - Present
Dole Food Comany May 2010 - March 2013
THQ April 2005 - May 2010
Global Core Strategies 1998 - 2003
Intech February 2001 - February 2002
GCS, Condor Technologies (one of them) 1997 - 2001
Condor Technology Solutions June 1998 - January 2000
aaiPharma 1998 - 1999
CooperTools 1997 - 1999
Skills
ERP, SAP, SAP R/3, EDI, SAP ERP, SAP GRC Access Control, SAP CRM, SAP BW
Education
Monash University 1984 — 1987
Bachelor of Science (B.Sc.), Computer Science & Accounting
Penny Wacaster Penny Wacaster's AAIPharma Experience ScientistAAIPharma Services Corp.1997 - Present
Job Scientist at AAIPharma
Industry Pharmaceuticals
Experience
AAIPharma ScientistAAIPharma Services Corp.1997 - Present
Baxter Healthacare 1990 - 1997
Education
Appalachian State University
AAIPharma ScientistAAIPharma Services Corp.1997 - Present
Baxter Healthacare 1990 - 1997
Education
Appalachian State University
Kruti Macwan's AAIPharma Experience 2009 - 2009
Job Clinical Data Management at AAIPharma
Industry Hospital & Health Care
Experience
AAIPharma 2009 - 2009
Allied Research International May 2008 - October 2008
Endpoint Research Ltd January 2007 - May 2008
Endpoint January 2007 - July 2007
Skills
Clinical Research, Clinical Data Management, Clinical Trials, GCP, Oracle Clinical, MedDRA, EDC, SAS
Education
Gujarat University 1999 — 2001
Bachelors in Science, Microbiology
AAIPharma 2009 - 2009
Allied Research International May 2008 - October 2008
Endpoint Research Ltd January 2007 - May 2008
Endpoint January 2007 - July 2007
Skills
Clinical Research, Clinical Data Management, Clinical Trials, GCP, Oracle Clinical, MedDRA, EDC, SAS
Education
Gujarat University 1999 — 2001
Bachelors in Science, Microbiology
Diane (Krysa) Lacroix's AAIPharma Experience February 2001 - 2004
Job Sr. Clinical Data Manager/eClinical Solutions
Industry Pharmaceuticals
Experience
Quintiles May 2010 - January 2015
ZeeCRO (formerly AAIPharma) 2005 - April 2010
Boston Scientific September 2004 - May 2005
AAIPharma February 2001 - 2004
AAIPharma March 1999 - February 2001
Skills
GCP
Education
Framingham State University 1996 — 1998
BS, Biology
Mount Ida College 1987 — 1989
Assoc., Graphic Design
Quintiles May 2010 - January 2015
ZeeCRO (formerly AAIPharma) 2005 - April 2010
Boston Scientific September 2004 - May 2005
AAIPharma February 2001 - 2004
AAIPharma March 1999 - February 2001
Skills
GCP
Education
Framingham State University 1996 — 1998
BS, Biology
Mount Ida College 1987 — 1989
Assoc., Graphic Design
Ashok Desai Ashok Desai's AAIPharma Experience 1988 - 2001
Job Senior Director, Product Development at Metrics, Inc.
Industry Pharmaceuticals
Experience
Mayne Pharma January 2013 - Present
Metrics, Inc. May 2005 - December 2012
aaiPharma 1988 - 2001
AAI Development Services 1988 - 2001
Skills
Pharmaceutical Industry, FDA, GMP, Technology Transfer, Validation, Drug Development, Formulation, Sop, Biotechnology, Regulatory Affairs, GLP, Pharmaceutics, Analytical Chemistry, Lifesciences, CRO, HPLC, 21 CFR Part 11, Clinical Trials, Quality by Design, CAPA
Education
LIU Brooklyn 1979 — 1984
Mayne Pharma January 2013 - Present
Metrics, Inc. May 2005 - December 2012
aaiPharma 1988 - 2001
AAI Development Services 1988 - 2001
Skills
Pharmaceutical Industry, FDA, GMP, Technology Transfer, Validation, Drug Development, Formulation, Sop, Biotechnology, Regulatory Affairs, GLP, Pharmaceutics, Analytical Chemistry, Lifesciences, CRO, HPLC, 21 CFR Part 11, Clinical Trials, Quality by Design, CAPA
Education
LIU Brooklyn 1979 — 1984
Alex Walden Alex Walden's AAIPharma Experience 2000 - 2003
Job
Industry Pharmaceuticals
Experience
Entera Health May 2014 - Present
Entera Health June 2013 - May 2014
Cornerstone Therapeutics February 2008 - June 2013
Ameriprise Financial November 2007 - February 2008
LipoScience, Inc April 2005 - November 2007
Mylan Bertek 2003 - 2005
aaiPharma 2000 - 2003
Skills
Medical Devices, Product Management, Cross-functional Team..., Pharmaceutical Industry, Biotechnology, Business Development, Business Planning, Healthcare, Strategic Planning, Forecasting, Product Development, Market Analysis, Start-ups, Lifesciences, Mergers, Cash Flow Forecasting, Variance Analysis, Financial Reporting, Public Speaking, Investor Relations, Management, Corporate FP&A, Finance, Budget Process, Operating Budgets, Budget Reconciliation, Revenue Forecasting, Income Statement, Balance Sheet, Balance Sheet Review, Market Research, Product Marketing, Product Launch, Cost Planning, MBA, German, English, International, Pharmaceutical Sales, Pulmonology, Sales, Mergers & Acquisitions, Neurology, Competitive Analysis, Cardiology, Hospital Sales, Commercialization, Dermatology, Gastroenterology, Life Sciences
Education
Penn State University 2002 — 2004
MBA
The Citadel 1997 — 2000
BS
Entera Health May 2014 - Present
Entera Health June 2013 - May 2014
Cornerstone Therapeutics February 2008 - June 2013
Ameriprise Financial November 2007 - February 2008
LipoScience, Inc April 2005 - November 2007
Mylan Bertek 2003 - 2005
aaiPharma 2000 - 2003
Skills
Medical Devices, Product Management, Cross-functional Team..., Pharmaceutical Industry, Biotechnology, Business Development, Business Planning, Healthcare, Strategic Planning, Forecasting, Product Development, Market Analysis, Start-ups, Lifesciences, Mergers, Cash Flow Forecasting, Variance Analysis, Financial Reporting, Public Speaking, Investor Relations, Management, Corporate FP&A, Finance, Budget Process, Operating Budgets, Budget Reconciliation, Revenue Forecasting, Income Statement, Balance Sheet, Balance Sheet Review, Market Research, Product Marketing, Product Launch, Cost Planning, MBA, German, English, International, Pharmaceutical Sales, Pulmonology, Sales, Mergers & Acquisitions, Neurology, Competitive Analysis, Cardiology, Hospital Sales, Commercialization, Dermatology, Gastroenterology, Life Sciences
Education
Penn State University 2002 — 2004
MBA
The Citadel 1997 — 2000
BS
Lyle Lohmeyer Lyle Lohmeyer's AAIPharma Experience December 2008 - April 2010
Job Cloud Pharmaceuticals, Chief Financial Officer
Industry Pharmaceuticals
Experience
Cloud Pharmaceuticals, Inc. 2015 - Present
The North Carolina Translational & Clinical Sciences Institute 2015 - Present
University of North Carolina Hospital 2014 - Present
Council for Entrepreneurial Development 2011 - Present
Qualia Networks August 2012 - October 2013
AAIPharma December 2008 - April 2010
Energy Conversion Systems Holdings LLC April 2004 - December 2008
Abaco Mobile 1999 - 2001
NAVTEQ 1997 - 1999
Tenneco Automotive 1995 - 1996
Skills
Due Diligence, Private Equity, Venture Capital, Forecasting, Mergers, Restructuring, Acquisition Integration, Cash Management, Financial Analysis, Financial Modeling, Joint Ventures, Turn Around Management, Financial Reporting, Executive Management, Business Planning, Manufacturing, Investor Relations, M&A experience, Divestitures, Global Management, Fund Raising, Debt Restructuring, Board Relations, Global Strategy, SAP R/3, Great Plains Software, Board Member, Clinical Research, Automotive, Financial Markets, Operations Management, Working Capital..., Debt Management, Lender Management, Pharmaceuticals, Electronics, Financial Planning, Financial Management, International Tax, General Management, MBA, Certified Public...
Education
Northwestern University - Kellogg School of Management 1987 — 1991
Masters of Management, Finance
Purdue University - Krannert School of Management 1971 — 1976
BSGM, Accounting & Finance
Cloud Pharmaceuticals, Inc. 2015 - Present
The North Carolina Translational & Clinical Sciences Institute 2015 - Present
University of North Carolina Hospital 2014 - Present
Council for Entrepreneurial Development 2011 - Present
Qualia Networks August 2012 - October 2013
AAIPharma December 2008 - April 2010
Energy Conversion Systems Holdings LLC April 2004 - December 2008
Abaco Mobile 1999 - 2001
NAVTEQ 1997 - 1999
Tenneco Automotive 1995 - 1996
Skills
Due Diligence, Private Equity, Venture Capital, Forecasting, Mergers, Restructuring, Acquisition Integration, Cash Management, Financial Analysis, Financial Modeling, Joint Ventures, Turn Around Management, Financial Reporting, Executive Management, Business Planning, Manufacturing, Investor Relations, M&A experience, Divestitures, Global Management, Fund Raising, Debt Restructuring, Board Relations, Global Strategy, SAP R/3, Great Plains Software, Board Member, Clinical Research, Automotive, Financial Markets, Operations Management, Working Capital..., Debt Management, Lender Management, Pharmaceuticals, Electronics, Financial Planning, Financial Management, International Tax, General Management, MBA, Certified Public...
Education
Northwestern University - Kellogg School of Management 1987 — 1991
Masters of Management, Finance
Purdue University - Krannert School of Management 1971 — 1976
BSGM, Accounting & Finance
Lorraine Rusch's AAIPharma Experience April 2008 - June 2009
Job Vice President, Business Development at Vince and Associates Clinical Research, Inc.
Industry Pharmaceuticals
Experience
Vince and Associates Clinical Research, Inc. June 2009 - Present
AAIPharma April 2008 - June 2009
MDS Pharma Services June 2004 - May 2008
Aton Pharma, Inc. April 2003 - May 2004
Emisphere Technologies, Inc. May 2000 - April 2003
Skills
CRO, Clinical Development, Clinical Trials, Bioanalysis, Pharmaceutical Industry, Drug Development, Biopharmaceuticals, Clinical Research, Lifesciences, Biotechnology, Clinical Pharmacology, Oncology, IND, Biomarkers, Business Development, CTMS, Clinical Data Management, Clinical Study Design, FDA, GCP, GLP, Infectious Diseases, Medical Writing, Pharmaceutics, Pharmacokinetics, Pharmacology, Protocol, Strategy, Therapeutic Areas, Toxicology
Education
Cleveland Clinic Foundation 1997 — 2000
Ph.D., Bioanalytical Chemistry and Laboratory Medicine
Cleveland State University 1996 — 2000
Ph.D., Bioanalytical Chemistry and Laboratory Medicine
Vince and Associates Clinical Research, Inc. June 2009 - Present
AAIPharma April 2008 - June 2009
MDS Pharma Services June 2004 - May 2008
Aton Pharma, Inc. April 2003 - May 2004
Emisphere Technologies, Inc. May 2000 - April 2003
Skills
CRO, Clinical Development, Clinical Trials, Bioanalysis, Pharmaceutical Industry, Drug Development, Biopharmaceuticals, Clinical Research, Lifesciences, Biotechnology, Clinical Pharmacology, Oncology, IND, Biomarkers, Business Development, CTMS, Clinical Data Management, Clinical Study Design, FDA, GCP, GLP, Infectious Diseases, Medical Writing, Pharmaceutics, Pharmacokinetics, Pharmacology, Protocol, Strategy, Therapeutic Areas, Toxicology
Education
Cleveland Clinic Foundation 1997 — 2000
Ph.D., Bioanalytical Chemistry and Laboratory Medicine
Cleveland State University 1996 — 2000
Ph.D., Bioanalytical Chemistry and Laboratory Medicine
Rusty Kelley Rusty Kelley's AAIPharma Experience September 1993 - October 1995
Job Burroughs Wellcome Fund
Industry Biotechnology
Experience
Burroughs Wellcome Fund April 2013 - Present
Health Research Alliance (HRA) January 2015 - Present
Tengion 2010 - February 2013
Tengion July 2007 - October 2010
UNC Chapel Hill School of Medicine June 2004 - June 2007
PPD October 1995 - August 1998
AAIPharma September 1993 - October 1995
Education
Duke University - The Fuqua School of Business 2015 — 2016
Candidate, Master of Business Administration (MBA)
LSU Health Sciences Center 1999 — 2004
PhD, Pharmacology & Experimental Therapeutics
UNC Chapel Hill 1989 — 1993
BA, Chemistry
Burroughs Wellcome Fund April 2013 - Present
Health Research Alliance (HRA) January 2015 - Present
Tengion 2010 - February 2013
Tengion July 2007 - October 2010
UNC Chapel Hill School of Medicine June 2004 - June 2007
PPD October 1995 - August 1998
AAIPharma September 1993 - October 1995
Education
Duke University - The Fuqua School of Business 2015 — 2016
Candidate, Master of Business Administration (MBA)
LSU Health Sciences Center 1999 — 2004
PhD, Pharmacology & Experimental Therapeutics
UNC Chapel Hill 1989 — 1993
BA, Chemistry
Robert Guardino Robert Guardino's AAIPharma Experience 1999 - 2012
Job Principal Microbiologist at MicroGuard Consulting LLC
Industry Pharmaceuticals
Experience
MicroGuard Consulting LLC May 2012 - Present
Microbiology Network 2012 - 2014
AAIPharma 1999 - 2012
Johnson and Johnson September 1995 - September 1999
Skills
Pharmaceutical..., GMP, Clinical Microbiology, Biblical Studies, Microbiology, Validation, Laboratory, GLP, USP, Aseptic Processing, Biotechnology, Sop, Lifesciences, Medical Writing, CAPA, Vaccines, Pharmaceutical Industry, Pharmaceutics, Environmental Monitoring, Sterilization, Chromatography, Aseptic Technique, Quality Control, FDA, Cleaning Validation
Education
Unversity of Buffalo, Buffalo, NY 1977 — 1979
Master of Science (M.S.), Medical Microbiology and Bacteriology
Rochester Institute of Technology 1973 — 1975
Bachelor of Science (B.S.), Medical Technology
MicroGuard Consulting LLC May 2012 - Present
Microbiology Network 2012 - 2014
AAIPharma 1999 - 2012
Johnson and Johnson September 1995 - September 1999
Skills
Pharmaceutical..., GMP, Clinical Microbiology, Biblical Studies, Microbiology, Validation, Laboratory, GLP, USP, Aseptic Processing, Biotechnology, Sop, Lifesciences, Medical Writing, CAPA, Vaccines, Pharmaceutical Industry, Pharmaceutics, Environmental Monitoring, Sterilization, Chromatography, Aseptic Technique, Quality Control, FDA, Cleaning Validation
Education
Unversity of Buffalo, Buffalo, NY 1977 — 1979
Master of Science (M.S.), Medical Microbiology and Bacteriology
Rochester Institute of Technology 1973 — 1975
Bachelor of Science (B.S.), Medical Technology
Felix Marusic Felix Marusic's AAIPharma Experience July 2007 - June 2012
Job Business Analyst at Astrix Technology Group
Industry Pharmaceuticals
Experience
Astrix Technology Group April 2014 - Present
CSC January 2014 - April 2014
CSC June 2012 - January 2014
AAIPharma July 2007 - June 2012
Azopharma September 2006 - July 2007
Noven Pharmaceuticals November 2004 - September 2006
Wyeth Pharmaceuticals 2003 - 2004
Wyeth Pharmaceuticals 2002 - 2003
PLIVA 2001 - 2002
Skills
LIMS, Crystal Reports, HTML, XML, CDS, ELN, Technical Documentation, Trackwise, Change Management, SDLC, GAMP, ECM, EDMS, Document Management, Electronic Lab Notebooks, Pharmaceutical Industry, Medical Devices, Change Control, GMP, Quality Control, HPLC, Testing, V, V&V, Validation, FDA, TrackWise, Enterprise Content..., 21 CFR Part 11, SOP, Computer System..., Quality Assurance
Education
New Jersey Institute of Technology 2002 — 2004
MS Certificate, Pharmaceutical Engineering
Fairleigh Dickinson University-Metropolitan Campus 1996 — 1999
BS, Environmental Science, 3.7
Widener University 1993 — 1995
Pre-Medicine
Astrix Technology Group April 2014 - Present
CSC January 2014 - April 2014
CSC June 2012 - January 2014
AAIPharma July 2007 - June 2012
Azopharma September 2006 - July 2007
Noven Pharmaceuticals November 2004 - September 2006
Wyeth Pharmaceuticals 2003 - 2004
Wyeth Pharmaceuticals 2002 - 2003
PLIVA 2001 - 2002
Skills
LIMS, Crystal Reports, HTML, XML, CDS, ELN, Technical Documentation, Trackwise, Change Management, SDLC, GAMP, ECM, EDMS, Document Management, Electronic Lab Notebooks, Pharmaceutical Industry, Medical Devices, Change Control, GMP, Quality Control, HPLC, Testing, V, V&V, Validation, FDA, TrackWise, Enterprise Content..., 21 CFR Part 11, SOP, Computer System..., Quality Assurance
Education
New Jersey Institute of Technology 2002 — 2004
MS Certificate, Pharmaceutical Engineering
Fairleigh Dickinson University-Metropolitan Campus 1996 — 1999
BS, Environmental Science, 3.7
Widener University 1993 — 1995
Pre-Medicine
Shari DeGrofft Powell Shari DeGrofft Powell's AAIPharma Experience August 2008 - October 2009
Job SPM II at AbbVie
Industry Pharmaceuticals
Experience
AbbVie August 2015 - Present
Premier Research September 2013 - August 2015
Premier Research December 2012 - September 2013
i3 Research October 2009 - December 2012
AAIPharma August 2008 - October 2009
AAIPharma August 2008 - July 2009
PRA International October 2007 - July 2008
Paragon Biomedical October 2005 - July 2007
Paragon Biomedical August 2003 - October 2005
Paragon Biomedical August 2002 - August 2003
Skills
EDC, Clinical Trial..., Protocol Development, CRO, GCP, Clinical Research, ICH-GCP, CRF design, Clinical Monitoring, Site Selection, Project Closeout, Project Planning, MS Project, Project Implementation, Project Finance, Project Execution, Project Delivery, Nursing, Women's Health, Oncology, Urology, Nephrology, Infectious Diseases, SOP Development, Process Improvement, Process Development, Training & Development, Training Delivery, Mentoring, Gastroenterology, Dermatology, CNS/Psychology, Phase I - IV, Timeline Management, Global Project..., Quality Management..., Clinical Research..., Clinical Research..., Employee Training, Management, CTMS, Clinical Data Management, Clinical Operations, Clinical Trials, Location Intelligence, Process Simulation, Project Management, SOP development, Clinical Development, Pharmaceutical Industry
Education
Regis University 1996 — 1997
BSN, Nursing
Colorado State University 1992 — 1996
BS, Biology, Anatomy & Neurobiology
AbbVie August 2015 - Present
Premier Research September 2013 - August 2015
Premier Research December 2012 - September 2013
i3 Research October 2009 - December 2012
AAIPharma August 2008 - October 2009
AAIPharma August 2008 - July 2009
PRA International October 2007 - July 2008
Paragon Biomedical October 2005 - July 2007
Paragon Biomedical August 2003 - October 2005
Paragon Biomedical August 2002 - August 2003
Skills
EDC, Clinical Trial..., Protocol Development, CRO, GCP, Clinical Research, ICH-GCP, CRF design, Clinical Monitoring, Site Selection, Project Closeout, Project Planning, MS Project, Project Implementation, Project Finance, Project Execution, Project Delivery, Nursing, Women's Health, Oncology, Urology, Nephrology, Infectious Diseases, SOP Development, Process Improvement, Process Development, Training & Development, Training Delivery, Mentoring, Gastroenterology, Dermatology, CNS/Psychology, Phase I - IV, Timeline Management, Global Project..., Quality Management..., Clinical Research..., Clinical Research..., Employee Training, Management, CTMS, Clinical Data Management, Clinical Operations, Clinical Trials, Location Intelligence, Process Simulation, Project Management, SOP development, Clinical Development, Pharmaceutical Industry
Education
Regis University 1996 — 1997
BSN, Nursing
Colorado State University 1992 — 1996
BS, Biology, Anatomy & Neurobiology
Gary Clapp Gary Clapp's AAIPharma Experience October 2000 - September 2005
Job Coordinator of Workforce Development and Grants Procurement at Western Institute Missouri Western State University
Industry Education Management
Experience
Western Institute - Missouri Western State University May 2015 - Present
GECCOM April 2014 - Present
CritiTech October 2012 - March 2015
Missouri Western State University 2008 - 2013
Institute for Industrial and Applied Life Science @ MWSU January 2006 - October 2012
AAIPharma October 2000 - September 2005
Oread Laboratories January 1999 - January 2000
Oread Labs 1996 - 1999
Hauser Laboratories March 1992 - December 1996
Skills
Pharmaceutical Industry, Drug Development, Lifesciences, FDA, GMP, Validation, Technology Transfer, R&D, Product Development, Regulatory Affairs, Medical Devices, Biotechnology, Chemistry, Drug Delivery, Analytical Chemistry, Formulation, Quality Assurance, GLP, Biopharmaceuticals, Life Sciences, Spectroscopy, HPLC, Clinical Development, Mass Spectrometry, Organic Chemistry, LIMS, Laboratory, Drug Discovery, Microbiology, UV/Vis, Science, Gas Chromatography, Chromatography, Quality Control, Sop, Purification, Pharmaceutics, Commercialization, Change Control, LC-MS, CRO, NMR, Program Management
Education
Oregon State University 1985 — 1990
PhD, Physical Organic Chemistry
Minnesota State University, Mankato 1982 — 1985
Bachelor of Science (BS), Chemistry
Western Institute - Missouri Western State University May 2015 - Present
GECCOM April 2014 - Present
CritiTech October 2012 - March 2015
Missouri Western State University 2008 - 2013
Institute for Industrial and Applied Life Science @ MWSU January 2006 - October 2012
AAIPharma October 2000 - September 2005
Oread Laboratories January 1999 - January 2000
Oread Labs 1996 - 1999
Hauser Laboratories March 1992 - December 1996
Skills
Pharmaceutical Industry, Drug Development, Lifesciences, FDA, GMP, Validation, Technology Transfer, R&D, Product Development, Regulatory Affairs, Medical Devices, Biotechnology, Chemistry, Drug Delivery, Analytical Chemistry, Formulation, Quality Assurance, GLP, Biopharmaceuticals, Life Sciences, Spectroscopy, HPLC, Clinical Development, Mass Spectrometry, Organic Chemistry, LIMS, Laboratory, Drug Discovery, Microbiology, UV/Vis, Science, Gas Chromatography, Chromatography, Quality Control, Sop, Purification, Pharmaceutics, Commercialization, Change Control, LC-MS, CRO, NMR, Program Management
Education
Oregon State University 1985 — 1990
PhD, Physical Organic Chemistry
Minnesota State University, Mankato 1982 — 1985
Bachelor of Science (BS), Chemistry
Stan Micek Stan Micek's AAIPharma Experience April 2002 - August 2005
Job Interim Vice President Technology Commercialization Office at The Ohio State University
Industry Higher Education
Experience
The Ohio State University April 2015 - Present
Catalyst Partners, LLC October 2012 - Present
The Ohio State University February 2014 - April 2015
Xanodyne Pharmaceuticals August 2005 - September 2012
aaiPharma April 2002 - August 2005
Abbott Laboratories January 2000 - March 2002
Abbott July 1998 - January 2000
Abbott Diagnostics January 1996 - July 1998
Skills
Pharmaceutical Industry, Medical Devices, Technology Transfer, Commercialization, FDA, Cross-functional Team..., Product Launch, Product Development, Regulatory Affairs, Pharmaceutical Sales, Pharmaceutics, Strategic Planning, Lifesciences, Mergers, R&D
Education
Northwestern University - Kellogg School of Management 1997 — 2001
MBA, Marketing; Int'l Management
Illinois Institute of Technology 1979 — 1983
B.S., Chemical Engineering
The Ohio State University April 2015 - Present
Catalyst Partners, LLC October 2012 - Present
The Ohio State University February 2014 - April 2015
Xanodyne Pharmaceuticals August 2005 - September 2012
aaiPharma April 2002 - August 2005
Abbott Laboratories January 2000 - March 2002
Abbott July 1998 - January 2000
Abbott Diagnostics January 1996 - July 1998
Skills
Pharmaceutical Industry, Medical Devices, Technology Transfer, Commercialization, FDA, Cross-functional Team..., Product Launch, Product Development, Regulatory Affairs, Pharmaceutical Sales, Pharmaceutics, Strategic Planning, Lifesciences, Mergers, R&D
Education
Northwestern University - Kellogg School of Management 1997 — 2001
MBA, Marketing; Int'l Management
Illinois Institute of Technology 1979 — 1983
B.S., Chemical Engineering
Rodney Butt MSc MBA Rodney Butt MSc MBA's AAIPharma Experience December 2005 - April 2010
Job Proven expertise in global drug development and clinical operations
Industry Biotechnology
Experience
Nutrasource Diagnostics Inc. October 2011 - Present
Discover Clinical Trials November 2011 - Present
Hamilton Medical Consultants Group October 2003 - Present
eMotion Picture Studios 2004 - Present
LEO Pharma June 2010 - October 2011
AAIPharma December 2005 - April 2010
ApoPharma 2005 - 2006
Pedagogue Medical 2003 - 2005
Boehringer Ingelheim June 1990 - September 2003
Skills
Patient Recruitment, Clinical Trial..., Regulatory Requirements, CRO, Clinical Trials, GCP, Clinical Development, Biotechnology, CTMS, Pharmacovigilance, Pharmaceutical Industry, Clinical Research, Regulatory Affairs, ICH-GCP, Regulatory Submissions, Strategy, Protocol, Drug Development, Infectious Diseases, Oncology, Clinical Operations, Pharmaceutics, Data Management, Medical Writing, Lifesciences, Medical Devices, Sop, EDC, Clinical Data Management, FDA, Technology Transfer, Neurology, Diabetes, Immunology, 21 CFR Part 11, Medicine, Biopharmaceuticals, Life Sciences
Education
Queen's University 2000 — 2002
MBA, Administration and Finance
McMaster University 1997 — 2000
MSc, Clinical Trial Methodology
Nutrasource Diagnostics Inc. October 2011 - Present
Discover Clinical Trials November 2011 - Present
Hamilton Medical Consultants Group October 2003 - Present
eMotion Picture Studios 2004 - Present
LEO Pharma June 2010 - October 2011
AAIPharma December 2005 - April 2010
ApoPharma 2005 - 2006
Pedagogue Medical 2003 - 2005
Boehringer Ingelheim June 1990 - September 2003
Skills
Patient Recruitment, Clinical Trial..., Regulatory Requirements, CRO, Clinical Trials, GCP, Clinical Development, Biotechnology, CTMS, Pharmacovigilance, Pharmaceutical Industry, Clinical Research, Regulatory Affairs, ICH-GCP, Regulatory Submissions, Strategy, Protocol, Drug Development, Infectious Diseases, Oncology, Clinical Operations, Pharmaceutics, Data Management, Medical Writing, Lifesciences, Medical Devices, Sop, EDC, Clinical Data Management, FDA, Technology Transfer, Neurology, Diabetes, Immunology, 21 CFR Part 11, Medicine, Biopharmaceuticals, Life Sciences
Education
Queen's University 2000 — 2002
MBA, Administration and Finance
McMaster University 1997 — 2000
MSc, Clinical Trial Methodology
Greg Ginn Greg Ginn's AAIPharma Experience February 2006 - September 2007
Job Sr. Statistician at St. Jude Medical
Industry Medical Devices
Experience
St. Jude Medical June 2014 - Present
CardioMEMS, Inc. September 2009 - Present
Stat-Tech Services, LLC September 2008 - June 2009
CardioMEMS September 2007 - September 2008
AAIPharma February 2006 - September 2007
Targacept, Inc. March 2002 - September 2005
Ginn Technologies, LLC 1998 - 2005
AtheroGenics June 1999 - March 2002
Medtronic Sofamor Danek November 1994 - June 1999
Schering-Plough November 1988 - September 1994
Skills
Biostatistics, Statistics, Clinical Trials, CDISC, MedDRA, ICH-GCP, EDC, Statistical Programming, Data Maintenance, Clinical Data Management, Medical Devices, SAS, Stata, Systat, CRO, Clinical Research, SAS programming, Clinical Study Design, Therapeutic Areas, Statistical Modeling, CRF design, Survival Analysis, Phase I, Brewing, FDA, Protocol, Data Management, Regulatory Affairs, Biotechnology, Medical Writing, GCP, Data Analysis, Clinical Operations, Clinical Development, Sop, Regulatory Submissions, Validation, Bayesian statistics, 21 CFR Part 11, Pharmaceutical Industry, PMA, Experimental Design, Lifesciences, Life Sciences, SAS Programming, SOP
Education
The University of Memphis 1999 — 2004
Ph.D. candidate-all but dissertation, Research and Statistics
The University of Memphis 1987 — 1999
MS, Statistics
Arkansas State University 1984 — 1985
BS, Computer Science
Arkansas State University 1980 — 1984
BSE, Biology Education
Marion High School 1977 — 1980
HS Diploma, College Prep
St. Jude Medical June 2014 - Present
CardioMEMS, Inc. September 2009 - Present
Stat-Tech Services, LLC September 2008 - June 2009
CardioMEMS September 2007 - September 2008
AAIPharma February 2006 - September 2007
Targacept, Inc. March 2002 - September 2005
Ginn Technologies, LLC 1998 - 2005
AtheroGenics June 1999 - March 2002
Medtronic Sofamor Danek November 1994 - June 1999
Schering-Plough November 1988 - September 1994
Skills
Biostatistics, Statistics, Clinical Trials, CDISC, MedDRA, ICH-GCP, EDC, Statistical Programming, Data Maintenance, Clinical Data Management, Medical Devices, SAS, Stata, Systat, CRO, Clinical Research, SAS programming, Clinical Study Design, Therapeutic Areas, Statistical Modeling, CRF design, Survival Analysis, Phase I, Brewing, FDA, Protocol, Data Management, Regulatory Affairs, Biotechnology, Medical Writing, GCP, Data Analysis, Clinical Operations, Clinical Development, Sop, Regulatory Submissions, Validation, Bayesian statistics, 21 CFR Part 11, Pharmaceutical Industry, PMA, Experimental Design, Lifesciences, Life Sciences, SAS Programming, SOP
Education
The University of Memphis 1999 — 2004
Ph.D. candidate-all but dissertation, Research and Statistics
The University of Memphis 1987 — 1999
MS, Statistics
Arkansas State University 1984 — 1985
BS, Computer Science
Arkansas State University 1980 — 1984
BSE, Biology Education
Marion High School 1977 — 1980
HS Diploma, College Prep
William N. Adamson's AAIPharma Experience September 2006 - March 2008
Job Site Manager at Clinical Research Solutions, LLC
Industry Pharmaceuticals
Experience
Clinical Research Solutions, LLC December 2012 - Present
HCCA International March 2010 - December 2012
Four Rivers Clinical Research March 2008 - September 2008
AAIPharma September 2006 - March 2008
Office Depot September 2000 - July 2006
Skills
Clinical Research, EDC, Data Management, GCP, Clinical Trials, ICH-GCP, CTMS, CRO, Validation, Phase I, Clinical Data Management, Sop, Clinical Monitoring, Informatics, FDA, Pharmaceutical Industry
Education
Austin Peay State University 2004 — 2005
Psychology
Ivy Tech Community College 2003 — 2004
Psychology
Clinical Research Solutions, LLC December 2012 - Present
HCCA International March 2010 - December 2012
Four Rivers Clinical Research March 2008 - September 2008
AAIPharma September 2006 - March 2008
Office Depot September 2000 - July 2006
Skills
Clinical Research, EDC, Data Management, GCP, Clinical Trials, ICH-GCP, CTMS, CRO, Validation, Phase I, Clinical Data Management, Sop, Clinical Monitoring, Informatics, FDA, Pharmaceutical Industry
Education
Austin Peay State University 2004 — 2005
Psychology
Ivy Tech Community College 2003 — 2004
Psychology
Carolyn Thompson, M.S., CCRC Carolyn Thompson, M.S., CCRC's AAIPharma Experience September 2009 - November 2010
Job Clinical Informatics Manager at PRA Health Sciences
Industry Research
Experience
PRA Health Sciences August 2014 - Present
UCB January 2013 - August 2014
Duke University December 2010 - December 2012
Duke University September 2009 - December 2010
AAIPharma September 2009 - November 2010
AAIPharma July 2007 - September 2009
AAIPharma 2006 - 2009
AAIPharma October 2006 - July 2007
AAIPharma August 2006 - October 2006
LabCorp May 2006 - August 2006
Skills
Clinical Data Management, Clinical Trials, Clinical Research, GCP, CRO, FDA, Medical Writing, Leadership, Protocol, Therapeutic Areas, EDC, IRB, CTMS, CRF design, Clinical Development
Education
University of North Carolina at Wilmington 2012 — 2014
Master's degree, Clinical Research and Product Development, 3.647
Rollins College 2001 — 2005
BA, Biology
Saint Mary's School 1997 — 2001
PRA Health Sciences August 2014 - Present
UCB January 2013 - August 2014
Duke University December 2010 - December 2012
Duke University September 2009 - December 2010
AAIPharma September 2009 - November 2010
AAIPharma July 2007 - September 2009
AAIPharma 2006 - 2009
AAIPharma October 2006 - July 2007
AAIPharma August 2006 - October 2006
LabCorp May 2006 - August 2006
Skills
Clinical Data Management, Clinical Trials, Clinical Research, GCP, CRO, FDA, Medical Writing, Leadership, Protocol, Therapeutic Areas, EDC, IRB, CTMS, CRF design, Clinical Development
Education
University of North Carolina at Wilmington 2012 — 2014
Master's degree, Clinical Research and Product Development, 3.647
Rollins College 2001 — 2005
BA, Biology
Saint Mary's School 1997 — 2001
Desiree Clemons, CCRA, RAC Desiree Clemons, CCRA, RAC's AAIPharma Experience March 2008 - September 2008
Job Clinical Study Manager at BioCryst Pharmaceuticals
Industry Pharmaceuticals
Experience
BioCryst Pharmaceuticals November 2013 - Present
Duke Clinical Research Institute November 2012 - October 2013
Gilead Sciences (formerly Pharmasset, Inc.) November 2010 - June 2012
Duke Clinical Research Unit September 2008 - November 2010
AAIPharma March 2008 - September 2008
PPD April 2007 - March 2008
Skills
Clinical Research, Clinical Trials, CRO, Pharmaceutical Industry, Clinical Development, ICH-GCP, Drug Development, Clinical Monitoring, Sop, Infectious Diseases, Project Management, Vendor Management
Education
North Carolina State University - College of Management
Master of Science, Management
University of North Carolina at Chapel Hill
Bachelor of Arts, Economics and French
BioCryst Pharmaceuticals November 2013 - Present
Duke Clinical Research Institute November 2012 - October 2013
Gilead Sciences (formerly Pharmasset, Inc.) November 2010 - June 2012
Duke Clinical Research Unit September 2008 - November 2010
AAIPharma March 2008 - September 2008
PPD April 2007 - March 2008
Skills
Clinical Research, Clinical Trials, CRO, Pharmaceutical Industry, Clinical Development, ICH-GCP, Drug Development, Clinical Monitoring, Sop, Infectious Diseases, Project Management, Vendor Management
Education
North Carolina State University - College of Management
Master of Science, Management
University of North Carolina at Chapel Hill
Bachelor of Arts, Economics and French
Donna Griffith, MA, PMP Donna Griffith, MA, PMP's AAIPharma Experience May 1990 - October 2010
Job Senior Customer Operations Director at Quintiles
Industry Pharmaceuticals
Experience
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
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
Tom Dent Tom Dent's AAIPharma Experience June 1986 - January 2000
Job Account Manager
Industry Research
Experience
Agilent Technologies / Varian February 2006 - Present
Athersys 2002 - 2005
Gliatech Inc February 2000 - June 2002
AAIPharma June 1986 - January 2000
Skills
GPC, HPLC, LC-MS, Validation, Analytical Chemistry, Chemistry, Quality Control, Chromatography, Method Development, Instrumentation, Gas Chromatography, Lifesciences, R&D, Polymers
Education
University of North Carolina at Wilmington 1995 — 1998
Premed, Chemistry/Biology
Ohio University 1987 — 1991
Business Administration, Finance
Agilent Technologies / Varian February 2006 - Present
Athersys 2002 - 2005
Gliatech Inc February 2000 - June 2002
AAIPharma June 1986 - January 2000
Skills
GPC, HPLC, LC-MS, Validation, Analytical Chemistry, Chemistry, Quality Control, Chromatography, Method Development, Instrumentation, Gas Chromatography, Lifesciences, R&D, Polymers
Education
University of North Carolina at Wilmington 1995 — 1998
Premed, Chemistry/Biology
Ohio University 1987 — 1991
Business Administration, Finance
James Murtagh James Murtagh's AAIPharma Experience January 2005 - Present
Job Formulation Development Director at AAIPharma
Industry Pharmaceuticals
Experience
AAIPharma January 2005 - Present
Oakwood Laboratories 1999 - 2004
Ben Venue Laboratories 1992 - 1998
Ben Venue Laboratories 1987 - 1998
Skills
Pharmaceutical Industry, GMP, Technology Transfer, Analytical Chemistry, FDA, Biotechnology, Sop, HPLC, Clinical Development, CRO, GLP, Oncology, Chemistry, Lifesciences, Drug Development, Clinical Trials
Education
Brown University 1980 — 1986
PhD, Chemistry
McGill University 1973 — 1977
BSc, Biochemistry
AAIPharma January 2005 - Present
Oakwood Laboratories 1999 - 2004
Ben Venue Laboratories 1992 - 1998
Ben Venue Laboratories 1987 - 1998
Skills
Pharmaceutical Industry, GMP, Technology Transfer, Analytical Chemistry, FDA, Biotechnology, Sop, HPLC, Clinical Development, CRO, GLP, Oncology, Chemistry, Lifesciences, Drug Development, Clinical Trials
Education
Brown University 1980 — 1986
PhD, Chemistry
McGill University 1973 — 1977
BSc, Biochemistry
Martin Hunicutt, CCMEP Martin Hunicutt, CCMEP's AAIPharma Experience September 2005 - October 2006
Job VP, Grant and Strategic Alliance Development at Scienta Healthcare Education
Industry Pharmaceuticals
Experience
Scienta Healthcare Education January 2007 - Present
AAIPharma September 2005 - October 2006
Mylan Bertek Pharmaceuticals September 2000 - June 2005
Quintiles August 1998 - July 2000
AAI Development Services December 1993 - June 1998
Burroughs Wellcome Co. April 1974 - November 1993
Education
East Carolina University - College of Business 1972 — 1974
BS BA, Business Admin with marketing concentration
Scienta Healthcare Education January 2007 - Present
AAIPharma September 2005 - October 2006
Mylan Bertek Pharmaceuticals September 2000 - June 2005
Quintiles August 1998 - July 2000
AAI Development Services December 1993 - June 1998
Burroughs Wellcome Co. April 1974 - November 1993
Education
East Carolina University - College of Business 1972 — 1974
BS BA, Business Admin with marketing concentration
Vanessa Bennett Vanessa Bennett's AAIPharma Experience July 2007 - October 2009
Job IRB Regulatory Administrator at WakeMed
Industry Individual & Family Services
Experience
WakeMed May 2012 - Present
Wake County Department of Social Services September 2010 - August 2011
BPW Raleigh 2009 - 2011
AAIPharma July 2007 - October 2009
UMDNJ October 2002 - June 2007
UMDNJ September 1999 - October 2002
Skills
Clinical Research, Clinical Trials, Research, Public Speaking, GCP, Non-profits, PowerPoint, Training, IRB, Hospitals, Administration, Process Improvement, Sop, Public Health, Policy, Community Outreach, Nonprofits, Data Entry, SOP, Recruiting, Healthcare
Education
Montclair State University 2000 — 2006
BA, Sociology
Montclair State University
Bachelor of Arts (B.A.), Sociology
WakeMed May 2012 - Present
Wake County Department of Social Services September 2010 - August 2011
BPW Raleigh 2009 - 2011
AAIPharma July 2007 - October 2009
UMDNJ October 2002 - June 2007
UMDNJ September 1999 - October 2002
Skills
Clinical Research, Clinical Trials, Research, Public Speaking, GCP, Non-profits, PowerPoint, Training, IRB, Hospitals, Administration, Process Improvement, Sop, Public Health, Policy, Community Outreach, Nonprofits, Data Entry, SOP, Recruiting, Healthcare
Education
Montclair State University 2000 — 2006
BA, Sociology
Montclair State University
Bachelor of Arts (B.A.), Sociology
Michael Schöll Michael Schöll's AAIPharma Experience 2001 - 2002
Job Visiting Scholar at UC Berkeley
Industry Research
Experience
UC Berkeley October 2014 - Present
MedTech West March 2014 - Present
Karolinska Institutet 2011 - Present
Sahlgrenska Academy at Gothenburg University November 2013 - February 2014
Prodema Medical September 2012 - November 2013
antwerpes ag 2004 - 2006
PAREXEL 2003 - 2004
Bethesda Health Group 2002 - 2002
AAIPharma 2001 - 2002
Ostalbklinikum 1999 - 2002
Skills
Neuroscience, Science, Life Sciences, Alzheimer's disease, Medical Imaging, MRI, Medicine, Lifesciences, Clinical Trials, Clinical Research, CRO, Scientific Writing
Education
Karolinska institutet 2007 — 2011
PhD, Medical Science / Neuroscience
NYU 2007 — 2007
Universität zu Köln 2004 — 2006
BSc, Neuroscience
Universität Ulm 2000 — 2002
Medicine
UC Berkeley October 2014 - Present
MedTech West March 2014 - Present
Karolinska Institutet 2011 - Present
Sahlgrenska Academy at Gothenburg University November 2013 - February 2014
Prodema Medical September 2012 - November 2013
antwerpes ag 2004 - 2006
PAREXEL 2003 - 2004
Bethesda Health Group 2002 - 2002
AAIPharma 2001 - 2002
Ostalbklinikum 1999 - 2002
Skills
Neuroscience, Science, Life Sciences, Alzheimer's disease, Medical Imaging, MRI, Medicine, Lifesciences, Clinical Trials, Clinical Research, CRO, Scientific Writing
Education
Karolinska institutet 2007 — 2011
PhD, Medical Science / Neuroscience
NYU 2007 — 2007
Universität zu Köln 2004 — 2006
BSc, Neuroscience
Universität Ulm 2000 — 2002
Medicine
Frederick D. Sancilio Frederick D. Sancilio's AAIPharma Experience 1979 - 2002
Job President of Sancilio and Company, Inc.
Industry Pharmaceuticals
Experience
Sancilio & Company, Inc. (SCI) January 2005 - Present
Averion International 2004 - 2008
AAIPharma 1979 - 2002
Applied Analytical Industries (AAI) 1979 - 2002
Burroughs Wellcome Company 1976 - 1979
Skills
Product Development, Pharmaceutical Industry, Validation, R&D, CRO, FDA, Contract Negotiation, Lifesciences, Drug Development, Quality System, Quality Assurance, Biotechnology, Technology Transfer, Analytical Chemistry, Competitive Analysis, New Business Development, Cross-functional Team..., Sop, Chemistry, Pharmaceutical Sales, GMP, Medical Devices, CMC, Strategy, Leadership, GLP, CAPA, Marketing Strategy, NDA, Clinical Development, Strategic Planning, Regulatory Affairs, Team Building, Business Development, Chromatography, HPLC, Pharmaceutics, Licensing, Laboratory, Clinical Trials, Account Management, Product Launch, Sales Management, Biopharmaceuticals, 21 CFR Part 11, Change Control, Commercialization, ANDA, Regulatory Submissions, Organic Chemistry
Education
Rutgers, The State University of New Jersey-Newark 1969 — 1974
Ph.D., Analytical Chemistry & Physical Chemistry
Sancilio & Company, Inc. (SCI) January 2005 - Present
Averion International 2004 - 2008
AAIPharma 1979 - 2002
Applied Analytical Industries (AAI) 1979 - 2002
Burroughs Wellcome Company 1976 - 1979
Skills
Product Development, Pharmaceutical Industry, Validation, R&D, CRO, FDA, Contract Negotiation, Lifesciences, Drug Development, Quality System, Quality Assurance, Biotechnology, Technology Transfer, Analytical Chemistry, Competitive Analysis, New Business Development, Cross-functional Team..., Sop, Chemistry, Pharmaceutical Sales, GMP, Medical Devices, CMC, Strategy, Leadership, GLP, CAPA, Marketing Strategy, NDA, Clinical Development, Strategic Planning, Regulatory Affairs, Team Building, Business Development, Chromatography, HPLC, Pharmaceutics, Licensing, Laboratory, Clinical Trials, Account Management, Product Launch, Sales Management, Biopharmaceuticals, 21 CFR Part 11, Change Control, Commercialization, ANDA, Regulatory Submissions, Organic Chemistry
Education
Rutgers, The State University of New Jersey-Newark 1969 — 1974
Ph.D., Analytical Chemistry & Physical Chemistry
Regina Madalena Regina Madalena's AAIPharma Experience 1997 - 1998
Job QA Senior Specialist at Medicago
Industry Biotechnology
Experience
Medicago June 2015 - Present
Argos Therapeutics January 2012 - June 2015
Pfizer (King Pharmaceuticals contractor) 2011 - 2012
Eisai Inc. 1998 - 2011
AAIPharma 1997 - 1998
Lenox 1996 - 1997
Gulbrandsen Chemicals 1994 - 1996
Skills
GMP, Documentation, CAPA, Biotechnology, USP, Sterile Processing, Collaborative Problem..., Troubleshooting, HPLC, Validation, Methods Development, Method Validation, Rheology, Particulate Matter..., Microscopy, IR Microscopy, FT-IR, Quality Assurance, Quality Control, R&D, Dissolution, Assay Development, V&V, FTIR
Education
Norwich University 2004 — 2006
MBA
Virginia Polytechnic Institute and State University 1989 — 1993
BS, Biochemistry
Medicago June 2015 - Present
Argos Therapeutics January 2012 - June 2015
Pfizer (King Pharmaceuticals contractor) 2011 - 2012
Eisai Inc. 1998 - 2011
AAIPharma 1997 - 1998
Lenox 1996 - 1997
Gulbrandsen Chemicals 1994 - 1996
Skills
GMP, Documentation, CAPA, Biotechnology, USP, Sterile Processing, Collaborative Problem..., Troubleshooting, HPLC, Validation, Methods Development, Method Validation, Rheology, Particulate Matter..., Microscopy, IR Microscopy, FT-IR, Quality Assurance, Quality Control, R&D, Dissolution, Assay Development, V&V, FTIR
Education
Norwich University 2004 — 2006
MBA
Virginia Polytechnic Institute and State University 1989 — 1993
BS, Biochemistry
Iñigo Pfeiffer, Ph. D. Iñigo Pfeiffer, Ph. D.'s AAIPharma Experience 1994 - 2005
Job Seeking Employment Opportunities in Triad, RTP, Charlotte. Pharmaceutical and Analytical Development
Industry Pharmaceuticals
Experience
Triad, RTP, Charlotte 2015 - Present
Targacept, Inc. February 2008 - December 2014
Targacept, Inc. April 2005 - January 2008
aaiPharma 1994 - 2005
Maricultura Inc April 1993 - September 1993
Skills
Outsourcing Management, Analytical Chemistry, Pharmaceutical..., CTM, IND, IMPD, GLP, GMP, Pharmaceuticals, Drug Discovery, API development, Clinical Development, Product Development, R&D, CRO, Analytical Equipment, Chromatography, HPLC, LC-MS, GC-FID, GC-MS, Thermal Analysis, Powder X-ray Diffraction, Equipment Maintenance, Pharmaceutical Industry, Method Development, Bioanalysis, Gas Chromatography, Validation, Technology Transfer, Pharmaceutics, Mass Spectrometry, Chemistry, Drug Development, CMC, TGA, Quality by Design, UV/Vis, FDA, ANDA, IR, Spectroscopy, Dissolution, Formulation, Toxicology, Medicinal Chemistry, Laboratory, NDA, Organic Synthesis, Small Molecules
Education
North Carolina State University 1983 — 1992
MS/PhD, Plant Physiology/Phytochemistry
Universidad Politécnica de Madrid 1979 — 1983
Bachelor's degree, Ag Eng
Colegio El Prado (Fomento) 1966 — 1978
Triad, RTP, Charlotte 2015 - Present
Targacept, Inc. February 2008 - December 2014
Targacept, Inc. April 2005 - January 2008
aaiPharma 1994 - 2005
Maricultura Inc April 1993 - September 1993
Skills
Outsourcing Management, Analytical Chemistry, Pharmaceutical..., CTM, IND, IMPD, GLP, GMP, Pharmaceuticals, Drug Discovery, API development, Clinical Development, Product Development, R&D, CRO, Analytical Equipment, Chromatography, HPLC, LC-MS, GC-FID, GC-MS, Thermal Analysis, Powder X-ray Diffraction, Equipment Maintenance, Pharmaceutical Industry, Method Development, Bioanalysis, Gas Chromatography, Validation, Technology Transfer, Pharmaceutics, Mass Spectrometry, Chemistry, Drug Development, CMC, TGA, Quality by Design, UV/Vis, FDA, ANDA, IR, Spectroscopy, Dissolution, Formulation, Toxicology, Medicinal Chemistry, Laboratory, NDA, Organic Synthesis, Small Molecules
Education
North Carolina State University 1983 — 1992
MS/PhD, Plant Physiology/Phytochemistry
Universidad Politécnica de Madrid 1979 — 1983
Bachelor's degree, Ag Eng
Colegio El Prado (Fomento) 1966 — 1978
Demir Bingol Demir Bingol's AAIPharma Experience 2002 - 2004
Job Head of Business Development & Licensing, The Americas at Grünenthal
Industry Pharmaceuticals
Experience
Grünenthal July 2013 - Present
WellDoc, Inc June 2011 - June 2013
Endo Pharmaceuticals 2006 - June 2011
Adolor 2004 - 2006
aaiPharma 2002 - 2004
AstraZeneca 1996 - 2002
American Heart Association September 1991 - January 1996
Skills
Marketing Strategy, Product Launch, Global Marketing, Sales Management, Segmentation
Education
Old Dominion University 1992 — 1994
MBA, Marketing
Christopher Newport University 1989 — 1991
BSBA, Marketing
Grünenthal July 2013 - Present
WellDoc, Inc June 2011 - June 2013
Endo Pharmaceuticals 2006 - June 2011
Adolor 2004 - 2006
aaiPharma 2002 - 2004
AstraZeneca 1996 - 2002
American Heart Association September 1991 - January 1996
Skills
Marketing Strategy, Product Launch, Global Marketing, Sales Management, Segmentation
Education
Old Dominion University 1992 — 1994
MBA, Marketing
Christopher Newport University 1989 — 1991
BSBA, Marketing
Pat Ling Pat Ling's AAIPharma Experience 2005 - 2007
Job Senior Director Business Development at Chiltern
Industry Pharmaceuticals
Experience
Chiltern January 2012 - Present
Chiltern 2010 - 2012
Clearstone Central Laboratories (formerly MDS Global Central Lab) 2009 - 2010
MDS Pharma Services, Global Central Lab and Centralized Cardiac Services 2007 - 2009
AAIPharma 2005 - 2007
Medifacts International 2004 - 2005
PAREXEL International 1999 - 2004
MDS Clinical Trial Services (Central Lab) 1997 - 1999
Med-Chem 1986 - 1997
Skills
CRO, Clinical Trials, Pharmaceutical Industry, Biotechnology, Account Management, Biopharmaceuticals, Business Development, Lifesciences, New Business Development, Oncology, Pharmaceutics, R, Strategic Planning, Cross-functional Team..., Clinical Research, Drug Development, EDC, Clinical Development, Life Sciences
Education
Ivey Business School at Western University 1998 — 2000
MBA
Fanshawe College
MLT, Medical Laboratory Technology
Western University
BSc, Biology
Chiltern January 2012 - Present
Chiltern 2010 - 2012
Clearstone Central Laboratories (formerly MDS Global Central Lab) 2009 - 2010
MDS Pharma Services, Global Central Lab and Centralized Cardiac Services 2007 - 2009
AAIPharma 2005 - 2007
Medifacts International 2004 - 2005
PAREXEL International 1999 - 2004
MDS Clinical Trial Services (Central Lab) 1997 - 1999
Med-Chem 1986 - 1997
Skills
CRO, Clinical Trials, Pharmaceutical Industry, Biotechnology, Account Management, Biopharmaceuticals, Business Development, Lifesciences, New Business Development, Oncology, Pharmaceutics, R, Strategic Planning, Cross-functional Team..., Clinical Research, Drug Development, EDC, Clinical Development, Life Sciences
Education
Ivey Business School at Western University 1998 — 2000
MBA
Fanshawe College
MLT, Medical Laboratory Technology
Western University
BSc, Biology
Joanne Hodgson Joanne Hodgson's AAIPharma Experience 2000 - 2007
Job Executive Assistant to Mary McCluskey, MD, EVP and Chief Medical Officer at WellPoint Government Business Division
Industry Hospital & Health Care
Experience
Amerigroup July 2013 - Present
Amerigroup Corporation September 2010 - Present
ZeeCRO, Inc. (formerly AAIPharma) 2006 - 2010
AAIPharma 2000 - 2007
Skills
Pharmaceutical Industry, Protocol
Education
Andover Institute of Business
Business
ECPI University
Computer Science, Information Technology
Amerigroup July 2013 - Present
Amerigroup Corporation September 2010 - Present
ZeeCRO, Inc. (formerly AAIPharma) 2006 - 2010
AAIPharma 2000 - 2007
Skills
Pharmaceutical Industry, Protocol
Education
Andover Institute of Business
Business
ECPI University
Computer Science, Information Technology
Ryan Taro Ryan Taro's AAIPharma Experience August 2003 - November 2010
Job Project Manager Product Development at AAIPharma Services Corp.
Industry Pharmaceuticals
Experience
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
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
Kristen (Cummings) D'Uva Kristen (Cummings) D'Uva's AAIPharma Experience November 2005 - April 2012
Job Associate Director of Quality Assurance at BioDelivery Sciences International Inc.
Industry Pharmaceuticals
Experience
BioDelivery Sciences International Inc (BD5) December 2014 - Present
e-store January 2003 - Present
Baxano Surgical May 2012 - October 2014
AAIPharma November 2005 - April 2012
AAIPharma June 2004 - November 2005
DSM July 2002 - May 2004
DSM April 2000 - July 2002
USA Self Employed September 1990 - December 1999
GlaxoWellcome May 1997 - August 1997
Skills
Microsoft Office, ISO, LIMS, Programming, European Union, GMP, FDA, Quality System, CAPA, Quality Assurance, Sop, Quality Auditing, Pharmaceutical Industry, GxP, Quality Control, Medical Devices, Quality Management, Regulatory Requirements, Auditing, Microbiology, Internal Audit, SAP, Project Management, 21 CFR Part 11, Change Control, Risk Management, ISO 13485, Computer System..., Aseptic Processing, Trackwise, Regulatory Affairs, Software Documentation, Biotechnology, Clinical Development, Cross-functional Team..., Pharmaceutics, GLP, Biopharmaceuticals, Technology Transfer, Regulatory Submissions, Clinical Trials, GCP, CRO, Lifesciences, SOP, Life Sciences, Environmental Education, Financial Accounting
Education
East Carolina University
Bachelor of Science
FDA's Medical Device QSR and QSIT Certification
ISO 13485 QMS Certification
ICS
A.A.S.
University of Rhode Island
B.S.
Northeastern University
B.S.
BioDelivery Sciences International Inc (BD5) December 2014 - Present
e-store January 2003 - Present
Baxano Surgical May 2012 - October 2014
AAIPharma November 2005 - April 2012
AAIPharma June 2004 - November 2005
DSM July 2002 - May 2004
DSM April 2000 - July 2002
USA Self Employed September 1990 - December 1999
GlaxoWellcome May 1997 - August 1997
Skills
Microsoft Office, ISO, LIMS, Programming, European Union, GMP, FDA, Quality System, CAPA, Quality Assurance, Sop, Quality Auditing, Pharmaceutical Industry, GxP, Quality Control, Medical Devices, Quality Management, Regulatory Requirements, Auditing, Microbiology, Internal Audit, SAP, Project Management, 21 CFR Part 11, Change Control, Risk Management, ISO 13485, Computer System..., Aseptic Processing, Trackwise, Regulatory Affairs, Software Documentation, Biotechnology, Clinical Development, Cross-functional Team..., Pharmaceutics, GLP, Biopharmaceuticals, Technology Transfer, Regulatory Submissions, Clinical Trials, GCP, CRO, Lifesciences, SOP, Life Sciences, Environmental Education, Financial Accounting
Education
East Carolina University
Bachelor of Science
FDA's Medical Device QSR and QSIT Certification
ISO 13485 QMS Certification
ICS
A.A.S.
University of Rhode Island
B.S.
Northeastern University
B.S.
Brian Willis Brian Willis's AAIPharma Experience January 2008 - July 2009
Job CIO & VP of IT at AshevilleBuncombe Technical Community College
Industry Information Technology and Services
Experience
Asheville-Buncombe Technical Community College December 2010 - Present
Beyond Next - IT Consulting Solutions September 2010 - December 2010
Pharm-Olam International April 2010 - December 2010
ZeeCRO, Inc. July 2009 - April 2010
AAIPharma January 2008 - July 2009
AAIPharma March 2007 - January 2008
AAIPharma October 2000 - March 2007
AAIPharma January 1999 - October 2000
AAIPharma April 1998 - January 1999
AAIPharma April 1998 - April 1998
Skills
Microsoft Exchange, Visio, SharePoint, Service Desk, Change Management, Microsoft SQL Server, Infrastructure, ERP, Integration, Project Management, Security, Program Management, Servers, Networking, Access, SAP, Process Improvement, Windows Server, Technical Support, Virtualization, Vendor Management, Disaster Recovery, Management, Cisco Technologies, Active Directory, Software Documentation, Telecommunications, Project Planning, System Administration, Troubleshooting, Windows, Business Analysis, Strategy
Education
University of North Carolina at Wilmington 1999 — 2001
MBA
Appalachian State University 1982 — 1992
BS, Applied Physics
Asheville-Buncombe Technical Community College December 2010 - Present
Beyond Next - IT Consulting Solutions September 2010 - December 2010
Pharm-Olam International April 2010 - December 2010
ZeeCRO, Inc. July 2009 - April 2010
AAIPharma January 2008 - July 2009
AAIPharma March 2007 - January 2008
AAIPharma October 2000 - March 2007
AAIPharma January 1999 - October 2000
AAIPharma April 1998 - January 1999
AAIPharma April 1998 - April 1998
Skills
Microsoft Exchange, Visio, SharePoint, Service Desk, Change Management, Microsoft SQL Server, Infrastructure, ERP, Integration, Project Management, Security, Program Management, Servers, Networking, Access, SAP, Process Improvement, Windows Server, Technical Support, Virtualization, Vendor Management, Disaster Recovery, Management, Cisco Technologies, Active Directory, Software Documentation, Telecommunications, Project Planning, System Administration, Troubleshooting, Windows, Business Analysis, Strategy
Education
University of North Carolina at Wilmington 1999 — 2001
MBA
Appalachian State University 1982 — 1992
BS, Applied Physics
Laura Blue Laura Blue's AAIPharma Experience January 2006 - August 2007
Job Scientist at Amgen
Industry Research
Experience
Amgen September 2013 - Present
Agilent Technologies July 2012 - August 2013
University of North Carolina at Chapel Hill August 2007 - July 2012
Graduate and Professional Student Federation April 2010 - May 2011
Student Advocates for Graduate Education April 2008 - April 2010
AAIPharma January 2006 - August 2007
Amgen Inc. August 2003 - January 2006
University of North Carolina at Wilmington August 2001 - August 2003
Skills
HPLC, GC, LC/MS, GC/MS, Chemstation, Millenium, MassLynx, method development, Gas Chromatography, Analytical Chemistry, LC-MS, Method Development, Chromatography, Validation, Sop, GMP, Laboratory, Assay Development
Education
University of North Carolina at Chapel Hill 2007 — 2012
PhD., analytical chemisty
University of North Carolina at Wilmington 2001 — 2003
M.S., Chemistry
Ohio Northern University 1997 — 2001
B.S., Biochemistry
Amgen September 2013 - Present
Agilent Technologies July 2012 - August 2013
University of North Carolina at Chapel Hill August 2007 - July 2012
Graduate and Professional Student Federation April 2010 - May 2011
Student Advocates for Graduate Education April 2008 - April 2010
AAIPharma January 2006 - August 2007
Amgen Inc. August 2003 - January 2006
University of North Carolina at Wilmington August 2001 - August 2003
Skills
HPLC, GC, LC/MS, GC/MS, Chemstation, Millenium, MassLynx, method development, Gas Chromatography, Analytical Chemistry, LC-MS, Method Development, Chromatography, Validation, Sop, GMP, Laboratory, Assay Development
Education
University of North Carolina at Chapel Hill 2007 — 2012
PhD., analytical chemisty
University of North Carolina at Wilmington 2001 — 2003
M.S., Chemistry
Ohio Northern University 1997 — 2001
B.S., Biochemistry
Janet Thomas, MBA Janet Thomas, MBA's AAIPharma Experience April 1996 - May 1997
Job Executive Recruiting, Professional Resume Developer & Career Services Coach at Absolute Professional Resumes
Industry Management Consulting
Experience
Absolute Professional Resumes November 1997 - Present
1st Choice Recruiting February 2012 - April 2013
Absolute Professional Services March 2007 - February 2012
Premium Waters Inc. February 2006 - March 2007
Absolute Professional.com, Inc. November 1997 - August 2004
AAIPharma April 1996 - May 1997
Skills
Communication, Strong Presentation, Analytical Approach, Entrepreneurial, Problem Solving, Self-Motivated, Delivering Results, Vendor Relations, Drive for Success, Problem Solving, Flexibility, Presentations, Communication, Process Improvement, Team Leadership, Leadership, Employee Engagement, Sales, Operations Management, Entrepreneurship, Manufacturing, Analytical Skills, Quality Assurance, Technical Writing, Report Writing, Coaching, Marketing, GMP, Continuous Improvement, Training, Project Management, Six Sigma, Management, Team Building, Cross-functional Team..., Strategic Planning, Recruiting, Budgets, Customer Service
Education
King College 2002 — 2004
MBA, Business, Human Resources & International Business
Tennessee Technological University 1991 — 1995
BS, Chemistry / Biochemistry, 3.6
Absolute Professional Resumes November 1997 - Present
1st Choice Recruiting February 2012 - April 2013
Absolute Professional Services March 2007 - February 2012
Premium Waters Inc. February 2006 - March 2007
Absolute Professional.com, Inc. November 1997 - August 2004
AAIPharma April 1996 - May 1997
Skills
Communication, Strong Presentation, Analytical Approach, Entrepreneurial, Problem Solving, Self-Motivated, Delivering Results, Vendor Relations, Drive for Success, Problem Solving, Flexibility, Presentations, Communication, Process Improvement, Team Leadership, Leadership, Employee Engagement, Sales, Operations Management, Entrepreneurship, Manufacturing, Analytical Skills, Quality Assurance, Technical Writing, Report Writing, Coaching, Marketing, GMP, Continuous Improvement, Training, Project Management, Six Sigma, Management, Team Building, Cross-functional Team..., Strategic Planning, Recruiting, Budgets, Customer Service
Education
King College 2002 — 2004
MBA, Business, Human Resources & International Business
Tennessee Technological University 1991 — 1995
BS, Chemistry / Biochemistry, 3.6
Jennifer Feagan, RN Jennifer Feagan, RN's AAIPharma Experience January 2008 - August 2012
Job Clinical Nurse II at Duke University Medical Center
Industry Hospital & Health Care
Experience
Duke University Medical Center January 2015 - Present
Duke University Medical Center August 2012 - Present
AAIPharma January 2008 - August 2012
aai Pharma July 2006 - January 2008
Skills
Sop, Pharmaceutical Industry, GMP, FDA, GLP, Biotechnology, HPLC, Validation, Analytical Chemistry, Lifesciences, Protocol, LIMS, Microbiology, Aseptic Technique, 21 CFR Part 11, Medical Devices, Nursing
Education
UNCW 2012 — 2013
BSN, Registered Nursing/Registered Nurse
Cape Fear Community College 2010 — 2012
ADN, Nursing, 3.2
Fairfield University 2002 — 2006
BS, Biology
Duke University Medical Center January 2015 - Present
Duke University Medical Center August 2012 - Present
AAIPharma January 2008 - August 2012
aai Pharma July 2006 - January 2008
Skills
Sop, Pharmaceutical Industry, GMP, FDA, GLP, Biotechnology, HPLC, Validation, Analytical Chemistry, Lifesciences, Protocol, LIMS, Microbiology, Aseptic Technique, 21 CFR Part 11, Medical Devices, Nursing
Education
UNCW 2012 — 2013
BSN, Registered Nursing/Registered Nurse
Cape Fear Community College 2010 — 2012
ADN, Nursing, 3.2
Fairfield University 2002 — 2006
BS, Biology
Kenny Price's AAIPharma Experience June 2003 - December 2004
Job Region Business Director at Egalet
Industry Pharmaceuticals
Experience
Egalet April 2015 - Present
Chiesi USA, Inc. July 2013 - April 2015
Endo Health Solutions July 2006 - July 2013
Schwarz Pharma January 2005 - June 2006
AAIPharma June 2003 - December 2004
Schering Plough January 2002 - May 2003
Hoechst Marion Roussel September 1992 - February 2000
Skills
Rheumatology, Pharmaceutical Sales, Neurology, Endocrinology, Pharmaceutical Industry, Oncology, Sales Operations, Cross-functional Team..., Sales Force Development, Urology, Pain Management, Sales Effectiveness, Clinical Development, Internal Medicine, Hospitals, Medical Devices, Selling Skills, Hospital Sales, Orthopedic, Strategy, Product Launch, Managed Care, Cardiology, Gastroenterology
Education
University of Pennsylvania - The Wharton School 2012 — 2012
Executive Education, Integrating Finance and Strategy for Value Creation
The University of Chicago - Booth School of Business 2011 — 2011
Executive Business Program, Financial Analysis
Kansas State University
Business, Finance
Egalet April 2015 - Present
Chiesi USA, Inc. July 2013 - April 2015
Endo Health Solutions July 2006 - July 2013
Schwarz Pharma January 2005 - June 2006
AAIPharma June 2003 - December 2004
Schering Plough January 2002 - May 2003
Hoechst Marion Roussel September 1992 - February 2000
Skills
Rheumatology, Pharmaceutical Sales, Neurology, Endocrinology, Pharmaceutical Industry, Oncology, Sales Operations, Cross-functional Team..., Sales Force Development, Urology, Pain Management, Sales Effectiveness, Clinical Development, Internal Medicine, Hospitals, Medical Devices, Selling Skills, Hospital Sales, Orthopedic, Strategy, Product Launch, Managed Care, Cardiology, Gastroenterology
Education
University of Pennsylvania - The Wharton School 2012 — 2012
Executive Education, Integrating Finance and Strategy for Value Creation
The University of Chicago - Booth School of Business 2011 — 2011
Executive Business Program, Financial Analysis
Kansas State University
Business, Finance
Jennifer Guzman's AAIPharma Experience December 2003 - December 2004
Job Senior Director, Marketing, Pricing and Reimbursement at Vital Therapies, Inc.
Industry Biotechnology
Experience
Vital Therapies, Inc. January 2015 - Present
Vital Therapies January 2013 - January 2015
Teva Health Systems July 2007 - January 2013
Edwards Lifesciences July 2006 - July 2007
Neurocrine Biosciences January 2005 - July 2006
aaiPharma December 2003 - December 2004
Agouron Pharmaceuticals, a subsidiary of Pfizer July 1993 - November 2003
Skills
Market Research, Forecasting, Sales Operations, Competitive Intelligence, Incentive Programs, Pharmaceuticals, Biotechnology, Medical Devices, Oncology, Strategic Planning, Cross-functional Team..., Infectious Diseases, Marketing Strategy, Pharmaceutical Industry, Lifesciences, FDA, Product Marketing, R&D, Neurology, Project Management, Strategy, Technology Transfer, Leadership, Product Development, Start-ups, Product Launch, Commercialization, Management
Education
San Diego State University 1999 — 2003
MBA, Marketing
University of California, San Diego 1989 — 1994
BA, Sociology
Vital Therapies, Inc. January 2015 - Present
Vital Therapies January 2013 - January 2015
Teva Health Systems July 2007 - January 2013
Edwards Lifesciences July 2006 - July 2007
Neurocrine Biosciences January 2005 - July 2006
aaiPharma December 2003 - December 2004
Agouron Pharmaceuticals, a subsidiary of Pfizer July 1993 - November 2003
Skills
Market Research, Forecasting, Sales Operations, Competitive Intelligence, Incentive Programs, Pharmaceuticals, Biotechnology, Medical Devices, Oncology, Strategic Planning, Cross-functional Team..., Infectious Diseases, Marketing Strategy, Pharmaceutical Industry, Lifesciences, FDA, Product Marketing, R&D, Neurology, Project Management, Strategy, Technology Transfer, Leadership, Product Development, Start-ups, Product Launch, Commercialization, Management
Education
San Diego State University 1999 — 2003
MBA, Marketing
University of California, San Diego 1989 — 1994
BA, Sociology
Matt Rushing's AAIPharma Experience March 2008 - December 2008
Job MD Candidate at The Brody School of Medicine East Carolina University
Industry Medical Practice
Experience
The Foxhall Group December 2008 - July 2012
AAIPharma March 2008 - December 2008
etrials Worldwide, Inc 2006 - March 2008
The National Institute of Environmental Health Sciences 2002 - 2006
The Reynolds and Reynolds Company 1997 - 2001
Skills
Research, Instructional Design, Project Management, Strategic Planning, Team Building, Leadership Development, Technical Writing, Change Management, Public Speaking, Program Management, Training, Microsoft Office, Microsoft Excel, Organizational..., PowerPoint, Data Management, Process Improvement, Analysis, Social Media, Access, Clinical Research, Clinical Data Management, System Administration, Nonprofits, Management, Leadership, Teaching, Performance Management
Education
The Brody School of Medicine at East Carolina University 2012 — 2016
Doctor of Medicine (M.D.)
North Carolina State University 2005 — 2007
Master of Education
North Carolina State University 1993 — 1997
Bachelor of Arts
New Hanover High School 1989 — 1993
The Governor's School of NC 1991 — 1991
The Foxhall Group December 2008 - July 2012
AAIPharma March 2008 - December 2008
etrials Worldwide, Inc 2006 - March 2008
The National Institute of Environmental Health Sciences 2002 - 2006
The Reynolds and Reynolds Company 1997 - 2001
Skills
Research, Instructional Design, Project Management, Strategic Planning, Team Building, Leadership Development, Technical Writing, Change Management, Public Speaking, Program Management, Training, Microsoft Office, Microsoft Excel, Organizational..., PowerPoint, Data Management, Process Improvement, Analysis, Social Media, Access, Clinical Research, Clinical Data Management, System Administration, Nonprofits, Management, Leadership, Teaching, Performance Management
Education
The Brody School of Medicine at East Carolina University 2012 — 2016
Doctor of Medicine (M.D.)
North Carolina State University 2005 — 2007
Master of Education
North Carolina State University 1993 — 1997
Bachelor of Arts
New Hanover High School 1989 — 1993
The Governor's School of NC 1991 — 1991
Nicole Sylvia's AAIPharma Experience April 2005 - July 2007
Job Contract Senior Clinical Data Manager at Chiltern
Industry Biotechnology
Experience
Chiltern August 2015 - Present
Genzyme August 2011 - August 2015
Veristat, Inc. March 2011 - July 2011
Genzyme October 2009 - October 2010
Synta Pharmaceuticals February 2009 - February 2009
Eisai Pharmaceuticals March 2008 - December 2008
Genzyme, a Sanofi company October 2007 - March 2008
AAIPharma April 2005 - July 2007
Alkermes August 2003 - December 2004
Boston Scientific November 1999 - August 2003
Skills
Oracle Clinical, Access, Excel, Word, Internet Explorer, EDC, Clinical Trials, Therapeutic areas, Data Management, Oncology, Clinical Data Management, Validation, Inform, CDISC, Pharmaceuticals, GCP, SOP, CRO, Medical Devices, CRF design, 21 CFR Part 11, Databases, ICH-GCP, Computer System..., Microsoft Excel, Pharmaceutical Industry, SAS, Therapeutic Areas, Clinical Development
Education
Northeastern University 1998 — 1999
Chiltern August 2015 - Present
Genzyme August 2011 - August 2015
Veristat, Inc. March 2011 - July 2011
Genzyme October 2009 - October 2010
Synta Pharmaceuticals February 2009 - February 2009
Eisai Pharmaceuticals March 2008 - December 2008
Genzyme, a Sanofi company October 2007 - March 2008
AAIPharma April 2005 - July 2007
Alkermes August 2003 - December 2004
Boston Scientific November 1999 - August 2003
Skills
Oracle Clinical, Access, Excel, Word, Internet Explorer, EDC, Clinical Trials, Therapeutic areas, Data Management, Oncology, Clinical Data Management, Validation, Inform, CDISC, Pharmaceuticals, GCP, SOP, CRO, Medical Devices, CRF design, 21 CFR Part 11, Databases, ICH-GCP, Computer System..., Microsoft Excel, Pharmaceutical Industry, SAS, Therapeutic Areas, Clinical Development
Education
Northeastern University 1998 — 1999
George Hollen, MBA's AAIPharma Experience 2005 - 2007
Job Senior Quality Analyst IVRS at PPD
Industry Pharmaceuticals
Experience
PPD March 2015 - Present
PPD March 2011 - Present
PPD Inc March 2007 - March 2011
AAIPharma 2005 - 2007
AAIPharma 2003 - 2005
AAIPharma 2001 - 2003
Corning Incorporated January 2001 - October 2001
US Cellular May 1998 - December 2000
Skills
Validation, Pharmaceutical Industry, FDA, 21 CFR Part 11, GMP, Sop, Quality Assurance, Data Management, LIMS, Process Improvement, CRO, Clinical Trials, Change Control, Cross-functional Team..., CAPA, V&V, Quality Control, Software Documentation, Root Cause Analysis, Testing, Computer System..., GLP, GxP, GCP, Manufacturing, Technology Transfer, Biotechnology, Quality System, SOP
Education
University of North Carolina at Wilmington 2006 — 2008
Masters, Business Administration
East Carolina University 1992 — 1999
Bachelor of Science (BS), Industrial Technology
E.A. Laney High School 1988 — 1992
Diploma
PPD March 2015 - Present
PPD March 2011 - Present
PPD Inc March 2007 - March 2011
AAIPharma 2005 - 2007
AAIPharma 2003 - 2005
AAIPharma 2001 - 2003
Corning Incorporated January 2001 - October 2001
US Cellular May 1998 - December 2000
Skills
Validation, Pharmaceutical Industry, FDA, 21 CFR Part 11, GMP, Sop, Quality Assurance, Data Management, LIMS, Process Improvement, CRO, Clinical Trials, Change Control, Cross-functional Team..., CAPA, V&V, Quality Control, Software Documentation, Root Cause Analysis, Testing, Computer System..., GLP, GxP, GCP, Manufacturing, Technology Transfer, Biotechnology, Quality System, SOP
Education
University of North Carolina at Wilmington 2006 — 2008
Masters, Business Administration
East Carolina University 1992 — 1999
Bachelor of Science (BS), Industrial Technology
E.A. Laney High School 1988 — 1992
Diploma
Patricia Ennis's AAIPharma Experience 2000 - 2005
Job Senior Document Review Specialist at PPD
Industry Pharmaceuticals
Experience
PPD 2005 - Present
AAIPharma 2000 - 2005
AAIPharma 1999 - 2000
AAIPharma 1997 - 1999
Skills
Pharmaceutical Industry, Clinical Development, GMP, Sop, CRO, Validation, Change Control, Technology Transfer
Education
North Carolina State University 1991 — 1995
Bachelor of Science, Chemical Engineering
PPD 2005 - Present
AAIPharma 2000 - 2005
AAIPharma 1999 - 2000
AAIPharma 1997 - 1999
Skills
Pharmaceutical Industry, Clinical Development, GMP, Sop, CRO, Validation, Change Control, Technology Transfer
Education
North Carolina State University 1991 — 1995
Bachelor of Science, Chemical Engineering
Deirdre Wahl's AAIPharma Experience March 2006 - October 2011
Job Vice President / Director of Operations at 360 Technology Solutions
Industry Management Consulting
Experience
360 Technology Solutions September 2014 - Present
Galvanek and Wahl Advertising Agency November 2011 - Present
Category 5 Networks January 2009 - Present
AAIPharma March 2006 - October 2011
Neose Technologies October 2004 - October 2005
Merck October 2002 - October 2004
Skills
GMP, Quality Assurance, Document Management, Technical Documentation, Validation, Sop, FDA, CAPA, 21 CFR Part 11, Change Control, Pharmaceutical Industry, Project Management, Project Planning, Microsoft Office, QuickBooks, Bookkeeping, Office Management, Market Research, Social Media, Communication, Small Business
Education
Rutgers, The State University of New Jersey-New Brunswick 1999 — 2002
Bachelor of Science (BS), Biochemistry
Rider University 1998 — 1999
360 Technology Solutions September 2014 - Present
Galvanek and Wahl Advertising Agency November 2011 - Present
Category 5 Networks January 2009 - Present
AAIPharma March 2006 - October 2011
Neose Technologies October 2004 - October 2005
Merck October 2002 - October 2004
Skills
GMP, Quality Assurance, Document Management, Technical Documentation, Validation, Sop, FDA, CAPA, 21 CFR Part 11, Change Control, Pharmaceutical Industry, Project Management, Project Planning, Microsoft Office, QuickBooks, Bookkeeping, Office Management, Market Research, Social Media, Communication, Small Business
Education
Rutgers, The State University of New Jersey-New Brunswick 1999 — 2002
Bachelor of Science (BS), Biochemistry
Rider University 1998 — 1999
Johnna Sloop's AAIPharma Experience August 1996 - January 1999
Job Audit Coordinator at Mayo Clinic
Industry Hospital & Health Care
Experience
Home August 2010 - Present
Mayo Clinic October 2008 - Present
PharmaDirections 2007 - 2009
PharmaDirections July 2007 - August 2008
The Weatherhills Group December 2006 - July 2007
Salix Pharmaceuticals April 2005 - July 2006
Mayne Pharma Inc April 1999 - March 2005
aaipharma August 1996 - January 1999
Education
High Point University 1992 — 1996
BS, Chemistry
Home August 2010 - Present
Mayo Clinic October 2008 - Present
PharmaDirections 2007 - 2009
PharmaDirections July 2007 - August 2008
The Weatherhills Group December 2006 - July 2007
Salix Pharmaceuticals April 2005 - July 2006
Mayne Pharma Inc April 1999 - March 2005
aaipharma August 1996 - January 1999
Education
High Point University 1992 — 1996
BS, Chemistry
Amanda Grim's AAIPharma Experience March 2007 - August 2008
Job Clinical QA Consulting & GCP Auditing at Amanda Grim's GCP Audits, LLC
Industry Pharmaceuticals
Experience
Amanda Grim's GCP Audits, LLC August 2008 - Present
Boston Scientific August 2008 - May 2009
AAIPharma March 2007 - August 2008
MedTrials, Inc. 2005 - 2007
Medex Clinical Trials (later acquired by Pharmanet) 1999 - 2000
Skills
GCP, CAPA, Quality Assurance, Auditing, Documentation, FDA, SOP, Quality Systems, ISO 13485, Clinical Trials, Change Control, Quality Auditing, Clinical Research, ICH-GCP, Regulatory Requirements, CRO, IRB, EDC, Regulatory Affairs, Sop, Validation, Software Documentation, 21 CFR Part 11, Quality System, Medical Devices, Protocol, Regulatory Submissions, Pharmaceutical Industry, GxP, Biotechnology, CTMS, Clinical Development, Pharmacovigilance, Clinical Monitoring
Education
Villanova University School of Law 1996 — 1999
JD, Health Care Law
Davidson College 1989 — 1993
BA/AB, Medical Ethics
Amanda Grim's GCP Audits, LLC August 2008 - Present
Boston Scientific August 2008 - May 2009
AAIPharma March 2007 - August 2008
MedTrials, Inc. 2005 - 2007
Medex Clinical Trials (later acquired by Pharmanet) 1999 - 2000
Skills
GCP, CAPA, Quality Assurance, Auditing, Documentation, FDA, SOP, Quality Systems, ISO 13485, Clinical Trials, Change Control, Quality Auditing, Clinical Research, ICH-GCP, Regulatory Requirements, CRO, IRB, EDC, Regulatory Affairs, Sop, Validation, Software Documentation, 21 CFR Part 11, Quality System, Medical Devices, Protocol, Regulatory Submissions, Pharmaceutical Industry, GxP, Biotechnology, CTMS, Clinical Development, Pharmacovigilance, Clinical Monitoring
Education
Villanova University School of Law 1996 — 1999
JD, Health Care Law
Davidson College 1989 — 1993
BA/AB, Medical Ethics
Adam DaSilva's AAIPharma Experience October 2005 - August 2007
Job Associate Director, Clinial Vendor Management at Shire
Industry Pharmaceuticals
Experience
Shire June 2015 - Present
Boston Scientific April 2012 - June 2015
Genzyme 2007 - April 2012
AAIPharma October 2005 - August 2007
Wyeth July 2003 - October 2005
Millennium Pharmaceuticals January 2002 - July 2003
Education
Bentley College - Elkin B. McCallum Graduate School of Business 1999 — 2002
MBA, Technology Management
Syracuse University 1994 — 1998
B.S., Biology
Shire June 2015 - Present
Boston Scientific April 2012 - June 2015
Genzyme 2007 - April 2012
AAIPharma October 2005 - August 2007
Wyeth July 2003 - October 2005
Millennium Pharmaceuticals January 2002 - July 2003
Education
Bentley College - Elkin B. McCallum Graduate School of Business 1999 — 2002
MBA, Technology Management
Syracuse University 1994 — 1998
B.S., Biology
Barbara Sturdivant's AAIPharma Experience October 2008 - June 2009
Job Business development
Industry Pharmaceuticals
Experience
Retired January 2011 - Present
Nexus Oncology June 2009 - January 2011
AAIPharma October 2008 - June 2009
MDS Pharma Services November 2002 - August 2008
Amgen 1990 - 2002
Skills
Clinical Pharmacology
Education
Pepperdine University, The George L. Graziadio School of Business and Management 1996 — 2001
MBA
Southern Methodist University 1968 — 1972
BA, History
Marple-Newtown High School 1964 — 1968
history
Retired January 2011 - Present
Nexus Oncology June 2009 - January 2011
AAIPharma October 2008 - June 2009
MDS Pharma Services November 2002 - August 2008
Amgen 1990 - 2002
Skills
Clinical Pharmacology
Education
Pepperdine University, The George L. Graziadio School of Business and Management 1996 — 2001
MBA
Southern Methodist University 1968 — 1972
BA, History
Marple-Newtown High School 1964 — 1968
history
Jerry Mcnair's AAIPharma Experience April 2005 - Present
Job Director, Project Management
Industry Pharmaceuticals
Experience
AAIPharma April 2005 - Present
Education
Fayetteville State University 1967 — 1972
BS, Chemistry, Biology, Mathematics
AAIPharma April 2005 - Present
Education
Fayetteville State University 1967 — 1972
BS, Chemistry, Biology, Mathematics
James Neshe's AAIPharma Experience April 1995 - September 2007
Job Associate Director Global PV Systems at Takeda Pharmaceuticals
Industry Pharmaceuticals
Experience
Takeda Pharmaceuticals January 2015 - Present
Millennium Pharmaceuticals September 2007 - January 2015
aaiPharma April 1995 - September 2007
William M. Mercer 1986 - 1992
ASEC 1984 - 1986
Lechmere 1978 - 1984
Skills
21 CFR Part 11, Oracle Clinical, Argus Safety, Clinical Development, Databases, Data Management, Computer System..., FDA, Pharmaceutical Industry, Strategy, GCP, CRO
Education
Brandeis University 2008 — 2014
Masters Degree, Information Technology Management
Northeastern University 1980 — 1984
Bachelor's degree
Takeda Pharmaceuticals January 2015 - Present
Millennium Pharmaceuticals September 2007 - January 2015
aaiPharma April 1995 - September 2007
William M. Mercer 1986 - 1992
ASEC 1984 - 1986
Lechmere 1978 - 1984
Skills
21 CFR Part 11, Oracle Clinical, Argus Safety, Clinical Development, Databases, Data Management, Computer System..., FDA, Pharmaceutical Industry, Strategy, GCP, CRO
Education
Brandeis University 2008 — 2014
Masters Degree, Information Technology Management
Northeastern University 1980 — 1984
Bachelor's degree
Carmen Kwong's AAIPharma Experience May 2001 - October 2002
Job Systems Support Specialist
Industry Biotechnology
Experience
Genentech February 2007 - October 2014
VaxGen September 2006 - January 2007
Abbott Vascular Devices April 2006 - September 2006
VaxGen May 2005 - October 2005
Corixa March 2003 - December 2004
InterMune December 2002 - March 2003
AAIPharma May 2001 - October 2002
PRA International October 1997 - August 2000
Skills
CTMS, Clinical Data, 21 CFR Part 11, Data Management, Biotechnology, Clinical Trials, EDC, Clinical Data Management, GCP, CRO, Oracle Clinical, Clinical Development, Medidata, Sop, Computer System..., SOP
Education
City College of San Francisco
Course Work - Business Administration
Genentech February 2007 - October 2014
VaxGen September 2006 - January 2007
Abbott Vascular Devices April 2006 - September 2006
VaxGen May 2005 - October 2005
Corixa March 2003 - December 2004
InterMune December 2002 - March 2003
AAIPharma May 2001 - October 2002
PRA International October 1997 - August 2000
Skills
CTMS, Clinical Data, 21 CFR Part 11, Data Management, Biotechnology, Clinical Trials, EDC, Clinical Data Management, GCP, CRO, Oracle Clinical, Clinical Development, Medidata, Sop, Computer System..., SOP
Education
City College of San Francisco
Course Work - Business Administration
Nick Lazaridis's AAIPharma Experience 1988 - 2006
Job Pharmaceutical and Diagnostic Executive.
Industry Biotechnology
Experience
AccuGenomics April 2011 - Present
Gene Express Inc. September 2006 - January 2010
AAIPharma 1988 - 2006
Skills
Quality Control, Pharmaceutics, Manufacturing, Drug Development, Clinical Development, Drug Delivery, Pharmaceutical Industry, Biomarkers, Biotechnology, Oncology, Clinical Trials, Clinical Pharmacology, Laboratory, FDA, Lifesciences, Strategy, Formulation, Drug Discovery, Technology Transfer, CRO, GLP, GCP, Regulatory Affairs, GMP, Validation, Sop, PCR, Chromatography, Biopharmaceuticals, Analytical Chemistry, HPLC, R&D, IND, Bioanalysis
Education
North Carolina State University 1982 — 1987
Ph.D., Chemistry
Jacksonville State University 1979 — 1982
BS, Chemistry
AccuGenomics April 2011 - Present
Gene Express Inc. September 2006 - January 2010
AAIPharma 1988 - 2006
Skills
Quality Control, Pharmaceutics, Manufacturing, Drug Development, Clinical Development, Drug Delivery, Pharmaceutical Industry, Biomarkers, Biotechnology, Oncology, Clinical Trials, Clinical Pharmacology, Laboratory, FDA, Lifesciences, Strategy, Formulation, Drug Discovery, Technology Transfer, CRO, GLP, GCP, Regulatory Affairs, GMP, Validation, Sop, PCR, Chromatography, Biopharmaceuticals, Analytical Chemistry, HPLC, R&D, IND, Bioanalysis
Education
North Carolina State University 1982 — 1987
Ph.D., Chemistry
Jacksonville State University 1979 — 1982
BS, Chemistry
Brian Conley's AAIPharma Experience December 2001 - February 2008
Job Senior Manager Statistical Programming at FORUM
Industry Pharmaceuticals
Experience
FORUM September 2013 - Present
Veristat September 2012 - September 2013
Veristat February 2008 - September 2013
AAIPharma December 2001 - February 2008
Prevision February 2001 - December 2001
Infomedtrics December 1999 - February 2001
PAREXEL 1997 - 1999
Skills
Statistical Programming, CRO, Clinical Trials, Clinical Data Management, EDC, SAS programming, Data Management, SAS, GCP, Biostatistics, CDISC, Clinical Development, 21 CFR Part 11, Oncology, CTMS
Education
Bentley College - Elkin B. McCallum Graduate School of Business 1995 — 1997
MS, Economics
FORUM September 2013 - Present
Veristat September 2012 - September 2013
Veristat February 2008 - September 2013
AAIPharma December 2001 - February 2008
Prevision February 2001 - December 2001
Infomedtrics December 1999 - February 2001
PAREXEL 1997 - 1999
Skills
Statistical Programming, CRO, Clinical Trials, Clinical Data Management, EDC, SAS programming, Data Management, SAS, GCP, Biostatistics, CDISC, Clinical Development, 21 CFR Part 11, Oncology, CTMS
Education
Bentley College - Elkin B. McCallum Graduate School of Business 1995 — 1997
MS, Economics
Judith Allen Owens's AAIPharma Experience January 2001 - June 2004
Job HR Professional
Industry Human Resources
Experience
Currently seeking employment May 2013 - Present
Danaher January 2013 - May 2013
Granite Services September 2004 - December 2012
AAIPharma January 2001 - June 2004
Bedford Fair Industries June 1994 - January 2001
Skills
Onboarding, Employee Relations, Recruiting, Talent Acquisition, HRIS, College Recruiting, Performance Management, Applicant Tracking..., Technical Recruiting, Human Resources, Leadership, Personnel Management
Education
East Carolina University 1978 — 1982
BS, Textile Analysis with Minors - Industrial Psychology and Business Administration
Currently seeking employment May 2013 - Present
Danaher January 2013 - May 2013
Granite Services September 2004 - December 2012
AAIPharma January 2001 - June 2004
Bedford Fair Industries June 1994 - January 2001
Skills
Onboarding, Employee Relations, Recruiting, Talent Acquisition, HRIS, College Recruiting, Performance Management, Applicant Tracking..., Technical Recruiting, Human Resources, Leadership, Personnel Management
Education
East Carolina University 1978 — 1982
BS, Textile Analysis with Minors - Industrial Psychology and Business Administration
David Garlow's AAIPharma Experience February 2008 - October 2008
Job Startup Team Manager at PPD
Industry Pharmaceuticals
Experience
PPD June 2012 - Present
INC Research May 2010 - April 2012
Cetero - formerly DGD Research January 2009 - July 2009
AAIPharma February 2008 - October 2008
Summit Medical Research, LLC April 2007 - February 2008
PAREXEL International March 2005 - April 2007
MedImmune Inc. January 2004 - August 2004
Wyeth 2001 - 2003
ClinTrials Research 1996 - 1997
Skills
CRO, Clinical Trials, EDC, CTMS, Clinical Data Management, Protocol, Regulatory Affairs, Clinical Development, Clinical Research, Oncology, Therapeutic Areas, Diabetes, Sop, Biotechnology, FDA, GCP, Clinical Monitoring, Medical Affairs, Immunology, Infectious Diseases, Regulatory Submissions, Endocrinology, ICH-GCP, Drug Safety, Drug Development, Patient Recruitment, 21 CFR Part 11, Pharmacovigilance, Clinical Operations, Ophthalmology, Medical Writing, Lifesciences, Pharmaceutical Industry
Education
James Madison University 1981 — 1985
Bachelor of Science, Biology
PPD June 2012 - Present
INC Research May 2010 - April 2012
Cetero - formerly DGD Research January 2009 - July 2009
AAIPharma February 2008 - October 2008
Summit Medical Research, LLC April 2007 - February 2008
PAREXEL International March 2005 - April 2007
MedImmune Inc. January 2004 - August 2004
Wyeth 2001 - 2003
ClinTrials Research 1996 - 1997
Skills
CRO, Clinical Trials, EDC, CTMS, Clinical Data Management, Protocol, Regulatory Affairs, Clinical Development, Clinical Research, Oncology, Therapeutic Areas, Diabetes, Sop, Biotechnology, FDA, GCP, Clinical Monitoring, Medical Affairs, Immunology, Infectious Diseases, Regulatory Submissions, Endocrinology, ICH-GCP, Drug Safety, Drug Development, Patient Recruitment, 21 CFR Part 11, Pharmacovigilance, Clinical Operations, Ophthalmology, Medical Writing, Lifesciences, Pharmaceutical Industry
Education
James Madison University 1981 — 1985
Bachelor of Science, Biology
Scott Neilson's AAIPharma Experience August 2008 - August 2009
Job Turnaround Specialist; Leadership Consultant; Motivational Speaker; www.scottneilson.com
Industry Pharmaceuticals
Experience
Mandala Partners International, LLC 2010 - Present
Catalent Pharma Solutions November 2010 - June 2012
AAIPharma August 2008 - August 2009
MDS Pharma Services September 2003 - January 2007
Laboratory Corporation of America (LabCorp) January 1998 - October 2002
Covance 1995 - 1997
SmithKline (GSK) 1985 - 1990
Skills
Pharmaceutical Industry, CRO, Clinical Research, Regulatory Affairs, Change Management, Business Development, Drug Development, Strategic Planning, Leadership, Organizational..., Clinical Development, Clinical Trials, Healthcare, Biotechnology, Lifesciences, Process Improvement, Oncology, Positioning, Cross-functional Team..., Strategy, Business, Finance, FDA, Biopharmaceuticals, Commercialization, Validation, Technology Transfer, Medical Devices, Sop, CTMS, GCP, Pharmaceutics, GMP, Vaccines, CAPA, Quality System, Laboratory, R&D, Drug Discovery, Contract Manufacturing, Presentations, GLP, Infectious Diseases, Product Launch, Global Marketing, Pharmacovigilance, Life Sciences, SOP
Education
American University 1992 — 1996
MS, Organization Development
Lehigh University - College of Business and Economics 1978 — 1979
MBA, Management
Lehigh University - College of Business and Economics 1972 — 1976
BS, Finance
Friends Academy
Mandala Partners International, LLC 2010 - Present
Catalent Pharma Solutions November 2010 - June 2012
AAIPharma August 2008 - August 2009
MDS Pharma Services September 2003 - January 2007
Laboratory Corporation of America (LabCorp) January 1998 - October 2002
Covance 1995 - 1997
SmithKline (GSK) 1985 - 1990
Skills
Pharmaceutical Industry, CRO, Clinical Research, Regulatory Affairs, Change Management, Business Development, Drug Development, Strategic Planning, Leadership, Organizational..., Clinical Development, Clinical Trials, Healthcare, Biotechnology, Lifesciences, Process Improvement, Oncology, Positioning, Cross-functional Team..., Strategy, Business, Finance, FDA, Biopharmaceuticals, Commercialization, Validation, Technology Transfer, Medical Devices, Sop, CTMS, GCP, Pharmaceutics, GMP, Vaccines, CAPA, Quality System, Laboratory, R&D, Drug Discovery, Contract Manufacturing, Presentations, GLP, Infectious Diseases, Product Launch, Global Marketing, Pharmacovigilance, Life Sciences, SOP
Education
American University 1992 — 1996
MS, Organization Development
Lehigh University - College of Business and Economics 1978 — 1979
MBA, Management
Lehigh University - College of Business and Economics 1972 — 1976
BS, Finance
Friends Academy
Amanda Flanagan's AAIPharma Experience July 1997 - March 2012
Job Assoc. Director at PharmaCore
Industry Pharmaceuticals
Experience
PharmaCore August 2015 - Present
PharmaCore September 2014 - July 2015
PharmaCore March 2012 - September 2014
AAIPharma July 1997 - March 2012
Skills
Dissolution, GMP, Laboratory, V&V, FDA, Wet Chemistry, Method Development, Chemistry, Validation, Analytical Chemistry, Sop, LC-MS, Chromatography, Technology Transfer, GLP, Gas Chromatography, CRO, SOP, HPLC
Education
North Carolina State University 1992 — 1996
North Moore HS 1988 — 1992
dipolma, science
PharmaCore August 2015 - Present
PharmaCore September 2014 - July 2015
PharmaCore March 2012 - September 2014
AAIPharma July 1997 - March 2012
Skills
Dissolution, GMP, Laboratory, V&V, FDA, Wet Chemistry, Method Development, Chemistry, Validation, Analytical Chemistry, Sop, LC-MS, Chromatography, Technology Transfer, GLP, Gas Chromatography, CRO, SOP, HPLC
Education
North Carolina State University 1992 — 1996
North Moore HS 1988 — 1992
dipolma, science
Doris Tocci's AAIPharma Experience March 2008 - July 2009
Job Software Validations/ Manager at AAIPharma
Industry Information Technology and Services
Experience
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
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
Lisa Bergen's AAIPharma Experience December 1995 - December 1999
Job Quality Assurance Engineer at Ajinomoto Co., Inc.
Industry Pharmaceuticals
Experience
Ajinomoto Co., Inc. December 2012 - Present
Burt's Bees December 2008 - December 2012
Enthalpy Analytical, Inc. July 2008 - September 2008
Pfizer (formerly Wyeth Biotech) April 2004 - April 2008
Catalent Pharma Solutions (formerly Cardinal Health) January 2000 - April 2004
AAIPharma December 1995 - December 1999
Bristol-Myers Squibb May 1995 - December 1995
Alpharma October 1990 - March 1993
Skills
CAPA, GMP, Sop, Validation, FDA, GLP, 21 CFR Part 11, Change Control, Cleaning Validation, LIMS, Pharmaceutical Industry, Trackwise, GxP, Quality System
Education
Cedarville University 1986 — 1990
Bachelor's degree, Biology, General
North Warren Regional High School 1980 — 1986
Diploma, College/University Preparatory and Advanced High School/Secondary Diploma Program
Ajinomoto Co., Inc. December 2012 - Present
Burt's Bees December 2008 - December 2012
Enthalpy Analytical, Inc. July 2008 - September 2008
Pfizer (formerly Wyeth Biotech) April 2004 - April 2008
Catalent Pharma Solutions (formerly Cardinal Health) January 2000 - April 2004
AAIPharma December 1995 - December 1999
Bristol-Myers Squibb May 1995 - December 1995
Alpharma October 1990 - March 1993
Skills
CAPA, GMP, Sop, Validation, FDA, GLP, 21 CFR Part 11, Change Control, Cleaning Validation, LIMS, Pharmaceutical Industry, Trackwise, GxP, Quality System
Education
Cedarville University 1986 — 1990
Bachelor's degree, Biology, General
North Warren Regional High School 1980 — 1986
Diploma, College/University Preparatory and Advanced High School/Secondary Diploma Program
Sandra Boyd's AAIPharma Experience 1996 - 2002
Job Staff Associate at Biogen Idec
Industry Pharmaceuticals
Experience
Biogen Idec 2011 - Present
Biogen Idec 2009 - 2011
Biogen Idec 2007 - 2009
Wyeth 2006 - 2007
Wyeth 2004 - 2006
Wyeth 2002 - 2004
AAIPharma 1996 - 2002
Skills
Quality Assurance, Change Control, FDA, GMP, Validation, Sop, Pharmaceutical Industry, Quality Management..., Medical Device...
Education
North Carolina State University 2002 — 2005
MBA, New Product Development
Biogen Idec 2011 - Present
Biogen Idec 2009 - 2011
Biogen Idec 2007 - 2009
Wyeth 2006 - 2007
Wyeth 2004 - 2006
Wyeth 2002 - 2004
AAIPharma 1996 - 2002
Skills
Quality Assurance, Change Control, FDA, GMP, Validation, Sop, Pharmaceutical Industry, Quality Management..., Medical Device...
Education
North Carolina State University 2002 — 2005
MBA, New Product Development
Jolie Best RN's AAIPharma Experience 2006 - 2007
Job Registered Nurse Business Development Executive
Industry Pharmaceuticals
Experience
Amedisys Home Health & Hospice 2012 - Present
other December 2011 - Present
AAIPharma 2006 - 2007
PPD/ DNA Sciences 2000 - 2002
Magellan Labs 2000 - 2001
Skills
Public Speaking, Client Development, Clinical Trials, New Business Development, CRO, Oncology, Contract Negotiation, Nursing, Sales, Customer Service, Drug Development, Healthcare, Pharmaceutics
Education
Butler University
Master of Business Administration (MBA)
IvyTech School of Nursing
ASN, Registered Nursing/Registered Nurse
University of California, San Diego
BA, Animal Physiology
Amedisys Home Health & Hospice 2012 - Present
other December 2011 - Present
AAIPharma 2006 - 2007
PPD/ DNA Sciences 2000 - 2002
Magellan Labs 2000 - 2001
Skills
Public Speaking, Client Development, Clinical Trials, New Business Development, CRO, Oncology, Contract Negotiation, Nursing, Sales, Customer Service, Drug Development, Healthcare, Pharmaceutics
Education
Butler University
Master of Business Administration (MBA)
IvyTech School of Nursing
ASN, Registered Nursing/Registered Nurse
University of California, San Diego
BA, Animal Physiology
Monaca Richardson's AAIPharma Experience 1998 - 2001
Job Associate Scientist, Technical Reviewer at Catalent Pharma Solutions
Industry Pharmaceuticals
Experience
Catalent April 2007 - Present
Cardinal Health 2002 - 2007
Magellan Laboratories 2001 - 2002
AAIPharma 1998 - 2001
Labcorp 1990 - 1998
Skills
Pharmaceutical Industry, GMP, Sop, Laboratory, Software Documentation, Quality Control, GLP, Analytical Chemistry, V&V, HPLC, CRO, UV/Vis, Validation, FDA, Biotechnology, Chromatography
Education
North Carolina State University 1984 — 1989
BS, Biological Sciences
Catalent April 2007 - Present
Cardinal Health 2002 - 2007
Magellan Laboratories 2001 - 2002
AAIPharma 1998 - 2001
Labcorp 1990 - 1998
Skills
Pharmaceutical Industry, GMP, Sop, Laboratory, Software Documentation, Quality Control, GLP, Analytical Chemistry, V&V, HPLC, CRO, UV/Vis, Validation, FDA, Biotechnology, Chromatography
Education
North Carolina State University 1984 — 1989
BS, Biological Sciences
Stacy DeVreese's AAIPharma Experience September 2002 - June 2004
Job CoFounder Sun Angels
Industry Apparel & Fashion
Experience
Sun Angels January 2013 - Present
Schering-Plough Pharmaceuticals June 2004 - March 2010
aaiPharma September 2002 - June 2004
Innovex March 2001 - August 2002
Faro Pharmaceuticals August 2000 - March 2001
Skills
Pharmaceutical Sales, Cardiology, Product Launch, Sales, Pharmaceutical Industry, Dermatology, Cold Calling
Education
Indiana University - Kelley School of Business 1992 — 1996
B.S., Marketing, Minor - Psychology
Sun Angels January 2013 - Present
Schering-Plough Pharmaceuticals June 2004 - March 2010
aaiPharma September 2002 - June 2004
Innovex March 2001 - August 2002
Faro Pharmaceuticals August 2000 - March 2001
Skills
Pharmaceutical Sales, Cardiology, Product Launch, Sales, Pharmaceutical Industry, Dermatology, Cold Calling
Education
Indiana University - Kelley School of Business 1992 — 1996
B.S., Marketing, Minor - Psychology
Michelle (Newkirk) Bradley's AAIPharma Experience August 2008 - November 2009
Job Program Manager for Global Services Strategy & Planning at Cisco
Industry Computer Networking
Experience
Cisco February 2015 - Present
Cisco Systems November 2011 - Present
Cisco Systems January 2011 - October 2011
AAIPharma August 2008 - November 2009
Creative Touch Interiors April 1999 - May 2008
Dominion Homes January 1998 - March 1999
P&D Builders June 1997 - January 1998
Airpic 1995 - 1996
Skills
Analysis, Budgets, Business Process..., Cross-functional Team..., Finance, Financial Analysis, Forecasting, Leadership, Management, Process Improvement, Project Management, Strategic Planning, Strategy
Education
Miami University 1993 — 1997
Cisco February 2015 - Present
Cisco Systems November 2011 - Present
Cisco Systems January 2011 - October 2011
AAIPharma August 2008 - November 2009
Creative Touch Interiors April 1999 - May 2008
Dominion Homes January 1998 - March 1999
P&D Builders June 1997 - January 1998
Airpic 1995 - 1996
Skills
Analysis, Budgets, Business Process..., Cross-functional Team..., Finance, Financial Analysis, Forecasting, Leadership, Management, Process Improvement, Project Management, Strategic Planning, Strategy
Education
Miami University 1993 — 1997
J. Spencer Goldsmith's AAIPharma Experience 1999 - 2002
Job President at HCRI
Industry Research
Experience
HCRI 2002 - Present
Harvard Clinical Research Institute 2002 - Present
Harvard Clinical Research Institute (HCRI) 2002 - Present
AAIPharma 1999 - 2002
AAI Development Services, formerly MTRA 1999 - 2002
AAIPharma/MTRA 1980 - 2002
Medical And Technical Research Associates 1980 - 2002
Medical & Technical Research Associates, Inc. (MTRA) 1996 - 2000
Education
Babson College - Franklin W. Olin Graduate School of Business 1979 — 1983
Master of Business Administration (MBA)
Bentley University 1969 — 1973
Bachelor of Science (BS), Accounting
HCRI 2002 - Present
Harvard Clinical Research Institute 2002 - Present
Harvard Clinical Research Institute (HCRI) 2002 - Present
AAIPharma 1999 - 2002
AAI Development Services, formerly MTRA 1999 - 2002
AAIPharma/MTRA 1980 - 2002
Medical And Technical Research Associates 1980 - 2002
Medical & Technical Research Associates, Inc. (MTRA) 1996 - 2000
Education
Babson College - Franklin W. Olin Graduate School of Business 1979 — 1983
Master of Business Administration (MBA)
Bentley University 1969 — 1973
Bachelor of Science (BS), Accounting
Tamela Blackstone's AAIPharma Experience 2000 - 2001
Job Program Clinical Data Manager at Takeda Pharmaceuticals
Industry Pharmaceuticals
Experience
Takeda Pharmaceuticals March 2009 - Present
Abbott Laboratories March 2008 - March 2009
RPS February 2007 - March 2008
TAP Pharmaceuticals February 2007 - March 2008
Kendle International July 2005 - 2007
Allos Therapeutics, Inc. 2001 - 2005
AAIPharma 2000 - 2001
Pharmacia 1995 - 2000
Pharmacia Corporation (fka: Pharmacia & Upjohn and The Upjohn Company 1992 - 2000
Upjohn 1991 - 2000
Skills
Clinical Data Management, Clinical Trials, Data Management, CRO, Clinical Data, EDC, Oracle Clinical, Clinical Research, CTMS
Education
Northern Illinois University 1986 — 1989
Master of Arts (M.A.), Psychology
University of Wisconsin-Madison
Bachelor of Applied Science (BASc), Psychology, Philosophy
Takeda Pharmaceuticals March 2009 - Present
Abbott Laboratories March 2008 - March 2009
RPS February 2007 - March 2008
TAP Pharmaceuticals February 2007 - March 2008
Kendle International July 2005 - 2007
Allos Therapeutics, Inc. 2001 - 2005
AAIPharma 2000 - 2001
Pharmacia 1995 - 2000
Pharmacia Corporation (fka: Pharmacia & Upjohn and The Upjohn Company 1992 - 2000
Upjohn 1991 - 2000
Skills
Clinical Data Management, Clinical Trials, Data Management, CRO, Clinical Data, EDC, Oracle Clinical, Clinical Research, CTMS
Education
Northern Illinois University 1986 — 1989
Master of Arts (M.A.), Psychology
University of Wisconsin-Madison
Bachelor of Applied Science (BASc), Psychology, Philosophy
Neal Wilhite's AAIPharma Experience 2000 - 2007
Job Senior Systems Analyst SAP / Business Relationship Manager at BorgWarner Thermal Systems
Industry Automotive
Experience
BorgWarner Inc. January 2014 - Present
Butterball, LLC January 2010 - December 2013
Butterball LLC December 2007 - January 2010
AAIPharma 2000 - 2007
Datahorse, Inc January 1998 - May 2000
CDH Informatics May 1997 - January 1998
University of South Carolina April 1994 - April 1997
Dreher High School August 1993 - April 1994
Richland Memorial Hospital August 1992 - May 1993
University of South Carolina August 1991 - August 1992
Skills
Process Improvement, SAP R/3, ABAP, SAP, Excel, Troubleshooting, Change Management, Programming, Analysis, Word, Problem Solving, Visual Basic, Microsoft Office, SAPScript, Microsoft Word, ERP, Project Management, SAP ERP, Management, Microsoft Excel, Software Documentation, Continuous Improvement, Cross-functional Team..., Smartforms, BAPI, IDOC, SD, Business Analysis, Data Migration, SAP Implementation, EDI, BDC, Business Process, ECC, Oracle, SAP XI, SAP Netweaver, WebDynpro, IDoc
Education
University of South Carolina-Columbia 1990 — 1994
MS, Computer Science
University of South Carolina-Columbia 1986 — 1990
Bachelor of Science (BS), Computer Science
Birmingham-Southern College 1978 — 1981
BS, Chemistry
BorgWarner Inc. January 2014 - Present
Butterball, LLC January 2010 - December 2013
Butterball LLC December 2007 - January 2010
AAIPharma 2000 - 2007
Datahorse, Inc January 1998 - May 2000
CDH Informatics May 1997 - January 1998
University of South Carolina April 1994 - April 1997
Dreher High School August 1993 - April 1994
Richland Memorial Hospital August 1992 - May 1993
University of South Carolina August 1991 - August 1992
Skills
Process Improvement, SAP R/3, ABAP, SAP, Excel, Troubleshooting, Change Management, Programming, Analysis, Word, Problem Solving, Visual Basic, Microsoft Office, SAPScript, Microsoft Word, ERP, Project Management, SAP ERP, Management, Microsoft Excel, Software Documentation, Continuous Improvement, Cross-functional Team..., Smartforms, BAPI, IDOC, SD, Business Analysis, Data Migration, SAP Implementation, EDI, BDC, Business Process, ECC, Oracle, SAP XI, SAP Netweaver, WebDynpro, IDoc
Education
University of South Carolina-Columbia 1990 — 1994
MS, Computer Science
University of South Carolina-Columbia 1986 — 1990
Bachelor of Science (BS), Computer Science
Birmingham-Southern College 1978 — 1981
BS, Chemistry
Linda Whittall's AAIPharma Experience 1993 - 2006
Job Manager Quality Control Technical Services
Industry Pharmaceuticals
Experience
Herbalife November 2013 - Present
Patheon April 2013 - November 2013
Banner Pharmacaps July 2008 - April 2013
Banner Pharmacaps November 2006 - July 2008
aaiPharma 1993 - 2006
Skills
Quality Control, GMP, Sop, Validation, FDA, GLP, CAPA, Analytical Chemistry, Pharmaceutical Industry, HPLC, Change Control, Technology Transfer, 21 CFR Part 11, LIMS, Cleaning Validation, Chromatography, Quality System, Regulatory Affairs, GxP
Education
Clemson University 1990 — 1993
MS, Chemistry
Western Carolina University 1986 — 1990
Bachelor of Science (BS), Chemistry
Herbalife November 2013 - Present
Patheon April 2013 - November 2013
Banner Pharmacaps July 2008 - April 2013
Banner Pharmacaps November 2006 - July 2008
aaiPharma 1993 - 2006
Skills
Quality Control, GMP, Sop, Validation, FDA, GLP, CAPA, Analytical Chemistry, Pharmaceutical Industry, HPLC, Change Control, Technology Transfer, 21 CFR Part 11, LIMS, Cleaning Validation, Chromatography, Quality System, Regulatory Affairs, GxP
Education
Clemson University 1990 — 1993
MS, Chemistry
Western Carolina University 1986 — 1990
Bachelor of Science (BS), Chemistry
Priscilla Mantone's AAIPharma Experience August 2006 - January 2008
Job Senior Clinical Trial Associate at ScheringPlough Research Institute
Industry Research
Experience
Schering-Plough Research Institute February 2008 - Present
Schering-Plough Research Institute 2008 - Present
Schering-Plough Research Institute 2008 - Present
Schering-Plough Corp 2008 - Present
AAIPharma August 2006 - January 2008
PRA International September 1997 - August 2006
Education
Ocean County College
Schering-Plough Research Institute February 2008 - Present
Schering-Plough Research Institute 2008 - Present
Schering-Plough Research Institute 2008 - Present
Schering-Plough Corp 2008 - Present
AAIPharma August 2006 - January 2008
PRA International September 1997 - August 2006
Education
Ocean County College
Brian Dillion's AAIPharma Experience January 2013 - Present
Job Senior Director, Quality Services at AAIPharma
Industry Pharmaceuticals
Experience
AAIPharma January 2013 - Present
AAIPharma Services Corp. 1993 - Present
Union Carbide September 1987 - October 1993
Skills
CRO, GMP, Pharmaceutical Industry, Contract Manufacturing, GLP, Validation, Biotechnology, Analytical Chemistry, Sop, CAPA, FDA, Technology Transfer, 21 CFR Part 11, Pharmaceutics, Regulatory Affairs, Drug Development, Formulation, Drug Discovery, Change Control, Quality System, V&V, Aseptic Processing, GCP, GxP, Quality Assurance, Cleaning Validation, Clinical Trials, Biopharmaceuticals, IND, Chromatography, HPLC, Clinical Development, LC-MS, Computer System..., Regulatory Submissions, Quality Auditing, Regulatory Requirements, Gas Chromatography, LIMS, SOP development, CTMS, UV/Vis, Dissolution, Pharmacovigilance, Drug Delivery, Trackwise, Chemistry, SOP
Education
University of North Carolina at Wilmington 2003 — 2006
MBA
Carson-Newman College 1984 — 1986
BS, Chemistry
AAIPharma January 2013 - Present
AAIPharma Services Corp. 1993 - Present
Union Carbide September 1987 - October 1993
Skills
CRO, GMP, Pharmaceutical Industry, Contract Manufacturing, GLP, Validation, Biotechnology, Analytical Chemistry, Sop, CAPA, FDA, Technology Transfer, 21 CFR Part 11, Pharmaceutics, Regulatory Affairs, Drug Development, Formulation, Drug Discovery, Change Control, Quality System, V&V, Aseptic Processing, GCP, GxP, Quality Assurance, Cleaning Validation, Clinical Trials, Biopharmaceuticals, IND, Chromatography, HPLC, Clinical Development, LC-MS, Computer System..., Regulatory Submissions, Quality Auditing, Regulatory Requirements, Gas Chromatography, LIMS, SOP development, CTMS, UV/Vis, Dissolution, Pharmacovigilance, Drug Delivery, Trackwise, Chemistry, SOP
Education
University of North Carolina at Wilmington 2003 — 2006
MBA
Carson-Newman College 1984 — 1986
BS, Chemistry
Terry Streng's AAIPharma Experience 1995 - 1996
Job Director, Technical Services at UpsherSmith Laboratories
Industry Pharmaceuticals
Experience
Upsher-Smith Laboratories Pharmaceutical ScientistRosemont PharmaceuticalsApril 1994 - 2001
AAIPharma 1995 - 1996
GlaxoWellcome 1989 - 1994
Vector Corporation 1981 - 1994
Skills
Sop, GMP, Change Management, FDA, Business Development, Team Building, Validation, Project Management, Technology Transfer, Pharmaceutical Industry, Training, Process Simulation, Formulation, CAPA, Analytical Chemistry, GLP, Regulatory Affairs
Education
Coe College 1977 — 1981
Upsher-Smith Laboratories Pharmaceutical ScientistRosemont PharmaceuticalsApril 1994 - 2001
AAIPharma 1995 - 1996
GlaxoWellcome 1989 - 1994
Vector Corporation 1981 - 1994
Skills
Sop, GMP, Change Management, FDA, Business Development, Team Building, Validation, Project Management, Technology Transfer, Pharmaceutical Industry, Training, Process Simulation, Formulation, CAPA, Analytical Chemistry, GLP, Regulatory Affairs
Education
Coe College 1977 — 1981
Wayne Whittingham's AAIPharma Experience February 2001 - May 2005
Job Vice President, Regulatory Affairs & Quality at CardioPharma, Inc.
Industry Pharmaceuticals
Experience
CardioPharma, Inc. July 2013 - Present
INC Research August 2011 - March 2013
INC Research August 2009 - August 2011
CardioPharma, Inc. November 2006 - January 2010
Paramount BioSciences 2005 - October 2006
AAIPharma February 2001 - May 2005
Bausch & Lomb Pharmaceuticals August 1998 - January 2001
Rivex Pharma May 1996 - July 1998
KRA Corporation October 1993 - May 1996
Biospherics, Inc. 1989 - 1994
Skills
Regulatory Affairs, Product Development, Laboratory, Pharmaceutical Industry, Clinical Trials, Clinical Development, CRO, FDA, GCP, Oncology, Regulatory Submissions, Sop, Biotechnology, Drug Development, Life Sciences, Clinical Research
Education
Howard University 1981 — 1987
BS, Zoology, Chemistry
CardioPharma, Inc. July 2013 - Present
INC Research August 2011 - March 2013
INC Research August 2009 - August 2011
CardioPharma, Inc. November 2006 - January 2010
Paramount BioSciences 2005 - October 2006
AAIPharma February 2001 - May 2005
Bausch & Lomb Pharmaceuticals August 1998 - January 2001
Rivex Pharma May 1996 - July 1998
KRA Corporation October 1993 - May 1996
Biospherics, Inc. 1989 - 1994
Skills
Regulatory Affairs, Product Development, Laboratory, Pharmaceutical Industry, Clinical Trials, Clinical Development, CRO, FDA, GCP, Oncology, Regulatory Submissions, Sop, Biotechnology, Drug Development, Life Sciences, Clinical Research
Education
Howard University 1981 — 1987
BS, Zoology, Chemistry
Sean Colwell's AAIPharma Experience January 2004 - March 2009
Job Sr. Manager, QC Microbiology & Sterilization at B Braun Medical
Industry Pharmaceuticals
Experience
B. Braun Medical January 2013 - Present
B. Braun Medical July 2012 - January 2013
Avrio Biopharmaceuticals (sister company of Irvine Pharmaceutical Services) January 2011 - July 2012
Irvine Pharmaceutical Services August 2010 - January 2011
AAIPharma January 2004 - March 2009
NAMSA November 2001 - December 2003
Cole Labs December 1998 - October 2001
BEC Laboratories 1993 - 1998
Skills
Microbiology, Sterilization, Aseptic Processing, Biological Indicators, Chemical Indicators, GMP, Environmental Monitoring, Validation, Clinical Trial Material..., Large Volume Parenteral..., Medical Devices, ISO 13485, Technology Transfer, USP, Biopharmaceuticals, R&D, Chemistry, Biotechnology, GLP, in Vitro Toxicology, V&V, Sterility Assurance, Regulatory Submissions, Aseptic Technique, Change Control, Cleaning Validation, Deviations, Laboratory, FDA GMP, CAPA
Education
Miami University 1988 — 1992
Bachelor's degree, Microbiology
Medical College of Ohio
B. Braun Medical January 2013 - Present
B. Braun Medical July 2012 - January 2013
Avrio Biopharmaceuticals (sister company of Irvine Pharmaceutical Services) January 2011 - July 2012
Irvine Pharmaceutical Services August 2010 - January 2011
AAIPharma January 2004 - March 2009
NAMSA November 2001 - December 2003
Cole Labs December 1998 - October 2001
BEC Laboratories 1993 - 1998
Skills
Microbiology, Sterilization, Aseptic Processing, Biological Indicators, Chemical Indicators, GMP, Environmental Monitoring, Validation, Clinical Trial Material..., Large Volume Parenteral..., Medical Devices, ISO 13485, Technology Transfer, USP, Biopharmaceuticals, R&D, Chemistry, Biotechnology, GLP, in Vitro Toxicology, V&V, Sterility Assurance, Regulatory Submissions, Aseptic Technique, Change Control, Cleaning Validation, Deviations, Laboratory, FDA GMP, CAPA
Education
Miami University 1988 — 1992
Bachelor's degree, Microbiology
Medical College of Ohio
Bill Hanna's AAIPharma Experience July 2004 - October 2007
Job Pharmaceutical / Medical Device Consultant
Industry Pharmaceuticals
Experience
Self Employed July 2012 - Present
Pharmaceutical Associates, Inc. June 2009 - July 2012
Valeant Pharmaceuticals October 2007 - June 2009
AAIPharma July 2004 - October 2007
AAI Development Services April 1997 - July 2004
AAI International December 1996 - April 1997
AAI International August 1995 - December 1996
AAI International November 1989 - August 1995
Skyland Scientific Services June 1988 - March 1989
Skyland Scientific Services July 1983 - June 1988
Skills
Validation, cGMP, Quality Assurance, Pharmaceuticals, SOP, Change Control, Quality Systems, Process Validation, CAPA, Quality Auditing, Quality Management, Cleaning Validation, Regulatory Requirements, GMP, Sop, Pharmaceutical Industry, Quality System, V&V, FDA, GLP, Root Cause Analysis, ISO, Medical Devices, GxP, 21 CFR Part 11, Regulatory Affairs, Clinical Trials, Technology Transfer, Aseptic Processing, Regulatory Submissions, GAMP, Manufacturing, LIMS, Biopharmaceuticals, Pharmaceutics, Computer System..., GCP, HPLC, CRO, Quality Control, Biotechnology
Education
Limestone College 1980 — 1985
BS, Management Science
North Carolina State University 1970 — 1972
Product Design, Mechanical Engineering
Self Employed July 2012 - Present
Pharmaceutical Associates, Inc. June 2009 - July 2012
Valeant Pharmaceuticals October 2007 - June 2009
AAIPharma July 2004 - October 2007
AAI Development Services April 1997 - July 2004
AAI International December 1996 - April 1997
AAI International August 1995 - December 1996
AAI International November 1989 - August 1995
Skyland Scientific Services June 1988 - March 1989
Skyland Scientific Services July 1983 - June 1988
Skills
Validation, cGMP, Quality Assurance, Pharmaceuticals, SOP, Change Control, Quality Systems, Process Validation, CAPA, Quality Auditing, Quality Management, Cleaning Validation, Regulatory Requirements, GMP, Sop, Pharmaceutical Industry, Quality System, V&V, FDA, GLP, Root Cause Analysis, ISO, Medical Devices, GxP, 21 CFR Part 11, Regulatory Affairs, Clinical Trials, Technology Transfer, Aseptic Processing, Regulatory Submissions, GAMP, Manufacturing, LIMS, Biopharmaceuticals, Pharmaceutics, Computer System..., GCP, HPLC, CRO, Quality Control, Biotechnology
Education
Limestone College 1980 — 1985
BS, Management Science
North Carolina State University 1970 — 1972
Product Design, Mechanical Engineering
Eric Kesslen, PhD's AAIPharma Experience June 1998 - Present
Job Senior Director, Analytical Services, AAIPharma
Industry Pharmaceuticals
Experience
AAIPharma June 1998 - Present
Skills
Pharmaceutical Industry, Product Development, Drug Development, Chromatography, HPLC, Gas Chromatography, Analytical Methods..., Analytical Method..., Compendial Method..., Analytical Chemistry, Compendial Testing, Packaging Components, GMP, GLP, Clinical Development, Sop, Management, Validation, FDA, LIMS
Education
Arizona State University 1982 — 1987
BA, Chemistry
University of Rhode Island
MS, PhD, Chemistry
AAIPharma June 1998 - Present
Skills
Pharmaceutical Industry, Product Development, Drug Development, Chromatography, HPLC, Gas Chromatography, Analytical Methods..., Analytical Method..., Compendial Method..., Analytical Chemistry, Compendial Testing, Packaging Components, GMP, GLP, Clinical Development, Sop, Management, Validation, FDA, LIMS
Education
Arizona State University 1982 — 1987
BA, Chemistry
University of Rhode Island
MS, PhD, Chemistry
Barry Winston's AAIPharma Experience January 1996 - December 1997
Job Pharmaceutical Professional
Industry Biotechnology
Experience
PharmaMatrix, LLC 2015 - Present
Pfizer 2013 - 2014
Pfizer 2012 - 2013
Pfizer 2005 - 2012
Pfizer 2002 - 2005
Wyeth Pharmaceuticals December 1997 - May 2002
AAIPharma January 1996 - December 1997
Skills
Quality Control, FDA, GMP, Sop, Validation, LIMS, 21 CFR Part 11, Quality Assurance, Change Control, SOP, CAPA, Quality System, Pharmaceutical Industry, Biotechnology
Education
Purdue University 2014 — 2015
Lean Six Sigma Green Belt
Northern Michigan University 1990 — 1994
BS, Biochemistry
PharmaMatrix, LLC 2015 - Present
Pfizer 2013 - 2014
Pfizer 2012 - 2013
Pfizer 2005 - 2012
Pfizer 2002 - 2005
Wyeth Pharmaceuticals December 1997 - May 2002
AAIPharma January 1996 - December 1997
Skills
Quality Control, FDA, GMP, Sop, Validation, LIMS, 21 CFR Part 11, Quality Assurance, Change Control, SOP, CAPA, Quality System, Pharmaceutical Industry, Biotechnology
Education
Purdue University 2014 — 2015
Lean Six Sigma Green Belt
Northern Michigan University 1990 — 1994
BS, Biochemistry
Lena Williams's AAIPharma Experience May 1990 - Present
Job Senior Manager at AAIPharma
Industry Financial Services
Experience
AAIPharma May 1990 - Present
AAI Pharma Services 1990 - Present
Skills
Pharmaceutical Industry, CRO, Validation, Sop, Change Control, SAP, GMP, GCP, Clinical Trials, FDA, Regulatory Affairs, 21 CFR Part 11
Education
Shaw University 1997 — 2000
AAIPharma May 1990 - Present
AAI Pharma Services 1990 - Present
Skills
Pharmaceutical Industry, CRO, Validation, Sop, Change Control, SAP, GMP, GCP, Clinical Trials, FDA, Regulatory Affairs, 21 CFR Part 11
Education
Shaw University 1997 — 2000
Vibhuti Shah, PMP's AAIPharma Experience 2006 - August 2009
Job Sr. Project Manager at INC Research
Industry Pharmaceuticals
Experience
INC Research January 2014 - Present
Duke Clinical Research Institute September 2009 - January 2014
AAIPharma 2006 - August 2009
Skills
Clinical Trials, Neuroscience, CRO, Infectious Diseases, EDC, Healthcare, Project Management, Therapeutic Areas, Clinical Development, CTMS, Phase I, Diabetes, GCP, Clinical Monitoring, ICH-GCP
Education
City University of New York City College 1996 — 1998
Master of Arts (M.A.), Psychology
INC Research January 2014 - Present
Duke Clinical Research Institute September 2009 - January 2014
AAIPharma 2006 - August 2009
Skills
Clinical Trials, Neuroscience, CRO, Infectious Diseases, EDC, Healthcare, Project Management, Therapeutic Areas, Clinical Development, CTMS, Phase I, Diabetes, GCP, Clinical Monitoring, ICH-GCP
Education
City University of New York City College 1996 — 1998
Master of Arts (M.A.), Psychology
Jeff Conlon's AAIPharma Experience 2002 - 2004
Job Senior Clinical Study Manager at Takeda Pharmaceuticals Int'l
Industry Pharmaceuticals
Experience
Takeda Pharmaceuticals November 2013 - Present
Millennium Pharmaceuticals July 2012 - November 2013
Execupharm, Inc June 2007 - July 2012
Pfizer March 2006 - June 2007
Serono 2004 - 2006
AAIPharma 2002 - 2004
Quintiles 1997 - 2002
Education
Boston University 1989 — 1993
B.S., Environmental Science/Marine Sciences
Takeda Pharmaceuticals November 2013 - Present
Millennium Pharmaceuticals July 2012 - November 2013
Execupharm, Inc June 2007 - July 2012
Pfizer March 2006 - June 2007
Serono 2004 - 2006
AAIPharma 2002 - 2004
Quintiles 1997 - 2002
Education
Boston University 1989 — 1993
B.S., Environmental Science/Marine Sciences
Jim Naumann's AAIPharma Experience 2004 - 2005
Job Consultant at Naumann Sales and Marketing
Industry Biotechnology
Experience
Naumann Sales and Marketing 2012 - Present
NanoImaging Services 2010 - 2011
NextGen Sciences, Inc. December 2009 - March 2010
Pharmaceutical Profiles May 2007 - November 2009
ACM 2005 - 2007
AAIPharma 2004 - 2005
Gene Logic 2000 - 2003
Skills
Biotechnology, Biomarkers, Biomarker Discovery, Lifesciences, Clinical Development, Pharmaceutical Industry, Oncology, Clinical Trials, CRO, Business Development, Vaccines, Infectious Diseases, GMP, Clinical Research, Medical Devices, Molecular Biology, Drug Discovery, Product Development, New Business Development, Technology Transfer
Education
San Diego State University-California State University
BS, Zoology
Naumann Sales and Marketing 2012 - Present
NanoImaging Services 2010 - 2011
NextGen Sciences, Inc. December 2009 - March 2010
Pharmaceutical Profiles May 2007 - November 2009
ACM 2005 - 2007
AAIPharma 2004 - 2005
Gene Logic 2000 - 2003
Skills
Biotechnology, Biomarkers, Biomarker Discovery, Lifesciences, Clinical Development, Pharmaceutical Industry, Oncology, Clinical Trials, CRO, Business Development, Vaccines, Infectious Diseases, GMP, Clinical Research, Medical Devices, Molecular Biology, Drug Discovery, Product Development, New Business Development, Technology Transfer
Education
San Diego State University-California State University
BS, Zoology
Brett Miles's AAIPharma Experience February 2002 - October 2007
Job Sales Manager at HMF Express
Industry Construction
Experience
HMF Express October 2007 - Present
AAIPharma February 2002 - October 2007
Biogen 1998 - 2002
Armstrong Pharmaceuticals 1996 - 1998
Armstrong Pharmaceuticals 1995 - 1998
HV Shuster Inc 1993 - 1995
Skills
Contract Negotiation, Sales Management, Team Building, New Business Development, Negotiation, Account Management, Sales, Strategic Planning, Contract Management, Operations Management, Business Development, Building Materials, Doors, Construction, Construction Management, Value Engineering, Key Account Management, Customer Satisfaction, Pricing, Sales Operations, Selling, Customer Service
Education
Roger Williams University 1989 — 1993
BS, Chemistry
HMF Express October 2007 - Present
AAIPharma February 2002 - October 2007
Biogen 1998 - 2002
Armstrong Pharmaceuticals 1996 - 1998
Armstrong Pharmaceuticals 1995 - 1998
HV Shuster Inc 1993 - 1995
Skills
Contract Negotiation, Sales Management, Team Building, New Business Development, Negotiation, Account Management, Sales, Strategic Planning, Contract Management, Operations Management, Business Development, Building Materials, Doors, Construction, Construction Management, Value Engineering, Key Account Management, Customer Satisfaction, Pricing, Sales Operations, Selling, Customer Service
Education
Roger Williams University 1989 — 1993
BS, Chemistry
Linda Strauss's AAIPharma Experience June 1999 - June 2004
Job Associate Business Systems Analyst at PPD
Industry Information Technology and Services
Experience
PPD June 2005 - Present
AAIPharma June 1999 - June 2004
Education
University of Mount Olive 2003 — 2005
B.S., Business Management
East Carolina University
Professional, Technical, Business, and Scientific Writing
PPD June 2005 - Present
AAIPharma June 1999 - June 2004
Education
University of Mount Olive 2003 — 2005
B.S., Business Management
East Carolina University
Professional, Technical, Business, and Scientific Writing
James Merritt's AAIPharma Experience May 1988 - August 1989
Job Associate Professor at Kean University
Industry Pharmaceuticals
Experience
Kean University July 2010 - Present
The College of New Jersey August 2009 - July 2010
Ligand Pharmaceuticals December 2008 - June 2010
Pharmacopeia January 1996 - December 2008
Duke University May 1994 - December 1995
AAIPharma May 1988 - August 1989
Skills
Medicinal Chemistry, Organic Chemistry, Higher Education, Inflammation, GPCRs, Drug Discovery, Chemistry, Laboratory, Drug Design, HPLC, NMR, Organic Synthesis, LC-MS, Drug Development, Pharmaceutical Industry, Lifesciences, Biochemistry, R&D, Synthetic Organic..., Science, Peptides, Chromatography, Purification, Protein Chemistry, UV/Vis, Biotechnology, Mass Spectrometry
Education
Duke University 1989 — 1994
Ph.D., Organic Chemistry, Carbohydrates
University of North Carolina at Wilmington 1985 — 1989
BS, Chemistry
Kean University July 2010 - Present
The College of New Jersey August 2009 - July 2010
Ligand Pharmaceuticals December 2008 - June 2010
Pharmacopeia January 1996 - December 2008
Duke University May 1994 - December 1995
AAIPharma May 1988 - August 1989
Skills
Medicinal Chemistry, Organic Chemistry, Higher Education, Inflammation, GPCRs, Drug Discovery, Chemistry, Laboratory, Drug Design, HPLC, NMR, Organic Synthesis, LC-MS, Drug Development, Pharmaceutical Industry, Lifesciences, Biochemistry, R&D, Synthetic Organic..., Science, Peptides, Chromatography, Purification, Protein Chemistry, UV/Vis, Biotechnology, Mass Spectrometry
Education
Duke University 1989 — 1994
Ph.D., Organic Chemistry, Carbohydrates
University of North Carolina at Wilmington 1985 — 1989
BS, Chemistry
Heather Mill's AAIPharma Experience August 2002 - December 2004
Job Senior Biopharmaceutical Sales Rep at Amgen
Industry Biotechnology
Experience
Amgen December 2004 - Present
AAIPharma August 2002 - December 2004
Purdue Pharma August 2000 - August 2002
Education
Indiana University Bloomington 1990 — 1994
BS, Public Affairs
Amgen December 2004 - Present
AAIPharma August 2002 - December 2004
Purdue Pharma August 2000 - August 2002
Education
Indiana University Bloomington 1990 — 1994
BS, Public Affairs
Jessica Ghidorzi, RAC's AAIPharma Experience 2005 - 2007
Job Regulatory Coordinator with DCRU
Industry Pharmaceuticals
Experience
Duke Clinical Research Unit April 2010 - Present
Portland VA Medical Center October 2008 - February 2010
PPD 2007 - 2008
Talecris Biotherapeutics, Inc. April 2007 - October 2007
AAIPharma 2005 - 2007
AAIPharma October 2004 - March 2005
AAIPharma 2003 - 2004
Skills
Clinical Trials, CTMS, ICH-GCP, Clinical Research, Pharmaceutical Industry, IRB, Regulatory Affairs, Clinical Development, Regulatory Submissions, Great Organizer, Great communications..., Sop, GCP, CRO
Education
North Carolina State University
B.S., Animal Science
Duke Clinical Research Unit April 2010 - Present
Portland VA Medical Center October 2008 - February 2010
PPD 2007 - 2008
Talecris Biotherapeutics, Inc. April 2007 - October 2007
AAIPharma 2005 - 2007
AAIPharma October 2004 - March 2005
AAIPharma 2003 - 2004
Skills
Clinical Trials, CTMS, ICH-GCP, Clinical Research, Pharmaceutical Industry, IRB, Regulatory Affairs, Clinical Development, Regulatory Submissions, Great Organizer, Great communications..., Sop, GCP, CRO
Education
North Carolina State University
B.S., Animal Science
Meredith Massey's AAIPharma Experience 1997 - 2002
Job Associate Director, Clinical Management at PPD
Industry Pharmaceuticals
Experience
PPD April 2014 - Present
PPD August 2004 - Present
aaiPharma 1997 - 2002
Skills
CRO, Clinical Trials, Pharmaceutical Industry, Clinical Development, Oncology, Sop, Clinical Research, Biotechnology, FDA, GMP, Technology Transfer, Validation, Drug Development
Education
University of North Carolina at Wilmington 1994 — 1997
MS, immunology/biology
Duke University 1990 — 1994
BS, biology
PPD April 2014 - Present
PPD August 2004 - Present
aaiPharma 1997 - 2002
Skills
CRO, Clinical Trials, Pharmaceutical Industry, Clinical Development, Oncology, Sop, Clinical Research, Biotechnology, FDA, GMP, Technology Transfer, Validation, Drug Development
Education
University of North Carolina at Wilmington 1994 — 1997
MS, immunology/biology
Duke University 1990 — 1994
BS, biology
Stanton Smith's AAIPharma Experience October 1998 - May 2005
Job CEO at Southeastern Nephrology Associates
Industry Medical Practice
Experience
Southeastern Nephrology Associates February 2015 - Present
Wilmington Surgical Associates March 2009 - January 2015
Taro Pharmaceuticals June 2005 - March 2009
AAIPharma October 1998 - May 2005
Laney Commercial Properties September 1997 - October 1998
Swiss Energy Corp March 1996 - June 1997
Lockheed Martin June 1984 - March 1996
Skills
Strategic Planning, Leadership, Project Management, Practice Management, Healthcare Information..., Pharmaceutical Industry, Business Planning, Financial Analysis, Team Building, Change Management, Budgets, Healthcare, Team Leadership, Business Analysis, Data Center, Management, Cross-functional Team..., Quality Assurance
Education
University of Colorado Denver 1993 — 1996
MBA, Finance, International Business
Kansas State University 1980 — 1984
BS, Electrical Engineering Technology
Southeastern Nephrology Associates February 2015 - Present
Wilmington Surgical Associates March 2009 - January 2015
Taro Pharmaceuticals June 2005 - March 2009
AAIPharma October 1998 - May 2005
Laney Commercial Properties September 1997 - October 1998
Swiss Energy Corp March 1996 - June 1997
Lockheed Martin June 1984 - March 1996
Skills
Strategic Planning, Leadership, Project Management, Practice Management, Healthcare Information..., Pharmaceutical Industry, Business Planning, Financial Analysis, Team Building, Change Management, Budgets, Healthcare, Team Leadership, Business Analysis, Data Center, Management, Cross-functional Team..., Quality Assurance
Education
University of Colorado Denver 1993 — 1996
MBA, Finance, International Business
Kansas State University 1980 — 1984
BS, Electrical Engineering Technology
Jaye Lehman's AAIPharma Experience 2000 - 2005
Job Clinical Trial Manager
Industry Pharmaceuticals
Experience
ICON plc February 2014 - Present
PPD June 2005 - January 2014
AAIPharma 2000 - 2005
Oneida Research 1998 - 2000
O'Brien & Gere 1989 - 1998
GE Aerospace 1986 - 1989
Skills
HPLC, Sop, FDA, CRO, Laboratory, Analytical Chemistry, Clinical Monitoring, Clinical Trials, GMP, Technology Transfer, EDC, CTMS, Clinical Development, GCP, ICH-GCP, Regulatory Submissions, Drug Development, Clinical Research
Education
SUNY Polytechnic Institute 1985 — 1988
BS, Natural Science
State University of New York College at Potsdam 1983 — 1985
BS, Biology
ICON plc February 2014 - Present
PPD June 2005 - January 2014
AAIPharma 2000 - 2005
Oneida Research 1998 - 2000
O'Brien & Gere 1989 - 1998
GE Aerospace 1986 - 1989
Skills
HPLC, Sop, FDA, CRO, Laboratory, Analytical Chemistry, Clinical Monitoring, Clinical Trials, GMP, Technology Transfer, EDC, CTMS, Clinical Development, GCP, ICH-GCP, Regulatory Submissions, Drug Development, Clinical Research
Education
SUNY Polytechnic Institute 1985 — 1988
BS, Natural Science
State University of New York College at Potsdam 1983 — 1985
BS, Biology
Heather Ege-Bridwell's AAIPharma Experience May 2000 - October 2003
Job Principal Chemist / Group Leader at Lancaster Laboratories
Industry Pharmaceuticals
Experience
Eurofins Lancaster Laboratories, Inc. October 2003 - Present
AAIpharma May 2000 - October 2003
Lancaster Laboratories June 1999 - May 2000
Skills
HPLC, Chromatography, LC-MS, Analytical Chemistry, Mass Spectrometry, UV/Vis, LIMS, Gas Chromatography, GC-MS, Chemistry, Method Development, GMP, Analytical Method..., Project Management, Project Planning, Staff Supervision
Education
Illinois Institute of Technology 2004 — 2007
MS, Analytical Chemistry
Indiana University of Pennsylvania 1994 — 1999
BS, Biochemisty
Eurofins Lancaster Laboratories, Inc. October 2003 - Present
AAIpharma May 2000 - October 2003
Lancaster Laboratories June 1999 - May 2000
Skills
HPLC, Chromatography, LC-MS, Analytical Chemistry, Mass Spectrometry, UV/Vis, LIMS, Gas Chromatography, GC-MS, Chemistry, Method Development, GMP, Analytical Method..., Project Management, Project Planning, Staff Supervision
Education
Illinois Institute of Technology 2004 — 2007
MS, Analytical Chemistry
Indiana University of Pennsylvania 1994 — 1999
BS, Biochemisty
Josh Labeda's AAIPharma Experience May 1997 - August 1999
Job EHS Professional II at Caterpillar Inc.
Industry Machinery
Experience
Caterpillar Inc. June 2012 - Present
New Hanover Regional Medical Center July 2009 - June 2012
Quality Chemical Laboratories August 2006 - May 2011
Metrics, Inc. August 2002 - August 2006
Covance Laboratories August 1999 - November 2002
AAIPharma May 1997 - August 1999
Skills
Chemistry, FDA, GMP, HPLC, Pharmaceutical Industry, Product Development, Sop, Training, Validation, GLP, Analytical Chemistry, Environmental Awareness, R, 21 CFR Part 11, Risk Assessment, Management, Manufacturing, Project Management, SOP, Six Sigma
Education
East Carolina University 2005 — 2007
MS, Occupational Safety
University of North Carolina at Wilmington 1994 — 1999
BS, Chemistry
Caterpillar Inc. June 2012 - Present
New Hanover Regional Medical Center July 2009 - June 2012
Quality Chemical Laboratories August 2006 - May 2011
Metrics, Inc. August 2002 - August 2006
Covance Laboratories August 1999 - November 2002
AAIPharma May 1997 - August 1999
Skills
Chemistry, FDA, GMP, HPLC, Pharmaceutical Industry, Product Development, Sop, Training, Validation, GLP, Analytical Chemistry, Environmental Awareness, R, 21 CFR Part 11, Risk Assessment, Management, Manufacturing, Project Management, SOP, Six Sigma
Education
East Carolina University 2005 — 2007
MS, Occupational Safety
University of North Carolina at Wilmington 1994 — 1999
BS, Chemistry
Tony Tocci's AAIPharma Experience January 2008 - May 2009
Job Associate Director, Clinical Project Management at Quintiles
Industry Pharmaceuticals
Erin Fuchs's AAIPharma Experience July 2008 - December 2008
Job Resourcing Analyst at Premier Research
Industry Pharmaceuticals
Experience
Premier Research October 2013 - Present
PRA International May 2013 - October 2013
PRA International March 2013 - May 2013
PRA International September 2010 - March 2013
INC Research August 2009 - October 2010
Best Lab Deals 2009 - 2009
AAIPharma July 2008 - December 2008
Skills
GCP, EDC, Clinical Monitoring, Oncology, Pharmaceutical Industry, Clinical Development, Therapeutic Areas, Sop, Clinical Data Management, Regulatory Submissions, Inform, Neurology, Regulatory Affairs, Biotechnology, Data Management, FDA, Medical Devices, Lifesciences, CTMS, Interpersonal Skill, Mentoring
Education
Western Governors University 2012 — 2013
Master of Business Administration (M.B.A.), Business Administration, Management and Operations
North Carolina State University 1992 — 1995
Bachelor's Degree, Communication, 3.75
Premier Research October 2013 - Present
PRA International May 2013 - October 2013
PRA International March 2013 - May 2013
PRA International September 2010 - March 2013
INC Research August 2009 - October 2010
Best Lab Deals 2009 - 2009
AAIPharma July 2008 - December 2008
Skills
GCP, EDC, Clinical Monitoring, Oncology, Pharmaceutical Industry, Clinical Development, Therapeutic Areas, Sop, Clinical Data Management, Regulatory Submissions, Inform, Neurology, Regulatory Affairs, Biotechnology, Data Management, FDA, Medical Devices, Lifesciences, CTMS, Interpersonal Skill, Mentoring
Education
Western Governors University 2012 — 2013
Master of Business Administration (M.B.A.), Business Administration, Management and Operations
North Carolina State University 1992 — 1995
Bachelor's Degree, Communication, 3.75
Patrick Hatem's AAIPharma Experience August 1998 - September 2006
Job Director, Clinical Manufacturing at UPM Pharmaceuticals
Industry Pharmaceuticals
Experience
UPM Pharmaceuticals, Inc. July 2015 - Present
Osmotica Pharmaceutical September 2006 - October 2014
AAIPharma August 1998 - September 2006
ICN Pharmaceuticals January 1996 - August 1998
Roxane Laboratories May 1991 - December 1995
Skills
Pharmaceutical Industry, FDA, GMP, SOP, Validation, Technology Transfer, Regulatory Affairs, Manufacturing, Biotechnology, CAPA
Education
Ohio Dominican University
Bachelor's of Science, Biology
UPM Pharmaceuticals, Inc. July 2015 - Present
Osmotica Pharmaceutical September 2006 - October 2014
AAIPharma August 1998 - September 2006
ICN Pharmaceuticals January 1996 - August 1998
Roxane Laboratories May 1991 - December 1995
Skills
Pharmaceutical Industry, FDA, GMP, SOP, Validation, Technology Transfer, Regulatory Affairs, Manufacturing, Biotechnology, CAPA
Education
Ohio Dominican University
Bachelor's of Science, Biology
Lisa Scholz's AAIPharma Experience 2008 - 2010
Job Keylime RN Consulting
Industry Hospital & Health Care
Experience
Keylime RN Consulting September 2011 - Present
AAIPharma 2008 - 2010
Physician Care Clinical Research June 2007 - November 2008
Bausch & Lomb, Inc. 2000 - 2007
Skills
Clinical Trials, Clinical Research, FDA, Sop, Healthcare, Quality Assurance, GCP, Nursing, CTMS, Regulatory Affairs, Informatics, Pharmaceutical Industry, Clinical Development, Oncology, CRO, ICH-GCP, Regulatory Submissions, Biotechnology, Drug Development, GMP, GLP, Clinical Monitoring, Clinical Operations, Protocol, EDC, Clinical Data Management, Pharmacovigilance, Therapeutic Areas, Neurology, Regulatory Requirements
Education
Bradley University 1977 — 1981
BS, Nursing
Keylime RN Consulting September 2011 - Present
AAIPharma 2008 - 2010
Physician Care Clinical Research June 2007 - November 2008
Bausch & Lomb, Inc. 2000 - 2007
Skills
Clinical Trials, Clinical Research, FDA, Sop, Healthcare, Quality Assurance, GCP, Nursing, CTMS, Regulatory Affairs, Informatics, Pharmaceutical Industry, Clinical Development, Oncology, CRO, ICH-GCP, Regulatory Submissions, Biotechnology, Drug Development, GMP, GLP, Clinical Monitoring, Clinical Operations, Protocol, EDC, Clinical Data Management, Pharmacovigilance, Therapeutic Areas, Neurology, Regulatory Requirements
Education
Bradley University 1977 — 1981
BS, Nursing
Anserd Fraser's AAIPharma Experience 2001 - 2004
Job Principal Owner of MRDY, LLC
Industry Pharmaceuticals
Experience
MRDY, LLC September 2013 - Present
Bausch + Lomb December 2006 - August 2013
Bausch & Lomb December 2006 - July 2011
Cardinal Health 2004 - 2006
AAIPharma 2001 - 2004
Bausch & Lomb Pharmaceuticals, Inc 1998 - 2001
Lederle Laboratories, div American Cyanamid 1979 - 1989
Skills
CAPA, Technology Transfer, Validation, Medical Devices, Quality System, Analytical Chemistry, FDA, GMP, Cross-functional Team..., Quality Assurance, Six Sigma, Pharmaceutical Industry, ISO, 21 CFR Part 11, Change Control, Aseptic Processing, Sop, Regulatory Requirements, Computer System..., Regulatory Affairs, Design Control, Operational Excellence, Lean Manufacturing, ISO 13485, GxP, R&D, Laboratory, Regulatory Submissions, GLP, Process Simulation, Pharmaceutics, Biopharmaceuticals, Product Development, Commercialization, LIMS, Formulation, SOP
Education
Columbia University - Fu Foundation School of Engineering and Applied Science 1984 — 1988
MS, Chemical Engineering
University of Georgia, Athens, GA 1975 — 1977
Master of Science (MS), Chemistry
MRDY, LLC September 2013 - Present
Bausch + Lomb December 2006 - August 2013
Bausch & Lomb December 2006 - July 2011
Cardinal Health 2004 - 2006
AAIPharma 2001 - 2004
Bausch & Lomb Pharmaceuticals, Inc 1998 - 2001
Lederle Laboratories, div American Cyanamid 1979 - 1989
Skills
CAPA, Technology Transfer, Validation, Medical Devices, Quality System, Analytical Chemistry, FDA, GMP, Cross-functional Team..., Quality Assurance, Six Sigma, Pharmaceutical Industry, ISO, 21 CFR Part 11, Change Control, Aseptic Processing, Sop, Regulatory Requirements, Computer System..., Regulatory Affairs, Design Control, Operational Excellence, Lean Manufacturing, ISO 13485, GxP, R&D, Laboratory, Regulatory Submissions, GLP, Process Simulation, Pharmaceutics, Biopharmaceuticals, Product Development, Commercialization, LIMS, Formulation, SOP
Education
Columbia University - Fu Foundation School of Engineering and Applied Science 1984 — 1988
MS, Chemical Engineering
University of Georgia, Athens, GA 1975 — 1977
Master of Science (MS), Chemistry
Sandra Baldi's AAIPharma Experience 1997 - 2000
Job Administrative/Special Events and Volunteer to End MS!
Industry Nonprofit Organization Management
Experience
United Way of Tri-County November 2012 - Present
I'm Walking Fido - Pet Care Service September 2012 - 2014
National Multiple Sclerosis Society May 2005 - April 2012
Lista International December 2000 - January 2005
AAIPharma 1997 - 2000
Hologic April 1996 - May 1996
IPL Systems, Inc 1991 - 1996
Canteen Service Co. 1987 - 1989
Skills
Volunteer Recruiting, Volunteer Management, Customer Service, Non-profits, Employee Relations, Microsoft Office, PowerPoint, Microsoft Word, Microsoft Excel, Outlook, Microsoft Access, Leadership, Social Media, Training, Benefits Administration, Recruiting, HRIS, Data Entry, SAP HR, New Hire Orientations, Human Resources
Education
Bentley University 1998 — 2001
Certificate in Human Resource Management, HRM Program
United Way of Tri-County November 2012 - Present
I'm Walking Fido - Pet Care Service September 2012 - 2014
National Multiple Sclerosis Society May 2005 - April 2012
Lista International December 2000 - January 2005
AAIPharma 1997 - 2000
Hologic April 1996 - May 1996
IPL Systems, Inc 1991 - 1996
Canteen Service Co. 1987 - 1989
Skills
Volunteer Recruiting, Volunteer Management, Customer Service, Non-profits, Employee Relations, Microsoft Office, PowerPoint, Microsoft Word, Microsoft Excel, Outlook, Microsoft Access, Leadership, Social Media, Training, Benefits Administration, Recruiting, HRIS, Data Entry, SAP HR, New Hire Orientations, Human Resources
Education
Bentley University 1998 — 2001
Certificate in Human Resource Management, HRM Program
Harsh Singh's AAIPharma Experience 2007 - 2009
Job Partnership / Alliance Management at Roche
Industry Pharmaceuticals
Experience
Roche 2015 - Present
Eurofins 2012 - 2015
inVentiv Health Clinical 2011 - 2012
Singh Consulting, LLC 2009 - 2011
AAIPharma 2007 - 2009
MDS Pharma Services 1999 - 2007
Education
The University of Western Ontario - Richard Ivey School of Business 2008 — 2010
Master of Business Administration (MBA)
Concordia University 1996 — 1999
B.Sc.
Brooklyn Technical High School 1989 — 1993
Mechanical Engineering
Roche 2015 - Present
Eurofins 2012 - 2015
inVentiv Health Clinical 2011 - 2012
Singh Consulting, LLC 2009 - 2011
AAIPharma 2007 - 2009
MDS Pharma Services 1999 - 2007
Education
The University of Western Ontario - Richard Ivey School of Business 2008 — 2010
Master of Business Administration (MBA)
Concordia University 1996 — 1999
B.Sc.
Brooklyn Technical High School 1989 — 1993
Mechanical Engineering
Kimberly Cirello's AAIPharma Experience 2002 - 2005
Job Top Performing Pharmaceutical Specialty Sales Professional looking for new opportunity
Industry Pharmaceuticals
Experience
Meda Pharmaceuticals July 2009 - January 2011
Alpharma November 2007 - April 2009
Medicure Pharmaceuticals 2006 - 2007
Ligand Pharmaceuticals 2005 - 2006
AAIPharma 2002 - 2005
Boron Lepore & Associates 1997 - 1999
Skills
Pharmaceutical Sales, Neurology, Dermatology, Rheumatology, Pulmonology, Allergy, Managed Care, Oncology, Cardiology, Gastroenterology, Endocrinology, OB/GYN, Pain Management, Hospital Sales, Medical Devices, Sales Operations, Urology, Sales Effectiveness, Therapeutic Areas, Hypertension, Healthcare, Biotechnology, Selling Skills, Pharmaceutical Industry, Infectious Diseases, Diabetes, Nephrology
Education
Montclair State University
BA, Psychology/Business Administration
Meda Pharmaceuticals July 2009 - January 2011
Alpharma November 2007 - April 2009
Medicure Pharmaceuticals 2006 - 2007
Ligand Pharmaceuticals 2005 - 2006
AAIPharma 2002 - 2005
Boron Lepore & Associates 1997 - 1999
Skills
Pharmaceutical Sales, Neurology, Dermatology, Rheumatology, Pulmonology, Allergy, Managed Care, Oncology, Cardiology, Gastroenterology, Endocrinology, OB/GYN, Pain Management, Hospital Sales, Medical Devices, Sales Operations, Urology, Sales Effectiveness, Therapeutic Areas, Hypertension, Healthcare, Biotechnology, Selling Skills, Pharmaceutical Industry, Infectious Diseases, Diabetes, Nephrology
Education
Montclair State University
BA, Psychology/Business Administration
Sharon (Ferris) Ermolowich's AAIPharma Experience 2004 - 2006
Job Analytical Chemist II at Metrics Contract Services
Industry Pharmaceuticals
Experience
Metrics Contract Services July 2015 - Present
SharonsGifts.miche.com March 2011 - Present
Metrics Contract Services February 2006 - June 2015
AAIPharma 2004 - 2006
Skills
Dissolution, HPLC, USP, Analytical Chemistry, Empower, UV/Vis, Gas Chromatography, GMP, Chemstation, Analytical Methods..., Chromatography, LIMS, Sop, Method Development, Wet Chemistry, Analytical Method..., UV, SOP, Pharmaceutical Industry, Validation
Education
University of North Carolina at Wilmington
Masters, Chemistry (Education concentration)
East Carolina University 2001 — 2003
Batchelors, Chemistry
Apex High School 1997 — 2001
Metrics Contract Services July 2015 - Present
SharonsGifts.miche.com March 2011 - Present
Metrics Contract Services February 2006 - June 2015
AAIPharma 2004 - 2006
Skills
Dissolution, HPLC, USP, Analytical Chemistry, Empower, UV/Vis, Gas Chromatography, GMP, Chemstation, Analytical Methods..., Chromatography, LIMS, Sop, Method Development, Wet Chemistry, Analytical Method..., UV, SOP, Pharmaceutical Industry, Validation
Education
University of North Carolina at Wilmington
Masters, Chemistry (Education concentration)
East Carolina University 2001 — 2003
Batchelors, Chemistry
Apex High School 1997 — 2001
Trish Reichel's AAIPharma Experience 1997 - 1998
Job Currently looking for opportunities
Industry Pharmaceuticals
Experience
Coldstream Laboratories, Inc. October 2011 - September 2013
Pfizer October 2001 - February 2002
GlaxoSmithKline 2001 - 2001
GlaxoWellcome 2000 - 2001
GlaxoWellcome 1999 - 1999
Novalon Pharmaceuticals 1998 - 1999
AAIPharma 1997 - 1998
Geneva Pharmaceuticals January 1993 - May 1997
Novartis 1993 - 1997
Skills
cGMP, HPLC, Safety, cGMP practices, Data Analysis, LC-MS, Dissolution, FTIR, SOP's, MSDS, Karl Fisher, Wet Chemistry, Method Development, LIMS, Validation, Drug Discovery, USP, GMP
Education
Colorado State University
BS, Microbiology
NY- Broome Community College
Associate of Arts and Sciences (AAS), Chemical Engineering
Coldstream Laboratories, Inc. October 2011 - September 2013
Pfizer October 2001 - February 2002
GlaxoSmithKline 2001 - 2001
GlaxoWellcome 2000 - 2001
GlaxoWellcome 1999 - 1999
Novalon Pharmaceuticals 1998 - 1999
AAIPharma 1997 - 1998
Geneva Pharmaceuticals January 1993 - May 1997
Novartis 1993 - 1997
Skills
cGMP, HPLC, Safety, cGMP practices, Data Analysis, LC-MS, Dissolution, FTIR, SOP's, MSDS, Karl Fisher, Wet Chemistry, Method Development, LIMS, Validation, Drug Discovery, USP, GMP
Education
Colorado State University
BS, Microbiology
NY- Broome Community College
Associate of Arts and Sciences (AAS), Chemical Engineering
Paul Bigwarfe's AAIPharma Experience June 2003 - January 2005
Job Director at Regeneron Pharmaceuticals
Industry Pharmaceuticals
Experience
Regeneron Pharmaceuticals January 2013 - Present
Regeneron Pharmaceuticals January 2010 - January 2013
Hospira January 2005 - January 2010
AAIPharma June 2003 - January 2005
Nanognesys, Inc September 2001 - May 2003
Skills
HPLC, NMR, IR, SEM, Mass Spectrometry, LC-MS, GC-MS, UV/Vis, ICP-MS, Chemistry, Drug Development, Monoclonal Antibodies, cIEF, CEX, Capillary..., PCR, Regulatory Filings, FDA, EMA, TGA, MHRA, IND, ANDAs, Analytical Method..., Cleaning Validation, Biotechnology, Pharmaceutical Industry, Method Development, ICH guidelines, Method Transfer, USP, EP, Disposables, Elastomers, Analytical Chemistry, GLP
Education
University at Buffalo 1999 — 2003
Ph.D., Analytical Biochemistry
St. John Fisher College 1995 — 1999
BS, Chemistry
Bishop Kearney High School 1992 — 1995
Regents, Honors/Regents High School/Secondary Diploma Program
Regeneron Pharmaceuticals January 2013 - Present
Regeneron Pharmaceuticals January 2010 - January 2013
Hospira January 2005 - January 2010
AAIPharma June 2003 - January 2005
Nanognesys, Inc September 2001 - May 2003
Skills
HPLC, NMR, IR, SEM, Mass Spectrometry, LC-MS, GC-MS, UV/Vis, ICP-MS, Chemistry, Drug Development, Monoclonal Antibodies, cIEF, CEX, Capillary..., PCR, Regulatory Filings, FDA, EMA, TGA, MHRA, IND, ANDAs, Analytical Method..., Cleaning Validation, Biotechnology, Pharmaceutical Industry, Method Development, ICH guidelines, Method Transfer, USP, EP, Disposables, Elastomers, Analytical Chemistry, GLP
Education
University at Buffalo 1999 — 2003
Ph.D., Analytical Biochemistry
St. John Fisher College 1995 — 1999
BS, Chemistry
Bishop Kearney High School 1992 — 1995
Regents, Honors/Regents High School/Secondary Diploma Program
Terri Anthony's AAIPharma Experience July 2008 - October 2009
Job Trade Compliance Assistant at Teleflex Medical
Industry Medical Devices
Experience
Teleflex Medical March 2015 - Present
DuPont Microcircuit Materials July 2013 - Present
Merck & Co March 2013 - July 2013
RTI International December 2010 - November 2012
AAIPharma July 2008 - October 2009
Umicore Marketing Services May 2004 - July 2008
Skills
Inventory Management, Budgeting, Contract Negotiation, Invoicing, Administrative Support, Budgets, Administrative..., Microsoft Word, Project Management, Outlook, Customer Service, Sales, Team Building, Administrative...
Education
Kaplan University 2002 — 2006
B.S., Paralegal Studies
Kaplan University-Davenport Campus
Teleflex Medical March 2015 - Present
DuPont Microcircuit Materials July 2013 - Present
Merck & Co March 2013 - July 2013
RTI International December 2010 - November 2012
AAIPharma July 2008 - October 2009
Umicore Marketing Services May 2004 - July 2008
Skills
Inventory Management, Budgeting, Contract Negotiation, Invoicing, Administrative Support, Budgets, Administrative..., Microsoft Word, Project Management, Outlook, Customer Service, Sales, Team Building, Administrative...
Education
Kaplan University 2002 — 2006
B.S., Paralegal Studies
Kaplan University-Davenport Campus
Tammy Bryan's AAIPharma Experience 1994 - 1999
Job Director, Business Development at PII Pharmaceutics International, Inc.
Industry Pharmaceuticals
Experience
Pii (Pharmaceutics International, Inc.). July 2000 - Present
AAIPharma 1994 - 1999
Skills
GMP, Biotechnology, Pharmaceutical Industry, Biopharmaceuticals, CRO, Technology Transfer, Drug Development, Pharmaceutics, Regulatory Affairs, FDA, Clinical Development
Education
Clemson University 1984 — 1988
BS, Marketing and Finance
Pii (Pharmaceutics International, Inc.). July 2000 - Present
AAIPharma 1994 - 1999
Skills
GMP, Biotechnology, Pharmaceutical Industry, Biopharmaceuticals, CRO, Technology Transfer, Drug Development, Pharmaceutics, Regulatory Affairs, FDA, Clinical Development
Education
Clemson University 1984 — 1988
BS, Marketing and Finance
Luda Trofimova's AAIPharma Experience July 1996 - August 2009
Job Sr. QA Associate II Audits & Compliance at Talecris Biotherapeutics
Industry Pharmaceuticals
Experience
Grifols November 2009 - Present
AAIPharma July 1996 - August 2009
Education
Harkivs'kij Nacional'nij Universitet im. V.N. Karazina 1975 — 1980
MS, Biology, biochemistry and microbiology, chemistry
Grifols November 2009 - Present
AAIPharma July 1996 - August 2009
Education
Harkivs'kij Nacional'nij Universitet im. V.N. Karazina 1975 — 1980
MS, Biology, biochemistry and microbiology, chemistry
James Fife's AAIPharma Experience December 2012 - Present
Job Sr. Director, Parenteral Operations at AAIPharma
Industry Pharmaceuticals
Experience
AAIPharma December 2012 - Present
Grand River Aseptic Manufacturing September 2009 - December 2012
Amylin Pharmaceuticals 2005 - 2009
Akorn, Inc 2003 - 2005
Cardinal Health 1999 - 2003
Meridian Medical Technologies 1990 - 1999
Education
Southern Illinois University, Edwardsville 1983 — 1990
AAIPharma December 2012 - Present
Grand River Aseptic Manufacturing September 2009 - December 2012
Amylin Pharmaceuticals 2005 - 2009
Akorn, Inc 2003 - 2005
Cardinal Health 1999 - 2003
Meridian Medical Technologies 1990 - 1999
Education
Southern Illinois University, Edwardsville 1983 — 1990
Tika Gorchess's AAIPharma Experience April 2005 - November 2007
Job Quality Services Specialist II at AAIPharma Services Corp.
Industry Pharmaceuticals
Experience
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. 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
Michael Fabozzi's AAIPharma Experience January 2012 - Present
Job Facilities Manager at AAI Pharma
Industry Pharmaceuticals
Experience
AAIPharma January 2012 - Present
Celsis Labs October 2007 - January 2012
Merrill Lynch October 1987 - March 2008
Skills
Facilities Management, Operations Management, Contract Negotiation, Budgets, Process Improvement, Project Planning, Vendor Management, Project Management, Program Management, Team Building, Construction, Contract Management, Management, Teamwork, Change Management, Customer Service, Strategic Planning, Coaching, Quality Assurance, New Business Development, Procurement, Business Development, Financial Analysis, Software Documentation, Leadership, Microsoft Excel, Strategy, Purchasing, Business Strategy, Training, Sales
Education
New York University 1994 — 1997
Certificate, Building Construction
AAIPharma January 2012 - Present
Celsis Labs October 2007 - January 2012
Merrill Lynch October 1987 - March 2008
Skills
Facilities Management, Operations Management, Contract Negotiation, Budgets, Process Improvement, Project Planning, Vendor Management, Project Management, Program Management, Team Building, Construction, Contract Management, Management, Teamwork, Change Management, Customer Service, Strategic Planning, Coaching, Quality Assurance, New Business Development, Procurement, Business Development, Financial Analysis, Software Documentation, Leadership, Microsoft Excel, Strategy, Purchasing, Business Strategy, Training, Sales
Education
New York University 1994 — 1997
Certificate, Building Construction
Natasha Guss's AAIPharma Experience September 2013 - May 2015
Job Quality Control Microbiology Manager at Glenmark Pharmaceuticals
Industry Pharmaceuticals
Experience
Glenmark Pharmaceuticals May 2015 - Present
AAIPharma September 2013 - May 2015
DPT Laboratories December 2012 - September 2013
Cangene bioPharma, Inc November 2006 - September 2012
Chesapeake Biological Laboratories January 2006 - November 2006
Chesapeake Biological Laboratories May 2002 - January 2006
MedImmune April 2004 - June 2005
Skills
GMP, Sop, FDA, CAPA, Validation, Microbiology, Biopharmaceuticals, 21 CFR Part 11, Quality Control, Pharmaceutical Industry, Aseptic Processing, LIMS, Change Control, Quality System, GLP, Environmental Monitoring, Biotechnology, Immunology, Aseptic Technique, Sterilization, Cleaning Validation, V&V, Filtration, Auditing, Internal Audit
Education
University of Maryland University College 2013 — 2015
Pending Degree; Master of Science, Project Management
Lincoln University
Bachelor of Science (BS), Biology/Biological Sciences, General
Glenmark Pharmaceuticals May 2015 - Present
AAIPharma September 2013 - May 2015
DPT Laboratories December 2012 - September 2013
Cangene bioPharma, Inc November 2006 - September 2012
Chesapeake Biological Laboratories January 2006 - November 2006
Chesapeake Biological Laboratories May 2002 - January 2006
MedImmune April 2004 - June 2005
Skills
GMP, Sop, FDA, CAPA, Validation, Microbiology, Biopharmaceuticals, 21 CFR Part 11, Quality Control, Pharmaceutical Industry, Aseptic Processing, LIMS, Change Control, Quality System, GLP, Environmental Monitoring, Biotechnology, Immunology, Aseptic Technique, Sterilization, Cleaning Validation, V&V, Filtration, Auditing, Internal Audit
Education
University of Maryland University College 2013 — 2015
Pending Degree; Master of Science, Project Management
Lincoln University
Bachelor of Science (BS), Biology/Biological Sciences, General
Joy Lewis's AAIPharma Experience December 2002 - December 2004
Job Associate Director Drug Safety at Onyx Pharmaceuticals
Industry Pharmaceuticals
Experience
Onyx Pharmaceuticals March 2015 - Present
PPD February 2008 - October 2012
PPD 2008 - 2012
aaiPharma December 2002 - December 2004
AAIPharma Services Corp. 2002 - 2004
New Hanover Regional Medical Center 1990 - 1996
Skills
CRO, CTMS, Clinical Monitoring, Clinical Trials, Clinical Research, Oncology, ICH-GCP, Pharmaceutical Industry, GCP, Clinical Development, Cardiology, Hematology, Therapeutic Areas, Pharmacovigilance, Pediatrics, EDC, Infectious Diseases, Pharmaceutical Sales, Medical Devices, Hospitals, Clinical Training, Post Approval, Medical Affairs, Oracle Clinical, Clinical Data Management, Drug Safety, Neurology, Diabetes, Regulatory Submissions, Protocol, Endocrinology
Education
Mount Olive College 1997 — 1999
Bachelor of Science (BS), Business, Management, Marketing, and Related Support Services, Graduated
James Sprunt Community College 1980 — 1982
AD Nursing, Registered Nursing/Registered Nurse, Graduated
Onyx Pharmaceuticals March 2015 - Present
PPD February 2008 - October 2012
PPD 2008 - 2012
aaiPharma December 2002 - December 2004
AAIPharma Services Corp. 2002 - 2004
New Hanover Regional Medical Center 1990 - 1996
Skills
CRO, CTMS, Clinical Monitoring, Clinical Trials, Clinical Research, Oncology, ICH-GCP, Pharmaceutical Industry, GCP, Clinical Development, Cardiology, Hematology, Therapeutic Areas, Pharmacovigilance, Pediatrics, EDC, Infectious Diseases, Pharmaceutical Sales, Medical Devices, Hospitals, Clinical Training, Post Approval, Medical Affairs, Oracle Clinical, Clinical Data Management, Drug Safety, Neurology, Diabetes, Regulatory Submissions, Protocol, Endocrinology
Education
Mount Olive College 1997 — 1999
Bachelor of Science (BS), Business, Management, Marketing, and Related Support Services, Graduated
James Sprunt Community College 1980 — 1982
AD Nursing, Registered Nursing/Registered Nurse, Graduated
Swapna Jayan's AAIPharma Experience
Job Associate Scientist at AAIPHARMA
Industry Pharmaceuticals
Experience
AAIPHARMA
Skills
HPLC, Dissolution, Disintegration, GC-MS, Karl Fisher, Analytical..., Synthetic Organic...
Education
Wake Forest University
Master's degree, Organic Chemistry
Bharathiar University
Master's degree, Polymer Chemistry
AAIPHARMA
Skills
HPLC, Dissolution, Disintegration, GC-MS, Karl Fisher, Analytical..., Synthetic Organic...
Education
Wake Forest University
Master's degree, Organic Chemistry
Bharathiar University
Master's degree, Polymer Chemistry
Mary M. Coley's AAIPharma Experience December 2000 - August 2007
Job Regulatory Documents Coordinator at PMG Research
Industry Research
Experience
PMG Research September 2014 - Present
Boice-Willis Clinic September 2012 - September 2014
BD June 2007 - June 2008
AAIPharma December 2000 - August 2007
Skills
15 years of Clinical..., Internal Auditing, Quality Assurance, Regulatory Submissions, Regulatory Maintenance, Study Start up
Education
Barton College 2004 — 2007
Bachelor of Applied Science (B.A.Sc.), Business Administration and Management, General
PMG Research September 2014 - Present
Boice-Willis Clinic September 2012 - September 2014
BD June 2007 - June 2008
AAIPharma December 2000 - August 2007
Skills
15 years of Clinical..., Internal Auditing, Quality Assurance, Regulatory Submissions, Regulatory Maintenance, Study Start up
Education
Barton College 2004 — 2007
Bachelor of Applied Science (B.A.Sc.), Business Administration and Management, General