AAI Development Services
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AAI Development Services Employees
Employee
Years
Job
Industry
Dionne Howe Dionne Howe's AAI Development Services Experience February 2003 - April 2005
Job Clinical Study Manager | Cystic Fibrosis | Oncology | Phase 13
Industry Research
Experience
Seattle Children's November 2012 - Present
UW Foster School of Business 2014 - 2015
FHCRC August 2010 - October 2012
University of Washington January 2010 - October 2010
Western Institutional Review Board June 2009 - December 2009
New Hanover Regional Medical Center June 2008 - May 2009
PPD May 2005 - March 2008
AAI Development Services February 2003 - April 2005
Skills
ONS BMT Certification, ACRP CRA Certification, ACRP Chapter President..., Oncology, Sop, Phase I, Clinical Trials, Clinical Study Design, Clinical Research, Pharmaceutical Industry, CRO, Clinical Development, GCP, Clinical Monitoring, CTMS, EDC, Biotechnology, FDA, ICH-GCP, Lifesciences, Infectious Diseases, Clinical Data Management, Cystic Fibrosis, SOP, Life Sciences
Education
University of Washington 2014 — 2017
Candidate MBA
University of North Carolina at Wilmington 1994 — 1996
BA, Chemistry
Hudson Valley Community College
AA, Liberal Arts
Seattle Children's November 2012 - Present
UW Foster School of Business 2014 - 2015
FHCRC August 2010 - October 2012
University of Washington January 2010 - October 2010
Western Institutional Review Board June 2009 - December 2009
New Hanover Regional Medical Center June 2008 - May 2009
PPD May 2005 - March 2008
AAI Development Services February 2003 - April 2005
Skills
ONS BMT Certification, ACRP CRA Certification, ACRP Chapter President..., Oncology, Sop, Phase I, Clinical Trials, Clinical Study Design, Clinical Research, Pharmaceutical Industry, CRO, Clinical Development, GCP, Clinical Monitoring, CTMS, EDC, Biotechnology, FDA, ICH-GCP, Lifesciences, Infectious Diseases, Clinical Data Management, Cystic Fibrosis, SOP, Life Sciences
Education
University of Washington 2014 — 2017
Candidate MBA
University of North Carolina at Wilmington 1994 — 1996
BA, Chemistry
Hudson Valley Community College
AA, Liberal Arts
Layne Los Layne Los's AAI Development Services Experience 1995 - 1998
Job
Industry Pharmaceuticals
Experience
Nextgen Pharma Technologies 2001 - Present
NextGen Development Group October 2012 - Present
Huntingdon Life Sciences January 1998 - October 2000
AAI Development Services 1995 - 1998
Merck 1984 - 1994
Bristol-Myers Squibb September 1977 - January 1984
Skills
Pharmacology, Toxicology, Consulting, Friendly Demeanor, Marketing Communications, IND, Drug Discovery, CRO, DMPK, Biotechnology, Drug Development, ADME, HPLC, Regulatory Submissions, GLP, Pharmaceutical Industry, Immunology, In Vivo, GCP, R&D, Pharmacokinetics, Pharmaceutics, In Vitro, Biomarkers, Clinical Development, Lifesciences, Biopharmaceuticals, Technology Transfer, FDA, Oncology, Validation, Regulatory Affairs, Clinical Trials, Life Sciences
Education
University of the Sciences in Philadelphia 1989 — 1991
PhD, Pharmacology and Toxicology
Cornell University 1975 — 1977
BS, Animal Sciences (Pre-Vet)
SUNY at Cobleskill 1973 — 1975
AAS, Science Lab Technology
Nextgen Pharma Technologies 2001 - Present
NextGen Development Group October 2012 - Present
Huntingdon Life Sciences January 1998 - October 2000
AAI Development Services 1995 - 1998
Merck 1984 - 1994
Bristol-Myers Squibb September 1977 - January 1984
Skills
Pharmacology, Toxicology, Consulting, Friendly Demeanor, Marketing Communications, IND, Drug Discovery, CRO, DMPK, Biotechnology, Drug Development, ADME, HPLC, Regulatory Submissions, GLP, Pharmaceutical Industry, Immunology, In Vivo, GCP, R&D, Pharmacokinetics, Pharmaceutics, In Vitro, Biomarkers, Clinical Development, Lifesciences, Biopharmaceuticals, Technology Transfer, FDA, Oncology, Validation, Regulatory Affairs, Clinical Trials, Life Sciences
Education
University of the Sciences in Philadelphia 1989 — 1991
PhD, Pharmacology and Toxicology
Cornell University 1975 — 1977
BS, Animal Sciences (Pre-Vet)
SUNY at Cobleskill 1973 — 1975
AAS, Science Lab Technology
Jessica Lowe Jessica Lowe's AAI Development Services Experience May 2011 - January 2012
Job Manager of Lacey's Place and Hot Spot
Industry Gambling & Casinos
Experience
Highland Management Group June 2015 - Present
Dynalabs April 2012 - June 2015
AAI Development Services May 2011 - January 2012
Skills
USP 788 Particulate..., USP 85 Endotoxin Testing, USP 71 Sterility Testing, Environmental..., Performing Technical..., USP 71 Method..., Scan RDI Testing, Microscopy, Pharmaceutical..., LIMS, GMP, Laboratory, Aseptic Technique, SOP development, ISO, Team Leadership, USP, Microbiology, FDA, Validation, Life Sciences, SOP, Pharmaceutical Industry, Biotechnology, GLP, R, SOP Development, Environmental Monitoring
Education
Southern Illinois University, Edwardsville 2005 — 2009
Bachelor of Science (B.S.), Biology/Biological Sciences, General
Highland Management Group June 2015 - Present
Dynalabs April 2012 - June 2015
AAI Development Services May 2011 - January 2012
Skills
USP 788 Particulate..., USP 85 Endotoxin Testing, USP 71 Sterility Testing, Environmental..., Performing Technical..., USP 71 Method..., Scan RDI Testing, Microscopy, Pharmaceutical..., LIMS, GMP, Laboratory, Aseptic Technique, SOP development, ISO, Team Leadership, USP, Microbiology, FDA, Validation, Life Sciences, SOP, Pharmaceutical Industry, Biotechnology, GLP, R, SOP Development, Environmental Monitoring
Education
Southern Illinois University, Edwardsville 2005 — 2009
Bachelor of Science (B.S.), Biology/Biological Sciences, General
Ron Casey Ron Casey's AAI Development Services Experience July 1998 - July 1999
Job Director, Manufacturing & Technical Operations at Braeburn Pharmaceuticals
Industry Pharmaceuticals
Experience
Braeburn Pharmaceuticals March 2015 - Present
Salix Pharmaceuticals July 2014 - March 2015
Otsuka Pharmaceutical Development & Commercialization, Inc July 2011 - June 2014
Otsuka America Pharmaceutical, Inc. September 2005 - July 2011
MiddleBrook Pharmaceuticals, Inc October 2003 - August 2005
pSivida fka Control Delivery Systems September 2000 - June 2003
Bausch & Lomb July 1999 - September 2000
AAI Development Services July 1998 - July 1999
Leiner Health Products fka Granutec June 1995 - June 1997
Skills
Pharmaceuticals, Drug Development, Technology Transfer, Drug Delivery, GMP, FDA, Validation, Regulatory Affairs, Pharmaceutics, Regulatory Submissions, Dissolution, IND, Medical Devices, Pharmaceutical Industry, JMP, R&D, Formulation, CMC, Contract Manufacturing, Pharmaceutical Research, V&V, Quality by Design
Education
Barton College 1996 — 1998
BS, Chemistry
Braeburn Pharmaceuticals March 2015 - Present
Salix Pharmaceuticals July 2014 - March 2015
Otsuka Pharmaceutical Development & Commercialization, Inc July 2011 - June 2014
Otsuka America Pharmaceutical, Inc. September 2005 - July 2011
MiddleBrook Pharmaceuticals, Inc October 2003 - August 2005
pSivida fka Control Delivery Systems September 2000 - June 2003
Bausch & Lomb July 1999 - September 2000
AAI Development Services July 1998 - July 1999
Leiner Health Products fka Granutec June 1995 - June 1997
Skills
Pharmaceuticals, Drug Development, Technology Transfer, Drug Delivery, GMP, FDA, Validation, Regulatory Affairs, Pharmaceutics, Regulatory Submissions, Dissolution, IND, Medical Devices, Pharmaceutical Industry, JMP, R&D, Formulation, CMC, Contract Manufacturing, Pharmaceutical Research, V&V, Quality by Design
Education
Barton College 1996 — 1998
BS, Chemistry
Glenn Meyer Glenn Meyer's AAI Development Services Experience 1995 - 2001
Job Pharmaceutical Development Expert
Industry Pharmaceuticals
Experience
Live Oak Pharmaceuticals, Inc. May 2012 - Present
Osmotica Pharmaceutical Corp. December 2001 - 2012
AAI Development Services 1995 - 2001
Abbott Laboratories 1989 - 1995
Skills
FDA, Pharmaceuticals, Validation, New product..., Regulatory Strategy, Scale up and process..., Clinical protocol design, Product Life Cycle..., IP strategies, Pharmaceutical Industry, Clinical Research, Product Lifecycle..., Process Optimization, Scale Up, Product Development, Clinical Trials, Drug Development, Drug Delivery, Analytical Chemistry, Strategy, CRO, Clinical Development, Formulation, Pharmaceutics, Sop, Technology Transfer, Chromatography, Drug Discovery, GLP, R&D, CTMS, GMP, Neurology, HPLC, GCP, Lifesciences, V&V, Regulatory Submissions, Biopharmaceuticals, IND, Biotechnology, CAPA, Pharmacology, Pharmaceutical Research, Pharmacokinetics, Bioanalysis, Quality by Design, Pharmacovigilance, Dissolution, CMC
Education
University of Connecticut 1984 — 1989
Ph.D., Pharmaceutical Sciences
Albany College of Pharmacy of Union University 1980 — 1984
Bachelor of Science (B.S.), Pharmacy
Live Oak Pharmaceuticals, Inc. May 2012 - Present
Osmotica Pharmaceutical Corp. December 2001 - 2012
AAI Development Services 1995 - 2001
Abbott Laboratories 1989 - 1995
Skills
FDA, Pharmaceuticals, Validation, New product..., Regulatory Strategy, Scale up and process..., Clinical protocol design, Product Life Cycle..., IP strategies, Pharmaceutical Industry, Clinical Research, Product Lifecycle..., Process Optimization, Scale Up, Product Development, Clinical Trials, Drug Development, Drug Delivery, Analytical Chemistry, Strategy, CRO, Clinical Development, Formulation, Pharmaceutics, Sop, Technology Transfer, Chromatography, Drug Discovery, GLP, R&D, CTMS, GMP, Neurology, HPLC, GCP, Lifesciences, V&V, Regulatory Submissions, Biopharmaceuticals, IND, Biotechnology, CAPA, Pharmacology, Pharmaceutical Research, Pharmacokinetics, Bioanalysis, Quality by Design, Pharmacovigilance, Dissolution, CMC
Education
University of Connecticut 1984 — 1989
Ph.D., Pharmaceutical Sciences
Albany College of Pharmacy of Union University 1980 — 1984
Bachelor of Science (B.S.), Pharmacy
John Anders John Anders's AAI Development Services Experience July 1993 - October 2006
Job Head of Quality Control of Nano ADM at Nanotherapeutics, Inc.
Industry Pharmaceuticals
Experience
Nanotherapeutics, Inc. July 2014 - Present
ABC Laboratories January 2013 - July 2014
ABC Laboratories August 2009 - December 2012
Gene Express Inc. October 2006 - August 2009
AAI Development Services July 1993 - October 2006
US Army November 1979 - June 1993
Skills
CRO, GLP, GMP, Biotechnology, Validation, Pharmaceutical Industry, HPLC, Analytical Chemistry, FDA, Sop, Bioanalysis, Chromatography, Clinical Development, Technology Transfer, Clinical Trials, ELISA, Drug Discovery, Drug Development, LC-MS, Protein Chemistry, Biopharmaceuticals, Molecular Biology, Cell, Biochemistry, Genomics, Chemistry, Pharmaceutics, LIMS, Mass Spectrometry, Biomarkers, Laboratory, Pharmacology, Immunology, PCR, IND, Lifesciences, qPCR, Medical Devices, Assay Development, UV/Vis, Toxicology, DNA, Formulation, Gas Chromatography, Purification, Protein Purification, In Vitro, Regulatory Affairs, 21 CFR Part 11, R&D
Education
University of Florida 1987 — 1990
Ph.D., Biochemistry & Molecular Biology
Auburn University 1976 — 1978
Master of Science (MS), Pharmacology and Toxicology
Florida State University 1972 — 1974
Bachelor of Science (BS), Biology, General
Nanotherapeutics, Inc. July 2014 - Present
ABC Laboratories January 2013 - July 2014
ABC Laboratories August 2009 - December 2012
Gene Express Inc. October 2006 - August 2009
AAI Development Services July 1993 - October 2006
US Army November 1979 - June 1993
Skills
CRO, GLP, GMP, Biotechnology, Validation, Pharmaceutical Industry, HPLC, Analytical Chemistry, FDA, Sop, Bioanalysis, Chromatography, Clinical Development, Technology Transfer, Clinical Trials, ELISA, Drug Discovery, Drug Development, LC-MS, Protein Chemistry, Biopharmaceuticals, Molecular Biology, Cell, Biochemistry, Genomics, Chemistry, Pharmaceutics, LIMS, Mass Spectrometry, Biomarkers, Laboratory, Pharmacology, Immunology, PCR, IND, Lifesciences, qPCR, Medical Devices, Assay Development, UV/Vis, Toxicology, DNA, Formulation, Gas Chromatography, Purification, Protein Purification, In Vitro, Regulatory Affairs, 21 CFR Part 11, R&D
Education
University of Florida 1987 — 1990
Ph.D., Biochemistry & Molecular Biology
Auburn University 1976 — 1978
Master of Science (MS), Pharmacology and Toxicology
Florida State University 1972 — 1974
Bachelor of Science (BS), Biology, General
Ashok Desai Ashok Desai's AAI Development Services 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
John McEntire John McEntire's AAI Development Services Experience 1993 - 1994
Job Principal at McEntire Consulting
Industry Pharmaceuticals
Experience
McEntire Consulting January 2000 - Present
BioReliance 1998 - 2000
MA Bioservices 1994 - 1998
AAI Development Services 1993 - 1994
Tektagen Corp. 1988 - 1993
UTMB 1974 - 1977
Skills
Biopharmaceuticals, Technology Transfer, Regulatory Requirements, Quality Assurance, Biotechnology, Pharmaceutical Industry, Validation, Product Development, GMP, Chemistry, GLP, Business Development, Quality System, Drug Discovery, Analytical Chemistry, HPLC, Medical Writing, FDA, Commercialization, Laboratory, Quality Auditing, Lifesciences, Testing, Pharmaceutics, Sop, 21 CFR Part 11, Drug Development, R&D, Cross-functional Team..., Regulatory Submissions, CRO, LIMS, Quality Control, V&V, Regulatory Affairs, CAPA, Vaccines, Change Control, Clinical Development, Clinical Trials, Immunology, GCP, Oncology, Medical Devices, Toxicology, Biochemistry, Computer System..., Pharmacology, Infectious Diseases, CTMS
Education
The University of Texas Medical Branch at Galveston 1978 — 1979
Post-Doctoral, Cellular Immunology
University of Houston 1975 — 1978
Ph.D., Biochemistry
University of Houston 1972 — 1974
M.S., Microbiology
Texas Christian University 1964 — 1968
B.S., Biology
McEntire Consulting January 2000 - Present
BioReliance 1998 - 2000
MA Bioservices 1994 - 1998
AAI Development Services 1993 - 1994
Tektagen Corp. 1988 - 1993
UTMB 1974 - 1977
Skills
Biopharmaceuticals, Technology Transfer, Regulatory Requirements, Quality Assurance, Biotechnology, Pharmaceutical Industry, Validation, Product Development, GMP, Chemistry, GLP, Business Development, Quality System, Drug Discovery, Analytical Chemistry, HPLC, Medical Writing, FDA, Commercialization, Laboratory, Quality Auditing, Lifesciences, Testing, Pharmaceutics, Sop, 21 CFR Part 11, Drug Development, R&D, Cross-functional Team..., Regulatory Submissions, CRO, LIMS, Quality Control, V&V, Regulatory Affairs, CAPA, Vaccines, Change Control, Clinical Development, Clinical Trials, Immunology, GCP, Oncology, Medical Devices, Toxicology, Biochemistry, Computer System..., Pharmacology, Infectious Diseases, CTMS
Education
The University of Texas Medical Branch at Galveston 1978 — 1979
Post-Doctoral, Cellular Immunology
University of Houston 1975 — 1978
Ph.D., Biochemistry
University of Houston 1972 — 1974
M.S., Microbiology
Texas Christian University 1964 — 1968
B.S., Biology
Rita Nespeca Rita Nespeca's AAI Development Services Experience 2000 - 2001
Job Clinical Data Management
Industry Pharmaceuticals
Experience
Gilead Sciences (formerly YM Biosciences) December 2010 - Present
Les Services Pharm-Olam International Inc. April 2010 - December 2010
ZeeCRO (formerly AAIPharma) 2001 - April 2010
AAI Development Services 2000 - 2001
Janssen-Ortho 1999 - 2000
MDS Pharma Services 1997 - 1999
Samuel Lunenfeld Research Institute 1989 - 1997
Skills
Clinical Trials, Data Management, Strategic Planning, Programming, CRO, Sop, ICH-GCP, Quality Assurance, Oracle Clinical, SAS programming, Clinical Data Management, Clinical Development, Biotechnology, Integration, EDC, CTMS, GCP, SOP
Education
University of Guelph 1994 — 1996
M.Sc., Analytical Epidemiology
University of Toronto 1984 — 1988
B.Sc., Pharmacology/Physiology
Gilead Sciences (formerly YM Biosciences) December 2010 - Present
Les Services Pharm-Olam International Inc. April 2010 - December 2010
ZeeCRO (formerly AAIPharma) 2001 - April 2010
AAI Development Services 2000 - 2001
Janssen-Ortho 1999 - 2000
MDS Pharma Services 1997 - 1999
Samuel Lunenfeld Research Institute 1989 - 1997
Skills
Clinical Trials, Data Management, Strategic Planning, Programming, CRO, Sop, ICH-GCP, Quality Assurance, Oracle Clinical, SAS programming, Clinical Data Management, Clinical Development, Biotechnology, Integration, EDC, CTMS, GCP, SOP
Education
University of Guelph 1994 — 1996
M.Sc., Analytical Epidemiology
University of Toronto 1984 — 1988
B.Sc., Pharmacology/Physiology
Audrey Rossow Audrey Rossow's AAI Development Services Experience 1997 - 2000
Job Principal, A Rossow Consulting, LLC
Industry Pharmaceuticals
Experience
A Rossow Consulting March 2011 - Present
Pulmatrix Inc. 2011 - 2013
Pulmatrix Inc. 2011 - 2013
ThreeWire July 2010 - April 2011
Sepracor June 2008 - July 2010
Sepracor 2001 - 2009
Inotek Pharmaceuticals 2007 - 2008
Quintiles 2005 - 2006
MTRA 1997 - 2001
AAI Development Services 1997 - 2000
Skills
Clinical Trials, Clinical Research, Biotechnology, Research, CRO selection, Trial Master Files, Process Improvement, Individualized Site..., Investigators Meetings, Vendor Management, Teamwork, Event Management, Pharmaceuticals, Medical Device R&D, protocol writing, Vendor selection, Site contracts and..., CSR Compilation, CT.gov postings &..., FIH studies
Education
University of New Hampshire 1982 — 1986
BA, Psychology, Minor in Business
Arlington High
A Rossow Consulting March 2011 - Present
Pulmatrix Inc. 2011 - 2013
Pulmatrix Inc. 2011 - 2013
ThreeWire July 2010 - April 2011
Sepracor June 2008 - July 2010
Sepracor 2001 - 2009
Inotek Pharmaceuticals 2007 - 2008
Quintiles 2005 - 2006
MTRA 1997 - 2001
AAI Development Services 1997 - 2000
Skills
Clinical Trials, Clinical Research, Biotechnology, Research, CRO selection, Trial Master Files, Process Improvement, Individualized Site..., Investigators Meetings, Vendor Management, Teamwork, Event Management, Pharmaceuticals, Medical Device R&D, protocol writing, Vendor selection, Site contracts and..., CSR Compilation, CT.gov postings &..., FIH studies
Education
University of New Hampshire 1982 — 1986
BA, Psychology, Minor in Business
Arlington High
Thomas Ingallinera's AAI Development Services Experience 2001 - 2004
Job VP Business Development, Technical Support Pharmaceutics International Pii
Industry Pharmaceuticals
Experience
Pii - Pharmaceutics International Inc. October 2011 - Present
TSI LLC 2011 - November 2011
BioCryst Pharmaceuticals 2007 - 2011
Erimos 2006 - 2007
Parenta Pharmaceuticals 2004 - 2006
AAI Development Services 2001 - 2004
Infimed Therapeutics June 2000 - September 2001
Genzyme 1996 - 2000
Burroughs Wellcome Co. 1990 - 1995
A.H. Robins Co. 1977 - 1990
Skills
preformulation, Validation, Formulation Development, Pharmaceutics, Formulation, Pharmaceutical Industry, Technology Transfer, GMP, FDA, Sop, Regulatory Affairs, Biotechnology, Analytical Chemistry, HPLC, R&D, Product Development, Medical Devices, Drug Development, CRO, Biopharmaceuticals, GLP, Regulatory Submissions
Education
Medical College of Virginia VCU 1975 — 1981
Ph.D., Pharmaceutics
University of Louisiana at Monroe 1972 — 1974
BS, Pharmacy
Pii - Pharmaceutics International Inc. October 2011 - Present
TSI LLC 2011 - November 2011
BioCryst Pharmaceuticals 2007 - 2011
Erimos 2006 - 2007
Parenta Pharmaceuticals 2004 - 2006
AAI Development Services 2001 - 2004
Infimed Therapeutics June 2000 - September 2001
Genzyme 1996 - 2000
Burroughs Wellcome Co. 1990 - 1995
A.H. Robins Co. 1977 - 1990
Skills
preformulation, Validation, Formulation Development, Pharmaceutics, Formulation, Pharmaceutical Industry, Technology Transfer, GMP, FDA, Sop, Regulatory Affairs, Biotechnology, Analytical Chemistry, HPLC, R&D, Product Development, Medical Devices, Drug Development, CRO, Biopharmaceuticals, GLP, Regulatory Submissions
Education
Medical College of Virginia VCU 1975 — 1981
Ph.D., Pharmaceutics
University of Louisiana at Monroe 1972 — 1974
BS, Pharmacy
Maureen E Hynes Maureen E Hynes's AAI Development Services Experience 2000 - 2003
Job Senior Clinical Professional with strong Proposal and Contract Management Expertise
Industry Pharmaceuticals
Experience
PAREXEL International September 2011 - August 2012
EMD Serono, an affiliate of Merck KGaA Darmstadt, Germany February 2011 - October 2011
Millennium Pharmaceuticals September 2007 - September 2010
Genzyme 2005 - 2007
Roche Pharmaceuticals April 2004 - February 2005
Purdue Pharma 2003 - 2004
AAI Development Services 2000 - 2003
PAREXEL International 1998 - 2000
Skills
Clinical Research, CRO, Clinical Trials, GCP, Pharmaceutical Industry, EDC, Strategy, Contract Negotiation, Leadership, Clinical Development, Outsourcing, Oncology, Management, Business Development, CTMS, Cross-functional Team..., Budgets, Proposal Writing
Education
Sweet Briar College
Bachelor's Degree, Psychology
PAREXEL International September 2011 - August 2012
EMD Serono, an affiliate of Merck KGaA Darmstadt, Germany February 2011 - October 2011
Millennium Pharmaceuticals September 2007 - September 2010
Genzyme 2005 - 2007
Roche Pharmaceuticals April 2004 - February 2005
Purdue Pharma 2003 - 2004
AAI Development Services 2000 - 2003
PAREXEL International 1998 - 2000
Skills
Clinical Research, CRO, Clinical Trials, GCP, Pharmaceutical Industry, EDC, Strategy, Contract Negotiation, Leadership, Clinical Development, Outsourcing, Oncology, Management, Business Development, CTMS, Cross-functional Team..., Budgets, Proposal Writing
Education
Sweet Briar College
Bachelor's Degree, Psychology
David Dobrowski David Dobrowski's AAI Development Services Experience 1994 - 1996
Job Vice President Research and Development at Merz North America
Industry Pharmaceuticals
Experience
Merz North America June 2015 - Present
Merz North America February 2014 - June 2015
Merz North America October 2013 - February 2014
Merz Pharmaceuticals, LLC March 2011 - October 2013
Salix Pharmaceuticals February 2008 - January 2011
Schwarz Biosciences January 2005 - February 2008
Wyeth Vaccines October 2003 - December 2004
Novartis Ophthalmics 1998 - October 2003
Catalytica February 1996 - June 1998
AAI Development Services 1994 - 1996
Skills
Regulatory Affairs, Drug Development, Regulatory Strategy, Strategy, Biologics, Regulatory Submissions, Clinical Development, Pharmacovigilance, Biotechnology, GCP, Pharmaceutical Industry, GMP, Regulations, FDA, Clinical Trials, IND, Clinical Research, Endocrinology, CRO
Education
University of North Carolina at Wilmington 1988 — 1992
BS
Merz North America June 2015 - Present
Merz North America February 2014 - June 2015
Merz North America October 2013 - February 2014
Merz Pharmaceuticals, LLC March 2011 - October 2013
Salix Pharmaceuticals February 2008 - January 2011
Schwarz Biosciences January 2005 - February 2008
Wyeth Vaccines October 2003 - December 2004
Novartis Ophthalmics 1998 - October 2003
Catalytica February 1996 - June 1998
AAI Development Services 1994 - 1996
Skills
Regulatory Affairs, Drug Development, Regulatory Strategy, Strategy, Biologics, Regulatory Submissions, Clinical Development, Pharmacovigilance, Biotechnology, GCP, Pharmaceutical Industry, GMP, Regulations, FDA, Clinical Trials, IND, Clinical Research, Endocrinology, CRO
Education
University of North Carolina at Wilmington 1988 — 1992
BS
Karyn Bowman Karyn Bowman's AAI Development Services Experience 2001 - 2003
Job Clinical Trial Manager at Novella Clinical, Inc.
Industry Pharmaceuticals
Experience
Novella Clinical, Inc. April 2012 - Present
PAREXEL September 2011 - March 2012
INC Research May 2010 - March 2011
INC Research February 2007 - May 2010
PPD 2004 - 2007
AAI Pharma 2003 - 2004
AAI Development Services 2001 - 2003
Wilmington Pathology 2000 - 2001
Skills
CRO, Clinical Research, Pharmaceutical Industry, Oncology, GCP, Clinical Operations
Education
North Carolina State University 1990 — 1995
BS, Biochemistry
Novella Clinical, Inc. April 2012 - Present
PAREXEL September 2011 - March 2012
INC Research May 2010 - March 2011
INC Research February 2007 - May 2010
PPD 2004 - 2007
AAI Pharma 2003 - 2004
AAI Development Services 2001 - 2003
Wilmington Pathology 2000 - 2001
Skills
CRO, Clinical Research, Pharmaceutical Industry, Oncology, GCP, Clinical Operations
Education
North Carolina State University 1990 — 1995
BS, Biochemistry
Vernon Bartlett Vernon Bartlett's AAI Development Services Experience 1988 - 1992
Job Senior Innovations Chemist at Restek Corporation
Industry Chemicals
Experience
Restek Corporation January 2002 - January 2008
Restek Corporation January 2000 - January 2002
Restek Corporation June 1998 - January 2000
Aronex Pharmaceuticals June 1997 - May 1998
Somerset Pharmaceuticals 1995 - 1997
UDL Laboratories 1992 - 1995
College of Charleston - department of Pharmacy 1992 - 1992
AAI Development Services 1988 - 1992
3-V Chemicals 1987 - 1988
Cargill August 1984 - September 1987
Education
Erskine College 1980 — 1984
BA, Chemistry
Private 1980 — 1984
BA, Chemistry -Premed
Restek Corporation January 2002 - January 2008
Restek Corporation January 2000 - January 2002
Restek Corporation June 1998 - January 2000
Aronex Pharmaceuticals June 1997 - May 1998
Somerset Pharmaceuticals 1995 - 1997
UDL Laboratories 1992 - 1995
College of Charleston - department of Pharmacy 1992 - 1992
AAI Development Services 1988 - 1992
3-V Chemicals 1987 - 1988
Cargill August 1984 - September 1987
Education
Erskine College 1980 — 1984
BA, Chemistry
Private 1980 — 1984
BA, Chemistry -Premed
Laura Trivett Laura Trivett's AAI Development Services Experience 1998 - 2000
Job Special Events and Marketing Director at Historic Wilmington Foundation
Industry Philanthropy
Experience
Historic Wilmington Foundation 2011 - Present
Carolina Place - Ardmore Neighborhood Association July 2008 - October 2010
Octapharma January 2005 - May 2006
Johnson & Johnson April 2000 - December 2004
Solvay Pharmaceuticals September 1998 - March 2000
AAI Development Services 1998 - 2000
Skills
Consultative Selling, Marketing Strategy, Strategic Planning, New Business Development, Customer Relations, Customer Service, Selling, Management, Sales, Project Management, Sales Operations, Marketing
Education
Emory University 1991 — 1993
BA, International Studies
Historic Wilmington Foundation 2011 - Present
Carolina Place - Ardmore Neighborhood Association July 2008 - October 2010
Octapharma January 2005 - May 2006
Johnson & Johnson April 2000 - December 2004
Solvay Pharmaceuticals September 1998 - March 2000
AAI Development Services 1998 - 2000
Skills
Consultative Selling, Marketing Strategy, Strategic Planning, New Business Development, Customer Relations, Customer Service, Selling, Management, Sales, Project Management, Sales Operations, Marketing
Education
Emory University 1991 — 1993
BA, International Studies
Martin Hunicutt, CCMEP Martin Hunicutt, CCMEP's AAI Development Services Experience December 1993 - June 1998
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
Felicia Kersey Angus's AAI Development Services Experience December 1998 - February 2001
Job Manufacturing Quality Manager at Novartis Animal Health
Industry Pharmaceuticals
Experience
Novartis Animal Health November 2012 - Present
Validant April 2012 - November 2012
Biogen Idec July 2011 - April 2012
GlaxoSmithKline August 2007 - July 2011
GSK 2007 - July 2011
Abraxis Oncology March 2007 - August 2007
DanChem Technologies, Inc. 2004 - 2007
Wyeth February 2001 - September 2006
AAI Development Services December 1998 - February 2001
Skills
FDA, CAPA, Validation, Quality Assurance, SOP, Change Control, GMP, Quality System, Pharmaceutical Industry, Quality Auditing
Education
North Carolina Agricultural and Technical State University 1990 — 1997
Bachelor of Science (BS), Chemistry
Novartis Animal Health November 2012 - Present
Validant April 2012 - November 2012
Biogen Idec July 2011 - April 2012
GlaxoSmithKline August 2007 - July 2011
GSK 2007 - July 2011
Abraxis Oncology March 2007 - August 2007
DanChem Technologies, Inc. 2004 - 2007
Wyeth February 2001 - September 2006
AAI Development Services December 1998 - February 2001
Skills
FDA, CAPA, Validation, Quality Assurance, SOP, Change Control, GMP, Quality System, Pharmaceutical Industry, Quality Auditing
Education
North Carolina Agricultural and Technical State University 1990 — 1997
Bachelor of Science (BS), Chemistry
Rachel F. Bonura Rachel F. Bonura's AAI Development Services Experience 2007 - 2007
Job Experienced Technical Advisor
Industry Pharmaceuticals
Experience
Bonura Pharmaceutical Consulting, Inc. September 2003 - December 2011
AAI Development Services 2007 - 2007
Tunnell Consultling 2005 - 2005
GlaxoSmithKline 1992 - 2003
lederle labs 1979 - 1984
Skills
Validation, Troubleshooting, Organizational..., Project Management, Employee Training, Employee Recognition, Employee Management, Project Planning, Project Coordination, GMP, Strategy, Regulatory Affairs, Software Documentation, Manufacturing, Regulatory Requirements, GLP, Pharmaceutical Industry, Formulation, FDA, Biopharmaceuticals, Drug Delivery, Pharmaceutics, Medical Devices, GxP, Quality by Design, Quality Assurance, Cross-functional Team..., Computer System..., Drug Development, Biotechnology, Data Analysis, V&V, Technology Transfer, Clinical Development, Generic Programming, Aseptic Processing, Quality System, Dissolution, R&D, Vaccines, Lifesciences, Sterilization, Change Control, Cleaning Validation, LIMS, Regulatory Submissions, 21 CFR Part 11, GAMP, Sop, CAPA
Education
Drake University 1969 — 1974
B.S., Pharmacy
Bonura Pharmaceutical Consulting, Inc. September 2003 - December 2011
AAI Development Services 2007 - 2007
Tunnell Consultling 2005 - 2005
GlaxoSmithKline 1992 - 2003
lederle labs 1979 - 1984
Skills
Validation, Troubleshooting, Organizational..., Project Management, Employee Training, Employee Recognition, Employee Management, Project Planning, Project Coordination, GMP, Strategy, Regulatory Affairs, Software Documentation, Manufacturing, Regulatory Requirements, GLP, Pharmaceutical Industry, Formulation, FDA, Biopharmaceuticals, Drug Delivery, Pharmaceutics, Medical Devices, GxP, Quality by Design, Quality Assurance, Cross-functional Team..., Computer System..., Drug Development, Biotechnology, Data Analysis, V&V, Technology Transfer, Clinical Development, Generic Programming, Aseptic Processing, Quality System, Dissolution, R&D, Vaccines, Lifesciences, Sterilization, Change Control, Cleaning Validation, LIMS, Regulatory Submissions, 21 CFR Part 11, GAMP, Sop, CAPA
Education
Drake University 1969 — 1974
B.S., Pharmacy
Bev Hudson's AAI Development Services Experience June 2003 - November 2004
Job Senior Director of Sales and Marketing at Frenova Renal Research
Industry Research
Experience
Frenova Renal Research March 2015 - Present
Oklahoma Heart Hospital Research Foundation April 2013 - September 2014
OmniComm Systems, Inc. June 2010 - March 2013
MedPoint Communications September 2007 - June 2010
Mayo Clinical Trial Services May 2005 - December 2006
AAI Development Services June 2003 - November 2004
Genentech 1988 - 1999
Skills
Clinical Research, Phase I, Biotechnology, Clinical Trials, Clinical Development, eClinical, Medical Devices, Product Development, Product Management, Cross-functional Team..., Therapeutic Areas, Mentoring, Leadership, Strategic Thinking, GCP, Strategy, 21 CFR Part 11, Sales, EDC, CTMS, Oncology, Pharmaceutical Industry, FDA, Infectious Diseases, ICH-GCP, Regulatory Affairs, Healthcare, Management, Data Management, Drug Development, Pharmaceutical Sales, Commercialization, Clinical Data Management, Biopharmaceuticals, Regulatory Submissions, Cardiology, Neurology, Validation, Sop, Biologics, Pharmaceutics, Regulatory Requirements
Education
Benedictine University
MBA, Business, Marketing
University of Illinois at Urbana-Champaign
BS, Occupational Therapy
Frenova Renal Research March 2015 - Present
Oklahoma Heart Hospital Research Foundation April 2013 - September 2014
OmniComm Systems, Inc. June 2010 - March 2013
MedPoint Communications September 2007 - June 2010
Mayo Clinical Trial Services May 2005 - December 2006
AAI Development Services June 2003 - November 2004
Genentech 1988 - 1999
Skills
Clinical Research, Phase I, Biotechnology, Clinical Trials, Clinical Development, eClinical, Medical Devices, Product Development, Product Management, Cross-functional Team..., Therapeutic Areas, Mentoring, Leadership, Strategic Thinking, GCP, Strategy, 21 CFR Part 11, Sales, EDC, CTMS, Oncology, Pharmaceutical Industry, FDA, Infectious Diseases, ICH-GCP, Regulatory Affairs, Healthcare, Management, Data Management, Drug Development, Pharmaceutical Sales, Commercialization, Clinical Data Management, Biopharmaceuticals, Regulatory Submissions, Cardiology, Neurology, Validation, Sop, Biologics, Pharmaceutics, Regulatory Requirements
Education
Benedictine University
MBA, Business, Marketing
University of Illinois at Urbana-Champaign
BS, Occupational Therapy
Caroline Royall Caroline Royall's AAI Development Services Experience September 2004 - June 2005
Job Interventional Account Manager, Medtronic, GI
Industry Medical Devices
Experience
Medtronic September 2013 - Present
Dynasplint Systems, Inc. August 2011 - September 2013
Intracoastal Realty Corporation October 2005 - August 2011
Synergistic Technologies Inc February 2011 - June 2011
AAI Development Services September 2004 - June 2005
AAI Development Services September 2004 - June 2005
University Directories October 2003 - September 2004
Skills
Sales Operations, Sales, Medical Devices, Business Development, CRM, Lead Generation, Sales Management, Marketing, Cold Calling, Selling, Leadership, B2B, Business Planning, Management, Training, Account Management, Customer Service, Negotiation, Product Launch, Strategic Planning, Product Development, Healthcare, Team Building, Project Management, New Business Development, Market Development
Education
University of North Carolina at Wilmington 1998 — 2003
B.A, Communication Studies
University of North Carolina at Wilmington 1998 — 2003
B.A, Spanish
Universidad Complutense de Madrid 2002 — 2002
Advanced Degree for Foreigners, Spanish Language
National Outdoor Leadership School (NOLS) 2000 — 2000
Graduate, Outdoor Leadership and Outdoor Education
Medtronic September 2013 - Present
Dynasplint Systems, Inc. August 2011 - September 2013
Intracoastal Realty Corporation October 2005 - August 2011
Synergistic Technologies Inc February 2011 - June 2011
AAI Development Services September 2004 - June 2005
AAI Development Services September 2004 - June 2005
University Directories October 2003 - September 2004
Skills
Sales Operations, Sales, Medical Devices, Business Development, CRM, Lead Generation, Sales Management, Marketing, Cold Calling, Selling, Leadership, B2B, Business Planning, Management, Training, Account Management, Customer Service, Negotiation, Product Launch, Strategic Planning, Product Development, Healthcare, Team Building, Project Management, New Business Development, Market Development
Education
University of North Carolina at Wilmington 1998 — 2003
B.A, Communication Studies
University of North Carolina at Wilmington 1998 — 2003
B.A, Spanish
Universidad Complutense de Madrid 2002 — 2002
Advanced Degree for Foreigners, Spanish Language
National Outdoor Leadership School (NOLS) 2000 — 2000
Graduate, Outdoor Leadership and Outdoor Education
Lindsay Melican's AAI Development Services Experience 2000 - 2004
Job Quality Engineer at SeraCare Life Sciences
Industry Biotechnology
Experience
SeraCare Life Sciences August 2008 - Present
Melican Construction 2003 - Present
Goss Consultants 2003 - Present
ViaCell 2005 - 2008
AAI Development Services 2000 - 2004
Education
Endicott College
Business Administration
SeraCare Life Sciences August 2008 - Present
Melican Construction 2003 - Present
Goss Consultants 2003 - Present
ViaCell 2005 - 2008
AAI Development Services 2000 - 2004
Education
Endicott College
Business Administration
Robert W. Lomax, SA Robert W. Lomax, SA's AAI Development Services Experience December 2007 - July 2009
Job
Industry Maritime
Experience
Lomax Marine Surveying and Consulting November 2014 - Present
SEA TOW INTERNATIONAL INC. July 2009 - Present
AAI Development Services December 2007 - July 2009
PPD March 2007 - October 2007
University of North Carolina at Wilmington August 2005 - May 2007
University of North Carolina at Wilmington May 2001 - August 2005
Skills
Contract Negotiation, Maritime, Customer Service, Strategic Planning, PowerPoint, Research, Microsoft Office, Public Speaking, Biotechnology, Advertising, GCP, Event Planning, Clinical Research, Microsoft Excel, SAS, QuickBooks
Education
University of North Carolina at Wilmington 2005 — 2008
MMS, Hydrology, Statistics
University of North Carolina at Wilmington 1997 — 2001
BS, Biology
Lomax Marine Surveying and Consulting November 2014 - Present
SEA TOW INTERNATIONAL INC. July 2009 - Present
AAI Development Services December 2007 - July 2009
PPD March 2007 - October 2007
University of North Carolina at Wilmington August 2005 - May 2007
University of North Carolina at Wilmington May 2001 - August 2005
Skills
Contract Negotiation, Maritime, Customer Service, Strategic Planning, PowerPoint, Research, Microsoft Office, Public Speaking, Biotechnology, Advertising, GCP, Event Planning, Clinical Research, Microsoft Excel, SAS, QuickBooks
Education
University of North Carolina at Wilmington 2005 — 2008
MMS, Hydrology, Statistics
University of North Carolina at Wilmington 1997 — 2001
BS, Biology
Bryan Hauser's AAI Development Services Experience 1995 - 1996
Job Teaching Assitant, Biology Dept, Davidson College
Industry Higher Education
Experience
Davidson College July 2011 - Present
Pharmacore, Inc May 2004 - July 2011
AAI Development Services 1995 - 1996
Skills
Organic Chemistry, Chemistry, Process Chemistry, Research, Organic Synthesis, LC-MS, Mass Spectrometry, Synthetic Organic..., Drug Discovery, NMR, Drug Design, Spectroscopy, Purification, Medicinal Chemistry, Organometallic Chemistry, IR
Education
University of North Carolina at Chapel Hill 1996 — 2001
Doctorate, Chemistry
University of North Carolina at Wilmington 1991 — 1995
Davidson College July 2011 - Present
Pharmacore, Inc May 2004 - July 2011
AAI Development Services 1995 - 1996
Skills
Organic Chemistry, Chemistry, Process Chemistry, Research, Organic Synthesis, LC-MS, Mass Spectrometry, Synthetic Organic..., Drug Discovery, NMR, Drug Design, Spectroscopy, Purification, Medicinal Chemistry, Organometallic Chemistry, IR
Education
University of North Carolina at Chapel Hill 1996 — 2001
Doctorate, Chemistry
University of North Carolina at Wilmington 1991 — 1995
Anna Del Tito's AAI Development Services Experience January 1989 - October 2001
Job Senior Quality Professional seeking opportunities in the pharmaceutical/biopharmaceutical industry
Industry Pharmaceuticals
Experience
Auxilium Pharmaceuticals, Inc. March 2014 - September 2014
Auxilium Pharmaceuticals, Inc. January 2012 - February 2014
Auxilium Pharmaceuticals, Inc. August 2009 - December 2011
Auxilium Pharmaceuticals, Inc. November 2006 - August 2009
Auxilium Pharmaceuticals, Inc. October 2004 - November 2006
Schering-Plough Research Institute March 2003 - October 2004
MedImmune Vaccines October 2001 - March 2004
AAI Development Services January 1989 - October 2001
Skills
V&V, GMP, Validation, GLP, Change Control, Analytical Chemistry, Microbiology, Manufacturing, Aseptic Processing, Regulatory Affairs, FDA, Technology Transfer, Quality System, CAPA, Sop, Regulatory Submissions, Quality Assurance, Biotechnology, Pharmaceutical Industry, 21 CFR Part 11, SOP
Education
University of North Carolina at Wilmington
Bachelor's Degree, Biology
Auxilium Pharmaceuticals, Inc. March 2014 - September 2014
Auxilium Pharmaceuticals, Inc. January 2012 - February 2014
Auxilium Pharmaceuticals, Inc. August 2009 - December 2011
Auxilium Pharmaceuticals, Inc. November 2006 - August 2009
Auxilium Pharmaceuticals, Inc. October 2004 - November 2006
Schering-Plough Research Institute March 2003 - October 2004
MedImmune Vaccines October 2001 - March 2004
AAI Development Services January 1989 - October 2001
Skills
V&V, GMP, Validation, GLP, Change Control, Analytical Chemistry, Microbiology, Manufacturing, Aseptic Processing, Regulatory Affairs, FDA, Technology Transfer, Quality System, CAPA, Sop, Regulatory Submissions, Quality Assurance, Biotechnology, Pharmaceutical Industry, 21 CFR Part 11, SOP
Education
University of North Carolina at Wilmington
Bachelor's Degree, Biology
Rita DeVico's AAI Development Services Experience 1999 - 2000
Job Manager, Clinical Operations at Boston Biomedical Associates
Industry Biotechnology
Experience
Boston Biomedical Associates August 2014 - Present
Boston Biomedical Associates July 2010 - Present
Boston Scientific September 2008 - July 2010
Averion International July 2001 - September 2008
BioChem Pharma November 2000 - June 2001
AAI Development Services 1999 - 2000
Children's Hospital of Michigan 1991 - 1999
Children's Hospital of Michigan 1991 - 1999
Laventhol & Horwath 1985 - 1990
Skills
Medical Devices, CAPA, Clinical Trials, GCP, CTMS, Clinical Development, CRO, Pharmaceutical Industry, FDA, Clinical Research, EDC, Biotechnology, Clinical Operations, Project Management, Clinical Research..., Employee Training
Education
Michigan State University 1983 — 1985
BA - Communications & Human Resources, Communications and Human resources
Macomb Community College 1979 — 1983
Assoc ofApllied Science - Business, Business/Communicagion
Boston Biomedical Associates August 2014 - Present
Boston Biomedical Associates July 2010 - Present
Boston Scientific September 2008 - July 2010
Averion International July 2001 - September 2008
BioChem Pharma November 2000 - June 2001
AAI Development Services 1999 - 2000
Children's Hospital of Michigan 1991 - 1999
Children's Hospital of Michigan 1991 - 1999
Laventhol & Horwath 1985 - 1990
Skills
Medical Devices, CAPA, Clinical Trials, GCP, CTMS, Clinical Development, CRO, Pharmaceutical Industry, FDA, Clinical Research, EDC, Biotechnology, Clinical Operations, Project Management, Clinical Research..., Employee Training
Education
Michigan State University 1983 — 1985
BA - Communications & Human Resources, Communications and Human resources
Macomb Community College 1979 — 1983
Assoc ofApllied Science - Business, Business/Communicagion
Nick Maraveyias's AAI Development Services Experience February 1988 - April 1996
Job Executive Director, Business Development at PPD
Industry Pharmaceuticals
Experience
PPD April 1996 - Present
AAI Development Services February 1988 - April 1996
Skills
Pharmaceutical Industry, GCP, CRO, Clinical Trials, Clinical Development, CTMS, Drug Development, GMP, Analytical Chemistry, Business Development, GLP, Clinical Data Management, Sop, Regulatory Submissions, FDA, Leadership, Biotechnology, Clinical Research, Management, Regulatory Affairs
Education
University of North Carolina at Wilmington 1982 — 1986
BS, Marine Biology, Chemistry
PPD April 1996 - Present
AAI Development Services February 1988 - April 1996
Skills
Pharmaceutical Industry, GCP, CRO, Clinical Trials, Clinical Development, CTMS, Drug Development, GMP, Analytical Chemistry, Business Development, GLP, Clinical Data Management, Sop, Regulatory Submissions, FDA, Leadership, Biotechnology, Clinical Research, Management, Regulatory Affairs
Education
University of North Carolina at Wilmington 1982 — 1986
BS, Marine Biology, Chemistry
Nina Sydney's AAI Development Services Experience June 2000 - June 2002
Job Drug Safety Associate at Sepracor
Industry Pharmaceuticals
Experience
Sepracor October 2005 - Present
Biogen 2004 - 2005
Averion International March 2004 - August 2004
Biogen October 2003 - February 2004
Abt Associates January 2003 - October 2003
Millenium Pharmaceuticals June 2002 - October 2002
AAI Development Services June 2000 - June 2002
VA Medical Center October 1998 - June 2000
New England Research Institutes July 1997 - July 1998
Children's Hospital Boston June 1995 - July 1997
Education
Boston University 1993 — 1995
MPH, Health Education
Syracuse University 1989 — 1993
BA, Psychology, Public Policy (health)
Sepracor October 2005 - Present
Biogen 2004 - 2005
Averion International March 2004 - August 2004
Biogen October 2003 - February 2004
Abt Associates January 2003 - October 2003
Millenium Pharmaceuticals June 2002 - October 2002
AAI Development Services June 2000 - June 2002
VA Medical Center October 1998 - June 2000
New England Research Institutes July 1997 - July 1998
Children's Hospital Boston June 1995 - July 1997
Education
Boston University 1993 — 1995
MPH, Health Education
Syracuse University 1989 — 1993
BA, Psychology, Public Policy (health)
Patti Raynor's AAI Development Services Experience 1999 - Present
Job SAP Analyst at AAIPharma
Industry Pharmaceuticals
Experience
AAIPharma SAP AnalystAAI Pharma1999 - Present
AAIPharma Services Corp. 1999 - Present
AAI Development Services 1999 - Present
Applied Analytical Industries (AAI) 1985 - Present
Education
University of North Carolina at Wilmington 1979 — 1982
AAIPharma SAP AnalystAAI Pharma1999 - Present
AAIPharma Services Corp. 1999 - Present
AAI Development Services 1999 - Present
Applied Analytical Industries (AAI) 1985 - Present
Education
University of North Carolina at Wilmington 1979 — 1982
Jill Hall's AAI Development Services Experience July 2005 - March 2008
Job Regulatory Officer / Medical Writer at Chiltern International
Industry Pharmaceuticals
Experience
Chiltern International April 2011 - Present
AAIPharma Services Corp. March 2008 - May 2011
AAI Development Services July 2005 - March 2008
AAI Development Services July 2000 - July 2005
Columbus Christian Academy August 1999 - June 2000
Skills
FDA, CRO, Pharmaceutical Industry, Regulatory Affairs, Sop, Clinical Research, Regulatory Submissions, Regulatory Requirements, Formulation, IND, Laboratory, Technology Transfer, GMP, Protocol, GLP, Quality Assurance, Analytical Chemistry, Medical Writing, Chemistry
Education
University of North Carolina at Wilmington
MS, Chemistry
University of North Carolina at Wilmington 1997 — 1999
Bachelor, Chemistry
Chiltern International April 2011 - Present
AAIPharma Services Corp. March 2008 - May 2011
AAI Development Services July 2005 - March 2008
AAI Development Services July 2000 - July 2005
Columbus Christian Academy August 1999 - June 2000
Skills
FDA, CRO, Pharmaceutical Industry, Regulatory Affairs, Sop, Clinical Research, Regulatory Submissions, Regulatory Requirements, Formulation, IND, Laboratory, Technology Transfer, GMP, Protocol, GLP, Quality Assurance, Analytical Chemistry, Medical Writing, Chemistry
Education
University of North Carolina at Wilmington
MS, Chemistry
University of North Carolina at Wilmington 1997 — 1999
Bachelor, Chemistry
Bill Hanna's AAI Development Services Experience April 1997 - July 2004
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
Jennifer Spaly's AAI Development Services Experience January 2001 - March 2005
Job Senior Clinical Research Associate at PRA Health Sciences
Industry Research
Experience
PRA Health Sciences July 2013 - Present
PRA Health Sciences September 2010 - July 2013
AAI Development Services January 2001 - March 2005
Terre Clinical Research Services January 2000 - December 2000
PPD January 1998 - June 1999
Skills
Clinical Research, CTMS, GCP, Clinical Trials, CRO, EDC, Pharmaceutical Industry, ICH-GCP, Infectious Diseases, Phase 1 - IV Trials, CNS, Oncology
Education
University of Michigan 1989 — 1992
BSN, Nursing
PRA Health Sciences July 2013 - Present
PRA Health Sciences September 2010 - July 2013
AAI Development Services January 2001 - March 2005
Terre Clinical Research Services January 2000 - December 2000
PPD January 1998 - June 1999
Skills
Clinical Research, CTMS, GCP, Clinical Trials, CRO, EDC, Pharmaceutical Industry, ICH-GCP, Infectious Diseases, Phase 1 - IV Trials, CNS, Oncology
Education
University of Michigan 1989 — 1992
BSN, Nursing
Linn Watt's AAI Development Services Experience August 2001 - November 2004
Job Director, Clinical Data Management at Synta Pharmaceuticals
Industry Pharmaceuticals
Experience
Synta Pharmaceuticals March 2015 - Present
Synta Pharmaceuticals November 2004 - March 2015
AAI Development Services August 2001 - November 2004
Skills
Clinical Development, Clinical Trials, Oncology, CRO, Clinical Data Management, Pharmaceutical Industry
Education
University of California, San Diego
B.A., Biology
Synta Pharmaceuticals March 2015 - Present
Synta Pharmaceuticals November 2004 - March 2015
AAI Development Services August 2001 - November 2004
Skills
Clinical Development, Clinical Trials, Oncology, CRO, Clinical Data Management, Pharmaceutical Industry
Education
University of California, San Diego
B.A., Biology
James R. Luch, Ph.D.'s AAI Development Services Experience June 2002 - August 2004
Job Sr. Director, Quality Assurance & Analytical Chemistry
Industry Pharmaceuticals
Experience
Matinas BioPharma November 2013 - June 2014
Luch Consulting, LLC June 2013 - October 2013
Endo Pharmaceuticals December 2009 - February 2013
GlaxoSmithKline December 2007 - June 2008
Reliant Pharmaceuticals September 2004 - December 2007
AAI Development Services June 2002 - August 2004
West Pharmaceutical Services July 2000 - April 2002
Solvay Pharmaceuticals May 1999 - April 2000
Novartis July 1976 - December 1999
CIBA Pharmaceuticals 1976 - 1998
Skills
Technology Transfer, Drug Delivery, Pharmaceuticals, Analytical Chemistry, Clinical Trials, Drug Development, FDA, Chemistry, Pharmaceutical Industry, Biotechnology, Sop, GLP, CRO, Quality Assurance, Quality System, Validation, Laboratory, R&D, LIMS
Education
The University of Kansas 1970 — 1976
Ph.D., Chemistry
Bowling Green State University 1966 — 1970
B.S., Chemistry
Matinas BioPharma November 2013 - June 2014
Luch Consulting, LLC June 2013 - October 2013
Endo Pharmaceuticals December 2009 - February 2013
GlaxoSmithKline December 2007 - June 2008
Reliant Pharmaceuticals September 2004 - December 2007
AAI Development Services June 2002 - August 2004
West Pharmaceutical Services July 2000 - April 2002
Solvay Pharmaceuticals May 1999 - April 2000
Novartis July 1976 - December 1999
CIBA Pharmaceuticals 1976 - 1998
Skills
Technology Transfer, Drug Delivery, Pharmaceuticals, Analytical Chemistry, Clinical Trials, Drug Development, FDA, Chemistry, Pharmaceutical Industry, Biotechnology, Sop, GLP, CRO, Quality Assurance, Quality System, Validation, Laboratory, R&D, LIMS
Education
The University of Kansas 1970 — 1976
Ph.D., Chemistry
Bowling Green State University 1966 — 1970
B.S., Chemistry
Susan Schluckebier's AAI Development Services Experience March 2001 - May 2004
Job Clinical Data Manager at Harvard Clinical Research Institute
Industry Research
Experience
Harvard Clinical Research Institute September 2008 - Present
BattelleCRO 2005 - 2008
Boston Scientific June 2004 - July 2005
AAI Development Services March 2001 - May 2004
Tufts Medical Center June 1999 - June 2000
The Forsyth Institute 1974 - 1997
Education
University of Illinois at Urbana-Champaign 1966 — 1970
B.S., Biology, Chemistry
Harvard Clinical Research Institute September 2008 - Present
BattelleCRO 2005 - 2008
Boston Scientific June 2004 - July 2005
AAI Development Services March 2001 - May 2004
Tufts Medical Center June 1999 - June 2000
The Forsyth Institute 1974 - 1997
Education
University of Illinois at Urbana-Champaign 1966 — 1970
B.S., Biology, Chemistry
Christopher Scannell's AAI Development Services Experience 1993 - 1999
Job CBO at Akrivis Technologies, LLC
Industry Biotechnology
Experience
Akrivis Technologies, LLC December 2012 - Present
Marker Test, Inc September 2009 - November 2012
Singulex March 2005 - March 2009
CuraGen Corporation February 2000 - February 2005
AAI Development Services 1993 - 1999
Education
Northeastern University 1986 — 1988
MBA High Technology
Massachusetts College of Liberal Arts
Bachelor's degree, Biochemistry
Akrivis Technologies, LLC December 2012 - Present
Marker Test, Inc September 2009 - November 2012
Singulex March 2005 - March 2009
CuraGen Corporation February 2000 - February 2005
AAI Development Services 1993 - 1999
Education
Northeastern University 1986 — 1988
MBA High Technology
Massachusetts College of Liberal Arts
Bachelor's degree, Biochemistry
Bob Horning's AAI Development Services Experience 2006 - 2007
Job at H&E Clinical Consulting, LLC
Industry Biotechnology
Experience
H&E Clinical Consulting, LLC June 2010 - Present
Prexera April 2008 - May 2010
North Coast Clincal Lab 2006 - 2008
AAI Development Services 2006 - 2007
IntraLinks 2004 - 2005
Education
The University of Akron 1973 — 1978
BS, Business
H&E Clinical Consulting, LLC June 2010 - Present
Prexera April 2008 - May 2010
North Coast Clincal Lab 2006 - 2008
AAI Development Services 2006 - 2007
IntraLinks 2004 - 2005
Education
The University of Akron 1973 — 1978
BS, Business
Gauri Nagrani's AAI Development Services Experience 2006 - 2006
Job Senior Manager, Clinical Programming (IxRS/ePRO)
Industry Pharmaceuticals
Experience
Chiltern September 2015 - Present
Theorem Clinical Research April 2015 - Present
Theorem Clinical Research September 2012 - Present
Theorem Clinical Research May 2008 - November 2012
AstraZeneca 2006 - 2008
AAI Development Services 2006 - 2006
Skills
Clinical Trials, Pharmaceutical Industry, GCP, CRO, Clinical Development, CTMS, EDC, ICH-GCP, Oncology, Clinical Data Management, 21 CFR Part 11, SOP, Biotechnology, Clinical Research
Education
McGill University
TIPT
Chiltern September 2015 - Present
Theorem Clinical Research April 2015 - Present
Theorem Clinical Research September 2012 - Present
Theorem Clinical Research May 2008 - November 2012
AstraZeneca 2006 - 2008
AAI Development Services 2006 - 2006
Skills
Clinical Trials, Pharmaceutical Industry, GCP, CRO, Clinical Development, CTMS, EDC, ICH-GCP, Oncology, Clinical Data Management, 21 CFR Part 11, SOP, Biotechnology, Clinical Research
Education
McGill University
TIPT
David Gelber's AAI Development Services Experience 2003 - 2005
Job PHARMACEUTICAL MANUFACTURING OPERATIONS PROFESSIONAL
Industry Pharmaceuticals
Experience
Coldstream Laboratories, Inc. 2010 - 2011
Avrio Biopharmaceuticals 2010 - 2010
Galaxe Pharma Sciences 2008 - 2009
Hollister-Stier Laboratories 2005 - 2007
AAI Development Services 2003 - 2005
B. Braun Medical 1997 - 2003
Steris Pharmaceuticals 1994 - 1997
Abbott Laboratories 1985 - 1994
Skills
cGMP, Manufacturing, Scheduling, Operations Management, Aseptic Processing, Aseptic Technique, Budgets, Business Development, CAPA, Change Control, Continuous Improvement, Contract Manufacturing, Cross-functional Team..., Engineering, FDA, GMP, Leadership, Lean Manufacturing, Management, Operational Excellence, Pharmaceutical Industry, Process Improvement, Process Scheduler, Process Simulation, Project Management, Project Planning, Purchasing, Quality Assurance, Regulatory Requirements, Sop, Start-ups, Sterilization, Technology Transfer, Training, V&V, Validation
Education
Mars Hill College
B.S., Biology
Coldstream Laboratories, Inc. 2010 - 2011
Avrio Biopharmaceuticals 2010 - 2010
Galaxe Pharma Sciences 2008 - 2009
Hollister-Stier Laboratories 2005 - 2007
AAI Development Services 2003 - 2005
B. Braun Medical 1997 - 2003
Steris Pharmaceuticals 1994 - 1997
Abbott Laboratories 1985 - 1994
Skills
cGMP, Manufacturing, Scheduling, Operations Management, Aseptic Processing, Aseptic Technique, Budgets, Business Development, CAPA, Change Control, Continuous Improvement, Contract Manufacturing, Cross-functional Team..., Engineering, FDA, GMP, Leadership, Lean Manufacturing, Management, Operational Excellence, Pharmaceutical Industry, Process Improvement, Process Scheduler, Process Simulation, Project Management, Project Planning, Purchasing, Quality Assurance, Regulatory Requirements, Sop, Start-ups, Sterilization, Technology Transfer, Training, V&V, Validation
Education
Mars Hill College
B.S., Biology
Varsha DeWitt's AAI Development Services Experience 2003 - 2004
Job Biotechnology Professional
Industry Biotechnology
susan barth's AAI Development Services Experience September 2002 - November 2004
Job Director at PAREXEL
Industry Pharmaceuticals
Experience
PAREXEL July 2008 - Present
PPD 2004 - 2008
AAI Development Services September 2002 - November 2004
Skills
Clinical Development, CRO, 21 CFR Part 11, Clinical Trials, Drug Development, Oncology, Regulatory Affairs, Biotechnology, CTMS, EDC, Pharmaceutical Industry, SOP
Education
Rochester Institute of Technology
Physics
The George Washington University - School of Business
Masters of Health Administrations
PAREXEL July 2008 - Present
PPD 2004 - 2008
AAI Development Services September 2002 - November 2004
Skills
Clinical Development, CRO, 21 CFR Part 11, Clinical Trials, Drug Development, Oncology, Regulatory Affairs, Biotechnology, CTMS, EDC, Pharmaceutical Industry, SOP
Education
Rochester Institute of Technology
Physics
The George Washington University - School of Business
Masters of Health Administrations