Biovail Technologies
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Biovail Technologies Employees
USDA-ARS November 2006 - Present
Biovail Technologies November 2003 - March 2006
Monsanto November 2002 - June 2003
NanoScale Corporation January 2000 - June 2002
Braun Intertec Corporation February 1997 - June 1999
BHP Petroleum November 1993 - June 1996
Skills
Chemistry, Biotechnology, R&D, HPLC, Analytical Chemistry, PCR, Quantitative Analysis, Microbiology, Molecular Cloning, UV/Vis, Molecular Biology, Chromatography
Education
University of Oregon 1982 — 1986
BS, General Science, Chemistry
Cameron University
Physical Chemistry
United States Pharmacopeia July 2015 - Present
United States Pharmacopeia February 2014 - June 2015
United States Pharmacopeia November 2012 - February 2014
United States Pharmacopeia July 2011 - November 2012
Biovail Technologies March 2007 - June 2011
Biovail Technologies March 2003 - March 2007
Skills
Technology Transfer, GMP, Analytical Chemistry, Sop, FDA, Pharmaceutical Industry, CAPA, V&V, Biotechnology, Laboratory, Drug Development, ANDA, HPLC, Formulation, 21 CFR Part 11, Validation, LC-MS, Regulatory Affairs, GLP, Pharmaceutics, Chemistry, Manufacturing, CMC, Cleaning Validation, Method Development, Dissolution, SOP, Chromatography, IND
Education
University of Madras
Master of Pharmacy (Pharmaceutical Chemistry), Pharmacy, Analytical Chemistry
University of Madras
Bachelor of Pharmacy
U.S. Pharmacopeia November 2011 - Present
Human Genome Sciences October 2006 - November 2011
Biovail Technologies July 2005 - October 2006
Skills
GLP, HPLC, Analytical Chemistry, UV/Vis, GMP, Sop, Biotechnology, Pharmaceutical Industry, Biopharmaceuticals, Monoclonal Antibodies, Chromatography, Protein Chemistry, Formulation, Drug Development
Education
University of Maryland College Park 2003 — 2005
MS, Chemistry
Longwood University 1999 — 2002
BS, Chemistry
U.S. Pharmacopeia January 2013 - Present
U.S. Pharmacopeia February 2011 - January 2013
Biovail Technologies March 2000 - January 2011
Biovail Technologies (formerly Fuisz Technologies) 1998 - 2000
Louisiana State University 1994 - 1995
Virginia Tech 1987 - 1992
Skills
GMP, Sop, CAPA, FDA, Validation, GLP, 21 CFR Part 11, Regulatory Affairs, V&V, Pharmaceutical Industry, Technology Transfer, Quality Assurance, Cleaning Validation, Biopharmaceuticals, Change Control, GxP, Regulatory Submissions, IND, Analytical Method..., LIMS, Analytical Chemistry, Drug Development, HPLC, SOP
Education
Louisiana State University 1982 — 1986
Bachelor of Science
Center for Creative Leadership
Leadership Development Program
FDA 2014 - Present
Focal Pharma Services LLC 2011 - 2014
Biovail 2008 - 2011
Biovail Technologies 2000 - 2007
Fuisz Technologies 1995 - 2000
Sterling Drug 1986 - 1990
Wellby Drugs, Eastern Valley Drugs, Dept of Veterans Affairs 1982 - 1986
Skills
Technology Transfer, FDA, Pharmaceutical Industry, Drug Delivery, Pharmaceutics, Biotechnology, R&D, Regulatory Affairs, Patents, Cross-functional Team..., Formulation, Intellectual Property, ANDA, Product Development, Strategy
Education
University of Texas at Austin 1990 — 1994
Ph.D., Pharmaceutics
University of Alabama at Birmingham 1983 — 1985
M.S., Biomedical Engineering
Albany College of Pharmacy of Union University 1977 — 1982
B.S., Pharmacy
Delaware Academy Central School
Delaware Academy Central School
Teva Pharmaceuticals December 2008 - August 2015
BARR Laboratories August 2002 - December 2008
Biovail Technologies October 2000 - July 2002
Biovail Technologies February 2000 - August 2000
Human Genome Sciences November 1999 - January 2000
Fuisz Technologies August 1998 - June 1999
Fuisz Technologies August 1997 - August 1998
Skills
Manufacturing, GMP, Materials, FDA, SAP, DEA, Pharmaceutical Industry, CAPA, SOP, Change Control, 21 CFR Part 11, Quality Assurance, Quality System, Software Documentation, LIMS, TrackWise, Oracle, Document Management, Incident Investigation, Team Management, Compounding, Tableting, Encapsulation, Batch Records, Solid Oral Dosage Forms
Education
Bridgewater College 1993 — 1997
Bachelor of Science (B.S.), Chemistry
Constellation Brands March 2015 - Present
Mars January 2009 - February 2015
Mars March 2007 - December 2008
Biovail Technologies September 2005 - February 2007
Barr Laboratories March 2004 - May 2005
Warner Lambert June 2000 - August 2001
Warner Lambert June 1999 - August 1999
Skills
HPLC, LC-MS, Method Development, Process Optimization, Instrumentation, Analytical Chemistry, Pharmaceutics, GMP, Dissolution, UV/Vis, NIR spectroscopy, Chemistry, R&D, Sop, Gas Chromatography, Technology Transfer, FTIR, GC-MS, Quality Control, Wet Chemistry, Laboratory, SOP
Education
University of Florida 2006 — 2008
MS, Pharmaceutical Science
University of Portland 1998 — 2002
BS, Chemistry and Music
The Rising Flour, LLC 2009 - Present
Nature's Inner Heath October 2010 - March 2013
Biovail Technologies December 2004 - March 2006
Fisher BioServices August 2002 - November 2004
Skills
HPLC
Education
University of Florida 2004 — 2006
Master's of Pharmaceutical Sciences, Forensic Drug Chemistry
Purdue University 1994 — 1999
Bachelor's of Science, Chemistry and Biochemistry
BioReliance April 2011 - January 2015
Covance Laboratories July 2007 - February 2011
Biovail Technologies October 2005 - December 2006
Baltimore Spice September 2001 - July 2005
Skills
GMP, GLP, Sop, HPLC, Quality Assurance, UV/Vis, Laboratory, Quality Control, Quality System, Six Sigma, Technical Writing, Microbiology, Software Documentation, Analysis, LIMS, LC/MS/MS, Mass Spectrometry, liquid chromatography, Biotechnology, LC-MS, Drug Discovery, CRO, Lifesciences, Titration, Validation, Analytical Chemistry, Chromatography, Toxicology, Life Sciences, SOP
Education
Towson University
Bachelor of Science, Biology, Chemistry
Otsuka Pharmaceutical America December 2012 - Present
Chantilly Biopharma, LLC. April 2011 - May 2012
Biovail Technologies March 1999 - February 2011
Skills
GMP, HPLC, Sop, Technology Transfer, Validation, Analytical Chemistry, FDA, Pharmaceutical Industry, Regulatory Affairs, Quality Control, Research and Development, 21 CFR Part 11, CAPA, Dissolution, SOP
Education
George Mason University 2004 — 2006
Master of Science (MS), Chemistry
U.S. Pharmacopeia January 2015 - Present
U.S. Pharmacopeia April 2013 - December 2014
MedImmune March 2007 - April 2013
Biovail Technologies August 2005 - February 2007
Talecris Biotherapeutics July 2004 - July 2005
Eno River Labs January 2002 - July 2004
Skills
Biotechnology, Project Management, Method Development, Assay Development, Protein Chemistry, Biopharmaceuticals, Monoclonal Antibodies, HPLC, GMP, GLP, Mass Spectrometry, CMC, CRO, Glycosylation, Method Transfer, Protein Sequencing, Gas Chromatography, Dissolution, Spectrophotometry
Education
The Johns Hopkins University 2009 — 2011
MS, Biotechnology
University of North Carolina at Chapel Hill 1997 — 2001
BS, Biology
Lou Who Heating & Air Conditioning ownerLou Who Contracting, IncMarch 2005 - Present
Biovail Technologies March 2000 - March 2005
Saab AB February 1999 - March 2000
Color Me Beautiful May 1991 - October 1999
Education
Old Dominion University 1977 — 1979
Biology, general
PA Consulting Group July 2015 - Present
Massanutten Consulting Services, LLC August 2012 - Present
Valeant Pharmaceuticals October 2010 - March 2012
Biovail Technologies August 2009 - October 2010
Intranasal Therapeutics, Inc. March 2008 - August 2009
sanofi-aventis July 2007 - March 2008
Kos Pharmaceuticals August 2005 - July 2007
Vela April 2005 - August 2005
Johnson & Johnson Pharm R&D October 1995 - May 2005
Bristol-Myers Squibb September 1984 - October 1995
Skills
Clinical Development, IND, NDA, Clinical Trials, Biotechnology, eCTD, Technology Transfer, Regulatory Submissions, GMP, CMC, Sop, Biopharmaceuticals, Pharmacovigilance, Regulatory Requirements, GLP, Pharmaceutics, HPLC, Drug Delivery, Strategy
Education
Louisiana State University 1976 — 1981
PhD
Wofford College
U.S. Pharmacopeia November 2013 - Present
Fairfax Court Appointed Special Advocates (CASA), Inc. January 2008 - Present
HCI integrated solutions April 2013 - November 2013
Freelance August 2012 - December 2012
ICF International January 2011 - September 2011
Biovail Technologies June 2007 - December 2010
Skills
Research, Report Writing, Government, Policy, Public Administration, Child Welfare, Justice, Qualitative Research, Community Outreach, Analysis, Microsoft Word, PowerPoint, Microsoft Excel, Program Development, Grants, Non-profits, Public Policy, Policy Analysis, Budgets, Program Evaluation, Nonprofits, Social Services, Program Management
Education
George Mason University 2009 — 2012
MPA, Policy Studies
George Mason University 2005 — 2007
B.A., Government and International Politics
MedGenesis Therapeutix January 2011 - Present
Biovail Technologies May 2010 - January 2011
Medarex September 2003 - May 2010
Medarex December 2002 - September 2003
Amarin Corporation March 2001 - November 2002
Pfizer September 1998 - March 2001
Warner Lambert May 1997 - August 1998
Warner Lambert April 1993 - April 1997
Ciba-Geigy November 1991 - March 1993
Croda June 1991 - November 1991
Skills
CMO Management, Technology Transfer, Biotechnology
Education
Rutgers University-New Brunswick 1992 — 1996
MS, Chemistry
St. Francis University 1987 — 1991
BS, Chemistry
Sandoz April 2014 - Present
Sandoz May 2011 - March 2014
Glatt Air Techniques March 2008 - April 2011
Omsetech Molecular Diagnostics 2007 - 2008
Biovail Technologies 2003 - 2007
Therics Inc 1997 - 2003
Skills
cGMP, Granulation, Formulation Development, Process Development, Product Development, Process Improvement, Excel, Word, Medical Devices, GMP, PowerPoint, Design of Experiments, SOP, R&D, Formulation, Sop, GLP, Quality System, Process Simulation, ISO 13485, Process Engineering, Quality Control, Validation, Regulatory Affairs, Manufacturing, Microsoft Excel, 21 CFR Part 11, Microsoft Word, Drug Delivery, Change Control, Pharmaceutics, Quality Assurance, FDA, LIMS, Lean Manufacturing, Design Control, Biopharmaceuticals, Pharmaceutical Industry, CAPA, Technology Transfer, Cleaning Validation, Biotechnology, Quality by Design, Contract Manufacturing, GxP, Trackwise, Minitab, Root Cause Analysis, Drug Development, cGMP practices
Education
Lehigh University 1990 — 1994
Bachelors, Industrial Engineer
George School 1986 — 1990
High School/Secondary Diplomas and Certificates
Catamaran December 2012 - May 2015
Ipsen August 2008 - December 2012
Solstice Neurosciences 2008 - 2008
Barrier Therapeutics 2007 - 2008
Biovail Technologies 2004 - 2007
King Pharmaceuticals 1998 - 2004
Elan 1998 - 2004
Dura Pharmaceuticals 1998 - 2004
SPEX CertiPrep 1990 - 1998
Skills
Buy & Bill, Injectable, Toxins, Neurology, Physical Medicine, Pain Management, Rheumatology, Dermatology, OB/GYN, Orthopedics, Hepatitis C, Specialty Pharmaceutical, Customer-focused, Pharmaceutical Sales, Managed Care, Cardiology, Diabetes, Orthopedic, Psychiatry, Selling Skills, Hospital Sales, Sales Effectiveness, Osteoporosis, Product Launch, Pharmaceutical Industry, Endocrinology, Pulmonology, Oncology, Allergy, Medical Devices, Gastroenterology, Hypertension, Infectious Diseases, Sales Force Development, Urology, Nephrology, Biotechnology, ENT, Therapeutic Areas, Infection, Sales, Neuroscience, KOL development
Education
Rutgers, The State University of New Jersey-New Brunswick 1986 — 1990
BA, Biology & Psychology
Wayne Hills High School 1982 — 1986
HS diploma, Academic
Shire Specialty Pharmaceuticals March 2011 - Present
Biovail Technologies February 2009 - January 2011
Biovail January 2006 - February 2009
Innocoll Technologies Ltd 2003 - 2005
Cardinal Health 2000 - 2003
Fuisz 1996 - 2000
Skills
Technology Transfer, Pharmaceutical Industry, Cross-functional Team..., Formulation, R&D, Six Sigma, Pharmaceutics, Process Improvement, Product Development, Program Management, Project Management, Manufacturing, GMP, CMC, FDA, Validation, Sop, Regulatory Affairs, GLP, Drug Development, CAPA, Biopharmaceuticals, SOP
Education
Villanova University 2010 — 2011
Master's Certificate in Lean Six Sigma (& LSS Black Belt)
Project Management Institute 2009 — 2009
PMP, Project Management Professional
University College Dublin 1993 — 1995
MSc
Dublin Institute of Technology 1992 — 1992
Graduateship of the Royal Society of Chemistry, Chemistry
University College Dublin 1988 — 1991
BSc, Chemistry, Math, Physics
Synge Street 1983 — 1988
Water Jel technologies February 2015 - Present
LTS - Lohmann Therapy Systems February 2014 - February 2015
SGS January 2012 - July 2013
Chantilly Biopharma LLC July 2011 - December 2011
Biovail Technologies May 2005 - January 2011
Baxter BioScience September 2001 - February 2005
Education
Lincoln University 1996 — 2000
B.S., Chemistry
Atrium Medical/Maquet Getinge Group December 2013 - Present
Teleflex Medical March 2013 - December 2013
Genzyme January 2009 - March 2013
Various Compannies as a Senior Validation Consultant 1985 - 2010
Teleflex Medical 2008 - 2009
Biovail Technologies 2008 - 2009
Bristol-Myers Squibb 2008 - 2008
Genetech San Fransico 2006 - 2006
Genetech San Fransico 2006 - 2006
Cordis 2006 - 2006
Skills
21 CFR Part 11, Validation, CAPA, GAMP, V&V, GMP, Cleaning Validation, ISO 13485, Sterilization, Quality Assurance, GxP, FDA, Change Control, Sop, Regulatory Affairs, Quality Management, Pharmaceutical Industry, Quality Auditing, Quality System, Medical Devices, Biopharmaceuticals, LIMS, GLP, Lifesciences, Biotechnology, Regulatory Requirements, Aseptic Processing, Technology Transfer, Process Simulation, R&D, Quality Control, Software Documentation, Design Control, Calibration, Document Management, HPLC, MES, GCP, Trackwise, Analytical Chemistry, Laboratory, Regulatory Submissions, SOP, TrackWise
Education
Colorado Technical University 2008 — 2009
ABS, Software engineer
Informa January 2014 - Present
Elsevier Business Intelligence September 2012 - December 2013
Elsevier Business Intelligence September 2008 - September 2012
"The Gray Sheet" March 2006 - August 2008
"The Gray Sheet" January 2005 - March 2006
American Chemical Society 2000 - 2004
Biovail Technologies 2000 - 2000
Skills
Editing, Regulations, Copy Editing, Creative Writing, Publications, Journalism, Proofreading, Content Development, Editorial, Publishing, Content Management, Magazines, Storytelling, Web Content, Copywriting, Blogging, Newsletters, Content Strategy, Online Publishing, Academic Publishing, Press Releases, Digital Media, Strategic Communications, Email Marketing, Feature Articles
Education
University of Rochester 1995 — 1999
B.S., Chemistry
CRIWW December 2010 - Present
NMS Neuro Consulting 2003 - Present
Biovail August 2008 - June 2010
Biovail Technologies 2008 - 2010
Kyowa Pharmaceutical Inc. April 2004 - June 2008
Kyowa 2004 - 2008
NMS NEURO CONSULTING, LLC 2003 - 2008
PRA Intl February 2000 - June 2003
Forest Laboratories February 1999 - February 2000
Bristol-Myers Squibb April 1995 - January 1999
Skills
Neurology, Clinical Development, Pain, Clinical Trials, Clinical, Psychiatry, Pain Management, Clinical Research
Education
University of Minnesota Medical School 1978 — 1979
Epilepsy and EEG
Thomas Jefferson University 1974 — 1977
Neurology
New York Medical College 1968 — 1972
MD
MedImmune October 2008 - Present
Angiotech February 2006 - June 2008
Ascend Therapeutics November 2003 - February 2006
Biovail Technologies April 2001 - November 2003
Covance 1996 - 2000
Skills
FDA, IND, Pharmaceutical Industry, Biotechnology, Regulatory Submissions, Clinical Trials, Regulatory Affairs, Medical Devices, Oncology, Clinical Development, GLP, Drug Development, Clinical Research, NDA, CRO
Education
Virginia Polytechnic Institute and State University 1990 — 1994
Animal Science, Biology, Chemistry
Hood College
Professional Certificate, Regulatory Affairs
The Catholic University of America August 2015 - Present
Johns Hopkins Bloomberg School of Public Health August 2009 - August 2015
University of Nebraska Medical Center December 2007 - July 2009
Northwestern University 2003 - 2009
Biovail Technologies June 2001 - June 2002
Skills
Lifesciences, Confocal Microscopy, Immunohistochemistry, Western Blotting, Biochemistry, Cell Biology, Fluorescence Microscopy, Research, Molecular Cloning, Molecular Biology, Epidemiology, Protein Chemistry, PCR, Protein Purification, Animal Models, Infectious Diseases, Cell Culture, Cell, RT-PCR, Cancer, Protein Expression, Genetics
Education
Northwestern University 2003 — 2009
University of Virginia 1998 — 2001
B.S., Biochemistry
Siius XM Radio Inc. August 2012 - Present
Sirius XM Radio January 2007 - August 2012
XM Satellite Radio May 2006 - August 2012
CarrAmerica April 2004 - April 2006
Biovail Technologies July 2000 - April 2004
Kearney & Company July 1999 - July 2000
Skills
Sarbanes-Oxley Act, Accounting, GAAP, Financial Analysis, General Ledger, Internal Controls, Variance Analysis, Hyperion Enterprise, US GAAP, Revenue Recognition, Essbase, Financial Accounting
Education
Bowie State University 1995 — 1999
BS, Business Administration with a concentration in Accounting
Ophthotech April 2015 - Present
CHDI April 2013 - March 2015
Ipsen Biopharmaceuticals February 2012 - March 2013
Lexicon Pharmaceuticals March 2011 - April 2012
Biovail Technologies July 2009 - October 2010
Genmab, inc. January 2008 - November 2008
Skills
CTMS, Clinical Trials, Oncology, CRO, GCP, Biotechnology, Pharmaceutical Industry, Clinical Research, Sop, EDC, Clinical Monitoring, ICH-GCP, Neurology, Drug Development, Regulatory Submissions
Education
Temple University 2004 — 2008
M.S., QA/RA
The College of New Jersey 1982 — 1984
B.S., Biology
Charles E. Ellis School 1969 — 1975
Cerecor Inc. 2014 - Present
Cerecor Inc. 2012 - 2014
Chantilly Biopharma LLC. 2011 - 2011
Biovail Technologies 2006 - 2011
Biovail Technologies 2002 - 2006
Biovail 1999 - 2002
Fuisz Technologies 1998 - 1999
Fuisz Technologies 1995 - 1997
Education
Algerian Institute of Petroleum
Bachelor of Engineering-Chemical
Stevens Institute of Technology
Master, Engineering-Chemical
VenKor Specialty Products LLC (venkorsp) June 2012 - Present
caprciorn pharma inc. 2000 - 2013
Biovail Technologies 2000 - 2012
Skills
FDA, Regulatory Submissions, Pharmaceutical Industry, Sop, Regulatory Requirements, Technology Transfer, Quality System, Drug Delivery, Biotechnology, Medical Devices, GMP, Validation, Regulatory Affairs, Commercialization, Biopharmaceuticals, Licensing, Quality Assurance, Pharmaceutics, V&V, Change Control, Strategy, CAPA, CRO, R&D, HPLC, Drug Development, GLP, Analytical Chemistry, Formulation, Chromatography, 21 CFR Part 11, Clinical Development, Drug Discovery, Clinical Trials, ANDA, Vaccines
Education
University of Pennsylvania - The Wharton School 1976 — 1978
Master of Business Administration (M.B.A.), Business and Finance
School Of Pharmacy, Andhra University, Vizag, India 1965 — 1966
M.S., Pharmaceutics
Collegium Pharmaceutical, Inc. June 2015 - Present
Durata Therapeutics August 2013 - June 2015
Seaside Therapeutics 2012 - 2013
Vertex Pharmaceuticals April 2009 - November 2011
Bausch & Lomb March 2006 - April 2009
Biovail 2003 - 2006
Biovail Technologies 2003 - 2006
Solvay Pharmaceuticals 1999 - 2001
Zeneca 1992 - 1999
Boehringer Ingelheim Pharmaceuticals 1991 - 1992
Skills
Pharmaceutical Industry, Regulatory Affairs, IND, Clinical Development, Drug Development, Biotechnology, FDA, R&D, Quality Assurance, Regulatory Submissions, GMP, GxP, Validation, CAPA, Biopharmaceuticals, Clinical Trials, Medical Devices, Regulations, GLP, GCP, 21 CFR Part 11, Technology Transfer, Oncology, CRO, Lifesciences, Drug Discovery, Sop, Pharmacovigilance, Medical Affairs
Education
The Ohio State University 1971 — 1975
PhD, Physiology
Saint Lawrence University 1966 — 1970
BS
Celgene June 2014 - Present
Celgene April 2013 - May 2014
APCER PHARMA September 2012 - April 2013
APCER PHARMA April 2011 - September 2012
Biovail Technologies 2009 - October 2010
Bristol-Myers Squibb 2007 - 2009
Pathmark Pharmacy 2007 - 2008
Skills
Medical Affairs, Pharmacovigilance, Pharmacists, Pharmaceutical Industry, Medical Writing, Healthcare, Pharmacy, Therapeutic Areas, Medical Communications, Oncology, Clinical Trials, Drug Safety, Pharmaceutics, Clinical Development, Regulatory Affairs
Education
Rutgers University-New Brunswick
PharmD, Pharmacy
inVentiv Health Clinical July 2009 - Present
PharmaNet Development Group, Inc. April 2006 - July 2008
Biovail Technologies January 2005 - April 2006
Skills
Contract Management, Business Development, Management, Mergers & Acquisitions, Negotiation, Team Building, Risk Management, Cross-functional Team..., Pharmaceutical Industry, Clinical Trials, Clinical Research, Contract Negotiation, Vendor Management
Education
Fairleigh Dickinson University-Florham Campus 1997 — 1999
MBA, Pharmaceutical Studies
Long Island University, Southampton Campus 1990 — 1994
BS, Enviromental Science
DBKE, llc (retail/office shopping center) March 2008 - Present
ERC (automative cleaning industry) March 2008 - Present
Fairfax County Government September 2007 - February 2008
Biovail Technologies January 2002 - October 2005
Lab Support, a division of On Assignment July 2001 - December 2001
Skills
Management, Maintenance, Supervising Personnel, Auditing, Customer Service, Inventory Management, Research, Writing, Public Relations, Public Speaking, Teaching, English, Microsoft Office, Word, PowerPoint, Excel, SAS, Quality Assurance, 21 CFR Part 11, FDA, Regulatory Affairs, GLP, Validation
Education
Institute for Integrative Nutrition 2015 — 2016
health coaching
George Mason University 2007 — 2010
MS, Bioinformatics and Computational Biology
Virginia Tech 1997 — 2001
BA, Chemistry
Lou Who Contracting, Inc December 2003 - Present
Biovail Technologies April 2000 - March 2005
Saab Avitronics March 1999 - March 2000
Color Me Beautiful March 1994 - December 1999
Education
Northern Virginia Community College