Alliance Pharmaceuticals
Industry: Pharmaceutical company
DescriptionHeadquarters: United Kingdom Founded: 1996 Subsidiaries: Cambridge Laboratories Limited, Unigreg Limited,
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Alliance Pharmaceuticals Employees
Thermo Fisher Scientific August 2012 - Present
Full Spectrum Analytics March 2009 - August 2012
Amylin Pharmaceuticals Inc March 2007 - November 2008
Abbott Laboratories December 2006 - March 2007
Ligand Pharmaceuticals 1999 - 2006
Alliance Pharmaceuticals February 1998 - September 1999
DepoTech 1996 - 1998
Allergan September 1995 - February 1996
Lederle Labs August 1992 - March 1995
Skills
Analytical Chemistry, HPLC, GxP, Laboratory, UV/Vis, Project Management, Gas Chromatography, Biotechnology, Pharmaceutical Industry, GMP, Validation, Lifesciences, Drug Discovery, GLP, Ion Chromatography, Dissolution, Mass Spectrometry, TOC, Quality Assurance, Quality Control, LC-MS, Chromatography, Purification, LIMS, Sop
Education
Rutgers, The State University of New Jersey-New Brunswick 1985 — 1989
Bachelor's of Science, Biological and Physical Sciences
Suffern High School 1980 — 1984
Diploma
Celgene October 2006 - December 2014
UCSD February 1998 - October 2006
Alliance Pharmaceuticals February 1996 - April 1998
Skills
GMP, Sop, Regulatory Affairs, Quality System, Biochemistry, Regulatory Requirements, Quality Assurance, Cross-functional Team..., Quality Auditing, EHS, CRO, R&D, Laboratory Management...
Education
Cal State San Marcos 1990 — 1993
Bachelor of Science (BS), Molecular Biology
MiraCosta College 1986 — 1990
Associate of Arts and Sciences (AAS), Biology, General
Avanir Pharmaceuticals June 2015 - Present
Allergan August 2006 - June 2015
Allergan August 2006 - February 2011
MDS Pharma Services July 2001 - August 2006
Alliance Pharmaceuticals February 2000 - June 2001
Skills
CTMS, Clinical Trials, Clinical Development, Neurology, Oncology, Clinical Data Management, EDC, Clinical Monitoring, Clinical Research, GCP, IRB, ICH-GCP, FDA, Diabetes, Regulatory Submissions, Urology, Pediatric Neurology, Pharmaceutical Industry
Education
Porterville College 1995 — 1997
AS, Biological and Physical Sciences
Porterville College
Associate of Science (A.S.), Biological and Physical Sciences
Bristol-Myers Squibb Director Regulatory AffairsBristol-Myers SquibbJanuary 2013 - Present
Bristol-Myers Squibb November 2010 - Present
sanofi-aventis April 2004 - November 2010
Alliance Pharmaceuticals July 1996 - August 2002
Johnson & Johnson August 1987 - August 1990
Skills
Biotechnology, Clinical Development, Drug Development, Regulatory Affairs, Pharmaceutical Industry, Oncology, Clinical Trials, GCP, Regulatory Submissions, FDA, SOP
Education
University of Virginia 1995 — 1996
Post Doctoral Fellowship, Molecular Physiology
Johns Hopkins University 1990 — 1995
Doctor of Philosophy (Ph.D.), Physiology
Chestnut Hill College
Bachelor of Science (BS), Biology
Targeson Inc January 2009 - Present
Alliance Pharmaceuticals September 2005 - December 2008
IMCOR Pharmaceutical January 2003 - September 2005
Orthoconcept Inc 1996 - 2000
Skills
Biotechnology
Education
Fairleigh Dickinson University
MBA, Business
Fairleigh Dickinson University
MS, Finance
Stephen F. Austin State University
BS, Marine biology
Eclipse Aesthetics International, LLC. March 2014 - Present
VIAS Partners LLC 2013 - Present
Aesthetic Factors, LLC 2010 - 2013
Garnet BioTherapeutics, Inc. 2010 - 2010
Johnson & Johnson 2005 - 2010
Centocor 2001 - 2004
Bracco Diagnostics 1997 - 2001
Alliance Pharmaceuticals 1993 - 1997
Education
1992 — 1993
Postdoctoral Fellow, Anatomy, Histology
Hokkaido University 1991 — 1992
Postdoctoral Fellow, Cardiology
University of Ottawa 1987 — 1991
Ph.D., Medical Physiology
University of Ottawa 1982 — 1986
B.Sc., Kinanthropology
Confederation High School 1978 — 1983
High School
bioMerieux October 2012 - July 2014
Sequence, Inc. April 2011 - October 2012
Biogen Idec August 2009 - November 2010
Biogen Idec April 2005 - August 2009
Idec Pharmaceuticals December 2000 - March 2005
Alliance Pharmaceuticals April 1999 - December 2000
Alliance Pharmaceuticals April 1999 - December 2000
Adria-Sterile Products/Pharmacia Inc. January 1992 - February 1995
Skills
Environmental Monitoring, Contamination Control, Six Sigma, Lean Manufacturing, Risk Assessment, LIMS, Microbiology, Biopharmaceuticals, QC, cGMP, Validation, GMP, Quality Systems, FDA, Pharmaceuticals, Biotechnology, Quality Assurance, Compliance, 21 CFR Part 11, CAPA, Change Control, Pharmaceutical Industry, Quality Control, Quality System, SOP, Sop, V
Education
Webster University 1992 — 1994
Master of Arts (M.A.), Management
Webster University 1992 — 1994
Master of Arts (M.A.), Computer Resources Management
Colorado State University 1987 — 1991
Bachelor of Science (BS), Biology/Biological Sciences, General
Norris Technical Writing Services 2011 - Present
LFB USA April 2015 - August 2015
Synta Pharmaceuticals 2012 - 2015
Genzyme 2004 - 2011
Ilex Oncology 2002 - 2004
ILEX Oncology, Inc. 2001 - 2002
Alliance Pharmaceuticals 2000 - 2001
Quintiles Consulting 1998 - 2000
Quintiles 1995 - 1998
Quintiles 1992 - 1995
Skills
Technical Writing, Writing, Medical Writing, Oncology, Clinical Development, Clinical Trials, Biotechnology, CRO, Regulatory Submissions, Pharmaceutical Industry, CTMS, Clinical Research, Regulatory Affairs, GCP, Protocol, FDA, Drug Development, Sop, Clinical Study Design, Infectious Diseases, Biopharmaceuticals, Therapeutic Areas, Neurology, Pharmaceutics, Lifesciences, 21 CFR Part 11, Immunology, Cancer, Drug Discovery, SOP, Life Sciences
Education
The University of Texas at Austin
BA, Psychology, Spanish
Intellect, formerly Interneer Inc. July 2000 - Present
South Bay Crest HOA June 2009 - December 2011
WWWID LLC September 1999 - June 2000
Synerdyne August 1997 - August 1999
stockjungle 1999 - 1999
alliance pharmaceuticals 1994 - 1995
Skills
Product Management, Enterprise Software, Strategy, Product Development, Business Development, Management Consulting, Entrepreneurship, Outsourcing, Project Management, Executive Management, International Sales, Marketing, Start-ups, IT Strategy, Competitive Analysis, SaaS, Strategic Partnerships, Cloud Computing, Solution Selling, Mergers & Acquisitions, Business Strategy, Program Management, Sales, Leadership, White Papers, Networking, Business Planning, Business Analysis, Integration, New Business Development, Consulting, Business Process..., Business Intelligence, Requirements Management, Selling, Business Process..., Sales Management, Strategic Planning, Team Leadership, Cross-functional Team..., Team Building, Manufacturing, Process Improvement
Education
UCLA 1995 — 1997
MS
University of California, San Diego 1992 — 1995
BS
Orange Coast College 1990 — 1992
College De La Salle
Highschool
Aptalis August 2013 - Present
Alliance Pharmaceuticals May 2012 - June 2013
Counsyl Bio-Technology May 2011 - March 2012
Pfizer Pharmaceuticals February 2000 - March 2011
Pfizer (Parke-Davis Merger) 1996 - 2000
Pfizer ( Parke-Davis Merger) 1993 - 1996
Pfizer (Parke-Davis Merger) 1990 - 1993
Skills
Contract Negotiations, Managed Care, GPO, Pharmaceutical Sales, Gastroenterology, Urology, Healthcare, Pharmaceutical Industry, Contract Negotiation, Clinical Research, Cross-functional Team..., Strategy, Endocrinology, Cardiology, Oncology, Neurology, Sales Effectiveness, Selling Skills, Rheumatology, Group Policy, Diabetes, Product Launch, Pulmonology, Sales Force Development, Medical Devices, Infectious Diseases, Sales
Education
Skidmore College
BA, Political Science and Biology
The University of Texas at Austin
Science, Biology
Stemcentrx, Inc. February 2010 - Present
Biogen Idec July 1999 - May 2008
Alliance Pharmaceuticals June 1995 - July 1999
Poms, Smith, Lande and Rose January 1993 - September 1994
Skills
Patents, Intellectual Property, Licensing, Prosecution, Technology Transfer, Patent Litigation, Corporate Law, Trademarks, Biotechnology, Patent Prosecution, Due Diligence, Pharmaceutical Industry, Legal Writing, Trade Secrets, Medical Devices, Clinical Development, Lifesciences, Drug Discovery, Biopharmaceuticals, Life Sciences
Education
California Western School of Law 1989 — 1992
JD, Law
University of California, San Diego 1980 — 1985
Bachelors, Chemistry
Seattle Genetics July 2009 - March 2013
Seattle Genetics April 2007 - July 2009
Fred Hutchinson Cancer Research Center 2001 - 2007
Omnigon 2000 - 2001
University of California, Santa Cruz 1995 - 2000
Alliance Pharmaceuticals 1993 - 1995
Alliance Pharmaceuticals 1993 - 1995
Education
University of California, Santa Cruz 1995 — 2000
Molecular, Cellular and Developmental Biology, RNA structure and Function
University of California, San Diego 1991 — 1995
B.S., Molecular Biology
SCHS
Profectus Pharma Consulting Inc 2009 - Present
FibroGen July 2008 - Present
Angiotech Pharmaceuticals 2005 - 2007
POINT Biomedical Corp. 2003 - 2005
Galileo Pharmaceuticals Inc 1999 - 2002
Alliance Pharmaceuticals 1992 - 1999
Education
Columbia University College of Physicians and Surgeons 1987 — 1989
PostDoc, Pharmacology
Cornell University 1981 — 1988
PhD, Pharmacology
Barnard College (Columbia University) 1979 — 1981
BS, Biology
Lycee Francais
Revision One 1996 - Present
Access Communications LLC 2008 - 2010
Access Communications LLC 2007 - 2008
DF Wines, Inc. 1999 - 2003
Alliance Pharmaceuticals 1997 - 1999
Science Applications International Corporation 1988 - 1997
Skills
Editing, Copy Editing, Proofreading, Web Content, Copywriting, Technical Writing, Marketing Communications, Freelance Writing, Corporate Communications, Feature Articles, Medical Writing, Fact-checking, Magazine Articles, Books, Content Development, Content Management, Creative Writing, Editorial, Leadership, Marketing, Newsletters, Proposal Writing, Publications, Publishing, Research, Social Media
Education
Colorado State University 1982 — 1986
BS, Chemical Engineering
University of California, San Diego
Specialized Certificate, Copyediting
P Boncer Consulting December 2013 - Present
Shire Pharmaceuticals January 2013 - December 2013
P Boncer Consulting May 1999 - December 2012
PSC Biotech 2011 - 2012
ProPharma Group 2010 - 2011
ISPE 2002 - 2006
Alliance Pharmaceuticals January 1992 - April 1999
Skills
European Union, Analytical Chemistry, Pharmaceutical Industry, Validation, Medical Devices, Environmental Monitoring, Engineering, Sop, Technology Transfer, Pharmaceutics, Quality Assurance, GMP, FDA, 21 CFR Part 11, Regulatory Affairs, ISO 13485, Quality System, CAPA, Aseptic Processing, Lifesciences, Clinical Trials, R&D, Biopharmaceuticals, Computer System..., GAMP, LIMS, Root Cause Analysis, Vaccines, Cleaning Validation, GxP, V&V, Change Control, Chromatography, Quality Auditing, Design Control, Process Engineering, Document Management, HPLC, Quality Control, Microbiology, Biotechnology, Regulatory Submissions, Manufacturing, Quality Management, Cross-functional Team..., Process Simulation, Regulatory Requirements, GLP, GCP, SOP
Education
University of California, Santa Barbara 1981 — 1986
BA, Geology
ProTrials Research October 2014 - Present
Replenish Inc January 2011 - July 2014
Vitreoretinal Technologies, Inc November 2007 - February 2010
Allergan, Inc May 2005 - October 2007
Prometheus Labs August 2001 - April 2004
ISTA Pharmaceuticals May 1999 - March 2004
Omnicare / IBAH May 1997 - December 1999
Alliance Pharmaceuticals January 1989 - December 1997
Newport Pharmaceuticals International January 1987 - December 1989
Edwards Lifesciences (Baxter) January 1985 - December 1987
Skills
Ophthalmology, Clinical Research..., Medical Devices, Pharmaceutials, Intravitreal Products, GXP Auditing, GCP, CRO, Clinical Trials, GxP, Biotechnology, Pharmaceutical Industry, Clinical Research, Regulatory Submissions, Regulatory Affairs, Oncology, Clinical Operations, Diabetes, Hematology
Education
Pepperdine University, The George L. Graziadio School of Business and Management 1980 — 1982
MBA
California State University-Fullerton 1968 — 1974
BA, Biological Sciences
American Peptide Company September 2008 - Present
American Peptide Company April 2007 - September 2008
N/A December 2005 - March 2007
Santarus, Inc November 2002 - December 2005
Advanced Tissue Sciences February 2002 - October 2002
Alliance Pharmaceuticals February 1998 - January 2002
Chemical Waste Management February 1994 - February 1998
Beckman Instruments June 1992 - September 1993
Skills
Sales Management, Product Development, Market Research, Management, Cross-functional Team..., Market Analysis, Manufacturing, New Business Development, HPLC, Chromatography, Regulatory Affairs, Quality System, Protein Chemistry, Product Launch, LC-MS, Drug Discovery, Sop, Medical Devices, Purification, Life Sciences, SOP, Biotechnology, Biochemistry, Biopharmaceuticals
Education
University of California, Irvine 1988 — 1991
BS, Biological Sciences
University of California San Diego Extension Courses 2000 — 2013
Porterville High School 1982 — 1986
Receptos, Inc. 2014 - Present
Santarus, Inc. 2002 - 2014
Alliance Pharmaceuticals 2001 - 2002
Dura Pharmaceuticals 1995 - 2001
SRI International 1993 - 1995
Skills
Pharmaceutical Industry, Product Development, Technology Transfer, GMP, Validation, FDA, Process Engineering, Supply Chain, Cross-functional Team..., Product Launch, CMC
Education
San Diego State University-California State University
Master of Business Administration (MBA)
Brigham Young University
Bachelor's degree, Chemical Engineering
Titan Buildings Services January 2011 - Present
Mayo Clinic March 2007 - December 2010
All Children's Hospital 2001 - 2007
Alliance Pharmaceuticals June 1992 - June 2000
ISPE 1990 - 2000
Skills
Operations Management, Strategic Planning, Facilities Management, Contract Negotiation, Project Management, Contract Management, Process Improvement, Team Building, Process Scheduler, Inventory Management, Quality Management, Budgets, Customer Service, Customer Satisfaction, Vendor Management, Cross-functional Team..., Project Planning, Change Management, MS Project, Continuous Improvement, Team Leadership, Engineering, Leadership, Negotiation, Program Management, Manufacturing, Management, Software Documentation, Employee Relations, Procurement, Healthcare, Construction Management, Purchasing, Quality Assurance, Training, Construction, PowerPoint, Supervisory Skills, GMP, Energy Management, Preventive Maintenance, Electricians, FDA, Biotechnology, Maintenance & Repair, Quality System, HVAC, SOP, Validation, Maintenance Management
Education
University of California, San Diego 1998 — 2002
St. Augustine Vocational Inistute 1980 — 1982
Plumbing & Pipefitting, Construction Engineering
* September 2009 - Present
* September 2009 - Present
Ardelyx, Inc. January 2013 - April 2015
FibroGen November 2002 - September 2009
Galileo Pharmaceuticals December 1999 - October 2002
Alliance Pharmaceuticals July 1998 - December 1999
Skills
Anemia, Drug Development, Drug Discovery, Pharmacology, Inflammation, Clinical Development, Lifesciences, Biotechnology, GLP, Pharmaceutical Industry, FDA, Sop, Veterinary Medicine, Physiology, Biopharmaceuticals, Veterinary, Immunology, SOP, Life Sciences
Education
Kansas State University
PhD
Kansas State University College of Veterinary Medicine
DVM
Options
University of Minnesota-Twin Cities
Genentech August 2005 - Present
Biogen Idec 2003 - 2004
IDEC 2001 - 2003
Alliance Pharmaceuticals 1997 - 2001
Skills
Quality Control, FDA, Biotechnology, Change Control, Sop, GMP, LIMS, Validation, Bioassay, real-time PCR, PCR, Technology Transfer, ELISA, Trackwise, Monoclonal Antibodies, Chromatography, Biochemistry, 21 CFR Part 11, Aseptic Technique, HPLC, Microbiology, Laboratory
Education
San Diego State University-California State University 1994 — 1998
B.S., Biology
ACADIA Pharmaceuticals Inc. January 2015 - Present
ACADIA Pharmaceuticals June 2012 - December 2014
Pharmaceutical companies July 2007 - May 2012
i3 Statprobe September 2005 - July 2007
ProSanos Corporation March 2004 - September 2005
Agouron Pharmaceutical / Pfizer April 1998 - March 2004
Alliance Pharmaceuticals September 1997 - April 1998
Biogen Idec November 1995 - September 1997
Skills
Biostatistics, Clinical Trials, Clinical Research, CRO, Clinical Development, Statistics, SAS programming, Drug Development, Pharmaceutical Industry
Education
San Diego State University-California State University 1993 — 1995
MPH, Biostatistics
University of California, Los Angeles - Fielding School of Public Health 1989 — 1991
National Taiwan University 1985 — 1989
BS, Agriculture
Intuit December 2013 - Present
Websense April 2007 - December 2013
Elan Pharmaceuticals November 2002 - July 2007
Alliance Pharmaceuticals September 1998 - November 2002
Skills
Software Development, Integration, Linux, Business Intelligence, SaaS, Microsoft SQL Server, Cloud Computing, SQL, Network Security, IT Management, SharePoint, Virtualization, Enterprise Software, IT Strategy, Cisco Technologies, Disaster Recovery, Security, Data Center, Team Leadership, Information Security, VMware, Unix, Firewalls, TCP/IP, Enterprise Architecture
Education
University of California, San Diego
Applied Mathematics
ICON Clinical Research December 2011 - Present
ICON Clinical Research April 2009 - December 2011
ICON Clinical Research September 2005 - April 2009
SCIREX Corporation March 1999 - September 2005
Alliance Pharmaceuticals July 1998 - March 1999
Quintiles January 1992 - July 1998
Education
Lehigh University
MS, Psychology
SDSU
BA, Psychology
eFFECTOR Therapeutics 2014 - Present
Samumed 2013 - Present
Aires Pharmaceuticals, Inc. 2010 - 2013
Ambit Biosciences 2009 - 2013
Aragon Pharmaceuticals, Inc. 2009 - 2010
Kalypsys 2007 - 2009
Pfizer Global R&D 2003 - 2007
Agouron Pharmaceuticals 1999 - 2003
Alliance Pharmaceuticals 1997 - 1999
DepoTech Corporation 1992 - 1997
Skills
Toxicology Operations, Toxicology, Drug Discovery, Drug Development, Pharmaceutical Industry, Preclinical, Nonclinical, Investigational New..., IND, New Drug Applications, NDA, Oncology, Ophthalmology, Diabetes, Pain, FDA, GLP, Clinical Research..., CROs, Quality Control, Clinical Development, Biotechnology, QC Documents, Life Sciences, Biopharmaceuticals, Pharmacology, Lifesciences, Clinical Trials
Education
San Diego State University-California State University
Wayne State University
Macomb Community College
Applied Science Degree, Veterinary Technology
Amylin Pharmaceutical October 2005 - Present
Amylin Pharmaceuticals 2005 - 2008
Pfizer Inc August 2002 - October 2005
Alliance Pharmaceuticals 2000 - 2002
Gen Probe July 1998 - August 2000
poison lab 1994 - 1998
Education
San Diego State University-California State University 1991 — 1992
MS, Physical Chemistry
Universidad de Alcalá 1979 — 1984
BS, Chemistry
MedImmune April 2007 - Present
Boston Scientific July 2004 - December 2006
Epega Herbs January 1999 - December 2006
Mallinckrodt Pharmaceuticals July 2003 - June 2004
B. Braun Medical February 2002 - July 2003
Aventis Behring January 2001 - January 2002
Alliance Pharmaceuticals December 1997 - April 1999
Bausch + Lomb June 1992 - November 1997
Skills
Computer System..., Process Validation, Project Engineering, Project Management, Quality Management, Equipment Qualification, Process Qualification, Process Improvement, 21 CFR Part 11, Manufacturing Scale-up, GLP, GMP, Quality Auditing
Education
University of Rochester 1991 — 1995
Chemical Engineering
Stemedica Cell Technologies January 2015 - Present
Hologic November 2006 - December 2014
SkyePharma January 2006 - October 2006
BiogenIdec January 2002 - January 2006
Alliance Pharmaceuticals November 2000 - December 2001
Sicor November 1998 - November 2000
International Medication Systems (IMS) April 1995 - November 1998
Skills
Validation, Quality Assurance, CAPA, FDA, V&V, GMP, 21 CFR Part 11, Quality System, ISO 13485, Change Control, Sop, Medical Devices, Biotechnology, Computer System..., Trackwise, Biopharmaceuticals, GLP, SOP, GxP
Education
University of California, Irvine 1990 — 1995
Bachelor of Science (B.S.), Biology/Biological Sciences, General
JEA Consulting November 2013 - Present
Synthes 2014 - 2014
Sangart July 2005 - November 2013
Imcor Pharmaceuticals 2002 - 2005
Alliance Pharmaceuticals 2000 - 2002
Solar Turbines October 1990 - April 2000
Solar Turbines 1990 - 2000
Skills
Instrumentation, Automation, Validation, FDA, GMP, Biotechnology, Quality Assurance, Change Control, 21 CFR Part 11, Computer System..., Biopharmaceuticals, GxP, Technology Transfer, Aseptic Processing, Process Automation, SOP, Pharmaceutical Industry, CAPA, Medical Devices, Manufacturing, Life Sciences, Quality System, V&V, R&D, GLP, Testing, Engineering, Project Management
Education
University of California, San Diego 1986 — 1990
Bachelor of Science (BS), Jacobs School of Engineering, Electrical Engineering
Cidara Therapeutics January 2015 - Present
Trius Therapeutics, A Cubist Company June 2012 - November 2014
Pfizer October 2007 - April 2012
Elan Pharmaceuticals September 2001 - October 2007
Alliance Pharmaceuticals 1997 - 2001
Education
University of San Diego
Master of Business Administration (MBA)
Medivation December 2014 - Present
Mary Ann Del Fiorentino Consulting April 2001 - Present
Favrille, Inc. 2007 - 2008
Neurocrine Biosciences 2001 - 2004
Pfizer January 2000 - April 2001
Alliance Pharmaceuticals 1998 - January 2000
Alliance Pharmaceutical Corp 1994 - 2000
Alliance Pharmaceuticals 1995 - 1997
Alliance Pharmaceuticals 1993 - 1995
Veteran’s Administration Medical Center 1990 - 1993
Skills
Clinical Development, Clinical Trials, Technical Writing, Oncology, Medical Writing, Protocol, Pharmaceutical Industry, Regulatory Submissions, Biotechnology, Clinical Study Design, GCP, Therapeutic Areas, IND, CRO, Drug Development
Education
University of California, San Diego 1986 — 1991
Tocagen Inc. February 2015 - Present
Tocagen Inc. January 2015 - February 2015
BDM Consulting, Inc. August 2013 - December 2014
Vical June 2010 - August 2013
Vical Inc. August 2006 - May 2010
ProSanos Corporation September 2002 - May 2006
Pfizer La Jolla November 1999 - September 2002
Alliance Pharmaceuticals November 1998 - November 1999
GlaxoSmithKline July 1997 - September 1998
ALZA Corporation April 1996 - June 1997
Skills
Clinical Development, Oncology, Infectious Diseases, Clinical Trials, Regulatory Submissions, CRO, Biostatistics, Medical Writing, Clinical Research, Biotechnology, Statistical Programming, Medical Coding, Staff Development, Process Improvement, IND, Pharmaceutical Industry, Protocol, Drug Safety, Regulatory Affairs, Therapeutic Areas, Data Management, Sop, Drug Development, Assay Development, Clinical Operations, GCP, SAS, EDC, SAS programming, CTMS, CDISC, Biopharmaceuticals, Clinical Data Management, Lifesciences, Drug Discovery, Life Sciences, SAS Programming, SOP, SAS Base
Education
University of California, Berkeley 1984 — 1986
MA, Biostatistics
San Diego June 2008 - Present
Otonomy, Inc 2015 - 2015
Quadrants Scientific September 2007 - June 2008
Alliance Pharmaceuticals 2000 - 2007
Bio-Interfaces 1995 - 1996
Telios Pharmaceuticals 1991 - 1994
Quidel 1986 - 1991
Skills
ISO 13485, Technology Transfer, Biotechnology, Six Sigma, FDA, Regulatory Affairs, Biochemistry, Manufacturing, GMP, Cross-functional Team..., V&V, Sop, Validation, Clinical Trials, ISO, Regulatory Submissions, Environmental Monitoring, Supplier Quality..., Quality System, Clean Rooms, ELISA, Quality Control, CE marking, Pharmaceutical Industry, GCP, Software Documentation, Oncology, Clinical Development, Aseptic Processing, CAPA, Biopharmaceuticals, GxP, 21 CFR Part 11, Change Control, R&D, HPLC, OOS, GAMP, Computer System..., Design Control, Purification, Quality Auditing, Chromatography, Product Development, Protein Chemistry, Microbiology, Analytical Chemistry, Drug Development, Lifesciences, Clinical Research
Education
Hudson Valley Community College
Catholic Health Initiatives May 2014 - Present
Nebraska Medicine July 2013 - Present
Alegent Creighton Health July 2013 - May 2014
Blue Cross and Blue Shield of Nebraska July 2012 - June 2013
The Nebraska Medical Center May 2009 - May 2010
The Nebraska Medical Center August 2008 - May 2009
Arena Pharmaceuticals June 2008 - July 2008
Genentech August 2005 - April 2008
Biogen Idec October 2002 - August 2005
Alliance Pharmaceuticals September 2001 - August 2002
Skills
Pharmaceutical Industry, Biotechnology, Clinical Trials, Clinical Research, Analytical Chemistry, Managed Care, FDA, Validation, HPLC, Laboratory, Sop, Assay Development, GMP, Healthcare, Pharmacy, Biopharmaceuticals, Quality Control, Technology Transfer, Chromatography, Life Sciences, Hospitals, Cell Culture
Education
University of Nebraska Medical Center 2008 — 2012
Doctor of Pharmacy (Pharm.D.)
San Diego State University-California State University
B.S., Chemistry
Pacira Pharmaceuticals, Inc. January 2013 - Present
Althea Technologies August 2008 - January 2013
BB Consulting Services February 2008 - August 2008
Althea Technologies 2008 - 2008
Genentech 2005 - 2007
Cell Genesys 2003 - 2005
KMI/Parexel 2003 - 2003
Alliance Pharmaceuticals 1996 - 2002
Skills
Validation, Microbiology, Quality Control, Pharmaceutical Industry, Laboratory, Sterilization
Education
San Diego State University-California State University 1990 — 1992
BS, Microbiology
Amgen May 2013 - December 2014
Amgen January 2012 - May 2013
Amgen November 2005 - January 2012
Amgen June 2004 - May 2006
Chugai Pharma USA September 2002 - May 2004
Alliance Pharmaceuticals 2001 - 2002
University of California 1999 - 2001
San Diego State University Foundation 1997 - 2000
San Diego Community Clinics 1997 - 1999
University of California San Diego School of Medicne May 1995 - August 1997
Skills
Pharmacovigilance, Drug Safety, Biotechnology, Biosimilars, Generics, Biopharmaceuticals, Mergers & Acquisitions, Report Writing, Regulatory Intelligence, Process Quality..., Talent Management, Training & Development, Clinical Trials, Oncology, Pharmaceutical Industry, CRO, Clinical Development, Medical Writing, Therapeutic Areas, Hematology, Clinical Research, Sop, Regulatory Submissions, Immunology, Clinical Study Design, Pharmacology, ICH-GCP, GCP, Medicine, Medical Affairs, Infectious Diseases, Drug Development, Lifesciences, Epidemiology, Regulatory Affairs, CTMS, EDC, Clinical Monitoring, Assay Development, Safety Management..., Site Inspections, Regulatory Compliance, Regulatory Interactions, Inspection, Quality Management, Patient Safety, Technical Writing, Report Development, International Joint..., Talent Acquisition
Education
San Diego State University-California State University 1997 — 1999
MPH, Epidemiology
University of California, San Diego 1993 — 1995
Bachelor of Science (BS), Animal Physiology and Neuroscience
Neurocrine Biosciences October 2000 - Present
Biopure Corporation 1997 - 2000
Hybridon 1996 - 1997
Alliance Pharmaceuticals 1989 - 1996
Medstone International 1988 - 1989
Allergan 1982 - 1988
Skills
Data Management, Biostatistics, Pharmaceutical Industry, Clinical Trials, GCP, Oracle Clinical, Clinical Development, Drug Development, Clinical Research, EDC, Protocol, Clinical Study Design, Regulatory Affairs, CRO, SAS, Sop, Regulatory Submissions, CTMS, Lifesciences
Education
California State University-San Bernardino
B.S., Mathematics
Oregon State University
M.S., Statistics
AH Clinical Research Services May 2013 - Present
Quintiles September 2004 - April 2013
Immusol 2002 - 2003
IDEC 2001 - 2002
Alliance Pharmaceuticals 1999 - 2001
Alliance Pharmaceuticals 1998 - 2000
Skills
Clinical Monitoring, Clinical Trials, CRO, Oncology, EDC, GCP, Data Management, Diabetes, Clinical Data Management, Regulatory Affairs, Cardiology, FDA, Inform, Rheumatoid Arthritis, Cancer, Endocrinology, Hematology, IRB, Clinical Operations, CRF design, Protocol, ICH-GCP, Rheumatology, Biotechnology, Neurology, Asthma, Gastroenterology, Dermatology, Hypertension, Medical Affairs, Ophthalmology, Informed Consent, Psychiatry, Medidata, Osteoporosis, 21 CFR Part 11, Oncology Clinical..., COPD, Cardiovascular Disease, Regulatory Documentation, Central Nervous System, Allergy, ICH guidelines, CTMS, Clinical Research, Patient Recruitment
Education
San Diego State University-California State University 1991 — 1998
BS, Biology
San Diego State University-California State University 1991 — 1998
BA, Psychology
. January 2010 - Present
Oliver Wight Americas January 2006 - January 2010
Amylin Pharmaceuticals 2003 - 2006
Alliance Pharmaceuticals 2001 - 2003
Molecular BioSystems Inc. (MBI) 1998 - 2000
Skills
Management Consulting, FDA, GMP, Manufacturing, Cross-functional Team..., Business Process..., Strategy, Supply Chain, Strategic Planning, GLP, Pharmaceutical Industry, Validation, Business Transformation, Change Control, Supply Chain Management, CAPA, Medical Devices, Quality System, Biotechnology, Change Management, Process Improvement, Operational Excellence, Biopharmaceuticals, Six Sigma, 21 CFR Part 11, Quality Assurance, Lean Manufacturing, Lifesciences, Sop, Continuous Improvement, Program Management, SOP, Life Sciences
Education
California State University-Long Beach
B.S., Microbiology
Patara Pharma January 2014 - Present
Independent Biotech Consultant September 2012 - Present
Elevation Pharmaceuticals April 2008 - September 2012
Verus Pharmaceuticals 2005 - 2008
SkyePharma 2002 - 2005
Alliance Pharmaceuticals 1996 - 2002
Skills
FDA, R&D, Drug Delivery, Pharmaceutical Industry, Biotechnology, Medical Devices, Infectious Diseases, Regulatory Affairs, Clinical Development, Medical Affairs, Drug Development, Clinical Trials
Education
Erasmus University Rotterdam 1990 — 1992
PhD, Respiratory Pathophysiology
University of Istanbul, Turkey 1980 — 1986
MD, Critical Care Medicine
Molecular Insight Pharmaceuticals 2011 - Present
Vision Quest Bioscience, LLC September 2001 - Present
Cytogen Corporation 2006 - October 2011
EUSA Pharma 2006 - 2011
Esperion 2001 - 2002
Fritz, Manspeaker, & Associates 1998 - 2001
ImaRx Pharmaceutical Company January 1997 - October 1998
Alliance Pharmaceuticals September 1993 - January 1997
Centocor 1986 - 1993
Dupont Merck Pharmaceuticals 1982 - 1986
Skills
Oncology, Clinical Research, Pharmaceutical Industry, Clinical Development, Clinical Trials, Medical Affairs, CRO, FDA, Sop, Lifesciences, Biotechnology, Medical Imaging, Medical Devices, Regulatory Affairs, Cardiology, Medical Education, Clinical Operations, Regulatory Submissions, Drug Discovery, Drug Development, GCP, Product Launch
Education
The Johns Hopkins University Bloomberg School of Hygiene and Public Health 1976 — 1980
Master of Health Science
St. Mary's College of Maryland 1970 — 1973
Bachelor of Science (BS)
Duke University
Supernus Pharmaceuticals, Inc. December 2013 - Present
Supernus Pharmaceuticals, Inc. November 2011 - December 2013
Eisai October 2006 - November 2011
Ligand Pharmaceuticals March 2005 - October 2006
Ligand Pharmaceuticals January 2004 - March 2005
Alliance Pharmaceuticals May 2001 - January 2004
Alliance Pharmaceuticals January 1998 - May 2001
La Jolla Pharmaceutical Company January 1997 - January 1998
Hybritech Inc January 1989 - January 1996
Beckman Instruments January 1985 - January 1989
Skills
Supply Chain, Pharmaceutical Industry, Materials Management, FDA, GCP, MRP, Supply Management, Biotechnology, Procurement, Sop, GMP, Strategic Sourcing, Manufacturing, Purchasing, Validation, R&D, Medical Devices, Product Development, Cross-functional Team..., Inventory Management, Contract Manufacturing, Six Sigma, Lifesciences, Pharmaceutics, Forecasting, Project Planning, ERP, Clinical Development, Quality Control, Quality System, SOP, Life Sciences
Education
San Diego State University-California State University 1985 — 1990
Howard Community College 1980 — 1982
University of Maryland Baltimore County 1980 — 1982
CGS Real Estate August 2013 - Present
CTBS November 1998 - Present
Davelly Real Estate and Services January 2011 - August 2013
Borrego Valley Realty 2008 - January 2011
Slaby Environmental, Inc March 2008 - July 2009
ERA Excel Realty October 2006 - March 2008
Alliance Pharmaceuticals 1998 - 2003
Skills
Real Estate, Relocation, Foreclosures, Short Sales, Real Estate Transactions, First Time Home Buyers, Sellers, Real Property, SFR, HUD, REO, Investors, Vacation Homes, Move Up Buyers, 1031 Exchanges, New Homes, Income Properties, Single Family Homes
Education
Palomar College 1992 — 1995
AA, Business
National University
Finance
Eli Lilly June 2003 - Present
West Pharmaceutical Services 2013 - 2013
DURECT Corporation 2000 - 2003
Vivus Inc 1994 - 1998
Syntex 1990 - 1994
Alliance Pharmaceuticals 1987 - 1990
Cell Bio Group Ltd. 1984 - 1987
Jim Coyne For Congress & Congressional Staff Member 1980 - 1982
Education
Delaware Valley University
BS, Business Administration
Rutgers, The State University of New Jersey-New Brunswick
Orexigen Therapeutics February 2015 - Present
Orexigen Therapeutics April 2008 - Present
Biosite May 2003 - August 2007
Alliance Pharmaceuticals 1997 - 2003
The Burnham Institute 1991 - 1997
Ernst & Young 1988 - 1991
Skills
SEC reporting, Compliance, Accounting, SOX, Financial Reporting, GAAP, Excel, Auditing, Internal Controls, Biotechnology, Revenue Recognition, SEC filings, Sarbanes-Oxley Act, Mergers & Acquisitions, Due Diligence
Education
San Diego State University-California State University 1995 — 1998
BS, Accounting
Synteract, Inc. April 2009 - Present
Synteract, Inc. August 2002 - March 2009
Elan Pharmaceuticals September 2001 - August 2002
Agouron Pharmaceuticals 1999 - 2001
Alliance Pharmaceuticals 1998 - 1999
Education
Gwynedd-Mercy College
BSN, Nursing
Gilead Sciences December 2014 - Present
Roche December 2008 - November 2014
Genentech January 2007 - December 2008
Genentech April 2005 - January 2007
Biogen Idec January 2003 - August 2005
IDEC Pharmaceuticals, Inc. 2002 - 2005
Alliance Pharmaceuticals 1997 - 2001
Scantibodies Laboratory, Inc 1992 - 1994
ALZA Corporation 1991 - 1992
Skills
GMP, Change Control, Biotechnology, Validation, FDA, Risk Compliance, Quality Assurance, Biopharmaceuticals, V&V, Continuous Improvement, Software Documentation, Sop, Quality System, 21 CFR Part 11, Manufacturing, Cross-functional Team..., Root Cause Analysis, Program Management, Six Sigma, Pharmaceutical Industry, CAPA, Process Improvement, GxP, ISO 13485, Operational Excellence, Quality Control, Computer System..., Medical Devices, Chromatography, SOP
Education
University of Phoenix 2008 — 2012
BS Management, Operations & Supply Chain Management
University of California, San Diego 2002 — 2004
Drug/Biologics Quality Program Management
Conventus Biomedical Solutions, Inc. November 2013 - Present
Shire Regenerative Medicine (formerly Advanced BioHealing) April 2012 - November 2013
Advanced BioHealing August 2009 - April 2012
Ceregene, Inc. July 2008 - November 2008
Biogen 2007 - 2008
Datafarm Inc 2005 - 2007
Isis Pharmaceuticals 1999 - 2003
Alliance Pharmaceuticals 1998 - 1999
University of California, Santa Barbara 1997 - 1998
University of Rochester Medical Center 1995 - 1997
Skills
FDA, eCTD, Biologics, Combination Products, IMPD, EMEA, CTD
Education
Weizmann Institute of Science 1988 — 1995
Ph.D., Chemistry (Materials and Interfaces)
Princeton University 1985 — 1987
MA, Chemistry
Oberlin College 1982 — 1985
BA, Chemistry
Par Pharmaceutical February 2014 - Present
Amylin Pharmaceuticals February 2007 - February 2014
SkyePharma November 2004 - February 2007
Pacira Pharmaceuticals 2004 - 2007
Pfizer November 1999 - November 2004
Agouron 1999 - 2004
Alliance Pharmaceuticals September 1997 - October 1999
Mycogen January 1990 - August 1997
Skills
Quality System, GMP, CAPA, FDA, Change Control, Training, Quality Auditing, 21 CFR Part 11, SOP, Pharmaceutical Industry, Quality Assurance, Project Planning, V&V, GxP, Validation, GLP
Education
University of California, San Diego 1985 — 1990
BA, Microbiology
Pfizer Inc December 2003 - Present
SkyePharma 2000 - 2002
Dura Pharmaceuticals 1994 - 2000
Alliance Pharmaceuticals 1994 - 1996
Skills
Regulatory Affairs, FDA, Ophthalmology, Clinical Development, Regulatory Submissions, Pharmaceutical Industry, Oncology, Infectious Diseases, IND, Therapeutic Areas
Education
San Diego State University-California State University 1982 — 1987
B.S., Microbiology
Envisia Therapeutics November 2013 - Present
Liquidia Technologies December 2012 - November 2013
Cirrus Pharmaceuticals, Inc. May 2008 - November 2012
Inspire Pharmaceuticals, Inc. September 2004 - May 2008
IMCOR Pharmaceutical Co., Inc. June 2003 - September 2004
Alliance Pharmaceuticals July 1989 - June 2003
Kabi Pharmacia June 1987 - July 1989
Skills
GMP, Validation, R&D, Product Development, Drug Delivery
Education
Université Nice Sophia Antipolis 1990 — 1994
Ph.D., Chemistry
Humboldt State University 1980 — 1985
B.S., Chemistry
PG&E August 2015 - Present
Enterprise Automation November 2009 - August 2015
Rutter Hinz Inc. November 2004 - September 2009
Biogen Idec May 2003 - October 2004
IDEC May 2003 - October 2004
Alliance Pharmaceuticals June 1996 - May 2002
Alliance/IMCOR 1998 - 2002
Alliance Pharmaceutical Corp. 1998 - 2002
Skills
Automation, Engineering, FDA, Validation, Biotechnology, GMP, Calibration, Medical Devices, Quality Control, ISO 13485, Process Control, PLC, Software Documentation, Manufacturing, HMIs, Change Control, Control Systems Design, Instrumentation, Process Automation, Commissioning
Education
University of California, San Diego 1993 — 1998
BS, Mechanical Engineering
PPD/Genentech September 2012 - Present
Independent Consultant September 2010 - August 2012
Anesiva January 2008 - September 2009
Bayer January 2007 - January 2008
Alliance Pharmaceuticals 1998 - 2000
Midwest Research Institute 1995 - 1998
Skills
Validation, Analytical Chemistry, Clinical Development, Assay Development, Clinical Research, Biotechnology, Technology Transfer, Lifesciences, FDA, GMP, Sop, Pharmaceutical Industry, R&D, Biopharmaceuticals, Regulatory Affairs, Project Management, Quality Systems
Education
Institut national polytechnique de Toulouse 2001 — 2006
PhD, Medicinal and Pharmaceutical Chemistry
Institut national polytechnique de Toulouse
Independent August 2004 - Present
Sangart September 2001 - August 2004
Alliance Pharmaceuticals January 1999 - September 2001
Peace Corps July 1996 - September 1998
Alliance Pharmaceuticals March 1993 - June 1996
Mycogen Corp (now Dow Chemicals) December 1991 - February 1993
Mycogen Corporation 1991 - 1993
Southwest Veterinary Diagnostic May 1991 - December 1991
Skills
Formulation, GxP, Validation, FDA, Biopharmaceuticals, Quality Assurance, Microbiology, Pharmaceutical Industry, Strategic Planning, Biotechnology, GMP, LIMS, Sop, Aseptic Processing, Quality Control, GCP, Product Development, Software Documentation, Medical Devices, CRO, Environmental Monitoring, Biochemistry, Technology Transfer, Drug Development, Purification, GLP, V&V, Quality Management, Project Management, CAPA, Regulatory Submissions, Quality Auditing, Pharmaceutics, Chromatography, Change Control, Regulatory Affairs, Quality System, Auditing, R&D, Cross-functional Team..., GAMP, Clinical Trials, Microsoft Office, IND, Computer System..., 21 CFR Part 11, HPLC, Biologics, Lifesciences, ISO 13485
Education
Arizona State University 1986 — 1991
BS, Microbiology
Scantibodies Laboratory, Inc June 2013 - Present
Sotera Wireless, Inc. September 2009 - January 2012
CardioDynamics April 2005 - August 2009
CardioDynamics August 1999 - April 2005
Alliance Pharmaceuticals August 1997 - April 1999
VIA Medical 1997 - 1997
Nellcor January 1991 - August 1991
United States Navy January 1985 - January 1991
Skills
Social Media, Medical Devices, R&D, Product Development, Cross-functional Team..., Design Control, Software Documentation, Start-ups, Process Improvement, Visio, Manufacturing, Microsoft Office, Matlab, Biomedical Engineering, Quality System, Project Management, Testing, Team Leadership, Strategic Planning, Linux, Six Sigma, Troubleshooting, ISO 13485, Quality Assurance, FDA, Validation, Data Analysis, CAPA
Education
CQE Refresher Course 2005 — 2006
Certified Quality Engineer
University of Phoenix San Diego 2000 — 2002
MBA, Technology Management
University of California, San Diego 1993 — 1996
BS, Bioengineering
N. B. Forrest High School 1974 — 1978
Diploma, High School Requirements
Department of Navy September 2009 - Present
Lee Hecht Harrison November 2008 - May 2009
The Scripps Research Institute 2001 - 2008
Neurocrine Biosciences 2000 - 2001
HNC Software 1999 - 2000
Alliance Pharmaceuticals 1998 - 1999
Education
San Diego State University-California State University
B.A.
UCSD Extension
Certificate Human Resources
Self-employed July 1999 - Present
Alliance Pharmaceuticals January 1996 - December 1998
Viagene, Inc. October 1991 - October 1994
Armstrong Laboratories 1989 - 1991
Copley Pharmaceuticals 1986 - 1989
Skills
Quality System, Quality Assurance, FDA, GMP, CAPA, Quality Control, Biotechnology, Biopharmaceuticals, Auditing, Validation, Technology Transfer, 21 CFR Part 11, GLP, Sop
Education
Colgate University 1982 — 1986
B.A., Natural Science
Lewiston
Lewiston
Cosmetic Laboratories of America January 2006 - Present
Alliance Pharmaceuticals January 1992 - January 1998
Alliance Pharmaceutical January 1989 - January 1992
GENSIA PHARMACEUTICALS January 1988 - January 1989
BROWN & WILLIAMSON TOBACCO CORPORATION January 1984 - January 1988
Brown & Williamson Tobacco Corp January 1982 - January 1984
Skills
Analytical Chemistry, FDA, Sop, HPLC, Chemistry, V&V, Chromatography, Quality Control, Laboratory, Gas Chromatography
Education
Centre College 1978 — 1982
BS, Chemistry
Centre College 1978 — 1982
Bachelor of Science Degree, Chemistry
Biogen Idec November 2004 - July 2008
IDEC Pharmaceuticals June 2003 - November 2004
Alliance Pharmaceuticals May 2002 - August 2002
BDS Marketing 2001 - 2002
Education
University of Nebraska Medical Center 2008 — 2013
Drug Delivery and Nanomedicine
University of California, Riverside
Genentech October 2012 - Present
Genentech September 2006 - October 2012
Bayer 2004 - 2006
Bayer 2000 - 2004
Alliance Pharmaceuticals 1993 - 2000
Skills
Automation, Process Control, Control Systems Design, Validation, Biotechnology, CAPA, Computer System..., Change Control, ISO 13485, Pharmaceutical Industry, Software Documentation, GMP, FDA, GAMP, Biopharmaceuticals, 21 CFR Part 11, Medical Devices, Six Sigma, V&V, Manufacturing, GxP, Instrumentation, Calibration, Sop, Technology Transfer, WebDAV, SOP
Education
University of California, San Diego
BS - Mechanical Engineering (Systems and Control)
Vical 1996 - Present
Alliance Pharmaceuticals 1992 - 1996
Hybritech, Inc. 1984 - 1992
Education
University of California, San Diego
Nutraceutical Corp. & Independent Consultant January 1998 - November 2012
San Diego City College September 1998 - June 2010
Alliance Pharmaceuticals January 1996 - January 1998
Depotech Corp January 1995 - January 1996
Skills
Leadership, Chemistry, Quality Assurance, HPLC, Chromatography
Education
University of California, San Diego 1994 — 1996
Master of Science (MS), Chemistry, GPA: 3.9/4.0
Rutgers University 1990 — 1994
Bachelor of Arts (B.A.), Chemistry & French, Cumulative GPA 3.9/4.0