Aviron Company
Industry: Sport
DescriptionRowing, often referred to as crew in the United States, is a sport whose origins reach back to Ancient Egyptian times. It involves propelling a boat on water using oars. By pushing against the water with an oar, a force is generated to move the boat. Highest governing body: International Rowing Federation (FISA)
Aviron List of Employees There's an exhaustive list of past and present employees! Get comprehensive information on the number of employees at Aviron. You can filter them based on skills, years of employment, job, education, department, and prior employment.
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36 Aviron employees in database. Find out everything there's to know about Aviron employees. We offer you a great deal of unbiased information from the internal database, personal records, and many other details that might be of interest to you.
Aviron Employees
Rhody Designs September 2008 - December 2012
Xerox June 2006 - August 2008
Xerox June 2005 - June 2006
Cornerstone Peripherals January 2004 - December 2005
American Legion Charitable Association Post 419 Bingo April 2000 - June 2004
Aviron 2001 - 2003
Silicon Quest International 1999 - 2001
Skills
Document Management, Enterprise Content..., Sales Presentations, Technical Support, Management, Graphic Design, Help Desk Support, Web Design, Software Licensing, Website Development, Social Media, Advocacy, Retail Management, Ballroom Dance, Latin Dance, Training, Troubleshooting, Customer Service, Salesforce.com
Education
University of Phoenix 2008 — 2012
Bachelor of Science, Information Technology/Visual Communications
Linkages Group 2012 - Present
SV2 2000 - Present
Codexis 2004 - April 2012
Applied Biosystems 1999 - 2003
Aviron 1997 - 1998
Skills
Meeting facilitation, Public Speaking, Corporate Communications, Non-profits, Writing & editing, Corporate Websites, Marketing Communications, Annual Reports, Investor Relations, Start-ups, Internal Communications, Nonprofits, Strategic Communications, Executive Coaching, Business Coaching, Job Coaching, Technical Writing, News Writing, Web Content, Website Development, Non-profit Leadership, Non-profit Board..., Educational Fundraising, Marketing, Leadership, Workshop Facilitation, Project Management, Strategic Planning, Messaging, Communication Training, Program Management, Message Development, Crisis Communications, Coaching, Fundraising, Training, Copywriting, Leadership Development, Management, Grant Writing, Media Relations, Strategy, Reputation Management
Education
Pepperdine University, The George L. Graziadio School of Business and Management
MBA
University of Missouri-Columbia
Bachelors, Journalism
Hudson Institute of Coaching
Certified Hudson Institute Coach, Leadership and Transitions Coaching
Novartis November 2012 - Present
Roche Pharmaceuticals October 2009 - November 2012
Hoffmann-La Roche 2009 - 2012
Roche 2009 - 2012
ForteBio January 2006 - October 2009
PneumRx Inc. August 2004 - January 2006
Targesome April 1999 - June 2003
Aviron November 1998 - March 1999
Syva Diagnostics June 1995 - October 1998
Dade-Behring / Syva Diagnostics 1995 - 1998
Skills
Polymers, Project Management, Assay Development, Leadership, Protein Chemistry, Biosensors, Drug Discovery, Biochemistry, Immunoassays, Antibodies, Analytical Chemistry, Chemistry, Organic Chemistry, Biacore, Biotechnology, Virology, ELISA, Inflammation, Drug Design, Drug Delivery, DNA, HPLC, Medical Devices, Biomarkers, Lead Change, Chromatography, Proteomics, In Vitro, Oncology, Organic Synthesis, LC-MS, Medicinal Chemistry, Protein Purification, High Throughput..., Purification, Drug Development, Small Molecules, Peptides, Biopharmaceuticals, Monoclonal Antibodies
Education
University of California, Berkeley 1993 — 1995
Post-doctoral Studies
The Ohio State University 1988 — 1993
PhD
Southern Illinois University, Edwardsville 1983 — 1988
B.S.
Wellness Science July 2011 - Present
Valeant Pharmaceuticals August 2009 - December 2010
CV Therapeutics September 2008 - August 2009
Johnson & Johnson 2006 - September 2008
Johnson & Johnson 2005 - 2006
Johnson & Johnson February 2003 - June 2005
Aviron 2001 - 2001
ALZA Corporation 1999 - 2001
Pennington Biomedical Research Center 1995 - 1997
Skills
Pharmacovigilance, Pharmaceutical Industry, Drug Safety, Analysis, Wellness, Medical Writing, Writing, Public Health, Nutrition, Freelance Writing, Healthcare, Leadership, GCP, Social Media, Clinical Research, Management, Pain Management, Cross-functional Team...
Education
Tulane University 1997 — 2000
M.P.H., Health Systems Management
Tulane University 1991 — 1995
B.S., Molecular Biology
Vaccine Research Center, NIAID, NIH May 2008 - Present
MedImmune 2005 - May 2008
Aviron/MedImmune 2001 - 2005
Aviron 1999 - 2001
Systemix 1992 - 1999
Aastrom 1991 - 1992
Eli Lilly 1981 - 1986
Skills
Lifesciences, Biopharmaceuticals, Vaccines, Biotechnology, Science, Process Simulation, Technology Transfer, Monoclonal Antibodies, FDA, GMP, Cell, Purification, Protein Purification, Clinical Trials, Immunology, Molecular Biology, Microbiology, Laboratory, Protein Chemistry, Infectious Diseases, Pharmaceutical Industry, GLP, Sop, Cell Culture, Cell Biology, Biochemistry, Drug Discovery, Chromatography, Virology, Western Blotting, Drug Development, ELISA, Assay Development, Fermentation, Validation, HPLC, Immunoassays, R&D, PCR, Commercialization, Clinical Development, Drug Delivery, High Throughput..., Genomics, Life Sciences, SOP
Education
University of Michigan 1986 — 1991
M.S. and Ph.D., Chemical Engineering
University of Michigan 1977 — 1981
B.S., Chemical Engineering
BioPharm Process Associates 2000 - Present
Aviron 1998 - 2000
Insite Vision 1996 - 1998
Chiron Corporation 1994 - 1996
Applied Immune Sciences 1992 - 1994
XOMA 1990 - 1992
Skills
Biopharmaceuticals, Manufacturing, Contract Manufacturing, Process Development, Process Engineering, Regulatory Submissions, Regulatory Strategy, Due Diligence, Technology Evaluation, Technology Transfer, Pharmaceuticals, Sop, GMP, Lifesciences, Process Simulation, Drug Development, Validation, FDA, Biotechnology, Strategy, Vaccines, Fermentation, Pharmaceutical Industry, GCP, GLP, Purification, Business Strategy, CAPA, Bioprocessing, Quality Assurance, SOP, Life Sciences
Education
University of California, Berkeley 1980 — 1986
Ph.D., Chemical Engineering
Cornell University 1976 — 1980
BS, Chemical Engineering
GT Consulting LLC 1996 - Present
Genentech June 2014 - Present
Onyx Pharmaceuticals January 2013 - July 2014
Bayer Emeryville 2008 - 2011
Amyris Biotechnologies 2007 - 2008
Chiron Corporation 2002 - 2007
Biogen Idec 1999 - 2001
Aviron 1997 - 1998
Bayer Berkeley 1989 - 1996
Fluor Daniel 1987 - 1989
Skills
Validation, Engineering, GMP, Lifesciences, Sop, CAPA, Pharmaceutical Industry, Biotechnology, Construction, Biopharmaceuticals, Quality Assurance, Technology Transfer, Commissioning, FDA, Purification, Program Management, V&V, Project Management, 21 CFR Part 11, Vaccines, Manufacturing, Process Engineering, Process Simulation, Analytical Chemistry, Biofuels, Change Control, Clinical Trials, Computer System..., GLP, Laboratory, Pharmaceutics, Quality Control, Quality System, R&D, Formulation, HPLC, Chemistry
Education
Colorado State University 1983 — 1985
MS, Chemical Engineering
Oregon State University 1975 — 1980
BS, Biochemistry/Biophysics
Oregon State University 1975 — 1980
BS, Chemical Engineering
Amee Chapman Music August 1986 - Present
Ecology Action June 2011 - Present
High Tide Design September 2005 - Present
Pajaro Valley Unified School District August 2006 - June 2011
Firelight Foundation August 2009 - May 2010
Sierra Adoption Services February 2001 - July 2006
TechPlanet, Inc May 2000 - December 2000
Aviron April 1999 - August 1999
Kodomo Therapy Service August 1998 - April 1999
Peace Creations January 1993 - August 1998
Skills
Database Management, Website Development, Technical Management, Web 2.0, Databases, Singing, Songwriting, Program Management, Non-profits, Project Management, Public Speaking, Community Outreach, Microsoft Office, Salesforce.com, Research, Strategic Planning, Project Planning, Social Media, Public Relations, Marketing, Microsoft Excel, Social Media Marketing, Salesforce Administrator, Salesforce.com..., FileMaker, Training, Nonprofits, OS X, Editing, Networking, Management
Education
University of California, Irvine 1990 — 1994
BA, Social Ecology
MAP Pharmaceuticals July 2007 - March 2013
VNUS Medical Technologies 2005 - 2007
R2 Technology 2002 - 2004
Aviron 2000 - 2002
Collagen Corporation 1995 - 1999
Education
Northeastern University School of Law 1979 — 1982
JD
Tufts University 1974 — 1978
BA
Sutro Biopharma, Inc. July 2015 - Present
Chinese biotech company, inVentiv Health, TransPerfect, Novalins, Medjaden March 2015 - September 2015
Abbott (Clinovo) February 2013 - September 2014
FibroGen (Advanced Clinical) December 2012 - December 2012
MedImmune August 2001 - September 2012
Aviron December 1996 - August 2001
Applied Immune Sciences September 1992 - September 1996
UC Davis January 1989 - August 1992
Skills
Medical Translation, Medical Writing, Technical Writing, Regulatory Submissions, Chinese word processsing, Technical Translation, FDA, Clinical Manufacturing, IND, CMC, CMO management, GMP, Sop, Formulation, Immunoassays, Virology, Validation, Bioassay, Vaccines, Stability Programs, Regulatory Filings, Influenza, Analytical Method..., Process Transfer, Analytical Methods..., HPLC, Freezing, Clinical Trials, Biotechnology, Protocol, V&V, SOP, Drug Discovery, CAPA, LIMS, Clinical Development, Assay Development, Aseptic Technique, Chromatography
Education
UCSC Extension 2013 — 2014
Certificate, Regulatory Affairs
China Medical University
Doctor of Medicine (MD), Public Health, 公共卫生
China Medical University
Master of Public Health (M.P.H.), 预防医学及毒理学, Preventive Medicine and Toxicology
NuvOx Pharma January 2013 - Present
Instant Bioscan December 2012 - Present
Desert Angels January 2012 - Present
Acorn Consulting June 2011 - Present
Advanced Biologics Co., Ltd. January 2009 - June 2011
Caris MPI July 2008 - December 2008
Medarex 2000 - 2008
Aviron January 1995 - December 1998
ImmuLogic 1990 - 1995
MAST Immunosystems (now Hitachi Medical) 1986 - 1990
Skills
Pharmaceuticals, Biotechnology, Diagnostics, Medical Devices, Clinical Research, Biologics, Pharmaceutical Industry, Vaccines, Lifesciences, Cleantech, Cross-functional Team..., Start-ups, Molecular Biology, Oncology, Regulatory Affairs, Drug Development, Product Development, Commercialization, Technology Transfer, FDA, Biopharmaceuticals, Clinical Development, Clinical Trials, Biomarkers, Assay Development, Mergers & Acquisitions, Drug Discovery, GMP, Immunology, CRO, Hardware Diagnostics, Biochemistry, Genomics, R&D, Due Diligence, Monoclonal Antibodies, Infectious Diseases, Validation, Cancer, Protein Chemistry, Pharmacology, IND, Sop, Cell, GLP, Regulatory Submissions, Cell Culture, GCP, Microbiology, CTMS
Education
Cornell University
Ph.D.
University of California, San Diego
BA
Wm. S. Hart High School
Shirley Nadell B.Com, MEd 1995 - Present
Private Consultation 1991 - Present
Aviron 2009 - 2010
Trafalgar School 1985 - 1987
Bialik High School 1977 - 1985
Skills
Psychology, Psychotherapy, Counseling Psychology, CBT, Mental Health, Treatment, Psychological Assessment, Adolescents, Family Therapy, Mindfulness, Self-esteem, Stress, Group Therapy, Interventions, Teacher Training, Teaching, Curriculum Design
Education
McGill University 1991 — 1998
PhD, still incomplete, Cognitive Science-Models of Teaching in Expert Domains, A
McGill University 1989 — 1991
Master's Degree, Educational Psychology:Comparative Studies in University Instruction, A
McGill University 1955 — 1959
Bachelor's Degree, Business/Managerial Economics, A
JMC BioPharm Consulting March 2007 - Present
LigoCyte Pharmaceuticals, Inc. 2009 - 2011
Telik January 2005 - February 2007
Medimmune Vaccines 2001 - December 2004
Aviron 1997 - 2001
Roche 1994 - 1997
Syntex 1994 - 1997
Skills
Biotechnology, Clinical Development, Oncology, Clinical Trials, Vaccines, Regulatory Affairs, Regulatory Submissions, Pharmaceutical Industry, Infectious Diseases, Biopharmaceuticals, Lifesciences, FDA, Immunology, Sop, Clinical Research, GCP, IND, Drug Development, Medical Devices, CRO, Clinical Operations
Education
California State University-East Bay 1984 — 1987
Bachelor of Science (B.Sc.), Health Education
Medimmune February 2001 - Present
Aviron July 1999 - February 2001
Skills
Vaccines, Assay Development, Molecular Biology, real-time RT-PCR, RT-PCR, Nucleic Acid Extraction, ELISA, Purification, Monoclonal Antibodies, GLP, GMP, Biotechnology, Cell Culture, SDS-PAGE, Immunoassays, Biopharmaceuticals, Immunology, Sop, Bioassay, Protein Purification, Cell, Clinical Trials, Aseptic Technique, Virology, FDA, Antibodies
Education
UC Berkeley 1995 — 1999
Bachelor of Arts (BA), Molecular Cellular Biology
Stanford University School of Medicine 2011 - Present
International AIDS Vaccine Initiative August 2001 - Present
Aviron 1997 - 2001
Aviron (now MedImmune, now AstraZeneca) 1997 - 2001
Division of AIDS, NIH 1990 - 1997
Skills
Infectious Diseases, Epidemiology, Clinical Trials, Vaccines, Prevention, Global Health, Immunology, Molecular Biology, Public Health, Virology, ELISA, Cell, Assay Development, Biotechnology, Biochemistry, Clinical Development, Cell Biology, Lifesciences, Life Sciences, Medicine, Translational Research, Drug Development, Science
Education
Michigan State University College of Human Medicine 1981 — 1984
MD, Medicine
UCLA
BA, Independent Major
Nektar Therapeutics October 2012 - Present
PDL BioPharma 2008 - April 2010
Symyx Technologies 2006 - 2007
Chiron Corporation 2005 - 2006
Geron Corporation 2004 - 2006
Abgenix 2001 - 2004
Intermune 2001 - 2002
Aviron 1999 - 2001
Chiron Corporation April 1991 - April 1999
Genentech 1983 - 1989
Skills
Computer System..., Validation, cGMP manufacturing, Quality Assurance, Project Management, Facilities Management, Quality Management, Business Process..., Business Process Design, Manufacturing..., Protein Purification, Formulation, Fermentation Process..., Supply Chain Management, 21 CFR Part 11, GMP, Biotechnology, Vaccines, FDA, Lifesciences, Biopharmaceuticals, Drug Discovery, Clinical Development, V&V, LIMS, Change Control, Technology Transfer, CAPA, GLP
Education
University of California, Davis 1979 — 1983
BS, Genetics
Exelixis April 2007 - Present
Telik January 2005 - March 2007
MedImmune 2002 - 2004
Aviron 1998 - 2002
Amgen 1996 - 1998
Skills
Biostatistics, Clinical Data Management, Regulatory Submissions, Clinical Trials, SAS programming, SDTM, EDC, CRF design, Strategic Leadership, Personnel Supervision, Medical Writing, Presentations, RFP preparation, Budget Preparation, Budget Oversight, Data Quality, External Audit, SOP development, Clinical Study Design, Clinical Development, Oncology, Vaccines, Infectious Diseases, CRO, Drug Development, SAS, Data Management, CDISC, GCP, Statistical Programming, Budgets, Statistics
Education
Keck School of Medicine of the University of Southern California 1994 — 1996
Master of Science (MS), Epidemiology and Applied Statistics
University of California, Irvine 1987 — 1992
Bachelor of Science (BS), Bachelor of Arts (BA), Biology, Political Science
Molecular Devices 2006 - 2007
MDS Analytical Technologies 2005 - 2007
Molecular Devices 2001 - 2006
Axon Instruments 2001 - 2003
MedImmune Vaccines 1999 - 2001
aviron 1999 - 2001
Skills
Cell, Validation, Cell Culture, Laboratory, Assay Development, GMP, FDA
Education
California Polytechnic State University-San Luis Obispo 1996 — 1998
Bachelor of Science (B.S.), Microbiology
University of Santo Tomas 1985 — 1989
Eichleay Engineers September 2011 - Present
V2 Bio-Consulting October 2009 - September 2011
Genentech September 2004 - September 2008
Biokinetics February 2001 - September 2004
Aviron June 1999 - February 2001
Quasar Engineering 1995 - 1998
Skills
Biotechnology, Biochemical Engineering, Process Engineering, Project Engineering, Engineering, Construction, Commissioning, Fermentation, Chromatography, Purification, Filtration, Cell Culture, Process Equipment, CIP, Downstream Processing, cGMP, SOP, GMP, Biopharmaceuticals, Project Management, Process Simulation, Validation, Sop
Education
Michigan State University 1981 — 1986
BS, Chemical Engineering
Genentech May 2014 - Present
Genentech October 2012 - Present
MedImmune October 2011 - September 2012
MedImmune November 2005 - September 2011
MedImmune November 2002 - October 2005
Aviron October 2000 - October 2002
Skills
Cell Culture, Aseptic Technique, Biotechnology, GMP, Sop, Operational Excellence, Six Sigma, 5S, Hybridoma, CAPA, Trackwise, ELISA, Cell Based Assays, Risk Assessment, Microsoft Excel, Microsoft Word, PowerPoint, Deviations, FFA, Automation, Incucyte, ViCell, WellMate, Multidrop, cGMP practices, Biopharmaceuticals, Cell, Monoclonal Antibodies, Vaccines, Validation, SOP
Education
University of San Francisco
BS, Biology, Chemistry
Bayhill therapeutics, Inc. CFOCorcept TherapeuticsFebruary 2004 - April 2007
Genitope Corporation February 2002 - January 2004
Aviron 1998 - 2002
Education
University of Chicago Graduate School of Business 1973 — 1976
MBA
University of Chicago Law School 1973 — 1976
Norac Pharma March 2003 - Present
Scientific Resources November 2001 - March 2003
Aviron November 2001 - April 2002
SNC-Lavalin Pharma 1997 - 2001
Skills
GMP, Validation, Quality System, Change Control, Sop, FDA, Quality Assurance, 21 CFR Part 11, Biotechnology, Computer System..., Aseptic Processing, V, Cleaning Validation, GAMP, Process Engineering, FDA GMP, Quality Control, Document Management, Pharmaceutical Industry, HPLC, Biopharmaceuticals, Calibration, Regulatory Affairs, Analytical Chemistry, Gas Chromatography, GxP
Education
University of Santo Tomas
BSChE, Chemical Engineering
Pharmacyclics LLC, An AbbVie Company July 2015 - Present
Pharmacyclics, Inc. June 2014 - July 2015
Novartis Pharmaceuticals Corp March 2014 - May 2014
Novartis Pharmaceuticals Corp September 2012 - March 2014
Pharmacyclics, Inc. August 2009 - September 2012
Pharmacyclics February 2009 - August 2009
Sgarlato Med, LLC January 2009 - August 2009
Gilead Sciences July 2005 - October 2008
Pharmacyclics 2001 - 2005
Aviron May 1999 - August 2001
Skills
GMP, FDA, Biotechnology, Validation, Change Control, CAPA, Manufacturing, cGMP, Auditing, SOP, Pharmaceuticals, Quality Systems, Document Management, Biopharmaceuticals, Small Molecules, CMO management, Compliance, Quality Assurance, Training, Global Regulatory..., GLP, Pharmaceutical Industry, Quality System, 21 CFR Part 11, Cross-functional Team..., GxP, Sop, Software Documentation, Lifesciences
Education
San Jose State University 1975 — 1980
BA, Biological Sciences
San Jose State University
Bachelor's Degree - Park Ranger Emphasis
AKQA June 2010 - Present
AKQA June 2010 - November 2012
DHAP Digital May 2004 - July 2010
Omniva Policy Systems March 2003 - March 2004
Intershop Communications August 1998 - February 2001
Aviron March 1992 - November 1996
Kan Zaman 1992 - 1996
Skills
Quality Assurance, Testing, Management, E-commerce, Test Strategy, Quality Management, Agile Methodologies, Project Management, Scrum, User Experience, Agile Project Management, Digital Marketing, Mobile Devices
Education
Trinity College Dublin 1987 — 1991
BSc, Biological Sciences
Castleknock College 1980 — 1986
Corcept Therapeutics Senior Director, FinanceAviron
Aviron 1998 - 2002
Education
University of Massachusetts, Amherst
MedImmune 1993 - Present
MedImmune January 1992 - Present
MedImmune, an AstraZeneca Company 1992 - Present
MedImmune Vaccines (formerly Aviron, purchased by Astra-Zeneca in 2007) 1992 - Present
Aviron 1992 - 2000
Education
University of Michigan 1972 — 1978
PhD, Epidemiologic Science
BioMarin Pharmaceutical Inc. July 2014 - Present
Bio-Rad Laboratories January 2011 - January 2014
Cell Genesys December 2003 - October 2008
Inhale 2000 - 2003
Aviron 1998 - 2000
Scios 1994 - 1998
Synergen March 1992 - August 1994
Some additional Information January 1984 - December 1984
Skills
Validation, Documentation, cGMP, Biotechnology, Quality Systems, Pharmaceuticals, Quality Assurance, Change Management, SOP, FDA, GLP, CAPA, Troubleshooting, Problem Solving, Program Management, Medical Devices, Scheduling, Software Documentation, Manufacturing, Testing, Sop, Quality System, Process Improvement, Pharmaceutical Industry, Automation, Calibration, Process Scheduler, GMP, Laboratory, Change Control
Education
Laney College 2012 — 2014
Machine Tool Technology/Machinist
Monterey Peninsula College 1981 — 1984
General Studies
Genentech April 2014 - Present
Genentech October 2013 - Present
Genentech March 2012 - October 2013
Prescient Life Sciences (formerly CIS) December 2009 - April 2012
Oregon Health and Science University (OHSU) November 2005 - October 2009
OHSU January 2003 - October 2005
OHSU February 2001 - November 2002
Aviron June 1995 - September 1995
Skills
Life Sciences, Biotechnology, Molecular Biology
Education
The University of Glasgow 1997 — 2000
Ph.D, Laboratory of Prof. Robert Brown, Department of Medical Oncology, Beatson Cancer Institute
Trinity College, Dublin 1993 — 1997
B.A. Mod. Genetics, Genetics, Biochemistry, Cell Biology & Microbiology.
Veracyte, Inc. May 2009 - Present
Facet Biotech / PDL BioPharma / Abbott Biologics January 2003 - January 2009
Eos Biotechnology January 1998 - January 2003
Affymetrix January 1996 - January 1998
Aviron January 1993 - January 1996
Skills
Biotechnology, Molecular Biology, Assay Development, Lifesciences, Immunology, PCR, Genomics, DNA sequencing, Biochemistry, Biomarker Discovery, DNA, Next Gen Sequencing, Bioinformatics, Biostatistics, RNA, Clinical Research, Gene Expression..., Microarray, Laboratory, Cancer, Sequencing, Biomarkers, Life Sciences, DNA Sequencing, Drug Discovery, Validation
Education
University of California, Berkeley 1989 — 1993
Bachelors, Molecular and Cell Biology
UCSC Extension Silicon Valley 2013 - Present
AstraZeneca 2007 - 2013
MedImmune 2002 - 2007
Aviron 1998 - 2002
Skills
Vaccines, ELISA, Monoclonal Antibodies, Assay Development, Biopharmaceuticals, ELISPOT, Cell Culture, GLP, Biotechnology, Virology, GMP, Purification, Immunoassays, SDS-PAGE
Education
Rutgers, The State University of New Jersey-Newark 1983 — 1986
Master's degree, Molecular Biology
Siemens Healthcare April 2014 - Present
Volcano Corporation December 2010 - April 2014
Volcano Corporation February 2010 - April 2014
Affymetrix April 2001 - June 2009
Aviron September 1998 - April 2001
Neotech Cosmetic Company April 1997 - August 1998
Skills
Quality Assurance, CAPA, ISO 13485, Manufacturing, GMP, FDA, Quality System, V&V, Change Control, Sop, 21 CFR Part 11, Validation, ISO
Education
Aquinas University
B.S., Chemistry
Relypsa October 2014 - Present
Relypsa December 2012 - September 2014
Relypsa September 2010 - December 2012
FibroGen September 2007 - September 2010
Biologics Consulting Group 2001 - 2007
Aviron 1999 - 2001
CCS Associates 1997 - 1999
Education
University of California, Irvine 1990 — 1996
B.S. Biology, Ecology and Evolutionary Biology Emphasis; Dance Minor
Genentech, Inc October 2006 - Present
Inc April 2005 - October 2006
Genentech, Inc September 2000 - April 2005
Genentech, Inc April 1999 - August 2000
Genentech, Inc September 1996 - April 1999
Aviron October 1994 - September 1996
Skills
Quality Assurance, Documentation, FDA, Manufacturing, Sop, GMP, Change Control, Quality Control, Validation, Technology Transfer, Trackwise, Quality System, Cross-functional Team..., Biotechnology, Aseptic Processing, 21 CFR Part 11, Purification, Biopharmaceuticals, LIMS, CAPA, GxP, Pharmaceutical Industry, Fermentation, TrackWise, SOP
Education
Holy Names College 1990 — 1994
BA, Biological Sciences
Lowell HS 1986 — 1990
Diploma
Novartis September 2013 - Present
Hyde Engineering + Consulting October 2011 - September 2013
Barry-Wehmiller Design Group 2009 - October 2011
NCSRT 2007 - 2009
URS, formerly Washington Group Intl. 2001 - 2006
Aviron 2001 - 2001
GlaxoSmithKline 2000 - 2001
SP Pharmaceuticals 1992 - 2000
Skills
Validation, GMP, CAPA, FDA, Sop, 21 CFR Part 11, Pharmaceutical Industry, GxP, Quality Control, Quality Assurance, V&V, Change Control, GAMP, Biopharmaceuticals, Microbiology, Aseptic Processing, Quality Auditing, Biotechnology, Cleaning Validation, Computer System..., Technology Transfer, Quality System, Process Simulation, Vaccines, Chromatography, SOP, HPLC, LIMS, Lifesciences
Education
Ashford University
Masters, Organizational Management, International Business
Ashford University
Bachelors, Organizational Management, Environmental Science
Self-employed Senior executive of Quality Assurance/Control with proven strengths in managing product and process quality throughout product Lifecycle in the Pharmaceutical industry. Demonstrated successfully both technical and management abilities in research and development, quality control operation, quality assurance systems, quality risk management, regulatory compliance and validation of both clinical and commercial products in both domestic and international markets. Have built strong teams of Quality professionals to support manufacturing of quality and safe products. Possess good interpersonal and analytical skills with strong attention to details.Director Worldwide QA Drugs and BiologicsAllergan Inc.2005 - 2015
Chiron Corporation 1999 - 2004
Aviron 1998 - 1999
Alpha Therapeutic Corp 1985 - 1997
Skills
Change Control, Technology Transfer, Pharmaceutical Industry, Quality System, Quality Assurance, Regulatory Requirements, Validation, Process Validation, Quality Control, LIMS Management, Laboratory, CMO Quality Management, Failure Investigation, Material Quality..., Analytical Method...
Education
Case Western Reserve University
Doctor of Philosophy (Ph.D.), BioPhysical Chemistry