BIOMARIN Pharmaceutical
Industry: Biotechnology company
DescriptionBioMarin Pharmaceutical Inc. is an American biotechnology company headquartered in San Rafael, California. It has offices and facilities in the United States, South America, Asia, and Europe. BioMarin's core business and research is in enzyme replacement therapies. Headquarters: Novato, CA CEO: Jean-Jacques Bienaime (May 2005–) Revenue: 1.31 billion USD (2017) Subsidiaries: Prosensa, BioMarin/Genzyme LLC,
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BIOMARIN Pharmaceutical Employees
BioMarin 2005 - 2010
BioMarin Pharmaceutical May 2003 - 2005
BioMarin 2001 - 2003
BioMarin 2000 - 2001
Genentech 1996 - 1997
Skills
QC, Microbiology, GMP, cGMP, SOP, Quality Auditing, GLP, Environmental Monitoring, Quality Control, Biotechnology, Biopharmaceuticals, Change Control, 21 CFR Part 11, Sop, LIMS, GxP, Aseptic Processing, CAPA, FDA, Pharmaceutical Industry
Education
University of California, Davis
BS, Microbiology
BioMarin Pharmaceutical Inc. March 2013 - Present
BioMarin 2004 - Present
BioMarin Pharmaceutical February 2004 - March 2013
Spherion\Genetech July 2003 - September 2003
The MONY Group April 2002 - April 2003
Skills
Active Directory, VMware ESX, Data Center, Validation, Microsoft SQL Server, Microsoft Exchange, Servers, EMC Storage, Citrix, Hyper-V, IT Management, 21 CFR Part 11, Document Management, Biotechnology, Vendor Management, Computer System..., Troubleshooting, Infrastructure, Network Administration, Cisco Technologies, vSphere, Networking, Storage, System Deployment, HP, Windows
Education
University of California, Davis 1996 — 2001
Private Biotechnology Company September 2015 - Present
BioMarin Pharmaceutical May 2013 - September 2015
Millennium Health June 2012 - May 2013
UC San Diego Medical Center July 2011 - June 2012
Skills
Molecular Biology, Protein Purification, Cell Culture, Microsoft Excel, PCR, PowerPoint, Laboratory, DNA sequencing, Excel, Mass Spectrometry, Laboratory Research, LC-MS, Analytical Chemistry, Data Analysis, Enzyme Assays, Cellular Assays, Drug Discovery, UV Spectroscopy, Laboratory Automation
Education
University of California, San Diego
B.S., Biochemistry and Cell Biology
University of California, San Diego - The Rady School of Management
Business
C&A Consulting, LLC March 2015 - Present
Sabbatical May 2014 - March 2015
BioMarin Pharmaceutical Inc. March 2013 - May 2014
BioMarin Pharmaceutical August 2007 - March 2013
BioMarin Pharmaceutical Inc. December 2006 - August 2007
BioMarin Pharmaceutical Inc. December 2003 - December 2006
BioMarin Pharmaceutical Inc. May 2002 - December 2003
Earl Haramaki September 2000 - May 2002
Quasar Services, Inc March 1999 - September 2000
Xoma, LLC March 1998 - March 1999
Skills
Validation, Change Control, GMP, CAPA, Cell Culture, Quality Assurance, FDA, Cleaning Validation, Trackwise, Project Management, Shutdown, Manufacturing, Sop, V&V, GLP, Biotechnology, Fermentation, 21 CFR Part 11, Quality System, LIMS, Aseptic Processing, Biopharmaceuticals, CMMS, GxP, SOP
Education
California Polytechnic State University-San Luis Obispo 1989 — 1994
Bachelor of Science (BS), Physiology, General
Private technology company October 2014 - Present
BioMarin Pharmaceutical August 2012 - October 2014
Valley Emergency Physicians March 2010 - December 2010
Skills
Microsoft Office, Cell Culture, PCR, Gel Electrophoresis, Aseptic Technique, GMP, Purification, Matlab, Fermentation, Salesforce.com, LIMS, Inventory Planning, Procurement, Scanning Electron..., Histology, Vendor Management
Education
University of California, Berkeley 2009 — 2012
Bachelor of Arts (B.A.), Integrative Biology
Nature Made Nutritional Supplements - Otsuka Pharmaceutical April 2014 - Present
BioMarin Pharmaceutical January 2013 - February 2014
Johnson & Johnson June 2012 - September 2012
Connecticut - Department of Pubic Health January 2012 - May 2012
Center for Disease Control and Prevention, Xiamen, China June 2011 - April 2012
Scripps Institution of Oceanography September 2008 - March 2009
Skills
Public Health, Global Health, Data Analysis, Epidemiology, Regulatory Affairs, GIS, SAS, Infectious Diseases, Policy Analysis, SPSS, Health Policy Review, Translation, Project Management, ICH guidelines, Orphan Drugs, Strategy, Analysis, Interviews, Research, CTD, FDA, Clinical Trials
Education
Yale School of Public Health 2010 — 2012
Master of Public Health, Major in Environmental Health Sciences; Minor in Regulatory Affairs
University of California, San Diego 2004 — 2009
B.S.; B.A., Environmental Biology; International Studies Economics
BioMarin Pharmaceutical Vice President, Research and DevelopmentRaven biotechnologies, inc.2000 - 2007
Genentech 1980 - 2000
Education
University of Cincinnati College of Medicine 1970 — 1975
Ph.D., Biological Chemistry
Bowling Green State University 1966 — 1970
B.S.
Medical Device Manufacturer July 2014 - Present
Advanced Sterilization Products July 2013 - July 2014
Advanced Sterilization Products April 2012 - August 2013
BioMarin Pharmaceutical July 2009 - April 2012
BioMarin Pharmaceutical November 2008 - July 2009
Boogie Limited August 2008 - October 2008
Media Rights Technologies November 2005 - July 2008
Skills
Documentation, Document Management, Group Presentations, Customer Service, Software Documentation, Employee Training, Training Delivery
Education
University of California, Santa Cruz 2004 — 2008
B.A, Environmental Studies & Economics
Terra Linda High School 2000 — 2004
High School Diploma
Jazz Pharmaceuticals April 2012 - Present
IMS Health August 2011 - March 2012
Kantar Health May 2007 - July 2011
Oncology Therapeutics Network January 2006 - May 2007
Biomarin Pharmaceutical September 2003 - December 2005
Amersham Pharmacia Biotech 2001 - September 2003
University of Phoenix April 2000 - September 2001
Molecular Dynamics 2000 - 2001
Ingenuity Systems 2000 - 2001
Boston Scientific 1999 - 1999
Skills
Oncology, Market Research, Clinical, Managed Care, Analytics, Longitudinal patient..., Managed Markets, Data, Clinical Research, Product Launch, Biotechnology, Business Intelligence, Data Analysis, Cross-functional Team..., Commercialization, Strategy
Education
Boston University Questrom School of Business 1997 — 1999
MBA, Finance
University of California, Davis 1991 — 1997
Ph.D, Genetic
San Jose State University 1985 — 1991
B.S., Molecular Biology
Los Medanos 1981 — 1986
Lycee Saint Louis 1970 — 1980
College Cevenol
BioMarin Pharmaceutical November 2012 - Present
Exelixis, Inc. February 2012 - July 2012
SciClone Pharmaceuticals January 2008 - February 2012
CELERA 2004 - 2008
QUEST DIAGNOSTICS, INC January 2001 - January 2003
NUTRICIA, INC January 1999 - January 2001
GENZYME CORPORATION January 1986 - January 1998
Skills
Supply Chain, MRP, Strategic Sourcing, Production Planning, Procurement, Purchasing, Six Sigma, Inventory Management, Contract Manufacturing, Logistics, Clinical Supply Chain, CMO management, S&OP implementation, Medical Devices, Biotechnology, Supply Management, Materials Management, Demand Planning, Global Sourcing, GMP, Process Improvement, SAP, ERP, Supply Chain Management, Forecasting, Sourcing, Strategy, Product Development
Education
Anna Maria College 1980 — 1983
MBA, Business
University of Massachusetts, Amherst 1973 — 1977
BBA, Business Management
BioMarin Pharmaceutical November 2010 - Present
The Clorox Company June 2010 - October 2010
Novartis Vaccines and Diagnostics January 2003 - January 2010
FormFactor 2000 - 2002
AirTouch Communications 1995 - 2000
Pacific Bell 1990 - 1995
Pacific Bell 1978 - 1995
Skills
Workshop Facilitation, Instructional Design, Project Management, Consulting, Organization, Learning Management..., Organizational..., Cross-functional Team..., Program Management, Human Resources, Talent Management, Employee Engagement, Adoption Management, Internal Communications, Strategy, Management, Performance Management, Organizational..., SAP, Continuous Improvement, Training, Leadership Development, Team Management, Leadership, Training Delivery, Team Leadership, Vendor Management, Organizational Design, Employee Training, Coaching, Management Consulting, Business Process..., Process Improvement
Education
University of San Francisco 1996 — 1998
MA, Human Resources and Organization Development
CSU Sacramento 1969 — 1972
English Literature, Teaching Credential
Ultragenyx Pharmaceutical Inc. May 2013 - Present
BioMarin January 2011 - May 2013
BioMarin January 2010 - January 2012
BioMarin Pharmaceutical January 2005 - January 2010
BioMarin January 2003 - January 2005
Institut Curie 1986 - 1992
Skills
Biotechnology, Lifesciences, Clinical Development, Cell Culture, Molecular Biology, ELISA, Protein Purification, Cell Biology, Immunology, Drug Development, Biochemistry, Cell, Assay Development, Drug Discovery, Flow Cytometry, Genetics, Western Blotting, Protein Expression, Pharmaceutical Industry, Oncology, Biopharmaceuticals, Protein Chemistry, Purification, In Vitro, Genomics, R&D, Project Management, Life Sciences
Education
Université Denis Diderot (Paris VII) 1986 — 1992
Ph.D., Virology
Université Paris Sud (Paris XI) 1985 — 1992
master, biologie
Université Claude Bernard Lyon 1 1981 — 1984
Deug B, biologie
lycee saint exupery 1981 — 1984
BS, Biology
College Andre Lassagne
Complete Genomics September 2010 - Present
Pacific Biosciences October 2005 - July 2010
Applied Biosystems Inc May 2002 - July 2005
BioMarin Pharmaceutical May 1999 - April 2002
University of California-Berkeley (Plant Gene Expression Center) 1996 - 1999
Skills
Validation, Experimental Design, Data Mining, Genomics, DNA sequencing, Sequencing, Drug Discovery, Assay Development, Biotechnology, Genetics, Molecular Biology, Biochemistry, Lifesciences, DNA, Cell Biology, Technology Transfer, Bioinformatics, Cell Culture, qPCR, Computational Biology, Microarray, Purification, Protein Chemistry, PCR, Genotyping, Sequence Analysis, Laboratory Automation, High Throughput..., Molecular Diagnostics, Proteomics, Life Sciences, DNA Sequencing
Education
University of Canterbury 1990 — 1993
PhD, Molecular Biology, Cell Biology, Genetics
Self Employed July 2014 - Present
BioMarin Pharmaceutical July 1999 - July 2014
XOMA November 1995 - July 1999
Somatix Therapy Corporation September 1993 - November 1995
XOMA December 1991 - September 1993
Cetus Corporation October 1979 - December 1991
Skills
Microbiology, Molecular Biology, Biopharmaceuticals, GMP, Biotechnology, CMMS, Facilities Management, Project Management, FDA, Change Control, Validation, Technology Transfer, Sop, Quality Assurance, R&D
Education
Golden Gate University 1983 — 1985
MBA, Management (1985)
The Ohio State University 1977 — 1979
MS, Molecular Biology (1979)
The Ohio State University 1974 — 1977
BS, Microbiology (1977)
Biomarin Pharmaceutical September 2015 - Present
The University of Texas Health Science Center at Houston September 2014 - May 2015
The University of Texas Health Science Center at Houston August 2012 - August 2014
University of Texas Medical Branch June 2006 - August 2012
Jawaharlal Nehru Center for Advanced Scientific Research April 2003 - June 2003
Skills
Protein Expression, Protein Purification, Protein Structure, High Throughput..., Protein Assays, Aptamers, SELEX, Drug Discovery, Drug Development, X-ray crystallography, Fluorescence..., Thermophoresis, NMR spectroscopy, Protein thermal..., Thermofluor, Molecular Biology, Protein Chemistry, Structural Biology, Biochemistry, NMR, Proteomics, Bioinformatics, Assay Development, Biophysics, Lifesciences, Molecular Cloning, Purification, Life Sciences
Education
Keck Graduate Institute 2015 — 2016
Postdoctoral Professional Masters (PPM), Bioscience Management
The University of Texas Medical Branch at Galveston 2006 — 2012
Doctor of Philosophy (Ph.D.), Molecular Biophysics Educational Track (MBET), 3.8
Anna University 2000 — 2004
B.Tech, Industrial Biotechnology
D.A.V. 1998 — 2000
High School, Biology, General
Valliammal 1986 — 1998
Secondary School
Hndrd January 2015 - Present
Finance and Treasury Advisory Services September 2014 - Present
BioMarin Pharmaceutical August 2008 - July 2014
UTStarcom Inc. September 2005 - July 2008
Genentech September 1999 - August 2005
Univeristy of Chicago 1997 - 1999
Skills
Corporate Finance, Strategic Planning, Risk Management, Finance, Management, Strategy, Mergers & Acquisitions, Forecasting, Leadership, Managerial Finance, Process Improvement, Business Strategy, Strategic Financial..., Executive Management, Portfolio Management, Analysis, Financial Planning
Education
The University of Chicago Booth School of Business 1997 — 1999
MBA, Finance and International Business
Georgia Institute of Technology
Doctor of Philosophy (Ph.D.), Chemical and Biomolecular Engineering
Indian Institute of Technology, Bombay
Bachelor of Technology (BTech), Chemical Engineering
University of California, San Diego- Department of Pharmacology June 2014 - Present
Claremont McKenna College- Keck Science Department August 2012 - May 2013
Keck Graduate Institute August 2012 - May 2013
Genentech May 2012 - August 2012
Genentech May 2011 - August 2011
BioMarin Pharmaceutical June 2010 - August 2010
Education
University of California, San Diego - School of Medicine
Doctor of Philosophy (Ph.D.), Biomedical Sciences
Claremont McKenna College 2009 — 2013
Bachelor of Arts (B.A.), Molecular Biology
Campolindo High School 2005 — 2009
BioMarin Pharmaceutical September 2006 - Present
Sun Microsystems 1998 - 2006
ITT Sheraton 1993 - 1998
GWV International January 1985 - February 1991
Skills
PMO, Project Coaching, Software Procurement, Bid Development, MS Project, Project Server, Timeline Management, Dashboards, Business Process, Software Training, Livelink, Publication Software, Event Planning, Business Operations, Cross-functional Team..., Dashboard, Management, Biotechnology, Document Management, Leadership, Software Documentation, Project Management
Education
Boston University
MSW, Management & Planning
Union College
BA, Spanish, Sociology
University of California, Berkeley
BioMarin Pharmaceutical September 2011 - Present
BioMarin Pharmaceutical September 2008 - September 2011
Skills
Process Optimization, SPC, Process Simulation, Design of Experiments, Multivariate Analysis, Data Management, Technology Evaluation, HPLC, Biotechnology, Technology Transfer, Protein Chemistry, Cell Culture, GMP, Process Analytical..., Fermentation
Education
The University of Calgary 2003 — 2008
PhD, Chemical Engineering
University of Waterloo 2000 — 2003
MASc, Chemical Engineering
University of Waterloo 1995 — 2000
BASc, Chemical Engineering
BioMarin Pharmaceutical May 2000 - Present
Genentech 1986 - 2000
Skills
GMP, Clinical Development, Leadership, Analytical Chemistry, Technology Transfer, Biotechnology, Biochemistry, Regulatory Submissions, Quality Control, Biopharmaceuticals, Lifesciences, Regulatory Requirements, GLP, Cell Culture, FDA, Management
Education
The Graduate Center, City University of New York 1976 — 1983
Ph.D., Biochemistry
Regis University 1999 — 2001
Master of Business Administration (M.B.A.)
ImmunoGen, Inc. June 2012 - Present
Bristol-Myers Squibb December 2010 - June 2012
Antisoma September 2009 - April 2010
Novartis Oncology September 2007 - September 2009
BioMarin Pharmaceutical January 2006 - September 2007
Onyx Pharmaceuticals April 2002 - January 2006
Amgen Inc. 2000 - 2002
Chiron Corporation 1989 - 2000
Skills
Project Management, Program Management, Oncology, Cross-functional Team..., Clinical Development, Product Development, Drug Development, Commercialization, Clinical Trials, Licensing, Marketing Strategy, Decision Analysis
Education
San Francisco State University, College of Business 1996 — 1998
mba, finance
University of California, Berkeley 1984 — 1989
BA, Biochemistry
BioMarin Pharmaceutical February 2007 - Present
Biogen Idec April 2001 - February 2007
Magellan Laboratories May 2000 - April 2001
Allermed Laboratories October 1997 - May 2000
McGhan Medical September 1992 - August 1997
Skills
IND, Regulatory Affairs, Regulatory Submissions, FDA
Education
San Diego State University-California State University 2001 — 2004
MS, Regulatory Affairs
San Diego State University-California State University 1997 — 1999
MS, Biology
UC Santa Barbara 1987 — 1992
BA, Biology
Incyte January 2015 - Present
Vital Therapies, Inc. August 2013 - Present
Biotechnology Industry Organization October 2006 - Present
BIOMARIN Pharmaceutical May 2005 - Present
BioMarin Pharmaceutical Inc. May 2005 - Present
Skills
Biotechnology, Pharmaceutical Industry, Commercialization, Lifesciences, Oncology, Market Access, Biopharmaceuticals, Cardiology, Product Launch, Drug Development, Clinical Development, Technology Transfer, Clinical Trials, Neurology
Education
University of Pennsylvania - The Wharton School 1978 — 1980
Master of Business Administration (MBA), Finance, General
Ecole Superieure de Commerce de Paris 1974 — 1976
ESCP diploma, econometircs, Finance
BioMarin Pharmaceutical January 2012 - Present
BioMarin Pharmaceutical November 2008 - December 2011
The Exploratorium of San Francisco September 2007 - November 2007
CHR HANSEN March 2007 - August 2007
CIRAD (Center for International Cooperation in Agronomic Research for Development) of Montpellier March 2006 - August 2006
Biosens (laboratory of agri-food analyses working with INRA) – Clermont-Ferrand, France August 2002 - August 2004
Skills
HPLC, Assay Development, LCMS, Analytical Method..., Watson LIMS, SOP development, ELISA, Electronic Lab Notebooks, Pharmaceutical Industry
Education
City College of San Francisco 2008 — 2008
GMP and GLP Principles
University Montpellier II 2004 — 2007
Master’s degree in Chemistry
University Institute of Technology, IUT Jean Monnet Saint-Étienne 2000 — 2002
Two-years Technical University Diploma, Biology and Environmental Sciences
Ambroise Brugière High School, Clermont-Ferrand
1999High School diploma in sciences, specializing in Biology
Novartis Institutes for BioMedical Research February 2010 - Present
Hoffmann-La Roche July 2009 - February 2010
Exelixis, Inc. April 2006 - July 2009
BioMarin Pharmaceutical October 2004 - April 2006
Southern Research Institute September 2002 - September 2004
CIIT June 2000 - September 2002
USEPA 1996 - 2000
Skills
oncology drug..., Discovery Toxicology, Biotechnology, Toxicology, Clinical Development, Oncology, Pharmacology, Pharmaceuticals, Biomarker Discovery, Drug Development, In Vivo, Pharmaceutical Industry, CRO, Pharmacokinetics, Drug Discovery, Protocol, Clinical Trials, Clinical Research, Biomarkers, Assay Development, GLP, In Vitro, Lifesciences, Immunology, Biopharmaceuticals, IND, Cell, Cancer, Regulatory Submissions, Vaccines, NDA, Life Sciences
Education
College of Wooster
BA, Biology
University of North Carolina at Chapel Hill
MSPH, School of Public Health/Environmental Sciences and Engineering
University of North Carolina at Chapel Hill
PhD, Toxicology
BioMarin Pharmaceutical 2014 - Present
Novartis Vaccines and Diagnostics February 2013 - 2014
Consultant March 2012 - February 2013
Amyris Biotechnologies June 2007 - March 2012
Chiron Corporation January 1991 - April 2007
Cetus Corporation 1982 - 1991
Skills
Biotechnology, GMP, Separations, Technology Transfer, Large Scale Deployments, Fermentation, Protein Chemistry, Microbiology, HPLC, Validation, Chemistry, Filtration, Purification, Process Simulation, Design of Experiments, Centrifugation, Chromatography, Cell, Biofuels, Lifesciences, Biopharmaceuticals, Laboratory, V&V, Protein Purification, Drug Discovery, Life Sciences
Education
University of California, Santa Cruz
Bachelor's degree, Biological Sciences
Amplyx Pharmaceuticals, Inc February 2009 - Present
BioMarin Pharmaceutical 2003 - Present
Fluxion Biosciences 2007 - 2012
Labcyte Inc July 2001 - October 2008
Applied Biosystems 1997 - 2000
Molecular Dynamics 1987 - 1991
Skills
Genomics, Chemistry, Molecular Biology, Drug Development, Science, R&D, Pharmaceutical Industry, Lifesciences, Mergers & Acquisitions, Drug Discovery, Biotechnology, Medical Devices, Marketing Strategy, Commercialization, Proteomics, Strategy, Start-ups, Oncology, Infectious Diseases, Technology Transfer, Board of Directors, Business Strategy, Licensing, Marketing, Leadership, Clinical Development, Immunology, Business Development, Product Development, Biochemistry, FDA, Board of Director..., Corporate Governance, Biopharmaceuticals, Protein Chemistry, Pharmaceutics, Hardware Diagnostics, Management
Education
Purdue University 1966 — 1974
B.S. Ph.D., chemistry
Pike High School Indianapolis
BioMarin Pharmaceutical March 2009 - Present
Bayer Healthcare May 2007 - Present
Bayer Healthcare March 2003 - May 2007
Scios 2001 - 2003
Scios - J&J Company 2001 - 2003
Skills
Centrifugation, Chromatography, Biopharmaceuticals, GMP, Validation, Cell Culture, Downstream Processing, Cell, Technology Transfer, Purification, Fermentation, recombinant DNA..., Filtration, Peptides, Protein Chemistry
Education
Technische Universität Hamburg-Harburg 1996 — 2000
Doctor of Philosophy (PhD), Biotechnol
University of Ibadan 1993 — 1994
Master's degree, Food Technology
BioMarin Pharmaceutical 2002 - Present
Education
University of Rochester - Simon Business School 1998 — 1999
MBA, Finance
California Polytechnic State University-San Luis Obispo 1988 — 1993
BioMarin Pharmaceutical June 1999 - Present
BioMarin 1999 - 2009
Skills
Protein Chemistry, Drug Development, Cell Culture, Protein Purification, Biopharmaceuticals, Assay Development, Drug Discovery, Team Management, Clinical Development, Biotechnology, ELISA, Molecular Biology
Education
Massachusetts Institute of Technology 1987 — 1993
BioMarin Pharmaceutical Inc December 2011 - Present
UC Berkeley March 2010 - Present
Bridge Clinical Solutions, LLC September 2005 - Present
Novartis July 2009 - December 2011
BioMarin Pharmaceutical August 2006 - December 2011
DSP Clinical Research June 2006 - December 2011
Ipsen January 2011 - June 2011
Proteus SA 2007 - 2008
Medtronic Vascular August 2002 - September 2005
Berlex Biosciences April 1999 - August 2002
Skills
GCP, Clinical Trials, Sop, Training, Protocol, Clinical Research, Cross-functional Team..., Project Management, System Monitoring, Biotechnology, Therapeutic Areas, Drug Development, FDA, Clinical Development, Pharmaceutical Industry, Lifesciences, Oncology, SOP, CTMS
Education
Delaware Valley University 1974 — 1978
BS, Biology
Halozyme Therapeutics, Inc. November 2011 - Present
Ambrx, Inc. April 2008 - November 2011
Xencor January 2006 - March 2008
Cancervax 2004 - 2005
BioMarin Pharmaceutical 1996 - 2003
Skills
Validation, Biopharmaceuticals, GMP, Contract Manufacturing, Manufacturing, Biotechnology, Technology Transfer, Lifesciences, Cell Culture, FDA, Purification, Clinical Development, Pharmaceutical Industry, CMC, Fermentation, Vaccines, V&V, Protein Chemistry, CAPA, Aseptic Processing, Sop, Protein Purification, GLP, Drug Development, IND
Education
The Ohio State University
BS
BioMarin Pharmaceutical May 2006 - Present
Dey, L.P. 2004 - 2006
Santen 2002 - 2004
QuantumShift 2000 - 2002
The Doctors' Company 1996 - 2000
Skills
Pharmaceuticals, Forecasting, Market Research, Product Launches, Data Analysis, Salesforce.com, Sales Operations, Sales Support, Planning, Biotechnology, Pharmaceutical Industry, Product Launch, Management, Sales Analysis, Strategy, Cross-functional Team..., Biopharmaceuticals, Lifesciences, Project Planning, Pharmaceutical Sales, Clinical Development, Market Analysis, Commercialization
Education
University of California, Berkeley - Walter A. Haas School of Business 1988 — 1990
Master of Business Administration (MBA)
Fordham University 1980 — 1984
BA, Mathemetics/Computer Science
BioMarin October 2011 - Present
BioMarin January 2009 - October 2011
BioMarin Pharmaceutical January 2007 - December 2009
Skills
Vendor Management, Biotechnology, Cross-functional Team..., IT Operations, Pharmaceutical Industry, Project Management, Computer System..., Biopharmaceuticals, SDLC, Program Management, 21 CFR Part 11, Document Management, FDA, Validation, Life Sciences, GMP, SOP, Change Control, Software Documentation, Cloud Computing, SaaS, Clinical Trials
Education
University of California, Los Angeles 1994 — 1997
B.S., Molecular, Cell, and Developmental Biology
The Permanente Medical Group June 2010 - Present
The Gordon and Betty Moore FOundation 2007 - 2010
BioMarin Pharmaceutical 2006 - 2007
Scios 2003 - 2006
Scios, Johnson & Johnson 2003 - 2006
Scios Inc./JNJ 2003 - 2006
Skills
Infectious Diseases, Medical Writing, Biotechnology, Life Sciences, Clinical Trials
Education
University of California, Davis - School of Medicine 1992 — 1996
Doctor of Medicine (MD)
Brown University
A.B., Urban Studies/Affairs
BioMarin Pharmaceutical May 2012 - Present
Vertex Pharmaceuticals 2011 - May 2012
Vertex Pharmaceuticals 2009 - 2011
Vertex Pharmaceuticals 2007 - 2009
Genentech 2007 - 2007
Skills
Drug Development, PK/PD, Clinical Pharmacology, GMP, Validation, Clinical Development, Pharmacokinetics, IND, Pharmacology, Translational Medicine, Biomarkers, Bioanalysis, Clinical Trials, Drug Discovery, CRO, Pharmaceutical Industry
Education
Duke University
Ph.D., Biomedical Engineering
University of Notre Dame
B.S., Chemical Engineering
University of Notre Dame
B.S., Biochemistry
BioMarin Pharmaceutical Inc. January 2013 - Present
BioMarin Pharmaceutical February 2004 - Present
Pacific Pulmonary Services January 2000 - January 2004
Education
Dominican University of California
Business
BioMarin January 2011 - Present
Human Genome Sciences March 2010 - December 2010
Human Genome Sciences November 2007 - March 2010
BioMarin Pharmaceutical 2001 - 2007
BioMarin 2001 - 2007
SRI International 2001 - 2001
Genentech 1998 - 2000
Skills
Biopharmaceuticals, FDA, Cell Culture, Technology Transfer, Chromatography, Purification, Protein Purification, GLP, Change Control, LIMS, GMP, CAPA, Pharmaceutical Industry, Sop, Validation, Biotechnology, Aseptic Processing, Protein Chemistry, Computer System..., Quality Control, Laboratory, Quality System, Immunoassays, Manufacturing, Filtration, Cell, GxP, Oncology, ELISA, HPLC, V&V, Clinical Development, Aseptic Technique, Vaccines, Trackwise, PCR, Formulation, Regulatory Submissions, Drug Development, Clinical Trials, Regulatory Affairs, Regulatory Requirements, CRO, GCP, Process Simulation, Molecular Biology, Cleaning Validation, 21 CFR Part 11, Fermentation, Microbiology
Education
Sacred Heart Cathedral Prep
San Francisco State University
Biochemistry, Nursing
University of California, Davis
Biochemistry, Medicine
GE Healthcare July 2015 - Present
Michelle F. Hutchinson, LLC October 2014 - June 2015
Dendreon Corporation March 2011 - March 2014
Biomarin Pharmaceutical August 2008 - March 2011
Genentech April 2001 - May 2008
Corixa Corporation September 1999 - March 2001
Bayer Pharmaceutical February 1999 - September 1999
Skills
Technical Leadership, Project Management, Written and Verbal..., Process Validation, Validation, Engineering, GMP Manufacturing, GMP Systems, FDA and ICH Guidelines, Audits and Regulatory..., Equipment Selection and..., Equipment Commissioning, IQ/OQ/PQ, Process Qualification, Scale Up, Process Monitoring, Statistical Process..., Lean Manufacturing, Process Optimization, Data Analysis, Risk Assessment, FMEA, Technical Writing, Kaizen, Deviations and CAPAs, Change Control, Chromatography, Filtration, V&V, FDA, GMP, Manufacturing, Biotechnology, Quality Assurance, Sop, Purification
Education
Stanford University 2006 — 2008
Certificate, Innovative Manufacturing, Management Science and Engineering
University of Michigan 1993 — 1998
Bachelor of Science, Chemical Engineering
Bayer HealthCare December 2003 - Present
BioMarin Pharmaceutical 1997 - 2003
Education
University of California, Los Angeles 1994 — 1997
Dynavax Technologies July 2015 - Present
Dynavax Technologies November 2013 - July 2015
Dynavax Technologies August 2013 - November 2013
Dynavax Technologies April 2012 - August 2013
BioMarin Pharmaceutical May 2011 - March 2012
CCBR Synarc July 2010 - May 2011
Synarc, Inc January 2006 - July 2010
San Francisco General Hospital TB Clinic June 2008 - January 2009
Synarc, Inc August 2004 - January 2006
Skills
GCP, Clinical Trials, Clinical, Clinical Trial..., Clinical Research, Inspection Readiness, Inspection, CTMS, ICH-GCP, FDA, Protocol, Clinical Operations, CAPA, EDC, Pharmaceutical Industry, Biotechnology
Education
San Francisco State University 2006 — 2008
Post Baccalaureate
University of California, Berkeley 2000 — 2004
BA
Thomas Jefferson High School 1996 — 2000
PolyLC Consult with biotechnology and biopharmaceutical customers on their HPLC and other separation needs and problems. Drawing on over 40 years experience separating proteins, peptides, polynucleotides, plasmids, lipids, polysaccharides, conjugated molecules, small molecule pharmaceuticals, vitamins and Adeno virus. I have worked with nitrogenase, Factor VIII, von Willebrand factor, PRPP synthetase, and a lipid peptide from Don Diamond at the City of Hope. I specialize in difficult separations that can't be done with reversed phase, even if it doesn't involve PolyLC products.ScientistAdvantar LaboratoriesMarch 2014 - Present
BioMarin Pharmaceutical September 2003 - December 2012
BioMarin September 2003 - December 2012
Onyx Pharmaceuticals 2001 - 2003
Pall Life Sciences 1999 - 2002
Telios Pharmaceuticals, Inc 1988 - 1993
Telios Pharmaceuticals/Integra Lifesciences 1986 - 1990
Skills
Mammalian Cell Culture, Chromatography, Filtration, Protein Chemistry, Validation, Centrifugation, Electrophoresis, Biotechnology, Pharmaceutical Industry, HPLC, R&D, Process Simulation, Peptides, Protein Purification, ELISA
Education
University of California, San Diego 1970 — 1973
MS, Biochemistry
University of Illinois at Urbana-Champaign 1966 — 1970
BA, Chemistry, Math, Music
Ultragenyx Pharmaceutical Inc. August 2011 - Present
BioMarin Pharmaceutical August 2007 - July 2011
Dey Pharma L.P October 2004 - August 2007
Dow Pharmaceutical Sciences May 2003 - October 2004
Aradigm Corporation May 1995 - May 1996
Dey Pharma L.P November 1991 - May 1995
Skills
IND, Clinical Development, Pharmaceutical Industry, Regulatory Submissions, Biotechnology, Clinical Trials, GCP, NDA, Regulatory Affairs, Drug Development, GMP, eCTD, CRO, FDA, Biopharmaceuticals, Sop, Formulation
Education
Cornell University 1996 — 2002
Ph.D., Pharmacology
California State University, Fresno 1987 — 1991
B.S., Biochemistry
Lancaster Laboratories January 2012 - Present
Dominion Diagnostics November 2003 - June 2011
Dow Chemical September 2002 - November 2004
BioMarin Pharmaceutical November 1999 - August 2002
Zeneca Agrochemicals 1994 - 2001
Skills
HPLC, Gas Chromatography, UV, Chromatography, Biotechnology, Analytical Chemistry, Chemistry, Validation, UV/Vis, Quality Control, Pharmaceutical Industry, Laboratory, Protein Chemistry, Biochemistry, Life Sciences, GLP, Lifesciences, Technology Transfer, LC-MS, Environmental Scientist
Education
California State University-Hayward 1985 — 1988
BS, Chemistry
Celgene May 2014 - Present
BioMarin Pharmaceutical March 2013 - May 2014
Genentech June 2008 - October 2012
Gilead Sciences 2006 - 2008
Merck 1989 - 2005
Skills
Biotechnology, Drug Development, Clinical Trials, GCP, Biopharmaceuticals, Therapeutic Areas, CRO, EDC, Clinical Monitoring, Pharmaceutical Industry, Clinical Operations, Lifesciences, Clinical Study Design, Regulatory Submissions, Trial Management, Clinical Development, Oncology
Education
Old Dominion University
Master of Science (MS), Chemistry with emphasis in biochemistry
University of Florida
Bachelor of Science (BS), Microbiology and Cell Science
Ultragenyx Pharmaceutical Inc. January 2015 - Present
BioMarin February 2013 - January 2015
BioMarin Pharmaceutical January 2011 - January 2013
BioMarin November 2006 - December 2010
BioMarin February 2005 - November 2006
BioMarin March 2004 - February 2005
BioMarin February 2003 - March 2004
Skills
Manufacturing, Packaging, Logistics, Contract Manufacturing, GMP, FDA, Validation, Pharmaceutical Industry, Biotechnology, 21 CFR Part 11, CAPA, Sop
Education
Michigan State University 2011 — 2014
Master's Degree, Packaging Science
University of California, Davis 1996 — 2001
B.S., BioChemical and Chemical Engineering
BioMarin Pharmaceutical April 2013 - June 2015
Invuity Inc August 2012 - March 2013
Bio-Rad Laboratories March 2009 - April 2012
Bio-Rad Laboratories March 2009 - April 2012
Bio-Rad Laboratories January 1999 - January 2009
Baxter Novacor January 1997 - January 1999
Connectware Inc./ATM Systems January 1995 - January 1997
Connectware Inc./ATM Systems 1995 - 1997
Origin Medsystems January 1991 - January 1995
Skills
Six Sigma, Supply Chain, Manufacturing, Medical Devices, Biotechnology, GMP, Lifesciences, FDA, Validation, Product Development, Materials Management, Procurement, ERP, Pharmaceutical Industry, Process Improvement, Purchasing, Quality System, Microsoft Office, Microsoft Excel, Customer Service, Negotiation, Supply Chain Management, PCR, HPLC, Microsoft Word, Chromatography, Change Management, Sop, Quality Assurance, Forecasting, Life Sciences, Sterilization, Single use bags, Tubing Assemblies, Oracle Applications, TrackWise, OBIEE, PowerPoint
Education
University of California, Berkeley
Economics
University of California, San Diego
Marine Biology
Solutio Partners September 2012 - Present
Medivation 2009 - 2012
BioMarin Pharmaceutical 2006 - 2009
Chiron Corporation 1996 - 2006
Skills
Regulatory Affairs, Drug Development, Regulatory Strategy..., Regulatory Intelligence, FDA Liaison, Clinical Regulatory..., Nonclinical Regulatory..., CMC Regulatory Affairs, Promotional Review, IND, NDA, CTD, CTAs, Fast Track, Special Protocol..., Biologics, Small Molecules, Oncology, Rare Diseases, Orphan Drugs, USAN-INN, Biopharmaceuticals, Clinical Trials, Regulatory Requirements, Regulatory Submissions, CMC, Drug Discovery, Biotechnology, Clinical Development, FDA
Education
Yale University
BS, Molecular Biophysics and Biochemistry
UCSF
Ph.D., Pharmaceutical Chemistry
Stanford University
NIH Postdoctoral Fellowship, Chemistry
ChemoCentryx May 2015 - July 2015
Genentech January 2012 - April 2015
BioMarin Pharmaceutical December 2008 - January 2012
UCSF March 2006 - November 2008
Centers for Disease Control and Prevention November 2003 - November 2004
UCSF October 2001 - May 2003
UCSF Medical Center September 2000 - May 2003
University of Iowa Hospitals and Clinics June 1998 - August 2000
Skills
Clinical Development, Pharmaceutical Industry, Clinical Trials, Biotechnology, Clinical Research, Immunology, Oncology, Healthcare, Molecular Biology, Leadership
Education
University of California, Irvine - College of Medicine 1992 — 1998
Doctor of Medicine (M.D.)
Massachusetts Institute of Technology 1987 — 1991
Science Baccalaureate, Biology
BioMarin Pharmaceutical March 2015 - Present
BioMarin Pharmaceutical Inc. September 2013 - Present
BioMarin Pharmaceutical Inc. March 2012 - September 2013
BioMarin May 2011 - March 2012
Buck Institute for Age Research July 2008 - July 2009
Skills
Matlab, VBA, Java, Data Analysis, Excel, Biopharmaceuticals, Microsoft Excel, Statistics
Education
Università di Bologna / University of Bologna 2006 — 2010
Masters, Biomedical Engineering
Università di Bologna / University of Bologna 2002 — 2006
BS, Biomedical Engineering
BioMarin Pharmaceutical July 2006 - Present
BioMarin June 2003 - Present
Dept. Mfg Process Service January 2012 - March 2013
Buffer/Media Group June 2005 - July 2006
BioMarin 2003 - 2005
Skills
Protein Purification, Media Processing, Buffer Process
Education
Angeles University Foundation
Medical Technology
Centro Escolar University
Medical Technology
Holy Family Academy
BioMarin Pharmaceutical May 2014 - August 2014
Skills
C++, Python, HTML, CSS, Microsoft Office, AutoCAD, Adobe Design Programs
Education
Gonzaga University 2013 — 2017
Computer Science
Gonzaga University
Bachelors of Science, Computer Science