IDEC Pharmaceuticals
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IDEC Pharmaceuticals Employees
POISeD Consulting 2006 - Present
Biogen Idec April 2004 - September 2005
InterMune Inc. April 2003 - April 2004
IDEC Pharmaceuticals December 2001 - March 2003
IDEC Pharmaceuticals June 1999 - December 2001
Genentech May 1997 - May 1999
Skills
eCTD Lifecycle..., Regulatory Submissions, Project Management, Regulatory Intelligence, Technical Writing, Document Management, IND, NDA, BLA, Information Architecture, Regulatory Operations, Regulatory Affairs, Pharmaceutical Industry, Problem Solving, Publishing, Team Building, FDA, Strategic Planning, eCTD
Education
San Diego State University 2003 — 2005
MS program, Regulatory Affairs
The College of William and Mary 1987 — 1991
BA, Government / History
San Diego State University
Certification, Regulatory Affairs
University of California, Berkeley
Professional Series in Copyediting
BioMarin June 2013 - Present
Baxter Healthcare May 2012 - June 2013
Baxter Healthcare June 2010 - May 2012
Pfizer Inc. July 2008 - July 2010
Amgen October 2006 - July 2008
Amgen December 2002 - September 2006
Idec Pharmaceuticals June 1999 - December 2002
Idec 1999 - 2002
Parexel International February 1997 - June 1999
Parexel 1997 - 1999
Skills
Auditing, Oncology, Clinical Trials, Data Management, Vendor Management, Internal Performance..., GCP, ISOtrain - LMS, 21 CFR Part 11, Biotechnology, CRO, CTMS, Change Management, Clinical Data Management, Clinical Development, Clinical Monitoring, Clinical Research, Drug Development, EDC, Employee Training, FDA, Immunology, Leadership, Lifesciences, Management, Medical Affairs, Oracle Clinical, Pharmaceutical Industry, Quality Assurance, Sop, Training, Validation, Life Sciences, SOP, Cross-functional Team...
Education
Biola University 2003 — 2005
BS, Organizational Leadership, Theology
PMI 2006 — 2006
Associate Certificate - Project Management
Contra Costa College 1992 — 1994
A.S., Allied Health/ Radiology
University of the Pacific 1991 — 1992
Carson High School
Advanced Chemical Transport, Inc. August 2008 - Present
Advanced Chemical Transport, Inc. April 2008 - August 2008
Advanced Chemical Transport, Inc. January 2004 - April 2008
IDEC Pharmaceuticals August 2003 - January 2004
IDEC Pharmaceuticals August 2002 - August 2003
Skills
Environmental Services, Environmental Compliance, Waste Management, Hazardous Waste..., RCRA, Recycling, Environmental..., Hazardous Materials, Waste, Environmental Awareness, Disposal, Environmental Consulting, Supervisory Skills, Safety Management..., Solid Waste, HAZWOPER, Operations Management, Remediation, EHS, Industrial Hygiene, Wastewater Treatment, Ergonomics, Industrial Safety, Waste Reduction, Workplace Safety, Hazardous Materials..., Environmental Permitting, Environmental Impact..., Asbestos, EPA, Occupational Health, Water, Soil, Water Treatment, ISO 14001, Environmental Issues, Phase I, Sustainability, Emergency Management, Environmental Policy, Risk Assessment, DOT regulations, Safety Training, Groundwater, Sampling, Environmental Science, Construction Safety, Environmental..., Mitigation
Education
University of Phoenix 2009 — 2011
BS, Business Management
Palomar College 2005 — 2009
AA, Behavioral Sciences
MarckEnterprises September 1998 - Present
Brecon Human Factors Design April 1996 - Present
Tri Com Consulting Placed @ Pfizer July 2008 - October 2008
Fairfield Residential LLC April 2006 - September 2006
Xerox February 2004 - June 2004
Xerox March 2000 - July 2002
IDEC Pharmaceuticals 1997 - 1999
Skills
Process Improvement, Team Building, Operations Management, Business Development, Project Management, Vendor Management, Strategic Planning, Change Management, Facilities Management, Purchasing, Customer Service, Contract Negotiation, Training, Market Research, Account Management, Business Analysis, Consulting, Budgets, Contract Management, Team Leadership, Analysis, Management, Project Planning, Cross-functional Team...
Education
State University of New York College at Brockport 1989 — 1991
None, Business Marketing
Bryant and Stratton College 1978 — 1979
Associates, Business & Office Administration
The John and Elizabeth Leonard Family Foundation 2011 - Present
Vaccinex, Inc January 2009 - Present
John Leonard Consulting, LLC September 2005 - December 2008
Biogen Idec August 1988 - September 2005
Idec Pharmaceuticals 1988 - 2003
Skills
Biotechnology, Biopharmaceuticals, Oncology, GMP, Drug Development, Clinical Development, Pharmacology, Cell Culture, Cell, Assay Development, IND, Toxicology, Regulatory Affairs, Monoclonal Antibodies, Clinical Research, Pharmaceutical Industry, Lifesciences, Antibodies, Protein Chemistry, Purification, Technology Transfer, ELISA, FDA, Clinical Trials
Education
University of California, Riverside 1972 — 1977
PhD, Biochemistry; Cell Biology
California State University-Long Beach 1970 — 1972
MS, Chemistry
Oasis Architecture & Design, Inc. August 2011 - Present
Lisa Franco Interiors December 2009 - Present
Angelman Syndrome Foundation 2005 - July 2013
IDEC Pharmaceuticals 1992 - 2000
Genentech 1990 - 1992
Skills
Excel, Biotechnology, Microsoft Office, Word, PowerPoint, Research, Microsoft Word, Microsoft Excel, Interior Design, Space-planning, Color Schemes, Concept Design, Floorplanning, Budget, Interpersonal..., Color Boards, Personal Shopping, Renovation, Budgets, Space planning, Furniture, Graphic Design, Photoshop
Education
University of California, Santa Cruz 1988 — 1990
Bachelor of Arts, Biology
Whittier College
Biology
Kennedy Publishing Company May 2014 - Present
Socrates' Scribes June 2003 - Present
Convention Staffing Solutions February 2011 - November 2011
Wireless Facilities, Inc. September 2004 - March 2006
Quidel Corporation March 2002 - June 2003
ACADIA Pharmaceuticals September 2000 - March 2002
IR PR Strategies, LLC March 1999 - September 2000
IDEC Pharmaceuticals May 1993 - March 1999
Skills
Writing, Copy Editing, Proofreading, Strategic Communications, Organizational..., Project Tracking, Follow-through Skills, Customer Service, Problem Solving, Meeting Planning, Website Administration, Public Speaking, Editing, Marketing, Fundraising, Leadership, Newsletters, Marketing Communications, Event Planning, Public Relations
Education
University of Redlands 1998 — 2000
Master of Business Administration (M.B.A.), Business Administration and Management, General
Michigan State University 1977 — 1981
Bachelor of Arts (B.A.), English
Allergan October 2011 - Present
Allergan June 2007 - October 2011
Idec Pharmaceuticals 2001 - 2003
Biogen Idec 2000 - 2003
IDEC 2000 - 2003
PAREXEL 1998 - 2000
Skills
EDC, Clinical Data Management, Oracle Clinical, CRO, GCP, Therapeutic Areas, Clinical Trials, CRF design, CTMS, ICH-GCP, Oncology, Inform, Data Management, Clinical Development, CDISC, Clinical Research, Pharmaceutical Industry, Sop, Validation, 21 CFR Part 11, Clinical Operations, Regulatory Submissions, Clinical Monitoring, Computer System..., FDA, Protocol, SOP
Education
George Washington Universtiy 2005 — 2008
Bachelor of Science (B.S.), Health Sciences Specialized in Clinical Research
GE Healthcare January 2015 - Present
Lantheus Medical Imaging January 2013 - December 2014
Lantheus Medical Imaging May 2010 - January 2013
ESA Biosciences May 2005 - September 2009
Berlex 2002 - 2004
Wyeth 2000 - 2002
IDEC Pharmaceuticals 1992 - 1996
RiboGene 1991 - 1992
Skills
GLP, Chromatography, GMP, Validation, Protein Chemistry, Pharmaceutical Industry, V&V, Clinical Trials, Formulation, Protein Expression, GCP, Gas Chromatography, HPLC, Quality System, CAPA, Technology Transfer, Analytical Chemistry, LC-MS, Method Development, Sop, FDA, 21 CFR Part 11
Education
University of Massachusetts Lowell 2008 — 2010
Clinical Pathology
University of New Hampshire 1984 — 1988
BS, Biochemistry
Hairstyles by Tony December 2014 - Present
Sidney's Hairdressing College February 2014 - December 2014
Lengel June 2013 - January 2014
Clarkston Consulting July 2005 - August 2013
Biogen Idec January 2004 - July 2005
IDEC Pharmaceuticals September 2002 - January 2004
Immunex Corporation November 2000 - August 2002
Immunex Corporation February 1998 - October 2000
Sanofi Winthrop Pharmaceuticals September 1995 - January 1998
Sanofi Winthrop Pharmaceuticals March 1993 - September 1995
Skills
Developing Practical..., Detailed Analysis, Quality Systems, Quality System, Validation, 21 CFR Part 11, Analysis, Solutions Marketing, GMP, CAPA, FDA, Change Control, V&V, Sop, Quality Assurance, Cross-functional Team..., Quality Control, Pharmaceutical Industry, Biotechnology, SAP, Quality Management, Change Management, GxP, Program Management, Medical Devices, Process Improvement, Software Documentation, Computer System..., Trackwise, Biopharmaceuticals, GLP, HPLC, Regulatory Submissions, Lifesciences, Technology Transfer, LIMS, Regulatory Affairs, Manufacturing, Commercialization, Quality Auditing, GAMP, R&D, ISO 13485, Laboratory, Analytical Chemistry, Drug Development, Pharmaceutics, Clinical Trials, Hardware Diagnostics, Testing
Education
Sidneys Hair Dressing College 2014 — 2014
Wichita State University 1993 — 1997
MBA
McPherson College 1976 — 1980
BA, Chemistry
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
Bristol-Myers Squibb/The Medical Affairs Company April 2015 - Present
Paisley Scientific May 2014 - April 2015
Pfizer January 2011 - May 2014
Biogen Idec September 2008 - February 2011
Biogen Idec June 2005 - September 2008
Biogen Idec June 2001 - June 2005
Idec Pharmaceuticals September 1997 - 2001
Idec Pharmaceuticals 1995 - 1997
The Scripps Research Institute 1993 - 1995
Johns Hopkins University May 1993 - December 1993
Skills
Oncology, Translational Medicine, Biomarkers, Clinical Development, Drug Discovery, Purification, Clinical Operations, CRO, Clinical Trials, Translational Research, Drug Development, Biomarker Discovery, Biopharmaceuticals, Clinical Research, Molecular Biology, Biotechnology, Pharmaceutical Industry, Life Sciences
Education
The Johns Hopkins University 1987 — 1993
Ph.D., Biochemistry
The University of Texas at Arlington
B.S, Biochemistry
University of California San Diego March 2003 - Present
Attenuon, LLC 2000 - 2003
IDEC Pharmaceuticals 1999 - 2000
Abbott Laboratories 1980 - 1995
Argonne National Laboratory 1978 - 1980
Skills
Lifesciences, Biotechnology, Commercialization, Drug Discovery, Licensing, Technology Transfer, Molecular Biology, Oncology, Pharmaceutical Industry, Biopharmaceuticals, Immunology, Genomics, Biochemistry, Drug Development, Cancer, Clinical Trials, Cell, Regulatory Affairs, Infectious Diseases, Medical Devices, Cell Biology, Cell Culture, Clinical Development, Chemistry, Intellectual Property, Patents, Biomarkers, Protein Chemistry, R&D, Genetics, Neuroscience, Pharmacology, Hardware Diagnostics, Assay Development, Bioinformatics, Personalized Medicine, PCR, Molecular Diagnostics, Proteomics, ELISA, DNA, Immunoassays, Biomarker Discovery, Laboratory, Monoclonal Antibodies, Microbiology, FDA, Medical Diagnostics, Science, Organic Chemistry
Education
Blackstone School of Law 1998 — 1999
Paralegal, Law
University of Illinois Medical Center 1972 — 1978
MS/PhD, Microbiology/Immunology
Quincy University 1968 — 1972
BS, Biology
SAGE (The Science of Aging) Blog July 2014 - Present
Buck Institute for Research on Aging June 2011 - Present
University of California, San Francisco September 2005 - May 2011
University of California, San Francisco September 2006 - December 2006
University of California, San Diego 2003 - 2005
Idec Pharmaceuticals June 2003 - August 2003
Skills
Protein Purification, Cell Signaling, Cell Based Assays, Biochemistry, Molecular Biology, Cell Biology, Tissue Culture, Organic Synthesis, NMR spectroscopy, Protein Chemistry, Cell, Assay Development, Transfection, PCR, Immunological techniques, Statistics for assay..., Immunofluorescence..., Drug Combination..., Cell Culture, Western Blotting, Fluorescence Microscopy, Molecular Cloning
Education
University of California, San Francisco 2005 — 2011
Ph.D, Chemistry and Chemical Biology
University of California, San Diego 2001 — 2005
B.S., Biochemistry/Chemistry
DJO Global December 2014 - Present
AstraZeneca September 2014 - Present
Partners Claim Services July 2014 - Present
Bristol-Myers Squibb February 2013 - June 2014
Amylin Pharmaceuticals October 2005 - December 2013
Genicon Sciences 1999 - 2002
IDEC Pharmaceuticals 1990 - 1999
Paul Ecke Ranch 1988 - 1990
Skills
Forecasting, General Ledger, Budgets, Analysis, Finance, Risk Management, Accounting, Auditing, JD Edwards, Cash Management, SEC filings, Aggregate Spend, Sunshine Act, FDA Drug Sample..., HCP Disclosure Reporting, Management, Transparency, Cross-functional Team...
Education
University of South Alabama 1984 — 1988
BS, Business Administration-Accounting
Grossmont College January 2012 - Present
Advanced BioHealing January 2011 - February 2012
Alere San Diego August 2009 - January 2011
Pacira Pharmaceuticals 2007 - February 2009
Genentech 2005 - 2007
Biogen Idec 2003 - 2005
IDEC 1998 - 2003
idec pharmaceuticals June 1995 - February 1998
Skills
GLP, LIMS, V&V, Lifesciences, Regulatory Submissions, Regulatory Affairs, HPLC
Education
Grossmont College 2012 — 2014
Forensic Technology Certificate, Forensic Science and Technology
San Diego State University-California State University 1990 — 1995
Bachelor of Applied Science (B.A.Sc.), Biology, General
Home May 2011 - Present
Johnson & Johnson April 2001 - May 2011
Johnson & Johnson April 2001 - April 2010
Immunex October 1998 - April 2001
IDEC Pharmaceuticals 1993 - 1998
Hybritech 1989 - 1990
Skills
Process Simulation, FDA, Product Development, Pharmaceutical Industry, Validation, Biotechnology, Manufacturing, Process Optimization, Drug Development, Technology Transfer, Medical Devices, Strategy, Commissioning, Process Modeling, Process Engineering, GMP, Biopharmaceuticals, V&V, Change Control, CAPA, SOP, 21 CFR Part 11, Life Sciences, Quality System, R&D
Education
UCSD 1989 — 1992
BS, Bioengineering
Emergent BioSolutions October 2010 - Present
Trubion Pharmaceuticals November 2009 - October 2010
Biogen Idec 2004 - November 2009
Chromagen 1998 - 2004
IDEC Pharmaceuticals 1995 - 1997
Hybritech, Inc. 1994 - 1995
Skills
Assay Development, Biotechnology
Education
University of California, San Francisco 1975 — 1977
M.S., Biochemistry
Vanderbilt University 1970 — 1974
B.A., Molecular Biology
JSerra Catholic High School July 2010 - June 2014
IDEC Pharmaceuticals 1996 - 2003
Skills
Protein Purification, Chemistry, Contract Negotiation, Physics, Curriculum Development, FDA, Biotechnology, Public Speaking, Cell Culture, Biopharmaceuticals, Aseptic Technique, Drug Discovery, 21 CFR Part 11, Validation, Clinical Development, Sop, GLP, Biology, Technology Transfer, Lifesciences, ELISA, Sales, Monoclonal Antibodies, Account Management, Chromatography, Life Sciences, Special Education, Regulatory Affairs, Vaccines, GMP, Educational Technology, HPLC, CAPA, V&V, LIMS, Change Control, Educational Leadership, Teaching, Purification, Pharmaceutical Industry
Education
California State University-Fullerton 2008 — 2010
SS Credential, Biology/Chemistry
San Diego State University-California State University
Genoptix November 2012 - Present
Illumina January 2011 - November 2012
Biogen Idec September 2009 - January 2011
Biogen Idec August 2006 - September 2009
Biogen Idec January 2006 - August 2006
Biogen Idec March 2005 - December 2005
Biogen Idec May 2004 - March 2005
Biogen Idec August 2003 - April 2004
IDEC Pharmaceuticals August 1999 - August 2003
Skills
21 CFR Part 11, Computer System..., FDA, Change Control, Validation, Compliance, Quality Assurance, SOP, Documentation, Quality Systems, Document Management, Biotechnology, cGMP, GMP, Software Documentation
Education
San Diego State University-California State University 2001 — 2005
MBA, Information Systems
University of Oregon 1995 — 1998
BA, English
Piksel Inc. November 2012 - April 2014
General Electric January 2010 - November 2012
Vertex Pharmaceuticals July 2007 - December 2009
Vertex Pharmaceuticals January 2006 - June 2007
PAREXEL INTERNATIONAL January 2004 - December 2005
Sigma Technologies July 2002 - December 2003
IDEC PHARMACEUTICALS April 1998 - July 2002
Skills
ITIL, MS Project, Lotus Notes, PowerPoint, Microsoft Word, EDC, CTMS, Earned Value Management, SDLC, Agile Methodologies, Six Sigma, Management, Software Project..., Requirements Analysis, Software Development, Leadership
Education
Boston University 2008 — 2008
PMP
University of California 1994 — 1998
Bachelors of Science, Computational Mathematics & Computer Science
Clarkson University 1994 — 1994
Chemical Engineering
Genoptix April 2010 - Present
Gen-Probe January 2007 - March 2010
Biogen Idec November 2003 - November 2005
Idec Pharmaceuticals March 1998 - November 2003
Sys-Tech Solutions 1992 - 1995
Programmable Controller Systems 1986 - 1988
Skills
FDA, Biotechnology, Agile Methodologies, Risk Management, Validation, Quality Assurance, 21 CFR Part 11, GxP, Computer System..., V&V, GMP, Sop, Cross-functional Team..., Medical Devices, LIMS, Quality System
Education
New Jersey Institute of Technology 1981 — 1986
Bachelor of Science (BS), Mechanical Engineering
Xencor April 2015 - Present
Stochos Consulting November 2013 - Present
Tocagen Inc. July 2014 - March 2015
Genoptix/Novartis April 2012 - November 2013
Amgen February 2011 - April 2012
Biogen Idec November 2002 - January 2011
Idec Pharmaceuticals 2002 - 2004
UCSD November 1995 - November 2002
National Cancer Institute July 1993 - October 1995
National Cancer Institute July 1990 - June 1993
Skills
Immunology, Business Development, Oncology, Clinical Research, Internal Medicine, HIV/AIDS, Translational Research, Medical affairs, Biostatistics, Hematology, Medical Diagnostics, Commercialization, Therapeutic Areas, Healthcare, Medicine, Clinical Trials, Medical Affairs, Clinical Development, Lifesciences, Drug Development, Pharmaceutical Industry, Biotechnology, Infectious Diseases, Biopharmaceuticals, Translational Medicine, FDA, Pharmacovigilance, Antibodies
Education
Northwestern University - The Feinberg School of Medicine 1984 — 1986
MD
Northwestern University 1980 — 1984
BS, Medicine
Celgene Corporation August 2012 - Present
H&H Biopharm Consulting January 2011 - December 2014
Boehringer Ingelheim August 2011 - August 2012
Biogen Idec March 2007 - February 2011
Biogen Idec Inc. March 2003 - March 2007
IDEC Pharmaceuticals April 1993 - March 2003
IDEC Pharmaceuticals September 1991 - March 1993
Skills
Drug Discovery, Clinical Development, Biotechnology, Oncology, Biopharmaceuticals, Drug Development, Translational Medicine, Lifesciences, Cell, Pharmaceutical Industry, Cross-functional Team..., Cell Biology, Immunology, Antibodies, Cancer, Monoclonal Antibodies, Translational Research, Animal Models, Pharmacology, Vaccines, Life Sciences
Education
University of Nebraska Medical Center 1988 — 1991
Ph.D., Immunology
University of Nebraska-Lincoln 1985 — 1988
M.S., Veterinary Sciences
University of Peradeniya 1979 — 1984
D.V.M, Veterinary Medicine
Genentech / Roche April 2015 - Present
Roche Carolina Inc October 2011 - April 2015
Genentech, a member of the Roche Group January 2010 - October 2011
Genentech April 2009 - December 2009
Genentech, Oceanside February 2007 - April 2009
Genentech June 2005 - February 2007
Biogen Idec November 2003 - June 2005
Idec Pharmaceuticals October 2000 - 2002
Limited Brands-Division of Express World Brands July 1988 - September 2000
Skills
GMP, Change Management, Training, Manufacturing, Biotechnology, Pharmaceutical Industry, Sop, Vendor Management, Process Improvement, Organizational..., Validation, Lifesciences, Biopharmaceuticals, Six Sigma, Continuous Improvement, Leadership, Management, FDA, CAPA, Strategy, LIMS, Project Planning, Aseptic Processing, 21 CFR Part 11, Change Control, Cross-functional Team..., Operational Excellence, Quality Assurance, Quality System, SOP, Life Sciences, Team Building, Project Management, Program Management, Strategic Planning, Sales
Education
London Business School 2011 — 2013
Roche Leadership Certification
University of San Diego 2007 — 2009
Exec MBA
Massachusetts Institute of Technology 2007 — 2008
Prof Courses/Certificate
The College of Saint Rose 1990 — 1994
BFA
Frankfort Schuyler High School 1986 — 1990
High School
TASK Ventures, LLC September 2007 - Present
RBBA: Rancho Bernardo Business Association July 2013 - October 2014
J. T. Gram & Associates, Inc. July 2013 - March 2014
Arthritis Foundation January 2006 - December 2011
Business Network International (BNI) June 2008 - December 2010
Favrille, Inc. September 2007 - June 2008
IDEC Pharmaceuticals March 1997 - December 2006
Adria Laboratories 1980 - 1996
Skills
Strategic Planning, Marketing Strategy, Market Planning, Product Marketing, Sales Management, Business Strategy, Small Business..., Business Development, Marketing, Strategy, Management, Sales, Selling, CRM, Public Relations, Fundraising, Market Research, Event Management, Entrepreneurship, Coaching, Leadership, Strategic Partnerships, Negotiation, Marketing Communications, Budgets, Small Business, Team Building, Product Development, Email Marketing, Social Networking, Cross-functional Team..., Business Planning, Contract Negotiation, Start-ups, Event Planning, Time Management, Retail, Customer Service, Training, Salesforce.com, Program Management, Advertising, Social Media Marketing, Competitive Analysis, Social Media, Human Resources, Leadership Development, Project Planning, New Business Development, Account Management
Education
Northwestern 1973 — 1977
BA, Business Administration
Hartley High School 1969 — 1973
diploma
Genentech September 2006 - Present
Biogen Idec 2003 - 2005
Idec Pharmaceuticals 2001 - 2005
Molecular Biosystems 1995 - 2001
Skills
FDA, Validation, Technology Transfer, GMP, Biotechnology, CAPA, GAMP, Sop, Quality System, Computer System..., Change Control, Chromatography, Manufacturing, Biopharmaceuticals, Pharmaceutical Industry, Lean Manufacturing, Process Engineering, V&V, Aseptic Processing, Cleaning Validation, Quality Control, Process Simulation, GxP, 21 CFR Part 11, ISO 13485, Purification, R&D, Fermentation, Quality Assurance, Design Control, Design of Experiments, Filtration, Medical Devices, FDA GMP, Commercialization, Contract Manufacturing, Lifesciences, Clean Rooms, Root Cause Analysis, Ultrafiltration, Engineering, Cross-functional Team..., Process Improvement, Engineering Management, Sterilization, SOP, Life Sciences
Education
Amirkabir University of Technology - Tehran Polytechnic
Polymer Engineering
University of California, San Diego
Bachelor, Chemical Engineering
Biogen Idec September 2008 - June 2011
Biogen Idec February 2006 - February 2008
Biogen Idec February 2005 - February 2006
Idec Pharmaceuticals May 2004 - February 2005
Idec Pharmaceuticals September 2002 - April 2004
Skills
Materials Management, Inventory Management, Biotechnology, Continuous Improvement, Logistics, Manufacturing, Process Improvement, Supply Chain Management
Education
Northern Arizona University 1997 — 2000
Bachelor of Science, Advertising/Communications/Photography
House of Puerto Rico San Diego January 2006 - Present
Hope Funds for Cancer Research 2007 - Present
Notre Dame Academy 2006 - Present
House of Puerto Rico San Diego January 2014 - January 2015
Onyx Pharmaceuticals 2002 - January 2015
House of Puerto Rico San Diego 2006 - December 2014
Food and Drug Administration 2003 - 2007
IDEC Pharmaceuticals November 1992 - January 2001
Skills
Clinical Research, Strategy, Biotechnology, Oncology, Clinical Development, Drug Development, Clinical Trials, Technology Transfer, Lifesciences, Pharmaceutical Industry, Biopharmaceuticals, FDA, Hematology, Drug Discovery, Medical Devices, Immunology, Cancer, Infectious Diseases, Medical Writing, Neurology, Biochemistry, Medical Affairs, Biologics, Pharmacology, Vaccines, Pharmacokinetics, Monoclonal Antibodies, Antibodies, Medicine, IND, Commercialization, Regulatory Affairs, Biomarkers, CRO, Regulatory Submissions, GCP, Translational Medicine, Assay Development, Therapeutic Areas, CTMS, Molecular Biology, 21 CFR Part 11, Drug Delivery, Rheumatology, GxP, Cell, Genomics, GLP, Protein Chemistry, Purification
Education
University of Puerto Rico School of Medicine
Doctor of Science (Honoris Causa), Scientific Investigation, DSc (hc)
University of Puerto Rico School of Medicine 1960 — 1964
MD, Int. Medicine, Hematology, Oncology Specialties completed in 1970.
Cushman & Wakefield October 2014 - Present
ViaSat September 2012 - October 2014
UGL-Unicco June 2011 - September 2012
Biogen Idec July 2006 - June 2011
Genentech May 2005 - July 2006
Biogen Idec February 2004 - July 2005
Idec Pharmaceuticals September 2001 - February 2004
Skills
Budgets, Change Management, Project Planning, Contract Negotiation, Process Scheduler, Contract Management, Facilities Management, Software Documentation, Project Management, Operations Management, Biotechnology, Forecasting, Process Improvement, Program Management, Six Sigma, Strategic Planning, Team Building, Vendor Management, Manufacturing
Education
University Of Phoenix 2002 — 2004
Masters, Business Management, Technology Management
San Diego State University-California State University 1994 — 2001
Bachelors, Public Administration
University of California, San Diego
Facilities Management
Medivation March 2013 - Present
ADVENTRX May 2012 - Present
CF Marketing consulting January 2011 - April 2012
Biogen Idec February 2004 - January 2011
IDEC Pharmaceuticals 2000 - 2004
Schering AG, Germany 1997 - 2000
Schering AG 1981 - 2000
Skills
Cross-functional Team..., Product Marketing, Global Marketing, Commercialization, Pharmaceutical Industry, Oncology, Biotechnology, Clinical Development, Strategic Planning, Product Development, Clinical Trials, Hematology, Strategy, Pharmaceutical Sales, Product Launch, Neurology, Cardiology, Therapeutic Areas, Dermatology, Urology, Biopharmaceuticals, Market Planning, Hospital Sales, Competitive Intelligence, Vaccines, Drug Development, Infectious Diseases, Managed Care, Market Access, Rheumatology, Leadership, Sales Effectiveness, Program Management, Gastroenterology, Endocrinology
Education
Damelin 1984 — 1985
Marketing Diploma
The Berlin School of Economics and Law 1979 — 1981
BS Business administration, Economics
Astute Medical December 2012 - Present
Gemological Institute of America, GIA February 2012 - December 2012
Baker & Taylor April 2001 - February 2012
IDEC Pharmaceuticals April 2000 - April 2001
Helicopter Squadron Light - 37, United States Navy October 1994 - October 1999
Skills
Servers, Active Directory, System Administration, Citrix, Operating Systems, Microsoft Exchange, Troubleshooting, VMware ESX, Microsoft Office, Blackberry Enterprise..., WSUS, Windows Server, Network Administration, Windows 7, Windows, Computer Hardware, Microsoft SQL Server, HP, Windows XP, .NET, Windows XP Pro, IIS, SharePoint, Cisco Technologies, Cisco ASA, Veeam, Barracuda Spam Firewall
Education
San Diego State University-California State University 2012 — 2014
Bachelor's Degree, Business Administration (Information Systems)
San Diego City College 2006 — 2009
A.A., Pre-Engineering and Mathematics
Sempra LNG - Engineering & Construction April 2015 - Present
Sempra LNG - Engineering & Construction October 2012 - Present
Sempra Energy Utilities April 2010 - October 2012
Sempra Global Services, Inc. - Engineering & Construction October 2008 - April 2010
Sempra LNG July 2004 - October 2008
REMEC November 2003 - July 2004
IDEC Pharmaceuticals February 2003 - November 2003
LightPointe February 2001 - November 2002
Clinicon Corporation March 1998 - February 2001
Southwest Fabricators August 1997 - February 1998
Skills
Document Management, Records Management, Business Analysis, SharePoint, Documentum, Information Management, Enterprise Content..., ERP, Microsoft Office, Process Improvement, Business Process, Requirements Analysis, Records, MRP, Compliance, Documentation, Outlook, SharePoint 2007 / 2010..., SharePoint 2007 / 2010..., SharePoint 2007 / 2010..., Information Governance, SharePoint 2013, Nintex Workflow
Education
San Diego Mesa College 1988 — 1990
Records Management/Office Information Systems
Milton Hershey School 1976 — 1985
Astra Zeneca (MedImmune Vaccines) August 2008 - May 2014
Johnson & Johnson (ALZA Corporation) May 2005 - August 2008
Johnson & Johnson (Centocor Inc.) September 2003 - May 2005
Johnson & Johnson (Centocor Inc.) April 1999 - September 2003
Idec Pharmaceuticals April 1996 - April 1999
Genentech Inc. September 1992 - October 1994
Genentech Inc. December 1987 - October 1992
Skills
GMP, FDA, Validation, Sop, CAPA, Biotechnology, GLP, Change Control, Pharmaceutical Industry, V&V, GxP, 21 CFR Part 11, Technology Transfer, Vaccines, Quality System, Clinical Research, Biopharmaceuticals, Process Improvement, Cell Culture, Aseptic Technique, SOP
Education
California State University-Hayward - School of Business and Economics 1988 — 1994
MBA, New Venture Small Business Management
University of Illinois at Urbana-Champaign 1983 — 1987
BS, Liberal Arts and Sciences, concentration in Chemistry
Thornridge High School 1979 — 1983
High School, General
Arena Pharmaceuticals November 2012 - Present
(Self-employed) January 2008 - October 2012
Genentech, Inc. / Tanox, Inc. January 2005 - December 2007
Cell Genesys / Chiron Corporation October 1997 - December 2004
Advanced Tissue Sciences November 1995 - September 1997
IDEC Pharmaceuticals March 1992 - December 1994
Skills
GMP, FDA, Biotechnology, Validation, Technology Transfer, 21 CFR Part 11, CAPA, Sop, Change Control, Quality System, Pharmaceutical Industry, Aseptic Processing, GxP, Lifesciences, Biopharmaceuticals, V&V, IND, Quality Control, Quality Assurance, Regulatory Affairs, Facility Start-up, Software Documentation, Clinical Trials, External Audit, GLP, Quality Management, Project Management, Microbiology, CRO, FDA GMP, Life Sciences, SOP
Education
University of California, San Diego 2010 — 2012
Professional Certificate, Project Management
San Diego State University-California State University 1998 — 2002
Minor, Cellular & Molecular Biology
University of California, Berkeley 1987 — 1991
Comparative Literature and Spanish
Henry M. Gunn High School
Regeneron Pharmaceuticals September 2013 - Present
GlaxoSmithKline February 2011 - September 2013
Anytime Fitness August 2008 - October 2010
Tanox 2005 - 2007
IDEC Pharmaceuticals 1997 - 2005
BASF Bioresearch 1996 - 1997
Genzyme 1995 - 1996
Genzyme 1995 - 1996
Genzyme 1995 - 1996
Genzyme 1995 - 1996
Skills
Strategic Planning, Sales Management, Marketing, Wellness, Marketing Strategy, Sop, Change Management, Technology Transfer, GMP, Pharmaceutical Industry, Business Development, Start-ups, Formulation, Biopharmaceuticals, Purification
Education
San Diego State University-California State University 1990 — 2003
University of Massachusetts, Amherst 1993 — 1995
Bachelor's degree, Biology, General
University of California, San Diego, Extension 2013 - Present
Software Intelligence Corporation 1984 - Present
Software Intelligence Corporation 1984 - Present
Judicial Council of California 2003 - 2003
IDEC Pharmaceuticals 2002 - 2002
Amgen 2002 - 2002
Synteract Inc. 2001 - 2001
City of Hope 1999 - 2000
Enterprise Systems Journal June 1997 - August 1999
Oracle Corporation 1998 - 1999
Skills
Systems Analysis, ODS, SAS, SDLC, Databases, SQL, SQL Tuning, SQL database design, SAS Macro, SAS/SQL, Debugging, Software Validation, Data Validation, Cleaning Validation, Performance Testing, System Testing, User Acceptance Testing, JCL, SAS programming, Database Tuning, Application Development, Software Conversions, Best Practices, PowerPoint, Hands-on Training, Instructor-led Training, Business Intelligence, Project Management, Consulting, sasNerd, Testing, Social Media, Relational Databases, Software Development, Mentoring, Data Analysis, Programming, Performance Tuning, OLAP, Analysis, Data Integration, Data Warehousing, Analytics, Unix, ETL, Entrepreneurship, Public Speaking, Data Mining, Data Management, DB2
Education
University of Miami - School of Business 1979 — 1982
Master of Science, Management Science Systems Analysis
The George Washington University 1981 — 1981
Post Graduate Studies, Telecommunications Management
University of Miami - School of Business 1974 — 1978
Bachelor of Science, Management Science Systems Analysis
Killian Sr. High 1972 — 1974
Illumina April 2006 - September 2015
SMITH AND NEPHEW 2004 - 2006
Bioserv Corporation 2003 - 2003
Biogen 2002 - 2003
Advanced Tissue 2000 - 2002
IDEC Pharmaceuticals 2000 - 2000
Skills
GMP, Validation, Technology Transfer, Biotechnology, FDA, Life Sciences, Biopharmaceuticals, SOP, CAPA, Lifesciences, Manufacturing, HPLC, Process Improvement, Variance Analysis, Genomics, DNA Sequencing, Cell Based Assays, Enzyme Assays, Enzyme Kinetics, FDA GMP, Clinical Development, Clinical Research, Medical Devices, Wound Care
Education
Villanova University
Bachelor of Biological Science, Biochemistry and Molecular Biology
University of California, San Diego
Molecular Biology, Biotechnology
New Brunswick college 1997 — 1999
Bachelor of Biological Science, Biochemistry and Molecular Biology, 4.0
Samsung BioLogics October 2014 - Present
Samsung BioLogics June 2014 - September 2014
Samsung BioLogics 2012 - May 2014
CMC Biologics June 2010 - 2011
Diosynth Biotechnology, a part of Merck 1997 - 2010
BioReliance (formerly Microbiological Associates) 1992 - 1997
IDEC Pharmaceuticals 1985 - 1992
TAGO 1984 - 1985
Univ. of CA, Medical School 1982 - 1984
Skills
Pharmaceutical Industry, Lifesciences, Biopharmaceuticals, Vaccines, GMP, Technology Transfer, Biotechnology, Organizational..., Cross-functional Team..., R&D, Business Development, FDA, Monoclonal Antibodies, Clinical Development, Commercialization, Drug Development, Drug Discovery, Validation, Biochemistry, Sop, HPLC, Medical Devices, Protein Chemistry, CRO, GLP, Purification, Immunology, Cell, Assay Development, Regulatory Affairs, Antibodies, Fermentation, IND, Cell Culture, Contract Manufacturing, Clinical Trials, Microbiology, V&V, Oncology, Life Sciences, SOP, Business Strategy, Negotiation
Education
University of California, San Diego 1979 — 1983
Immunology, Virology, Biochemistry, Psychology
San Francisco State University
Immunopathology, Virology of Cancer
University of California, Berkeley
Finance, Business Law, Intellectual Property, Business Development
University of California, Berkeley
HPLC
University of North Carolina at Chapel Hill - Kenan-Flagler Business School
Principles of Negotiation
Alcock & McFadden October 2004 - Present
Artes Medical 2005 - 2006
Biogen Idec 2003 - 2004
Idec Pharmaceuticals 2000 - 2004
Skills
Employee Relations, Biotechnology, Applicant Tracking..., Deferred Compensation, Technical Recruiting, Building Relationships, College Recruiting, Human Resources, Talent Acquisition, Performance Management, Onboarding, Personnel Management, Employee Benefits, Recruiting, Interviews, Talent Management
Education
California Polytechnic State University-San Luis Obispo 1992 — 1996
BS, Business Administration, Human Resources Management
Genentech August 2005 - Present
Genentech August 2005 - Present
BiogenIdec Pharmaceuticals November 2003 - August 2005
IDEC Pharmaceuticals January 1996 - November 2003
Skills
21 CFR Part 11, Change Control, Sop, Validation, SDLC, Requirements Analysis, Integration, ERP, Oracle, Business Analysis, Project Management, LIMS, Computer System..., Software Documentation, Troubleshooting, Quality Assurance, Biotechnology, Pharmaceutical Industry, SOP
Education
University of Delaware
Pfizer August 2014 - Present
GNF/Novartis June 2011 - July 2014
Biogen Idec 2010 - June 2011
Biogen Idec Inc 2006 - 2009
Biogen Idec Inc 2003 - 2005
Idec Pharmaceuticals 2000 - 2002
Sanford-Burnham Medical Research Institute 1997 - 2000
Skills
Cell Biology, Drug Discovery, Biotechnology, Lifesciences, Assay Development, Oncology, Molecular Biology, Antibodies, Target Identification, Signal Transduction, Cancer, Small Molecules, Cell Signaling, Biologics, Cellular Assays, Pharmaceutical Industry, Biomarker Discovery, Translational Research, Drug Development, Monoclonal Antibodies, Biopharmaceuticals, Biochemistry, Protein Chemistry, Immunology, Biomarkers, In Vitro, Clinical Development, Microbiology, IND
Education
Purdue University 1990 — 1996
Ph.D, Cell Biology and Cancer Research
National Chemical Laboratory, Pune 1988 — 1990
M.Phil, Biotechnology
University of Pune 1986 — 1988
M.Sc, Biotechnology
Sophia College, Mumbai 1983 — 1986
B.Sc, Microbiology
MCB Clinical Research Centers March 2007 - Present
GCP auditor June 1997 - December 2010
Northern California Regional January 1996 - December 2010
BRIGITTE M. KLAIB October 1994 - December 2010
Medtronic Vascular March 2007 - June 2008
Medtronics March 2007 - March 2008
Scios 2000 - 2003
Scios Inc 2000 - 2003
Biogen-Idec 1995 - 2003
IDEC Pharmaceuticals 1995 - 2003
Skills
Phase I Unit, Top Enrollment Site, Experienced Staff, Oncology, Phase I, Gynecology, Pharmaceuticals, Neurology, Surgery, Pharmaceutical Industry, Clinical Trials, CRO, EDC, CTMS, Psychiatry, Pediatrics, Clinical Monitoring, Infectious Diseases, Protocol, Clinical Development, Clinical Research, Neuroscience, GCP, FDA, Biotechnology
Education
San Jose State 1989 — 1991
BACHELORS AND GRADUATE WORK, CHEMISTRY AND PHYSICS- FORENSICS ; COMPUTER INFORMATION SYSTEMS AND MARKETING
California State University-Sacramento 1989 — 1990
MS, Foresic Chemistry
San Jose State University 1986 — 1989
BS, Chemistry, Physics
San Jose State University 1977 — 1980
BA, Marketing
Rigel Pharmaceuticals Inc. January 2014 - Present
Rigel Pharmaceuticals Inc. January 2012 - December 2013
Rigel Pharmaceuticals Inc. July 2010 - December 2011
XOMA January 2008 - June 2010
Xoma US (LLC) April 2005 - December 2007
DNAX Research Institute March 2002 - March 2005
IDEC Pharmaceuticals June 1992 - June 1995
Skills
Immunology, Antibodies, Flow Cytometry, In Vivo, Drug Discovery, Cell Culture, ELISA, Assay Development, Monoclonal Antibodies, Cell Biology, Molecular Biology, Biotechnology, In Vitro, Cell, Lifesciences, PCR, Animal Models, Autoimmune Diseases, Metabolism
Education
Weill Medical College of Cornell University 1995 — 2001
Ph.D., Immunology
U.C. Berkeley 1988 — 1992
B.A., Molecular & Cell Biology
Genentech June 2014 - Present
Roche August 2012 - May 2014
Genentech November 2009 - August 2012
Genentech June 2005 - December 2009
Biogen Idec November 2003 - August 2005
IDEC Pharmaceuticals December 2000 - November 2003
various pharma and biotech firms April 1998 - December 2000
Peregrine Pharmaceuticals September 1997 - April 1998
Techniclone January 1996 - September 1997
Abbott Laboratories May 1995 - December 1995
Skills
Validation, FDA, Pharmaceutical Industry, Biotechnology, GMP, Quality Assurance, Technology Transfer, Change Control, LIMS, Statistics, CAPA, Technical Writing, Quality System, Biopharmaceuticals, Regulatory Submissions, Computer System..., Biochemistry, EMA, USP, Equipment Qualification, Method Validation, SPC, Small Molecules, Biologics, VBA
Education
Harvey Mudd College 1989 — 1994
Bachelor's Degree
Merck Serono October 2013 - Present
AbbVie September 2012 - June 2013
Pfizer Inc. July 2010 - August 2012
Pfizer Inc. January 2009 - June 2010
Pfizer Inc. January 2008 - December 2008
Biogen Idec May 2004 - October 2007
Idec Pharmaceuticals May 2003 - May 2004
Idec Pharmaceuticals May 2002 - May 2003
Agouron Pharmaceuticals May 2001 - May 2002
Pfizer Inc. January 1999 - August 1999
Skills
Oncology, Regulatory Affairs, Governmental Affairs, Biotechnology, Biosimilars, International, European Union, BRIC, Public Policy, Biopharmaceuticals, Immunology, Clinical Trials, Strategic Planning, Strategy, Cross-functional Team..., Leadership, Biologics, Neurology, Policy, Clinical Development, Regulatory Submissions, Pharmaceutical Industry, Lifesciences, FDA
Education
University of Southern California 2001 — 2003
MS, School of Pharmacy
Loyola Marymount University 1993 — 1997
BA, Government (International Affairs)
London School of Economics and Political Science, U. of London 1996 — 1996
Certificate, British Government
Principal Consultant 2015 - Present
AstraZeneca (formerly BMS, Amylin Pharmaceuticals) 2011 - 2014
Biogen Idec 2008 - 2011
Catalent Pharma Solutions 2005 - 2007
Biogen Idec 1999 - 2005
IDEC Pharmaceuticals 1997 - 1999
Skills
21 CFR Part 11, Aseptic Processing, Biotechnology, CAPA, CQA, Change Control, FDA, GMP, Quality Assurance, Quality System, Reviews, Root Cause Analysis, SOP
Education
Marquette University
BA, Communications
PriceSmart, Inc. November 2010 - Present
UCSD Extension April 2010 - November 2010
Biogen Idec February 2005 - August 2008
IDEC Pharmaceuticals February 1999 - December 2004
Amylin Pharmaceuticals February 1996 - January 1999
Price Costo / Price Company June 1978 - December 1994
Skills
Healthcare IT, ITIL, Vendor Relations, Budgeting, Business Process, Policy, Business Analysis, Vendor Management, Process Improvement, HIPAA, Quality Assurance, Change Management, PMP, Strategic Planning, Compliance, IT Management, Process Development, Problem Solving, SOX, IT Service Management, Analysis, Start-ups, Training, Software Documentation, Project Management, Team Leadership, Budgets, Team Building, Sarbanes-Oxley Act, Troubleshooting, Outsourcing, Business Process..., Technical Support, Program Management
Education
Univ of Phx 2008 — 2012
BS, Information Systems
University of California, San Diego 2009 — 2009
Certification, Healthcare IT
Dependency Legal Group of San Diego February 2011 - Present
Sequana Thereapeutics, Inc. September 1996 - July 1998
Idec Pharmaceuticals March 1988 - June 1996
Education
California Western School of Law 1998 — 2001
Juris Doctor, Law
University of California, Berkeley 1984 — 1987
B.S., Genetics
Genentech, Inc. April 1993 - Present
Abgenix 2003 - 2004
IDEC Pharmaceuticals November 1991 - April 1993
Lockheed Missiles and Space 1984 - 1985
Education
Massachusetts Institute of Technology 1986 — 1991
M.S., Ph.D.
University of California, Davis 1980 — 1984
B.S.
Willow Glen High School
Vital Therapies, Inc. September 2013 - Present
Shire Regenerative Medicine May 2012 - September 2013
Ambit Biosciences June 2008 - May 2012
Favrille October 2005 - June 2008
Biogen Idec March 2000 - September 2005
IDEC Pharmaceuticals 2000 - 2003
Skills
Regulatory Submissions, eCTD, IND, Biotechnology, FDA, Clinical Trials, Oncology, 21 CFR Part 11, Pharmaceutical Industry, Regulatory Affairs, Validation, CRO, Biopharmaceuticals, GCP, GxP, Regulatory Operations, GMP, GLP, Clinical Research, Drug Development, Clinical Development, Lifesciences, Sop, Computer System..., EDC, Change Control, Clinical Data Management, CTMS, Technology Transfer
Education
San Diego State University-California State University
Bachelor of Science, Biology
Genentech June 2005 - Present
Genentech 2005 - Present
Biogen Idec 2003 - 2005
idec 1995 - 2003
Idec Pharmaceuticals 1982 - 2003
Skills
Quality System, CAPA, Manufacturing, IND, FDA, Biopharmaceuticals, GMP, Biotechnology, Validation, Quality Assurance, Regulatory Submissions, Analytical Chemistry, Pharmaceutical Industry, GxP, Drug Development, Sop, Change Control, 21 CFR Part 11, Technology Transfer, Microbiology, Pharmaceutics, GLP, Regulatory Requirements, Strategic Planning, CMC, Clinical Development, V&V, Cleaning Validation, Aseptic Processing, Formulation, Biologics, Regulatory Affairs
Education
San Diego State University-California State University
CRB Engineering February 2014 - Present
Sequoia Consulting Group, LLC February 2014 - Present
Shire Pharmaceuticals July 2011 - December 2013
Pacira Pharmaceuticals June 2008 - February 2009
Genentech June 2007 - April 2008
Idec/BiogenIdec/Genentech August 2001 - June 2007
IDEC Pharmaceuticals April 1994 - November 2001
Education
University of California, San Diego
BS, Bioengineering
ALZA Corporation, Johnson & Johnson PRD May 2005 - Present
Centocor Inc. September 2003 - May 2005
Centocor April 1999 - September 2003
Idec Pharmaceuticals April 1996 - April 1999
Genentech Inc. September 1992 - October 1994
Genentech Inc. December 1987 - September 1992
Education
California State University-Hayward - School of Business and Economics
University of Illinois at Urbana-Champaign 1983 — 1987
BS, Liberal Arts and Sciences, concentration in Chemistry
Receptos, Inc. January 2015 - Present
Lumena/Shire Pharmaceuticals March 2014 - January 2015
Pfizer January 2011 - February 2014
Pfizer June 2008 - January 2011
Paramount BioSciences July 2006 - May 2008
Biogen Idec 2002 - 2006
Idec Pharmaceuticals 2002 - 2003
Amgen 1995 - 2002
Amylin Pharmaceuticals 1993 - 1995
Skills
Pharmaceutical Industry, Lifesciences, Cross-functional Team..., Clinical Trials, Oncology, Ophthalmology, Biotechnology, Drug Development, Biopharmaceuticals, Immunology, Project Management, Clinical Development
Education
Pepperdine University, The George L. Graziadio School of Business and Management 1998 — 2000
Master of Business Administration (MBA)
University of California, San Diego 1989 — 1993
B.S, Biology
ACADIA Pharmaceuticals September 2013 - Present
Ardea Biosciences August 2012 - Present
Ardea Biosciences December 2011 - August 2012
Spectrum Pharmaceuticals January 2009 - February 2010
Favrille Inc. September 2006 - June 2008
Elan Pharmaceuticals 2005 - 2006
La Jolla Pharmaceutical Company October 2002 - March 2005
Advanced Tissue Sciences June 1999 - October 2002
Idec Pharmaceuticals April 1998 - June 1999
Parexel 1994 - 1998
Skills
FDA, CRO, EDC, Software Documentation, Validation, Oncology, Sop, GCP, SOP, Biotechnology
Education
University of New Hampshire 1988 — 1992
BA, Zoology/PreMed
Banner Health October 2004 - Present
Tres Amigos Furniture and Accessories June 2003 - October 2003
IDEC Pharmaceuticals 2000 - 2002
Skills
Email Marketing, Social Media Marketing, Local Search..., Brand Awareness, Integrated Marketing, Healthcare, Google Adwords, Google Analytics, Advertising, Strategic Partnerships, Marketing Communications, Brand Development, SEM, Marketing, Social Media, Social Networking, Strategic Planning, Sales, Event Planning, Marketing Strategy, Management, Copywriting, Online Marketing, Leadership
Education
University of Arizona 1996 — 2000
BS, Marketing
Genentech 2008 - Present
Genentech April 2006 - June 2008
Genentech August 2005 - April 2006
Biogen Idec November 2004 - August 2005
Idec Pharmaceuticals December 1998 - November 2004
Skills
Pharmaceutical Industry, Biopharmaceuticals, Biotechnology, GMP, FDA, V&V, Validation, Cell Culture, Sop
Education
University of California, Santa Barbara 1991 — 1996
Bachelor of Science (B.S.), Zoology/Animal Biology
Genentech Manager, ManufacturingBiogenNovember 2004 - September 2005
Biogen Idec 2004 - 2005
IDEC Pharmaceuticals 2000 - 2003
Baxter 1995 - 2000
Skills
Clinical Trials, CAPA, 21 CFR Part 11, Biopharmaceuticals, Validation, Biotechnology, GMP, Change Control, Technology Transfer, FDA, Sop, Pharmaceutical Industry, LIMS, V&V, Quality Control, Lifesciences, GxP, Project Management, Quality Assurance, Life Sciences, SOP
Education
California State University-Dominguez Hills 1986 — 1992
BS, Chemistry and Biology
Shire Regenerative Medicine (formerly Advanced BioHealing) 2010 - 2014
Biotech Industry 2006 - 2009
Favrille, Inc. 2002 - 2006
IDEC Pharmaceuticals 2002 - 2002
Advanced Tissue Sciences 1995 - 2002
Molecular Biosystems 1993 - 1995
Biosurface Technology / Genzyme Tissue Repair 1990 - 1993
Skills
GMP, Aseptic Processing, Manufacturing, Clean Rooms, Validation, Cell Culture, Aseptic Technique, Medical Devices, FDA, Operations Management, Biotechnology, Tissue Culture, DMAIC, Biologics, V&V, Biopharmaceuticals, Tissue Engineering, Operational Excellence, Media Preparation, Lean Process Improvement, CAPA, 21 CFR Part 11, Quality System, Technology Transfer, Technical Writing, Mentoring, coaching, ISO 13485, Process Simulation, Sop, Change Control, Coaching, SOP
Education
University of Massachusetts Boston
Bachelor of Science (BS), Biology
Malden Catholic High School
College prep
Genentech July 2012 - Present
Genentech February 2010 - July 2012
Genentech July 2008 - November 2010
Genentech June 2005 - June 2008
Biogen Idec 2003 - 2005
IDEC Pharmaceuticals 1997 - 2003
Skills
GMP, FDA, Validation, CAPA, Change Control, Biopharmaceuticals, Sop, Biotechnology, Quality System, Pharmaceutical Industry, Technology Transfer, V&V, GAMP, Aseptic Processing, 21 CFR Part 11, Computer System..., Lifesciences, GxP, GLP, LIMS
Education
University of Phoenix 2002 — 2005
Bachelor of Science (BSc), Business Administration and Management, General
Mobile Health Engagement Strategies, LLC June 2014 - Present
NSITE Group, LLC September 2009 - June 2014
Celerity Healthcare Solutions, Inc January 2006 - September 2009
Ligand Pharmaceuticals 2002 - 2005
IDEC Pharmaceuticals 1997 - 2002
Skills
Oncology, Pharmaceutical Industry, Biotechnology, Lifesciences, Cross-functional Team..., Strategic Planning, Product Development, Medical Devices, Pharmaceutical Sales, Marketing Strategy, Sales Management, New Business Development, Business Strategy, Market Access, Commercialization, Healthcare, Market Research, Strategy, Clinical Research, Sales Effectiveness, Product Launch, Competitive Analysis, Neurology, Managed Care, Business Development, Global Marketing, Urology, Biopharmaceuticals, Cardiology, Dermatology, Life Sciences
Education
Central Michigan University 1985 — 1989
BSBA, Marketing and Management
MGO, LLP January 2014 - Present
CEA, LLP October 2013 - January 2014
McGladrey LLP August 2004 - September 2013
RSM McGladrey 2004 - December 2010
JGD & Associates 2002 - 2004
IDEC Pharmaceuticals 1998 - 2002
Skills
Auditing, Accounting, SOX, SEC reporting, Compliance, Internal Controls, Financial Reporting, Efficiency..., Strategy, Sarbanes-Oxley Act, Budgets, Management, SEC filings, Analysis, US GAAP, CPA, Tax Research, Tax, Finance, Corporate Tax, SEC Filings
Education
California State University-San Marcos - College of Business Administration 1999 — 2001
Bachelor of Science (B.S.), Accountancy
Universidad de Puerto Rico 1993 — 1997
BS, Animal Science
Mylan Institutional December 2007 - Present
Genentech 2005 - 2007
Biogen Idec 2003 - 2005
Idec Pharmaceuticals 2001 - 2003
PetSmart 1999 - 2001
Idec Pharmaceuticals 1997 - 2001
Veterinary Surgical Specialists 1995 - 1997
Pet Emergency and Specialty Center 1993 - 1995
Rancho San Diego Animal Hospital 1993 - 1995
Melrose Pet Clinic 1991 - 1993
Education
Chapman University 2001 — 2005
Bachelor of Arts (B.A.), Organizational Leadership
San Diego Mesa College 1993 — 1995
Associates Degree, Animal Health Technology Degree
Sanofi Pasteur January 2009 - Present
Genentech April 2006 - June 2009
Biogen Idec January 2004 - August 2005
Idec Pharmaceuticals 2003 - 2004
DSM Biologics 2001 - 2003
Education
Université du Québec à Montréal 1998 — 2001
Bachelor, Molecular Biology and Biotechnology
Banksia Regulatory Consulting June 2010 - Present
Biogen Idec January 1999 - 2010
IDEC Pharmaceuticals 1999 - 2003
FDA April 1994 - December 1998
Skills
eCTD, IND, Regulatory Submissions, Clinical Development, Biotechnology, Regulatory Affairs, Biopharmaceuticals, Oncology, Biologics, Monoclonal Antibodies, Drug Development, Immunology, FDA, CMC, Technology Transfer, Pharmaceutical Industry, Clinical Trials
Education
The University of British Columbia
B.S., Zoology
The University of Western Australia
Ph.D., Biochemistry
Halozyme Therapeutics, Inc. January 2012 - Present
Biogen Idec August 1988 - March 2011
Biogen Idec 2003 - 2008
IDEC Pharmaceuticals 1999 - 2003
Skills
Oncology, Biotechnology, Clinical Trials, Clinical Trial..., Drug Development, Clinical Research, Clinical Development, CRO, FDA, CTMS, Sop, Infectious Diseases, Cross-functional Team...
Education
University of California, Davis
Bachelor of Science, Genetics
Foresight Group International AG June 2012 - Present
Foresight Group International, AG 2007 - 2012
Roche January 2009 - December 2010
Genentech April 2008 - December 2008
Pfizer August 2007 - February 2008
Johnson & Johnson February 2006 - August 2007
Schering-Plough Research Institute April 2004 - January 2006
Chiron Corporation September 2003 - April 2004
St. Jude Children's Research Hospital May 2003 - July 2003
IDEC Pharmaceuticals January 2003 - April 2003
Skills
21 CFR Part 11, Computer System..., Quality Assurance, Software Documentation, Validation
Education
University of California, Davis
Bachelor of Science, Biochemistry
Boehringer Ingelheim Chemicals October 2008 - Present
Boehringer Ingelheim September 2007 - October 2008
Eli Lilly November 2003 - August 2007
MedImmune, Inc. December 1999 - November 2003
IDEC Pharmaceuticals January 1999 - December 1999
IDEC Parmaceuticals February 1997 - January 1999
Novum Inc. August 1993 - September 1996
Biogen, Inc. April 1989 - May 1993
Bioran Mediacal Lab September 1986 - April 1989
Education
Bethany College 1981 — 1985
B.S., Biology
Procopio, Cory, Hargreaves & Savitch LLP March 2012 - Present
Law Offices of Johnny Manriquez November 2008 - March 2012
Private Company August 2003 - May 2008
Law Offices of Johnny F.R. Manriquez January 2001 - January 2003
IDEC Pharmaceuticals May 2000 - August 2000
Neil, Dymott, Perkins May 1998 - August 1998
Skills
Intellectual Property, Licensing, Litigation, Patents, Copyright Law, Legal Assistance, Contract Negotiation, Corporate Law, Litigation Support, Trademarks, Legal Writing, Commercial Litigation, Business Formation, Legal Research, Corporate Governance, Due Diligence, Trademark Prosecution, Civil Litigation, Start-ups, Joint Ventures, E-Discovery Consulting, technology transactions, Trade Secrets, Document Review
Education
California Western School of Law 1998 — 2001
JD
Loma Linda University 1998 — 1999
MPH, Healthcare Administration
Loma Linda University 1989 — 1993
BS, Biological Sciences
home ec. studio July 2009 - Present
La Bete Handmade January 2007 - Present
Biogen Idec 1998 - 2002
Idec Pharmaceuticals 1996 - 2002
Skills
Sewing, Crochet, Manufacturing, Biotechnology, cGMP, Word, GMP, Validation, FDA, SOP, Change Control, Pharmaceutical Industry, Technology Transfer, CAPA, Quality System, Cross-functional Team..., Cell Culture
Education
University of California, San Diego 1990 — 1995
B.S., Chemical Engineering
Genentech, Inc. December 2007 - Present
Genentech 2005 - 2007
Biogen Idec 2003 - 2005
IDEC Pharmaceuticals 1995 - 2003
Skills
Biotechnology, GMP, Biopharmaceuticals, Validation, Change Control, Manufacturing, CAPA, Quality Assurance, Aseptic Processing, GAMP, Quality System, Sop, FDA, Technology Transfer, V&V, GxP, 21 CFR Part 11, LIMS, Cleaning Validation, Computer System..., SOP
Education
California State University-San Bernardino 1989 — 1992
Bachelors, Environmental Studies; Geography, Geology, Urban Studies, Biology, Chemistry
GenMark Diagnostics October 2012 - Present
YMCA of San Diego County 2000 - 2015
Gen-Probe October 2005 - September 2012
IDEC Pharmaceuticals 2002 - 2005
Agouron Pharmaceuticals 1999 - 2002
Quintiles 1999 - 2000
Amylin Pharmaceuticals 1995 - 1999
Scripps Memorial Hospital 1992 - 1993
Skills
Biotechnology, Oncology, Clinical Trials, FDA, Clinical Development, Lifesciences, Pharmaceutical Industry, Regulatory Affairs, CRO, GCP, CTMS, Clinical Research, Regulatory Submissions, IND, Sop
Education
University of San Diego 1989 — 1993
Bachelor of Arts (B.A.), Communication Studies and Political Science
University of California, San Diego
Regulatory Affairs, Certificate, Extension Program
University of California, San Diego
Clinical Trials Management & Design, Extension Program
University of California, San Diego
Certificate in Spanish Language
Aaron Industries, Inc. September 2010 - August 2012
Sandoz February 2009 - October 2010
Aaron Industries, Inc September 2002 - September 2008
Alpharma November 1999 - August 2002
IDEC Pharmaceuticals 1997 - 1999
KPL April 1995 - June 1997
MicroGeneSys 1987 - 1992
Skills
Quality Systems, CAPA, GMP, Validation, Sop, Pharmaceutical Industry, Technology Transfer, Change Control, FDA, Quality Assurance, GxP, 21 CFR Part 11, V&V, Cleaning Validation, Manufacturing, Aseptic Processing, Computer System..., Quality System, Quality Auditing
Education
University of Phoenix 1998 — 2000
MBA
University of Connecticut 1986 — 1990
B.S.
Genentech October 2010 - Present
Genentech January 2008 - September 2010
Genentech August 2005 - December 2007
Biogen Idec July 2004 - August 2005
Idec Pharmaceuticals August 2002 - June 2004
Idec Pharmaceuticals June 2001 - July 2002
Genentech September 1998 - May 2001
Thermo Energy - Independent Contractor May 1998 - September 1998
Modesto Energy July 1989 - April 1998
Skills
Engineering, cGMP, HVAC, GMP, Continuous Improvement, SOP, Six Sigma, Biotechnology, Manufacturing, Technology Transfer, Root Cause Analysis, Commissioning, Process Improvement, Lean Manufacturing, DMAIC, Value Stream Mapping, Supervisory Skills, Problem Solving, Troubleshooting, Procurement, Operations Management, Documentation, Life Sciences, Visio, Budgeting, PLC, Calibration, Instrumentation, Team Building, Excel
Education
State of California - Board of Engineering 2012 — 2012
Registered Professional Engineer, Mechanical Engineering
University of California, San Diego 2008 — 2009
HVAC Engineering
University of Southern California 1987 — 1988
Safety and Systems Management
Naval Nuclear Power School 1983 — 1984
Mechanical Technician, HTFF, ETMO, Radiation Theory, etc.
Ripon College 1977 — 1981
Tunnell Consulting, Inc. June 2014 - Present
Quintiles November 2011 - Present
Boehringer Ingelheim Chemicals, Inc. October 2008 - March 2011
Boehringer Ingelheim Chemicals September 2007 - September 2008
Eli Lilly and Company November 2003 - August 2007
MedImmune December 1999 - November 2003
IDEC Pharmaceuticals February 1997 - December 1999
Novum Inc. August 1993 - September 1996
Biogen, Inc. April 1989 - May 1993
Bioran Medical Laboratory September 1986 - April 1989
Skills
Pharmaceutical Industry, Biopharmaceuticals, Medical Devices, API, Quality System, Supplier Quality, Supplier Auditing, Internal Auditing, Deviation Management, Change Management, Document Management, CAPA, Annual Product Reviews, Batch Release, Internal Audit, Reviews, Sop, Quality Assurance, V&V, Cleaning Validation, FDA, GMP, Validation, Trackwise, Quality Auditing, Change Control, Quality Control, Auditing, APIs, GxP, LIMS, Computer System..., 21 CFR Part 11, Biotechnology, GLP, Software Documentation, HPLC, Regulatory Requirements, Regulatory Affairs, Technology Transfer, Regulatory Submissions, GAMP, Laboratory, Deviations, Drug Development, Pharmacovigilance, Pharmaceutics, Aseptic Processing, Vaccines, Clinical Development
Education
Bethany College 1981 — 1985
B.S., Biology
Allos Therapeutics October 2009 - January 2011
Imclone Systems Incorporated March 2007 - December 2009
Millennium Pharmaceuticals March 2003 - June 2007
Genomic Health Incorporated July 2006 - March 2007
IDEC Pharmaceuticals July 1997 - March 2003
Adria/Pharmacia Corporation June 1986 - July 1997
Education
Arizona State University 1976 — 1980
BS, Business/Communications
Genentech August 2005 - Present
Biogen Idec 2003 - 2005
IDEC Pharmaceuticals 2003 - 2004
Baxter 2002 - 2003
Skills
Biotechnology, LIMS, Quality Control, Change Control, Biopharmaceuticals, GMP
Education
University of California, Irvine 1998 — 2002
BS, Biology
The Hong Kong University of Science and Technology 2000 — 2001
Biology
Jakarta International School 1993 — 1996
Nido de Aguilas 1990 — 1993
Lincoln School 1987 — 1990
Genentech August 2013 - Present
Genentech August 2005 - Present
Biogen Idec November 2003 - August 2005
IDEC Pharmaceuticals August 2003 - November 2003
Sequenom April 2002 - April 2003
Skills
HPLC, Quality, qPCR, FDA, Biotechnology, GMP, Chromatography, PCR, Laboratory, Quality Control, LIMS, Biochemistry, Molecular Biology, Trackwise, Monoclonal Antibodies, Sop, Validation, GLP, Assay Development, SOP
Education
University of California, San Diego 1999 — 2003
BS, Biochemistry and Cell Biology
Cal State San Marcos
Master of Science (MS), Biology, General
University of Illinois at Chicago College of Pharmacy Rockford October 2010 - Present
Catalent Pharma Solutions March 2010 - October 2010
Thermo Fisher Scientific January 2008 - September 2008
Genentech July 2005 - June 2007
Biogen Idec January 2001 - July 2005
IDEC Pharmaceuticals January 1995 - December 2000
Skills
Biotechnology, FDA, Chromatography, Pharmaceutical Industry, Cell Culture, Validation, HPLC, Protein Purification, ELISA, GMP, Biopharmaceuticals, Aseptic Technique, Technology Transfer, Sop, Clinical Trials, Microbiology, Cross-functional Team..., LIMS, Analytical Chemistry, GLP, PCR, Regulatory Affairs, CAPA, Molecular Biology, UV/Vis, DNA, Laboratory, Purification, Biochemistry, LC-MS, SDS-PAGE, Immunology, Manufacturing, Protein Chemistry, Western Blotting, Mass Spectrometry, Cell
Education
University of Illinois at Chicago 2011 — 2016
MS, Medical Biotechnology
Rockford University 2007 — 2009
BS, Biology
Genentech December 2013 - Present
Genentech January 2010 - December 2013
Genentech August 2005 - January 2010
Biogen Idec 2003 - 2005
IDEC Pharmaceuticals 2001 - 2003
Bioserv Corp August 2001 - December 2002
Elan (Dura) Pharmaceuticals March 2000 - June 2001
Isis Pharmaceuticals 1997 - 2000
Skills
GMP, Change Control, CAPA, Inspection management, Manufacturing, Validation, Quality Control, Quality Assurance, 21 CFR Part 11, Sop, Quality System, FDA
Education
University of California, Davis 1992 — 1995
Bachelors of Science, Biochemistry
College of the Redwoods 1990 — 1992
Associate of Arts and Sciences (AAS), Biochemistry
Biogen March 2015 - Present
Biogen Idec August 2010 - Present
Biogen Idec November 2008 - August 2010
Biogen Idec November 2003 - November 2008
IDEC Pharmaceuticals February 2001 - November 2003
University of Bonn 1989 - 1992
Education
University of Düsseldorf 1993 — 2000
Habilitation, Biochemical Engineering
The University of Bonn 1989 — 1992
PhD, Chemistry
The University of Bonn 1983 — 1989
MS, Chemistry
Jeff Nakamatsu Consulting October 2006 - Present
Jeff Nakamatsu Consulting October 2006 - Present
Cardinal Health 2002 - 2006
Idec Pharmaceuticals 2001 - 2002
telios Pharmaceutical 1994 - 1994
Adanced Tissue Science 1993 - 1994
IMS LTD 1990 - 1992
Skills
Life Sciences, Biotechnology, Microbiology, ELISA, Molecular Biology, R&D, FDA, Cell Culture, Research, Product Development, Pharmaceuticals, Cell Biology, GMP, PCR, Validation, Medical Devices, Technology Transfer, Purification, Biochemistry, SOP, cGMP, Quality Systems, HPLC, GLP, Genetics, LIMS, Bioinformatics, Process Validation, Regulatory Affairs, Quality Assurance, Manufacturing, Strategic Planning, Clinical, Microsoft Office, Problem Solving, QC, Sop, V&V, Pharmaceutical Industry, Aseptic Processing, Change Control, Chromatography, 21 CFR Part 11, Biopharmaceuticals, CAPA, Oncology, Quality Auditing, Clinical Research, Clinical Trials, Quality System
Education
California State University-Long Beach 1977 — 2003
B.S., Medical Microbiology
California State University-Long Beach 1977 — 1983
B.S., Microbiology
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
Halyard Health October 2013 - Present
Bayer HealthCare July 2010 - September 2013
Constien and Associates, Inc June 2007 - August 2009
OXIS International March 2005 - June 2006
OXIS Internationsl January 2005 - March 2005
MEDINOX, INC June 2000 - July 2003
IDEC PHARMACEUTICALS March 2000 - June 2000
AMYLIN PHARMACEUTICALS, INC February 2000 - March 2000
ZONAGEN, INC January 1999 - January 2000
KELCO OIL FIELD January 1998 - January 1999
Skills
HPLC, Chemistry, GMP, Validation, GLP, Sop, JMP, Laboratory, Statistical Data..., Gas Chromatography, Quality Assurance, Formulation, Assay Development, Quality Control, Pharmaceutical Industry, Manufacturing, R&D, SOP, FDA
Education
Sam Houston State University
Bachelor of Science, Chemistry
Stemedica Cell Technologies August 2010 - Present
Genentech July 2005 - September 2006
Biogen Idec February 2003 - August 2005
IDEC Pharmaceuticals 2000 - 2003
Skills
GMP, Biotechnology, Sop, Aseptic Processing, FDA, Validation, CAPA, Change Control, Pharmaceutical Industry, Cell Culture, Lifesciences, Biopharmaceuticals, GLP, Fermentation, 21 CFR Part 11, SOP, Life Sciences, Technology Transfer
Education
Southwestern College
InCyte Corporation June 2011 - Present
Biogen Idec January 2001 - 2011
IDEC Pharmaceuticals January 2001 - 2004
Sequus Pharmaceuticals 1996 - 1997
Glaxo Smithkline 1985 - 1996
Skills
Biotechnology
Education
University of North Carolina at Greensboro
Genentech November 2012 - Present
Genentech August 2005 - Present
Biogen Idec 2003 - August 2005
IDEC Pharmaceuticals January 1999 - 2003
Skills
SAP R/3, Forklift Operator, IATA / DOT HazMat..., Materials Management
Education
Miramar College 1996 — 1998
Ashford University
Currently Enrolled, Supply Chain Management
Self-employed EVP - Knowledge and Innovation NetworksBiogen IdecNovember 1991 - January 2009
IDEC Pharmaceuticals 1992 - 2004
Skills
Strategic Planning, Non-profit Board..., Organizational..., Marketing Strategy, Corporate Communications, Organizational..., Entrepreneurship, Nonprofits, Change Management, Leadership, Fundraising, Leadership Development, Strategy, Program Development, Project Planning, Cross-functional Team..., Program Management, Team Building, Start-ups, Executive Coaching, Business Strategy
Education
Stanford University 1975 — 1977
MBA, Marketing, Finance
Stanford University 1971 — 1975
Bachelor of Arts (B.A.), English - Honors program
My Home January 2014 - Present
ePark Systems, Inc. October 2010 - December 2013
My Home May 2004 - September 2010
Biogen Idec November 2003 - April 2004
IDEC Pharmaceuticals July 2000 - November 2003
IDEC Pharmaceuticals January 1997 - November 2000
Pacific Computer Solutions April 1993 - January 1997
DynCorp International November 1990 - March 1993
ManTech International, Inc. July 1985 - October 1990
Logicon, Inc. October 1984 - June 1985
Skills
Databases, ERP, Software Development, Oracle, Budgets, Business Intelligence, IT Management, IT Strategy, Integration, Mergers & Acquisitions, Enterprise Architecture, SharePoint, SDLC, Disaster Recovery, Data Center, Software Documentation, Vendor Management, Business Analysis, Requirements Analysis, Enterprise Software, Process Improvement, System Administration, Executive Management, Microsoft SQL Server
Education
University of San Diego 1972 — 1977
Bachelor of Science (BS), Business Administration and Management, General
Tocagen Inc. August 2015 - Present
Arena Pharmaceuticals May 2013 - August 2015
Avid Bioservices January 2011 - May 2013
Genentech August 2007 - January 2011
Biogen Idec August 2003 - August 2005
IDEC Pharmaceuticals January 2001 - January 2005
IDEC Pharmaceuticals January 2001 - August 2003
IDEC Pharmaceuticals November 1996 - February 1998
IDEC Pharmaceuticals November 1995 - November 1996
IDEC Pharmaceuticals January 1995 - November 1995
Skills
Quality System, Quality Assurance, Quality Control, FDA GMP, ICH guidelines, CQA, Lean Tools, Six Sigma, Project Management, Validation, Analytical Chemistry, Investigation, Troubleshooting, CMC, OOS, CAPA, Raw Materials, SOP development, Instrument Validation, Analytical Method..., Deviation Management, Report Writing, Document Review, Data Analysis
Education
California Polytechnic State University-San Luis Obispo 1992 — 1994
Bachelor of Science (BS), Biochemistry
University of California, San Diego 1988 — 1989