Cygnus Inc
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Cygnus Inc Employees
Quest Aircraft Company, L.L.C. January 2015 - Present
Selle Design Group / Alpaca Culture Magazine September 2014 - December 2014
Cygnus, Inc. May 2013 - August 2014
Anvil Corporation April 2008 - October 2010
VCA Antech May 2006 - January 2007
The Four Dam Pool Power Agency September 2004 - March 2006
KBK Financial December 1999 - August 2002
The Associates Commercial Corporation November 1997 - October 1999
Comerica Bank - TX July 1996 - November 1997
PMC Capital September 1992 - July 1996
Skills
Organize vast amounts..., Type 70 wpm, 10-key by touch, Benefits Administration, Medical Terminology, Payroll, Scheduling, Bid Preparation, Appraisal review, Phase I and II ESA..., Plans & Specs review, Survey Review, Title Search/Report..., Flood map review, Blue Print review, Lien Waivers, UCC filings, UCC Searches, Tax Liens, Judgment Searches, Analyze Financial..., Purchase Orders, Work Orders, Legal Contract Review, Document Financial..., Microsoft Word, Microsoft Excel, Access, PowerPoint, LaserPro, Construction Loans, SBA 504, Adobe Acrobat, Outlook, Budgets, Quality Assurance, Program Management, Process Scheduler, Training, Project Management, Customer Service, Contract Management
Education
University of Alaska Anchorage 2004 — 2004
Pre-Nursing Studies, B+
University of Florida 1979 — 1983
Bachelor of Science (B.S.), Business Administration - Finance
Genomic Health January 2015 - Present
Boreal Genomics July 2014 - September 2014
Genomic Health January 2007 - July 2014
Scios December 2003 - January 2007
Cygnus Inc October 1997 - October 2003
Skills
Biostatistics, SAS, Clinical Trials, Oncology, Biotechnology, Statistics, Clinical Development, Lifesciences, Clinical Data Management, Life Sciences, Protocol, Pharmaceutical Industry, CRO
Education
University of Minnesota-Twin Cities 1995 — 1997
M.S., Statistics, minor in Biostatistics
Novosibirsk State University (NSU) 1986 — 1991
B.S., Economics, minor in Mathematics
MaxVal Group, Inc. January 2004 - Present
NTERO Surgical 1998 - 2002
ALZA Corporation 1996 - 1998
Cygnus, Inc. 1991 - 1995
Skills
Intellectual Property, Patents, Patent Strategy, Patent Prosecution, Technology Transfer, Intellectual Property...
Education
Stanford University Law School 1995 — 1998
JD, Law
University of California, Berkeley 1986 — 1990
PhD, Bioengineering
University of California, San Francisco 1986 — 1990
PhD, Bioengineering
Indian Institute of Technology, Kanpur 1984 — 1985
MS, Chemical Engineering
Anna University 1980 — 1984
BS, Chemical Engineering
Gilead Sciences, Inc. March 2006 - November 2010
Telik, Inc. June 2004 - March 2006
Genentech, Inc. April 2004 - June 2004
Cygnus, Inc. 1998 - 2004
Education
California Institute of the Arts 1974 — 1976
BFA
California State University-Los Angeles 1971 — 1974
Bonner County Idaho November 2000 - Present
Cygnus Inc September 1996 - November 2000
Superior Industries 1989 - 1993
Cooper Communities 1987 - 1989
Hilliard Oil & Gas Inc. April 1979 - December 1986
Skills
Variance Analysis, Financial Reporting, Accounting, Fixed Assets, Budgets, Microsoft Excel, Cost Accounting, Activity Based Costing, Standard Costs, General Ledger, Account Reconciliation, GAAP, Financial Accounting, Internal Controls, Financial Statements
Education
CSU Sacramento 1975 — 1977
Bachelor's of Science, Accounting
De Anza College 1972 — 1974
Thermo Fisher Scientific February 2013 - Present
Affymetrix March 2010 - January 2013
Boston Scientific April 2009 - March 2010
Johnson & Johnson January 2006 - March 2009
Johnson & Johnson, Lifescan January 2002 - January 2005
Johnson & Johnson, Lifescan January 2001 - January 2002
Johnson & Johnson, Lifescan January 1999 - January 2001
Cygnus Inc January 1998 - January 1999
Hyseq Inc January 1997 - January 1998
Skills
Medical Device..., Team Leadership, Program Management, Cross-functional Team..., Change Management, Green Belt, Medical Devices, FDA, Product Management, Design Control, SDLC, Strategy, Business Process, Product Development, Supply Chain, ISO 13485, Quality Assurance, Validation, R&D, Project Management, Six Sigma, Design for Manufacturing, Lean Manufacturing, Leadership, Manufacturing, Project Planning, Testing, GMP, Commercialization, CAPA
Education
University of Arizona, Eller College of Management 1999 — 2001
MBA, Executive MBA
University of California, Santa Cruz 1994 — 1997
BA, Biology
Alameda Health Services December 2010 - Present
PRACTICE THERAPEUTICS March 2007 - October 2008
Alameda County Public Health Department January 2006 - March 2007
Animas Corporation September 2003 - January 2006
Cygnus Inc. April 2002 - April 2003
Innovex February 2001 - March 2002
Therasense February 2000 - February 2001
LifeScan 1996 - 2000
Skills
Diabetes, Nutrition, Public Relations, Team Building, Health, Clinical, Public Health, Clinical Research, Community Outreach, Quality Assurance, Healthcare, Public Speaking, Medical Devices, Customer Service, Research, Teaching, Writing, Coaching, Product Development
Education
San Jose State University 1986 — 1988
Master in Public Health, Public Health Education and Promotion
California Polytechnic State University-San Luis Obispo 1980 — 1984
Bachelor of Science (BS), Dietetics Food Administration
Cygnus Inc May 2014 - Present
Cygnus Inc - Makers of wall mounted workstations for healthcare March 2006 - May 2014
Uof M Alumni Camp Michigania 2002 - 2006
Ludlow Enterprises 2000 - 2002
Sterling Bank & Trust 1996 - 2000
Skills
Healthcare, Management, Lead Generation, Market Research, Sales Management, New Business Development, Sales Process, Product Development, Healthcare Information..., Medical Devices, Market Development, Direct Sales, Selling, Account Management, Marketing, Sales Operations, Product Launch, Capital Equipment, Sales, Sales Presentations, Cold Calling, Salesforce.com, Product Marketing, Cross-functional Team..., Product Management, Business Development, Start-ups, Market Analysis, Competitive Analysis, Solution Selling, CRM, Market Planning, Strategy, B2B, Strategic Partnerships, Key Account Management, Leadership, Executive Management, Contract Negotiation
Education
University of Michigan-Dearborn 1990 — 1992
Political Science, Management
Embry-Riddle Aeronautical University 1988 — 1990
Airway Computer Science
AcelRx Pharmaceuticals, Inc. October 2012 - Present
AcelRx Pharmaceuticals, Inc. February 2012 - October 2012
Alexza Pharmaceuticals June 2010 - February 2012
Alexza Pharmaceuticals September 2009 - June 2010
Calibra Medical, Inc 2008 - 2009
AccessClosure 2007 - 2008
Guidant Corp. / Abbott Vascular 2004 - 2007
Guidant Corp. 2003 - 2004
AlgoRx/POWDERJECT TECHNOLOGIES 1998 - 2003
CYGNUS INC 1996 - 1998
Skills
FDA, Engineering, Medical Devices, Design Control, Testing, CAPA
Education
San Jose State University
BSME, Mechanical Engineering
Thoratec July 2012 - Present
Caliper Life Sciences - A Perkin Elmer Company January 2010 - February 2012
Roche Molecular Systems March 2000 - May 2009
VIROLOGIC, INC January 1999 - March 2000
CYGNUS, INC January 1988 - January 1999
Cooper BioMedics Laboratory, Inc. July 1987 - January 1988
GLAXO CANADA INC January 1980 - January 1987
Skills
System Integrators, Systems Engineering, Risk Management, Medical Devices, Requirements Management, Doors, Validation, Diagnostics, IVD, Automation, R&D, Documentation, FDA, Process Development, Quality Systems, Biotechnology, Life Sciences, GMP, Data Analysis, Regulatory Affairs, QSR, Quality Management, Quality Assurance, Lifesciences, Hardware Diagnostics, Quality System, SLAS 2013 Liquid..., LIMS, Testing, Quality Control, Pharmaceutical Industry, ISO 13485, PCR, CAPA, Assay Development, Design Control, 21 CFR Part 11, Process Simulation, Software Documentation, Medical Diagnostics
Education
Humber College 1985 — 1987
Certification, Computer Programming
Far Eastern University
BS in Chemistry, Analytical Chemistry
Far Eastern University
BS in Preparatory Medicine, Medicine
Humber College
Computer Programming
Vascular Pathways, Inc. September 2012 - Present
Bard Medical, CR Bard April 2006 - September 2012
Venetec International August 2001 - April 2006
Cygnus, Inc. July 2000 - August 2001
Disetronic Medical Systems July 1998 - July 2000
Skills
Medical Devices, Clinical Research, Clinical Development, Nursing Management, Sales Management, Sales, Team Leadership, Product Development, Marketing, Strategic Planning, Budgets, Medical Education, Learning Management, Educational Technology, Customer Service, Project Management, Public Speaking, Hospitals, Vascular, Urology, Wound Care, Infection Control, Certified Diabetes..., Diabetes Care, Autism Spectrum..., Learning Disabilities, Product Launch
Education
Michigan State University 1985 — 1988
Bachelor's Degree, Nursing
CHEMOCENTRYX, INC 2001 - Present
ADVANCED INHALATION RESEARCH, INC 1998 - 2001
MILLENNIUM PHARMACEUTICALS, INC. 1998 - 1998
CYGNUS, INC. 1991 - 1996
UNIVERSITY OF MICHIGAN, COLLEGE OF PHARMACY 1988 - 1989
RATHAUS APOTHECARY 1984 - 1985
Education
Harvard Business School
Master of Business Administration (MBA)
J.W. GOETHE UNIVERSITY – College of Pharmacy
Philosophiae Doctor in Pharmaceutical Technology
J.W. GOETHE UNIVERSITY – College of Pharmacy
Bachelor of Science (BS), Pharmacy
Bristol-Myers Squibb 2015 - Present
Melinta Therapeutics 2014 - 2014
UCSF 2011 - 2014
UCSF HARC 2011 - 2014
Advanced Genetic Systems (AGS), Inc. 2011 - 2014
UC Irvine 2005 - 2010
Genentech 2003 - 2005
Cygnus Inc 2002 - 2003
Santa Cruz Biotechnology 1998 - 2001
Cytokinetics 2000 - 2000
Skills
Medical Liaison, Medical Communications, KOL Identification, KOL Development, KOL Management, Scientific..., Medical Affairs, Regulatory Compliance, Relationship Building, Relationship Management, Cross Functional..., Infectious Diseases, Clinical Trials, Hematology, Oncology, Cell, Assay Development, ELISA, Biochemistry, Protein Chemistry, Virology, Immunology, Cell Biology, Molecular Biology, Microbiology, RNA isolation, Immunofluorescence, Molecular Cloning, Purification, GMP, Vaccines, DNA sequencing, PCR, Cell Culture, Genetic Engineering, recombinant DNA..., Validation, Western Blotting, qPCR, Tissue Culture, Bioinformatics, Fluorescence Microscopy, Molecular Evolution, Gene Therapy, Proteomics, Mass Spectrometry, Protein Expression, Genomics, Protein Purification, Entrepreneurship
Education
University of California, San Francisco
Postdoctoral Research Fellowship, Retroviral Pathogenesis, Immunology
St. Ignatius College Preparatory
Diploma
University of California, Irvine
Doctorate of Philosophy, Virology, Experimental Pathology
University of California, Santa Cruz
Bachelor of Science, Molecular, Cellular, and Developmental Biology
University of California, Santa Cruz
Bachelor of Arts (B.A.), Music - Piano and Composition
Onyx Pharmaceuticals, An Amgen Subsidiary April 2012 - Present
ALEXZA Pharmaceuticals January 2008 - February 2012
ALZA Corporation 2000 - 2007
Ortho-McNeil Pharmaceutical 1999 - 2000
Cygnus, Inc. 1998 - 1999
Skills
Analytical Chemistry, HPLC, GLP, LC-MS, GMP, Drug Delivery, Technology Transfer, FDA, Drug Development, CMC, Formulation, Chromatography, IND, SOP, cGMP, Methods Development, Methods Validation, GC
Education
Meerut University
Ph.D., Chemistry
University of Guelph
M.S., Chemistry
Modus eDiscovery May 2013 - Present
Modus eDiscovery January 2012 - May 2013
Epiq Systems March 2010 - January 2012
Cygnus, Inc. October 2008 - March 2010
Boise State University August 2007 - May 2008
Skills
Excel, Access, Litigation Support, Microsoft Office, Customer Service, Project Management, Troubleshooting, Document Management, Process Improvement, Data Analysis, Relativity, Clearwell, Microsoft Excel, EDRMS
Education
Boise State University 2006 — 2008
Business Management
Mylan Tecnologies, Inc. February 2005 - Present
ChemScope Inc., Biopharmaceutical Consultancy May 2000 - January 2005
Aradigm Corporation 1998 - 2000
ALZA Corporation 1995 - 1998
ALZA (a J&J company) 1995 - 1998
Cygnus, Inc. December 1990 - March 1995
Skills
Transdermal, Controlled Release, Process Development, New Equipment..., Product Development, Combination Medical..., Aseptic Manufacturing, Continuous Manufacturing, Regulatory Submissions, Biofermentation, QBD, CTD, Equipment Qualification, Process Validation, Senior Management, Polymers, Polymer Chemistry, Polymer Rheology, GMP Manufacturing, Adhesives, Bio Separation, Production Planning, Fluid Dynamics, Process Analytical..., Process Simulation, HPLC, IND, V&V, UV, GMP, Patents, Biopharmaceuticals, Pharmaceutical process..., Quality by Design, FDA, ANDA, Executive Management, Lyophilization, Pharmaceutics, Inhalation, GLP, Formulation, eCTD, Rheology, Sop, Analytical Chemistry, Aseptic Technique, Change Control, Generic Programming, Combination Products
Education
University of California, Santa Barbara 1988 — 1990
MS
University of California, Davis 1980 — 1985
BS
Champlain Elementary
University of California, Berkeley
Russ Potts Consulting, LLC 2002 - Present
FreeLance, Inc 2009 - 2012
Vyteris 2005 - 2011
Solianis 2008 - 2009
Cygnus, Inc November 1990 - July 2002
Pfizer 1982 - 1990
Skills
Medical Devices, Biotechnology, Patents, FDA, Drug Delivery, Patent Litigation, Technology Transfer, Continuous Improvement, Drug Development, Product Development, ISO 13485, Validation, Quality System, Mergers & Acquisitions, Strategy, Chemistry, Clinical Trials, Process Simulation, Clinical Research, Sop, Commercialization, Pharmaceutical Industry, Licensing, GMP, Biopharmaceuticals, Due Diligence, Analytical Chemistry, R&D, Regulatory Affairs, Regulatory Submissions, Design of Experiments, Drug Discovery, Protein Chemistry, Clinical Development, Life Sciences, CAPA, Pharmaceutics, Lifesciences, Formulation, Start-ups, Design Control
Education
Yale University 1979 — 1980
PostDoctoral Fellow, Chemistry
University of Massachusetts, Amherst 1975 — 1978
PhD, Biochemisty
Cornell University 1968 — 1970
MS, Chemistry
Michigan State University 1964 — 1968
BS, Chemistry
Cygnus, Inc. August 2011 - Present
Skills
Machining
Education
Lake Washington Technical College
mastercam university online degree
Zealcon Corporation July 2014 - Present
MyHealth Access Network July 2013 - July 2014
Univesity of Oklahoma, Division of Medical Informatics June 2010 - July 2013
Cygnus Inc January 1999 - June 2011
The Society of Exploration Geophysicists September 2007 - July 2008
General Communications Inc. June 2002 - April 2007
Spring Street Software September 1995 - December 1998
General Communcations Inc January 1995 - March 1996
GTE Government Systems June 1993 - December 1994
Digital Equipment Corporation September 1989 - June 1993
Skills
Business Intelligence, Agile Methodologies, JavaScript, Microsoft SQL Server, Pentaho, Oracle, Databases, SharePoint, SQL, Java, Software Development, Unix, XML
Education
Northeastern University 1986 — 1989
MSCS, Computer Science
University of Montana 1976 — 1980
BSCS, Computer Science
IGM Resins May 2014 - Present
SUNY-ESF September 2012 - Present
Brewer Science September 2010 - May 2014
Linn-Benton Community College January 2010 - October 2010
Hewlett-Packard April 2005 - January 2010
University of Southern California February 2004 - March 2005
Cygnus, Inc February 1996 - August 1998
Skills
R&D, Chemistry, Nanotechnology, Thin Films, Coatings, Analytical Chemistry, Materials, Physics, Sensors, Formulation, Adhesives, Materials Science, Cross-functional Team..., Manufacturing, Design of Experiments, Polymers, Electronics, Polymer Chemistry, AFM, Process Engineering, Science, Organic Chemistry, Semiconductors, IC, Characterization, MEMS, Testing, TGA, FTIR, Differential Scanning..., Process Simulation, Polymer Characterization
Education
University of California, Los Angeles 1998 — 2004
PhD, Chemistry
University of California, Berkeley 1992 — 1995
BS, Chemistry, Molecular and cell biology
Osborne Construction Co October 2010 - Present
Cygnus, Inc. September 2008 - September 2009
Northern Air Frames January 2008 - September 2008
Architects Alaska 1997 - 2005
Skills
AutoCAD, Trimble, Terramodel, Photoshop, Revit, Microsoft Office, Microsoft Excel, Microsoft Word, Solidworks, PowerPoint, Research, English, Windows, Outlook, Catia, Customer Service
Education
University of Alaska Anchorage 1996 — 2004
Associate of Applied Science In Architectural and Engineering Technologies, Architecture and Engineering
Redmond High School 1988 — 1989
High School Diploma
Biotechnology and Pharmaceutical Industry July 2014 - Present
Stanford University School of Medicine July 2009 - Present
University of Rochester May 2011 - Present
Esperion Therapeutics, Plymouth, MI July 2013 - July 2014
JANSSEN Alzheimer Immunotherapy, a Johnson & Johnson Company April 2010 - June 2013
CV Therapeutics 2002 - 2009
PowderJect Technologies 2001 - 2002
VIVUS Inc 1997 - 2001
Cygnus Inc 1989 - 1997
Janssen Pharmaceutica 1979 - 1989
Skills
Pharmaceutical Industry, Biotechnology, Regulatory Affairs, Translational Medicine, Drug Development, Commercialization, Development Strategy, Cross-functional Team..., R&D, Clinical Development, Drug Safety, Quality Assurance, Compliance, Clinical Trials, Strategy, FDA, Start-ups, Biopharmaceuticals, GxP, Lifesciences, CRO, Drug Discovery, GCP, Cardiology, Regulatory Submissions, Life Sciences
Education
University of Rochester
Hunter College High School
Genentech September 2013 - Present
Exelixis March 2013 - August 2013
Stanford University, Research Compliance Office November 2012 - March 2013
JANSSEN Alzheimer Immunotherapy September 2011 - September 2012
Roche Genentech September 2009 - April 2011
Roche Pharmaceuticals August 2007 - September 2009
Roche August 2001 - July 2007
US Affiliate Study Management February 2000 - August 2001
Clinical OperationsRoche Global Development June 1998 - February 2000
Cygnus Inc. April 1997 - May 1998
Skills
Clinical Trials, Clinical Development, GCP, Publications, CTMS, CRO, Oncology, Biotechnology, FDA, EDC, IND, Pharmacovigilance, Regulatory Submissions, Clinical Operations, ICH guidelines, IRB, SOP development, GxP, 21 CFR Part 11, Clinical Monitoring, Infectious Diseases, Regulatory Affairs, Medical Writing, Protocol, Clinical Data Management, Medical Affairs, Drug Safety, Biopharmaceuticals, Pharmaceutics, Drug Discovery
Education
University of Colorado Denver 1986 — 1988
B.S.N, Nursing
Santen, Inc. March 2011 - Present
Genentech, Inc. October 2010 - March 2011
MacuSight, Inc. 2009 - June 2010
MacuSight, Inc. 2004 - 2009
Corium International Inc. August 2000 - July 2004
PowderJect Technologies, Inc. September 1999 - August 2000
Cygnus Inc. December 1997 - September 1999
UCSF, Dr.Howard Maibach's Lab December 1996 - December 1997
ALZA Corporation 1996 - 1996
Neurex Coproration 1995 - 1995
Education
University of the Pacific 1991 — 1997
PhD, Pharmaceutical Sciences
Jadavpur University
M.Pharm, Pharmacology
Kakatiya University
B.Pharm, Pharmacy
CV Ingenuity July 2012 - Present
Asthmatx, A Boston Scientific Company March 2009 - July 2012
XTENT, Inc. February 2006 - February 2009
CYTYC May 2000 - February 2006
Novacept 2000 - 2002
Cygnus Inc September 1996 - May 2000
Skills
Auditing, CAPA, GMP, ISO 13485, Medical Devices, Quality System
Education
University of California, Santa Cruz 1991 — 1996
BA
George Washington High School
FDAzilla 2010 - Present
Zymergi, Inc. January 2007 - Present
Genentech October 2004 - January 2007
Genentech, Inc. October 1999 - October 2004
Cygnus, Inc. August 1998 - October 1999
Skills
FDA, Biotechnology, Manufacturing, Entrepreneurship, Start-ups, GMP, Technology Transfer, Cell Culture, Strategy, Data Analysis, Process Improvement, Business Development, Pharmaceutical Industry, Lifesciences, Chemical Engineering, Cross-functional Team..., Analysis, Commercialization, Process Engineering, Product Development, Statistics, Process Simulation, Life Sciences, Six Sigma, Process Optimization, Quality Assurance, Validation, R&D, Quality System
Education
Cornell University 1997 — 1998
M.Eng, Chemical Engineering
Cornell University 1993 — 1997
B.S., Agricultural and Biological Engineering
Franklin Regional HS 1989 — 1993
Diploma
NuLayer Inc. November 2006 - Present
Kovio 2007 - 2008
Zinc Matrix Power April 2005 - October 2006
Smiths Detection January 2004 - March 2005
DuPont Displays July 2003 - December 2003
Cygnus Inc August 2001 - June 2003
Oplink Communications July 2000 - June 2001
PPG Industries July 1991 - March 2000
Skills
Biosensors, Coatings, Sensors, Materials, Batteries, Thin Films, Electrochemistry, Materials Science, Ink, Chemistry, R&D
Education
University of Kentucky 1986 — 1991
PhD, Inorganic Chemistry
Peking University 1979 — 1983
BSc, Radiochemistry
J Tamada Consulting December 2012 - Present
ArKal Medical December 2007 - November 2012
ALZA Corporation, Johnson and Johnson May 2005 - October 2007
Alexza Pharmaceuticals May 2004 - April 2005
Cygnus, Inc. December 1991 - April 2004
Skills
Medical Devices, Combination Products, Drug Delivery, Diabetes, Pain Management, Continuous Glucose..., Transdermal, Inhalation, Biosensors, Microfluidics, Transport Phenomena, Separations, Polymer Characterization, Formulation, Design Control, PMA, IND, GCP, Biomedical Device Design, Team Leadership, Scientific Management, Project Management, Strategic Thinking, R&D, Biomedical Engineering, Commercialization, FDA, ISO 13485, Cross-functional Team..., Clinical Development, Sop
Education
Massachusetts Institute of Technology 1989 — 1991
NIH Postdoctoral Fellow
University of California, Berkeley 1984 — 1989
Ph.D.
California Institute of Technology 1980 — 1984
BS
Theravance August 2009 - Present
Alexza Pharmaceuticals May 2005 - February 2009
Vaxgen, Inc. August 2004 - April 2005
Millennium Pharmaceuticals January 2003 - June 2004
Cygnus, Inc. August 2000 - December 2002
Superstore Industries September 1999 - July 2000
Education
University of California, Davis 1999 — 2001
B.S., Biological Sciences
Second Sight Medical Products 2007 - Present
Boston Scientific 2003 - 2007
Cygnus, Inc. 2001 - 2003
Abbott Laboratories 1999 - 2000
St. Jude Medical (formerly Ventritex) 1993 - 1998
Education
Stanford University 1980 — 1982
MS, Engineering, Product Design
Massachusetts Institute of Technology 1976 — 1980
BS, Architecture
Alexza Pharmaceuticals 2004 - Present
Bioassay Laboratories April 2003 - September 2004
Cygnus, Inc April 2000 - October 2002
Education
Metropolitan State University of Denver 1993 — 1998
PneumRx, Inc. September 2013 - Present
Avantis Medical Systems December 2010 - September 2013
McKesson July 2010 - December 2010
Sciton January 2010 - April 2010
LifeScan, Inc. April 2004 - March 2009
Avantis Medical Systems 2009 - 2009
Cygnus, Inc. May 2000 - April 2003
Cygnus, Inc. August 1997 - April 2000
Skills
Medical Devices, Product Marketing, Product Launch, Product Development, Competitive Analysis, Cross-functional Team..., Start-ups, Product Management, Commercialization, R&D, Strategic Partnerships, Strategy, Marketing, Market Development, FDA, Sales Operations, Global Marketing, Marketing Management, Capital Equipment
Education
Santa Clara University 2004 — 2008
MBA
University of California, Berkeley 1991 — 1995
BA, Molecular and Cellular Biology
Pharmaceutical Consulting October 2006 - Present
Depomed, Inc. 1998 - 2007
Cygnus Systems, Inc. 1994 - 1998
Cygnus, Inc. 1994 - 1998
Ciba-Geigy 1984 - 1994
Skills
Drug Delivery, Technology Transfer, Pharmaceutical Industry, Biotechnology, Lifesciences, GMP, GLP, FDA, Clinical Development, Sop, Validation, Formulation, IND, Drug Development, Regulatory Submissions, Regulatory Affairs, Drug Discovery, Biopharmaceuticals, Clinical Trials, Commercialization, 21 CFR Part 11, CAPA, SOP, Life Sciences
Education
UCLA 1973 — 1978
PhD
University of Rochester 1969 — 1972
Theravance, Inc. April 2002 - Present
Cygnus, Inc. 1995 - 2002
Lederle Laboratories, American Cyanamid 1989 - 1995
Skills
Pharmaceutical Industry, Biotechnology, Cross-functional Team..., Product Development, Medical Devices, Lifesciences, Market Research, Strategic Planning, Marketing Strategy, Competitive Intelligence, R&D, Strategic Partnerships, Product Management
Education
Carnegie Mellon University - Tepper School of Business 1987 — 1989
MBA
The Ohio State University 1983 — 1987
DVM, Veterinary Medicine
Orexigen Therapeutics June 2015 - Present
Dart NeuroScience LLC January 2013 - June 2015
Amylin February 2003 - January 2013
Amylin Pharmaceuticals, Inc. February 2003 - January 2005
Intrabiotics 2001 - 2002
Intrabiotics 2000 - 2001
Cygnus, Inc 1998 - 2000
Cygnus 1997 - 1998
Gilead Sciences 1991 - 1997
Skills
Project Management, Contract Negotiation, Team Leadership, FDA, Protein Chemistry, Technology Transfer, Biopharmaceuticals, Drug Development, Pharmaceutical Industry, Change Control, Validation, Analytical Chemistry, Formulation, GMP, Drug Delivery, Software Documentation, Biotechnology, Strategic Planning, Regulatory Submissions, Cross-functional Team..., V&V, CMC, CRO, Quality Assurance, 21 CFR Part 11, Sop, Clinical Trials, GLP, Drug Discovery, Chemistry, HPLC, CAPA, Medical Devices, Lifesciences, Commercialization, Quality Control, Chromatography, Medicinal Chemistry, Regulatory Affairs, Clinical Development, Pharmacology, Oncology, Quality System, R&D, Pharmaceutics, Organic Chemistry, IND, GCP, Vaccines, Infectious Diseases
Education
University of Michigan 1985 — 1990
Doctor of Philosophy (PhD), Organic Chemistry
Miami University 1981 — 1985
B.S., Chemistry
Onyx Pharmaceutical May 2013 - Present
StemPar Sciences, Inc. September 2009 - May 2013
Johnson and Johnson Pharmaceutical August 2004 - February 2009
Genentech Inc July 2001 - June 2004
Cygnus Inc January 2000 - July 2001
Cygnus Inc November 1998 - December 1999
Cygnus Inc November 1996 - October 1998
Cygnus Inc September 1995 - October 1996
Skills
Drug Delivery, Drug Development, Cross-functional Team..., Strategic Alliances, Infectious Diseases, Operations Management, Biotechnology, Management, Pharmaceutics, Clinical Trials, Clinical Development, Leadership, Product Development, Medical Devices, Oncology, Strategic Planning, Project Planning, Strategy, Entrepreneurship, Biopharmaceuticals, Product Lifecycle..., Pharmaceutical Industry, Start-ups, Data Analysis, Program Management, Science, IND, Budgets, Project Management
Education
Indian Institute of Science 1982 — 1989
Ph.D., Condensed Matter Physics
Stanford University Graduate School of Business 2009 — 2009
From start-up to IPO
Smith College Consortium 2006 — 2006
Smith Executive Education
UC Continuing Education 2005 — 2010
Cancer Biology, Physiology, Bioscience, Business Development, Pharmaceutical Marketing
University of Delaware 1993 — 1995
Post Doc, Chemical Engineering
Ecole normale supérieure 1991 — 1993
Post Doc, Physics
Centre d'Etude Nucleaire d' Saclay 1989 — 1991
Post Doc
Cygnus, Inc June 2000 - November 2004
National Institutes of Health January 1990 - May 2000
Georgetown University Medical Center June 1984 - January 1990
Education
Harvard Medical School 1968 — 1972
MD, Medicine
Stanford University 1964 — 1968
BS, Biology
Cygnus, Inc. November 2007 - Present
Thorne Research, Inc. May 2007 - October 2007
Unicep Packaging, Inc. June 2006 - May 2007
Sandpoint Gas N Go September 2004 - June 2006
Self Employed March 2003 - June 2006
Skills
AutoCAD Mechanical, Catia, Solid Edge, Unigraphics, Solidworks, Lean Manufacturing, Technical Documentation, Problem Solving, Root Cause Analysis, Operations Management, Manufacturing, Engineering, Aerospace, Kaizen, Quality Assurance, Six Sigma, Continuous Improvement, Process Improvement, Liquid Penetrant Testing, Excel, PowerPoint, HTML, Word, SolidWorks
Education
University of Pennsylvania - The Wharton School 2013 — 2013
Operations Management, 4.0
Swoosh Technologies 2013 — 2013
NX8 CAD Fundamentals, 100%
Spokane Community College 2012 — 2012
CAD in the Shop Technical Training
CAD Institute 2008 — 2008
Certificate, AutoCAD Basics
University of Phoenix 2003 — 2004
Business Management
OXiGENE, Inc. February 2015 - Present
InterMune March 2014 - March 2015
Onyx Pharmaceuticals April 2013 - March 2014
Elan July 2007 - March 2013
Cutera April 2005 - June 2007
Cygnus, Inc. June 1998 - March 2005
Skills
Financial Reporting, Accounting, Financial Analysis, Forecasting, SAP, Sarbanes-Oxley Act, Accruals, Auditing, Revenue Recognition, Microsoft Excel, Payroll, Sales & Use Tax, Fixed Assets, Cash Flow Forecasting, SEC filings, GAAP, Department Budgeting, Budget Forecasts, Cash Flow, Flux Analysis
Education
San Francisco State University, College of Business
Bachelor of Business Administration (B.B.A.), Accounting
Life Technologies 2011 - 2013
Life Technologies 2006 - 2011
Pacific Biosciences 2008 - 2009
Applied Biosystems 2004 - 2006
GeneMachines 1998 - 2003
Cygnus Inc. 1997 - 1998
ALZA Corporation 1996 - 1997
Calgene (Monsanto) 1993 - 1996
Education
Université de Technologie de Compiègne 1990 — 1993
Ingenieur Genie Biologique, Produits Biologiques et Alimentaires
Lycee du Parc - Lyon 1987 — 1990
Math Sup/Spe Bio
Lycee Jean Puy - Roanne 1983 — 1987
Baccalaureat C, Sciences, Mention AB
Nuvelo, Inc. 2004 - 2008
Cygnus, Inc. 2000 - 2004
Roche Diagnostics Corp. 1993 - 1999
Roche Diagnostics Corp. 1993 - 1999
Skills
FDA, GMP, Design Control, Quality System, Medical Devices, Quality Auditing
Education
Quinnipiac University
Clinical Chemistry
University of Vermont
B.S., Medical Technology
American Medical Systems August 2012 - Present
Medtronic Spine & Biologics August 2010 - June 2012
Medtronic November 2009 - August 2010
Abbott Vascular Devices September 2007 - August 2009
Abbott Vascular Devices March 2006 - September 2007
Cygnus, Inc. April 2002 - April 2005
Johnson & Johnson 2000 - 2001
Johnson & Johnson 1996 - 2000
Education
Santa Barbara Community College
ADN and AA, Registered Nurse and Psychology
University of California, Santa Barbara
BA, Sociology
University of San Francisco
MPA, Masters of Public Administration, Health Services Administration
Onyx Pharmaceuticals March 2013 - Present
Onyx Pharmaceuticals July 2011 - February 2013
Abbott Laboratories (Formerly Facet Biotech/PDL) August 2008 - April 2011
Genitope June 2006 - May 2008
Vaxygen 2005 - 2006
Johnson & Johnson March 2004 - June 2005
Cygnus Inc. 2000 - 2003
JSS Medical College and Hospital, Mysore India 1997 - 1999
Skills
GMP, Validation, CAPA, Quality System, FDA, Biotechnology, Regulatory Affairs, Change Control, GLP, Pharmaceutical Industry, Quality Assurance, 21 CFR Part 11, Biopharmaceuticals, HPLC, Clinical Development
Education
The Johns Hopkins University 2011 — 2014
MS, Regulatory Science
Manipal Academy of Higher Education 1994 — 1997
MS, Medical Biochemistry
University of Mysore 1991 — 1994
BS, Microbiology, Biochemistry, Botany
Boyle, Platte & Kee August 2014 - Present
Cygnus, Inc. February 2011 - June 2014
Integrated Ideas & Technologies, Inc. July 2010 - March 2011
Unicep Packaging, Inc. November 2006 - August 2010
All-American Publishing January 2005 - November 2006
Skills
Manufacturing, Lean Manufacturing, Customer Service, Purchasing, Project Management, Microsoft Office, Program Management, Account Management, Accounts Receivable, Event Planning, Marketing, Sales, Aerospace Manufacturing, Pharmaceutical Packaging, Customer Management, Contract Manufacturing, cGMP manufacturing, AS9100, Iso 9000, Internal Audit, Procurement, Process Improvement, Operations Management, Office Management, Office Administration, Databases
Education
Boise State University 2003 — 2005
B.S., Health Science/Psychology
Albertson College of Idaho 1999 — 2001
Biology
SHS
Intarcia Therapeutics 2007 - May 2013
Cygnus, Inc. 1998 - 2006
Chiron Corporation 1990 - 1998
Townsend & Townsend 1989 - 1990
DuPont 1986 - 1989
Education
University of Pennsylvania Law School 1984 — 1987
Doctor of Law (JD)
University of California, San Diego 1973 — 1977
B.A., Anthropology/Biology
AURI September 2007 - Present
GelStat 2004 - 2007
Boston Scientific 2003 - 2004
CIMA LABS 1999 - 2004
Cygnus Inc. 1997 - 1999
Shaman Pharmaceuticals 1992 - 1995
University of Hawaii September 1984 - June 1990
Skills
R&D, Technology Transfer, FDA, Product Development, Analytical Chemistry, HPLC, Medical Devices, Validation, Chromatography, Chemistry, GLP, Pharmaceutical Industry, Biotechnology, Strategic Planning, Regulatory Affairs, Biofuels, GMP, Laboratory, Commercialization, Science, Lifesciences, Life Sciences
Education
University of Arizona 1979 — 1984
Ph.D., Chemistry
University of Minnesota-Twin Cities 1973 — 1978
B.A., Chemistry
Cygnus Inc January 2004 - Present
North Country Community Mental Health 1999 - 2004
Campbell Soup Company / Price Waterhouse 1993 - 1996
Campbell Soup 1993 - 1996
Daytons 1990 - 1991
Skills
Healthcare Information..., Hospitals, Process Improvement, EMR, EHR, Sourcing, Procurement, Government Contracting, Customer Relations, Copywriting, Product Development, Distribution, Database Administration, Excel, ERP, Flexibility, Graphic Design, HRIS, Integration, Inventory Management, Internet, Lean Manufacturing, Microsoft Office, Manufacturing, Program Management, New Business Development, Organizational..., Strategic Planning, Photography, Quality Assurance, Research, SQL, Problem Solving, Troubleshooting, Vendor Management, Lead Generation
Education
North Central Michigan College 2002 — 2004
Continuing Education, Information Technology
The Defiance College 1977 — 1981
BS, Communications
Cygnus Inc. Assistant ManagerGriffin ArenaAugust 2003 - May 2005
Education
Michigan State University 1991 — 1995
Business, Materials & Logistics Management Logistics
PneumRx, Inc., a BTG International group company May 2015 - Present
Auxogyn, Inc. March 2014 - April 2015
Experien Group March 2013 - March 2014
J Anastas Consulting January 2013 - March 2013
Vibrynt, Inc. September 2008 - December 2012
Abbott Vascular January 2007 - September 2008
Guidant January 2005 - December 2006
Guidant 2002 - 2004
Cygnus Inc. 1998 - 2002
Chiron Corporation 1994 - 1998
Skills
Medical Devices, FDA, PMA, 501(k), Regulatory Requirements, CE marking, Clinical Trials, Design Control, V&V, Validation, Clinical Development, GCP, Quality System, Technical Writing, 21 CFR, Biotechnology
Education
Boston University
MPH, Public Health
Boston University
BA, Chemistry with Biology Minor
Nuvelo August 2004 - Present
Cygnus, Inc. January 1997 - August 2004
Education
Wayne State University 1984 — 1988
Ph.D., Chemistry
University of Michigan-Dearborn 1980 — 1984
B.S., Chemistry
Independent 2014 - Present
Corium International 2005 - 2013
Cygnus, Inc. 1996 - 2004
Beckman Coulter 1988 - 1996
Skills
Medical Devices, Product Development, FDA, Manufacturing, Packaging, GMP, Quality System, Validation, Process Improvement, Cross-functional Team..., R&D, Engineering, Project Management, Supply Chain Management, Biotechnology, Start-ups, Lean Manufacturing, CAPA, V&V
Education
Santa Clara University 1983 — 1986
MS, Engineering Management
San Jose State University 1978 — 1980
BS, Mechanical Engineering
Bio-Rad Laboratories June 2008 - Present
Johnson & Johnson 1997 - 2007
Cygnus, Inc. 1996 - 1997
Lifescan 1995 - 1996
Skills
GMP, LIMS, Sop, Validation, CAPA, Quality System, 21 CFR Part 11, Quality Control, Quality Assurance, GLP, Change Control, FDA, V&V, Biotechnology, GxP, SOP
Education
San Jose State University
Bachelor of Science (BS), Biochemistry
University of Phoenix
Master of Business Administration (MBA), Business Administration and Management, General
LoPresti and Associates January 2012 - Present
ChemGenex Pharmaceuticals, Inc. October 2008 - December 2011
Maxygen November 2007 - November 2008
Abbott Laboratories October 2005 - November 2007
VaxGen September 2004 - June 2005
Scios Inc September 2003 - September 2004
Sugen Inc January 2002 - September 2003
Cygnus Inc May 2000 - October 2001
Litmus Concepts August 1994 - February 1999
Biocircuits Corporation April 1992 - August 1994
Education
University of California, Santa Cruz 2005 — 2007
Certificate Programs, Clinical Trials Management and Regulatory Affairs
San Jose State University 1989 — 1991
B.S. Biology, Minor Chemistry, Biology, Chemistry, Marine Sciences
Cygnus, Inc. 1996 - 2001
Allergan November 1977 - December 1995
Skills
Microsoft Office, Microsoft Word, Social Media
Education
University of La Verne 1986 — 1989
BS, Management and Organizational Behavior
Reno High School 1973 — 1976
hs Dipolma
Emergent BioSolutions February 2012 - Present
Human Genome Sciences September 2010 - January 2012
MedImmune January 2004 - September 2010
MedImmune December 2002 - December 2003
Baxter Healthcare August 2001 - December 2002
Cygnus, Inc October 1997 - December 2000
Skills
Quality System, Supplier Quality, CQA, CAPA, Quality Assurance, FDA
Education
San Jose State University 1990 — 1995
BS, Microbiology
University of Baltimore
MBA
Rexel USA January 2014 - Present
Rexel USA December 2009 - January 2014
Cygnus, Inc. 1992 - 2009
Greater Cleveland Growth Association/COSE 1988 - 1999
Skills
Product Development, Direct Sales, Business Planning, Manufacturing, Six Sigma, Sales Management, Motion Control, Product Marketing, New Business Development, Motors, Electronics, Key Account Management, Negotiation, Team Building, Project Management
Education
The University of Akron 2009 — 2009
LEAN Enterprise Mastery Certificate
Baldwin Wallace University 1987 — 1990
B.A., Business
San Mateo County November 2000 - Present
Timely Data Resources 1995 - 1998
Cygnus, Inc. 1993 - 1995
Frost & Sullivan 1992 - 1993
UCSF Medical Center 1979 - 1991
Skills
Microsoft Office, Microsoft Excel, Microsoft Word, Customer Service, English, Research, Windows, Teaching, Clinical Trials, Clinical Data Management, SAS programming, book group leader, Volunteer Management, Medical Writing, Medical Devices, Pharmaceutical Industry, Library Reference, Library Instruction, Library Research, Reader's Advisory, Data Analysis
Education
SUNY Stony Brook
Bachelor's degree, Education
N.A. April 2008 - April 2010
N.A. November 2006 - April 2008
Dow Pharmaceutical Sciences, Inc February 2005 - November 2006
Gilead Sciences, Inc September 2001 - February 2004
Corium Technology Group December 1999 - September 2001
Cygnus, Inc September 1991 - December 1999
Graphic Controls Corporation August 1988 - August 1991
Skills
Formulation, Drug Delivery, Characterization, Polymers, In Vitro, Coatings, Product Development, Adhesives, UV/Vis
Education
University at Buffalo 1983 — 1990
PhD, Chemistry
Canisius College 1979 — 1983
BS, Chemistry
Kelly Services for Novartis June 2012 - May 2014
SFL Regulatory Affairs & Scientific Communication Ltd January 2010 - September 2011
Eli Lilly (Elanco) 2006 - 2009
Pfizer, Inc. 2004 - 2006
Pharmacia 2000 - 2003
Center for Bioanalytical Research (Higuchi Biosciences Center) 1997 - 2000
Cygnus, Inc. 1995 - 1997
Oread Laboratories 1994 - 1995
Skills
GMP, Drug Discovery, Pharmaceutics, Formulation, Medical Devices, Cross-functional Team..., Project Management, Pharmaceutical Industry, Drug Development, Regulatory Submissions, Lifesciences, GLP, HPLC, Validation, Chromatography, Life Sciences
Education
Clarke University 1988 — 1992
B.S.
The University of Kansas
Cygnus Inc. January 2008 - Present
Education
Full Sail University 2010 — 2014
Bachelor's degree, Animation, Interactive Technology, Video Graphics and Special Effects
Nevada Union High School 1980 — 1984
Cepheid May 2006 - Present
Fluidigm Corporation October 2007 - August 2008
Southwall Technologies April 2005 - May 2006
LeapFrog March 2003 - July 2004
Cygnus, Inc March 1995 - March 2003
Skills
Cost Accounting, ERP, Manufacturing, Variance Analysis, Budgets, Sarbanes-Oxley Act, Account Reconciliation, Analysis, Access, Management, Target Costing, Inventory Control, Project Management, Process Improvement, Accounting, Cross-functional Team...
Education
San Jose State University
Bachelor's degree, Accounting
Cygnus, Inc June 2013 - Present
Harbor Industries September 2007 - 2013
Harbor Industries 1993 - 2007
Harbor Industries 1986 - 1993
Beatrice Cheese, Inc 1984 - 1986
Skills
Finance and Operations, P&L background includes..., Leadership, Business Development, Strategic Planning, Budgets, Accounting, Manufacturing, Cost Accounting, Finance, Financial Reporting, Pricing, Forecasting, Management, Process Improvement, Cross-functional Team..., P&L Management
Education
Grand Valley State University 1981 — 1984
Bachelor of Business Administration (BBA), Accounting
Northern Michigan University 1974 — 1977
none