Experience
Gilead Sciences  January 2015 - Present
Gilead Sciences  September 2011 - January 2015
Viasystems  2008 - 2011
Novo Nordisk Delivery Technologies   February 2006 - March 2008
Genencor, A Danisco Division  July 1999 - February 2006
COR Therapeutics  September 1994 - July 1999

Skills
Quality System, Six Sigma, EH&S Compliance, Program Management, Certified Safety..., Biosafety, Chemical Safety, Radiation Safety, ISO 14001, OHSAS18001, Emergency Spill Response, Ergonomics, Risk Assessment, Validation, Cross-functional Team..., Root Cause Analysis, EHS, Manufacturing, GMP, FDA, Engineering, Quality Assurance, Hazardous Waste..., Leadership, Industrial Hygiene, Contract Negotiation, Continuous Improvement, R&D, Process Improvement

Education
The Johns Hopkins University   1987 — 1991
Bachelor's degree, Biology and German

Experience
Levi Strauss & Co.   May 2012 - Present
Verisign Inc.  April 2008 - September 2011
Novo Nordisk Delivery Technologies   March 2005 - December 2007
IPLocks Inc. (acquired by Fortinet)   December 2003 - March 2005
Google  June 2003 - October 2003
Ciena (formerly ONI Systems)   September 1999 - November 2002
Sun Microsystems  September 1997 - September 1999
Tolerant Systems Inc.   1982 - 1986
Tolerant Systems Inc.   1982 - 1986
Tolerant Systems Inc.   1982 - 1986

Skills
Vendor Relations, HRIS, Program Management, Start-ups, Performance Management, HR Strategy, HR Policies, SAP, Oracle HR, Benefits Design, Benefits Administration, Talent Acquisition, Technical Recruiting, Recruiting, Personnel Management, Employee Benefits

Education
San Jose State University
Bachelor of Science, Business Administration - Human Resources Management

Experience
NSTec  April 2015 - Present
Brady Corporation  December 2013 - July 2014
JDSU  October 2011 - May 2013
Sandia National Laboratories  June 2008 - October 2011
Novo Nordisk Delivery Technologies   September 2005 - May 2008
Lawrence Livermore National Laboratory  March 2004 - September 2005
Coherent (Lambda Physik)   October 2000 - February 2004
Department of Defence  February 1999 - October 2000
United States Air Force  July 1987 - May 1998

Skills
Laser, Six Sigma, Engineering, Manufacturing, Program Management, Testing, Occupational Health, Design of Experiments, Optics, Electronics, R&D, Training, Inspection, Semiconductors, Integration, Systems Engineering, Engineering Management, Troubleshooting, Hardware, Test Equipment, Root Cause Analysis, Failure Analysis, Automation, Validation, EHS, Security Clearance, Process Engineering, Quality Assurance, Continuous Improvement, Process Simulation, ISO

Education
Embry Riddle Aeronautical University-Worldwide   2013 — 2015
Master of Science (MS), Occupational Safey Management, 17

Embry-Riddle Aeronautical University   2000 — 2005
BS, Professional Aeronautics/Aviation Safety

Experience
Complete Genomics Inc.  March 2014 - Present
Biotech Industry  October 2013 - March 2014
Tethys Bioscience, Inc.   January 2012 - September 2013
iPierian  November 2010 - December 2011
XDx  June 2006 - November 2010
Novo Nordisk Delivery Technologies   October 2004 - June 2006
Quest Diagnostics  December 2002 - July 2004

Skills
LIMS, Biotechnology, ELISA, Lifesciences, PCR, Genomics, HPLC, Drug Discovery, Cell Culture, GLP, Validation, Biochemistry, High Throughput..., Medical Devices, R&D, Purification, Oncology, Immunoassays, Assay Development, Troubleshooting, FDA GMP, CLIA, Laboratory, Laboratory Automation, Instrumentation, Product Development, FDA, DNA, Life Sciences

Education
University of California, Berkeley   1997 — 2002
Bachelors of Science

California State University-Fullerton   2004 — 2004
Certificate

Experience
Medtronic Minimally Invasive Therapies Group  January 2011 - Present
Intero Real Estate  June 2009 - December 2010
Sequoia Voting Systems  November 2008 - November 2010
ASICSoft   February 2009 - June 2009
Novo Nordisk Delivery Technologies   October 2007 - February 2008
MedTech Development   August 2006 - October 2007
Varian Medical Systems  May 2006 - August 2006
Tyco Healthcare  June 2005 - April 2006
Graphics Microsystems  February 2005 - June 2005
Elmeco   November 2004 - June 2005

Skills
ISO 13485, Design Control, Medical Devices, Validation, FDA, R&D, Design of Experiments, CAPA, Quality System, FMEA, Design for Manufacturing, Manufacturing..., Manufacturing, Biomedical Engineering, V&V, Product Development, GMP, SPC, Root Cause Analysis, ISO 14971, Electronics, ISO, DMAIC, Minitab, Process Simulation, Supplier Quality, Six Sigma, Cross-functional Team..., Catheters, Solidworks, Lean Manufacturing, Injection Molding, Manufacturing..., Kaizen, Product Launch, Continuous Improvement, 5S, Engineering Management, Failure Analysis, Quality Assurance

Education
San Francisco State University   1995 — 1999
Master's Degree Program, Electrical Engineering / Power Electronics

Experience
Phillips-Medisize  September 2014 - Present
ZELTIQ  July 2013 - August 2014
dba. Engineering FX   November 2008 - July 2013
Flextronics  July 2008 - November 2008
Novo Nordisk Delivery Technologies   2006 - May 2008
Thermage  December 2000 - November 2005
Pinacle Composite Solutions   June 1998 - November 2000
Stargate Technologies  March 1998 - June 1998
Plynetics Express   November 1995 - September 1997
Satelite Models   November 1995 - March 1997

Skills
Design for Manufacturing, Medical Devices, Solidworks, Product Development, Pro Engineer, CAD, Manufacturing, Injection Molding, Product Design, R&D, Rapid Prototyping, Design Control, FDA, Quality System, Mechanical Engineering, Design of Experiments, Industrial Design, FMEA, Machining, Product Launch, Manufacturing..., Root Cause Analysis, Plastics, Materials, Solid Modeling, Lean Manufacturing, Pro/Engineer, Prototyping, 3D Printing, SolidWorks, PTC Creo

Education
Chabot College
AA, Machine Tool Technology/Machinist

Experience
Bio-Rad Laboratories  August 2010 - Present
Mazzetti Nash Lipsey Burch  May 2008 - September 2010
Novo Nordisk Delivery Technologies   April 2005 - April 2008
Harvest Technical Services, Inc. @ Genentech   February 2004 - April 2005
Lifescan, Inc., a Johnson & Johnson company   November 1986 - January 2003

Skills
Quality System, FDA, Engineering, Medical Devices, CAPA, Quality Assurance, Solidworks, AutoCAD, Program Management, CAD, R&D, GMP, Manufacturing, Sop, Change Control, ISO 13485, Software Documentation, Project Management, Document Management, Validation

Education
Suffolk County Community College   1976 — 1978
Associate of Applied Science, Mechanical Technology

Experience
Deloitte Consulting LLP  2008 - Present
UC Berkeley  August 2007 - May 2008
Novo Nordisk Delivery Technologies   May 2006 - December 2006

Skills
IT Strategy, Project Management, Management Consulting, Business Process..., Strategy, Data Center, Program Management, Business Strategy, Process Improvement, Project Planning, Microsoft Office, Mergers, Divestitures, Benchmarking, Enterprise Architecture, Cost Reduction..., Network Infrastructure, Network Architecture, System Architecture, Core Banking, Retail Banking, Payments, Data Analytics, Quantitative Analytics

Education
University of California, Berkeley   2007 — 2008
MS, Mechanical Engineering

University of California, Berkeley   2003 — 2008
BS, Mechanical Engineering

Experience
Envia Systems, Inc.   December 2008 - Present
Skeletal Kinetics  September 2008 - October 2008
Novo Nordisk Pharmaceuticals  April 2007 - February 2008
Novonordisk  2000 - 2008
Novo Nordisk Delivery Technologies   2000 - 2008
Aradigm Corporation  2000 - 2005
Mcghan Medical (Collagen Corporation) presently Allergan   1998 - 2000
Collagen Corporation (Presently Allergan)   1989 - 1990

Skills
CAPA, Aseptic Processing, GMP, Leadership, Sop, Quality System, Validation, Troubleshooting, Manufacturing, Clean Rooms, Design of Experiments, Change Control, R&D, Aseptic Technique, FDA, Engineering, V&V, ISO 13485, Medical Devices, SOP

Education
California State University-East Bay
Environmental Studies

Hartnell Jr. College
A.A., Biology & Water Technology

San Jose State University
Environmental Studies

Experience
Adventist Health/JLL   April 2014 - Present
Start Up Engineering, Inc   2005 - Present
City of Hope Medical Center  January 2011 - August 2013
Leiner Health Products  March 2008 - August 2008
Novo Nordisk Delivery Technologies   2006 - 2007
BAXTER Bioscience  2002 - 2005
Watson Pharmaceuticals Inc.  1999 - 2002
Aventis Pastuer (now Sanofi Aventis)   1998 - 1999
B.Braun/McGaw   1991 - 1998
Johnson Matthey  1984 - 1990

Skills
Validation, GMP, FDA, Pharmaceutical Industry, Biotechnology, Aseptic Processing, Manufacturing, Engineering, Project Management, Medical Devices, Project Planning, Sop, Quality System, Change Control, Budgets, Start-ups, V&V, Cross-functional Team..., Technology Transfer, Lean Manufacturing, GxP, FDA GMP, Root Cause Analysis, Six Sigma, ISO 13485, GAMP, Supply Chain, Management, Computer System..., Process Simulation, Quality Auditing, Quality Assurance, Quality Management, Testing, Regulatory Affairs, Process Engineering, Design of Experiments, Leadership, ISO, Pharmaceutics, Design Control, Minitab, R&D, Cleaning Validation, Continuous Improvement, Biopharmaceuticals, FMEA, Process Improvement, Quality Control, Sterilization

Education
Univ of Michigan (MSChE, BSChE with Dean's Honor), Grand Valley State U (MBA)
BSChE

Grand Valley State University
Master of Business Administration (MBA), Management & Finance

University of Michigan---Rackham School of Graduate Studies
MSE, Chemical Engineering

University of Michigan--College of Engineering
BSE, Chemical Engineering

University of Stuggart
German Language

Newman College
High School, Secondary School Certificate

Experience
Nanosys  October 2014 - Present
Daniel Barry & Associates   June 2009 - Present
Lawrence Berkeley National Laboratory  September 2013 - February 2014
Onyx Pharmaceuticals  January 2012 - August 2012
Novartis  March 2011 - December 2011
Life Technologies (merger of Applied Biosystems and Invitrogen)   June 2008 - May 2009
Novo Nordisk Delivery Technologies   January 2006 - February 2008
Daniel Barry & Associates   1999 - 2005
Four Winds Ropes Course and Outdoor Team Building Center   1997 - 2004

Skills
Sourcing, Biotechnology, Talent Acquisition, Medical Devices, Applicant Tracking..., Life Sciences, Contract Negotiations, Executive Search, Team Building, Screening, Interviewing, Problem Solving, Strategic Sourcing, Pharmaceuticals, Hiring, Recruiting, Lifesciences, Management, Temporary Placement, Onboarding, Pharmaceutical Industry, Talent Management, Interviews, Musical Background, Strategy, Contract Negotiation, Leadership, Musical Instruments, Consulting, Staffing Services, Coaching, Cold Calling, Competitive Analysis, Negotiation

Education
Dublin Institute of Technology   1987 — 1990
Advanced Diploma in Marketing

St. Benildus

Experience
iD Tech Camps  July 2013 - Present
Artisan Technology   October 2004 - Present
Various Clients  October 2004 - Present
Various Clients  October 2004 - Present
Novo Nordisk Delivery Technologies   2006 - 2008
InStep Technologies   1996 - 2004
Digital Equipment Corporation  June 1984 - January 1996
Inslaw   July 1982 - June 1984

Skills
C#, Business Process..., Software Solution..., Custom Software..., Data Modeling, Business Process..., Mobile Applications, Management Consulting, Enterprise Architecture, Business Efficiency, Microsoft SQL Server, Requirements Analysis, XML, Visual Basic, Agile Methodologies, ASP.NET, Software Development, Software Design, SaaS, Strategy, SQL, Program Management, Databases, Software Documentation, Architecture, Web Applications, Software Engineering, Solution Architecture, Software Project..., System Architecture, Agile Project Management, Enterprise Software, Cloud Computing, Architectures, Integration, Database Design, .NET

Education
American University   1982 — 1984
M.S., Computer Science

University of Michigan - School of Information   1975 — 1976
M.A, Information Science

Experience
SanDisk  June 2008 - Present
AMAT  February 2008 - June 2008
Novo Nordisk Delivery Technologies   August 2007 - February 2008

Skills
Currently learning..., Failure Analysis, Semiconductors, R&D, Etching, Scanning Electron..., Flash Memory, Metrology, EDX

Education
San Joaquin Delta College   1994 — 2007
AA, Electron Microscopy

Experience
AlliedBarton Security Services  July 2007 - Present
Bio-Rad Laboratories  June 2011 - Present
Bayer HealthCare  June 2008 - February 2011
Novo Nordisk Delivery Technologies   July 2007 - June 2008
Renaissance Stanford Court Hotel   1999 - 2006

Skills
Security, CCTV, Security Management, Corporate Security, Access Control, Physical Security, Security Operations, Protection, Alarm Systems, Security Awareness, R, Loss Prevention, Customer Service, Training, Surveillance, Executive Protection, Investigation, First Aid, Risk Management, Statistics, Data Science, Microsoft Word, Microsoft Excel, AED, POS, GMP, PowerPoint, Linear Regression, Regression Analysis, Cashiering, Data Analysis, Machine Learning, Python, SQL, Adult CPR, AMAG, Pegasys, Honeywell DCS, Environmental Monitoring, IP CCTV, Matlab, Mathematics, Food Service, Property Management..., Micros, TWIC Card, CMS

Education
University of California, Berkeley   1994 — 2007
B.A., Mathematics

Coursera   2013 — 2014

Orange Coast College   1991 — 1994
Mathematics

Experience
Seatel Cobham   Materials PlannerUltracellpowerOctober 2009 - April 2010
UltraCell  2009 - 2010
Pronet - Fremont Chapter - EDD experienced Unlimited   April 2009 - October 2009
Celerity  2008 - 2008
Novo Nordisk Delivery Technologies   1999 - 2008
Aradigm Corporation  1990 - 2005
Flextronics International  1996 - 1999
Quadrus Manufacturing   1995 - 1996
SCI Manufacturing   1994 - 1995
Target Therapeutics  1988 - 1994

Skills
Logistics, Leadership, Purchasing, Procurement, Inventory Control, Lean Manufacturing, Process Improvement, Six Sigma, Medical Devices, Microsoft Office, Marketing, Project Planning, Pharmaceutical Industry, Product Development, CAPA, Cross-functional Team..., GMP, FDA, Materials, Process Scheduler, Program Management, Contract Negotiation, Continuous Improvement, Validation

Education
Saint Louis University (PH)   1975 — 1980

Experience
Nektar Therapeutics  December 2013 - Present
InSound Medical  March 2013 - November 2013
Boehringer Ingelheim  April 2010 - March 2013
Invuity Inc  January 2010 - April 2010
Corium International  December 2008 - December 2009
Genentech  July 2008 - December 2008
Novo Nordisk Delivery Technologies   January 2005 - May 2008
Aradigm Corporation  November 2000 - January 2005
Bayer Diagnostics  January 1997 - November 2000

Skills
Validation, Medical Devices, Manufacturing, GMP, Aseptic Processing, Packaging, FDA, Project Management, Pharmaceutical Industry, Cross-functional Team..., Product Development, R&D, Continuous Improvement, Quality Assurance, Six Sigma, Biotechnology, Process Simulation, ISO 13485, Sop, CAPA, Engineering, ISO, Manufacturing..., Testing, Quality System, Root Cause Analysis, V&V, Design of Experiments, Change Control, FMEA, Quality Control, 21 CFR Part 11, Computer System..., Design Control, Lean Manufacturing, SPC, Technology Transfer, Solidworks, Process Engineering, SOP

Education
Rensselaer Polytechnic Institute   1996 — 1997
MS, Mechanical Engineering

Massachusetts Institute of Technology   1995 — 1996
Mechanical Engineering

Rensselaer Polytechnic Institute   1991 — 1995
BS, Mechanical Engineering

Experience
Amgen  April 2014 - Present
Novo Nordisk Delivery Technologies   May 2012 - April 2014
Apria Healthcare  April 2010 - May 2012
Novartis Pharmaceuticals  September 2006 - November 2009
Hallmark Marketing Corporation  January 2006 - September 2006
Enterprise Rent-A-Car  November 2002 - December 2005

Skills
B2B, CRM, Cardiology, Cold Calling, Cross-functional Team..., Customer Service, Human Resources, Leadership, Managed Care, Management, Marketing, Marketing Strategy, Neurology, New Business Development, Sales, Sales Operations, Sales Presentations, Sales Process, Selling, Training, Urology

Education
University of Northern Iowa   1998 — 2002
BA, Organizational Communications, Business

Experience
Abbott Diabetes Care  2008 - Present
Novo Nordisk Delivery Technologies   February 2005 - June 2008
Aradigm Corporation  2000 - 2005
LifeScan  1991 - 2000
Westinghouse, Inc.   1989 - 1991
City of San Jose  1985 - 1989
American River Hospital  1980 - 1983

Skills
Quality Assurance, FDA, Medical Devices, CAPA, Validation, GMP, ISO 13485, Pharmaceutical Industry, Quality System, Sop, Cross-functional Team..., Change Control, Process Simulation, Process Improvement, Clinical Trials, Product Development, Root Cause Analysis

Education
California State University-Sacramento
Bachelor of Science

San Jose State University
Bachelor of Science

Experience
Novo Nordisk Delivery Technologies   May 2000 - February 2008
PowderJect Pharmaceutical PLC   1997 - 2000
ALZA Corporation  1992 - 1997
COBE Cardiovascular  1987 - 1992

Skills
FDA, Medical Devices, Validation, Product Development, Pharmaceutical Industry, Quality Assurance, Project Management, Engineering, Strategy, Management, Leadership, Testing, Technology Transfer, Start-ups, Design of Experiments, Project Planning, Engineering Management, R&D, Cross-functional Team...

Education
Punjab Engineering College   1970 — 1974
BS, Aerospace Engineering

University at Buffalo
MS, Engineering Science

University of Colorado Boulder
ME, Engineering Management

Experience
Revance Therapeutics  October 2014 - Present
Medicines360  June 2013 - October 2014
Roche Molecular Systems  September 2012 - May 2013
Dynavax Technologies  March 2012 - August 2012
Genentech  April 2011 - December 2011
Cerexa Pharmaceuticals, Inc.   March 2008 - April 2011
Novo Nordisk Delivery Technologies   September 2005 - February 2008
Aradigm Corporation  October 2000 - September 2005
Aradigm Corporation  October 2000 - September 2005

Skills
Pharmaceuticals, Clinical Trials, Compliance, FDA regulations/ICH..., CTMS, EDC, CRO, Therapeutic Areas, Infectious Diseases, FDA, Clinical Research, Immunology, Endocrinology, Sop, Clinical Development, GCP, Project Management, Pharmaceutical Industry, Clinical Study Design, Vaccines, Clinical Operations, Protocol, Clinical Monitoring, SOP

Education
California State University-Fresno
Bachelor of Science

Experience
Black Diamond Networks  July 2013 - Present
Oxford Global Resources  March 2012 - June 2013
Abbott Vascular Structural Heart  August 2010 - February 2012
Veracord   May 2010 - August 2010
Infusion Systems, LLC  May 2008 - January 2010
Novo Nordisk Delivery Technologies   September 2007 - February 2008
Nektar Therapeutics  2004 - 2007
Lifescan  2002 - 2004
Nellcor Puritan Bennett  1994 - 1999
Medtronic Vascular  1993 - 1994

Skills
V&V, Process/Cost Improvement, Product Development, Supplier Development, Risk Analysis, FDA, Medical Devices, Quality System, FMEA, Manufacturing..., Quality Control, Manufacturing, Cross-functional Team..., Quality Assurance, Testing, Process Improvement, Process Simulation, ISO 13485, Change Control, Sop, CAPA, Supplier Quality, Design Control, GMP, Root Cause Analysis, SPC, Quality Auditing, Design of Experiments, ISO, DMAIC, Validation, Engineering, 21 CFR Part 11, Lean Manufacturing, Quality Management, R&D, Six Sigma, Continuous Improvement, Management, Design for Manufacturing, Leadership, SOP

Education
University of Phoenix   1996 — 1999
MBA, Technology Management

University of Phoenix   1994 — 1996
BS, Business

Experience
Abbott Diabetes Care  May 2008 - Present
Novo Nordisk Delivery Technologies   September 2005 - April 2008
Hunter Paine Enterprises   December 2004 - May 2005
Shaklee Corporation  November 2000 - December 2004
Shaklee Corporation  July 1997 - October 2000
Baxter Healthcare  September 1994 - June 1997

Skills
ERP, MRPII, Inventory Control, Demand Planning, Demand Forecasting, Production Activity..., Supply Chain Management, Cross-functional Team..., Six Sigma, Program Management, Inventory Management, Process Improvement, Manufacturing, Forecasting, Supply Chain, Continuous Improvement, Leadership, Project Planning, Logistics, Management, Materials Management, Purchasing, Product Development, MRP, Medical Devices, GMP

Education
University of San Francisco   2002 — 2005
MSIS, Master of Science, Information Systems

Saint Mary's College of California
MBA

Southern Illinois University, Carbondale
B.S., Industrial technology

Experience
Benvenue Medical  June 2014 - Present
Accuray  March 2010 - June 2014
Accuray  March 2010 - May 2012
ThermFisher Scientific   April 2008 - March 2010
Novo Nordisk Delivery Technologies   2005 - March 2008
Carl Zeiss Meditec  2000 - 2005

Skills
CAPA, Quality System, FDA, ISO 13485, Project Management, Validation, Design Control, V&V, GMP, Medical Devices, Change Control, Quality Assurance, Software Documentation, 21 CFR Part 11, Sop, Regulatory Affairs, Quality Auditing, ISO, Pharmaceutical Industry, Training, Environmental Monitoring, Non-Conforming, Complaint Management, GLP, FDA GMP, ISO 14971, CE marking, FMEA, Process Improvement, Root Cause Analysis, Computer System..., Document Management, Minitab, Six Sigma, Supplier Quality, Cross-functional Team..., DMAIC, Continuous Improvement, Auditing, 21 CFR, CQA, 5S, Kaizen, Value Stream Mapping, Risk Management, Supplier Quality..., SOP

Education
Accuray Operational Excellence   2013 — 2013
Six Sigma Green Belt

American Society of Quality   2008 — 2008
Certified Quality Auditing (CQA)

University of California, Davis
Bachelor of Science (BS), Environmental Toxicology

Experience
Sequoia Consulting Group, LLC  May 2015 - Present
Alere, Inc.   December 2012 - Present
Genentech  January 2010 - 2011
PRONET JOB SEARCH ORGANIZATION   May 2009 - April 2010
Boston Scientific  April 2008 - April 2009
Novo Nordisk Delivery Technologies   2006 - 2008
Abgenix/Amgen   2003 - 2006
Incyte Genomics  1998 - 2000

Skills
Technical Writing, Quality Assurance, Sop, Quality System, Microsoft Excel, Microsoft Office, Document Management, Documentations, Document Review, GMP, Validation, V&V, Process Improvement, Change Control, Documentation, FDA, CAPA, SOP

Education
San Diego State University-California State University
MA, Education

San Diego State University-California State University
BA, Journalism

Experience
Tonya Thornburgh Enterprises   May 2014 - Present
Facilities First  November 2011 - May 2014
Facilities First  February 2008 - November 2011
Novo Nordisk Delivery Technologies   February 2007 - February 2008
CB Richard Ellis  April 2005 - February 2007
Applied Biosystems  April 2000 - April 2005
Aperture  September 1997 - April 2000

Skills
AutoCAD, Strategic Planning, Facilities Management, Facilities Planning, Excel, Microsoft Office, MS Project, Word, Program Management, Space Planning, Space-planning, Microsoft Excel, Project Planning, Microsoft Word, Space planning, Project Management, Contract Management, Vendor Management, LEED, Management, Construction, Contract Negotiation, Leadership, Budgets, Operations Management, Cross-functional Team..., Team Leadership, CAFM, Strategy, Construction Management, Move Management, Sustainability, Process Improvement, Submittals, Furniture, Feasibility Studies, Corporate Real Estate, Sustainable Design, Purchasing, Process Scheduler, LEED AP

Education
Art Institute of Dallas   1993 — 1995
Associates Degree, Interior Design

Experience
Spinal Modulation Inc   November 2010 - Present
Spinal Modulation Inc   November 2009 - November 2010
Penumbra Inc  2008 - 2009
Novo Nordisk Delivery Technologies   2005 - 2008

Skills
FDA, ISO 13485, ISO 14971, V&V, Quality System, Design Control, CAPA, Validation, Medical Devices, R&D, Biomedical Engineering, Embedded Systems, GMP, Cross-functional Team..., Manufacturing

Education
Université Mohamed Boudiaf des Sciences et de la Technologie d'Oran
BS Electrical Engineering

Experience
BioMarin Pharmaceutical Inc.  2014 - Present
BioMarin  June 2008 - April 2014
Novo Nordisk Delivery Technologies   September 2001 - February 2008
Novo Nordisk  2007 - 2008
Aradigm Corporation  2001 - 2004

Education
California State University-East Bay   1997 — 2001

Experience
Aloha United Soccer Club   August 2015 - Present
Genentech  August 2009 - Present
Abbott Diabetes Care  December 2008 - August 2009
Novo Nordisk Delivery Technologies   May 2007 - April 2008
Novo Nordisk Delivery Technologies   July 2006 - May 2007
Genentech  October 2002 - July 2006
Genentech  November 1999 - October 2002
St. Francis Memorial Hospital  August 1997 - November 1999

Skills
Aseptic Processing, GMP, CAPA, Sop, Validation, FDA, Biotechnology, Quality System, Pharmaceutical Industry, Manufacturing, Quality Assurance, Aseptic Technique, Medical Devices, Troubleshooting, Microbiology, Quality Control, R&D, Process Improvement, SOP, Documentation, cGMP practices, Inspection

Education
Wagner College   1995 — 1997
Masters, Education

Ohio University   1991 — 1995
BS, Athletic Training

Experience
Gilead Sciences  July 2013 - Present
Gilead Sciences  June 2008 - Present
Novo Nordisk Delivery Technologies   May 2006 - May 2008
NNIT  2003 - 2006
OFS Fitel Denmark   2001 - 2003
Bigwords   March 1998 - August 1999

Skills
Cross-functional Team..., Quality Assurance, Validation, 21 CFR Part 11, Computer System..., Management, Pharmaceutical Industry, IT Strategy, Program Management, Software Documentation, FDA, GxP, Project Management, Business Process, GMP, Testing, Training, MS Project, Process Improvement, Leadership, Project Planning, Risk Management

Education
University of California, Los Angeles   1989 — 1992
M.S., Atmospheric Science

Experience
Novo Nordisk Delivery Technologies   June 2005 - Present
Chiron Corporation  2004 - June 2005
Aradigm Corporation  2000 - 2003

Education
Ohlone College   1994 — 1997

Experience
Novo Nordisk Delivery Technologies   2005 - 2008

Education
California State University-East Bay   1997 — 2000

Experience
DigitalOptics Corporation™  May 2012 - Present
LensVector  September 2008 - March 2012
Novo Nordisk Delivery Technologies   December 2005 - May 2008
Quantum Corporation  June 1994 - July 2001

Skills
Solidworks, R&D, Testing, Labview, Electronics, Engineering, Manufacturing

Education
University of California, Berkeley
MS, Mechanical Engineering

University of California, Berkeley
BS, Mechanical Engineering

Experience
The Medicines Company  August 2013 - Present
Theranos  January 2013 - August 2013
Electro Scientific Industries, Inc  June 2008 - December 2012
Novo Nordisk Delivery Technologies   January 2005 - April 2008
Arcturus Bioscience  July 1999 - April 2004
Continuum  May 1997 - July 1999
Kigre, Inc.   December 1992 - May 1997
Kearfott Guidance and Navigation  June 1983 - August 1990

Skills
Product Development, Medical Devices, Lean Manufacturing, Process Development, Engineering, Manufacturing, R&D, ISO 13485, Process Simulation, FDA, Quality Assurance, Cross-functional Team..., Manufacturing..., Optics, Laser, Testing, Semiconductors, Design for Manufacturing, Six Sigma, Failure Analysis, Design Control, Process Engineering, Engineering Management, Continuous Improvement, Design of Experiments, Electronics, Metrology, Quality System, Root Cause Analysis, Validation, Labview, SPC, Robotics, Calibration, Mechanical Engineering, Materials, ISO, FMEA, Injection Molding, Laser Physics, CAPA, 5S, V&V, Quality Control, Photonics, Supplier Quality, DMAIC, Manufacturing..., Systems Engineering, Zemax

Education
Syracuse University   1979 — 1984
B.S. Aerospace Engineering

Experience
Stryker  2008 - 2011
Novo Nordisk Delivery Technologies   2006 - 2008
Hutchinson Technology Inc  2004 - 2006

Skills
R&D, Manufacturing, Medical Devices, Design of Experiments, Cross-functional Team..., FDA

Education
University at Buffalo   2001 — 2003

Experience
Genentech  April 2009 - Present
Cell Genesys  2008 - 2008
Novo Nordisk Delivery Technologies   2005 - 2008
Micro-Virology Laboratories   2004 - 2005

Skills
Sop, FDA, GMP, CAPA, Change Control, Quality Control, LIMS, Validation, GLP, Biotechnology, Aseptic Processing

Education
University of California, Berkeley   2002 — 2004

Experience
Boston Scientific  March 2008 - Present
Novo Nordisk Delivery Technologies   January 2004 - February 2008
Novo Nordisk  2005 - 2008
NNDT  2004 - 2008
Aradigm Corporation  October 2000 - January 2004
LifeScan  1997 - October 2000
Bio-Rad Laboratories  1992 - 1996
Bio-Rad  1990 - 1994
3M  1987 - 1991

Skills
FDA, Validation, 21 CFR Part 11, FMEA, Biotechnology, Requirements Analysis, Firmware, Planning, FMECA, Hazard Analysis, GMP, Software Validation, Quality Systems, Medical Devices, ISO 13485, CAPA, Quality Assurance, Design Control, cGMP, ISO, Manufacturing, Testing, Software Quality..., Process Validation, Computer System..., Process Development, R&D, SOP, V&V, Sop, Quality System, Cross-functional Team..., Change Control, Quality Control, Design of Experiments, SPC, Root Cause Analysis, Automation, Software Documentation, Iso 9000, Process Simulation, Project Planning

Education
Mills College   1983 — 1984
Bachelors or Arts, Computer Science

Experience
Gilead Sciences  September 2014 - Present
Impax Laboratories  April 2013 - September 2014
Impax Laboratories  July 2012 - April 2013
Impax Laboratories  July 2011 - July 2012
Abaxis  January 2011 - June 2011
Zosano Pharma  August 2009 - November 2010
Onyx Pharmaceuticals  2010 - 2010
Solazyme, Inc.   2008 - 2009
Novo Nordisk Delivery Technologies   2005 - 2008
Aradigm Corporation  1999 - 2005

Skills
cGMP, Quality Systems, Validation, CAPA, GMP, Pharmaceuticals, SOP, Documentation, HPLC, Microsoft Office, GLP, LIMS, PowerPoint, Excel, Word, Sop, Deviations, Quality System, Quality Assurance, FDA, V&V, 21 CFR Part 11, Change Control, GxP, Technology Transfer, Quality Control, Trackwise, ISO 13485, Pharmaceutical Industry, TrackWise

Education
California State University-Hayward
Biology/Biological Sciences, General

Experience
Thermo Fisher Scientific (Life Technologies)   2011 - Present
Life Technologies  2010 - 2011
Aradigm Corporation  2008 - 2008
Novo Nordisk Delivery Technologies   2006 - 2008

Skills
Biotechnology, GMP, Analytical Chemistry, HPLC, Validation, Sop, FDA, GLP, Pharmaceutical Industry, LIMS, CAPA, Technology Transfer, V&V, Biopharmaceuticals, Chromatography, Aseptic Processing, R&D, Change Control, Medical Devices

Education
University of California, Berkeley
Bachelor of Arts (B.A.)

Experience
Novo Nordisk Delivery Technologies   2006 - 2008
Scios, Inc.   2004 - 2006
Scios Inc. (Johnson & Johnson)   2004 - 2006
TheraSense  2000 - 2004

Education
University of California, Berkeley   1995 — 1998
BA, Molecular and Cell Biology

Experience
Advantage Converting   1980 - Present
Novo Nordisk Delivery Technologies   2000 - 2008
Novo Nordisk Delivery Technologies   2000 - 2008
Aradigm Corporation  2000 - 2008

Skills
FDA, Medical Devices, ISO 13485, GMP, CAPA, Validation, V&V, Quality System, Design Control, Manufacturing, Cross-functional Team..., Pharmaceutical Industry

Education
University of California, Berkeley   1965 — 1968

Experience
Impax Laboratories  November 2014 - Present
Impax Laboratories  April 2014 - November 2014
Impax Laboratories  May 2012 - April 2014
Genomic Health  June 2008 - April 2012
Novo Nordisk Delivery Technologies   January 2005 - February 2008
NNDT  January 2005 - February 2008
Aradigm Corporation  June 2001 - January 2005
Kaiser Permanente  October 1994 - May 2001

Skills
Lean Manufacturing, LIMS, CAPA, HPLC, Spectroscopy, Enzyme Assays, FDA, GMP, Medical Devices, Quality Control, Pharmaceutical Industry, Validation, UV/Vis, Biotechnology, Sop, Quality Management, SOP

Education
California State University-East Bay
BS, Biology

Experience
Abaxis  2008 - 2009
Novo Nordisk Delivery Technologies   2005 - 2008
NNDT  2005 - 2008
Aradigm Corporation  1998 - 2005
Genentech  1985 - 1998

Education
Southern Illinois University, Edwardsville   1979 — 1982
M. Sc, Chemistry, Environmental Sciences

Experience
Novo Nordisk Delivery Technologies   January 2005 - March 2008
Aradigm Corporation  April 2001 - January 2005

Education
University of California, Davis   1995 — 1999
B.S., Biology

Experience
Novo Nordisk Delivery Technologies   2005 - Present
Aradigm Corporation  1997 - 2005

Education
Shanghai Normal University
B.S. Biology, major and minor in Protein Chemistry and Molecular & Cell Biology

Experience
Genentech  2013 - Present
MAP Pharmaceuticals  September 2011 - January 2013
MAP Pharmaceuticals  October 2008 - September 2011
Novo Nordisk Delivery Technologies   January 2008 - May 2008
Novo Nordisk Delivery Technologies   May 2006 - January 2008
Novo Nordisk Delivery Technologies   January 2005 - May 2006
Aradigm Corporation  March 2000 - January 2004
Matrix Pharmaceuticals A/S   1999 - 2000
Varian  May 1996 - June 1999

Skills
GMP, Validation, FDA, Pharmaceutical Industry, HPLC, Biotechnology, Analytical Chemistry, V&V, Drug Delivery, Medical Devices, CAPA, Sop, Pharmaceutics, Change Control, Chromatography, Regulatory Submissions, Quality Control, Quality System, Drug Development, Method Development, CMC, R&D, Formulation, UV/Vis, Assay Development, Gas Chromatography, Protein Chemistry, FTIR, Technology Transfer, Process Simulation, IND

Education
Brigham Young University
Master's degree

复旦大学
B.S.

Experience
Novartis  September 2012 - Present
IAP Worldwide Services  2009 - 2012
OptiSolar  2008 - 2009
Novo Nordisk Delivery Technologies   2007 - 2008
ALZA Corporation (a Johnson & Johnson Company)   2001 - 2007
International Isotopes  1999 - 2001
Advanced Environmental, Inc.   1996 - 1999

Skills
Facilities Management, Facilities Operations, Operations Management, GMP, Operating Budgets, Cost Reduction/Avoidance, Increase Productivity, EHS, Validation, Lean Operations, Energy Management, Metrics, Six Sigma, Best Practices, Cross-functional Team..., Third Party Vendor..., CMMS, Team Building, Oral & Written..., Financial Analysis, Working in A Union..., RCRA, Asset Life Cycle..., Capital Budgeting, Reliability Centered...

Education
University of California, Los Angeles
MBA, Management

University of Massachusetts, Amherst
MS, Chemcial Enginering

Union College, Schenectady, NY
BS, Chemistry

Experience
Pearl Therapeutics  November 2013 - Present
MAP Pharmaceuticals  January 2011 - August 2013
MAP Pharmaceuticals  February 2009 - January 2011
Aradigm Corporation  June 2008 - February 2009
Novo Nordisk Delivery Technologies   January 2005 - May 2008

Skills
GMP, Validation, CAPA, Drug Delivery, FDA, Biotechnology, Sop, GLP, Pharmaceutical Industry, HPLC, Technology Transfer, Change Control, R&D, Computer System..., GxP, Chromatography, SOP

Education
California State University-East Bay   1998 — 2001
Bachelors, Biology

Experience
Solta Medical, Inc. (formerly Thermage)   2008 - 2013
Novo Nordisk Delivery Technologies   2007 - 2008
Cornor Medsystems - Division of Johnson & Johnson   2007 - 2007

Skills
Design Control, Medical Devices, R&D, FDA, Biomedical Engineering, Product Development, CAPA, Quality System, Product Launch, Biotechnology, Design of Experiments, V&V, Validation, Regulatory Affairs, Lifesciences, ISO 14971, GMP

Education
University of Illinois at Chicago   2003 — 2005
Bachelor's degree, Bioengineering and Biomedical Engineering

Experience
ApoCell, Inc.   September 2010 - Present
Dave Hasegawa Consulting   July 2010 - October 2010
BCTech   August 2008 - May 2010
Novo Nordisk Delivery Technologies   January 2008 - May 2008
Novo Nordisk Delivery Technologies   January 2005 - January 2008
Aradigm Corp.   1998 - 2005
Syva Corporation   1989 - 1996

Skills
Medical Devices, FDA, Design Control, ISO 13485, Biotechnology, V&V, Validation, CAPA, R&D, Quality System, Product Development, GMP, Technology Transfer, Manufacturing, Design for Manufacturing, Commercialization, Testing, Systems Engineering, Design of Experiments, Pharmaceutical Industry, Cross-functional Team..., Drug Delivery, Product Launch, Biopharmaceuticals, Change Control, Clinical Development, Process Simulation, Biomedical Engineering, Regulatory Affairs, GLP, Regulatory Submissions, Sop, 21 CFR Part 11, Engineering, Lifesciences, Hardware Diagnostics, Quality Assurance, LIMS, Clinical Trials, SOP, Life Sciences

Education
University of California, Berkeley
Master of Science (MS), Mechanical Engineering

UC Berkeley
Bachelor of Science (BS), Engineering Science

Experience
Gap Inc.  April 2013 - Present
Gap Inc.  April 2012 - March 2013
The Levy Group Limited, LLC   October 2010 - June 2012
Novo Nordisk A/S  January 2010 - June 2010
Novo Nordisk  February 2008 - February 2010
Novo Nordisk Delivery Technologies   June 2006 - December 2007
University of San Francisco  February 2005 - June 2006
7-Eleven  October 2001 - February 2005
7-Eleven  October 2001 - September 2002

Skills
Accounting, Financial Reporting, Forecasting, Internal Controls, Financial Analysis, SAP, Cross-functional Team..., Microsoft Excel, Sarbanes-Oxley, Financial Accounting, Financial Modeling, SOX, Budgeting, PowerPoint, Word, Excel, Process Improvement, Cash Flow, Supervisory Skills, Compliance, Variance Analysis, Business Process..., Problem Solving, US GAAP, Change Management, General Ledger, Oracle 11i, Oracle Discoverer, JDEdwards, Sarbanes-Oxley Act

Education
University of San Diego   1995 — 1999
Bachelor of Science, Accountancy

Gap
Strategic Thinking, Advanced ImYou

Novo Nordisk A/S
Global Finance Academy II

Novo Nordisk A/S
Project Management I

Novo Nordisk A/S
Basic Lean Training

University of San Francisco
ERP Facilitator course

Experience
Alexza Pharmaceuticals  February 2013 - Present
CMC Regulatory Consulting   July 2008 - Present
Novo Nordisk Delivery Technologies   2005 - 2008
Nektar Therapeutics  1999 - 2003
Matrix Pharmaceutical  1992 - 1999
Collagen Corp   1987 - 1992

Skills
FDA, Process Simulation, GMP, Biotechnology, V&V, Validation, CAPA, Pharmaceutical Industry, Medical Devices, Cross-functional Team..., Chemistry, 21 CFR Part 11, Regulatory Affairs, Commercialization, Quality System

Education
Lehigh University   1969 — 1971
MS, Chemical Engineering

Rutgers University-New Brunswick   1965 — 1969
BS, Chemical Engineering

Experience
Gametime United  July 2014 - Present
L.E.K. Consulting   June 2013 - August 2013
Self employed  July 2010 - July 2012
BD  November 2008 - July 2010
Novo Nordisk Delivery Technologies   June 2007 - September 2007

Education
MIT Sloan School of Management   2012 — 2014
Master of Business Administration (MBA)

University of California, Davis   2003 — 2008
Bachelors, Biological Systems Engineering

University of California, Davis   2003 — 2008
Bachelors, Economics

Experience
Qualitest Pharmaceuticals  April 2013 - May 2013
Bio-Rad Laboratories  April 2012 - February 2013
Novartis Vaccines and Diagnostics  January 2011 - January 2012
CDI Corporation  March 2008 - April 2009
Novo Nordisk Delivery Technologies   May 2005 - February 2008

Education
University of California, Berkeley   1982 — 1985
BA, Paleontology

Experience
Uber  September 2015 - Present
Yahoo!  June 2013 - September 2015
Nike  2009 - June 2013
Novo Nordisk Delivery Technologies   2004 - 2007
Amgen  2002 - 2003
Sun Microsystems  1997 - 2002
The Clorox Company  1995 - 1997
GE  1990 - 1995

Skills
Organizational..., Employee Engagement, Workforce Planning, Talent Management, Organizational Design, Performance Management, Workshop Facilitation, Executive Coaching, Leadership Development, Change Management, Organizational..., Coaching, Career Development, Culture Change, Strategy, Employee Relations, Personnel Management, Leadership, Cross-functional Team..., Succession Planning, Talent Acquisition, Onboarding, Human Resources, Management

Education
Michigan State University   1988 — 1989
Masters Labor & Industrial Relations, Human Resources Management/Personnel Administration, General

University of Michigan Business School   1986 — 1988
Bachelor of Business Administration (BBA), Human Resources Management

The University of Georgia   1984 — 1986
Business Adminstration

Experience
KEYSTONE DENTAL  August 2009 - Present
Keystone Dental Inc.  2009 - 2010
Medtronic  August 2007 - August 2009
MEDTRONIC MINIMED, INC   February 2004 - August 2009
Medtronic diabetes  2004 - 2009
President's Club FY07   February 2004 - August 2007
NOVO NORDISK PHARMACEUTICALS  June 2001 - February 2004
Novo Nordisk Delivery Technologies   2001 - 2004
JANSSEN PHARMACEUTICAL  January 2000 - June 2001
Johnson & Johnson  2000 - 2001

Education
Eastern Kentucky University   1995 — 1997
M.S., Kinesiology

Asbury University
Bachelor of Science, Kinesiology