NNDT Company
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NNDT Employees
NNE Pharmaplan April 1996 - Present
NNE Pharmaplan January 2010 - January 2011
NNE Pharmaplan January 2007 - January 2010
NNDT 2007 - 2008
PT. Sorini November 1994 - April 1996
Pedersen Engineering Ltd. November 1993 - November 1994
Kruger 1993 - 1993
Education
Stanford University Graduate School of Business 2009 — 2009
Finance & Accounting for Nonfinancial Executives
PMI 2007 — 2007
PMP - Project Management Professional
Pathfinder 2005 — 2005
The Pathfinder Programme
Danmarks Tekniske Universitet 1989 — 1993
B.Sc., Mechanical Engineering
Gilead Sciences May 2013 - Present
Depomed, Inc. August 2008 - May 2013
Novo Nordisk Delivery Technologies January 2005 - May 2008
NNDT 2005 - 2008
Aradigm Corporation 2001 - 2002
Education
Holy Names University 1997 — 2001
B.S., Biology
Genentech September 2014 - Present
Onyx Pharmaceuticals November 2013 - September 2014
Onyx Pharmaceuticals September 2011 - November 2013
Depomed Inc August 2007 - September 2011
Depomed, Inc. August 2007 - August 2008
NNDT July 2006 - July 2007
Aradigm Corp April 2005 - June 2006
Skills
FDA, Validation, Regulatory Affairs, GxP, IND, CMC, Quality Control, Clinical Research, eCTD, CTAs, ICH guidelines, Clinical Development, EMEA, Product Development, NDA, Protocol
Education
University of San Francisco 1998 — 2003
BS, Chemistry
Rainin Instrument LLC April 2008 - Present
NNDT 2005 - April 2008
Aradigm Corporation 2001 - 2005
Aradigm Corporation 1997 - 2001
Nellcor 1991 - 1997
Skills
Validation, Design of Experiments, GMP, Project Management, Metrology, Data Analysis, Biocompatibility, Medical Devices, Design Control, FDA, Pharmaceutical Industry, Biotechnology, Drug Delivery, R&D, Manufacturing, Automation, Design for Manufacturing, Injection Molding, CAPA, Manufacturing..., SPC, Product Development, Cross-functional Team..., Product Design, FMEA, Mechanical Engineering, Product Launch
Education
Massachusetts Institute of Technology 1989 — 1991
MS, Mechanical Engineering
Stanford University 1985 — 1989
BS, Mechanical Engineering
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
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
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
Heron Therapeutics (Formally known as A.P.Pharma) November 2013 - Present
A.P.Pharma June 2008 - November 2013
Lab support 2008 - 2008
NNDT 2005 - 2008
Skills
Drug Delivery, Research, GMP, Analytical Chemistry, Biotechnology, Chromatography, GLP, Clinical Development, Formulation, Pharmaceutical Industry, Gas Chromatography, HPLC, Lifesciences, FDA, CRO, Sop, Validation, Drug Development, Technology Transfer, Chemistry, Drug Discovery, Regulatory Submissions, Clinical Trials, Organic Chemistry, LIMS, Biopharmaceuticals, IND, CAPA, Life Sciences, SOP
Education
California State University-East Bay 1997 — 2002
Bachelor of Science (BS) in Biology minor in Chemistry
Independent December 2009 - Present
Novo Nordisk 2005 - 2008
NNDT 1997 - 2008
Aradigm Corporation 1997 - 2005
Syntex 1984 - 1995
Skills
GMP, Validation
Education
Case Western Reserve University 1974 — 1978
McKesson October 2014 - Present
Conmed Corporation June 2009 - Present
Hoana Medical 2007 - 2009
NNDT 2005 - 2007
Diagnostic Ultrasound 2002 - 2005
Bioject 1999 - 2002
Spacelabs Medical 1994 - 1999
Skills
V&V, FDA, ISO 13485, Medical Devices, Regulatory Affairs, Design Control, ISO 14971, Regulatory Submissions, GMP, CAPA, Quality System, ISO, Quality Assurance, Continuous Improvement, Six Sigma, Quality Management, Root Cause Analysis, 21 CFR Part 11, Change Control, FMEA, Injection Molding, Product Development, Quality Auditing, Supplier Quality, Validation
Education
University of Washington 2003 — 2006
Bachelor of Arts - Business, International Business, Innovation and Technology
ESC Rouen France 1997 — 1998
Master of Business Administration
Purdue University - Krannert School of Management 1997 — 1998
Master of Science in Management, International Business
West Valley High School Spokane Valley 1969 — 1972
Diploma, General Studies