Aradigm Corporation
Industry: Pharmaceutical company
DescriptionHeadquarters: Hayward, CA Founded: 1991
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Aradigm Corporation Employees
Employee
Years
Job
Industry
Reid Rubsamen, M.D. Reid Rubsamen, M.D.'s Aradigm Corporation Experience June 1991 - June 2001
Job CEO and CoFounder at Immunity Project
Industry Hospital & Health Care
Experience
Immunity Project October 2010 - Present
Massachusetts General Hospital October 2011 - Present
John Muir Health January 2004 - Present
Flow Pharma, Inc. June 2002 - Present
MAC/Sheridan Healthcorp June 2002 - Present
Aradigm Corporation June 1991 - June 2001
Massachusetts General Hospital July 1990 - June 1991
Massachusetts General Hospital January 1989 - June 1989
Skills
Board Certified..., Engineer, Entrepreneur, Clinical Research, Medicine, Clinical Trials, Medical Devices, Informatics, Healthcare, Board Certified, Healthcare Management, Hospitals, Medical Education, Surgery, Biotechnology, Healthcare Information..., Lifesciences, Pharmaceutical Industry, Clinical Development, Entrepreneurship, FDA, Infectious Diseases, Anesthesia, Patient Safety, EMR, Treatment, Regulatory Affairs, EHR, Cancer, Healthcare Consulting, Physicians, Medical Device R&D, Technology Integration, Patient Outcomes, Medical Technology, Managed Care, Medical Imaging, Radiology, Hardware Diagnostics, Healthcare Industry, Public Health, Health Information..., Neuroscience, Revenue Cycle, HIPAA, Critical Care, Life Sciences
Education
Massachusetts Institute of Technology 1989 — 1991
NONE, Computer Science
Stanford University 1979 — 1985
M.S., Computer Science
Stanford University School of Medicine 1979 — 1985
M.D., Medicine
University of California, Berkeley 1974 — 1979
A.B., Biochemistry and Computer Science
Immunity Project October 2010 - Present
Massachusetts General Hospital October 2011 - Present
John Muir Health January 2004 - Present
Flow Pharma, Inc. June 2002 - Present
MAC/Sheridan Healthcorp June 2002 - Present
Aradigm Corporation June 1991 - June 2001
Massachusetts General Hospital July 1990 - June 1991
Massachusetts General Hospital January 1989 - June 1989
Skills
Board Certified..., Engineer, Entrepreneur, Clinical Research, Medicine, Clinical Trials, Medical Devices, Informatics, Healthcare, Board Certified, Healthcare Management, Hospitals, Medical Education, Surgery, Biotechnology, Healthcare Information..., Lifesciences, Pharmaceutical Industry, Clinical Development, Entrepreneurship, FDA, Infectious Diseases, Anesthesia, Patient Safety, EMR, Treatment, Regulatory Affairs, EHR, Cancer, Healthcare Consulting, Physicians, Medical Device R&D, Technology Integration, Patient Outcomes, Medical Technology, Managed Care, Medical Imaging, Radiology, Hardware Diagnostics, Healthcare Industry, Public Health, Health Information..., Neuroscience, Revenue Cycle, HIPAA, Critical Care, Life Sciences
Education
Massachusetts Institute of Technology 1989 — 1991
NONE, Computer Science
Stanford University 1979 — 1985
M.S., Computer Science
Stanford University School of Medicine 1979 — 1985
M.D., Medicine
University of California, Berkeley 1974 — 1979
A.B., Biochemistry and Computer Science
Karen Xu Karen Xu's Aradigm Corporation Experience 2004 - 2005
Job Senior Principal Scientist/Group Leader at Pfizer Vaccine Research
Industry Pharmaceuticals
Experience
Pfizer Vaccine Research January 2014 - Present
Pfizer Vaccine Research 2009 - December 2013
Wyeth Vaccine Research and Early Development 2007 - 2009
Wyeth Vaccine Research and Development 2005 - 2007
ARADIGM CORPORATION 2004 - 2005
PENTA BIOTECH. INC 2000 - 2004
Skills
Drug Discovery, Drug Development, Validation, Sop, GMP, Analytical Chemistry, Clinical Trials, Vaccines, FDA, Biopharmaceuticals, HPLC, Laboratory, Quality Control, SOP
Education
University of Wyoming 1995 — 2000
Doctor of Philosophy (Ph.D.), Analytical Chemistry
Peking University 1988 — 1992
Bachelor's degree, Applied Chemistry
Pfizer Vaccine Research January 2014 - Present
Pfizer Vaccine Research 2009 - December 2013
Wyeth Vaccine Research and Early Development 2007 - 2009
Wyeth Vaccine Research and Development 2005 - 2007
ARADIGM CORPORATION 2004 - 2005
PENTA BIOTECH. INC 2000 - 2004
Skills
Drug Discovery, Drug Development, Validation, Sop, GMP, Analytical Chemistry, Clinical Trials, Vaccines, FDA, Biopharmaceuticals, HPLC, Laboratory, Quality Control, SOP
Education
University of Wyoming 1995 — 2000
Doctor of Philosophy (Ph.D.), Analytical Chemistry
Peking University 1988 — 1992
Bachelor's degree, Applied Chemistry
Owen Dayton Owen Dayton's Aradigm Corporation Experience May 2014 - Present
Job Student at University of Portland
Industry
Experience
Aradigm Corporation May 2014 - Present
Aradigm Corporation May 2013 - August 2013
Skills
Public Speaking, Teamwork, Self-driven, Customer Service, Microsoft Word, Microsoft Excel, Microsoft Office, Editing, Social Networking, Fundraising
Education
Stuart Hall High School 2012 — 2016
University of Portland 2012 — 2016
Bachelor's Degree, Biology
Aradigm Corporation May 2014 - Present
Aradigm Corporation May 2013 - August 2013
Skills
Public Speaking, Teamwork, Self-driven, Customer Service, Microsoft Word, Microsoft Excel, Microsoft Office, Editing, Social Networking, Fundraising
Education
Stuart Hall High School 2012 — 2016
University of Portland 2012 — 2016
Bachelor's Degree, Biology
Jerry Beers Jerry Beers's Aradigm Corporation Experience July 1997 - September 2001
Job Principal at R. J. Beers & Associates
Industry Biotechnology
Experience
R. J. Beers & Associates January 2012 - Present
Pharmatech Associates, Inc. 2013 - 2014
Calidus Biotherapeutics, Inc. 2011 - February 2012
Itero Biopharmaceuticals, LLC September 2006 - September 2011
R. J. Beers & Associates 2005 - 2007
Questcor Pharmaceuticals September 2003 - March 2005
Aradigm Corporation July 1997 - September 2001
Genentech, Inc. November 1995 - December 1996
Genentech Canada Inc November 1993 - October 1995
Genentech, Inc. November 1989 - October 1993
Skills
Global Business..., Strategy Development, Product Development, Biotechnology, Commercialization, Licensing, Entrepreneurship, Pharmaceutical Industry, Strategy, Cross-functional Team..., Business Planning, Negotiation, Product Management, Business Strategy, Start-ups, Marketing, Venture Capital, Business Development, Executive Management, Oncology, Medical Devices, Biopharmaceuticals, Product Launch, Clinical Development, Cardiology, Immunology, Corporate Development, Lifesciences, Technology Transfer, Marketing Strategy, Pharmaceutical Sales, R&D, Drug Development, FDA, Regulatory Affairs, Managed Care, Life Sciences
Education
Northwestern University - Kellogg School of Management 1982 — 1984
Masters of Management, Business
Brown University 1966 — 1970
B.A., Political Science
R. J. Beers & Associates January 2012 - Present
Pharmatech Associates, Inc. 2013 - 2014
Calidus Biotherapeutics, Inc. 2011 - February 2012
Itero Biopharmaceuticals, LLC September 2006 - September 2011
R. J. Beers & Associates 2005 - 2007
Questcor Pharmaceuticals September 2003 - March 2005
Aradigm Corporation July 1997 - September 2001
Genentech, Inc. November 1995 - December 1996
Genentech Canada Inc November 1993 - October 1995
Genentech, Inc. November 1989 - October 1993
Skills
Global Business..., Strategy Development, Product Development, Biotechnology, Commercialization, Licensing, Entrepreneurship, Pharmaceutical Industry, Strategy, Cross-functional Team..., Business Planning, Negotiation, Product Management, Business Strategy, Start-ups, Marketing, Venture Capital, Business Development, Executive Management, Oncology, Medical Devices, Biopharmaceuticals, Product Launch, Clinical Development, Cardiology, Immunology, Corporate Development, Lifesciences, Technology Transfer, Marketing Strategy, Pharmaceutical Sales, R&D, Drug Development, FDA, Regulatory Affairs, Managed Care, Life Sciences
Education
Northwestern University - Kellogg School of Management 1982 — 1984
Masters of Management, Business
Brown University 1966 — 1970
B.A., Political Science
Kerri Patterson Kerri Patterson's Aradigm Corporation Experience September 2002 - July 2004
Job J.D., Georgetown University Law Center
Industry Law Practice
Experience
Venable LLP May 2014 - July 2014
United States District Court for the Northern District of New York June 2013 - August 2013
Millennium Pharmaceuticals February 2007 - 2011
Millennium Pharmaceuticals September 2004 - March 2007
Aradigm Corporation September 2002 - July 2004
Education
Georgetown University Law Center 2012 — 2015
Doctor of Law (J.D.)
University of California, Santa Cruz
Bachelor of Science (B.S.), Chemistry, with College Honors
Venable LLP May 2014 - July 2014
United States District Court for the Northern District of New York June 2013 - August 2013
Millennium Pharmaceuticals February 2007 - 2011
Millennium Pharmaceuticals September 2004 - March 2007
Aradigm Corporation September 2002 - July 2004
Education
Georgetown University Law Center 2012 — 2015
Doctor of Law (J.D.)
University of California, Santa Cruz
Bachelor of Science (B.S.), Chemistry, with College Honors
David Wyatt Sr. David Wyatt Sr.'s Aradigm Corporation Experience July 1996 - Present
Job Operations Supervisor at Aradigm Corporation
Industry Biotechnology
Experience
Aradigm Corporation July 1996 - Present
DW Productions 1969 - 2008
Aradigm 1996 - June 2004
Cygnus Systems, Inc. 1990 - 1996
Barnes-Hind Pharmaceutical 1976 - 1990
Skills
Biotechnology, Medical Devices, Product Development, Quality Assurance, Pharmaceutical Industry, Strategic Planning, Project Management, Marketing, Contract Negotiation, Team Building, Team Leadership, Process Improvement, Cross-functional Team..., Research, Start-ups, Project Planning, R&D, Analysis, Budget, Manufacturing, GMP, Six Sigma, Leadership, Budgets, Troubleshooting
Education
Foothill College 1980 — 1985
Radio Broadcasting, Communications
California State University, Fresno 1974 — 1975
Business Admin
Fresno City College 1973 — 1975
AA, Business
Fresno High School 1971 — 1973
Required Subjects
Aradigm Corporation July 1996 - Present
DW Productions 1969 - 2008
Aradigm 1996 - June 2004
Cygnus Systems, Inc. 1990 - 1996
Barnes-Hind Pharmaceutical 1976 - 1990
Skills
Biotechnology, Medical Devices, Product Development, Quality Assurance, Pharmaceutical Industry, Strategic Planning, Project Management, Marketing, Contract Negotiation, Team Building, Team Leadership, Process Improvement, Cross-functional Team..., Research, Start-ups, Project Planning, R&D, Analysis, Budget, Manufacturing, GMP, Six Sigma, Leadership, Budgets, Troubleshooting
Education
Foothill College 1980 — 1985
Radio Broadcasting, Communications
California State University, Fresno 1974 — 1975
Business Admin
Fresno City College 1973 — 1975
AA, Business
Fresno High School 1971 — 1973
Required Subjects
Evangeline Co Evangeline Co's Aradigm Corporation Experience May 2000 - December 2000
Job QC Analyst at Celera Diagnostics
Industry Biotechnology
Experience
Celera Corporation January 2009 - Present
Cell Genesys April 2006 - October 2008
Chiron Corporation March 2003 - March 2006
Illumina formerly Lynx Therapeutics August 2001 - April 2002
Mendel Biotech January 2001 - August 2001
Aradigm Corporation May 2000 - December 2000
Skills
GMP, Sop, Biotechnology, FDA, Validation, GLP, Pharmaceutical Industry, Biopharmaceuticals, CAPA, Life Sciences, Quality Control, Technology Transfer, SOP, 21 CFR Part 11, LIMS
Education
California State University-East Bay 1997 — 1999
B.S. Biology
California State University-East Bay
BS Biology
Celera Corporation January 2009 - Present
Cell Genesys April 2006 - October 2008
Chiron Corporation March 2003 - March 2006
Illumina formerly Lynx Therapeutics August 2001 - April 2002
Mendel Biotech January 2001 - August 2001
Aradigm Corporation May 2000 - December 2000
Skills
GMP, Sop, Biotechnology, FDA, Validation, GLP, Pharmaceutical Industry, Biopharmaceuticals, CAPA, Life Sciences, Quality Control, Technology Transfer, SOP, 21 CFR Part 11, LIMS
Education
California State University-East Bay 1997 — 1999
B.S. Biology
California State University-East Bay
BS Biology
Charles Bryden Charles Bryden's Aradigm Corporation Experience 1998 - 2006
Job Retired Healthcare Professional
Industry Pharmaceuticals
Experience
Xenoport Inc. July 2006 - March 2009
Aradigm Corporation 1998 - 2006
Alza Corporation 1994 - 1997
Scios 1993 - 1994
Baxter Healthcare 1991 - 1993
Hercules Inc. 1981 - 1991
Education
University of North Carolina at Chapel Hill 1976 — 1981
PhD, Analytical Chemistry
Stanford University 1959 — 1963
BS, Chemistry
Xenoport Inc. July 2006 - March 2009
Aradigm Corporation 1998 - 2006
Alza Corporation 1994 - 1997
Scios 1993 - 1994
Baxter Healthcare 1991 - 1993
Hercules Inc. 1981 - 1991
Education
University of North Carolina at Chapel Hill 1976 — 1981
PhD, Analytical Chemistry
Stanford University 1959 — 1963
BS, Chemistry
Brendon Bolos Brendon Bolos's Aradigm Corporation Experience April 2003 - July 2003
Job Medical Device Engineer Independent Consultant
Industry Medical Devices
Experience
Medical Device Startups May 2014 - July 2015
Evalve, Inc. [a wholly owned subsidiary of Abbott Vascular, Inc.] October 2013 - April 2014
Incumedx April 2012 - April 2013
Stryker August 2009 - March 2012
Boston Scientific August 2009 - December 2010
Biomerix Corporation September 2007 - July 2009
Embolic Protection Inc. - Boston Scientific September 2004 - September 2007
Aradigm Corporation April 2003 - July 2003
The Neurosciences Institute January 2003 - July 2003
Skills
R&D, Product Development, FDA, Validation, Design Control, Biomedical Engineering, ISO 13485, Medical Devices, Design of Experiments, V&V, Biomaterials, CAPA, Minitab, Quality System, ISO 14971, Product Design, Solidworks, Catheters, FMEA, Design for Manufacturing, GMP, Medical Device R&D, Regulatory Affairs, Stents, 21 CFR, Commercialization, Gage R&R, CE marking
Education
University of California, San Diego 1999 — 2003
Bachelors of Sciences, Bioengineering
Carlmont 1995 — 1999
Medical Device Startups May 2014 - July 2015
Evalve, Inc. [a wholly owned subsidiary of Abbott Vascular, Inc.] October 2013 - April 2014
Incumedx April 2012 - April 2013
Stryker August 2009 - March 2012
Boston Scientific August 2009 - December 2010
Biomerix Corporation September 2007 - July 2009
Embolic Protection Inc. - Boston Scientific September 2004 - September 2007
Aradigm Corporation April 2003 - July 2003
The Neurosciences Institute January 2003 - July 2003
Skills
R&D, Product Development, FDA, Validation, Design Control, Biomedical Engineering, ISO 13485, Medical Devices, Design of Experiments, V&V, Biomaterials, CAPA, Minitab, Quality System, ISO 14971, Product Design, Solidworks, Catheters, FMEA, Design for Manufacturing, GMP, Medical Device R&D, Regulatory Affairs, Stents, 21 CFR, Commercialization, Gage R&R, CE marking
Education
University of California, San Diego 1999 — 2003
Bachelors of Sciences, Bioengineering
Carlmont 1995 — 1999
Bernard Kuffler's Aradigm Corporation Experience November 2004 - December 2006
Job
Industry Information Technology and Services
Experience
ICE Consulting INC July 2008 - Present
Endsight January 2007 - July 2008
Aradigm Corporation November 2004 - December 2006
Information Technology Works, Inc July 2002 - November 2004
Applied Materials January 1997 - November 2001
Entex, Foster City, CA (at Applied Materials) July 1995 - January 1997
Education
Heald College 1986 — 1988
Associates
De Anza College
ICE Consulting INC July 2008 - Present
Endsight January 2007 - July 2008
Aradigm Corporation November 2004 - December 2006
Information Technology Works, Inc July 2002 - November 2004
Applied Materials January 1997 - November 2001
Entex, Foster City, CA (at Applied Materials) July 1995 - January 1997
Education
Heald College 1986 — 1988
Associates
De Anza College
John Lemke John Lemke's Aradigm Corporation Experience 1995 - 1995
Job Vice President, Engineering at The Medicines Company
Industry Pharmaceuticals
Experience
The Medicines Company 2013 - Present
Incline Therapeutics, Inc 2010 - 2013
Johnson & Johnson 2006 - 2009
FoviOptics, Inc. (early-stage start-up) 2005 - 2006
Johnson & Johnson 1992 - 2005
Aradigm Corporation 1995 - 1995
Greyhawk Systems (early-stage start-up) 1988 - 1992
Atcor Corporation (acquired by Entegris) 1981 - 1988
Skills
Validation, V, Technology Transfer, Strategy, Six Sigma, Root Cause Analysis, R, Quality System, Product Launch, Product Development, Product Design, Pharmaceutical Industry, Medical Devices, Hardware Diagnostics, Engineering, Drug Delivery, Design Control, Cross-functional Team..., Clinical Trials, Biotechnology
Education
University of California, Berkeley 1982 — 1985
ab
The Medicines Company 2013 - Present
Incline Therapeutics, Inc 2010 - 2013
Johnson & Johnson 2006 - 2009
FoviOptics, Inc. (early-stage start-up) 2005 - 2006
Johnson & Johnson 1992 - 2005
Aradigm Corporation 1995 - 1995
Greyhawk Systems (early-stage start-up) 1988 - 1992
Atcor Corporation (acquired by Entegris) 1981 - 1988
Skills
Validation, V, Technology Transfer, Strategy, Six Sigma, Root Cause Analysis, R, Quality System, Product Launch, Product Development, Product Design, Pharmaceutical Industry, Medical Devices, Hardware Diagnostics, Engineering, Drug Delivery, Design Control, Cross-functional Team..., Clinical Trials, Biotechnology
Education
University of California, Berkeley 1982 — 1985
ab
Arnold Blanco Arnold Blanco's Aradigm Corporation Experience 2001 - 2004
Job Biotechnology Professional
Industry Biotechnology
Experience
PerkinElmer Optoelectronics January 2008 - December 2010
Novo Nordisk Pharmaceuticals May 2005 - February 2008
Impax laboratories Inc. 2004 - 2005
Aradigm Corporation 2001 - 2004
Xerox 1996 - 2001
Education
Heald College 1998 — 2000
AS and Electronic Certification, Computer Technology and Electronics
PerkinElmer Optoelectronics January 2008 - December 2010
Novo Nordisk Pharmaceuticals May 2005 - February 2008
Impax laboratories Inc. 2004 - 2005
Aradigm Corporation 2001 - 2004
Xerox 1996 - 2001
Education
Heald College 1998 — 2000
AS and Electronic Certification, Computer Technology and Electronics
Mark Roach Mark Roach's Aradigm Corporation Experience 1999 - 2005
Job
Industry Pharmaceuticals
Experience
Adamas Pharmaceuticals March 2009 - November 2012
Dey L.P. April 2007 - December 2008
Par Pharmaceutical February 2005 - April 2007
Aradigm Corporation 1999 - 2005
Isis Pharmaceuticals September 1995 - December 1998
Roche Pharmaceuticals May 1993 - August 1995
Syntex September 1987 - April 1993
Stanford Univeristy 1985 - 1987
Madras Christian College 1976 - 1979
Skills
Pharmaceutical Industry, Technology Transfer, GMP, Validation, Biotechnology, Sop, Clinical Development, FDA, Clinical Trials, Pharmaceutics, GLP, Regulatory Affairs, Analytical Chemistry, Medical Devices, Regulatory Submissions, CRO, Cross-functional Team..., Drug Development, Drug Discovery, R&D, CMC, Formulation, Bioanalysis, Change Control, Chromatography, Drug Delivery, V&V, LIMS, HPLC, NDA, 21 CFR Part 11, Pharmacokinetics, Lifesciences, CAPA, IND, Biopharmaceuticals, Generic Programming
Education
Stanford University 1986 — 1987
Post-Doc, Analytical Chemistry
The University of Kansas 1979 — 1985
Ph.D., Analytical Chemistry
University of Madras
B.Sc., Chemistry
Adamas Pharmaceuticals March 2009 - November 2012
Dey L.P. April 2007 - December 2008
Par Pharmaceutical February 2005 - April 2007
Aradigm Corporation 1999 - 2005
Isis Pharmaceuticals September 1995 - December 1998
Roche Pharmaceuticals May 1993 - August 1995
Syntex September 1987 - April 1993
Stanford Univeristy 1985 - 1987
Madras Christian College 1976 - 1979
Skills
Pharmaceutical Industry, Technology Transfer, GMP, Validation, Biotechnology, Sop, Clinical Development, FDA, Clinical Trials, Pharmaceutics, GLP, Regulatory Affairs, Analytical Chemistry, Medical Devices, Regulatory Submissions, CRO, Cross-functional Team..., Drug Development, Drug Discovery, R&D, CMC, Formulation, Bioanalysis, Change Control, Chromatography, Drug Delivery, V&V, LIMS, HPLC, NDA, 21 CFR Part 11, Pharmacokinetics, Lifesciences, CAPA, IND, Biopharmaceuticals, Generic Programming
Education
Stanford University 1986 — 1987
Post-Doc, Analytical Chemistry
The University of Kansas 1979 — 1985
Ph.D., Analytical Chemistry
University of Madras
B.Sc., Chemistry
Juergen Froehlich Juergen Froehlich's Aradigm Corporation Experience November 2013 - Present
Job Chief Medical Officer at Aradigm Corporation
Industry Pharmaceuticals
Experience
Aradigm Corporation November 2013 - Present
Thrombolytic Sciences International, Cambridge, MA, USA May 2009 - Present
Vertex Pharmaceuticals, Cambridge, MA, USA October 2011 - September 2013
Vertex Pharmaceuticals, Cambridge, MA, USA April 2011 - October 2011
Ipsen January 2008 - March 2011
Ipsen - Biomeasure, Milford, MA, USA April 2005 - December 2007
Bristol-Myers Squibb, Princeton, New Jersey March 2004 - March 2005
Bristol-Myers Squibb, Princeton, New Jersey October 2001 - February 2004
Bristol- Meyers Squibb Internat Corporation- Waterloo, Belgium October 1999 - September 2001
Quintiles CVA, - Strasbourg, France July 1997 - September 1999
Skills
Clinical Pharmacology, Drug Development, Clinical Development, Oncology, Clinical Trials
Education
Medical School at Julius-Maximilians-Universität Würzburg 1978 — 1982
MD, Medicine
Graduate School of Business Administration Zurich 2001 — 2005
MBA, Business Administration
Dientzenhofer Gymnasium, Bamberg, Germany
Aradigm Corporation November 2013 - Present
Thrombolytic Sciences International, Cambridge, MA, USA May 2009 - Present
Vertex Pharmaceuticals, Cambridge, MA, USA October 2011 - September 2013
Vertex Pharmaceuticals, Cambridge, MA, USA April 2011 - October 2011
Ipsen January 2008 - March 2011
Ipsen - Biomeasure, Milford, MA, USA April 2005 - December 2007
Bristol-Myers Squibb, Princeton, New Jersey March 2004 - March 2005
Bristol-Myers Squibb, Princeton, New Jersey October 2001 - February 2004
Bristol- Meyers Squibb Internat Corporation- Waterloo, Belgium October 1999 - September 2001
Quintiles CVA, - Strasbourg, France July 1997 - September 1999
Skills
Clinical Pharmacology, Drug Development, Clinical Development, Oncology, Clinical Trials
Education
Medical School at Julius-Maximilians-Universität Würzburg 1978 — 1982
MD, Medicine
Graduate School of Business Administration Zurich 2001 — 2005
MBA, Business Administration
Dientzenhofer Gymnasium, Bamberg, Germany
Tanya O'Neal, MD's Aradigm Corporation Experience October 2014 - Present
Job
Industry Biotechnology
Experience
Aradigm Corporation October 2014 - Present
ACTAVIS, PLC., July 2014 - Present
Forest Laboratories, Pharmaceuticals Division (Cerexa) 2006 - Present
Cerexa, Inc. July 2006 - August 2011
Johnson & Johnson 2004 - 2006
Guidant (now Boston Scientific) 2003 - 2004
Cerus 2000 - 2003
Skills
Clinical Development, Clinical Research, Clinical Trials, FDA, Medical Affairs, Medicine, Drug Safety, CTMS, GCP, Infectious Diseases, Oncology, CRO, Drug Development, Pharmaceutical Industry, Biotechnology, Regulatory Submissions, Clinical Data Management, EDC, Pediatrics, Regulatory Affairs, Protocol, Biopharmaceuticals, Clinical Study Design, Vaccines, Medical Devices, Cancer, Sop, Immunology, Drug Discovery, Lifesciences
Education
Charles University in Prague 1980 — 1986
Pediatrics, Medicine
Komenius University
Pediatrics, Medicine, Post-grad
Aradigm Corporation October 2014 - Present
ACTAVIS, PLC., July 2014 - Present
Forest Laboratories, Pharmaceuticals Division (Cerexa) 2006 - Present
Cerexa, Inc. July 2006 - August 2011
Johnson & Johnson 2004 - 2006
Guidant (now Boston Scientific) 2003 - 2004
Cerus 2000 - 2003
Skills
Clinical Development, Clinical Research, Clinical Trials, FDA, Medical Affairs, Medicine, Drug Safety, CTMS, GCP, Infectious Diseases, Oncology, CRO, Drug Development, Pharmaceutical Industry, Biotechnology, Regulatory Submissions, Clinical Data Management, EDC, Pediatrics, Regulatory Affairs, Protocol, Biopharmaceuticals, Clinical Study Design, Vaccines, Medical Devices, Cancer, Sop, Immunology, Drug Discovery, Lifesciences
Education
Charles University in Prague 1980 — 1986
Pediatrics, Medicine
Komenius University
Pediatrics, Medicine, Post-grad
Russell Beste, MS ChE Russell Beste, MS ChE's Aradigm Corporation Experience 1998 - 2000
Job
Industry Pharmaceuticals
Experience
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
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
Kathy Pitta Kathy Pitta's Aradigm Corporation Experience May 1998 - February 2009
Job Sr. Executive Administrative Assistant at Metabolex, Inc.
Industry Biotechnology
Experience
Currently searching February 2009 - January 2014
Aradigm Corporation May 1998 - February 2009
Education
Saddleback College 1989 — 1990
None, Business
Currently searching February 2009 - January 2014
Aradigm Corporation May 1998 - February 2009
Education
Saddleback College 1989 — 1990
None, Business
Andrew Galindez Andrew Galindez's Aradigm Corporation Experience 2000 - 2005
Job Senior Process Technician at Envia Systems
Industry Oil & Energy
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
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
William Hodder William Hodder's Aradigm Corporation Experience 1997 - 2001
Job Senior Vice President, Corporate Development at Protagonist Therapeutics
Industry Biotechnology
Experience
Protagonist Therapeutics December 2014 - Present
BioPharma Strategy and Consulting 2010 - December 2014
Promedior, Inc. December 2013 - July 2014
Trenovus Inc. 2010 - December 2012
FibroGen Inc. April 2001 - January 2010
Aradigm Corporation 1997 - 2001
Penederm Incorporated 1994 - 1997
Ciba-Geigy 1992 - 1994
Ciba-Geigy 1991 - 1991
Bristol-Myers Squibb 1988 - 1989
Skills
Corporate Development, Business Development, Licensing, Biotechnology, Pharmaceutical Industry, Corporate Fundraising, Start-ups, Medical Devices, Product Marketing, Technology Transfer, Commercialization, Venture Capital, Drug Development, Lifesciences, Clinical Development, Drug Delivery, Clinical Trials, Pharmacueticals, R&D, Biochemistry, FDA
Education
The University of Chicago - Booth School of Business 1989 — 1992
Master of Business Administration
Oakland University 1981 — 1985
Bachelor of Science, Biology
Protagonist Therapeutics December 2014 - Present
BioPharma Strategy and Consulting 2010 - December 2014
Promedior, Inc. December 2013 - July 2014
Trenovus Inc. 2010 - December 2012
FibroGen Inc. April 2001 - January 2010
Aradigm Corporation 1997 - 2001
Penederm Incorporated 1994 - 1997
Ciba-Geigy 1992 - 1994
Ciba-Geigy 1991 - 1991
Bristol-Myers Squibb 1988 - 1989
Skills
Corporate Development, Business Development, Licensing, Biotechnology, Pharmaceutical Industry, Corporate Fundraising, Start-ups, Medical Devices, Product Marketing, Technology Transfer, Commercialization, Venture Capital, Drug Development, Lifesciences, Clinical Development, Drug Delivery, Clinical Trials, Pharmacueticals, R&D, Biochemistry, FDA
Education
The University of Chicago - Booth School of Business 1989 — 1992
Master of Business Administration
Oakland University 1981 — 1985
Bachelor of Science, Biology
David Mabanglo David Mabanglo's Aradigm Corporation Experience 1998 - 2006
Job Pharmaceutical/Biopharmaceutical Professional
Industry Pharmaceuticals
Experience
Elan Pharmaceuticals, Inc. 2007 - 2013
Depomed, Inc. 2006 - 2007
Aradigm Corporation 1998 - 2006
ALZA Corporation 1995 - 1998
Skills
GMP, HPLC, Analytical Chemistry, Analytical Methods..., Analytical Method..., Analytical Method..., GAMP, Computer System..., Validation, Sop, FDA, GLP, Change Control, GxP, CAPA, Pharmaceutical Industry, LIMS, Biotechnology, 21 CFR Part 11, Biopharmaceuticals, Medical Devices, V&V, Drug Development, Formulation, Clinical Development, Assay Development, Quality System, Drug Delivery, Dissolution, R&D, Chromatography, CRO, Pharmaceutics, SOP
Education
California State University, East Bay (Hayward)
M.S., Chemistry
University of California, Santa Barbara
B.A., Biological Sciences
Elan Pharmaceuticals, Inc. 2007 - 2013
Depomed, Inc. 2006 - 2007
Aradigm Corporation 1998 - 2006
ALZA Corporation 1995 - 1998
Skills
GMP, HPLC, Analytical Chemistry, Analytical Methods..., Analytical Method..., Analytical Method..., GAMP, Computer System..., Validation, Sop, FDA, GLP, Change Control, GxP, CAPA, Pharmaceutical Industry, LIMS, Biotechnology, 21 CFR Part 11, Biopharmaceuticals, Medical Devices, V&V, Drug Development, Formulation, Clinical Development, Assay Development, Quality System, Drug Delivery, Dissolution, R&D, Chromatography, CRO, Pharmaceutics, SOP
Education
California State University, East Bay (Hayward)
M.S., Chemistry
University of California, Santa Barbara
B.A., Biological Sciences
Camille Yabut Camille Yabut's Aradigm Corporation Experience June 2005 - September 2005
Job Graduate Research Assistant at UCLA
Industry Research
Experience
UCLA July 2011 - Present
UCLA September 2012 - June 2013
U.S. Geological Survey (USGS) March 2011 - July 2011
Michigan State University February 2010 - December 2010
Wilson Sonsini Goodrich & Rosati July 2007 - January 2010
VCA Animal Hospitals 2005 - 2007
Aradigm Corporation June 2005 - September 2005
UC Davis January 2005 - June 2005
Skills
Molecular Biology, Lifesciences, PCR, Project Coordination, Research, Genetics, Science, Field Work, Permit Applications, Grant Writing, Science Communication, DNA extraction, Gel Electrophoresis, Laboratory Skills, Database Administration, Data Analysis, Corporate Law, Client Correspondence, Securities, Document Drafting, Legal Research, Records Management, Biology
Education
University of California, Los Angeles 2011 — 2014
Master of Science (M.S.), Biology, 3.965 / 4.0
University of California, Davis 2003 — 2007
Bachelor of Science (B.S.), Wildlife, Fish and Conservation Biology
UCLA July 2011 - Present
UCLA September 2012 - June 2013
U.S. Geological Survey (USGS) March 2011 - July 2011
Michigan State University February 2010 - December 2010
Wilson Sonsini Goodrich & Rosati July 2007 - January 2010
VCA Animal Hospitals 2005 - 2007
Aradigm Corporation June 2005 - September 2005
UC Davis January 2005 - June 2005
Skills
Molecular Biology, Lifesciences, PCR, Project Coordination, Research, Genetics, Science, Field Work, Permit Applications, Grant Writing, Science Communication, DNA extraction, Gel Electrophoresis, Laboratory Skills, Database Administration, Data Analysis, Corporate Law, Client Correspondence, Securities, Document Drafting, Legal Research, Records Management, Biology
Education
University of California, Los Angeles 2011 — 2014
Master of Science (M.S.), Biology, 3.965 / 4.0
University of California, Davis 2003 — 2007
Bachelor of Science (B.S.), Wildlife, Fish and Conservation Biology
Mariel Estanislao Mariel Estanislao's Aradigm Corporation Experience January 2001 - April 2002
Job Bioprocess Technologist at Codexis, Inc.
Industry Biotechnology
Experience
Codexis, Inc. May 2007 - Present
Cell Genesys May 2003 - March 2007
FibroGen 2002 - 2003
Aradigm Corporation January 2001 - April 2002
Skills
Biotechnology
Education
Penn State University
Fermentation Methods and Scale Up Strategies
Colegio de San Juan de Letran
Bachelor of Science (B.S.), Accounting
Colegio de San Juan de Letran
Bachelor of Science (B.S.), Accounting
Codexis, Inc. May 2007 - Present
Cell Genesys May 2003 - March 2007
FibroGen 2002 - 2003
Aradigm Corporation January 2001 - April 2002
Skills
Biotechnology
Education
Penn State University
Fermentation Methods and Scale Up Strategies
Colegio de San Juan de Letran
Bachelor of Science (B.S.), Accounting
Colegio de San Juan de Letran
Bachelor of Science (B.S.), Accounting
Kenneth Brandt Kenneth Brandt's Aradigm Corporation Experience 1999 - 2005
Job Director of Manufacturing at Avrio Biopharmaceuticals
Industry Biotechnology
Experience
Quintiles Transnational 2011 - Present
Avrio Biopharmaceuticals January 2010 - October 2011
Cell Therapeutics, Inc. 2009 - 2010
Boston Scientific 2008 - 2009
Pharmatech Associates 2006 - 2009
Aradigm Corporation 1999 - 2005
Genentech, Inc. 1990 - 1996
Skills
GMP, FDA, Pharmaceutical Industry, V&V, Validation, CAPA, Technology Transfer, Sop, Change Control, Quality System, 21 CFR Part 11, GLP, Medical Devices, Biotechnology, Computer System..., Aseptic Processing, Biopharmaceuticals, Regulatory Affairs, GxP, Cleaning Validation, Lifesciences, R&D, ISO 13485, Quality Assurance, LIMS, Pharmaceutics, Regulatory Submissions, Manufacturing, Quality Auditing, Clinical Development, Contract Manufacturing, Continuous Improvement, Formulation, Analytical Chemistry, Process Simulation, Regulatory Requirements, Quality Control, Clinical Trials, CRO, Chemistry, GCP, HPLC, GAMP, Sterilization, IND, Commercialization, Drug Delivery, Oncology, Design Control, Chromatography
Education
Century University
B.S. Business Adminstration
City College of San Francisco
Organic Chemistry
Quintiles Transnational 2011 - Present
Avrio Biopharmaceuticals January 2010 - October 2011
Cell Therapeutics, Inc. 2009 - 2010
Boston Scientific 2008 - 2009
Pharmatech Associates 2006 - 2009
Aradigm Corporation 1999 - 2005
Genentech, Inc. 1990 - 1996
Skills
GMP, FDA, Pharmaceutical Industry, V&V, Validation, CAPA, Technology Transfer, Sop, Change Control, Quality System, 21 CFR Part 11, GLP, Medical Devices, Biotechnology, Computer System..., Aseptic Processing, Biopharmaceuticals, Regulatory Affairs, GxP, Cleaning Validation, Lifesciences, R&D, ISO 13485, Quality Assurance, LIMS, Pharmaceutics, Regulatory Submissions, Manufacturing, Quality Auditing, Clinical Development, Contract Manufacturing, Continuous Improvement, Formulation, Analytical Chemistry, Process Simulation, Regulatory Requirements, Quality Control, Clinical Trials, CRO, Chemistry, GCP, HPLC, GAMP, Sterilization, IND, Commercialization, Drug Delivery, Oncology, Design Control, Chromatography
Education
Century University
B.S. Business Adminstration
City College of San Francisco
Organic Chemistry
Aurora Sosa Aurora Sosa's Aradigm Corporation Experience May 2014 - Present
Job Director of Regulatory Affairs at Aradigm Corporation
Industry Pharmaceuticals
Experience
Aradigm Corporation May 2014 - Present
Cerexa April 2013 - March 2014
Dow Pharmaceutical Sciences (Division of Valeant Pharmaceuticals International) December 2011 - December 2012
RQIS, Regulatory and Quality International Solutions, LLC April 2011 - December 2011
ARCA February 2009 - March 2011
Gilead Sciences January 2003 - January 2009
ICOS February 2001 - December 2002
Bayer August 1998 - February 2001
Bayer March 1995 - July 1998
Bayer April 1988 - March 1994
Skills
FDA, Clinical Development, Regulatory Affairs, Clinical Trials, Pharmaceutical Industry, Biotechnology, Validation, Biopharmaceuticals, IND, Drug Development, Clinical Research, eCTD, NDA, Immunology, Quality Assurance, Cross-functional Team..., CMC, V&V, Sop, Regulatory Submissions, CRO, GLP, Assay Development, 21 CFR Part 11, Protocol, GMP, CAPA, Regulatory Requirements, FDA GMP, GCP
Education
John F. Kennedy University 1987 — 1991
MA, Holistic Health and Counseling Psychology
Baylor College of Medicine 1980 — 1982
Biochemisty
Trinity University 1976 — 1980
BS, Biology
Aradigm Corporation May 2014 - Present
Cerexa April 2013 - March 2014
Dow Pharmaceutical Sciences (Division of Valeant Pharmaceuticals International) December 2011 - December 2012
RQIS, Regulatory and Quality International Solutions, LLC April 2011 - December 2011
ARCA February 2009 - March 2011
Gilead Sciences January 2003 - January 2009
ICOS February 2001 - December 2002
Bayer August 1998 - February 2001
Bayer March 1995 - July 1998
Bayer April 1988 - March 1994
Skills
FDA, Clinical Development, Regulatory Affairs, Clinical Trials, Pharmaceutical Industry, Biotechnology, Validation, Biopharmaceuticals, IND, Drug Development, Clinical Research, eCTD, NDA, Immunology, Quality Assurance, Cross-functional Team..., CMC, V&V, Sop, Regulatory Submissions, CRO, GLP, Assay Development, 21 CFR Part 11, Protocol, GMP, CAPA, Regulatory Requirements, FDA GMP, GCP
Education
John F. Kennedy University 1987 — 1991
MA, Holistic Health and Counseling Psychology
Baylor College of Medicine 1980 — 1982
Biochemisty
Trinity University 1976 — 1980
BS, Biology
Delmica Karigaca Delmica Karigaca's Aradigm Corporation Experience February 2001 - February 2003
Job Quality Assurance Analyst, Compliance at Abbott Laboratories
Industry Biotechnology
Experience
Abbott Laboratories October 2010 - Present
Baxter BioScience July 2010 - October 2010
Abbott Diabetes Care August 2009 - July 2010
Cepheid November 2008 - June 2009
Novo Nordisk Delivery Technologies February 2003 - March 2008
Aradigm Corporation February 2001 - February 2003
UCLA Office of Environment Health and Safety 1996 - 1999
Skills
GMP, Validation, FDA, LIMS, Sop, Chemistry, GLP, 5S, Process Improvement, Biotechnology, ISO 13485, Quality Management, Quality System, CAPA, Medical Devices, Auditing, Biopharmaceuticals, Quality Auditing, Lean Manufacturing, Change Control, Analytical Chemistry, Quality Control, Quality Assurance, V&V
Education
University of California, Los Angeles
B.S., Biology
Abbott Laboratories October 2010 - Present
Baxter BioScience July 2010 - October 2010
Abbott Diabetes Care August 2009 - July 2010
Cepheid November 2008 - June 2009
Novo Nordisk Delivery Technologies February 2003 - March 2008
Aradigm Corporation February 2001 - February 2003
UCLA Office of Environment Health and Safety 1996 - 1999
Skills
GMP, Validation, FDA, LIMS, Sop, Chemistry, GLP, 5S, Process Improvement, Biotechnology, ISO 13485, Quality Management, Quality System, CAPA, Medical Devices, Auditing, Biopharmaceuticals, Quality Auditing, Lean Manufacturing, Change Control, Analytical Chemistry, Quality Control, Quality Assurance, V&V
Education
University of California, Los Angeles
B.S., Biology
David Cipolla David Cipolla's Aradigm Corporation Experience May 2015 - Present
Job
Industry Pharmaceuticals
Experience
Aradigm Corporation May 2015 - Present
Aradigm January 1996 - May 2015
Genentech 1988 - 1996
Skills
Cystic Fibrosis, Formulation, Aerosol Science, Pharmaceutics, Analytical Chemistry, Drug Delivery, Regulatory Science, CMC development, Intellectual Property, Patent Applications, R&D, Medical Devices, Drug Discovery, Validation, Chromatography, GMP, Pharmaceutical Industry, HPLC, Biotechnology, CMC, Clinical Development, Drug Development, FDA, Clinical Trials, Lifesciences, Technology Transfer, Biopharmaceuticals, GLP, IND, Protein Chemistry, Regulatory Submissions, Sop, Quality by Design, Regulatory Affairs, Pharmaceutical Research, V&V, Biologics, CRO, CAPA, LC-MS, Commercialization, 21 CFR Part 11, Chemistry, LIMS, Antibodies, GxP, UV/Vis, Aseptic Processing
Education
Massachusetts Institute of Technology
SB
University of California, Davis
MS
University of Sydney
Doctor of Philosophy (Ph.D.)
Aradigm Corporation May 2015 - Present
Aradigm January 1996 - May 2015
Genentech 1988 - 1996
Skills
Cystic Fibrosis, Formulation, Aerosol Science, Pharmaceutics, Analytical Chemistry, Drug Delivery, Regulatory Science, CMC development, Intellectual Property, Patent Applications, R&D, Medical Devices, Drug Discovery, Validation, Chromatography, GMP, Pharmaceutical Industry, HPLC, Biotechnology, CMC, Clinical Development, Drug Development, FDA, Clinical Trials, Lifesciences, Technology Transfer, Biopharmaceuticals, GLP, IND, Protein Chemistry, Regulatory Submissions, Sop, Quality by Design, Regulatory Affairs, Pharmaceutical Research, V&V, Biologics, CRO, CAPA, LC-MS, Commercialization, 21 CFR Part 11, Chemistry, LIMS, Antibodies, GxP, UV/Vis, Aseptic Processing
Education
Massachusetts Institute of Technology
SB
University of California, Davis
MS
University of Sydney
Doctor of Philosophy (Ph.D.)
Felipe Quijano Felipe Quijano's Aradigm Corporation Experience 1999 - 2005
Job Process Engineering Technician at Abaxis
Industry Pharmaceuticals
Experience
Abaxis August 2010 - Present
Abbott Vascular April 2010 - August 2010
Inverness Medical (Formerly Cholestech) July 2008 - November 2009
Novo Nordisk Delivery Technologies January 2005 - May 2008
Aradigm Corporation 1999 - 2005
Quidel Corp (Formerly Metra Biosystems Inc) 1995 - 1999
Skills
FDA, Validation, GMP, CAPA, Medical Devices, R&D, Quality Assurance, Manufacturing, Biotechnology, SOP
Education
Foothill College
Abaxis August 2010 - Present
Abbott Vascular April 2010 - August 2010
Inverness Medical (Formerly Cholestech) July 2008 - November 2009
Novo Nordisk Delivery Technologies January 2005 - May 2008
Aradigm Corporation 1999 - 2005
Quidel Corp (Formerly Metra Biosystems Inc) 1995 - 1999
Skills
FDA, Validation, GMP, CAPA, Medical Devices, R&D, Quality Assurance, Manufacturing, Biotechnology, SOP
Education
Foothill College
Justus Wunderle Justus Wunderle's Aradigm Corporation Experience 2005 - 2007
Job Mechanical Engineer at IntegenX, Inc.
Industry Medical Devices
Experience
IntegenX. Inc. July 2012 - Present
Zogenix, Inc. April 2010 - July 2012
Abbott Diabetes Care October 2006 - April 2010
Aradigm Corporation 2005 - 2007
Molecular Devices 2003 - 2005
Applied Biosystems 1998 - 2003
Bio-Rad Laboratories October 1989 - December 1997
Skills
Analytical Chemistry, Drug Delivery, Leadership, Science, Analysis, Design Control, FDA, ISO 13485, Validation, Quality System
Education
Rensselaer Polytechnic Institute 1970 — 1973
Bachelor of Mechanical Engineering, Mechanisms, fluid mechanics, heat transfer
IntegenX. Inc. July 2012 - Present
Zogenix, Inc. April 2010 - July 2012
Abbott Diabetes Care October 2006 - April 2010
Aradigm Corporation 2005 - 2007
Molecular Devices 2003 - 2005
Applied Biosystems 1998 - 2003
Bio-Rad Laboratories October 1989 - December 1997
Skills
Analytical Chemistry, Drug Delivery, Leadership, Science, Analysis, Design Control, FDA, ISO 13485, Validation, Quality System
Education
Rensselaer Polytechnic Institute 1970 — 1973
Bachelor of Mechanical Engineering, Mechanisms, fluid mechanics, heat transfer
Jody J. Savage, MS, MBA's Aradigm Corporation Experience March 1999 - August 2001
Job Associate Director of Regulatory Affairs at Grifols Diagnostic Systems (formerly Novartis Diagnostics)
Industry Biotechnology
Experience
Grifols Diagnostic Systems (formerly Novartis Diagnostics) April 2009 - Present
Abbott Diabetes Care October 2005 - April 2009
Aradigm Corporation March 1999 - August 2001
Boehringer Mannheim July 1997 - September 1998
Chiron Corporation May 1995 - June 1997
Pharmacyclics March 1994 - March 1995
Skills
Regulatory Submissions, Strategy, Editing, FDA, CAPA, ISO 13485, GxP, Change Control, GMP, Pharmaceutical Industry, Medical Devices, Validation, PMA, Biotechnology, Technical Writing, Post Approval Changes, CMC Regulatory Affairs, Clinical Regulatory..., In Vitro Diagnostics, Combination Products, 510(k), Biologics, Project Teams, Regulatory Requirements, V&V, Quality System, Clinical Trials, Clinical Development, GLP, GCP, Lifesciences, Computer System..., IND, Cross-functional Team..., Document Management, 21 CFR, Regulations, Immunology, Regulatory Filings, Patents, Design Control, BLA, Professional Mentoring, SOP authoring, Partner Management, Hardware Diagnostics, Sop, 21 CFR Part 11, Drug Development, Vaccines
Education
California State University-Hayward 1987 — 1991
MS, Cell and Molecular Biology
Columbia University - Columbia Business School 1976 — 1978
MBA, Finance
Pomona College 1971 — 1975
BA, English with Writing Emphasis
Grifols Diagnostic Systems (formerly Novartis Diagnostics) April 2009 - Present
Abbott Diabetes Care October 2005 - April 2009
Aradigm Corporation March 1999 - August 2001
Boehringer Mannheim July 1997 - September 1998
Chiron Corporation May 1995 - June 1997
Pharmacyclics March 1994 - March 1995
Skills
Regulatory Submissions, Strategy, Editing, FDA, CAPA, ISO 13485, GxP, Change Control, GMP, Pharmaceutical Industry, Medical Devices, Validation, PMA, Biotechnology, Technical Writing, Post Approval Changes, CMC Regulatory Affairs, Clinical Regulatory..., In Vitro Diagnostics, Combination Products, 510(k), Biologics, Project Teams, Regulatory Requirements, V&V, Quality System, Clinical Trials, Clinical Development, GLP, GCP, Lifesciences, Computer System..., IND, Cross-functional Team..., Document Management, 21 CFR, Regulations, Immunology, Regulatory Filings, Patents, Design Control, BLA, Professional Mentoring, SOP authoring, Partner Management, Hardware Diagnostics, Sop, 21 CFR Part 11, Drug Development, Vaccines
Education
California State University-Hayward 1987 — 1991
MS, Cell and Molecular Biology
Columbia University - Columbia Business School 1976 — 1978
MBA, Finance
Pomona College 1971 — 1975
BA, English with Writing Emphasis
Michelle Leal Michelle Leal's Aradigm Corporation Experience 2001 - 2001
Job Graphic Designer II at Nugget Market, Inc.
Industry Graphic Design
Experience
Nugget Market, Inc. September 2011 - Present
Word Wonder Design 2010 - Present
Dove Lewis Emergency Animal Hospital June 2005 - August 2011
Bear Deluxe Magazine 2005 - May 2011
Exelixis Plant Science 2001 - 2005
Aradigm Corporation 2001 - 2001
Alameda Hospital 2000 - 2000
Seminis 1997 - 2000
Skills
Logo Design, Graphic Design, Layout, Illustrator, Fundraising, Art Direction, Illustration, Posters, Advertising, Adobe Creative Suite, Brochures, InDesign, Graphics, Marketing, Newsletters, Direct Mail, Photoshop, Web Design, Web Content Management, Brand Management, Brand Development
Education
Portland Community College 2003 — 2005
AAS, Graphic Design
California College of the Arts 1992 — 1997
BFA, Fine Arts, Printmaking
Nugget Market, Inc. September 2011 - Present
Word Wonder Design 2010 - Present
Dove Lewis Emergency Animal Hospital June 2005 - August 2011
Bear Deluxe Magazine 2005 - May 2011
Exelixis Plant Science 2001 - 2005
Aradigm Corporation 2001 - 2001
Alameda Hospital 2000 - 2000
Seminis 1997 - 2000
Skills
Logo Design, Graphic Design, Layout, Illustrator, Fundraising, Art Direction, Illustration, Posters, Advertising, Adobe Creative Suite, Brochures, InDesign, Graphics, Marketing, Newsletters, Direct Mail, Photoshop, Web Design, Web Content Management, Brand Management, Brand Development
Education
Portland Community College 2003 — 2005
AAS, Graphic Design
California College of the Arts 1992 — 1997
BFA, Fine Arts, Printmaking
Rachel Aigen's Aradigm Corporation Experience March 2014 - Present
Job Clinical Trial Assistant
Industry Biotechnology
Experience
Aradigm Corporation March 2014 - Present
Sutton Swim School October 2013 - February 2014
Lindsay Wildlife Museum April 2012 - December 2012
Wildlife Rescue, Inc. June 2006 - July 2007
Skills
Social Networking, Sports, Animal Welfare, Baseball, Social Skills, Sports Coaching, Highly personable, Microsoft Word, Multi Tasking, Focused Execution, Exceptional People..., Overcome Obstacles, Teach Others, Improvisation, Timely Decision Making, Building Relationships, Community Outreach, Intuition, Advocate, Social Media, Conceptualizer, Data Analysis, Human Behavior, Follow Directions, Follow Through, Sociology, Hardwork, Learning Quickly, Computer Proficiency, Microsoft Excel, Note Taking, Agenda Development, Spreadsheets, International Shipping, Document Review, Event Planning, Corporate Events, Clinical Trials
Education
Saint Mary's College of California 2010 — 2013
Bachelor of Arts (B.A.), Sociology
Foothill College 2009 — 2010
N/A, Sociology
University of Hawaii at Manoa 2008 — 2009
Sociology
Aradigm Corporation March 2014 - Present
Sutton Swim School October 2013 - February 2014
Lindsay Wildlife Museum April 2012 - December 2012
Wildlife Rescue, Inc. June 2006 - July 2007
Skills
Social Networking, Sports, Animal Welfare, Baseball, Social Skills, Sports Coaching, Highly personable, Microsoft Word, Multi Tasking, Focused Execution, Exceptional People..., Overcome Obstacles, Teach Others, Improvisation, Timely Decision Making, Building Relationships, Community Outreach, Intuition, Advocate, Social Media, Conceptualizer, Data Analysis, Human Behavior, Follow Directions, Follow Through, Sociology, Hardwork, Learning Quickly, Computer Proficiency, Microsoft Excel, Note Taking, Agenda Development, Spreadsheets, International Shipping, Document Review, Event Planning, Corporate Events, Clinical Trials
Education
Saint Mary's College of California 2010 — 2013
Bachelor of Arts (B.A.), Sociology
Foothill College 2009 — 2010
N/A, Sociology
University of Hawaii at Manoa 2008 — 2009
Sociology
Jonathan Rigby Jonathan Rigby's Aradigm Corporation Experience 2002 - 2006
Job President, CEO and Board Member at SteadyMed Ltd
Industry Biotechnology
Experience
SteadyMed Ltd, 2011 - Present
Zogenix Inc August 2006 - December 2011
Aradigm Corporation 2002 - 2006
Profile 1995 - 2002
Merck, Bristol Myers Squibb 1990 - 1995
Skills
Pharmaceutical Industry, Drug Delivery, Medical Devices, Product Launch, Commercialization, Start-ups, Strategic Leadership, CEOs, Biotechnology
Education
The University of Sheffield, UK 1986 — 1990
Biological Sciences, Honors
University of Portsmouth
MBA
SteadyMed Ltd, 2011 - Present
Zogenix Inc August 2006 - December 2011
Aradigm Corporation 2002 - 2006
Profile 1995 - 2002
Merck, Bristol Myers Squibb 1990 - 1995
Skills
Pharmaceutical Industry, Drug Delivery, Medical Devices, Product Launch, Commercialization, Start-ups, Strategic Leadership, CEOs, Biotechnology
Education
The University of Sheffield, UK 1986 — 1990
Biological Sciences, Honors
University of Portsmouth
MBA
Don Clyde's Aradigm Corporation Experience 1998 - 2009
Job Interactive Producer, PM Radio Producer, Copy Editor, Reporter
Industry Media Production
Experience
KQED September 2011 - Present
ZERO1 2012 - 2012
The Guardsman, City College of San Francisco's Student Newspaper 2009 - 2011
Newsdesk 2010 - 2010
Aradigm Corporation 1998 - 2009
KPFA Radio September 2003 - April 2004
UC Berkeley Physics Department, Dmitry Budker's Atomic Physics Research Group 1996 - 1998
Skills
Editing, Journalism, Blogging, Multimedia, Reporting, Broadcast, Social Media, Copy Editing, Statistics, Digital Photography, Adobe Photoshop, Adobe Premiere CC, Audio Editing, Mathematics, HTML, CSS, WordPress, CMS, Microsoft Office, Eclipse, Mac & PC platforms, Data Analysis
Education
University of California, Berkeley 1994 — 1997
Bachelor's Degree, Physics
KQED September 2011 - Present
ZERO1 2012 - 2012
The Guardsman, City College of San Francisco's Student Newspaper 2009 - 2011
Newsdesk 2010 - 2010
Aradigm Corporation 1998 - 2009
KPFA Radio September 2003 - April 2004
UC Berkeley Physics Department, Dmitry Budker's Atomic Physics Research Group 1996 - 1998
Skills
Editing, Journalism, Blogging, Multimedia, Reporting, Broadcast, Social Media, Copy Editing, Statistics, Digital Photography, Adobe Photoshop, Adobe Premiere CC, Audio Editing, Mathematics, HTML, CSS, WordPress, CMS, Microsoft Office, Eclipse, Mac & PC platforms, Data Analysis
Education
University of California, Berkeley 1994 — 1997
Bachelor's Degree, Physics
Chris Ayeko Chris Ayeko's Aradigm Corporation Experience June 2007 - August 2007
Job Family Nurse Practitioner
Industry Hospital & Health Care
Experience
Samuel Merritt University January 2014 - December 2014
Hayward Day Laborers Clinic January 2014 - December 2014
Samuel Merritt University September 2012 - December 2014
Brighter Beginnings January 2014 - April 2014
Sutter Health September 2012 - December 2012
Peace Corps August 2007 - August 2009
Aradigm Corporation June 2007 - August 2007
Regal Entertainment Group 2004 - 2007
American Red Cross 2004 - 2005
Skills
BLS, ACLS, PALS, Cpr Certified, Critical Care, Nursing, Public Health
Education
Samuel Merritt University 2011 — 2014
Master of Science in Nursing (MSN), Family Nurse Practitioner
University of San Diego 2002 — 2006
Bachelor of Arts (BA), Theology and Religious Studies
Samuel Merritt University January 2014 - December 2014
Hayward Day Laborers Clinic January 2014 - December 2014
Samuel Merritt University September 2012 - December 2014
Brighter Beginnings January 2014 - April 2014
Sutter Health September 2012 - December 2012
Peace Corps August 2007 - August 2009
Aradigm Corporation June 2007 - August 2007
Regal Entertainment Group 2004 - 2007
American Red Cross 2004 - 2005
Skills
BLS, ACLS, PALS, Cpr Certified, Critical Care, Nursing, Public Health
Education
Samuel Merritt University 2011 — 2014
Master of Science in Nursing (MSN), Family Nurse Practitioner
University of San Diego 2002 — 2006
Bachelor of Arts (BA), Theology and Religious Studies
Debbie Yim's Aradigm Corporation Experience August 2009 - December 2009
Job Manager at Onyx Pharmaceuticals
Industry Pharmaceuticals
Experience
Onyx Pharmaceuticals March 2013 - Present
Onyx Pharmaceuticals April 2011 - March 2013
JANSSEN Alzheimer Immunotherapy December 2010 - April 2011
Elan Pharmaceuticals December 2009 - November 2010
Aradigm Corporation August 2009 - December 2009
Aradigm Corporation February 2003 - August 2009
Aradigm Corporation January 1999 - February 2003
Aradigm Corporation April 1997 - January 1999
Education
University of California, Davis
Bachelor of Science in Biochemistry
Onyx Pharmaceuticals March 2013 - Present
Onyx Pharmaceuticals April 2011 - March 2013
JANSSEN Alzheimer Immunotherapy December 2010 - April 2011
Elan Pharmaceuticals December 2009 - November 2010
Aradigm Corporation August 2009 - December 2009
Aradigm Corporation February 2003 - August 2009
Aradigm Corporation January 1999 - February 2003
Aradigm Corporation April 1997 - January 1999
Education
University of California, Davis
Bachelor of Science in Biochemistry
Jennifer Merlin Jennifer Merlin's Aradigm Corporation Experience 2005 - 2008
Job Validation and Quality Engineering Consultant jennifer.liu.merlin@gmail.com
Industry Medical Devices
Experience
Medtech Consulting 2013 - Present
Intuitive Surgical June 2011 - 2013
Medtech Consulting 2009 - May 2011
Aradigm Corporation 2005 - 2008
Abbott Vascular Devices 2003 - 2005
Perclose 2001 - 2003
Abbott Diagnostics 1998 - 2001
Abbott Laboratories 1996 - 1999
Skills
FDA, Validation, Design Control
Education
Northwestern University 1992 — 1996
Bachelor of Science, Chemical Engineering, specialization in Biomedical Engineering
Medtech Consulting 2013 - Present
Intuitive Surgical June 2011 - 2013
Medtech Consulting 2009 - May 2011
Aradigm Corporation 2005 - 2008
Abbott Vascular Devices 2003 - 2005
Perclose 2001 - 2003
Abbott Diagnostics 1998 - 2001
Abbott Laboratories 1996 - 1999
Skills
FDA, Validation, Design Control
Education
Northwestern University 1992 — 1996
Bachelor of Science, Chemical Engineering, specialization in Biomedical Engineering
Donna Fe De Guzman Donna Fe De Guzman's Aradigm Corporation Experience 1990 - 2005
Job Accomplished Production Planner/Scheduler in the pharmaceuticals, electronics and medical device industries.
Industry Biotechnology
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
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
Andrew Morozovsky Andrew Morozovsky's Aradigm Corporation Experience April 1997 - July 1998
Job Senior Regulatory Program Director, Knowledge Management at Roche Genentech
Industry Biotechnology
Experience
Roche - Genentech March 2015 - Present
Roche - Genentech March 2013 - March 2015
Roche-Genentech December 2007 - March 2013
PRTM Management Consultants January 2007 - December 2007
Improve Daily or Lose Ground October 1991 - November 2007
Berkeley Advanced Biomaterials, Inc. March 2004 - January 2007
Microgenics November 1998 - October 2002
Aradigm Corporation April 1997 - July 1998
BD Biosciences January 1993 - April 1997
Oracle Diagnostics 1992 - 1993
Skills
Operational Excellence, Manufacturing, Product Development, Engineering, Materials, Quality Management, Quality System, Organizational..., Cross-functional Team..., Biotechnology, Pharmaceutical Industry, Medical Devices, FDA, Six Sigma, CAPA, GMP, Quality Control, Process Improvement, Validation, Technology Transfer, Quality Assurance, ISO 13485, Process Simulation, Biopharmaceuticals, Lifesciences, GLP, 21 CFR Part 11, Sop, Life Sciences, Management, Strategy, Change Control, Leadership, SOP
Education
Argosy University San Francisco Bay Area 2008 — 2010
Doctoral Student, Organizational Leadership
Santa Clara University 1994 — 1996
MBA, Operations Research
University of Miami - School of Business 1988 — 1989
Executive MBA
California State University-Long Beach 1976 — 1979
Bachelor of Science, Zoology
Sequoia High School 1970 — 1974
Roche - Genentech March 2015 - Present
Roche - Genentech March 2013 - March 2015
Roche-Genentech December 2007 - March 2013
PRTM Management Consultants January 2007 - December 2007
Improve Daily or Lose Ground October 1991 - November 2007
Berkeley Advanced Biomaterials, Inc. March 2004 - January 2007
Microgenics November 1998 - October 2002
Aradigm Corporation April 1997 - July 1998
BD Biosciences January 1993 - April 1997
Oracle Diagnostics 1992 - 1993
Skills
Operational Excellence, Manufacturing, Product Development, Engineering, Materials, Quality Management, Quality System, Organizational..., Cross-functional Team..., Biotechnology, Pharmaceutical Industry, Medical Devices, FDA, Six Sigma, CAPA, GMP, Quality Control, Process Improvement, Validation, Technology Transfer, Quality Assurance, ISO 13485, Process Simulation, Biopharmaceuticals, Lifesciences, GLP, 21 CFR Part 11, Sop, Life Sciences, Management, Strategy, Change Control, Leadership, SOP
Education
Argosy University San Francisco Bay Area 2008 — 2010
Doctoral Student, Organizational Leadership
Santa Clara University 1994 — 1996
MBA, Operations Research
University of Miami - School of Business 1988 — 1989
Executive MBA
California State University-Long Beach 1976 — 1979
Bachelor of Science, Zoology
Sequoia High School 1970 — 1974
Thor Wilbanks Thor Wilbanks's Aradigm Corporation Experience 2006 - June 2009
Job Research Scientist at Agilent Technologies
Industry Biotechnology
Experience
Agilent Technologies April 2014 - Present
Thor Wilbanks June 2009 - April 2014
Agilent Technologies April 2012 - March 2014
Raydiance, Inc. January 2011 - March 2012
Zogenix July 2009 - January 2011
Aradigm Corporation 2006 - June 2009
Aradigm Corporation January 1996 - 2006
UC Berkeley Physics Department June 1994 - January 1996
UC Berkeley Physics Department September 1986 - May 1994
Skills
Electronics, Materials, Physics, Drug Delivery, Medical Devices, R&D, Engineering, Product Development, GMP, Process Development, Analysis, Research, Validation, Data Analysis, Cross-functional Team..., cGMP
Education
University of California, Berkeley 1986 — 1994
PhD, Physics, Astrophysics, Cosmology
Harvard University 1982 — 1986
AB, Physics
Berkeley High School 1978 — 1982
High School
King Middle School 1976 — 1978
Agilent Technologies April 2014 - Present
Thor Wilbanks June 2009 - April 2014
Agilent Technologies April 2012 - March 2014
Raydiance, Inc. January 2011 - March 2012
Zogenix July 2009 - January 2011
Aradigm Corporation 2006 - June 2009
Aradigm Corporation January 1996 - 2006
UC Berkeley Physics Department June 1994 - January 1996
UC Berkeley Physics Department September 1986 - May 1994
Skills
Electronics, Materials, Physics, Drug Delivery, Medical Devices, R&D, Engineering, Product Development, GMP, Process Development, Analysis, Research, Validation, Data Analysis, Cross-functional Team..., cGMP
Education
University of California, Berkeley 1986 — 1994
PhD, Physics, Astrophysics, Cosmology
Harvard University 1982 — 1986
AB, Physics
Berkeley High School 1978 — 1982
High School
King Middle School 1976 — 1978
Nate Dolar's Aradigm Corporation Experience November 2000 - January 2005
Job Technical Program Manager, Nektar Therapeutics
Industry Biotechnology
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
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
William (Barney) Krebs William (Barney) Krebs's Aradigm Corporation Experience March 2005 - October 2006
Job Independent Consultant in Biostatistics and Statistics
Industry Biotechnology
Experience
Nevro Corp November 2011 - Present
Premier Research Group October 2011 - Present
InSite Vision, Inc. June 2011 - Present
Santen May 2002 - Present
Self-Employed August 1998 - Present
Novartis Vaccines and Diagnostics March 2006 - April 2011
Advanced Clinical Services 1999 - 2011
John Wayne Cancer Institute October 2000 - May 2007
Aradigm Corporation March 2005 - October 2006
Chiron Corporation March 2000 - March 2006
Education
UC Berkeley 1982 — 1988
Ph.D.
University of California, Santa Barbara 1979 — 1980
M.A.
University of California, Santa Barbara 1979 — 1980
M.A.
UC Santa Barbara 1976 — 1979
B.A.
Nevro Corp November 2011 - Present
Premier Research Group October 2011 - Present
InSite Vision, Inc. June 2011 - Present
Santen May 2002 - Present
Self-Employed August 1998 - Present
Novartis Vaccines and Diagnostics March 2006 - April 2011
Advanced Clinical Services 1999 - 2011
John Wayne Cancer Institute October 2000 - May 2007
Aradigm Corporation March 2005 - October 2006
Chiron Corporation March 2000 - March 2006
Education
UC Berkeley 1982 — 1988
Ph.D.
University of California, Santa Barbara 1979 — 1980
M.A.
University of California, Santa Barbara 1979 — 1980
M.A.
UC Santa Barbara 1976 — 1979
B.A.
Justin Drish Justin Drish's Aradigm Corporation Experience January 2002 - April 2006
Job Laser Process Engineer at Lake Region Medical
Industry Medical Devices
Experience
Lake Region Medical September 2014 - Present
Accellent May 2006 - Present
Aradigm Corporation January 2002 - April 2006
Novo Nordisk A/S 2005 - 2006
3M June 1997 - January 2002
Skills
Laser, Optics, Manufacturing, Metrology, Medical Devices, Troubleshooting, Engineering, Design of Experiments, Machining, FMEA
Education
Indian Hills Community College 1995 — 1997
AA
Lake Region Medical September 2014 - Present
Accellent May 2006 - Present
Aradigm Corporation January 2002 - April 2006
Novo Nordisk A/S 2005 - 2006
3M June 1997 - January 2002
Skills
Laser, Optics, Manufacturing, Metrology, Medical Devices, Troubleshooting, Engineering, Design of Experiments, Machining, FMEA
Education
Indian Hills Community College 1995 — 1997
AA
Nicole Snyder Nicole Snyder's Aradigm Corporation Experience August 1999 - January 2005
Job Look forward!
Industry Pharmaceuticals
Experience
Rockville/Bethesda MD August 2015 - Present
Bayer August 2012 - January 2013
Maternity Leave October 2010 - July 2012
Bayer HealthCare May 2010 - September 2010
Novo Nordisk Delivery Technologies January 2005 - March 2007
Aradigm Corporation August 1999 - January 2005
Skills
Validation, HPLC, Pharmaceutics, Biotechnology, GMP, Pharmaceutical Industry, LIMS, Chromatography, Analytical Chemistry, FDA, Analytical Methods..., Hands-on Training, Stability, Project Coordination, CAPA, SOP authoring, Report Writing, Communication Skills, Deviations, Regulatory Guidelines, Supervising, Change Control, CMC, GLP, Sop, Lifesciences, Life Sciences, SOP, Quality Assurance, Quality Control
Education
UC Irvine, Extension 2015 — 2015
Regulatory Requirements for Pharmaceutical Products
UC Berkeley, Extension 2010 — 2010
Project Management Class
University of Oklahoma Health Sciences Center 1997 — 1999
MS, Industrial Hygiene
Wake Forest University 1993 — 1997
BA, Chemistry
Rockville/Bethesda MD August 2015 - Present
Bayer August 2012 - January 2013
Maternity Leave October 2010 - July 2012
Bayer HealthCare May 2010 - September 2010
Novo Nordisk Delivery Technologies January 2005 - March 2007
Aradigm Corporation August 1999 - January 2005
Skills
Validation, HPLC, Pharmaceutics, Biotechnology, GMP, Pharmaceutical Industry, LIMS, Chromatography, Analytical Chemistry, FDA, Analytical Methods..., Hands-on Training, Stability, Project Coordination, CAPA, SOP authoring, Report Writing, Communication Skills, Deviations, Regulatory Guidelines, Supervising, Change Control, CMC, GLP, Sop, Lifesciences, Life Sciences, SOP, Quality Assurance, Quality Control
Education
UC Irvine, Extension 2015 — 2015
Regulatory Requirements for Pharmaceutical Products
UC Berkeley, Extension 2010 — 2010
Project Management Class
University of Oklahoma Health Sciences Center 1997 — 1999
MS, Industrial Hygiene
Wake Forest University 1993 — 1997
BA, Chemistry
Eric Johansson's Aradigm Corporation Experience September 1991 - November 2008
Job VP of R&D at Silverbow 1
Industry Medical Devices
Experience
Silverbow 1 November 2013 - Present
ZELTIQ February 2012 - October 2013
Breathe Technologies, Inc. June 2010 - February 2012
- February 2010 - February 2012
AcelRx Pharmaceuticals, Inc. May 2009 - January 2010
Aradigm Corporation September 1991 - November 2008
Nellcor 1982 - 1991
Skills
Design Control, Systems Engineering, Cross-functional Team..., Product Development, Validation, Embedded Systems, Start-ups, R&D, Medical Devices, Electronics, Quality System, Quality Assurance, Software Development, V&V, CAPA, Project Management, FDA, Testing, Manufacturing, ISO 13485, Engineering, GMP, Design of Experiments, ISO, Root Cause Analysis, Design for Manufacturing, Engineering Management, FMEA, ISO 14971, Product Launch, Process Simulation, Injection Molding, Biomedical Engineering, Manufacturing..., SPC, Solidworks, Biotechnology, Product Design, Program Management, Commercialization
Education
University of California, Berkeley 1981 — 1985
BSEE, Electronics design, computer science
Silverbow 1 November 2013 - Present
ZELTIQ February 2012 - October 2013
Breathe Technologies, Inc. June 2010 - February 2012
- February 2010 - February 2012
AcelRx Pharmaceuticals, Inc. May 2009 - January 2010
Aradigm Corporation September 1991 - November 2008
Nellcor 1982 - 1991
Skills
Design Control, Systems Engineering, Cross-functional Team..., Product Development, Validation, Embedded Systems, Start-ups, R&D, Medical Devices, Electronics, Quality System, Quality Assurance, Software Development, V&V, CAPA, Project Management, FDA, Testing, Manufacturing, ISO 13485, Engineering, GMP, Design of Experiments, ISO, Root Cause Analysis, Design for Manufacturing, Engineering Management, FMEA, ISO 14971, Product Launch, Process Simulation, Injection Molding, Biomedical Engineering, Manufacturing..., SPC, Solidworks, Biotechnology, Product Design, Program Management, Commercialization
Education
University of California, Berkeley 1981 — 1985
BSEE, Electronics design, computer science
Harry Abe's Aradigm Corporation Experience 2000 - 2005
Job
Industry Medical Devices
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
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
Herman Gee's Aradigm Corporation Experience 2001 - 2004
Job Associate at Egon Zehnder International
Industry Management Consulting
Experience
Egon Zehnder International August 2008 - Present
Kimco Staffing August 2006 - July 2008
Kelly Scientific Resources 2004 - 2006
Aradigm Corporation 2001 - 2004
Skills
Executive Search, Pharmaceutical Industry, Recruiting, Life Sciences, GMP, Medical Devices, Biotechnology
Education
University of California, Santa Cruz
B.A., Molecular, Cellular and Development Biology
Egon Zehnder International August 2008 - Present
Kimco Staffing August 2006 - July 2008
Kelly Scientific Resources 2004 - 2006
Aradigm Corporation 2001 - 2004
Skills
Executive Search, Pharmaceutical Industry, Recruiting, Life Sciences, GMP, Medical Devices, Biotechnology
Education
University of California, Santa Cruz
B.A., Molecular, Cellular and Development Biology
Christopher Keenan's Aradigm Corporation Experience April 2002 - September 2006
Job Vice President, Investor Relations & Corporate Communications at Depomed, Inc.
Industry Biotechnology
Experience
Depomed, Inc. July 2015 - Present
Peregrine Pharmaceuticals January 2012 - June 2015
Cytokinetics, Inc. October 2006 - January 2012
Aradigm Corporation April 2002 - September 2006
PerkinElmer Inc. May 2000 - February 2001
Isis Pharmaceuticals Inc., March 1997 - April 2000
The Weinberg Group August 1990 - March 1997
Skills
Public Relations, Marketing, Advertising, Crisis Management, Corporate Branding, Trade Shows, Investor Relations, Biotechnology, Corporate Communications, Strategic Planning, Crisis Communications, Strategic Communications, Media Relations, Oncology, Marketing Communications, Pharmaceutical Industry, Lifesciences, Editing, Medical Devices, Project Management
Education
Kenyon College 1986 — 1990
BA, English
Depomed, Inc. July 2015 - Present
Peregrine Pharmaceuticals January 2012 - June 2015
Cytokinetics, Inc. October 2006 - January 2012
Aradigm Corporation April 2002 - September 2006
PerkinElmer Inc. May 2000 - February 2001
Isis Pharmaceuticals Inc., March 1997 - April 2000
The Weinberg Group August 1990 - March 1997
Skills
Public Relations, Marketing, Advertising, Crisis Management, Corporate Branding, Trade Shows, Investor Relations, Biotechnology, Corporate Communications, Strategic Planning, Crisis Communications, Strategic Communications, Media Relations, Oncology, Marketing Communications, Pharmaceutical Industry, Lifesciences, Editing, Medical Devices, Project Management
Education
Kenyon College 1986 — 1990
BA, English
Salena Grewal's Aradigm Corporation Experience October 2000 - September 2005
Job Senior Clinical Research Associate at Revance Therapeutics
Industry Pharmaceuticals
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
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
Sothy Yi's Aradigm Corporation Experience January 1999 - March 1999
Job
Industry Biotechnology
Experience
Rigel April 2007 - Present
Genentech March 1999 - April 2007
Aradigm Corporation January 1999 - March 1999
Skills
Molecular Biology, Immunology, Gene Expression..., Antibodies, ELISA, Cell Biology, Flow Cytometry, Cell Culture, Western Blotting, Small Molecules, Troubleshooting, Monoclonal Antibodies, Protein Purification, Biomarkers, Protein Expression, qPCR, Transfection, Molecular Cloning, Immunoassays, Drug Development, Assay Development, Drug Discovery
Education
University of California, Berkeley
Bachelor's degree, Molecular Biology
Rigel April 2007 - Present
Genentech March 1999 - April 2007
Aradigm Corporation January 1999 - March 1999
Skills
Molecular Biology, Immunology, Gene Expression..., Antibodies, ELISA, Cell Biology, Flow Cytometry, Cell Culture, Western Blotting, Small Molecules, Troubleshooting, Monoclonal Antibodies, Protein Purification, Biomarkers, Protein Expression, qPCR, Transfection, Molecular Cloning, Immunoassays, Drug Development, Assay Development, Drug Discovery
Education
University of California, Berkeley
Bachelor's degree, Molecular Biology
Dimple Win's Aradigm Corporation Experience 1997 - 1998
Job LIMS and Lab Systems Consultant
Industry Information Technology and Services
Experience
Pendant Alliance INC. April 2008 - Present
Conor Medsystems 2007 - 2008
ALZA Corporation July 2004 - April 2007
GPSG, a Unit of ALZA Corporation (a Johnson and Johnson Company) 2004 - 2007
ALZA Corporation 2002 - 2004
Jacobs Sverdrup April 2001 - October 2001
Aradigm Corporation 1997 - 1998
Skills
LIMS, Computer System..., LabWare LIMS, SDLC, Risk Assessment, Project Management, Software Project..., Laboratory Automation, Entrepreneurship, Start-ups, Strategic Partnerships, 21 CFR Part 11, GMP, FDA, GxP, Biotechnology, Pharmaceutical Industry
Education
University of California, Davis
B.S.
Pendant Alliance INC. April 2008 - Present
Conor Medsystems 2007 - 2008
ALZA Corporation July 2004 - April 2007
GPSG, a Unit of ALZA Corporation (a Johnson and Johnson Company) 2004 - 2007
ALZA Corporation 2002 - 2004
Jacobs Sverdrup April 2001 - October 2001
Aradigm Corporation 1997 - 1998
Skills
LIMS, Computer System..., LabWare LIMS, SDLC, Risk Assessment, Project Management, Software Project..., Laboratory Automation, Entrepreneurship, Start-ups, Strategic Partnerships, 21 CFR Part 11, GMP, FDA, GxP, Biotechnology, Pharmaceutical Industry
Education
University of California, Davis
B.S.
Bryan Lennon's Aradigm Corporation Experience 1995 - 2001
Job EMC Engineer at Agilent Technologies
Industry Medical Devices
Experience
Agilent Technologies 2009 - Present
Agilent Technologies 2001 - 2009
Aradigm Corporation 1995 - 2001
Trimble Navigation 1994 - 1995
Nellcor 1991 - 1994
Watkins-Johnson Company 1983 - 1991
Skills
Electronics, PCB design, Medical Devices, Engineering Management, RF, Test Engineering, Test Equipment, Engineering, Product Development, Wireless, Manufacturing, R&D, Design for Manufacturing, Design of Experiments, Failure Analysis, Embedded Systems, Process Simulation, Testing, Analog, Manufacturing..., New Product Roll Out, New Product..., Introducing New Products, New Product Ideas, Robotics, Labview, Systems Engineering, FMEA, Hardware, Medical Equipment, Electrical Engineering, Calibration, Circuit Design, SPC, Simulations, Mixed Signal, Automation, IC, Debugging, Spectrum Analyzer
Education
California Polytechnic State University-San Luis Obispo 1979 — 1983
Bs. ET/EL, Engineering Technology - Electronics
San Joaquin Delta College 1977 — 1979
Electronics Technology/GE
Agilent Technologies 2009 - Present
Agilent Technologies 2001 - 2009
Aradigm Corporation 1995 - 2001
Trimble Navigation 1994 - 1995
Nellcor 1991 - 1994
Watkins-Johnson Company 1983 - 1991
Skills
Electronics, PCB design, Medical Devices, Engineering Management, RF, Test Engineering, Test Equipment, Engineering, Product Development, Wireless, Manufacturing, R&D, Design for Manufacturing, Design of Experiments, Failure Analysis, Embedded Systems, Process Simulation, Testing, Analog, Manufacturing..., New Product Roll Out, New Product..., Introducing New Products, New Product Ideas, Robotics, Labview, Systems Engineering, FMEA, Hardware, Medical Equipment, Electrical Engineering, Calibration, Circuit Design, SPC, Simulations, Mixed Signal, Automation, IC, Debugging, Spectrum Analyzer
Education
California Polytechnic State University-San Luis Obispo 1979 — 1983
Bs. ET/EL, Engineering Technology - Electronics
San Joaquin Delta College 1977 — 1979
Electronics Technology/GE
Dar Rosario's Aradigm Corporation Experience May 2000 - April 2004
Job Vice President, Research Program Management
Industry Biotechnology
Experience
MannKind Corporation September 2005 - Present
Chiron Corporation March 2004 - June 2005
Aradigm Corporation May 2000 - April 2004
Education
St. Mary's College, Moraga CA 2001 — 2003
MBA
Eastern University 1976 — 1980
MannKind Corporation September 2005 - Present
Chiron Corporation March 2004 - June 2005
Aradigm Corporation May 2000 - April 2004
Education
St. Mary's College, Moraga CA 2001 — 2003
MBA
Eastern University 1976 — 1980
James Ivey's Aradigm Corporation Experience June 2005 - September 2005
Job Graduate Student & Research Assistant, Mechanical Engineering at University of Alberta
Industry Mechanical or Industrial Engineering
Experience
University of Alberta April 2012 - Present
Pearl Therapeutics January 2009 - April 2012
Pearl Therapeutics August 2007 - January 2009
MedImmune November 2005 - August 2007
Aradigm Corporation June 2005 - September 2005
Skills
CFD, Fluid Mechanics, Particle Engineering, Spray Drying, Mass Transfer, Validation, Technology Transfer, R&D, GMP, FDA, Biotechnology, Mechanical Engineering, Drug Delivery, Medical Devices, CAPA, Formulation, Pharmaceutical Industry, Process Simulation
Education
University of California, Santa Barbara 1999 — 2004
BS, Mechanical Engineering
University of Alberta April 2012 - Present
Pearl Therapeutics January 2009 - April 2012
Pearl Therapeutics August 2007 - January 2009
MedImmune November 2005 - August 2007
Aradigm Corporation June 2005 - September 2005
Skills
CFD, Fluid Mechanics, Particle Engineering, Spray Drying, Mass Transfer, Validation, Technology Transfer, R&D, GMP, FDA, Biotechnology, Mechanical Engineering, Drug Delivery, Medical Devices, CAPA, Formulation, Pharmaceutical Industry, Process Simulation
Education
University of California, Santa Barbara 1999 — 2004
BS, Mechanical Engineering
Angelina Novion's Aradigm Corporation Experience 2001 - 2002
Job Commercial QA
Industry Pharmaceuticals
Experience
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
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
Larry Ensler's Aradigm Corporation Experience 1998 - 2000
Job Member of Technical Staff Mechanical at Intevac Photonics
Industry Mechanical or Industrial Engineering
Experience
Intevac Photonics November 2014 - Present
Google November 2012 - November 2014
Solta Medical, Inc August 2012 - November 2012
Echelon March 2012 - August 2012
Genentech August 2011 - March 2012
Siemens Medical Solutions February 2011 - August 2011
Optovue, Inc. May 2005 - November 2010
Lyncean Technologies Inc, 2003 - 2005
First Medical Inc Mt View CA 1994 - 2002
Aradigm Corporation 1998 - 2000
Skills
Mechanical Engineering..., Pro/Engineer, Windchill PLM Admin, Windchill, Numerical Analysis, Product Launch, Medical Devices, Product Development, R&D, Feature Based Solid..., Solidworks, Design for Manufacturing, Mechanical Engineering, Pro Engineer, Manufacturing, CAD, Sheet Metal, Engineering, Finite Element Analysis, Engineering Management, PTC Creo, SolidWorks, Product Lifecycle...
Education
University of California, Berkeley 1976 — 1981
MS, Mechanical Engineering
University of California, Berkeley 1974 — 1976
BS, Mechanical Engineering
Intevac Photonics November 2014 - Present
Google November 2012 - November 2014
Solta Medical, Inc August 2012 - November 2012
Echelon March 2012 - August 2012
Genentech August 2011 - March 2012
Siemens Medical Solutions February 2011 - August 2011
Optovue, Inc. May 2005 - November 2010
Lyncean Technologies Inc, 2003 - 2005
First Medical Inc Mt View CA 1994 - 2002
Aradigm Corporation 1998 - 2000
Skills
Mechanical Engineering..., Pro/Engineer, Windchill PLM Admin, Windchill, Numerical Analysis, Product Launch, Medical Devices, Product Development, R&D, Feature Based Solid..., Solidworks, Design for Manufacturing, Mechanical Engineering, Pro Engineer, Manufacturing, CAD, Sheet Metal, Engineering, Finite Element Analysis, Engineering Management, PTC Creo, SolidWorks, Product Lifecycle...
Education
University of California, Berkeley 1976 — 1981
MS, Mechanical Engineering
University of California, Berkeley 1974 — 1976
BS, Mechanical Engineering
Karen Buenconsejo's Aradigm Corporation Experience 1999 - 2001
Job Deputy Project Manager at Booz Allen Hamilton
Industry Information Technology and Services
Experience
Booz Allen Hamilton June 2007 - Present
Apptis 2006 - 2007
Color Me Mine 2005 - 2007
CGI June 2004 - August 2006
NASA June 2003 - August 2003
Aradigm Corporation 1999 - 2001
Skills
Associate
Education
The Johns Hopkins University 2007 — 2010
MS
University of Virginia 2001 — 2004
BS
Booz Allen Hamilton June 2007 - Present
Apptis 2006 - 2007
Color Me Mine 2005 - 2007
CGI June 2004 - August 2006
NASA June 2003 - August 2003
Aradigm Corporation 1999 - 2001
Skills
Associate
Education
The Johns Hopkins University 2007 — 2010
MS
University of Virginia 2001 — 2004
BS
Natasha S. Chee's Aradigm Corporation Experience 2000 - 2001
Job IP, Entertainment Law, General Litigation, Criminal Defense Attorney
Industry Law Practice
Experience
Walsh Law Firm 2007 - 2011
Ramsey Law Group 2007 - 2011
Fiprovex September 2010 - September 2010
Tutor 2003 - 2007
Bay Area Air Quality Management District May 2004 - August 2004
Cerus 2002 - 2002
Motorola Life Sciences 2001 - 2001
Aradigm Corporation 2000 - 2001
Skills
Intellectual Property, Legal Writing, Entertainment Law, Entertainment Licensing, Litigation, Legal Research, Negotiation, Copyright Law, Litigation Research, Document Drafting, Litigation Preparation, Civil Litigation, Drafting and Reviewing..., Criminal Law, Criminal Defense, Patents, Courts, Trademarks, Corporate Law
Education
Santa Clara University School of Law 2002 — 2005
Doctor of Law (J.D.), High Technology Law Certificate
University of California, Los Angeles 1996 — 1999
Bachelor of Science, Biochemistry, French
Walsh Law Firm 2007 - 2011
Ramsey Law Group 2007 - 2011
Fiprovex September 2010 - September 2010
Tutor 2003 - 2007
Bay Area Air Quality Management District May 2004 - August 2004
Cerus 2002 - 2002
Motorola Life Sciences 2001 - 2001
Aradigm Corporation 2000 - 2001
Skills
Intellectual Property, Legal Writing, Entertainment Law, Entertainment Licensing, Litigation, Legal Research, Negotiation, Copyright Law, Litigation Research, Document Drafting, Litigation Preparation, Civil Litigation, Drafting and Reviewing..., Criminal Law, Criminal Defense, Patents, Courts, Trademarks, Corporate Law
Education
Santa Clara University School of Law 2002 — 2005
Doctor of Law (J.D.), High Technology Law Certificate
University of California, Los Angeles 1996 — 1999
Bachelor of Science, Biochemistry, French
Chris Bonny's Aradigm Corporation Experience June 2005 - July 2006
Job Executive Director, Commercial Business Development at Roxane Laboratories, Inc.
Industry Pharmaceuticals
Experience
Roxane Laboratories, Inc. July 2014 - Present
Baxter International Inc. February 2013 - July 2014
Baxter Healthcare July 2009 - February 2013
Avaan Therapeutics March 2008 - February 2009
MGI PHARMA, Inc. June 2006 - February 2008
Aradigm Corporation June 2005 - July 2006
RxKinetix, Inc. August 2000 - June 2004
Skills
Biopharmaceuticals, Market Research, Team Management, Strategy, Biotechnology, Drug Discovery, Clinical Development, Pharmaceutical Industry, Product Launch, Drug Development, Business Development, Negotiation, Oncology, Cross-functional Team..., Regulatory Affairs, Lifesciences, Commercialization, Portfolio Management, Technology Transfer, Medical Devices
Education
University of Colorado at Boulder - Leeds School of Business 2003 — 2005
MBA, Business Administration and Management, General
Trinity College-Hartford 1992 — 1996
BS, Neuroscience
Roxane Laboratories, Inc. July 2014 - Present
Baxter International Inc. February 2013 - July 2014
Baxter Healthcare July 2009 - February 2013
Avaan Therapeutics March 2008 - February 2009
MGI PHARMA, Inc. June 2006 - February 2008
Aradigm Corporation June 2005 - July 2006
RxKinetix, Inc. August 2000 - June 2004
Skills
Biopharmaceuticals, Market Research, Team Management, Strategy, Biotechnology, Drug Discovery, Clinical Development, Pharmaceutical Industry, Product Launch, Drug Development, Business Development, Negotiation, Oncology, Cross-functional Team..., Regulatory Affairs, Lifesciences, Commercialization, Portfolio Management, Technology Transfer, Medical Devices
Education
University of Colorado at Boulder - Leeds School of Business 2003 — 2005
MBA, Business Administration and Management, General
Trinity College-Hartford 1992 — 1996
BS, Neuroscience
Bob Reed's Aradigm Corporation Experience April 2015 - Present
Job Vice President, Regulatory CMC & Quality at Aradigm Corporation
Industry Pharmaceuticals
Experience
Aradigm Corporation April 2015 - Present
Celsion Corporation March 2014 - April 2015
Celsion Corporation March 2011 - June 2014
Celsion Corporation May 2009 - March 2011
XenoPort, Inc. May 2006 - April 2009
Merck November 1993 - October 2005
The Liposome Company 1991 - 1993
Skills
GMP, EMEA, FDA, Technology Transfer, Stability Studies, Specifications, Biotechnology, Product Development, Strategy, Regulatory Submissions, Analytical Chemistry, Clinical Trials, CMC, Drug Development, Pharmaceutical Industry, Organic Chemistry, IND, Pharmaceutics, SOP
Education
Princeton University 1987 — 1990
Post-Doc, Time-Resolved Spectroscopy
University of North Carolina at Chapel Hill 1982 — 1987
Doctor of Philosophy (Ph.D.), Chemistry
Eastern Nazarene College 1978 — 1982
B.S., Chemistry
Aradigm Corporation April 2015 - Present
Celsion Corporation March 2014 - April 2015
Celsion Corporation March 2011 - June 2014
Celsion Corporation May 2009 - March 2011
XenoPort, Inc. May 2006 - April 2009
Merck November 1993 - October 2005
The Liposome Company 1991 - 1993
Skills
GMP, EMEA, FDA, Technology Transfer, Stability Studies, Specifications, Biotechnology, Product Development, Strategy, Regulatory Submissions, Analytical Chemistry, Clinical Trials, CMC, Drug Development, Pharmaceutical Industry, Organic Chemistry, IND, Pharmaceutics, SOP
Education
Princeton University 1987 — 1990
Post-Doc, Time-Resolved Spectroscopy
University of North Carolina at Chapel Hill 1982 — 1987
Doctor of Philosophy (Ph.D.), Chemistry
Eastern Nazarene College 1978 — 1982
B.S., Chemistry
Neeraj Pakala's Aradigm Corporation Experience 1998 - 2001
Job Executive Director, Manufacturing and Engineering at Alexza Pharmaceuticals
Industry Pharmaceuticals
Experience
Alexza Pharmaceuticals March 2015 - Present
Alexza Pharmaceuticals June 2014 - March 2015
Alexza Pharmaceuticals July 2012 - June 2014
Alexza Pharmaceuticals, Inc November 2010 - July 2012
Alexza Pharmaceuticals, Inc February 2010 - October 2010
NanoGram Corporation February 2008 - January 2010
Nektar Therapeutics September 2002 - 2008
Aradigm Corporation 1998 - 2001
Skills
Product Development, Medical Devices, Biotechnology, Six Sigma, GMP, FDA, Quality System, Cross-functional Team..., Pharmaceutical Industry, Lean Manufacturing, Manufacturing, Process Improvement, R&D, V&V, Validation, Process Simulation, Supply Chain, Leadership, Supply Chain Management, Regulatory Submissions, Vendor Management, Start-ups, Technology Transfer
Education
San Jose State University - Lucas Business School 2014 — 2016
Master of Business Administration (M.B.A.), Business Administration and Management, General
University of Toledo
Ph.D., Engineering Science
Indian Institute of Technology, Kanpur
MS, Chemical Engineering
Sri Venkateswara University
BS, Chemical Engineering
Alexza Pharmaceuticals March 2015 - Present
Alexza Pharmaceuticals June 2014 - March 2015
Alexza Pharmaceuticals July 2012 - June 2014
Alexza Pharmaceuticals, Inc November 2010 - July 2012
Alexza Pharmaceuticals, Inc February 2010 - October 2010
NanoGram Corporation February 2008 - January 2010
Nektar Therapeutics September 2002 - 2008
Aradigm Corporation 1998 - 2001
Skills
Product Development, Medical Devices, Biotechnology, Six Sigma, GMP, FDA, Quality System, Cross-functional Team..., Pharmaceutical Industry, Lean Manufacturing, Manufacturing, Process Improvement, R&D, V&V, Validation, Process Simulation, Supply Chain, Leadership, Supply Chain Management, Regulatory Submissions, Vendor Management, Start-ups, Technology Transfer
Education
San Jose State University - Lucas Business School 2014 — 2016
Master of Business Administration (M.B.A.), Business Administration and Management, General
University of Toledo
Ph.D., Engineering Science
Indian Institute of Technology, Kanpur
MS, Chemical Engineering
Sri Venkateswara University
BS, Chemical Engineering
Wade Liggett's Aradigm Corporation Experience 2001 - 2001
Job Production Supervisor at Penumbra, Inc
Industry Medical Devices
Experience
Penumbra, Inc. August 2015 - Present
Consulting at Accarent Inc April 2015 - August 2015
CooperVision September 2014 - March 2015
Alexza Pharmaceuticals April 2013 - August 2014
Boston Scientific January 2008 - March 2013
Alza (a subsidiary of Johnson and Johnson) 2003 - 2007
Aradigm Corporation 2001 - 2001
Chiron (formerly Ciba Corning Diagnostics Corp.), 1994 - February 1998
Ciba Corning Diagnostics 1992 - 1994
Skills
V&V, Continuous Improvement, ISO 13485, Sop, Medical Devices, Six Sigma, Lean Manufacturing, Design of Experiments, FDA, DMAIC, Root Cause Analysis, Manufacturing, Design Control, Cross-functional Team..., Pharmaceutical Industry, Minitab, CAPA, Change Control, Process Improvement, Quality System, Validation, FMEA, Technology Transfer, GMP, Quality Assurance, Process Simulation, Aseptic Processing, SPC, Process Engineering, 21 CFR Part 11, ISO 14971, Quality Control, ISO, Quality Auditing, R&D, Supplier Quality, Value Stream Mapping, Process Capability, Manufacturing..., Calibration, Quality Management, Gage R&R, GLP, 5S, Manufacturing Operations, Kaizen, Manufacturing..., Cleaning Validation, Design for Manufacturing, Contract Manufacturing
Education
San Jose State University 1979 — 1983
BS Aeronautics Operations
San Jose State University 1979 — 1982
Bachelor of Science (BS), Aeronautics Operations
Penumbra, Inc. August 2015 - Present
Consulting at Accarent Inc April 2015 - August 2015
CooperVision September 2014 - March 2015
Alexza Pharmaceuticals April 2013 - August 2014
Boston Scientific January 2008 - March 2013
Alza (a subsidiary of Johnson and Johnson) 2003 - 2007
Aradigm Corporation 2001 - 2001
Chiron (formerly Ciba Corning Diagnostics Corp.), 1994 - February 1998
Ciba Corning Diagnostics 1992 - 1994
Skills
V&V, Continuous Improvement, ISO 13485, Sop, Medical Devices, Six Sigma, Lean Manufacturing, Design of Experiments, FDA, DMAIC, Root Cause Analysis, Manufacturing, Design Control, Cross-functional Team..., Pharmaceutical Industry, Minitab, CAPA, Change Control, Process Improvement, Quality System, Validation, FMEA, Technology Transfer, GMP, Quality Assurance, Process Simulation, Aseptic Processing, SPC, Process Engineering, 21 CFR Part 11, ISO 14971, Quality Control, ISO, Quality Auditing, R&D, Supplier Quality, Value Stream Mapping, Process Capability, Manufacturing..., Calibration, Quality Management, Gage R&R, GLP, 5S, Manufacturing Operations, Kaizen, Manufacturing..., Cleaning Validation, Design for Manufacturing, Contract Manufacturing
Education
San Jose State University 1979 — 1983
BS Aeronautics Operations
San Jose State University 1979 — 1982
Bachelor of Science (BS), Aeronautics Operations
Shiksha Jain's Aradigm Corporation Experience 2000 - 2003
Job Associate Scientist I at Gilead Sciences
Industry Pharmaceuticals
Experience
Gilead Sciences September 2003 - Present
aradigm 2001 - 2003
aradigm corporation 2000 - 2003
Education
Aligarh Muslim University 1988 — 1999
Gilead Sciences September 2003 - Present
aradigm 2001 - 2003
aradigm corporation 2000 - 2003
Education
Aligarh Muslim University 1988 — 1999
Michael Abraham's Aradigm Corporation Experience March 2000 - January 2001
Job Senior Director Global Quality Assurance "GxP" at Astex Pharmaceuticals
Industry Pharmaceuticals
Experience
Astex Pharmaceuticals Inc, An Otsuka Company.. April 2014 - Present
Astex Pharmaceuticals-OTSUKA Pharmaceuticals(Wholly own subs of Otsuka Pharmaceuticals Co.,Ltd.) October 2013 - Present
Astex Pharmaceuticals September 2011 - October 2013
Supergen, Inc November 2006 - September 2011
SuperGen January 2001 - November 2006
Aradigm Corporation March 2000 - January 2001
BD February 1999 - March 2000
Genentech September 1997 - October 1998
ALZA Corporation April 1994 - September 1997
Skills
Validation, CAPA, FDA, GxP, Biotechnology, Quality Assurance, V&V, Quality System, Computer System..., GMP, 21 CFR Part 11, IND, Quality Control, Clinical Development, Change Control, CRO, Cleaning Validation, GLP, GCP, Regulatory Affairs, Quality Management, Biopharmaceuticals, cGMP, Auditing, Technology Transfer, Regulatory Submissions, CTMS, Process Validation, Document Management, EDC, Pharmaceuticals, Quality Systems, Quality Auditing, ISO 13485, LIMS, Validations, GAMP, Clinical Trials, Regulatory Requirements, ISO, CMC, Data Center, Electronics, PLC, Analytical Chemistry, QC, Process Development, HPLC, EU Annex- 11, IT Infrastucture...
Education
San Jose State University 1988 — 1992
Bachelor of Science (BS), Industrial Technology, Quality Assurance, and Computer Electronics Minor-Business
San Jose State University
Astex Pharmaceuticals Inc, An Otsuka Company.. April 2014 - Present
Astex Pharmaceuticals-OTSUKA Pharmaceuticals(Wholly own subs of Otsuka Pharmaceuticals Co.,Ltd.) October 2013 - Present
Astex Pharmaceuticals September 2011 - October 2013
Supergen, Inc November 2006 - September 2011
SuperGen January 2001 - November 2006
Aradigm Corporation March 2000 - January 2001
BD February 1999 - March 2000
Genentech September 1997 - October 1998
ALZA Corporation April 1994 - September 1997
Skills
Validation, CAPA, FDA, GxP, Biotechnology, Quality Assurance, V&V, Quality System, Computer System..., GMP, 21 CFR Part 11, IND, Quality Control, Clinical Development, Change Control, CRO, Cleaning Validation, GLP, GCP, Regulatory Affairs, Quality Management, Biopharmaceuticals, cGMP, Auditing, Technology Transfer, Regulatory Submissions, CTMS, Process Validation, Document Management, EDC, Pharmaceuticals, Quality Systems, Quality Auditing, ISO 13485, LIMS, Validations, GAMP, Clinical Trials, Regulatory Requirements, ISO, CMC, Data Center, Electronics, PLC, Analytical Chemistry, QC, Process Development, HPLC, EU Annex- 11, IT Infrastucture...
Education
San Jose State University 1988 — 1992
Bachelor of Science (BS), Industrial Technology, Quality Assurance, and Computer Electronics Minor-Business
San Jose State University
Aimee Olivares's Aradigm Corporation Experience July 2002 - December 2004
Job QC Applications Specialist at BioMarin
Industry Pharmaceuticals
Experience
BioMarin May 2013 - Present
Mylan Specialty January 2013 - May 2013
Mylan Specialty (F/K/A Dey Pharma) September 2011 - May 2013
Dey, L.P. December 2004 - September 2011
Aradigm Corporation July 2002 - December 2004
Pharmacyclics July 1998 - July 2002
Skills
Regulations, Validation, FDA, GMP, Sop, CAPA, Quality System, LIMS, Change Control, Pharmaceutical Industry, HPLC, Chromatography, Quality Control, 21 CFR Part 11, Trackwise, Quality Assurance
Education
California State University-Hayward
Bachelor of Science (B.S.), Physical Science
BioMarin May 2013 - Present
Mylan Specialty January 2013 - May 2013
Mylan Specialty (F/K/A Dey Pharma) September 2011 - May 2013
Dey, L.P. December 2004 - September 2011
Aradigm Corporation July 2002 - December 2004
Pharmacyclics July 1998 - July 2002
Skills
Regulations, Validation, FDA, GMP, Sop, CAPA, Quality System, LIMS, Change Control, Pharmaceutical Industry, HPLC, Chromatography, Quality Control, 21 CFR Part 11, Trackwise, Quality Assurance
Education
California State University-Hayward
Bachelor of Science (B.S.), Physical Science
Ervin Yabut's Aradigm Corporation Experience 2000 - 2001
Job IT Quality Engineering Manager at Gilead Sciences
Industry Biotechnology
Experience
Gilead Sciences January 2014 - Present
Onyx pharmaceuticals April 2013 - January 2014
Onyx pharmaceuticals April 2012 - April 2013
PRO Unlimited October 2010 - April 2012
Genentech 2008 - 2010
Genentech 2007 - 2008
Genentech 2005 - 2007
Xoma October 2002 - May 2005
Affymetrix April 2001 - October 2002
Aradigm Corporation 2000 - 2001
Skills
Validation, GMP, Software Documentation, Process Improvement, Quality Assurance, SDLC, Quality System, GLP, Sop
Education
California State University-East Bay 1993 — 1998
BS, Biology
Gilead Sciences January 2014 - Present
Onyx pharmaceuticals April 2013 - January 2014
Onyx pharmaceuticals April 2012 - April 2013
PRO Unlimited October 2010 - April 2012
Genentech 2008 - 2010
Genentech 2007 - 2008
Genentech 2005 - 2007
Xoma October 2002 - May 2005
Affymetrix April 2001 - October 2002
Aradigm Corporation 2000 - 2001
Skills
Validation, GMP, Software Documentation, Process Improvement, Quality Assurance, SDLC, Quality System, GLP, Sop
Education
California State University-East Bay 1993 — 1998
BS, Biology
Max Fiore's Aradigm Corporation Experience 1994 - 2003
Job Chief Development and Operations Officer at NxThera
Industry Medical Devices
Experience
NxThera February 2015 - Present
The Fiore Group March 2013 - Present
American Medical Systems August 2009 - February 2013
OmniSonics Medical Technologies August 2005 - February 2009
Smith and Nephew Endoscopy 2003 - 2005
Aradigm Corporation 1994 - 2003
LifeScan 1990 - 1994
Abbott Diagnostics February 1988 - January 1991
Abbott Diagnostics January 1985 - February 1988
Abbott Diagnostics February 1982 - January 1985
Skills
Ultrasound, Corporate Governance, Medical Devices, R&D, Product Development, Diagnostics, Engineering, Start-ups, Drug Delivery, FDA, Strategic Planning, Manufacturing, Design Control, Biotechnology, Mergers, Cross-functional Team..., Healthcare, Team Building, Budgeting, Team Leadership, Research, New Business Development, Life Sciences, Change Management, Intellectual Property, Clinical Trials, Executive Networking, Executive Management, Board Search, Board of Directors, C-Level Negotiation, Design of Experiments, Product Launch, Lifesciences, Capital Equipment, Regulatory Affairs, Hardware Diagnostics, ISO 14971, Process Improvement, Medical Device R&D, GMP, Management, Biomaterials, Budgets, Surgery, Project Management, Technology Transfer, Leadership, Cardiology, Lean Manufacturing
Education
University of Wisconsin-Madison 1978 — 1980
MSEE, Biomedical instrumentation
Northwestern University 1973 — 1977
BSEE; BSEngr, Electrical and Electronics Engineering and Biomedical Engineering
NxThera February 2015 - Present
The Fiore Group March 2013 - Present
American Medical Systems August 2009 - February 2013
OmniSonics Medical Technologies August 2005 - February 2009
Smith and Nephew Endoscopy 2003 - 2005
Aradigm Corporation 1994 - 2003
LifeScan 1990 - 1994
Abbott Diagnostics February 1988 - January 1991
Abbott Diagnostics January 1985 - February 1988
Abbott Diagnostics February 1982 - January 1985
Skills
Ultrasound, Corporate Governance, Medical Devices, R&D, Product Development, Diagnostics, Engineering, Start-ups, Drug Delivery, FDA, Strategic Planning, Manufacturing, Design Control, Biotechnology, Mergers, Cross-functional Team..., Healthcare, Team Building, Budgeting, Team Leadership, Research, New Business Development, Life Sciences, Change Management, Intellectual Property, Clinical Trials, Executive Networking, Executive Management, Board Search, Board of Directors, C-Level Negotiation, Design of Experiments, Product Launch, Lifesciences, Capital Equipment, Regulatory Affairs, Hardware Diagnostics, ISO 14971, Process Improvement, Medical Device R&D, GMP, Management, Biomaterials, Budgets, Surgery, Project Management, Technology Transfer, Leadership, Cardiology, Lean Manufacturing
Education
University of Wisconsin-Madison 1978 — 1980
MSEE, Biomedical instrumentation
Northwestern University 1973 — 1977
BSEE; BSEngr, Electrical and Electronics Engineering and Biomedical Engineering
Peter Noymer's Aradigm Corporation Experience 1999 - 2006
Job EVP of R&D and CTO at SteadyMed Therapeutics
Industry Pharmaceuticals
Experience
Los Gatos Union School District 2014 - Present
SteadyMed Therapeutics 2013 - Present
Alexza Pharmaceuticals 2006 - 2013
Aradigm Corporation 1999 - 2006
Carnegie Mellon University 1997 - 1999
GE 1988 - 1993
Skills
Pharmaceutical Industry, Medical Devices, Combination Products, Executive Management, R&D, Product Development, Cross-functional Team..., GMP, Quality System, Clinical Development, Clinical Trials, Drug Delivery, Validation, Product Management, Clinical Research, Biopharmaceuticals, Lifesciences, Leadership, FDA, Biotechnology, Regulatory Submissions, V&V, Design Control, Strategy, Commercialization, ISO 13485, Technology Transfer, Change Control, 21 CFR Part 11, Regulatory Affairs, Sop, Pharmaceutics, GLP
Education
Massachusetts Institute of Technology 1993 — 1997
MS & PhD, Mechanical Engineering
Princeton University 1984 — 1988
BSE, Mechanical & Aerospace Engineering
Marblehead High School
Los Gatos Union School District 2014 - Present
SteadyMed Therapeutics 2013 - Present
Alexza Pharmaceuticals 2006 - 2013
Aradigm Corporation 1999 - 2006
Carnegie Mellon University 1997 - 1999
GE 1988 - 1993
Skills
Pharmaceutical Industry, Medical Devices, Combination Products, Executive Management, R&D, Product Development, Cross-functional Team..., GMP, Quality System, Clinical Development, Clinical Trials, Drug Delivery, Validation, Product Management, Clinical Research, Biopharmaceuticals, Lifesciences, Leadership, FDA, Biotechnology, Regulatory Submissions, V&V, Design Control, Strategy, Commercialization, ISO 13485, Technology Transfer, Change Control, 21 CFR Part 11, Regulatory Affairs, Sop, Pharmaceutics, GLP
Education
Massachusetts Institute of Technology 1993 — 1997
MS & PhD, Mechanical Engineering
Princeton University 1984 — 1988
BSE, Mechanical & Aerospace Engineering
Marblehead High School
Jennifer Szonye's Aradigm Corporation Experience May 2004 - June 2004
Job QA & Document Services Specialist at Ariosa Diagnostics
Industry Medical Devices
Experience
Ariosa Diagnostics July 2011 - Present
Crescendo Bioscience June 2010 - July 2011
Various Diagnostic Companies March 2009 - June 2010
Aviir, Inc. June 2008 - March 2009
HemoSense June 2006 - June 2008
SurgRx April 2005 - June 2006
Boston Scientific November 2004 - April 2005
Natus Medical September 2003 - August 2004
Aradigm Corporation May 2004 - June 2004
Phaton August 2003 - August 2003
Skills
FDA, Quality Assurance, Document Management, ISO, ISO 13485, Medical Devices, Quality Control, Change Control, CAPA, Validation
Education
University of Phoenix 2005 — 2007
BS
De Anza College 2001 — 2004
AA
Copper Connection 2000 — 2000
Certificate
Batavia School of Drafting 1996 — 1997
Certificate
Ariosa Diagnostics July 2011 - Present
Crescendo Bioscience June 2010 - July 2011
Various Diagnostic Companies March 2009 - June 2010
Aviir, Inc. June 2008 - March 2009
HemoSense June 2006 - June 2008
SurgRx April 2005 - June 2006
Boston Scientific November 2004 - April 2005
Natus Medical September 2003 - August 2004
Aradigm Corporation May 2004 - June 2004
Phaton August 2003 - August 2003
Skills
FDA, Quality Assurance, Document Management, ISO, ISO 13485, Medical Devices, Quality Control, Change Control, CAPA, Validation
Education
University of Phoenix 2005 — 2007
BS
De Anza College 2001 — 2004
AA
Copper Connection 2000 — 2000
Certificate
Batavia School of Drafting 1996 — 1997
Certificate
Sandra Harris's Aradigm Corporation Experience 1997 - 2004
Job Associate Director, Quality Systems
Industry Biotechnology
Experience
Gilead Sciences April 2009 - Present
CV Therapeutics 2007 - 2009
Genitope Corporation 2004 - 2007
Aradigm Corporation 1997 - 2004
Skills
Validation, FDA, Quality Systems, Quality Assurance, cGMP, Computer System..., 21 CFR Part 11, Risk Management, Quality System, Analytical Chemistry, Aseptic Processing, Biopharmaceuticals, Biotechnology, Cleaning Validation, Clinical Trials, Cross-functional Team..., Design Control, CAPA, Change Control, Drug Development, FDA GMP, GAMP, GLP, GCP, GMP, GxP, IND, HPLC, Lifesciences, ISO 13485, Pharmaceutical Industry, Quality Auditing, Quality Management, Regulatory Affairs, Medical Devices, Regulatory Requirements, Regulatory Submissions, SOP, LIMS, Technology Transfer, V, Sop
Education
California State University-East Bay
Gilead Sciences April 2009 - Present
CV Therapeutics 2007 - 2009
Genitope Corporation 2004 - 2007
Aradigm Corporation 1997 - 2004
Skills
Validation, FDA, Quality Systems, Quality Assurance, cGMP, Computer System..., 21 CFR Part 11, Risk Management, Quality System, Analytical Chemistry, Aseptic Processing, Biopharmaceuticals, Biotechnology, Cleaning Validation, Clinical Trials, Cross-functional Team..., Design Control, CAPA, Change Control, Drug Development, FDA GMP, GAMP, GLP, GCP, GMP, GxP, IND, HPLC, Lifesciences, ISO 13485, Pharmaceutical Industry, Quality Auditing, Quality Management, Regulatory Affairs, Medical Devices, Regulatory Requirements, Regulatory Submissions, SOP, LIMS, Technology Transfer, V, Sop
Education
California State University-East Bay
Steve Nierlich's Aradigm Corporation Experience 2001 - 2005
Job Senior Project Engineer at Rainin Instrument LLC
Industry Pharmaceuticals
Experience
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
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
Linh Pressman's Aradigm Corporation Experience 2002 - 2005
Job Pharmaceuticals Professional
Industry Pharmaceuticals
Experience
Bayer Pharmaceuticals May 2008 - June 2009
Novo Nordisk Delivery Technologies June 2007 - February 2008
Novo Nordisk Delivery Technologies April 2002 - June 2007
Aradigm Corporation 2002 - 2005
Inamed December 2000 - April 2002
Education
University of California, Los Angeles 1991 — 1996
Bayer Pharmaceuticals May 2008 - June 2009
Novo Nordisk Delivery Technologies June 2007 - February 2008
Novo Nordisk Delivery Technologies April 2002 - June 2007
Aradigm Corporation 2002 - 2005
Inamed December 2000 - April 2002
Education
University of California, Los Angeles 1991 — 1996
Annie Howe's Aradigm Corporation Experience 2001 - 2004
Job QA Associate at BioMarin
Industry Biotechnology
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
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
Chuck Franzino's Aradigm Corporation Experience March 2001 - July 2003
Job Sr. Mfg. Supervisor at Proteus Digital Health, Inc
Industry Pharmaceuticals
Experience
Proteus Digital Health, Inc September 2012 - Present
Alexza Pharmaceuticals May 2008 - February 2011
Novo Nordisk Delivery Technologies May 2005 - February 2008
Aradigm Corporation March 2001 - July 2003
Skills
Aseptic Processing, CAPA, Change Control, Continuous Improvement, FDA, GMP, Lean Manufacturing, Manufacturing, Medical Devices, Quality Control, Quality System, Sop, Validation
Education
Evergreen Valley College 1985 — 1990
Proteus Digital Health, Inc September 2012 - Present
Alexza Pharmaceuticals May 2008 - February 2011
Novo Nordisk Delivery Technologies May 2005 - February 2008
Aradigm Corporation March 2001 - July 2003
Skills
Aseptic Processing, CAPA, Change Control, Continuous Improvement, FDA, GMP, Lean Manufacturing, Manufacturing, Medical Devices, Quality Control, Quality System, Sop, Validation
Education
Evergreen Valley College 1985 — 1990
Carlo Massucci's Aradigm Corporation Experience April 1998 - April 2005
Job Operations Manager at Kaiser Permanente
Industry Hospital & Health Care
Experience
Kaiser Permanente August 2008 - Present
Novo Nordisk April 2005 - July 2008
Aradigm Corporation April 1998 - April 2005
Boehringer Mannheim March 1997 - February 1998
McGaw Lab 1985 - 1992
Skills
Inventory Management, Packaging, Logistics, Warehousing, Supply Chain, Manufacturing, GMP, Team Building, Change Management, Mentoring, Troubleshooting, SOX, cGMP, Coaching, Organizational..., Biotechnology, Continuous Improvement, Materials, Start-ups, Customer Service, FDA, Cross-functional Team..., Contract Negotiation, Supply Chain Management, Leadership, Management, Process Improvement, Program Management, Strategic Planning, Employee Relations, Validation, Quality Assurance, Six Sigma, Recruiting, Software Documentation, Lean Manufacturing, Quality Management, Process Engineering, Operations Management, Business Process..., Vendor Management, Project Planning, Medical Devices, Quality System, Process Simulation
Education
Pierce College
Kaiser Permanente August 2008 - Present
Novo Nordisk April 2005 - July 2008
Aradigm Corporation April 1998 - April 2005
Boehringer Mannheim March 1997 - February 1998
McGaw Lab 1985 - 1992
Skills
Inventory Management, Packaging, Logistics, Warehousing, Supply Chain, Manufacturing, GMP, Team Building, Change Management, Mentoring, Troubleshooting, SOX, cGMP, Coaching, Organizational..., Biotechnology, Continuous Improvement, Materials, Start-ups, Customer Service, FDA, Cross-functional Team..., Contract Negotiation, Supply Chain Management, Leadership, Management, Process Improvement, Program Management, Strategic Planning, Employee Relations, Validation, Quality Assurance, Six Sigma, Recruiting, Software Documentation, Lean Manufacturing, Quality Management, Process Engineering, Operations Management, Business Process..., Vendor Management, Project Planning, Medical Devices, Quality System, Process Simulation
Education
Pierce College
Stephen Zimmermann's Aradigm Corporation Experience 2000 - 2003
Job Pharmaceutical / Biotechnology
Industry Pharmaceuticals
Experience
Novo Nordisk Delivery Technologies June 2005 - Present
Chiron Corporation 2004 - June 2005
Aradigm Corporation 2000 - 2003
Education
Ohlone College 1994 — 1997
Novo Nordisk Delivery Technologies June 2005 - Present
Chiron Corporation 2004 - June 2005
Aradigm Corporation 2000 - 2003
Education
Ohlone College 1994 — 1997
Robert Herman's Aradigm Corporation Experience March 1999 - December 2004
Job Scientist, Quality Control
Industry Pharmaceuticals
Experience
Novartis September 2014 - Present
Cobalt Technologies March 2013 - August 2014
Amyris Biotechnologies September 2008 - February 2013
Novo Nordisk Delivery Technologies January 2005 - February 2008
Aradigm Corporation March 1999 - December 2004
ALZA Corporation July 1998 - February 1999
Zeneca 1987 - 1997
Skills
Analytical Quality..., Chromatography, Chromeleon data system, Quality Control, Analytical Skills, Data, Dionex, Analytical Chemistry, GMP, HPLC, TOC, ELISA, UV/Vis, Validation, IR, JMP, CAPAs, OOS, Quality Investigations, High Throughput..., Gas Chromatography, Protocol Review, Biotechnology, Statistical Tools, LC-MS, GC-MS, Quality System, Technology Transfer, Laboratory, Sop, CAPA, V&V, Drug Delivery, Pharmaceutical Industry, R&D
Education
University of California, Santa Cruz
Chemistry
University of San Francisco
Novartis September 2014 - Present
Cobalt Technologies March 2013 - August 2014
Amyris Biotechnologies September 2008 - February 2013
Novo Nordisk Delivery Technologies January 2005 - February 2008
Aradigm Corporation March 1999 - December 2004
ALZA Corporation July 1998 - February 1999
Zeneca 1987 - 1997
Skills
Analytical Quality..., Chromatography, Chromeleon data system, Quality Control, Analytical Skills, Data, Dionex, Analytical Chemistry, GMP, HPLC, TOC, ELISA, UV/Vis, Validation, IR, JMP, CAPAs, OOS, Quality Investigations, High Throughput..., Gas Chromatography, Protocol Review, Biotechnology, Statistical Tools, LC-MS, GC-MS, Quality System, Technology Transfer, Laboratory, Sop, CAPA, V&V, Drug Delivery, Pharmaceutical Industry, R&D
Education
University of California, Santa Cruz
Chemistry
University of San Francisco
Scott Bean's Aradigm Corporation Experience June 2009 - September 2009
Job Director of Manufacturing Engineering at SteadyMed Therapeutics
Industry Medical Devices
Experience
SteadyMed Therapeutics August 2014 - Present
SOLON Corporation December 2013 - March 2014
SOLON Corporation June 2012 - April 2013
Thoratec December 2009 - January 2011
Aradigm Corporation June 2009 - September 2009
Aradigm Corporation July 2007 - June 2009
Novo Nordisk Delivery Technologies January 2005 - July 2007
Aradigm April 2000 - January 2005
Cholestech Corporation March 1998 - April 2000
LifeScan - Johnson and Johnson January 1994 - March 1998
Skills
Design Control, R&D, Manufacturing..., Product Development, Engineering, Finite Element Analysis, ISO 13485, Validation, V&V, Quality System, Manufacturing, Design of Experiments, Cross-functional Team..., Program Management, Medical Devices, Lean Manufacturing, Design for Manufacturing, FDA, Process Simulation, Automation, CAPA, FMEA, Process Improvement, Solidworks, Six Sigma, Mechanical Engineering, Injection Molding, Root Cause Analysis, SolidWorks, SPC, Process Automation
Education
University of California, Berkeley
B.S., Mechanical Engineering
SteadyMed Therapeutics August 2014 - Present
SOLON Corporation December 2013 - March 2014
SOLON Corporation June 2012 - April 2013
Thoratec December 2009 - January 2011
Aradigm Corporation June 2009 - September 2009
Aradigm Corporation July 2007 - June 2009
Novo Nordisk Delivery Technologies January 2005 - July 2007
Aradigm April 2000 - January 2005
Cholestech Corporation March 1998 - April 2000
LifeScan - Johnson and Johnson January 1994 - March 1998
Skills
Design Control, R&D, Manufacturing..., Product Development, Engineering, Finite Element Analysis, ISO 13485, Validation, V&V, Quality System, Manufacturing, Design of Experiments, Cross-functional Team..., Program Management, Medical Devices, Lean Manufacturing, Design for Manufacturing, FDA, Process Simulation, Automation, CAPA, FMEA, Process Improvement, Solidworks, Six Sigma, Mechanical Engineering, Injection Molding, Root Cause Analysis, SolidWorks, SPC, Process Automation
Education
University of California, Berkeley
B.S., Mechanical Engineering
Edith Maverick Folger's Aradigm Corporation Experience October 2000 - January 2004
Job Principal Software QA Engineer at Boston Scientific
Industry Biotechnology
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
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
Nick Trilokekar's Aradigm Corporation Experience December 2001 - February 2004
Job Senior Manager at Allergan Medical
Industry Medical Devices
Experience
Allergan Medical July 2008 - December 2013
Novo Nordisk Delivery Technologies February 2004 - June 2008
Aradigm Corporation December 2001 - February 2004
Radiance Medical Systems September 2000 - October 2001
Thoratec Corporation June 1998 - September 2000
Skills
R&D, Product Development, Supply Chain Management, Materials, Biomaterials, Leadership, Vendor Management, FDA, Medical Devices, Process Simulation, Validation, Biotechnology, V&V, Design Control, Pharmaceutical Industry, CAPA, GMP, ISO 13485, Sourcing, Drug Delivery
Education
Clemson University
Ph.D. Bioengineering
Allergan Medical July 2008 - December 2013
Novo Nordisk Delivery Technologies February 2004 - June 2008
Aradigm Corporation December 2001 - February 2004
Radiance Medical Systems September 2000 - October 2001
Thoratec Corporation June 1998 - September 2000
Skills
R&D, Product Development, Supply Chain Management, Materials, Biomaterials, Leadership, Vendor Management, FDA, Medical Devices, Process Simulation, Validation, Biotechnology, V&V, Design Control, Pharmaceutical Industry, CAPA, GMP, ISO 13485, Sourcing, Drug Delivery
Education
Clemson University
Ph.D. Bioengineering
Daisy Nguyen CPA's Aradigm Corporation Experience 2004 - 2005
Job Accounting Manager at Novo Nordisk Inc.
Industry Pharmaceuticals
Experience
Novo Nordisk Inc. August 2008 - Present
Novo Nordisk Delivery Technologies, Inc. January 2005 - July 2008
Aradigm Corporation 2004 - 2005
Education
Santa Clara University 1987 — 1991
Bachelor of Science, Finance
Santa Teresa H.S.
Novo Nordisk Inc. August 2008 - Present
Novo Nordisk Delivery Technologies, Inc. January 2005 - July 2008
Aradigm Corporation 2004 - 2005
Education
Santa Clara University 1987 — 1991
Bachelor of Science, Finance
Santa Teresa H.S.
Lorelei Mejia's Aradigm Corporation Experience 1999 - 2005
Job Quality Assurance
Industry Pharmaceuticals
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
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
Diana Le's Aradigm Corporation Experience 2008 - 2008
Job Associate Scientist I at Novo Nordisk Delivery Technologies
Industry Biotechnology
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.)
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.)
Antonio Cinco Jr's Aradigm Corporation Experience August 1999 - June 2009
Job Analytical Chemist
Industry Medical Devices
Experience
Aradigm Corporation August 1999 - June 2009
Education
San Francisco State University 1994 — 1999
Aradigm Corporation August 1999 - June 2009
Education
San Francisco State University 1994 — 1999
Beth Mallory-Russell's Aradigm Corporation Experience August 1998 - 2003
Job Laboratory Supervisor, Base Oil Analytical Unit at Chevron Corporation
Industry Oil & Energy
Experience
Chevron Corporation January 2009 - Present
Shape Products October 2008 - December 2008
Novo Nordisk Delivery Technologies September 2006 - May 2008
Aradigm Corporation August 1998 - 2003
Aradigm Corporation August 1998 - 2003
Skills
GMP, Validation, HPLC, Sop, Quality System, Process Improvement, Chromatography, UV/Vis, Quality Control, Project Management, Troubleshooting, SAP, Analytical Chemistry, Medical Devices, Biotechnology, Quality Assurance, R, SOP, FDA, Calibration, Process Simulation
Education
Bemidji State University
Bachelor's degree
Chevron Corporation January 2009 - Present
Shape Products October 2008 - December 2008
Novo Nordisk Delivery Technologies September 2006 - May 2008
Aradigm Corporation August 1998 - 2003
Aradigm Corporation August 1998 - 2003
Skills
GMP, Validation, HPLC, Sop, Quality System, Process Improvement, Chromatography, UV/Vis, Quality Control, Project Management, Troubleshooting, SAP, Analytical Chemistry, Medical Devices, Biotechnology, Quality Assurance, R, SOP, FDA, Calibration, Process Simulation
Education
Bemidji State University
Bachelor's degree
Kathi Holton's Aradigm Corporation Experience 2000 - 2008
Job Senior Buyer/Planner at Novo Nordisk Delivery Technologies
Industry Pharmaceuticals
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
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
Rendie Borje's Aradigm Corporation Experience June 2001 - January 2005
Job Quality Engineering Supervisor at Impax Laboratories
Industry Pharmaceuticals
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
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
Allen Lam's Aradigm Corporation Experience 1998 - 2005
Job Scientist at NNDT
Industry Pharmaceuticals
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
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
Alfred Khaleel's Aradigm Corporation Experience April 2001 - January 2005
Job Associate Scientist II at Novo Nordisk Delivery Technologies
Industry Pharmaceuticals
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
Novo Nordisk Delivery Technologies January 2005 - March 2008
Aradigm Corporation April 2001 - January 2005
Education
University of California, Davis 1995 — 1999
B.S., Biology
Mauri Okamoto-Kearney's Aradigm Corporation Experience 1998 - 2000
Job VP Development
Industry Biotechnology
Experience
Aeglea BioTherapeutics April 2015 - Present
Children's Global Health Initiative May 2012 - February 2013
KAI Pharmaceuticals, Inc. December 2003 - January 2011
Corgentech 2002 - 2003
Corgentech, Inc. 2000 - 2002
Aradigm Corporation 1998 - 2000
Genentech, Inc. 1991 - 1998
Skills
Leadership coaching, Organizational..., Biotechnology, Lifesciences, Technology Transfer, Pharmaceutical Industry, Clinical Development, Medical Devices, Clinical Trials, Oncology, Drug Development, FDA, Regulatory Affairs, Commercialization, Infectious Diseases, Biopharmaceuticals, Cross-functional Team..., Regulatory Submissions, Clinical Research, Immunology, Strategy, R&D, Product Development, Leadership Development, Leadership, Management, CTMS, Product Launch
Education
New York University - Leonard N. Stern School of Business 1986 — 1988
MBA, Marketing, Finance
Stanford University 1973 — 1977
Bachelor of Arts (BA), Human Biology
Punahou School 1969 — 1973
Aeglea BioTherapeutics April 2015 - Present
Children's Global Health Initiative May 2012 - February 2013
KAI Pharmaceuticals, Inc. December 2003 - January 2011
Corgentech 2002 - 2003
Corgentech, Inc. 2000 - 2002
Aradigm Corporation 1998 - 2000
Genentech, Inc. 1991 - 1998
Skills
Leadership coaching, Organizational..., Biotechnology, Lifesciences, Technology Transfer, Pharmaceutical Industry, Clinical Development, Medical Devices, Clinical Trials, Oncology, Drug Development, FDA, Regulatory Affairs, Commercialization, Infectious Diseases, Biopharmaceuticals, Cross-functional Team..., Regulatory Submissions, Clinical Research, Immunology, Strategy, R&D, Product Development, Leadership Development, Leadership, Management, CTMS, Product Launch
Education
New York University - Leonard N. Stern School of Business 1986 — 1988
MBA, Marketing, Finance
Stanford University 1973 — 1977
Bachelor of Arts (BA), Human Biology
Punahou School 1969 — 1973
Alicia Xu's Aradigm Corporation Experience 1997 - 2005
Job Pharmaceuticals Professional
Industry Pharmaceuticals
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
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
Guicheng Gracie Sheng's Aradigm Corporation Experience March 2000 - January 2004
Job Pharm Tech Development Quality
Industry Biotechnology
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.
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.
William Yartey (PMP)'s Aradigm Corporation Experience March 2003 - February 2005
Job Senior Consultant at EMC Corporation
Industry Information Technology and Services
Experience
EMC July 2013 - Present
IBM Global Services February 2005 - July 2013
IBM 2005 - July 2013
Amgen April 2009 - August 2010
Pfizer 2007 - 2008
Genentech 2005 - 2008
Novartis Vaccines and Diagnostics July 2007 - November 2007
Aradigm Corporation March 2003 - February 2005
BlackHawk Information Services, Inc. 2000 - 2003
Baxter February 1999 - May 2000
Skills
21 CFR Part 11, Computer System..., GxP, Validation, Change Control, Integration, SDLC, LIMS, Software Development, Project Management, Requirements Analysis, Biotechnology, Quality Assurance, Consulting, Management, MES, Business Analysis, Business Process, Program Management, IT Strategy
Education
University of San Francisco
MS, Information Systems
Kwame Nkrumah' University of Science and Technology, Kumasi
BS, Computer Science
EMC July 2013 - Present
IBM Global Services February 2005 - July 2013
IBM 2005 - July 2013
Amgen April 2009 - August 2010
Pfizer 2007 - 2008
Genentech 2005 - 2008
Novartis Vaccines and Diagnostics July 2007 - November 2007
Aradigm Corporation March 2003 - February 2005
BlackHawk Information Services, Inc. 2000 - 2003
Baxter February 1999 - May 2000
Skills
21 CFR Part 11, Computer System..., GxP, Validation, Change Control, Integration, SDLC, LIMS, Software Development, Project Management, Requirements Analysis, Biotechnology, Quality Assurance, Consulting, Management, MES, Business Analysis, Business Process, Program Management, IT Strategy
Education
University of San Francisco
MS, Information Systems
Kwame Nkrumah' University of Science and Technology, Kumasi
BS, Computer Science
Laurel Wellington's Aradigm Corporation Experience 1998 - 2005
Job at Ariat International
Industry Executive Office
Experience
Ariat International, Inc. December 2010 - June 2011
Novo Nordisk Delivery Technologies July 2005 - February 2008
Novo Nordisk Delivery Technologies (NNDT) 2005 - 2008
Aradigm Corporation 1998 - 2005
Nellcor June 1991 - July 1998
Wells Fargo Leasing Corporation 1978 - 1990
Skills
Advanced level of..., FDA, Program Management, Sop, GMP, Validation, Software Documentation, Pharmaceutical Industry, Outlook, Administrative..., Project Management, Quality Assurance
Education
University of Cincinnati 1968 — 1969
Ariat International, Inc. December 2010 - June 2011
Novo Nordisk Delivery Technologies July 2005 - February 2008
Novo Nordisk Delivery Technologies (NNDT) 2005 - 2008
Aradigm Corporation 1998 - 2005
Nellcor June 1991 - July 1998
Wells Fargo Leasing Corporation 1978 - 1990
Skills
Advanced level of..., FDA, Program Management, Sop, GMP, Validation, Software Documentation, Pharmaceutical Industry, Outlook, Administrative..., Project Management, Quality Assurance
Education
University of Cincinnati 1968 — 1969
Nancy Hillis's Aradigm Corporation Experience 1999 - 2006
Job Mgr, Admin Services at Zogenix
Industry Biotechnology
Experience
Zogenix September 2006 - Present
Aradigm Corporation 1999 - 2006
Skills
Pharmaceutical Industry, Biotechnology, FDA, Life Sciences, Medical Devices, GMP, Validation, Clinical Trials, Management, Cross-functional Team..., Clinical Development, Meeting and Event...
Education
California State University-East Bay 1973 — 1975
Bachelor’s Degree
Zogenix September 2006 - Present
Aradigm Corporation 1999 - 2006
Skills
Pharmaceutical Industry, Biotechnology, FDA, Life Sciences, Medical Devices, GMP, Validation, Clinical Trials, Management, Cross-functional Team..., Clinical Development, Meeting and Event...
Education
California State University-East Bay 1973 — 1975
Bachelor’s Degree
Francis Jacinto's Aradigm Corporation Experience June 2008 - February 2009
Job Scientist at Pearl Therapeutics
Industry Biotechnology
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
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
Huiying Wu's Aradigm Corporation Experience August 1999 - Present
Job Scientist at Aradigm Corporation
Industry Pharmaceuticals
Experience
Aradigm Corporation August 1999 - Present
Skills
HPLC, Biotechnology, Validation, GMP, GLP, Chromatography
Education
University of California, Berkeley
B.A.
Aradigm Corporation August 1999 - Present
Skills
HPLC, Biotechnology, Validation, GMP, GLP, Chromatography
Education
University of California, Berkeley
B.A.
L Francisco's Aradigm Corporation Experience January 2001 - December 2002
Job Staff Engineer @ Siluria Technologies
Industry Research
Experience
Siluria Technologies, Inc. December 2010 - Present
Kateeva, Inc October 2009 - November 2010
Kovio March 2003 - January 2010
Aradigm Corporation January 2001 - December 2002
Skills
Nanomaterials, Nanotechnology, Thin Films, Semiconductors, Materials Science, R&D, Design of Experiments, Failure Analysis
Education
The University of New Mexico 1994 — 1999
Siluria Technologies, Inc. December 2010 - Present
Kateeva, Inc October 2009 - November 2010
Kovio March 2003 - January 2010
Aradigm Corporation January 2001 - December 2002
Skills
Nanomaterials, Nanotechnology, Thin Films, Semiconductors, Materials Science, R&D, Design of Experiments, Failure Analysis
Education
The University of New Mexico 1994 — 1999
Elizabeth (Lisa) Erdos's Aradigm Corporation Experience 1997 - 2005
Job Master Gardener
Industry Farming
Experience
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
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
Ankita Chitre's Aradigm Corporation Experience 2001 - 2004
Job Director, Quality Operations Genentech/Roche
Industry Pharmaceuticals
Experience
Genentech August 2015 - Present
Genentech June 2013 - Present
Gilead Sciences January 2009 - June 2013
Cell Genesys, Inc January 2006 - November 2008
Nektar Therapeutics 2004 - 2006
Aradigm Corporation 2001 - 2004
Abbott Laboratories 1992 - 2001
University of Chicago 1991 - 1992
Skills
Sop, Quality System, Quality Control, Medical Devices, Quality Management, Clinical Trials, Drug Development, Manufacturing, Process Improvement, R&D, Program Management, Cell, Project Management, Clinical Research, CAPA, FDA, Biopharmaceuticals, Biotechnology, Change Control, GLP, Cell Culture
Education
DePaul University 1989 — 1991
MS, BioPharmaceuticals
University of Mumbai 1986 — 1988
Master Of Science, Immunology
University of Mumbai 1982 — 1985
Bachelor Of Science, Microbiology
Genentech August 2015 - Present
Genentech June 2013 - Present
Gilead Sciences January 2009 - June 2013
Cell Genesys, Inc January 2006 - November 2008
Nektar Therapeutics 2004 - 2006
Aradigm Corporation 2001 - 2004
Abbott Laboratories 1992 - 2001
University of Chicago 1991 - 1992
Skills
Sop, Quality System, Quality Control, Medical Devices, Quality Management, Clinical Trials, Drug Development, Manufacturing, Process Improvement, R&D, Program Management, Cell, Project Management, Clinical Research, CAPA, FDA, Biopharmaceuticals, Biotechnology, Change Control, GLP, Cell Culture
Education
DePaul University 1989 — 1991
MS, BioPharmaceuticals
University of Mumbai 1986 — 1988
Master Of Science, Immunology
University of Mumbai 1982 — 1985
Bachelor Of Science, Microbiology
Tiffany Crowell's Aradigm Corporation Experience February 2001 - August 2003
Job Quality Compliance Specialist
Industry Information Technology and Services
Experience
Dell March 2013 - Present
Shire Regenerative Medicine (formerly Advanced BioHealing) June 2010 - January 2013
Sequenom January 2010 - June 2010
Hologic Gen-Probe May 2009 - February 2010
La Jolla Pharmaceutical Company September 2003 - April 2009
Aradigm Corporation February 2001 - August 2003
Skills
V&V, CAPA, GMP, Validation, Change Control, 21 CFR Part 11, FDA, Sop, Aseptic Processing, Quality System
Education
University of California, Los Angeles 1996 — 2000
Bachelor of Science (B.S.), Psychobiology
Dell March 2013 - Present
Shire Regenerative Medicine (formerly Advanced BioHealing) June 2010 - January 2013
Sequenom January 2010 - June 2010
Hologic Gen-Probe May 2009 - February 2010
La Jolla Pharmaceutical Company September 2003 - April 2009
Aradigm Corporation February 2001 - August 2003
Skills
V&V, CAPA, GMP, Validation, Change Control, 21 CFR Part 11, FDA, Sop, Aseptic Processing, Quality System
Education
University of California, Los Angeles 1996 — 2000
Bachelor of Science (B.S.), Psychobiology
Keerthini Manda's Aradigm Corporation Experience March 2005 - May 2006
Job Sr. Analytical Chemist at CooperVision
Industry Pharmaceuticals
Experience
CooperVision February 2012 - Present
Amyris Biotechnologies August 2007 - February 2012
Ilypsa, Inc. August 2006 - June 2007
Aradigm Corporation March 2005 - May 2006
Skills
Fermentation, Gas Chromatography, Analytical Chemistry, Organic Chemistry, HPLC, UV/Vis, NMR, Biotechnology, Laboratory, Cell, Validation, Assay Development, FTIR, Method Development, Lifesciences
Education
San Jose State University 2004 — 2007
MS, Analytical Chemistry
CooperVision February 2012 - Present
Amyris Biotechnologies August 2007 - February 2012
Ilypsa, Inc. August 2006 - June 2007
Aradigm Corporation March 2005 - May 2006
Skills
Fermentation, Gas Chromatography, Analytical Chemistry, Organic Chemistry, HPLC, UV/Vis, NMR, Biotechnology, Laboratory, Cell, Validation, Assay Development, FTIR, Method Development, Lifesciences
Education
San Jose State University 2004 — 2007
MS, Analytical Chemistry
Quyen Bao's Aradigm Corporation Experience September 2007 - November 2008
Job Reagent Chemist at Quidel
Industry Pharmaceuticals
Experience
Quidel 2009 - 2012
Aradigm Corporation September 2007 - November 2008
ALZA Corporation January 2007 - August 2007
ALZA Corporation June 2005 - January 2007
Skills
LIMS, CAPA, GMP, HPLC, Chromatography, Sop, Gas Chromatography, FDA, Validation, Formulation, Assay Development, Biotechnology, Clinical Development, Dissolution, GLP, Pharmaceutics
Education
University of California, Berkeley
B.S.
Quidel 2009 - 2012
Aradigm Corporation September 2007 - November 2008
ALZA Corporation January 2007 - August 2007
ALZA Corporation June 2005 - January 2007
Skills
LIMS, CAPA, GMP, HPLC, Chromatography, Sop, Gas Chromatography, FDA, Validation, Formulation, Assay Development, Biotechnology, Clinical Development, Dissolution, GLP, Pharmaceutics
Education
University of California, Berkeley
B.S.
Satyam Upadrashta's Aradigm Corporation Experience March 2005 - Present
Job Vice President, Regulatory Affairs & Quality at Aradigm Corporation
Industry Pharmaceuticals
Experience
Aradigm Corporation March 2005 - Present
Education
University of Iowa 1984 — 1988
Aradigm Corporation March 2005 - Present
Education
University of Iowa 1984 — 1988
Chris Tong's Aradigm Corporation Experience 2000 - 2002
Job Staff Project Engineer at CALCET
Industry Biotechnology
Experience
CALCET July 1998 - Present
Impax Laboratories 2005 - Present
Novo Nordisk A/S 2005 - 2006
Baxter Healthcare 2000 - 2006
Aradigm Corporation 2000 - 2002
Cell Genesys 2000 - 2001
Baxter Healthcare 1999 - 2000
Bayer 1998 - 2000
Bayer 1997 - 1998
Skills
V&V, Computer System..., Manufacturing, Validation, Biotechnology, CAPA, Change Control, GMP, Quality System, FDA, 21 CFR Part 11, Medical Devices, ISO 13485, GxP, Aseptic Processing, Technology Transfer, Sop, LIMS, GAMP, R&D, Cleaning Validation, Biopharmaceuticals
Education
Bellarmine College Preparatory 1986 — 1990
University of California, Berkeley
Bachelor of Science (BS), Chemical Engineering
CALCET July 1998 - Present
Impax Laboratories 2005 - Present
Novo Nordisk A/S 2005 - 2006
Baxter Healthcare 2000 - 2006
Aradigm Corporation 2000 - 2002
Cell Genesys 2000 - 2001
Baxter Healthcare 1999 - 2000
Bayer 1998 - 2000
Bayer 1997 - 1998
Skills
V&V, Computer System..., Manufacturing, Validation, Biotechnology, CAPA, Change Control, GMP, Quality System, FDA, 21 CFR Part 11, Medical Devices, ISO 13485, GxP, Aseptic Processing, Technology Transfer, Sop, LIMS, GAMP, R&D, Cleaning Validation, Biopharmaceuticals
Education
Bellarmine College Preparatory 1986 — 1990
University of California, Berkeley
Bachelor of Science (BS), Chemical Engineering
Carl DeHaven's Aradigm Corporation Experience April 2002 - July 2003
Job Security Coordinator at Linear Technology Corporation
Industry Electrical/Electronic Manufacturing
Experience
Linear Technology Corporation October 2003 - Present
Aradigm Corporation April 2002 - July 2003
Solectron August 1998 - January 2002
Pinkerton Security and Investigative Services July 1995 - August 1998
Vanguard Security Services November 1988 - July 1995
Education
Chabot College
Associate of Arts (A.A.), General Studies
Linear Technology Corporation October 2003 - Present
Aradigm Corporation April 2002 - July 2003
Solectron August 1998 - January 2002
Pinkerton Security and Investigative Services July 1995 - August 1998
Vanguard Security Services November 1988 - July 1995
Education
Chabot College
Associate of Arts (A.A.), General Studies
soleiman osman's Aradigm Corporation Experience June 2000 - September 2008
Job Scientist at Roche Molecular Systems
Industry Medical Devices
Experience
University of California, Davis, Medical Center August 2010 - April 2012
Roche Molecular Systems December 2009 - April 2012
Laboratory Experience 1995 - 2011
Aradigm Corporation June 2000 - September 2008
CSU, East Bay, Chemistry and Biochemistry Department March 2008 - July 2008
Novo Nordisk Delivery Technologies 2005 - 2007
with late Prof. Paul A. Molé November 1995 - June 2000
Skills
Biotechnology, HPLC, Chromatography, Protein Chemistry
Education
California State University-East Bay 2007 — 2009
MS, Chemistry
California State University-Long Beach 2008 — 2008
NA, Proteomics
University of California, Davis
BS, Microbiology
University of California, Davis, Medical Center August 2010 - April 2012
Roche Molecular Systems December 2009 - April 2012
Laboratory Experience 1995 - 2011
Aradigm Corporation June 2000 - September 2008
CSU, East Bay, Chemistry and Biochemistry Department March 2008 - July 2008
Novo Nordisk Delivery Technologies 2005 - 2007
with late Prof. Paul A. Molé November 1995 - June 2000
Skills
Biotechnology, HPLC, Chromatography, Protein Chemistry
Education
California State University-East Bay 2007 — 2009
MS, Chemistry
California State University-Long Beach 2008 — 2008
NA, Proteomics
University of California, Davis
BS, Microbiology
Adia Jackson's Aradigm Corporation Experience June 2014 - Present
Job Senior Clinical Research Associate at Aradigm Corporation
Industry Pharmaceuticals
Experience
Aradigm Corporation June 2014 - Present
Covance July 2012 - June 2014
Sangamo BioSciences August 2007 - July 2012
Optiscan Biomedical August 2005 - August 2007
Kaiser Permanente February 2004 - August 2005
Children's Hospital, Oakland Ca March 2001 - February 2004
Skills
Clinical Development, GCP, Clinical Trials, Biotechnology, CRO, HPLC, EDC, Drug Development, Diabetes, CTMS, ICH-GCP, Clinical Monitoring, Microbiology, Pediatrics, Clinical Research, Pharmaceutical Industry, Infectious Diseases
Education
Association of Clinical Research Professionals (ACRP)
Certified Clinical Research Associate
The George Washington University
Masters of Science, Health Science, Clinical Research Administration
University of California, Berkeley
Bachelor of Arts (BA), Molecular and Cell Biology, Neurobiology
Aradigm Corporation June 2014 - Present
Covance July 2012 - June 2014
Sangamo BioSciences August 2007 - July 2012
Optiscan Biomedical August 2005 - August 2007
Kaiser Permanente February 2004 - August 2005
Children's Hospital, Oakland Ca March 2001 - February 2004
Skills
Clinical Development, GCP, Clinical Trials, Biotechnology, CRO, HPLC, EDC, Drug Development, Diabetes, CTMS, ICH-GCP, Clinical Monitoring, Microbiology, Pediatrics, Clinical Research, Pharmaceutical Industry, Infectious Diseases
Education
Association of Clinical Research Professionals (ACRP)
Certified Clinical Research Associate
The George Washington University
Masters of Science, Health Science, Clinical Research Administration
University of California, Berkeley
Bachelor of Arts (BA), Molecular and Cell Biology, Neurobiology
Everette Moss, Jr.'s Aradigm Corporation Experience April 1997 - January 1998
Job Manager at Verizon Corporate Resources Group
Industry Telecommunications
Experience
Verizon Corporate Resources Group July 2004 - Present
Mirant July 2001 - June 2004
MCI Worldcom September 1999 - July 2001
Bank of America March 1998 - September 1999
Aradigm Corporation April 1997 - January 1998
Wells Fargo May 1991 - April 1997
Education
California State University-Hayward - School of Business and Economics 1996 — 1997
MBA, International Business
California State University-Hayward - School of Business and Economics 1991 — 1994
Bachelor of Science, Accounting
Verizon Corporate Resources Group July 2004 - Present
Mirant July 2001 - June 2004
MCI Worldcom September 1999 - July 2001
Bank of America March 1998 - September 1999
Aradigm Corporation April 1997 - January 1998
Wells Fargo May 1991 - April 1997
Education
California State University-Hayward - School of Business and Economics 1996 — 1997
MBA, International Business
California State University-Hayward - School of Business and Economics 1991 — 1994
Bachelor of Science, Accounting
Farzana Poyan's Aradigm Corporation Experience 1998 - 2000
Job Dentist at Alamo Smiles
Industry Health, Wellness and Fitness
Experience
Alamo Smiles November 2013 - Present
Smile Brands Inc. August 2012 - November 2013
Smile Brands Inc. August 2008 - June 2012
Aradigm Corporation 1998 - 2000
Skills
Periodontics, Dentistry, Cosmetic Dentistry, Veneers, Restorative, Clinical Research, Endodontics, Restorative Dentistry, Teeth Whitening, Oral Surgery, Prosthodontics, Dental Care, Implantology, Invisalign, Pediatric Dentistry, Dentures
Education
Indiana University-Purdue University at Indianapolis 2000 — 2004
DDS, Dentistry
Indiana University-Purdue University at Indianapolis 2000 — 2004
DDS, Dentistry
Alamo Smiles November 2013 - Present
Smile Brands Inc. August 2012 - November 2013
Smile Brands Inc. August 2008 - June 2012
Aradigm Corporation 1998 - 2000
Skills
Periodontics, Dentistry, Cosmetic Dentistry, Veneers, Restorative, Clinical Research, Endodontics, Restorative Dentistry, Teeth Whitening, Oral Surgery, Prosthodontics, Dental Care, Implantology, Invisalign, Pediatric Dentistry, Dentures
Education
Indiana University-Purdue University at Indianapolis 2000 — 2004
DDS, Dentistry
Indiana University-Purdue University at Indianapolis 2000 — 2004
DDS, Dentistry
Gina Capiaux's Aradigm Corporation Experience May 1995 - May 1996
Job Sr. Director at Ultragenyx
Industry Biotechnology
Experience
Ultragenyx Pharmaceutical Inc. August 2011 - Present
BioMarin Pharmaceutical August 2007 - July 2011
Dey Pharma L.P October 2004 - August 2007
Dow Pharmaceutical Sciences May 2003 - October 2004
Aradigm Corporation May 1995 - May 1996
Dey Pharma L.P November 1991 - May 1995
Skills
IND, Clinical Development, Pharmaceutical Industry, Regulatory Submissions, Biotechnology, Clinical Trials, GCP, NDA, Regulatory Affairs, Drug Development, GMP, eCTD, CRO, FDA, Biopharmaceuticals, Sop, Formulation
Education
Cornell University 1996 — 2002
Ph.D., Pharmacology
California State University, Fresno 1987 — 1991
B.S., Biochemistry
Ultragenyx Pharmaceutical Inc. August 2011 - Present
BioMarin Pharmaceutical August 2007 - July 2011
Dey Pharma L.P October 2004 - August 2007
Dow Pharmaceutical Sciences May 2003 - October 2004
Aradigm Corporation May 1995 - May 1996
Dey Pharma L.P November 1991 - May 1995
Skills
IND, Clinical Development, Pharmaceutical Industry, Regulatory Submissions, Biotechnology, Clinical Trials, GCP, NDA, Regulatory Affairs, Drug Development, GMP, eCTD, CRO, FDA, Biopharmaceuticals, Sop, Formulation
Education
Cornell University 1996 — 2002
Ph.D., Pharmacology
California State University, Fresno 1987 — 1991
B.S., Biochemistry
Christine Woods's Aradigm Corporation Experience June 1996 - April 2000
Job Sr. Director, Regulatory Affairs at Puma Biotechnology, Inc.
Industry Pharmaceuticals
Experience
Puma Biotechnology, Inc. November 2011 - Present
Ortho Biotech Oncology R&D, Unit of Cougar Biotechnology, Inc. February 2009 - November 2011
Watson Pharmaceuticals, Inc. September 2002 - January 2009
Pain Therapeutics, Inc. April 2000 - September 2002
Aradigm Corporation June 1996 - April 2000
Cygnus Therapeutic Systems (Cynus Research Corp.) February 1989 - June 1996
Liposome Technology, Inc. June 1988 - February 1989
Education
San Jose State University
MA, Toxicology
Dominican University of California 1984 — 1988
BS, Biology / Chemistry
Golden & Mesa View Schools
MDHS
Puma Biotechnology, Inc. November 2011 - Present
Ortho Biotech Oncology R&D, Unit of Cougar Biotechnology, Inc. February 2009 - November 2011
Watson Pharmaceuticals, Inc. September 2002 - January 2009
Pain Therapeutics, Inc. April 2000 - September 2002
Aradigm Corporation June 1996 - April 2000
Cygnus Therapeutic Systems (Cynus Research Corp.) February 1989 - June 1996
Liposome Technology, Inc. June 1988 - February 1989
Education
San Jose State University
MA, Toxicology
Dominican University of California 1984 — 1988
BS, Biology / Chemistry
Golden & Mesa View Schools
MDHS
Thomas Chesterman's Aradigm Corporation Experience 2002 - 2007
Job Looking for the next challenge
Industry Executive Office
Experience
GCI - General Communication Inc. April 2013 - July 2015
Bionovo, Inc. July 2007 - January 2012
Aradigm Corporation 2002 - 2007
Windrush School 1997 - 2005
Bio-Rad Laboratories 1996 - 2002
Europolitan AB 1993 - 1996
AirTouch 1983 - 1993
Skills
Accounting, Financial Reporting, Financial Analysis, Budget Process, Financial Management, Tax Strategy, Investor Relations, Capital Markets, Acquistions, Contract Negotiation, International Business, Information Technology, Strategic Planning, P&L Responsibility, Start-up Environment, Quality Systems Design, Internal Audit, Policy and Procedure..., Human Resources, Biotechnology, Leadership, Commercialization, Managerial Finance, Pharmaceutical Industry, Executive Management, Lifesciences, Tax, Venture Capital, Finance
Education
University of California, Davis - Graduate School of Management 1982 — 1984
MBA, Management Science, Accounting
Harvard University 1978 — 1982
AB, Statistical Linguistics, Romance Languages
Cathedral School for Boys 1969 — 1973
GCI - General Communication Inc. April 2013 - July 2015
Bionovo, Inc. July 2007 - January 2012
Aradigm Corporation 2002 - 2007
Windrush School 1997 - 2005
Bio-Rad Laboratories 1996 - 2002
Europolitan AB 1993 - 1996
AirTouch 1983 - 1993
Skills
Accounting, Financial Reporting, Financial Analysis, Budget Process, Financial Management, Tax Strategy, Investor Relations, Capital Markets, Acquistions, Contract Negotiation, International Business, Information Technology, Strategic Planning, P&L Responsibility, Start-up Environment, Quality Systems Design, Internal Audit, Policy and Procedure..., Human Resources, Biotechnology, Leadership, Commercialization, Managerial Finance, Pharmaceutical Industry, Executive Management, Lifesciences, Tax, Venture Capital, Finance
Education
University of California, Davis - Graduate School of Management 1982 — 1984
MBA, Management Science, Accounting
Harvard University 1978 — 1982
AB, Statistical Linguistics, Romance Languages
Cathedral School for Boys 1969 — 1973
Mary Hipona's Aradigm Corporation Experience December 2014 - Present
Job
Industry Pharmaceuticals
Experience
Aradigm Corporation December 2014 - Present
Optiscan Biomedical March 2006 - November 2014
LifeScan 1996 - 2006
Education
University of California, Davis 1990 — 1995
B.S., Nutrition Science
Aradigm Corporation December 2014 - Present
Optiscan Biomedical March 2006 - November 2014
LifeScan 1996 - 2006
Education
University of California, Davis 1990 — 1995
B.S., Nutrition Science
Shyamli Kumar's Aradigm Corporation Experience 1999 - 2001
Job FP&A Consultant at Meritus LLC
Industry Biotechnology
Experience
Meritus LLC April 2010 - Present
Flow Pharma 2007 - 2008
InterMune 2005 - 2007
Aradigm Corporation 1999 - 2001
Gilead Sciences 1997 - 1999
McKesson/HPR Inc. 1995 - 1997
Liberty Mutual September 1991 - March 1995
Skills
Business Planning, Financial Reporting, Financial Analysis, Variance Analysis, Forecasting, Strategic Planning, Business Development, Business Strategy, Mergers & Acquisitions, Project Management, Analysis, Business Process..., Organizational..., Valuation, Cross-functional Team..., Venture Capital, Product Marketing, Financial Modeling, Marketing Strategy, ERP, Budgets, Change Management, Entrepreneurship, Strategic Financial..., Strategic Partnerships, Executive Management, Financial Goals, Team Building, Contract Negotiation, Management, Corporate Finance, Leadership, Accounting, Finance, Start-ups, Vendor Management, Strategy, Project Planning, New Business Development, Operations Management, Program Management, Due Diligence, Product Management, Team Leadership
Education
D'Amore-McKim School of Business at Northeastern University
Meritus LLC April 2010 - Present
Flow Pharma 2007 - 2008
InterMune 2005 - 2007
Aradigm Corporation 1999 - 2001
Gilead Sciences 1997 - 1999
McKesson/HPR Inc. 1995 - 1997
Liberty Mutual September 1991 - March 1995
Skills
Business Planning, Financial Reporting, Financial Analysis, Variance Analysis, Forecasting, Strategic Planning, Business Development, Business Strategy, Mergers & Acquisitions, Project Management, Analysis, Business Process..., Organizational..., Valuation, Cross-functional Team..., Venture Capital, Product Marketing, Financial Modeling, Marketing Strategy, ERP, Budgets, Change Management, Entrepreneurship, Strategic Financial..., Strategic Partnerships, Executive Management, Financial Goals, Team Building, Contract Negotiation, Management, Corporate Finance, Leadership, Accounting, Finance, Start-ups, Vendor Management, Strategy, Project Planning, New Business Development, Operations Management, Program Management, Due Diligence, Product Management, Team Leadership
Education
D'Amore-McKim School of Business at Northeastern University
Ray Cummings's Aradigm Corporation Experience 1995 - 1998
Job Director, Market Dynamics at PATH
Industry Nonprofit Organization Management
Experience
PATH July 2015 - Present
PATH 2013 - Present
PATH 2009 - 2013
AVI BioPharma (now Sarepta Therapeutics) 2004 - 2009
Cummings Consulting, LLC 1998 - 2004
Aradigm Corporation 1995 - 1998
Celtrix (now Insmed, Inc.) 1994 - 1995
Searle (now Pfizer) 1992 - 1995
Immunex 1990 - 1992
Codon (now Bayer AG) 1984 - 1990
Skills
Executive Management, Global Health, Pharmaceutical Industry, Biotechnology, Non-profit management, Business Development, Licensing, Global Access, Contract Negotiation, Government Proposals, Intellectual Property, Vaccines, Technology Transfer, Lifesciences, Cell, Drug Development, Nonprofits, Commercialization, Program Management, Mergers & Acquisitions, Strategy, Leadership, Due Diligence, Business Planning, Product Development, Biopharmaceuticals, Drug Discovery, Infectious Diseases, Clinical Development, Life Sciences
Education
Harvard University
MS, Biochemistry and Molecular Biology
Stanford University
BS, Biology
University of California, Berkeley - Walter A. Haas School of Business
MBA
PATH July 2015 - Present
PATH 2013 - Present
PATH 2009 - 2013
AVI BioPharma (now Sarepta Therapeutics) 2004 - 2009
Cummings Consulting, LLC 1998 - 2004
Aradigm Corporation 1995 - 1998
Celtrix (now Insmed, Inc.) 1994 - 1995
Searle (now Pfizer) 1992 - 1995
Immunex 1990 - 1992
Codon (now Bayer AG) 1984 - 1990
Skills
Executive Management, Global Health, Pharmaceutical Industry, Biotechnology, Non-profit management, Business Development, Licensing, Global Access, Contract Negotiation, Government Proposals, Intellectual Property, Vaccines, Technology Transfer, Lifesciences, Cell, Drug Development, Nonprofits, Commercialization, Program Management, Mergers & Acquisitions, Strategy, Leadership, Due Diligence, Business Planning, Product Development, Biopharmaceuticals, Drug Discovery, Infectious Diseases, Clinical Development, Life Sciences
Education
Harvard University
MS, Biochemistry and Molecular Biology
Stanford University
BS, Biology
University of California, Berkeley - Walter A. Haas School of Business
MBA
Dorothy Fowler's Aradigm Corporation Experience March 2000 - January 2001
Job Accounts Payable Specialist
Industry Accounting
Experience
CMG Financial November 2012 - July 2013
Seneca Family of Agencies March 2012 - November 2012
Pican Oakland Restaurant June 2011 - March 2012
Leukemia & Lymphoma Society April 2009 - October 2010
The Clorox Sales Company, Oakland, CA November 2007 - October 2008
Con-Cise Contact Lens, San Leandro, CA May 2007 - September 2007
GSC Logistics December 2006 - January 2007
Fitzgerald Abbott & Beardsley LLP May 2001 - November 2006
Aradigm Corporation March 2000 - January 2001
Endymion Systems, Inc November 1996 - January 2000
Skills
Accounts Payable, Payroll, Customer Service, Accounting, General Ledger, Account Reconciliation, Journal Entries, ADP Payroll, Accruals, Human Resources, Bookkeeping, Outlook, Microsoft Word, Microsoft Excel, Microsoft Office, Accounts Receivable, Leadership
Education
University of Phoenix 1999 — 2002
Bachelor of Science in Business Administration, Business Administration
OAKLAND EVENING ADULT SCHOOL 1984 — 1985
Certificate, Computer Operations Certificate
COLLEGE OF ALAMEDA 1971 — 1976
Accounting/Business
Castlemont High School 1969 — 1971
Diploma, General Education
CMG Financial November 2012 - July 2013
Seneca Family of Agencies March 2012 - November 2012
Pican Oakland Restaurant June 2011 - March 2012
Leukemia & Lymphoma Society April 2009 - October 2010
The Clorox Sales Company, Oakland, CA November 2007 - October 2008
Con-Cise Contact Lens, San Leandro, CA May 2007 - September 2007
GSC Logistics December 2006 - January 2007
Fitzgerald Abbott & Beardsley LLP May 2001 - November 2006
Aradigm Corporation March 2000 - January 2001
Endymion Systems, Inc November 1996 - January 2000
Skills
Accounts Payable, Payroll, Customer Service, Accounting, General Ledger, Account Reconciliation, Journal Entries, ADP Payroll, Accruals, Human Resources, Bookkeeping, Outlook, Microsoft Word, Microsoft Excel, Microsoft Office, Accounts Receivable, Leadership
Education
University of Phoenix 1999 — 2002
Bachelor of Science in Business Administration, Business Administration
OAKLAND EVENING ADULT SCHOOL 1984 — 1985
Certificate, Computer Operations Certificate
COLLEGE OF ALAMEDA 1971 — 1976
Accounting/Business
Castlemont High School 1969 — 1971
Diploma, General Education
Ken Brandt's Aradigm Corporation Experience April 2003 - May 2006
Job Tech Specialist II at JCCSF
Industry Information Technology and Services
Experience
JCCSF January 2008 - Present
Menlo College November 2007 - January 2008
California Teachers Association October 2007 - November 2007
Insite Corporation August 2006 - October 2007
Aradigm Corporation April 2003 - May 2006
United States Marine Corps June 1999 - June 2005
Skills
Management, Business Analysis, Business Development, Program Evaluation, Organizational Behavior, Marketing Strategy, Public Policy, CRM Integration, UAT Coordination, SaaS, Data Analysis, Data Validation, Regulatory Compliance, Program Management, Project Management, System Administration, Active Directory, VPN, Microsoft Office, Wireless Networking, Customer Service, Microsoft Technologies, VMware, Network Administration, OS X, Servers, Windows Server, Network Security, Windows 7, Networking, Microsoft Exchange, Nonprofits, Microsoft Excel, Military, Storage Area Networks, Router Configuration, Linux Server, Mac OS X Server, Mac OS, FDA GMP, Manufacturing Operations, Clean Rooms, Aseptic Technique, Cpr Certified, Operational Risk..., TCP/IP, Computer Forensics, SOX Compliancy, Leadership
Education
University of San Francisco 2013 — 2015
Bachelor of Science (B.S.), Business Administration and Management, General, 3.80 GPA
University of San Francisco - School of Management 2013 — 2015
Bachelor of Science (B.S.), Business, Management, Marketing, and Related Support Services
JCCSF January 2008 - Present
Menlo College November 2007 - January 2008
California Teachers Association October 2007 - November 2007
Insite Corporation August 2006 - October 2007
Aradigm Corporation April 2003 - May 2006
United States Marine Corps June 1999 - June 2005
Skills
Management, Business Analysis, Business Development, Program Evaluation, Organizational Behavior, Marketing Strategy, Public Policy, CRM Integration, UAT Coordination, SaaS, Data Analysis, Data Validation, Regulatory Compliance, Program Management, Project Management, System Administration, Active Directory, VPN, Microsoft Office, Wireless Networking, Customer Service, Microsoft Technologies, VMware, Network Administration, OS X, Servers, Windows Server, Network Security, Windows 7, Networking, Microsoft Exchange, Nonprofits, Microsoft Excel, Military, Storage Area Networks, Router Configuration, Linux Server, Mac OS X Server, Mac OS, FDA GMP, Manufacturing Operations, Clean Rooms, Aseptic Technique, Cpr Certified, Operational Risk..., TCP/IP, Computer Forensics, SOX Compliancy, Leadership
Education
University of San Francisco 2013 — 2015
Bachelor of Science (B.S.), Business Administration and Management, General, 3.80 GPA
University of San Francisco - School of Management 2013 — 2015
Bachelor of Science (B.S.), Business, Management, Marketing, and Related Support Services
Jennifer Sykes's Aradigm Corporation Experience 2001 - 2001
Job Saving the world, one small molecule at a time.
Industry Chemicals
Experience
Green Hair Inc. 2009 - Present
AGAT Laboratories 2007 - 2009
Guidant Corporation 2004 - 2004
A.P. Pharma, Inc. 2002 - 2003
Connetics Corp 2001 - 2002
Aradigm Corporation 2001 - 2001
Alpha-Beta Technology 1992 - 1995
Paper Mate 1990 - 1992
Skills
GC-MS, LC-MS, Method Development, Analytical Method..., ICP-MS, HPLC, FTIR, Wet Chemistry, LIMS, Laboratory Safety, Chemical Safety, Waste Disposal, Supply Management, Chemstation, Method Transfer, MALDI-TOF, Dissolution Testing, Size Exclusion, Rheometry, Karl Fisher, TLC, GPC, UV/Vis, Column Chromatography, Paper Chromatography, Affinity Chromatography, Gas Chromatography, Dionex, pH meter, Organic Chemistry, Chemistry, R&D, Quality Control
Education
Massachusetts Institute of Technology
Bachelor of Science (BS), Chemistry
Berklee College of Music
Music Theory and Composition
Bronx High School of Science
Green Hair Inc. 2009 - Present
AGAT Laboratories 2007 - 2009
Guidant Corporation 2004 - 2004
A.P. Pharma, Inc. 2002 - 2003
Connetics Corp 2001 - 2002
Aradigm Corporation 2001 - 2001
Alpha-Beta Technology 1992 - 1995
Paper Mate 1990 - 1992
Skills
GC-MS, LC-MS, Method Development, Analytical Method..., ICP-MS, HPLC, FTIR, Wet Chemistry, LIMS, Laboratory Safety, Chemical Safety, Waste Disposal, Supply Management, Chemstation, Method Transfer, MALDI-TOF, Dissolution Testing, Size Exclusion, Rheometry, Karl Fisher, TLC, GPC, UV/Vis, Column Chromatography, Paper Chromatography, Affinity Chromatography, Gas Chromatography, Dionex, pH meter, Organic Chemistry, Chemistry, R&D, Quality Control
Education
Massachusetts Institute of Technology
Bachelor of Science (BS), Chemistry
Berklee College of Music
Music Theory and Composition
Bronx High School of Science
Denise Cuenca's Aradigm Corporation Experience April 2005 - February 2008
Job Research/Quality Control Professional
Industry Biotechnology
Experience
BP November 2011 - July 2014
Aradigm Corporation April 2005 - February 2008
Inamed Corporation 2002 - 2004
Skills
HPLC, Analysis, Laboratory, Biotechnology, GMP, Validation, Microbiology, Quality Control, SOP, Chemistry, Process Simulation
Education
University of California, Davis
Bachelor of Science, Biochemistry
De Anza College 1995 — 1999
Associate’s Degree, Liberal Arts and Sciences/Liberal Studies
BP November 2011 - July 2014
Aradigm Corporation April 2005 - February 2008
Inamed Corporation 2002 - 2004
Skills
HPLC, Analysis, Laboratory, Biotechnology, GMP, Validation, Microbiology, Quality Control, SOP, Chemistry, Process Simulation
Education
University of California, Davis
Bachelor of Science, Biochemistry
De Anza College 1995 — 1999
Associate’s Degree, Liberal Arts and Sciences/Liberal Studies
Keith Hurley's Aradigm Corporation Experience September 2004 - February 2006
Job VP Sales & Marketing at Enco Pharmaceutical Development, Inc.
Industry Pharmaceuticals
Experience
Enco Pharmaceutical Development, Inc. February 2009 - Present
Aradigm Corporation September 2004 - February 2006
Azopharma Contract Pharmaceutical Services 2004 - 2006
Cardinal Health September 1998 - August 2004
Magellan Laboratories September 1998 - May 2002
Skills
Drug Delivery, Pharmaceutical Industry, FDA, Technology Transfer, GMP, Inhalation, Validation, Analytical Chemistry, Sop, Pharmaceutics, Regulatory Affairs, Biopharmaceuticals, Clinical Development, GLP, Medical Devices, Biotechnology, 21 CFR Part 11, Drug Development, Drug Discovery, Nasal, CAPA, Formulation, CRO, R&D, HPLC, Life Sciences
Education
University of North Carolina at Greensboro 1987 — 1989
Bachelors, Chemistry/Biology
University of Minnesota-Twin Cities
Ph.D., MedChem
Enco Pharmaceutical Development, Inc. February 2009 - Present
Aradigm Corporation September 2004 - February 2006
Azopharma Contract Pharmaceutical Services 2004 - 2006
Cardinal Health September 1998 - August 2004
Magellan Laboratories September 1998 - May 2002
Skills
Drug Delivery, Pharmaceutical Industry, FDA, Technology Transfer, GMP, Inhalation, Validation, Analytical Chemistry, Sop, Pharmaceutics, Regulatory Affairs, Biopharmaceuticals, Clinical Development, GLP, Medical Devices, Biotechnology, 21 CFR Part 11, Drug Development, Drug Discovery, Nasal, CAPA, Formulation, CRO, R&D, HPLC, Life Sciences
Education
University of North Carolina at Greensboro 1987 — 1989
Bachelors, Chemistry/Biology
University of Minnesota-Twin Cities
Ph.D., MedChem
Hafiza Azizi's Aradigm Corporation Experience 2000 - 2004
Job Associate Director, Commercial Quality Assurance at Gilead Sciences
Industry Pharmaceuticals
Experience
Gilead Sciences June 2012 - Present
Depomed, Inc. October 2011 - September 2012
Depomed, Inc. April 2010 - October 2011
Zosano Pharma 2008 - April 2010
BioEnterprise 2007 - 2008
Boehringer Ingelheim 2005 - 2006
Aradigm Corporation 2000 - 2004
Skills
GMP, Quality Assurance, Validation, CAPA, Quality Control, Biotechnology, Pharmaceutical Industry, Sop, Quality System, Regulatory Affairs, V&V, GLP, LIMS, Change Control, GxP, 21 CFR Part 11, FDA, Technology Transfer, HPLC
Education
University of Akron, School of Business
University of California, Berkeley
Gilead Sciences June 2012 - Present
Depomed, Inc. October 2011 - September 2012
Depomed, Inc. April 2010 - October 2011
Zosano Pharma 2008 - April 2010
BioEnterprise 2007 - 2008
Boehringer Ingelheim 2005 - 2006
Aradigm Corporation 2000 - 2004
Skills
GMP, Quality Assurance, Validation, CAPA, Quality Control, Biotechnology, Pharmaceutical Industry, Sop, Quality System, Regulatory Affairs, V&V, GLP, LIMS, Change Control, GxP, 21 CFR Part 11, FDA, Technology Transfer, HPLC
Education
University of Akron, School of Business
University of California, Berkeley
Adrienne Ste. Marie's Aradigm Corporation Experience August 2015 - Present
Job Clinical Project Director at Aradigm Corporation
Industry Pharmaceuticals
Experience
Aradigm Corporation August 2015 - Present
Worldwide Clinical Trials January 2015 - August 2015
BioClinica (previously Synarc) January 2012 - January 2015
AVI BioPharma 2010 - 2011
Ste. Marie Consulting 2009 - 2010
Acologix 2005 - 2009
ARYx Therapeutics 2003 - 2005
Santen Pharmaceuticals 1999 - 2002
Celtrix 1995 - 1999
Skills
Project Management, Pharmaceutical..., Clinical Research, Clinical Development, Drug Development, Product Development, Strategic Planning, CMC, Cross-functional Team..., Pharmaceutical Industry, Biotechnology
Education
Santa Clara University - Leavey School of Business
MBA
University of California, Berkeley
BA
Aradigm Corporation August 2015 - Present
Worldwide Clinical Trials January 2015 - August 2015
BioClinica (previously Synarc) January 2012 - January 2015
AVI BioPharma 2010 - 2011
Ste. Marie Consulting 2009 - 2010
Acologix 2005 - 2009
ARYx Therapeutics 2003 - 2005
Santen Pharmaceuticals 1999 - 2002
Celtrix 1995 - 1999
Skills
Project Management, Pharmaceutical..., Clinical Research, Clinical Development, Drug Development, Product Development, Strategic Planning, CMC, Cross-functional Team..., Pharmaceutical Industry, Biotechnology
Education
Santa Clara University - Leavey School of Business
MBA
University of California, Berkeley
BA
Sharda Chaudhry's Aradigm Corporation Experience January 2000 - January 2003
Job Biotechnology Professional
Industry Biotechnology
Experience
Genentech, Incorporation 2003 - 2009
Aradigm Corporation January 2000 - January 2003
Yamanouchi Pharma Technologies January 1996 - January 2000
Syntex 1990 - 1996
Education
Saurashtra University 1970 — 1972
M.S. Degree, Experimental Biology
Agra University
B.Ed
Delhi University
B.S. Degree, Biology and Chemistry
Genentech, Incorporation 2003 - 2009
Aradigm Corporation January 2000 - January 2003
Yamanouchi Pharma Technologies January 1996 - January 2000
Syntex 1990 - 1996
Education
Saurashtra University 1970 — 1972
M.S. Degree, Experimental Biology
Agra University
B.Ed
Delhi University
B.S. Degree, Biology and Chemistry
Alvin Montgomery's Aradigm Corporation Experience November 2000 - February 2002
Job Senior Accountant at Shoretel, Inc.
Industry Staffing and Recruiting
Experience
Shoretel, Inc. June 2011 - Present
Robert Half Management Resources February 2000 - June 2011
Shoretel, Inc. August 2010 - May 2011
Markettools, Inc. February 2008 - January 2010
Bay Area Rapid Transit September 2007 - January 2008
Luminent Mortgage Capital, Inc. October 2005 - August 2007
Benefit Cosmetics March 2005 - October 2005
Kelmscott, Inc. November 2004 - August 2005
Chela Financial, Inc. February 2000 - August 2004
Aradigm Corporation November 2000 - February 2002
Skills
Accounting, Account Reconciliation, Financial Analysis, Financial Reporting, Forecasting, Internal Controls, Accounts Payable, Accounts Receivable, Auditing, SEC filings, Revenue Recognition, Sarbanes-Oxley Act
Education
University of New Orleans 1982 — 1988
BS, Accounting
Shoretel, Inc. June 2011 - Present
Robert Half Management Resources February 2000 - June 2011
Shoretel, Inc. August 2010 - May 2011
Markettools, Inc. February 2008 - January 2010
Bay Area Rapid Transit September 2007 - January 2008
Luminent Mortgage Capital, Inc. October 2005 - August 2007
Benefit Cosmetics March 2005 - October 2005
Kelmscott, Inc. November 2004 - August 2005
Chela Financial, Inc. February 2000 - August 2004
Aradigm Corporation November 2000 - February 2002
Skills
Accounting, Account Reconciliation, Financial Analysis, Financial Reporting, Forecasting, Internal Controls, Accounts Payable, Accounts Receivable, Auditing, SEC filings, Revenue Recognition, Sarbanes-Oxley Act
Education
University of New Orleans 1982 — 1988
BS, Accounting
Scott Huie's Aradigm Corporation Experience 1995 - 1997
Job VP, Regulatory Affairs and Product Compliance at Valeritas, Inc.
Industry Medical Devices
Experience
Valeritas, Inc. January 2011 - Present
Valeritas September 2002 - January 2011
Baxter BioScience 2002 - 2002
Fusion Medical Technologies 1997 - 2002
Aradigm Corporation 1995 - 1997
Cygnus Therapeutic Systems 1990 - 1995
Ciba-Geigy 1985 - 1990
3M 1980 - 1985
Skills
Medical Devices, Design Control, Pharmaceutical Industry, Technology Transfer, ISO 13485, GMP, FDA, Regulatory Affairs, Engineering, Product Development, Process Engineering
Education
Rensselaer Polytechnic Institute 1976 — 1980
BS, Chemical Engineering
Valeritas, Inc. January 2011 - Present
Valeritas September 2002 - January 2011
Baxter BioScience 2002 - 2002
Fusion Medical Technologies 1997 - 2002
Aradigm Corporation 1995 - 1997
Cygnus Therapeutic Systems 1990 - 1995
Ciba-Geigy 1985 - 1990
3M 1980 - 1985
Skills
Medical Devices, Design Control, Pharmaceutical Industry, Technology Transfer, ISO 13485, GMP, FDA, Regulatory Affairs, Engineering, Product Development, Process Engineering
Education
Rensselaer Polytechnic Institute 1976 — 1980
BS, Chemical Engineering
Paul Bruinenberg MD MBA's Aradigm Corporation Experience 2007 - 2011
Job Chief Medical Officer and Head R&D at Eagle Pharmaceuticals, Inc.
Industry Biotechnology
Experience
Eagle Pharmaceuticals, Inc. 2011 - Present
Aradigm Corporation 2007 - 2011
Fulcrum Pharma Developments 2006 - 2007
Biotrack Consultancy BV 2003 - 2006
Yamanouchi Europe 2000 - 2003
Roche Pharmaceuticals (Basel -Switzerland) 1994 - 2000
Roche Pharmaceuticals 1990 - 1994
Netherlands 1983 - 1990
Skills
Clinical Development, Drug Development, Pharmaceutical Industry, Clinical Trials, Oncology, Regulatory Affairs, Medical Devices, R&D, Medicine, Biopharmaceuticals, Clinical Research, Biotechnology, Regulatory Submissions, CRO, Immunology, Technology Transfer, GCP, FDA, Lifesciences, Pharmaceutics, IND, CTMS, Drug Discovery, Drug Delivery, Commercialization, Infectious Diseases, Pharmacology
Education
Stellenbosch University/Universiteit Stellenbosch 1976 — 1983
MD
Nyenrode Business University
MBA
Rochester University
MBA
Stellenbosch University/Universiteit Stellenbosch
Eagle Pharmaceuticals, Inc. 2011 - Present
Aradigm Corporation 2007 - 2011
Fulcrum Pharma Developments 2006 - 2007
Biotrack Consultancy BV 2003 - 2006
Yamanouchi Europe 2000 - 2003
Roche Pharmaceuticals (Basel -Switzerland) 1994 - 2000
Roche Pharmaceuticals 1990 - 1994
Netherlands 1983 - 1990
Skills
Clinical Development, Drug Development, Pharmaceutical Industry, Clinical Trials, Oncology, Regulatory Affairs, Medical Devices, R&D, Medicine, Biopharmaceuticals, Clinical Research, Biotechnology, Regulatory Submissions, CRO, Immunology, Technology Transfer, GCP, FDA, Lifesciences, Pharmaceutics, IND, CTMS, Drug Discovery, Drug Delivery, Commercialization, Infectious Diseases, Pharmacology
Education
Stellenbosch University/Universiteit Stellenbosch 1976 — 1983
MD
Nyenrode Business University
MBA
Rochester University
MBA
Stellenbosch University/Universiteit Stellenbosch
Fred Aflatuni's Aradigm Corporation Experience October 2001 - July 2008
Job Sr staff. Mechanical Engineer at Green Design and Consulting Inc.
Industry Mechanical or Industrial Engineering
Experience
Green Design and Consulting Inc. July 2008 - Present
Aradigm Corporation October 2001 - July 2008
HP (Hewlett Packard Company) November 2000 - October 2001
Rotoflex International, Inc - Mississauga, Ontario- Canada September 1996 - November 2000
Lembo /Arrow Converting Machinery May 1995 - September 1996
K.N.Toosi University of Technology September 1992 - December 1994
Semnan Cauline Co June 1987 - September 1992
Skills
Finite Element Analysis, Validation, Medical Devices, Design for Manufacturing, Injection Molding, Engineering, AutoCAD, Machine Design, Product Development, Engineers, Control Theory, Project Management, Software, SolidWorks, 3D design softwares, C, Robatics, GMP Requirements, Control and Dynamic..., Project Managements, Professional Engineer..., GD&T, Simulation, Solidworks, Failure Analysis, Simulations, Testing, Engineering Management, Six Sigma, Mechanical Engineering, Product Design, Automation, Pro Engineer, Design of Experiments, Robotics, Manufacturing..., Sheet Metal, R&D
Education
Amirkabir University of Tech. 1983 — 1985
MS, Mechanical Engineering, 3.6
Sharif University of Technology 1976 — 1983
BS, Mechanical Engineering, 16.34/20
Hakim Sanaee 1973 — 1976
High School, Mathematics, 18.5/20
Green Design and Consulting Inc. July 2008 - Present
Aradigm Corporation October 2001 - July 2008
HP (Hewlett Packard Company) November 2000 - October 2001
Rotoflex International, Inc - Mississauga, Ontario- Canada September 1996 - November 2000
Lembo /Arrow Converting Machinery May 1995 - September 1996
K.N.Toosi University of Technology September 1992 - December 1994
Semnan Cauline Co June 1987 - September 1992
Skills
Finite Element Analysis, Validation, Medical Devices, Design for Manufacturing, Injection Molding, Engineering, AutoCAD, Machine Design, Product Development, Engineers, Control Theory, Project Management, Software, SolidWorks, 3D design softwares, C, Robatics, GMP Requirements, Control and Dynamic..., Project Managements, Professional Engineer..., GD&T, Simulation, Solidworks, Failure Analysis, Simulations, Testing, Engineering Management, Six Sigma, Mechanical Engineering, Product Design, Automation, Pro Engineer, Design of Experiments, Robotics, Manufacturing..., Sheet Metal, R&D
Education
Amirkabir University of Tech. 1983 — 1985
MS, Mechanical Engineering, 3.6
Sharif University of Technology 1976 — 1983
BS, Mechanical Engineering, 16.34/20
Hakim Sanaee 1973 — 1976
High School, Mathematics, 18.5/20
Susie Grant Owen's Aradigm Corporation Experience March 2006 - October 2006
Job Clinical Research Nurse Kaiser Permanente Vaccine Study Center
Industry Medical Practice
Experience
Kaiser Permanente Vaccine Study Center September 2011 - Present
Mollen Immunization Clinics August 2009 - September 2011
Children's Hospital November 2009 - August 2011
Aradigm Corporation March 2006 - October 2006
Aradigm Corporation March 2003 - March 2006
Aradigm Corporation May 2000 - March 2003
Abbott Diagnostics Division August 1998 - May 2000
Abbott Diagnostics Division February 1997 - August 1998
Abbott Diagnostics Division May 1995 - February 1997
San Jose State University January 1994 - December 1994
Education
San Francisco State University
B.S, Nursing
San Jose State University
M.S, Biochemistry
Columbia College, Columbia University
B.A, Premed/Sociology
Kaiser Permanente Vaccine Study Center September 2011 - Present
Mollen Immunization Clinics August 2009 - September 2011
Children's Hospital November 2009 - August 2011
Aradigm Corporation March 2006 - October 2006
Aradigm Corporation March 2003 - March 2006
Aradigm Corporation May 2000 - March 2003
Abbott Diagnostics Division August 1998 - May 2000
Abbott Diagnostics Division February 1997 - August 1998
Abbott Diagnostics Division May 1995 - February 1997
San Jose State University January 1994 - December 1994
Education
San Francisco State University
B.S, Nursing
San Jose State University
M.S, Biochemistry
Columbia College, Columbia University
B.A, Premed/Sociology
David DiMare's Aradigm Corporation Experience November 1999 - February 2003
Job Engineering Program Manager at HewlettPackard
Industry Information Technology and Services
Experience
Hewlett-Packard December 2010 - Present
IMA July 2012 - June 2015
ArcSight (Acquired by HP) January 2010 - December 2010
Force10 Networks June 2008 - January 2010
RoseRyan October 2007 - June 2008
UTStarcom October 2006 - October 2007
ESS Technology July 2003 - October 2006
Aradigm Corporation November 1999 - February 2003
SDL (JDSU) November 1997 - November 1999
Vivus Inc April 1996 - November 1997
Education
San Jose State University 1978 — 1980
B.S., Accounting
College of San Mateo 1975 — 1978
A.A., Business Administration
Hewlett-Packard December 2010 - Present
IMA July 2012 - June 2015
ArcSight (Acquired by HP) January 2010 - December 2010
Force10 Networks June 2008 - January 2010
RoseRyan October 2007 - June 2008
UTStarcom October 2006 - October 2007
ESS Technology July 2003 - October 2006
Aradigm Corporation November 1999 - February 2003
SDL (JDSU) November 1997 - November 1999
Vivus Inc April 1996 - November 1997
Education
San Jose State University 1978 — 1980
B.S., Accounting
College of San Mateo 1975 — 1978
A.A., Business Administration
Jack Lloyd's Aradigm Corporation Experience 1990 - 1995
Job Engineering Fellow at Triple Ring Technologies
Industry Medical Devices
Experience
Triple Ring Technologies Board MemberAlere, Inc.1996 - 2005
Aradigm Corporation 1990 - 1995
Nellcor 1980 - 1989
Humphrey Instruments 1974 - 1979
Education
UC Berkeley
BS, Mechanical Engineering
Triple Ring Technologies Board MemberAlere, Inc.1996 - 2005
Aradigm Corporation 1990 - 1995
Nellcor 1980 - 1989
Humphrey Instruments 1974 - 1979
Education
UC Berkeley
BS, Mechanical Engineering
Alan Alonso, PHR, MBA's Aradigm Corporation Experience June 2005 - September 2005
Job Human Resources Generalist at Bay Equity, LLC
Industry Human Resources
Experience
Bay Equity, LLC May 2014 - Present
Target September 2012 - 2014
NCLG October 2010 - June 2012
Safeway January 2007 - January 2008
Nelson Staffing January 2006 - January 2007
Aradigm Corporation June 2005 - September 2005
Skills
Leadership, Microsoft Office, Retail, PowerPoint, Employee Relations, Access, Management, Data Entry, Time Management, Microsoft Excel, Public Speaking, Social Media, Outlook, Microsoft Word, Customer Service, Human Resources, Social Networking, Facebook, Teamwork, Marketing, Team Leadership, Inventory Management, Analysis, Data Analysis, MS Office Suite, Sales, Training, Event Planning, Team Building, Strategic Planning, Recruiting, Project Management, Employee Training, Leadership Development, Finance, Event Management, CRM, Interviews, Onboarding, Employee Benefits, HRIS, HR Policies, ADP Payroll
Education
California State University-East Bay
Master of Business Administration (M.B.A.), Human Resources, Organizational Behavior, Operations & Supply Chain Management
California State University-East Bay 2007 — 2010
Bachelor of Science, Business Administration; double option in Finance, Economics
Bay Equity, LLC May 2014 - Present
Target September 2012 - 2014
NCLG October 2010 - June 2012
Safeway January 2007 - January 2008
Nelson Staffing January 2006 - January 2007
Aradigm Corporation June 2005 - September 2005
Skills
Leadership, Microsoft Office, Retail, PowerPoint, Employee Relations, Access, Management, Data Entry, Time Management, Microsoft Excel, Public Speaking, Social Media, Outlook, Microsoft Word, Customer Service, Human Resources, Social Networking, Facebook, Teamwork, Marketing, Team Leadership, Inventory Management, Analysis, Data Analysis, MS Office Suite, Sales, Training, Event Planning, Team Building, Strategic Planning, Recruiting, Project Management, Employee Training, Leadership Development, Finance, Event Management, CRM, Interviews, Onboarding, Employee Benefits, HRIS, HR Policies, ADP Payroll
Education
California State University-East Bay
Master of Business Administration (M.B.A.), Human Resources, Organizational Behavior, Operations & Supply Chain Management
California State University-East Bay 2007 — 2010
Bachelor of Science, Business Administration; double option in Finance, Economics
Satyam Upadrashta, PhD, RAC, FRAPS's Aradigm Corporation Experience March 2005 - March 2009
Job Senior Director, Global Regulatory Affairs CMC Takeda Pharmaceuticals International Co.
Industry Pharmaceuticals
Experience
Takeda Pharmaceuticals International Co. (formerly Millennium Pharmaceuticals) October 2013 - Present
Millennium Pharmaceuticals May 2011 - September 2013
Forest Laboratories March 2009 - May 2011
Aradigm Corporation March 2005 - March 2009
Chiron Corporation February 2003 - January 2005
Bristol-Myers Squibb August 1996 - February 2003
Bristol-Myers Squibb Company 1995 - 1996
Bristol-Myers Squibb Company 1992 - 1996
University of Missouri 1988 - 1992
Skills
Regulatory Affairs, CMC, Regulations, Pharmaceutical Industry, Regulatory Submissions, Drug Development, FDA, Technology Transfer, Biotechnology, GMP, Clinical Trials, Quality Systems, CMC Development, Teaching and mentoring, Quality System, Pharmaceutics, Formulation, CMC development, Validation
Education
University of Iowa 1984 — 1988
Doctor of Philosophy (PhD), Pharmaceutics
Osmania University
MSc, Chemistry
Osmania University
BSc, Chemistry
Takeda Pharmaceuticals International Co. (formerly Millennium Pharmaceuticals) October 2013 - Present
Millennium Pharmaceuticals May 2011 - September 2013
Forest Laboratories March 2009 - May 2011
Aradigm Corporation March 2005 - March 2009
Chiron Corporation February 2003 - January 2005
Bristol-Myers Squibb August 1996 - February 2003
Bristol-Myers Squibb Company 1995 - 1996
Bristol-Myers Squibb Company 1992 - 1996
University of Missouri 1988 - 1992
Skills
Regulatory Affairs, CMC, Regulations, Pharmaceutical Industry, Regulatory Submissions, Drug Development, FDA, Technology Transfer, Biotechnology, GMP, Clinical Trials, Quality Systems, CMC Development, Teaching and mentoring, Quality System, Pharmaceutics, Formulation, CMC development, Validation
Education
University of Iowa 1984 — 1988
Doctor of Philosophy (PhD), Pharmaceutics
Osmania University
MSc, Chemistry
Osmania University
BSc, Chemistry
Merck
Johnson & Johnson
GlaxoSmithKline
Bristol Myers Squibb
Eli Lilly and Company
Novartis
Abbott Laboratories
AstraZeneca