Alexza Pharmaceuticals
Industry: Pharmaceutical company
DescriptionHeadquarters: California Founder: Alejandro Zaffaroni Founded: 2000 Subsidiaries: Alexza UK Ltd, Symphony Allegro, Inc., Parent organization: Ferrer Therapeutics, Inc.
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Alexza Pharmaceuticals Employees
Employee
Years
Job
Industry
Carlos Parra Carlos Parra's Alexza Pharmaceuticals Experience 2008 - 2009
Job On Sabbatical
Industry Pharmaceuticals
Experience
None June 2014 - Present
Theravance July 2009 - May 2014
Alexza Pharmaceuticals 2008 - 2009
Telik 2002 - 2008
West Coast Associates 1996 - 2002
Somatogen 1992 - 1994
Syntex Research, Palo Alto 1990 - 1992
Genentech Inc 1988 - 1990
Abbott Laboratories 1982 - 1988
American Hospital Supply Corp (Now Baxter) 1976 - 1982
Skills
Validation, Quality Assurance, Microbiology, Compliance, Auditing, Quality Management, Pharmaceuticals, Quality Systems, GMP, Clinical Trials, GCP, Continuous Improvement, Risk Management, Medical Devices, Process Validation, Technology Transfer, GLP, Biopharmaceuticals, Pharmaceutical Industry, Quality System, Drug Discovery, Regulatory Affairs, Biotechnology, FDA, GxP, Clinical Development
Education
The University of Texas at El Paso
B.S., Microbiology
None June 2014 - Present
Theravance July 2009 - May 2014
Alexza Pharmaceuticals 2008 - 2009
Telik 2002 - 2008
West Coast Associates 1996 - 2002
Somatogen 1992 - 1994
Syntex Research, Palo Alto 1990 - 1992
Genentech Inc 1988 - 1990
Abbott Laboratories 1982 - 1988
American Hospital Supply Corp (Now Baxter) 1976 - 1982
Skills
Validation, Quality Assurance, Microbiology, Compliance, Auditing, Quality Management, Pharmaceuticals, Quality Systems, GMP, Clinical Trials, GCP, Continuous Improvement, Risk Management, Medical Devices, Process Validation, Technology Transfer, GLP, Biopharmaceuticals, Pharmaceutical Industry, Quality System, Drug Discovery, Regulatory Affairs, Biotechnology, FDA, GxP, Clinical Development
Education
The University of Texas at El Paso
B.S., Microbiology
Maureen Jordan Maureen Jordan's Alexza Pharmaceuticals Experience September 2006 - March 2009
Job Continuous Improvement Manager at BD
Industry Pharmaceuticals
Experience
BD September 2012 - Present
BD Biosciences March 2010 - November 2012
Alexza Pharmaceuticals September 2006 - March 2009
Alza/ Johnson & Johnson 1996 - 2006
L. Perrigo Co 1989 - 1996
Skills
DMAIC, Lean Manufacturing, Continuous Improvement, Problem Solving, Validation, CAPA, cGMP, Quality Systems, Process Development, DOE, Product Launch, Team Building, Quality System, GMP, Design of Experiments, Six Sigma, V&V, Technology Transfer, Pharmaceutical Industry, Process Improvement, Change Control, Manufacturing, Black Belt, Minitab, Project Management, Commercialization, Value Stream Mapping, Green Belt, Process Excellence, Contract Manufacturing, Process Simulation, Product Development, 5S, Medical Devices, Sop, Kaizen, FDA, Design Control, Combination Products, ISO 13485, FDA GMP, SPC, 21 CFR Part 11, R&D, Quality Assurance, Process Engineering, FMEA, Root Cause Analysis, Quality Auditing, Operational Excellence
Education
University of California, Berkeley
BS, Nutrition and Food Science
BD September 2012 - Present
BD Biosciences March 2010 - November 2012
Alexza Pharmaceuticals September 2006 - March 2009
Alza/ Johnson & Johnson 1996 - 2006
L. Perrigo Co 1989 - 1996
Skills
DMAIC, Lean Manufacturing, Continuous Improvement, Problem Solving, Validation, CAPA, cGMP, Quality Systems, Process Development, DOE, Product Launch, Team Building, Quality System, GMP, Design of Experiments, Six Sigma, V&V, Technology Transfer, Pharmaceutical Industry, Process Improvement, Change Control, Manufacturing, Black Belt, Minitab, Project Management, Commercialization, Value Stream Mapping, Green Belt, Process Excellence, Contract Manufacturing, Process Simulation, Product Development, 5S, Medical Devices, Sop, Kaizen, FDA, Design Control, Combination Products, ISO 13485, FDA GMP, SPC, 21 CFR Part 11, R&D, Quality Assurance, Process Engineering, FMEA, Root Cause Analysis, Quality Auditing, Operational Excellence
Education
University of California, Berkeley
BS, Nutrition and Food Science
David Gao David Gao's Alexza Pharmaceuticals Experience November 2005 - February 2012
Job
Industry Pharmaceuticals
Experience
Onyx Pharmaceuticals, An Amgen subsidiary February 2012 - Present
Alexza Pharmaceuticals November 2005 - February 2012
Theravance January 2001 - November 2005
Amersham Biosciences June 1999 - January 2001
Skills
Validation, NDA, Instrumentation, Technical Transfers, Method Development, Pharmaceutical...
Education
San Jose State University 2000 — 2003
MBA
Iowa State University 1995 — 1999
Ph.D., Analytical Chemistry
Peking University
MS & BS, Organic Chemistry
Onyx Pharmaceuticals, An Amgen subsidiary February 2012 - Present
Alexza Pharmaceuticals November 2005 - February 2012
Theravance January 2001 - November 2005
Amersham Biosciences June 1999 - January 2001
Skills
Validation, NDA, Instrumentation, Technical Transfers, Method Development, Pharmaceutical...
Education
San Jose State University 2000 — 2003
MBA
Iowa State University 1995 — 1999
Ph.D., Analytical Chemistry
Peking University
MS & BS, Organic Chemistry
Qiang Chen Qiang Chen's Alexza Pharmaceuticals Experience June 2004 - August 2011
Job Sr. Quality Technical Product Manager IMP Quality Operations, US and APAC
Industry Pharmaceuticals
Experience
Genentech May 2015 - Present
Genentech April 2014 - April 2015
Impax Laboratories January 2014 - April 2014
Allergan Inc. September 2012 - December 2013
Micropoint Bioscience, Inc. August 2011 - December 2011
Alexza Pharmaceuticals June 2004 - August 2011
Corium International July 2002 - June 2004
Cygnus 1997 - 2002
University of Texas at Austin December 1995 - July 1997
Skills
Validation, Analytical Chemistry, FDA, Quality Systems, Medical Devices, HPLC, Quality Auditing, Pharmaceutics, GMP, GLP, Pharmaceutical Industry, Method Development, Cleaning Validation, ISO 13485, CMC, USP, NDA, Method Transfer, UV/Vis, GxP, Change Control, Sop, CAPA, Quality Control, 21 CFR Part 11, Computer System..., Design Control, IND, Quality Assurance, LC-MS, Drug Delivery, Regulatory Submissions, Quality System
Education
New Mexico State University 1991 — 1995
Ph. D., Analytical Chemistry
Xiamen University
M.S., Analytical Chemistry
Genentech May 2015 - Present
Genentech April 2014 - April 2015
Impax Laboratories January 2014 - April 2014
Allergan Inc. September 2012 - December 2013
Micropoint Bioscience, Inc. August 2011 - December 2011
Alexza Pharmaceuticals June 2004 - August 2011
Corium International July 2002 - June 2004
Cygnus 1997 - 2002
University of Texas at Austin December 1995 - July 1997
Skills
Validation, Analytical Chemistry, FDA, Quality Systems, Medical Devices, HPLC, Quality Auditing, Pharmaceutics, GMP, GLP, Pharmaceutical Industry, Method Development, Cleaning Validation, ISO 13485, CMC, USP, NDA, Method Transfer, UV/Vis, GxP, Change Control, Sop, CAPA, Quality Control, 21 CFR Part 11, Computer System..., Design Control, IND, Quality Assurance, LC-MS, Drug Delivery, Regulatory Submissions, Quality System
Education
New Mexico State University 1991 — 1995
Ph. D., Analytical Chemistry
Xiamen University
M.S., Analytical Chemistry
Rosario Quintero-Vives Rosario Quintero-Vives's Alexza Pharmaceuticals Experience August 2007 - September 2007
Job Sr. Regulatory & Compliance Spec.
Industry Biotechnology
Experience
Pfizer April 2014 - Present
RQV Consulting January 2011 - Present
ECS June 2013 - November 2013
PharmaceuticalOnline August 2012 - July 2013
Amgen September 2011 - October 2011
IMPRA August 2011 - September 2011
US Census Bureau February 2010 - January 2011
RQV Consulting December 2007 - February 2010
Alexza Pharmaceuticals August 2007 - September 2007
TVS April 2007 - June 2007
Skills
EDM Quality, Document Management, Technical Training, Medical Devices, IR spectroscopy, Western Blotting, Validation, Process Validation, CAPA, cGMP, FDA, GMP, SOP, Pharmaceuticals, Biotechnology, Quality Assurance, Quality Systems, Documentation, Life Sciences, Compliance, Technical Writing, Troubleshooting, Problem Solving, Validations, Software Documentation, V&V, Statistics, Quality System, Microbiology, Testing, Change Control, Quality Control, Leadership, Quality Auditing, Training, GAMP, GxP, Pharmaceutical Industry, LIMS, Lifesciences, Computer System..., Technology Transfer, Biochemistry, Laboratory, Root Cause Analysis, Purification, Biopharmaceuticals, PCR, GLP, Trackwise
Education
Inter-American University of Puerto Rico-Arecibo Campus 2003 — 2004
BS, Biology minnor Chemistry
Universidad de Puerto Rico 1995 — 2002
n/a, Biology
Pfizer April 2014 - Present
RQV Consulting January 2011 - Present
ECS June 2013 - November 2013
PharmaceuticalOnline August 2012 - July 2013
Amgen September 2011 - October 2011
IMPRA August 2011 - September 2011
US Census Bureau February 2010 - January 2011
RQV Consulting December 2007 - February 2010
Alexza Pharmaceuticals August 2007 - September 2007
TVS April 2007 - June 2007
Skills
EDM Quality, Document Management, Technical Training, Medical Devices, IR spectroscopy, Western Blotting, Validation, Process Validation, CAPA, cGMP, FDA, GMP, SOP, Pharmaceuticals, Biotechnology, Quality Assurance, Quality Systems, Documentation, Life Sciences, Compliance, Technical Writing, Troubleshooting, Problem Solving, Validations, Software Documentation, V&V, Statistics, Quality System, Microbiology, Testing, Change Control, Quality Control, Leadership, Quality Auditing, Training, GAMP, GxP, Pharmaceutical Industry, LIMS, Lifesciences, Computer System..., Technology Transfer, Biochemistry, Laboratory, Root Cause Analysis, Purification, Biopharmaceuticals, PCR, GLP, Trackwise
Education
Inter-American University of Puerto Rico-Arecibo Campus 2003 — 2004
BS, Biology minnor Chemistry
Universidad de Puerto Rico 1995 — 2002
n/a, Biology
Jim Zhang Jim Zhang's Alexza Pharmaceuticals Experience January 2015 - Present
Job Analytical Development and Quality Control Professional with 15+ Years Pharmaceutical Developement Experience
Industry Pharmaceuticals
Experience
Alexza Pharmaceuticals January 2015 - Present
Gilead Sciences 2013 - November 2014
Infinity Pharmaceuticals 2011 - 2013
Affymax, Inc. 2002 - 2011
Affymax Research Institute, GlaxoSmithKline 2000 - 2002
AstraZeneca 1998 - 2000
Archer Daniels Midland Company 1995 - 1998
University of California, San Francisco 1994 - 1995
Skills
Peptides, Problem Solving, HPLC, GMP, Mass Spectrometry, Pharmaceutical..., Analytical Chemistry, LC-MS, Pharmaceuticals, Chemistry, Chromatography, Biotechnology, Validation, Drug Discovery, NMR, Formulation Development, Characterization, Regulatory Submissions, R&D, Protein Purification, Purification, IR, Product Development, Pharmaceutical Industry, Oncology, Formulation, Drug Development, FDA, Protein Chemistry, Pharmaceutics, IND, Technology Transfer, Biopharmaceuticals, CMC, Medicinal Chemistry, CRO, Clinical Development, NDA, Organic Chemistry, Sop, Lifesciences, Assay Development, Life Sciences
Education
University of Illinois at Urbana-Champaign
Doctor of Philosophy (Ph.D.), Chemistry
Alexza Pharmaceuticals January 2015 - Present
Gilead Sciences 2013 - November 2014
Infinity Pharmaceuticals 2011 - 2013
Affymax, Inc. 2002 - 2011
Affymax Research Institute, GlaxoSmithKline 2000 - 2002
AstraZeneca 1998 - 2000
Archer Daniels Midland Company 1995 - 1998
University of California, San Francisco 1994 - 1995
Skills
Peptides, Problem Solving, HPLC, GMP, Mass Spectrometry, Pharmaceutical..., Analytical Chemistry, LC-MS, Pharmaceuticals, Chemistry, Chromatography, Biotechnology, Validation, Drug Discovery, NMR, Formulation Development, Characterization, Regulatory Submissions, R&D, Protein Purification, Purification, IR, Product Development, Pharmaceutical Industry, Oncology, Formulation, Drug Development, FDA, Protein Chemistry, Pharmaceutics, IND, Technology Transfer, Biopharmaceuticals, CMC, Medicinal Chemistry, CRO, Clinical Development, NDA, Organic Chemistry, Sop, Lifesciences, Assay Development, Life Sciences
Education
University of Illinois at Urbana-Champaign
Doctor of Philosophy (Ph.D.), Chemistry
Kathleen Simis Kathleen Simis's Alexza Pharmaceuticals Experience June 2004 - December 2009
Job Scientific & Regulatory Medical Writer
Industry Pharmaceuticals
Experience
various American and European Pharmaceutical companies June 2009 - Present
Alexza Pharmaceuticals June 2004 - December 2009
Alexza MDC June 2004 - May 2009
UC Berkeley August 2003 - June 2004
Alza January 2001 - August 2001
Skills
Regulatory Writing, Scientific Writing, Medical Writing, Research, Pharmaceutical..., Characterization, Polymers, Asthma, Writing, Medical Devices, Biomaterials, R&D, Product Development, Pharmaceutical Industry, Lifesciences, Laboratory, FDA, Chemistry, Biotechnology, Technology Transfer
Education
University of California, Berkeley 1999 — 2004
MS, Bioengineering, Mechanical Engineering
various American and European Pharmaceutical companies June 2009 - Present
Alexza Pharmaceuticals June 2004 - December 2009
Alexza MDC June 2004 - May 2009
UC Berkeley August 2003 - June 2004
Alza January 2001 - August 2001
Skills
Regulatory Writing, Scientific Writing, Medical Writing, Research, Pharmaceutical..., Characterization, Polymers, Asthma, Writing, Medical Devices, Biomaterials, R&D, Product Development, Pharmaceutical Industry, Lifesciences, Laboratory, FDA, Chemistry, Biotechnology, Technology Transfer
Education
University of California, Berkeley 1999 — 2004
MS, Bioengineering, Mechanical Engineering
Lisa Garman's Alexza Pharmaceuticals Experience May 2008 - June 2010
Job Associate Marketing Director/Head of U.S. Public Relations at Kowa Pharmaceuticals
Industry Pharmaceuticals
Experience
Kowa Pharmaceuticals America, Inc March 2011 - Present
Alexza Pharmaceuticals May 2008 - June 2010
New Mom August 2007 - May 2008
UCB Pharma July 1995 - August 2007
UCB Pharmaceuticals January 1999 - August 2001
UCB Pharmaceuticals August 1997 - January 1999
UCB Pharmaceuticals July 1995 - August 1997
Skills
Marketing Communications, Public Relations, Patient Advocacy, Crisis Communications, Marketing Strategy, Business Planning, Corporate Communications, Internal Communications, Pharmaceuticals, Product Management, Pharmaceutical Industry, Cross-functional Team..., Product Launch, Strategy, Neurology, Sales Effectiveness, Pharmaceutical Sales, Rheumatology, Gastroenterology, Marketing, Integrated Marketing, Market Research, Leadership, Advertising, Management, Product Development, Strategic Planning, Dermatology, Hospital Sales, Market Planning, Training, Urology, Psychiatry, Infectious Diseases, Cardiology, Endocrinology, Healthcare, Oncology, Global Marketing, Diabetes, Medical Devices, Biopharmaceuticals, Managed Care, Allergy, Commercialization, Biotechnology, Market Access, Pharmaceutics, Medical Affairs
Education
UCLA Anderson School of Management
Advanced Certificate, Medical Marketing
Shorter University
Bachelor of Science, Business Management, Marketing
Kowa Pharmaceuticals America, Inc March 2011 - Present
Alexza Pharmaceuticals May 2008 - June 2010
New Mom August 2007 - May 2008
UCB Pharma July 1995 - August 2007
UCB Pharmaceuticals January 1999 - August 2001
UCB Pharmaceuticals August 1997 - January 1999
UCB Pharmaceuticals July 1995 - August 1997
Skills
Marketing Communications, Public Relations, Patient Advocacy, Crisis Communications, Marketing Strategy, Business Planning, Corporate Communications, Internal Communications, Pharmaceuticals, Product Management, Pharmaceutical Industry, Cross-functional Team..., Product Launch, Strategy, Neurology, Sales Effectiveness, Pharmaceutical Sales, Rheumatology, Gastroenterology, Marketing, Integrated Marketing, Market Research, Leadership, Advertising, Management, Product Development, Strategic Planning, Dermatology, Hospital Sales, Market Planning, Training, Urology, Psychiatry, Infectious Diseases, Cardiology, Endocrinology, Healthcare, Oncology, Global Marketing, Diabetes, Medical Devices, Biopharmaceuticals, Managed Care, Allergy, Commercialization, Biotechnology, Market Access, Pharmaceutics, Medical Affairs
Education
UCLA Anderson School of Management
Advanced Certificate, Medical Marketing
Shorter University
Bachelor of Science, Business Management, Marketing
Robert Lippe Robert Lippe's Alexza Pharmaceuticals Experience February 2014 - June 2015
Job Chief Operations Officer at Liquidia Technologies
Industry Biotechnology
Experience
Liquidia Technologies July 2015 - Present
Alexza Pharmaceuticals February 2014 - June 2015
Ironwood Pharmaceuticals January 2011 - February 2014
Roche October 2007 - January 2011
Genentech April 2006 - October 2007
Genentech May 2004 - April 2006
Genentech May 2002 - May 2004
Lawrence Livermore National Laboratory May 1992 - May 2002
Skills
FDA, GMP, Biotechnology, Technology Transfer, Pharmaceutical Industry, Sop, Validation, Cross-functional Team..., Operational Excellence, CAPA, Biopharmaceuticals, Quality System, Manufacturing, Contract Manufacturing, V&V, Process Improvement, Six Sigma, Start-ups, Commercialization, Change Control, Strategic Planning, Medical Devices, Manufacturing Operations, Project Management, Process Simulation, SOP, Continuous Improvement, Quality Assurance, 21 CFR Part 11
Education
University of California, Berkeley, Haas School of Business 2001 — 2004
MBA, Finance and Management
University of California, Berkeley 1991 — 1994
MPH, Environmental and Industrial Health Sciences
U.S. Coast Guard Academy 1982 — 1986
BS, Marine/Mechanical Engineering
Liquidia Technologies July 2015 - Present
Alexza Pharmaceuticals February 2014 - June 2015
Ironwood Pharmaceuticals January 2011 - February 2014
Roche October 2007 - January 2011
Genentech April 2006 - October 2007
Genentech May 2004 - April 2006
Genentech May 2002 - May 2004
Lawrence Livermore National Laboratory May 1992 - May 2002
Skills
FDA, GMP, Biotechnology, Technology Transfer, Pharmaceutical Industry, Sop, Validation, Cross-functional Team..., Operational Excellence, CAPA, Biopharmaceuticals, Quality System, Manufacturing, Contract Manufacturing, V&V, Process Improvement, Six Sigma, Start-ups, Commercialization, Change Control, Strategic Planning, Medical Devices, Manufacturing Operations, Project Management, Process Simulation, SOP, Continuous Improvement, Quality Assurance, 21 CFR Part 11
Education
University of California, Berkeley, Haas School of Business 2001 — 2004
MBA, Finance and Management
University of California, Berkeley 1991 — 1994
MPH, Environmental and Industrial Health Sciences
U.S. Coast Guard Academy 1982 — 1986
BS, Marine/Mechanical Engineering
Denise Van Leemput Denise Van Leemput's Alexza Pharmaceuticals Experience January 2013 - Present
Job Executive Administrative Assistant at Alexza Pharmaceuticals
Industry Health, Wellness and Fitness
Experience
Alexza Pharmaceuticals January 2013 - Present
Parelius Insurance Services April 2011 - September 2012
iD Tech Camps June 2010 - September 2010
Advogent October 2006 - November 2008
Vander Zwaag Financial, Inc. April 2005 - October 2006
American Express Financial Advisors April 2002 - April 2004
DirecTV Broadband December 1999 - September 2001
LifeScan August 1998 - March 1999
Skills
Social Media, Outlook, Customer Service, Microsoft Office, PowerPoint, Microsoft Excel, Project Management, Software Documentation, Lotus Notes, Access, Microsoft Word, Project Planning, QuickBooks, ACT, Account Management, Salesforce.com, Management, Recruiting, Program Management, Training
Education
Evergreen Valley College 2009 — 2011
Associate of Arts (AA), Health Sciences
West Valley College 1999 — 2001
Psychology
Alexza Pharmaceuticals January 2013 - Present
Parelius Insurance Services April 2011 - September 2012
iD Tech Camps June 2010 - September 2010
Advogent October 2006 - November 2008
Vander Zwaag Financial, Inc. April 2005 - October 2006
American Express Financial Advisors April 2002 - April 2004
DirecTV Broadband December 1999 - September 2001
LifeScan August 1998 - March 1999
Skills
Social Media, Outlook, Customer Service, Microsoft Office, PowerPoint, Microsoft Excel, Project Management, Software Documentation, Lotus Notes, Access, Microsoft Word, Project Planning, QuickBooks, ACT, Account Management, Salesforce.com, Management, Recruiting, Program Management, Training
Education
Evergreen Valley College 2009 — 2011
Associate of Arts (AA), Health Sciences
West Valley College 1999 — 2001
Psychology
Bijan Amini Bijan Amini's Alexza Pharmaceuticals Experience April 2006 - December 2011
Job Senior Security Analyst at TIBCO Software Inc.
Industry Information Technology and Services
Experience
TIBCO Software Inc. November 2013 - Present
Pitney Bowes October 2012 - November 2013
Alexza Pharmaceuticals April 2006 - December 2011
Symantec 2004 - 2006
Skills
Document Management, Citrix, Cloud Computing, VMware, System Administration, Medical Devices, Customer Service, VPN, Active Directory, VMware ESX, Software Documentation, Project Management, VMware Infrastructure, Troubleshooting, Virtualization, Servers, Data Center, DNS, DHCP
Education
DeVry University-California 2002 — 2004
B.S., Networking and Communications Management
TIBCO Software Inc. November 2013 - Present
Pitney Bowes October 2012 - November 2013
Alexza Pharmaceuticals April 2006 - December 2011
Symantec 2004 - 2006
Skills
Document Management, Citrix, Cloud Computing, VMware, System Administration, Medical Devices, Customer Service, VPN, Active Directory, VMware ESX, Software Documentation, Project Management, VMware Infrastructure, Troubleshooting, Virtualization, Servers, Data Center, DNS, DHCP
Education
DeVry University-California 2002 — 2004
B.S., Networking and Communications Management
Oya Thomson, CPIM's Alexza Pharmaceuticals Experience November 2014 - Present
Job Senior Business Analyst at Alexza Pharmaceuticals
Industry Information Technology and Services
Experience
Alexza Pharmaceuticals November 2014 - Present
E2open April 2014 - November 2014
Kinaxis November 2012 - February 2014
SAP July 2012 - November 2012
SAP April 2011 - August 2012
Genentech April 2009 - April 2011
Adobe Systems January 2008 - April 2009
Team Consulting Group June 2007 - September 2007
SAP April 2005 - April 2007
SASC March 2002 - April 2005
Skills
Supply Chain Management, SAP ERP, Business Process..., Enterprise Architecture, Business Architecture, Agile Methodologies, Project and Program..., SAP-SCM, SAP-SCRM, SAP, ERP, Business Process, IT Strategy, Business Process..., Solution Architecture, Business Process Design, Process Improvement, Integration, Process Engineering, Business Intelligence, Supply Chain, Business Process..., Testing, Project Planning, Consulting, Management, Leadership, Enterprise Software, Software Project..., Business Analysis, SDLC, Requirements Analysis, PMP, SAP APO, Master Data Management, Project Portfolio..., Data Warehousing, SaaS, PMO, SOA, Program Management, Vendor Management, Cross-functional Team..., Agile Project Management, Project Management
Education
Stanford University 2010 — 2012
Professional Certification, Advanced Project Management
Florida State University 1986 — 1990
BS, College of Business and Engineering
Alexza Pharmaceuticals November 2014 - Present
E2open April 2014 - November 2014
Kinaxis November 2012 - February 2014
SAP July 2012 - November 2012
SAP April 2011 - August 2012
Genentech April 2009 - April 2011
Adobe Systems January 2008 - April 2009
Team Consulting Group June 2007 - September 2007
SAP April 2005 - April 2007
SASC March 2002 - April 2005
Skills
Supply Chain Management, SAP ERP, Business Process..., Enterprise Architecture, Business Architecture, Agile Methodologies, Project and Program..., SAP-SCM, SAP-SCRM, SAP, ERP, Business Process, IT Strategy, Business Process..., Solution Architecture, Business Process Design, Process Improvement, Integration, Process Engineering, Business Intelligence, Supply Chain, Business Process..., Testing, Project Planning, Consulting, Management, Leadership, Enterprise Software, Software Project..., Business Analysis, SDLC, Requirements Analysis, PMP, SAP APO, Master Data Management, Project Portfolio..., Data Warehousing, SaaS, PMO, SOA, Program Management, Vendor Management, Cross-functional Team..., Agile Project Management, Project Management
Education
Stanford University 2010 — 2012
Professional Certification, Advanced Project Management
Florida State University 1986 — 1990
BS, College of Business and Engineering
Jesse McFarland Jesse McFarland's Alexza Pharmaceuticals Experience January 2003 - August 2003
Job Scientist at Catalent Biologics West
Industry Research
Experience
Catalent Biologics - West (formerly Redwood Bioscience) September 2013 - Present
UCSF June 2008 - September 2013
UC Berkeley August 2003 - May 2008
Alexza Pharmaceuticals January 2003 - August 2003
Zyomyx 2001 - 2002
Skills
Organic Chemistry, Organic Synthesis, Drug Discovery, Chemistry, Analytical Chemistry, Cell Culture, Medicinal Chemistry, Assay Development, Bioorganic Chemistry, Bioconjugate Chemistry, NMR, Protein Purification, Cell Biology, Protein Chemistry, HPLC, Biochemistry, Cell-based assays, Antibody Drug..., Antibody...
Education
UC Berkeley 2003 — 2008
Doctor of Philosophy (PhD), Chemistry
Cornell University 1996 — 2000
Bachelor of Arts (BA), Chemistry
Catalent Biologics - West (formerly Redwood Bioscience) September 2013 - Present
UCSF June 2008 - September 2013
UC Berkeley August 2003 - May 2008
Alexza Pharmaceuticals January 2003 - August 2003
Zyomyx 2001 - 2002
Skills
Organic Chemistry, Organic Synthesis, Drug Discovery, Chemistry, Analytical Chemistry, Cell Culture, Medicinal Chemistry, Assay Development, Bioorganic Chemistry, Bioconjugate Chemistry, NMR, Protein Purification, Cell Biology, Protein Chemistry, HPLC, Biochemistry, Cell-based assays, Antibody Drug..., Antibody...
Education
UC Berkeley 2003 — 2008
Doctor of Philosophy (PhD), Chemistry
Cornell University 1996 — 2000
Bachelor of Arts (BA), Chemistry
Celeste Karpow Celeste Karpow's Alexza Pharmaceuticals Experience June 2008 - July 2008
Job PGY1 Pharmacy Resident at Henry Ford Health System
Industry Hospital & Health Care
Experience
Henry Ford Health System June 2015 - Present
University of Connecticut January 2011 - May 2014
Waterbury Public Health Department January 2013 - July 2013
Belle Haven Club June 2012 - August 2012
CVS Health September 2009 - April 2010
Alexza Pharmaceuticals June 2008 - July 2008
Education
University of Connecticut 2010 — 2015
Doctor of Pharmacy (PharmD), Pharmacy
University of Connecticut 2012 — 2015
Master of Public Health (MPH), Public Health
Wheaton College (MA) 2005 — 2009
BA, Biochemistry
Henry Ford Health System June 2015 - Present
University of Connecticut January 2011 - May 2014
Waterbury Public Health Department January 2013 - July 2013
Belle Haven Club June 2012 - August 2012
CVS Health September 2009 - April 2010
Alexza Pharmaceuticals June 2008 - July 2008
Education
University of Connecticut 2010 — 2015
Doctor of Pharmacy (PharmD), Pharmacy
University of Connecticut 2012 — 2015
Master of Public Health (MPH), Public Health
Wheaton College (MA) 2005 — 2009
BA, Biochemistry
Jim Horvath Jim Horvath's Alexza Pharmaceuticals Experience June 2010 - February 2012
Job Sr. Manager, Manufacturing Engineering at AcelRx Pharmaceuticals, Inc.
Industry Medical Devices
Experience
AcelRx Pharmaceuticals, Inc. October 2012 - Present
AcelRx Pharmaceuticals, Inc. February 2012 - October 2012
Alexza Pharmaceuticals June 2010 - February 2012
Alexza Pharmaceuticals September 2009 - June 2010
Calibra Medical, Inc 2008 - 2009
AccessClosure 2007 - 2008
Guidant Corp. / Abbott Vascular 2004 - 2007
Guidant Corp. 2003 - 2004
AlgoRx/POWDERJECT TECHNOLOGIES 1998 - 2003
CYGNUS INC 1996 - 1998
Skills
FDA, Engineering, Medical Devices, Design Control, Testing, CAPA
Education
San Jose State University
BSME, Mechanical Engineering
AcelRx Pharmaceuticals, Inc. October 2012 - Present
AcelRx Pharmaceuticals, Inc. February 2012 - October 2012
Alexza Pharmaceuticals June 2010 - February 2012
Alexza Pharmaceuticals September 2009 - June 2010
Calibra Medical, Inc 2008 - 2009
AccessClosure 2007 - 2008
Guidant Corp. / Abbott Vascular 2004 - 2007
Guidant Corp. 2003 - 2004
AlgoRx/POWDERJECT TECHNOLOGIES 1998 - 2003
CYGNUS INC 1996 - 1998
Skills
FDA, Engineering, Medical Devices, Design Control, Testing, CAPA
Education
San Jose State University
BSME, Mechanical Engineering
Andy Malcolm's Alexza Pharmaceuticals Experience January 2010 - October 2010
Job Packaging Engineer Consultant and Project Manager for the life science, wine, beverage & food industries.
Industry Packaging and Containers
Experience
P. Andrew Malcolm Consulting, Inc. (PAMC) June 1999 - Present
Gilead Sciences July 2014 - Present
Thermal Packaging Solutions, LLC July 2009 - Present
MannKind Corporation August 2013 - November 2014
Zyomyx May 2013 - June 2014
Shire Pharmaceuticals June 2012 - October 2013
Bayer HealthCare January 2011 - November 2011
Packaging Consultants Council of the IoPP July 2009 - September 2011
Promega April 2010 - December 2010
Alexza Pharmaceuticals January 2010 - October 2010
Skills
Manufacturing, Packaging, Engineering, Automation, Process Improvement, Beverage Industry, Food & Beverage, Packaging Engineering, Pharmaceutical Industry, Wine & Spirits Industry, Bottling, Capital Equipment, Pharmaceutical..., Pharmaceutical Packaging, Project Management, GMP, Testing, Management, Engineering Management, Equipment Engineering, Custom Automated..., User Requirements, Close Attention to..., Vendor Management, Vendor Relationships, Project Planning, Project Engineering, Equipment Installation, Program Management, Biopharmaceuticals, Medical Devices, Budgets, Product Launch, Biotechnology, Change Control, Cross-functional Team..., Vendor Relationship..., Quality System, Process Simulation, Quality Assurance, Commercialization, Lean Manufacturing, Continuous Improvement, Process Engineering, Product Development, Product Management
Education
Cornell University
BSME, Mechanical Engineering
St. Mary's College of California
MBA, Entrepreneurship
Avonworth High School
P. Andrew Malcolm Consulting, Inc. (PAMC) June 1999 - Present
Gilead Sciences July 2014 - Present
Thermal Packaging Solutions, LLC July 2009 - Present
MannKind Corporation August 2013 - November 2014
Zyomyx May 2013 - June 2014
Shire Pharmaceuticals June 2012 - October 2013
Bayer HealthCare January 2011 - November 2011
Packaging Consultants Council of the IoPP July 2009 - September 2011
Promega April 2010 - December 2010
Alexza Pharmaceuticals January 2010 - October 2010
Skills
Manufacturing, Packaging, Engineering, Automation, Process Improvement, Beverage Industry, Food & Beverage, Packaging Engineering, Pharmaceutical Industry, Wine & Spirits Industry, Bottling, Capital Equipment, Pharmaceutical..., Pharmaceutical Packaging, Project Management, GMP, Testing, Management, Engineering Management, Equipment Engineering, Custom Automated..., User Requirements, Close Attention to..., Vendor Management, Vendor Relationships, Project Planning, Project Engineering, Equipment Installation, Program Management, Biopharmaceuticals, Medical Devices, Budgets, Product Launch, Biotechnology, Change Control, Cross-functional Team..., Vendor Relationship..., Quality System, Process Simulation, Quality Assurance, Commercialization, Lean Manufacturing, Continuous Improvement, Process Engineering, Product Development, Product Management
Education
Cornell University
BSME, Mechanical Engineering
St. Mary's College of California
MBA, Entrepreneurship
Avonworth High School
Jane Han Jane Han's Alexza Pharmaceuticals Experience 2012 - Present
Job Pharmaceutical and medical Device IndustryProfessional
Industry Pharmaceuticals
Experience
Validant/Gilead July 2013 - Present
Alexza Pharmaceuticals 2012 - Present
Skills
FDA, GMP, HPLC, Pharmaceutical Industry, Sop, Analytical Chemistry, GLP, Validation, Biopharmaceuticals, cGMP, Pharmaceuticals, IND, NDA, Method development and..., Preclinical project, Quality control, CRO, PAI, GMP Audit, CAPA, Qaulity Audit, Agile Advantage, Document Control, Electronic Data..., OOS/OOT, Quality System, Metrics Reporting, Bill of Material, Empower, Chemstation, Editing, manufacturing batch..., specifications, Stability, LIMS,, USP, solid dosage, Combination Products, Method Transfer, Compendial Methods, Compendial Procedure..., SOP
Education
Oregon Health and Science University
Doctor of Philosophy (Ph.D.), Chemistry
Wuhan University
Bachelor of chemistry(B.A.Sc.), Physical Chemistry
Validant/Gilead July 2013 - Present
Alexza Pharmaceuticals 2012 - Present
Skills
FDA, GMP, HPLC, Pharmaceutical Industry, Sop, Analytical Chemistry, GLP, Validation, Biopharmaceuticals, cGMP, Pharmaceuticals, IND, NDA, Method development and..., Preclinical project, Quality control, CRO, PAI, GMP Audit, CAPA, Qaulity Audit, Agile Advantage, Document Control, Electronic Data..., OOS/OOT, Quality System, Metrics Reporting, Bill of Material, Empower, Chemstation, Editing, manufacturing batch..., specifications, Stability, LIMS,, USP, solid dosage, Combination Products, Method Transfer, Compendial Methods, Compendial Procedure..., SOP
Education
Oregon Health and Science University
Doctor of Philosophy (Ph.D.), Chemistry
Wuhan University
Bachelor of chemistry(B.A.Sc.), Physical Chemistry
Ali Komeyli Ali Komeyli's Alexza Pharmaceuticals Experience October 2004 - August 2009
Job Director Technical Services
Industry Pharmaceuticals
Experience
Onyx Pharmaceuticals May 2014 - Present
Genentech April 2012 - May 2014
PolyPeptide Laboratories August 2009 - April 2012
Alexza Pharmaceuticals October 2004 - August 2009
ALZA Corporation 2001 - 2004
CV Therapeutics 1999 - 2001
Merck 1995 - 1999
G D Searle 1993 - 1995
Skills
GMP, Validation, Technology Transfer, Continuous Improvement, FDA, ISO, Manufacturing, Six Sigma, Cross-functional Team..., Change Control, Clinical Development, CAPA, Risk Assessment, Pharmaceutics, Regulatory Requirements, V&V, Quality System, SOP, Commercialization, 21 CFR Part 11, Green Belt, Quality by Design, Lean Principles and..., Black Belt
Education
Cleveland State University 1988 — 1992
BS, Chemical Engineering
Onyx Pharmaceuticals May 2014 - Present
Genentech April 2012 - May 2014
PolyPeptide Laboratories August 2009 - April 2012
Alexza Pharmaceuticals October 2004 - August 2009
ALZA Corporation 2001 - 2004
CV Therapeutics 1999 - 2001
Merck 1995 - 1999
G D Searle 1993 - 1995
Skills
GMP, Validation, Technology Transfer, Continuous Improvement, FDA, ISO, Manufacturing, Six Sigma, Cross-functional Team..., Change Control, Clinical Development, CAPA, Risk Assessment, Pharmaceutics, Regulatory Requirements, V&V, Quality System, SOP, Commercialization, 21 CFR Part 11, Green Belt, Quality by Design, Lean Principles and..., Black Belt
Education
Cleveland State University 1988 — 1992
BS, Chemical Engineering
Vi Pham Vi Pham's Alexza Pharmaceuticals Experience June 2014 - August 2014
Job Research Associate I at Teikoku Pharma USA
Industry Pharmaceuticals
Experience
Teikoku Pharma USA October 2014 - Present
Alexza Pharmaceuticals June 2014 - August 2014
One on One Tutoring January 2014 - June 2014
VN CARES October 2012 - June 2013
Skills
GC, LC, DSC, HPLC, TGA, Skin Flux, Viscometry, Method Development, Microsoft Office, Research, Differential Scanning..., Teaching, Public Speaking, Outlook, Strategic Planning, Laboratory, Chemistry, Biochemistry, Tutoring, Data Analysis
Education
University of California, Davis 2010 — 2014
Bachelor's Degree, Biochemistry and Molecular Biology
Teikoku Pharma USA October 2014 - Present
Alexza Pharmaceuticals June 2014 - August 2014
One on One Tutoring January 2014 - June 2014
VN CARES October 2012 - June 2013
Skills
GC, LC, DSC, HPLC, TGA, Skin Flux, Viscometry, Method Development, Microsoft Office, Research, Differential Scanning..., Teaching, Public Speaking, Outlook, Strategic Planning, Laboratory, Chemistry, Biochemistry, Tutoring, Data Analysis
Education
University of California, Davis 2010 — 2014
Bachelor's Degree, Biochemistry and Molecular Biology
Alexis Palefsky Alexis Palefsky's Alexza Pharmaceuticals Experience July 2008 - May 2010
Job Senior Manager, Global Commercial Operations at BioMarin Pharmaceutical Inc.
Industry Biotechnology
Experience
BioMarin Pharmaceutical Inc. March 2015 - Present
BioMarin Pharmaceutical Inc. July 2013 - March 2015
Amgen June 2012 - July 2013
Amgen June 2011 - August 2011
Alexza Pharmaceuticals July 2008 - May 2010
Alexza Pharmaceuticals August 2007 - June 2008
Gentiae Clinical Research June 2005 - May 2006
Gentiae Clinical Research April 2005 - May 2005
Clinimetrics September 2004 - April 2005
Skills
Oncology, Pharmaceutical Industry, Biotechnology, Cross-functional Team..., Medical Devices, Lifesciences, Biopharmaceuticals, Project Management, FDA, Clinical Development, Process Improvement, Business Strategy, Clinical Trials, Commercialization, Drug Development, Leadership
Education
Carnegie Mellon University 2010 — 2012
Master of Business Administration (MBA), Track - Management of Innovation and Product Development, Concentrations - Marketing, Organizational Behavior
University of Southern California 2000 — 2004
BS, Kinesiology
Menlo School
BioMarin Pharmaceutical Inc. March 2015 - Present
BioMarin Pharmaceutical Inc. July 2013 - March 2015
Amgen June 2012 - July 2013
Amgen June 2011 - August 2011
Alexza Pharmaceuticals July 2008 - May 2010
Alexza Pharmaceuticals August 2007 - June 2008
Gentiae Clinical Research June 2005 - May 2006
Gentiae Clinical Research April 2005 - May 2005
Clinimetrics September 2004 - April 2005
Skills
Oncology, Pharmaceutical Industry, Biotechnology, Cross-functional Team..., Medical Devices, Lifesciences, Biopharmaceuticals, Project Management, FDA, Clinical Development, Process Improvement, Business Strategy, Clinical Trials, Commercialization, Drug Development, Leadership
Education
Carnegie Mellon University 2010 — 2012
Master of Business Administration (MBA), Track - Management of Innovation and Product Development, Concentrations - Marketing, Organizational Behavior
University of Southern California 2000 — 2004
BS, Kinesiology
Menlo School
Sarah L Goertzen's Alexza Pharmaceuticals Experience October 2014 - Present
Job Analytical R&D Associate II at Alexza Pharmaceuticals
Industry Research
Experience
Alexza Pharmaceuticals October 2014 - Present
Leyden Energy May 2011 - May 2014
Dalhousie University September 2008 - December 2009
Wilfrid Laurier University January 2007 - April 2008
Wilfrid Laurier University May 2007 - August 2007
Deep River Science Academy May 2006 - August 2006
Skills
Electrochemistry, Spectroscopy, Analytical Chemistry, Physical Chemistry, SEM, Microsoft Excel, Microsoft Word, UV/Vis, Chemistry, Coin cell testing, Organizational..., Event Planning, OneNote, Access, Arbin, Materials, R&D, Volunteering, XPS, Microscopy, Cyclic Voltammetry, Statistics, Fluorescence, IR spectroscopy, Polymers, Gas Chromatography, Titration, Laboratory, Characterization, Optical Microscopy, Experimentation, Volunteer Leadership, Excel, HPLC, Word, Outlook, IR Spectroscopy
Education
Dalhousie University 2008 — 2010
Master of Science, Chemistry
Wilfrid Laurier University 2004 — 2008
Bachelor of Science, Chemistry
Alexza Pharmaceuticals October 2014 - Present
Leyden Energy May 2011 - May 2014
Dalhousie University September 2008 - December 2009
Wilfrid Laurier University January 2007 - April 2008
Wilfrid Laurier University May 2007 - August 2007
Deep River Science Academy May 2006 - August 2006
Skills
Electrochemistry, Spectroscopy, Analytical Chemistry, Physical Chemistry, SEM, Microsoft Excel, Microsoft Word, UV/Vis, Chemistry, Coin cell testing, Organizational..., Event Planning, OneNote, Access, Arbin, Materials, R&D, Volunteering, XPS, Microscopy, Cyclic Voltammetry, Statistics, Fluorescence, IR spectroscopy, Polymers, Gas Chromatography, Titration, Laboratory, Characterization, Optical Microscopy, Experimentation, Volunteer Leadership, Excel, HPLC, Word, Outlook, IR Spectroscopy
Education
Dalhousie University 2008 — 2010
Master of Science, Chemistry
Wilfrid Laurier University 2004 — 2008
Bachelor of Science, Chemistry
Robert Fishman Robert Fishman's Alexza Pharmaceuticals Experience 2008 - 2012
Job Chief Medical Officer at Corcept Therapeutics
Industry Pharmaceuticals
Experience
Corcept Therapeutics 2015 - Present
InterMune 2012 - 2015
Alexza Pharmaceuticals 2008 - 2012
Anthera Pharmaceuticals 2005 - 2008
Aerogen 1997 - 2005
Heartport 1995 - 1997
Stanford University School of Medicine 1993 - 1995
Harvard University Health Services 1990 - 1993
Skills
Clinical Development, Clinical Trials, Drug Development, Medical Devices, FDA, Pulmonary Disease, Aerosol Science, Lifesciences, Pulmonology, Pharmaceutical Industry, Biotechnology, Internal Medicine, Asthma, Psychiatry, NDA, Hematology, Medicine, Clinical Research, Infectious Diseases, Biopharmaceuticals
Education
Massachusetts General Hospital 1989 — 1992
Fellowship in Pulmonary & Critical Care Medicine
BI / Deaconess Medical Center 1986 — 1989
Residency in Internal Medicine
Stanford University School of Medicine 1982 — 1986
MD, Medicine
Harvard University 1978 — 1982
AB, Biology
Corcept Therapeutics 2015 - Present
InterMune 2012 - 2015
Alexza Pharmaceuticals 2008 - 2012
Anthera Pharmaceuticals 2005 - 2008
Aerogen 1997 - 2005
Heartport 1995 - 1997
Stanford University School of Medicine 1993 - 1995
Harvard University Health Services 1990 - 1993
Skills
Clinical Development, Clinical Trials, Drug Development, Medical Devices, FDA, Pulmonary Disease, Aerosol Science, Lifesciences, Pulmonology, Pharmaceutical Industry, Biotechnology, Internal Medicine, Asthma, Psychiatry, NDA, Hematology, Medicine, Clinical Research, Infectious Diseases, Biopharmaceuticals
Education
Massachusetts General Hospital 1989 — 1992
Fellowship in Pulmonary & Critical Care Medicine
BI / Deaconess Medical Center 1986 — 1989
Residency in Internal Medicine
Stanford University School of Medicine 1982 — 1986
MD, Medicine
Harvard University 1978 — 1982
AB, Biology
Caitlin Devereaux Caitlin Devereaux's Alexza Pharmaceuticals Experience December 2004 - August 2008
Job Medical Writer / Design Control Consultant
Industry Medical Devices
Experience
Genentech November 2012 - Present
Independent Contractor August 2008 - May 2012
Alexza Pharmaceuticals December 2004 - August 2008
CyberSense September 2000 - December 2004
Skills
Medical Devices, Agile Methodologies, R&D, Regulatory Requirements, Regulatory Submissions, Design Control, Medical Writing, Combination Products, Pharmaceutical Industry, Biotechnology, FDA, IND
Education
Massachusetts Institute of Technology 2002 — 2004
Master of Science (M.S.), Materials Science and Technology
Harvey Mudd College 1998 — 2002
Bachelor of Science (B.S.), Chemistry
Genentech November 2012 - Present
Independent Contractor August 2008 - May 2012
Alexza Pharmaceuticals December 2004 - August 2008
CyberSense September 2000 - December 2004
Skills
Medical Devices, Agile Methodologies, R&D, Regulatory Requirements, Regulatory Submissions, Design Control, Medical Writing, Combination Products, Pharmaceutical Industry, Biotechnology, FDA, IND
Education
Massachusetts Institute of Technology 2002 — 2004
Master of Science (M.S.), Materials Science and Technology
Harvey Mudd College 1998 — 2002
Bachelor of Science (B.S.), Chemistry
Shuchi Kuo's Alexza Pharmaceuticals Experience March 2015 - May 2015
Job QC Microbiology/Validation/Environmental Monitoring/Analytical Chemistry Data Review
Industry Biotechnology
Experience
Alexza Pharmaceuticals March 2015 - May 2015
MedImmune January 2010 - December 2012
MedImmune August 2005 - December 2009
MedImmune January 2002 - July 2005
Antech Diagnostics September 2001 - January 2002
Skills
GMP, CAPA, LIMS, Sop, Microbiology, Validation, Environmental Monitoring, Vaccines, Quality Control, cGMP practices, USP, Regulatory Requirements, GLP, Aseptic Technique, non-conformance, Supervising, ISO, Analytical Method..., Investigation, OOS, Risk Assessment, VSCR, Internal Audit, External Audit, OOT, cGLP, Regulatory Guidelines, Method Transfer, Critical Utility..., Autoclave sterlization..., Analytical Chemistry..., Medical Devices
Education
San Jose State University 1997 — 2001
BS, Microbiology
Alexza Pharmaceuticals March 2015 - May 2015
MedImmune January 2010 - December 2012
MedImmune August 2005 - December 2009
MedImmune January 2002 - July 2005
Antech Diagnostics September 2001 - January 2002
Skills
GMP, CAPA, LIMS, Sop, Microbiology, Validation, Environmental Monitoring, Vaccines, Quality Control, cGMP practices, USP, Regulatory Requirements, GLP, Aseptic Technique, non-conformance, Supervising, ISO, Analytical Method..., Investigation, OOS, Risk Assessment, VSCR, Internal Audit, External Audit, OOT, cGLP, Regulatory Guidelines, Method Transfer, Critical Utility..., Autoclave sterlization..., Analytical Chemistry..., Medical Devices
Education
San Jose State University 1997 — 2001
BS, Microbiology
Nate Patterson Nate Patterson's Alexza Pharmaceuticals Experience April 2015 - Present
Job Associate Director, QC Stability at Alexza Pharmaceuticals
Industry Pharmaceuticals
Experience
Alexza Pharmaceuticals April 2015 - Present
Alexza Pharmaceuticals July 2014 - Present
Global Stability, LLC October 2012 - Present
Gilead Sciences January 2013 - March 2014
Inspiration Biopharmaceuticals November 2010 - October 2012
Vertex Pharmaceuticals 2006 - November 2010
Chiron Corporation 1987 - 2006
Chiron/Novartis 1987 - 2006
Skills
Biopharmaceuticals, GLP, Pharmaceutical Industry, Validation, GMP, Biotechnology, Drug Development, Technology Transfer, 21 CFR Part 11, IND, Sop, GCP, Chromatography, GxP, Quality Control, Aseptic Processing, Regulatory Affairs, LIMS, Computer System..., CMC, Pharmaceutics, Quality System, CRO, Regulatory Submissions, Analytical Chemistry, HPLC, Lifesciences, Clinical Development, Change Control, Drug Discovery, CAPA, FDA, Clinical Trials, Vaccines, Formulation, Quality by Design, LC-MS
Education
San Francisco State University 1982 — 1985
MA, Cell&Molec Biology; Genetic Engineering
San Jose State University 1976 — 1979
BA, Marine Biology / Minor Chemistry / Environmental Studies
Alexza Pharmaceuticals April 2015 - Present
Alexza Pharmaceuticals July 2014 - Present
Global Stability, LLC October 2012 - Present
Gilead Sciences January 2013 - March 2014
Inspiration Biopharmaceuticals November 2010 - October 2012
Vertex Pharmaceuticals 2006 - November 2010
Chiron Corporation 1987 - 2006
Chiron/Novartis 1987 - 2006
Skills
Biopharmaceuticals, GLP, Pharmaceutical Industry, Validation, GMP, Biotechnology, Drug Development, Technology Transfer, 21 CFR Part 11, IND, Sop, GCP, Chromatography, GxP, Quality Control, Aseptic Processing, Regulatory Affairs, LIMS, Computer System..., CMC, Pharmaceutics, Quality System, CRO, Regulatory Submissions, Analytical Chemistry, HPLC, Lifesciences, Clinical Development, Change Control, Drug Discovery, CAPA, FDA, Clinical Trials, Vaccines, Formulation, Quality by Design, LC-MS
Education
San Francisco State University 1982 — 1985
MA, Cell&Molec Biology; Genetic Engineering
San Jose State University 1976 — 1979
BA, Marine Biology / Minor Chemistry / Environmental Studies
Athena McCall Athena McCall's Alexza Pharmaceuticals Experience March 2014 - Present
Job Senior QC Analyst/LIR Specialist at Alexza Pharmaceuticals
Industry Medical Devices
Experience
Alexza Pharmaceuticals March 2014 - Present
Gilead Sciences October 2012 - February 2014
Abbott Vascular (formerly Guidant) June 2002 - June 2012
Aerogen June 2000 - June 2002
Skills
HPLC, UPLC, UV/Vis, Karl Fisher, LIMS, Sop, Deviations, CAPA, GPC, OOS, Leadership Trainer, Quality Control, FDA, GMP, GLP, GC-FID, Microsoft Excel, Microsoft Word, PowerPoint, Experienced Trainer, IV, Microsoft Office
Education
UC Santa Cruz
Bachelor of Science (BS), Chemistry
Alexza Pharmaceuticals March 2014 - Present
Gilead Sciences October 2012 - February 2014
Abbott Vascular (formerly Guidant) June 2002 - June 2012
Aerogen June 2000 - June 2002
Skills
HPLC, UPLC, UV/Vis, Karl Fisher, LIMS, Sop, Deviations, CAPA, GPC, OOS, Leadership Trainer, Quality Control, FDA, GMP, GLP, GC-FID, Microsoft Excel, Microsoft Word, PowerPoint, Experienced Trainer, IV, Microsoft Office
Education
UC Santa Cruz
Bachelor of Science (BS), Chemistry
Anu Garg Anu Garg's Alexza Pharmaceuticals Experience January 2008 - February 2012
Job Senior Scientist II, CMC Analytical at Onyx Pharmaceuticals, An Amgen Subsidiary
Industry Pharmaceuticals
Experience
Onyx Pharmaceuticals, An Amgen Subsidiary April 2012 - Present
ALEXZA Pharmaceuticals January 2008 - February 2012
ALZA Corporation 2000 - 2007
Ortho-McNeil Pharmaceutical 1999 - 2000
Cygnus, Inc. 1998 - 1999
Skills
Analytical Chemistry, HPLC, GLP, LC-MS, GMP, Drug Delivery, Technology Transfer, FDA, Drug Development, CMC, Formulation, Chromatography, IND, SOP, cGMP, Methods Development, Methods Validation, GC
Education
Meerut University
Ph.D., Chemistry
University of Guelph
M.S., Chemistry
Onyx Pharmaceuticals, An Amgen Subsidiary April 2012 - Present
ALEXZA Pharmaceuticals January 2008 - February 2012
ALZA Corporation 2000 - 2007
Ortho-McNeil Pharmaceutical 1999 - 2000
Cygnus, Inc. 1998 - 1999
Skills
Analytical Chemistry, HPLC, GLP, LC-MS, GMP, Drug Delivery, Technology Transfer, FDA, Drug Development, CMC, Formulation, Chromatography, IND, SOP, cGMP, Methods Development, Methods Validation, GC
Education
Meerut University
Ph.D., Chemistry
University of Guelph
M.S., Chemistry
Christopher Humm, CPIM, C.P.M. Christopher Humm, CPIM, C.P.M.'s Alexza Pharmaceuticals Experience 2010 - 2010
Job Supply Chain Management Professional
Industry Biotechnology
Experience
Thoratec Corporation January 2009 - March 2010
Alexza Pharmaceuticals 2010 - 2010
Cell Genesys, Inc October 2007 - December 2008
Genentech, Inc July 2005 - September 2007
Chiron Corporation October 1998 - January 2005
RIX Industries January 1997 - January 1998
Bio-Rad Laboratories, Inc January 1990 - January 1997
Education
California State University-East Bay
MBA, Supply Chain Management
California State University-Sacramento
BS, Business Administration, Production, Operations and Systems Mgmt.
Thoratec Corporation January 2009 - March 2010
Alexza Pharmaceuticals 2010 - 2010
Cell Genesys, Inc October 2007 - December 2008
Genentech, Inc July 2005 - September 2007
Chiron Corporation October 1998 - January 2005
RIX Industries January 1997 - January 1998
Bio-Rad Laboratories, Inc January 1990 - January 1997
Education
California State University-East Bay
MBA, Supply Chain Management
California State University-Sacramento
BS, Business Administration, Production, Operations and Systems Mgmt.
Lucas Domian Lucas Domian's Alexza Pharmaceuticals Experience June 2013 - February 2014
Job Metrology Coordinator
Industry Medical Devices
Experience
St. Jude Medical August 2014 - Present
FibroGen May 2014 - June 2014
Alexza Pharmaceuticals June 2013 - February 2014
Dendreon 2006 - 2012
Dendreon 2006 - 2010
Intermountain Radiopharmacy 2005 - 2006
Starbucks 2002 - 2006
Skills
Biotechnology, GMP, Sop, FDA, GLP, Scrum, Process Mapping, Change Management, Visio, Metrics, KPI Reports, Business Analysis, IQ/OQ/PQ, 21 CFR Part 11, ISO 13485, CFR 820 part 11, Quality Auditing, CAPA, Quality Control, Root Cause Analysis, Quality Improvement..., Deviations, Situational Leadership, Cross-functional Team..., Technical Subject Matter, EM, ERP Oracle, FDQM, CMMS, BMRAM, CSV, cGMP practices, Change Control, Business Process Mapping
Education
Certified Careers Institute
Software Engineering
Salt Lake Community College
Computer Engineering; Network Engineering
School of Visual Concepts
Graphic Design
Weber State University
Criminal Justice
St. Jude Medical August 2014 - Present
FibroGen May 2014 - June 2014
Alexza Pharmaceuticals June 2013 - February 2014
Dendreon 2006 - 2012
Dendreon 2006 - 2010
Intermountain Radiopharmacy 2005 - 2006
Starbucks 2002 - 2006
Skills
Biotechnology, GMP, Sop, FDA, GLP, Scrum, Process Mapping, Change Management, Visio, Metrics, KPI Reports, Business Analysis, IQ/OQ/PQ, 21 CFR Part 11, ISO 13485, CFR 820 part 11, Quality Auditing, CAPA, Quality Control, Root Cause Analysis, Quality Improvement..., Deviations, Situational Leadership, Cross-functional Team..., Technical Subject Matter, EM, ERP Oracle, FDQM, CMMS, BMRAM, CSV, cGMP practices, Change Control, Business Process Mapping
Education
Certified Careers Institute
Software Engineering
Salt Lake Community College
Computer Engineering; Network Engineering
School of Visual Concepts
Graphic Design
Weber State University
Criminal Justice
Peter Wong Peter Wong's Alexza Pharmaceuticals Experience November 2008 - January 2009
Job Process Development Engineer at Baxter International Inc.
Industry Biotechnology
Experience
Baxter International Inc. May 2013 - Present
CSIX CONNECT PENINSULA January 2009 - Present
Amgen March 2012 - February 2013
Bayer HealthCare February 2011 - September 2011
An Architech-Engineer Company in Oakland, CA July 2009 - August 2010
Alexza Pharmaceuticals November 2008 - January 2009
Genentech April 2008 - October 2008
AccessClosure, Inc. March 2006 - March 2008
ALZA Corporation 2005 - 2006
Amgen-Fremont, Inc. June 2004 - January 2005
Skills
Validation, Medical Devices, CAPA, FMEA, PLC, Root Cause Analysis, FDA, Manufacturing, Instrumentation, Engineering, Process Development, Automation, Optimization, Quality Systems, ISO, R&D, Quality Assurance, Documentation, GMP, Troubleshooting, Process Improvement, Biotechnology, Software Documentation, Quality System, Testing, 21 CFR Part 11, Design Control, Change Control, Cross-functional Team..., Process Simulation, ISO 13485, Computer System..., Sop, Commissioning, GLP, Process Control, GxP, Six Sigma, Design of Experiments, Commercialization, Chromatography, Quality Control, Process Engineering, Minitab, Regulatory Affairs, Lifesciences, Calibration, Technology Transfer, Chemistry, Quality Management
Education
University of California, Berkeley 1974 — 1977
B.S., Chemical Engineering
City College of San Francisco 1972 — 1974
A.S., Chemistry
Baxter International Inc. May 2013 - Present
CSIX CONNECT PENINSULA January 2009 - Present
Amgen March 2012 - February 2013
Bayer HealthCare February 2011 - September 2011
An Architech-Engineer Company in Oakland, CA July 2009 - August 2010
Alexza Pharmaceuticals November 2008 - January 2009
Genentech April 2008 - October 2008
AccessClosure, Inc. March 2006 - March 2008
ALZA Corporation 2005 - 2006
Amgen-Fremont, Inc. June 2004 - January 2005
Skills
Validation, Medical Devices, CAPA, FMEA, PLC, Root Cause Analysis, FDA, Manufacturing, Instrumentation, Engineering, Process Development, Automation, Optimization, Quality Systems, ISO, R&D, Quality Assurance, Documentation, GMP, Troubleshooting, Process Improvement, Biotechnology, Software Documentation, Quality System, Testing, 21 CFR Part 11, Design Control, Change Control, Cross-functional Team..., Process Simulation, ISO 13485, Computer System..., Sop, Commissioning, GLP, Process Control, GxP, Six Sigma, Design of Experiments, Commercialization, Chromatography, Quality Control, Process Engineering, Minitab, Regulatory Affairs, Lifesciences, Calibration, Technology Transfer, Chemistry, Quality Management
Education
University of California, Berkeley 1974 — 1977
B.S., Chemical Engineering
City College of San Francisco 1972 — 1974
A.S., Chemistry
Stephanie Hart, PHR Stephanie Hart, PHR's Alexza Pharmaceuticals Experience September 2005 - May 2011
Job Manager, Human Resource Business Partner at Natera
Industry Pharmaceuticals
Experience
Natera January 2014 - Present
Onyx Pharmaceuticals May 2011 - December 2013
Alexza Pharmaceuticals September 2005 - May 2011
Affymetrix June 2005 - September 2005
BBSI January 2005 - June 2005
Abgenix/BBSI October 2003 - December 2004
Skills
Employee Relations, Training, Employee Communications, Talent Management, Leave Administration, Recruiting, Benefits Administration, HRIS, Sourcing, Internal Communications, Leadership, Vendor Management, Human Resources, Interviews, Onboarding, Employee Benefits, Process Improvement, Performance Management, Management, Applicant Tracking..., Program Management, Project Management, Customer Service, Temporary Placement, New Hire Orientations, Change Management, Talent Acquisition, Succession Planning, Organizational..., Workforce Planning, Conflict Resolution, Personnel Management, College Recruiting, Employee Engagement, Technical Recruiting, Employee Training, Internet Recruiting, Organizational..., Compensation & Benefit, Career Development, Organizational Design, Employer Branding, HR Policies, HR Consulting, Screening, Team Management
Education
University of San Francisco
BS, Organizational Behavior and Leadership
Villanova University 2005 — 2005
HR Cert, HR Management
Florida Institute of Technology
AA, Liberal Arts
HR Certification Institute (HRCI)
Professional in Human Resources, PHR
Homestead High School
Natera January 2014 - Present
Onyx Pharmaceuticals May 2011 - December 2013
Alexza Pharmaceuticals September 2005 - May 2011
Affymetrix June 2005 - September 2005
BBSI January 2005 - June 2005
Abgenix/BBSI October 2003 - December 2004
Skills
Employee Relations, Training, Employee Communications, Talent Management, Leave Administration, Recruiting, Benefits Administration, HRIS, Sourcing, Internal Communications, Leadership, Vendor Management, Human Resources, Interviews, Onboarding, Employee Benefits, Process Improvement, Performance Management, Management, Applicant Tracking..., Program Management, Project Management, Customer Service, Temporary Placement, New Hire Orientations, Change Management, Talent Acquisition, Succession Planning, Organizational..., Workforce Planning, Conflict Resolution, Personnel Management, College Recruiting, Employee Engagement, Technical Recruiting, Employee Training, Internet Recruiting, Organizational..., Compensation & Benefit, Career Development, Organizational Design, Employer Branding, HR Policies, HR Consulting, Screening, Team Management
Education
University of San Francisco
BS, Organizational Behavior and Leadership
Villanova University 2005 — 2005
HR Cert, HR Management
Florida Institute of Technology
AA, Liberal Arts
HR Certification Institute (HRCI)
Professional in Human Resources, PHR
Homestead High School
Elaine Stracker Elaine Stracker's Alexza Pharmaceuticals Experience March 2002 - May 2004
Job General Counsel at Pharmacyclics, Inc.
Industry Pharmaceuticals
Experience
Pharmacyclics, Inc. 2013 - Present
Medtronic Inc. 2011 - 2013
Gilead Sciences, Inc. January 2011 - August 2011
Merck & Co 2008 - 2011
SuperGen January 2007 - November 2007
Isbester & Thackray, LLP 2004 - 2007
Alexza Pharmaceuticals March 2002 - May 2004
Skills
Patents, Technology Transfer, Biotechnology, Intellectual Property, Patent Prosecution, Contract Negotiation, Patent Litigation, Licensing, Business Development, Life Sciences, Pharmaceutical Industry, Prosecution, Due Diligence, Biopharmaceuticals, Drug Discovery
Education
University of California, Berkeley - School of Law 1997 — 1999
JD, ILaw - Intellectual Property
University of California, Davis 1987 — 1992
Ph.D, Organic Chemistry
Pharmacyclics, Inc. 2013 - Present
Medtronic Inc. 2011 - 2013
Gilead Sciences, Inc. January 2011 - August 2011
Merck & Co 2008 - 2011
SuperGen January 2007 - November 2007
Isbester & Thackray, LLP 2004 - 2007
Alexza Pharmaceuticals March 2002 - May 2004
Skills
Patents, Technology Transfer, Biotechnology, Intellectual Property, Patent Prosecution, Contract Negotiation, Patent Litigation, Licensing, Business Development, Life Sciences, Pharmaceutical Industry, Prosecution, Due Diligence, Biopharmaceuticals, Drug Discovery
Education
University of California, Berkeley - School of Law 1997 — 1999
JD, ILaw - Intellectual Property
University of California, Davis 1987 — 1992
Ph.D, Organic Chemistry
Jeff Williams Jeff Williams's Alexza Pharmaceuticals Experience April 2008 - March 2010
Job President and CEO eNicotine Technologies
Industry Medical Devices
Experience
e-Nicotine Technology November 2011 - Present
NanoSurface Technologies June 2010 - June 2013
CIRCA Scientific April 2010 - Present
r4 Vascular January 2010 - Present
Summit Access January 2010 - Present
Summit Life Science Partners, LLC October 2009 - Present
Infinia Corporation September 2011 - December 2013
Infinia Corp. January 2012 - May 2012
Addicere Therapeutics May 2009 - March 2012
Alexza Pharmaceuticals April 2008 - March 2010
Skills
Venture Capital, Business Development, Product Development, Biotechnology, Medical Devices, Finance, Pharmaceutical Industry, Manufacturing, Fundraising, Start-ups, Corporate Development, Mergers & Acquisitions, Business Strategy, Executive Management, Strategy, Due Diligence, Entrepreneurship, Cross-functional Team..., Business Planning, Private Equity
Education
Massachusetts Institute of Technology - Sloan School of Management 1992 — 1994
Masters Science of Management
Brigham Young University 1984 — 1989
BA, Economics
e-Nicotine Technology November 2011 - Present
NanoSurface Technologies June 2010 - June 2013
CIRCA Scientific April 2010 - Present
r4 Vascular January 2010 - Present
Summit Access January 2010 - Present
Summit Life Science Partners, LLC October 2009 - Present
Infinia Corporation September 2011 - December 2013
Infinia Corp. January 2012 - May 2012
Addicere Therapeutics May 2009 - March 2012
Alexza Pharmaceuticals April 2008 - March 2010
Skills
Venture Capital, Business Development, Product Development, Biotechnology, Medical Devices, Finance, Pharmaceutical Industry, Manufacturing, Fundraising, Start-ups, Corporate Development, Mergers & Acquisitions, Business Strategy, Executive Management, Strategy, Due Diligence, Entrepreneurship, Cross-functional Team..., Business Planning, Private Equity
Education
Massachusetts Institute of Technology - Sloan School of Management 1992 — 1994
Masters Science of Management
Brigham Young University 1984 — 1989
BA, Economics
Athena Kakoliris Athena Kakoliris's Alexza Pharmaceuticals Experience July 2010 - February 2012
Job Patent Prosecution Paralegal at Kilpatrick Townsend & Stockton LLP
Industry Law Practice
Experience
Kilpatrick Townsend & Stockton LLP May 2012 - Present
Alexza Pharmaceuticals July 2010 - February 2012
Alexza Pharmaceuticals 2008 - 2010
Alza Corporation / Johnson & Johnson Corporation 2002 - 2007
ALZA Corporation 2000 - 2002
Skills
Medical Devices, Patents, Intellectual Property, Pharmaceutical Industry, Biotechnology
Education
San Jose State University
Bachelor of Science, Marketing
West Valley College
ABA Approved Paralegal Certificate, Paralegal
Kilpatrick Townsend & Stockton LLP May 2012 - Present
Alexza Pharmaceuticals July 2010 - February 2012
Alexza Pharmaceuticals 2008 - 2010
Alza Corporation / Johnson & Johnson Corporation 2002 - 2007
ALZA Corporation 2000 - 2002
Skills
Medical Devices, Patents, Intellectual Property, Pharmaceutical Industry, Biotechnology
Education
San Jose State University
Bachelor of Science, Marketing
West Valley College
ABA Approved Paralegal Certificate, Paralegal
Kathy Stopol Crankshaw Kathy Stopol Crankshaw's Alexza Pharmaceuticals Experience November 2006 - February 2012
Job Senior Director, Project Team Leader at Clovis Oncology
Industry Pharmaceuticals
Experience
Clovis Oncology May 2012 - Present
Abbott Biotherapeutics February 2012 - May 2012
Alexza Pharmaceuticals November 2006 - February 2012
ALZA/JNJ March 1984 - August 2006
ALZA/JNJ January 2001 - April 2004
Skills
Cross-functional Team..., Life Sciences, Regulatory Submissions, Pharmaceuticals, Medical Devices, Functional Leadership, Drug Development, Drug Delivery, Pharmaceutical Industry, Clinical Development, Biotechnology, Lifesciences, GMP, Technology Transfer, FDA, Validation, Project Management, Drug Discovery, Biopharmaceuticals
Education
University of California, Santa Cruz 1976 — 1980
BA, Biology
Clovis Oncology May 2012 - Present
Abbott Biotherapeutics February 2012 - May 2012
Alexza Pharmaceuticals November 2006 - February 2012
ALZA/JNJ March 1984 - August 2006
ALZA/JNJ January 2001 - April 2004
Skills
Cross-functional Team..., Life Sciences, Regulatory Submissions, Pharmaceuticals, Medical Devices, Functional Leadership, Drug Development, Drug Delivery, Pharmaceutical Industry, Clinical Development, Biotechnology, Lifesciences, GMP, Technology Transfer, FDA, Validation, Project Management, Drug Discovery, Biopharmaceuticals
Education
University of California, Santa Cruz 1976 — 1980
BA, Biology
Kirk Steyer Kirk Steyer's Alexza Pharmaceuticals Experience September 2010 - December 2010
Job STEYER CONSULTING ENGINEERING RESOURCES LLC: Process Development, Project, & Validation Engineering
Industry Pharmaceuticals
Experience
Steyer Consulting Engineering Resources LLC May 2015 - Present
Steyer Consulting Engineering Resources LLC December 2013 - May 2015
Novartis Vaccines and Diagnostics April 2013 - October 2013
Eichleay Engineers July 2012 - December 2012
Abbott Diabetes Care July 2011 - July 2012
BD Biosciences January 2011 - August 2011
Alexza Pharmaceuticals September 2010 - December 2010
Yoh Engineering (Teva Pharmaceuticals) May 2010 - July 2010
Yoh Engineering (Almac Clinical Services) December 2009 - May 2010
American Institute of Chemical Engineers October 2009 - May 2010
Skills
Validation, V&V, GMP, Medical Devices, Process Simulation, R&D, Biochemical Engineering, FDA, Sop, Chromatography, Chemical Engineering, Manufacturing, Budgets, Finance, Biotechnology, Pharmaceutical Industry, Lifesciences, Technology Transfer, Process Engineering, Process Validation, Process Optimization, Process Development, FMEA, DOE, ANOVA, Statistical Process..., PROJECT ENGINEER, Design of Experiments, SOP
Education
San Jose State University 2000 — 2007
B.Sc., Biochemical Engineering
POST – GRADUATE EDUCATION
Steyer Consulting Engineering Resources LLC May 2015 - Present
Steyer Consulting Engineering Resources LLC December 2013 - May 2015
Novartis Vaccines and Diagnostics April 2013 - October 2013
Eichleay Engineers July 2012 - December 2012
Abbott Diabetes Care July 2011 - July 2012
BD Biosciences January 2011 - August 2011
Alexza Pharmaceuticals September 2010 - December 2010
Yoh Engineering (Teva Pharmaceuticals) May 2010 - July 2010
Yoh Engineering (Almac Clinical Services) December 2009 - May 2010
American Institute of Chemical Engineers October 2009 - May 2010
Skills
Validation, V&V, GMP, Medical Devices, Process Simulation, R&D, Biochemical Engineering, FDA, Sop, Chromatography, Chemical Engineering, Manufacturing, Budgets, Finance, Biotechnology, Pharmaceutical Industry, Lifesciences, Technology Transfer, Process Engineering, Process Validation, Process Optimization, Process Development, FMEA, DOE, ANOVA, Statistical Process..., PROJECT ENGINEER, Design of Experiments, SOP
Education
San Jose State University 2000 — 2007
B.Sc., Biochemical Engineering
POST – GRADUATE EDUCATION
Adriane Contreras's Alexza Pharmaceuticals Experience December 2014 - Present
Job Quality Assurance Manager at Alexza Pharmaceuticals
Industry Medical Devices
Experience
Alexza Pharmaceuticals December 2014 - Present
Stryker Neurovascular/Concentric Medical September 2013 - December 2014
Stryker July 2012 - May 2013
Boston Scientific May 2006 - June 2012
Solectron September 2001 - April 2006
S&R Precision September 1999 - September 2000
Southwall Technologies 1994 - 1999
Skills
CAPA, ISO 13485, Quality System, Medical Devices, Quality Auditing, Root Cause Analysis, FDA, Quality Assurance, GMP, Quality Control, Regulatory Affairs, Document Management, Change Control, ISO, Cross-functional Team..., Technical Writing, DMAIC, Sop, SPC, Complaint Management, Six Sigma, Manufacturing, Continuous Improvement, Internal Audit, Quality Management, Minitab, R&D, Calibration, Design of Experiments, Process Engineering, Manufacturing..., Manufacturing..., Manufacturing Operations, Biomedical Engineering, Process Improvement, Medical Device Directive, Trackwise, Kaizen, Document Control, SOP
Education
Menlo College 1997 — 1999
Bachelor of Applied Science (B.A.Sc.), Business Administration and Management, General
DeAnza College 1991 — 1994
Associate of Arts (AA), Quality Assurance
Alexza Pharmaceuticals December 2014 - Present
Stryker Neurovascular/Concentric Medical September 2013 - December 2014
Stryker July 2012 - May 2013
Boston Scientific May 2006 - June 2012
Solectron September 2001 - April 2006
S&R Precision September 1999 - September 2000
Southwall Technologies 1994 - 1999
Skills
CAPA, ISO 13485, Quality System, Medical Devices, Quality Auditing, Root Cause Analysis, FDA, Quality Assurance, GMP, Quality Control, Regulatory Affairs, Document Management, Change Control, ISO, Cross-functional Team..., Technical Writing, DMAIC, Sop, SPC, Complaint Management, Six Sigma, Manufacturing, Continuous Improvement, Internal Audit, Quality Management, Minitab, R&D, Calibration, Design of Experiments, Process Engineering, Manufacturing..., Manufacturing..., Manufacturing Operations, Biomedical Engineering, Process Improvement, Medical Device Directive, Trackwise, Kaizen, Document Control, SOP
Education
Menlo College 1997 — 1999
Bachelor of Applied Science (B.A.Sc.), Business Administration and Management, General
DeAnza College 1991 — 1994
Associate of Arts (AA), Quality Assurance
John Kim, MD John Kim, MD's Alexza Pharmaceuticals Experience July 2001 - April 2002
Job Glaucoma Specialist and Eye Surgeon
Industry Hospital & Health Care
Experience
Mosier Eye Center April 2015 - Present
Inland Eye Institute August 2011 - Present
UC Irvine Medical Center July 2010 - June 2011
Texas Tech University Health Sciences Center July 2007 - July 2010
Kaiser Permanente July 2006 - June 2007
Alexza Pharmaceuticals July 2001 - April 2002
Skills
Surgery, Ophthalmology, Healthcare, Glaucoma, Cataract, Board Certified, Cataract Surgery, Medicine
Education
Icahn School of Medicine at Mount Sinai 2002 — 2006
MD, Medicine
University of California, Berkeley 1997 — 2001
BA, Molecular and Cell Biology
Lynbrook High School 1993 — 1997
Mosier Eye Center April 2015 - Present
Inland Eye Institute August 2011 - Present
UC Irvine Medical Center July 2010 - June 2011
Texas Tech University Health Sciences Center July 2007 - July 2010
Kaiser Permanente July 2006 - June 2007
Alexza Pharmaceuticals July 2001 - April 2002
Skills
Surgery, Ophthalmology, Healthcare, Glaucoma, Cataract, Board Certified, Cataract Surgery, Medicine
Education
Icahn School of Medicine at Mount Sinai 2002 — 2006
MD, Medicine
University of California, Berkeley 1997 — 2001
BA, Molecular and Cell Biology
Lynbrook High School 1993 — 1997
Evelyn Choy Evelyn Choy's Alexza Pharmaceuticals Experience October 2012 - June 2015
Job Specialist, QC Scientist Virology and Cell Characteristics at Bayer HealthCare
Industry Pharmaceuticals
Experience
Bayer HealthCare June 2015 - Present
Alexza Pharmaceuticals October 2012 - June 2015
Zosano Pharma March 2009 - November 2010
XOMA October 2007 - March 2009
Solstice NeuroSciences Inc. March 2005 - October 2007
Medarex September 2004 - March 2005
Elan Pharmaceuticals May 2003 - August 2004
Incyte Genomics Inc. February 2000 - January 2003
Skills
Sop, Laboratory, Quality Control, Immunoassays, Biotechnology, GMP, Pharmaceutical Industry, Molecular Biology, Lifesciences, Validation, FDA, Biopharmaceuticals, HPLC
Education
The University of Hong Kong 1995 — 1999
Master (M.Phil), Physiology
Western University 1991 — 1994
BSc., Biology
Bayer HealthCare June 2015 - Present
Alexza Pharmaceuticals October 2012 - June 2015
Zosano Pharma March 2009 - November 2010
XOMA October 2007 - March 2009
Solstice NeuroSciences Inc. March 2005 - October 2007
Medarex September 2004 - March 2005
Elan Pharmaceuticals May 2003 - August 2004
Incyte Genomics Inc. February 2000 - January 2003
Skills
Sop, Laboratory, Quality Control, Immunoassays, Biotechnology, GMP, Pharmaceutical Industry, Molecular Biology, Lifesciences, Validation, FDA, Biopharmaceuticals, HPLC
Education
The University of Hong Kong 1995 — 1999
Master (M.Phil), Physiology
Western University 1991 — 1994
BSc., Biology
William Coble William Coble's Alexza Pharmaceuticals Experience January 2015 - July 2015
Job Director, Training and Organizational Development at Alexza Pharmaceuticals
Industry Pharmaceuticals
Experience
Alexza Pharmaceuticals January 2015 - July 2015
Novartis Consumer Health January 2012 - January 2015
Pfizer July 2006 - January 2012
Productivity Point International July 2003 - June 2006
Accenture June 1997 - August 2002
Florida State University August 1994 - June 1997
Skills
Knowledge Management, Leadership, Management, Learning Management..., Training, Instructional Design, Learning Management, E-Learning, Time Management, Cross-functional Team..., Change Management, Pharmaceutical Industry, Budgets, Project Planning, Organizational Design, GMP, Project Management, Process Improvement, Leadership Development, Six Sigma, Business Analysis, Program Management, Strategy, Corporate Communications, Distance Learning, Continuous Improvement, Research, Business Process..., Validation, FDA, SOP, Biotechnology, Quality Assurance, Organizational..., Consulting
Education
Florida State University 1994 — 1997
MS, Communication - Interactive
Georgetown University 1984 — 1987
BA, Economics
Alexza Pharmaceuticals January 2015 - July 2015
Novartis Consumer Health January 2012 - January 2015
Pfizer July 2006 - January 2012
Productivity Point International July 2003 - June 2006
Accenture June 1997 - August 2002
Florida State University August 1994 - June 1997
Skills
Knowledge Management, Leadership, Management, Learning Management..., Training, Instructional Design, Learning Management, E-Learning, Time Management, Cross-functional Team..., Change Management, Pharmaceutical Industry, Budgets, Project Planning, Organizational Design, GMP, Project Management, Process Improvement, Leadership Development, Six Sigma, Business Analysis, Program Management, Strategy, Corporate Communications, Distance Learning, Continuous Improvement, Research, Business Process..., Validation, FDA, SOP, Biotechnology, Quality Assurance, Organizational..., Consulting
Education
Florida State University 1994 — 1997
MS, Communication - Interactive
Georgetown University 1984 — 1987
BA, Economics
Sandy Yu Sandy Yu's Alexza Pharmaceuticals Experience May 2015 - June 2015
Job Inventory Control and Production Planning Clinical Supply Chain at Coherus Biosciences
Industry Pharmaceuticals
Experience
Coherus BioSciences June 2015 - Present
Alexza Pharmaceuticals May 2015 - June 2015
Alexza Pharmaceuticals August 2013 - May 2015
Genemed Biotechnologies, Inc. March 2008 - August 2013
Skills
Antibodies, Biotechnology, Immunohistochemistry, Quality Control, Product Development, Production Managment, ERP, MRP, CAPA, Quality System, Supply Chain, Production Planning, Supply Chain Management, Customer Support, Change Control, Aseptic Technique, ISO 13485, Immunoassays, ELISA, DNA sequencing, Cell Culture, Agarose Gel..., Molecular Biology, Tissue Culture, PCR, SDS-PAGE
Education
University of California, Berkeley 2003 — 2007
Bachelor of Arts (B.A.), Cell/Cellular and Molecular Biology
Coherus BioSciences June 2015 - Present
Alexza Pharmaceuticals May 2015 - June 2015
Alexza Pharmaceuticals August 2013 - May 2015
Genemed Biotechnologies, Inc. March 2008 - August 2013
Skills
Antibodies, Biotechnology, Immunohistochemistry, Quality Control, Product Development, Production Managment, ERP, MRP, CAPA, Quality System, Supply Chain, Production Planning, Supply Chain Management, Customer Support, Change Control, Aseptic Technique, ISO 13485, Immunoassays, ELISA, DNA sequencing, Cell Culture, Agarose Gel..., Molecular Biology, Tissue Culture, PCR, SDS-PAGE
Education
University of California, Berkeley 2003 — 2007
Bachelor of Arts (B.A.), Cell/Cellular and Molecular Biology
Ginny Fleming Ginny Fleming's Alexza Pharmaceuticals Experience 2009 - 2011
Job Medical & Scientific Writer
Industry Writing and Editing
Experience
Bristol-Myers Squibb 2015 - Present
Lucidize Medical & Scientific Editing 2015 - Present
InterMune 2013 - 2015
PATH 2013 - 2014
Gilead Sciences 2004 - 2014
Pharmacyclics 2012 - 2013
Achaogen 2011 - 2013
Jazz Pharmaceuticals 2005 - 2013
Alexza Pharmaceuticals 2009 - 2011
PDL BioPharma 2001 - 2007
Skills
Medical Writing, Clinical Research, Neurology, Validation, Protocol, IND, Manuscript, Biotechnology, Drug Development, Regulatory Submissions, Clinical Trials, Pharmaceutical Industry, CRO, Clinical Development, Clinical Study Design, Oncology, CTMS, FDA, Therapeutic Areas, GCP, Regulatory Affairs, Scientific Writing
Education
San Jose State University
BA, Biology, molecular
San Jose State University
MS, Computer Science/Math
Bristol-Myers Squibb 2015 - Present
Lucidize Medical & Scientific Editing 2015 - Present
InterMune 2013 - 2015
PATH 2013 - 2014
Gilead Sciences 2004 - 2014
Pharmacyclics 2012 - 2013
Achaogen 2011 - 2013
Jazz Pharmaceuticals 2005 - 2013
Alexza Pharmaceuticals 2009 - 2011
PDL BioPharma 2001 - 2007
Skills
Medical Writing, Clinical Research, Neurology, Validation, Protocol, IND, Manuscript, Biotechnology, Drug Development, Regulatory Submissions, Clinical Trials, Pharmaceutical Industry, CRO, Clinical Development, Clinical Study Design, Oncology, CTMS, FDA, Therapeutic Areas, GCP, Regulatory Affairs, Scientific Writing
Education
San Jose State University
BA, Biology, molecular
San Jose State University
MS, Computer Science/Math
Leslie Ann Cruz Leslie Ann Cruz's Alexza Pharmaceuticals Experience July 2014 - August 2015
Job Regulatory Affairs Associate at Optovue
Industry Biotechnology
Experience
Optovue August 2015 - Present
Alexza Pharmaceuticals July 2014 - August 2015
Stanford University July 2011 - November 2013
University of California, San Francisco September 2004 - June 2011
Sunesis Pharmaceuticals February 2002 - August 2004
MediChem Research (now deCODE Chemistry) January 2001 - October 2001
Skills
Protein Expression, Purification, Chemistry, Drug Discovery, Molecular Cloning, Biochemistry, Structural Biology, Mass Spectrometry, Medicinal Chemistry, NMR, Mammalian Cell Culture, Protein Purification, Protein Chemistry, Site-directed..., FPLC, Protein Engineering, Cell Culture, Chemical Biology, Enzyme Kinetics, Grant Writing, Western Blotting, Biophysics, Synthetic Organic..., Aikido, X-ray crystallography, Pymol, ExPASy, NCBI, Sequence Alignment, Docking, Virtual Screening, Directed Evolution, Protein Crystallization, Structure Determination, Reporter Gene Assays, Transient Transfection, Regulatory Affairs, CMC Regulatory Affairs, IND, NDA, MAA
Education
University of California, San Francisco 2004 — 2010
PhD, Chemistry and Chemical Biology
University of Chicago 1996 — 2000
BS, Chemistry
Optovue August 2015 - Present
Alexza Pharmaceuticals July 2014 - August 2015
Stanford University July 2011 - November 2013
University of California, San Francisco September 2004 - June 2011
Sunesis Pharmaceuticals February 2002 - August 2004
MediChem Research (now deCODE Chemistry) January 2001 - October 2001
Skills
Protein Expression, Purification, Chemistry, Drug Discovery, Molecular Cloning, Biochemistry, Structural Biology, Mass Spectrometry, Medicinal Chemistry, NMR, Mammalian Cell Culture, Protein Purification, Protein Chemistry, Site-directed..., FPLC, Protein Engineering, Cell Culture, Chemical Biology, Enzyme Kinetics, Grant Writing, Western Blotting, Biophysics, Synthetic Organic..., Aikido, X-ray crystallography, Pymol, ExPASy, NCBI, Sequence Alignment, Docking, Virtual Screening, Directed Evolution, Protein Crystallization, Structure Determination, Reporter Gene Assays, Transient Transfection, Regulatory Affairs, CMC Regulatory Affairs, IND, NDA, MAA
Education
University of California, San Francisco 2004 — 2010
PhD, Chemistry and Chemical Biology
University of Chicago 1996 — 2000
BS, Chemistry
Beth Stannard, CCRP, CCRC's Alexza Pharmaceuticals Experience September 2010 - February 2012
Job Clinical Research Director Specializing in Therapeutic Drug, Device, and Biologic Development for CNS Indications
Industry Research
Experience
Semnur Pharmaceuticals, Inc. May 2015 - Present
BrainStorm Cell Therapeutics April 2015 - Present
Cervel Neurotech March 2012 - Present
InterMune October 2012 - September 2014
Auspex Pharmaceuticals, Inc. January 2013 - January 2014
Alexza Pharmaceuticals September 2010 - February 2012
Corcept Therapeutics April 2004 - August 2010
Stanford University February 2001 - April 2004
Stanford University August 2000 - February 2001
University of Arizona Cancer Center August 1999 - September 2000
Skills
Clinical Trials, Clinical Development, Clinical Research, FDA, Drug Development, Clinical Operations, Protocol, Medical Devices, Clinical Study Design, GCP, Pharmaceutical Industry, CNS disorders, Psychiatry, Microsoft Office, Clinical Monitoring, Protocol Development, EDC, Medical Writing, Patient Recruitment, ICH guidelines, Vendor Management, Adobe Acrobat, Regulatory Affairs, Clinical Data Management, Psychopharmacology, 21 CFR Part 11, Trial Master Files, Psychometrics, FDA Advisory Committee..., Site Management, Mental Health Treatment, Transcranial Magnetic..., Operational Efficiency, CRO, Data Analysis, Biostatistics, CSRs, Team Leadership, Strategic Planning, Operational Planning, Project Management, Quality Assurance, Executive Level..., Executive Leadership, C-Level Relationships, Professional Mentoring, Orphan Drugs, Biotechnology, ALS
Education
Drexel University College of Medicine 2013 — 2016
Master's Degree, Clinical Research Organization and Management
University of California, Santa Cruz 2004 — 2008
Post-graduate Certificate, Clinical Trials Design & Management
University of Arizona 1997 — 2000
Bachelor of Science (BS), Biology with minors in Chemistry, Physics, Math and Psychology
Semnur Pharmaceuticals, Inc. May 2015 - Present
BrainStorm Cell Therapeutics April 2015 - Present
Cervel Neurotech March 2012 - Present
InterMune October 2012 - September 2014
Auspex Pharmaceuticals, Inc. January 2013 - January 2014
Alexza Pharmaceuticals September 2010 - February 2012
Corcept Therapeutics April 2004 - August 2010
Stanford University February 2001 - April 2004
Stanford University August 2000 - February 2001
University of Arizona Cancer Center August 1999 - September 2000
Skills
Clinical Trials, Clinical Development, Clinical Research, FDA, Drug Development, Clinical Operations, Protocol, Medical Devices, Clinical Study Design, GCP, Pharmaceutical Industry, CNS disorders, Psychiatry, Microsoft Office, Clinical Monitoring, Protocol Development, EDC, Medical Writing, Patient Recruitment, ICH guidelines, Vendor Management, Adobe Acrobat, Regulatory Affairs, Clinical Data Management, Psychopharmacology, 21 CFR Part 11, Trial Master Files, Psychometrics, FDA Advisory Committee..., Site Management, Mental Health Treatment, Transcranial Magnetic..., Operational Efficiency, CRO, Data Analysis, Biostatistics, CSRs, Team Leadership, Strategic Planning, Operational Planning, Project Management, Quality Assurance, Executive Level..., Executive Leadership, C-Level Relationships, Professional Mentoring, Orphan Drugs, Biotechnology, ALS
Education
Drexel University College of Medicine 2013 — 2016
Master's Degree, Clinical Research Organization and Management
University of California, Santa Cruz 2004 — 2008
Post-graduate Certificate, Clinical Trials Design & Management
University of Arizona 1997 — 2000
Bachelor of Science (BS), Biology with minors in Chemistry, Physics, Math and Psychology
Tracy Chen's Alexza Pharmaceuticals Experience April 2007 - April 2011
Job Director Quality Assurance at Plexxikon Inc.
Industry Pharmaceuticals
Experience
Plexxikon Inc. December 2014 - Present
GMP Compliance Consulting August 2014 - December 2014
Abbott Medical Optics January 2014 - July 2014
Sinotherapeutics Inc. September 2013 - January 2014
Anacor Pharmaceuticals April 2011 - August 2013
Anacor Pharmaceuticals April 2011 - June 2012
Alexza Pharmaceuticals April 2007 - April 2011
Johnson & Johnson Pharmaceutical R&D February 2001 - January 2007
Life Sciences International January 1999 - June 2000
Scios, Inc July 1997 - January 1999
Skills
CAPA, FDA, Project Management, GMP, Pharmaceutical Industry, Quality System, Validation, Biotechnology, Change Control, V&V, GxP, Quality Assurance, FMEA, Clinical Development, GCP, Quality Auditing, Quality Control, Manufacturing, Computer System..., Sop, Aseptic Processing, Technology Transfer, 21 CFR Part 11, Design Control, GLP, Lifesciences, Continuous Improvement, Medical Devices, Cleaning Validation, Biopharmaceuticals, ISO 13485, Cross-functional Team..., Regulatory Affairs, Life Sciences, SOP
Education
San Francisco State University 2005 — 2006
Certificate, Clinical Trials Design and Management
San Francisco State University, College of Business 2001 — 2003
MBA, Management
University of California, Berkeley 1988 — 1992
B.A., Biology
Plexxikon Inc. December 2014 - Present
GMP Compliance Consulting August 2014 - December 2014
Abbott Medical Optics January 2014 - July 2014
Sinotherapeutics Inc. September 2013 - January 2014
Anacor Pharmaceuticals April 2011 - August 2013
Anacor Pharmaceuticals April 2011 - June 2012
Alexza Pharmaceuticals April 2007 - April 2011
Johnson & Johnson Pharmaceutical R&D February 2001 - January 2007
Life Sciences International January 1999 - June 2000
Scios, Inc July 1997 - January 1999
Skills
CAPA, FDA, Project Management, GMP, Pharmaceutical Industry, Quality System, Validation, Biotechnology, Change Control, V&V, GxP, Quality Assurance, FMEA, Clinical Development, GCP, Quality Auditing, Quality Control, Manufacturing, Computer System..., Sop, Aseptic Processing, Technology Transfer, 21 CFR Part 11, Design Control, GLP, Lifesciences, Continuous Improvement, Medical Devices, Cleaning Validation, Biopharmaceuticals, ISO 13485, Cross-functional Team..., Regulatory Affairs, Life Sciences, SOP
Education
San Francisco State University 2005 — 2006
Certificate, Clinical Trials Design and Management
San Francisco State University, College of Business 2001 — 2003
MBA, Management
University of California, Berkeley 1988 — 1992
B.A., Biology
Reynaldo Quintana's Alexza Pharmaceuticals Experience September 2001 - February 2012
Job Sr. Director of Engineering at NJOY Electronic Cigarettes
Industry Medical Devices
Experience
NJOY Electronic Cigarettes March 2014 - Present
Sunovion Respiratory Developmenet September 2012 - March 2014
Genentech 2013 - 2013
Elevation Pharmaceuticals 2012 - 2013
Alexza Pharmaceuticals September 2001 - February 2012
ZOLL Medical Corporation (formerly Revivant) September 1998 - September 2001
Aerogen July 1998 - September 1999
IDEO December 1995 - July 1997
Electro-Physiology Technologies February 1994 - December 1995
Skills
Solidworks, Spanish, Engineering, CAD, Biomedical Engineering, Design for Manufacturing, Medical Devices, Drug Delivery, Cross-functional Team..., Manufacturing, Mechanical Engineering, Product Development, Product Design, Start-ups, 3D Modeling, FDA, Design Control, Testing, R&D
Education
The Catholic University of America 1990 — 1992
MS, Biomedical Engineering
University of Maryland College Park 1984 — 1986
B.S., Mechanical Engineering
Frostburg State University 1982 — 1984
B.S., Physics
NJOY Electronic Cigarettes March 2014 - Present
Sunovion Respiratory Developmenet September 2012 - March 2014
Genentech 2013 - 2013
Elevation Pharmaceuticals 2012 - 2013
Alexza Pharmaceuticals September 2001 - February 2012
ZOLL Medical Corporation (formerly Revivant) September 1998 - September 2001
Aerogen July 1998 - September 1999
IDEO December 1995 - July 1997
Electro-Physiology Technologies February 1994 - December 1995
Skills
Solidworks, Spanish, Engineering, CAD, Biomedical Engineering, Design for Manufacturing, Medical Devices, Drug Delivery, Cross-functional Team..., Manufacturing, Mechanical Engineering, Product Development, Product Design, Start-ups, 3D Modeling, FDA, Design Control, Testing, R&D
Education
The Catholic University of America 1990 — 1992
MS, Biomedical Engineering
University of Maryland College Park 1984 — 1986
B.S., Mechanical Engineering
Frostburg State University 1982 — 1984
B.S., Physics
Jeanette Smith's Alexza Pharmaceuticals Experience 2013 - 2013
Job Clinical Quality Management Assistant at Pharmacyclics LLC an AbbVie Company
Industry Biotechnology
Experience
Pharmacyclics LLC an AbbVie Company August 2015 - Present
Avinger Inc. 2015 - 2015
SpineMark Corporation 2014 - 2014
Astex Pharmaceuticals 2013 - 2014
Alexza Pharmaceuticals 2013 - 2013
PRC CLINICAL 2013 - 2013
Telomere Diagnostics, Inc. 2011 - 2013
Education
San Francisco State University 2011 — 2012
University of California, Santa Cruz
Pharmacyclics LLC an AbbVie Company August 2015 - Present
Avinger Inc. 2015 - 2015
SpineMark Corporation 2014 - 2014
Astex Pharmaceuticals 2013 - 2014
Alexza Pharmaceuticals 2013 - 2013
PRC CLINICAL 2013 - 2013
Telomere Diagnostics, Inc. 2011 - 2013
Education
San Francisco State University 2011 — 2012
University of California, Santa Cruz
Kathryn Kaczmarski, PhD's Alexza Pharmaceuticals Experience 2007 - 2009
Job Organizational Strategy & Transformation
Industry Management Consulting
Experience
Various Clients 2014 - Present
Onyx Pharmaceuticals 2012 - 2014
Onyx Pharmaceuticals 2009 - 2012
Alexza Pharmaceuticals 2007 - 2009
Omelas Consulting Group, Inc. 1999 - 2007
Skills
Biotechnology, Talent Management, Strategy, Leadership Development, Performance Management, Organizational..., Strategic Planning, Mergers & Acquisitions, Leadership, Program Management, Coaching, Internal Communications, Start-ups, Process Improvement, Employee Engagement, Management Consulting, Cross-functional Team..., Change Management, Human Resources, Team Building, Continuous Improvement, Business Strategy, Management, Organizational Design, Succession Planning, Executive Management, Organizational..., Integration, Career Development, Executive Coaching, Biopharmaceuticals, Pharmaceutical Industry, Business Process, Personnel Management, Recruiting, Commercialization, Consulting, Entrepreneurship
Education
Case Western Reserve University
PhD, Organizational Behavior
Columbia University in the City of New York
MA, Organizational Psychology
Rensselaer Polytechnic Institute
BS, Chemical Engineering
Various Clients 2014 - Present
Onyx Pharmaceuticals 2012 - 2014
Onyx Pharmaceuticals 2009 - 2012
Alexza Pharmaceuticals 2007 - 2009
Omelas Consulting Group, Inc. 1999 - 2007
Skills
Biotechnology, Talent Management, Strategy, Leadership Development, Performance Management, Organizational..., Strategic Planning, Mergers & Acquisitions, Leadership, Program Management, Coaching, Internal Communications, Start-ups, Process Improvement, Employee Engagement, Management Consulting, Cross-functional Team..., Change Management, Human Resources, Team Building, Continuous Improvement, Business Strategy, Management, Organizational Design, Succession Planning, Executive Management, Organizational..., Integration, Career Development, Executive Coaching, Biopharmaceuticals, Pharmaceutical Industry, Business Process, Personnel Management, Recruiting, Commercialization, Consulting, Entrepreneurship
Education
Case Western Reserve University
PhD, Organizational Behavior
Columbia University in the City of New York
MA, Organizational Psychology
Rensselaer Polytechnic Institute
BS, Chemical Engineering
Aimee Loomis Aimee Loomis's Alexza Pharmaceuticals Experience April 2013 - August 2015
Job Regulatory Affairs, Regulatory Operations Specialist |I
Industry Biotechnology
Experience
Alexza Pharmaceuticals April 2013 - August 2015
Intarcia Therapeutics, Inc August 2008 - April 2013
Intarcia Therapeutics, Inc June 2007 - August 2008
Skills
Microsoft Office 2007, Filemaker Pro, Reference Manager 9, Adobe Acrobat, FDA Paper Submissions, CTD format, Regulatory Submissions, FDA, IND, Clinical Research, Clinical Development, Drug Development, Biotechnology, Clinical Trials, GCP, Regulatory Affairs, Sop, SOP, Pharmaceutical Industry
Education
San Diego State University-California State University 2009 — 2010
Advanced Certificate, Regulatory Affairs
California Baptist University 2003 — 2007
English, English
Alexza Pharmaceuticals April 2013 - August 2015
Intarcia Therapeutics, Inc August 2008 - April 2013
Intarcia Therapeutics, Inc June 2007 - August 2008
Skills
Microsoft Office 2007, Filemaker Pro, Reference Manager 9, Adobe Acrobat, FDA Paper Submissions, CTD format, Regulatory Submissions, FDA, IND, Clinical Research, Clinical Development, Drug Development, Biotechnology, Clinical Trials, GCP, Regulatory Affairs, Sop, SOP, Pharmaceutical Industry
Education
San Diego State University-California State University 2009 — 2010
Advanced Certificate, Regulatory Affairs
California Baptist University 2003 — 2007
English, English
Ranah Panlilio Ranah Panlilio's Alexza Pharmaceuticals Experience March 2006 - December 2010
Job Marketing Programs Specialist
Industry Computer Software
Experience
Kapow Software, A Kofax Company January 2011 - September 2014
Kapow Software, A Kofax Company January 2011 - October 2013
Alexza Pharmaceuticals March 2006 - December 2010
Y's Therapeutics, Inc March 2005 - February 2006
Skills
Administration, Document Management, Accounting, Accounts Payable, Invoicing, Microsoft Office, Coordinating Events, Pardot, Marketing, System Administration, Social Media, Marketing Event Planning, Human Resources, Process Improvement, Logistics, Agile Methodologies, Management, Change Control, Office Management, Project Management, Microsoft Excel, FDA, Salesforce.com, Event Planning, Budgets, Software Documentation, Microsoft Word, Data Entry, Training, Team Leadership, Enterprise Software, Enterprise Search
Education
California State University-East Bay 2005 — 2009
Bachelors of Science Degree, Business Administration; concentration in Accounting and Human Resources
Kapow Software, A Kofax Company January 2011 - September 2014
Kapow Software, A Kofax Company January 2011 - October 2013
Alexza Pharmaceuticals March 2006 - December 2010
Y's Therapeutics, Inc March 2005 - February 2006
Skills
Administration, Document Management, Accounting, Accounts Payable, Invoicing, Microsoft Office, Coordinating Events, Pardot, Marketing, System Administration, Social Media, Marketing Event Planning, Human Resources, Process Improvement, Logistics, Agile Methodologies, Management, Change Control, Office Management, Project Management, Microsoft Excel, FDA, Salesforce.com, Event Planning, Budgets, Software Documentation, Microsoft Word, Data Entry, Training, Team Leadership, Enterprise Software, Enterprise Search
Education
California State University-East Bay 2005 — 2009
Bachelors of Science Degree, Business Administration; concentration in Accounting and Human Resources
Andrea Sikora Andrea Sikora's Alexza Pharmaceuticals Experience February 2002 - October 2004
Job Human Resources Manager at Lowe's Home Improvement
Industry Retail
Experience
Lowe's Home Improvement February 2012 - Present
Home October 2010 - February 2012
Warehouse Demo Services 2007 - 2010
Alexza Pharmaceuticals February 2002 - October 2004
Skills
Licensed Massage..., Massage, Supervisory Experience, Quality Assurance, Sop, FDA, Laboratory, GMP, Sterilization, Pharmacueticals, Quality Control, Process Scheduler, GLP, Change Control, Clinical Research, Validation, Microsoft Office, Microsoft Excel
Education
UC Berkely Extension 1998 — 1999
Semiconductor Course, Semiconductor
Mission College 1985 — 1987
AA Degree, Nursing
Berufsaufbauschule St. Wendel 1979 — 1981
Social Studies, Nursing
Palatinate Technical School 1977 — 1978
3.5 Semester, Chemistry
Hauptschule Freisen
Lowe's Home Improvement February 2012 - Present
Home October 2010 - February 2012
Warehouse Demo Services 2007 - 2010
Alexza Pharmaceuticals February 2002 - October 2004
Skills
Licensed Massage..., Massage, Supervisory Experience, Quality Assurance, Sop, FDA, Laboratory, GMP, Sterilization, Pharmacueticals, Quality Control, Process Scheduler, GLP, Change Control, Clinical Research, Validation, Microsoft Office, Microsoft Excel
Education
UC Berkely Extension 1998 — 1999
Semiconductor Course, Semiconductor
Mission College 1985 — 1987
AA Degree, Nursing
Berufsaufbauschule St. Wendel 1979 — 1981
Social Studies, Nursing
Palatinate Technical School 1977 — 1978
3.5 Semester, Chemistry
Hauptschule Freisen
Dennis Solas Dennis Solas's Alexza Pharmaceuticals Experience March 2009 - March 2011
Job Experienced Research Scientist/Synthetic Organic Chemist
Industry Pharmaceuticals
Experience
Alexza Pharmaceuticals March 2009 - March 2011
Alexza Pharmaceuticals August 2001 - February 2009
Affymax Research Institute 1991 - 2001
Metafluor, Inc. 1986 - 1991
Skills
Drug Discovery, Analytical Chemistry, NMR, Chemistry, LC-MS, HPLC, Biotechnology, Chromatography, Medicinal Chemistry, Medical Devices, Laboratory, Technology Transfer, GMP, Organic Synthesis, R&D, Organic Chemistry, Formulation, IR, Drug Delivery, Purification, Cell, Peptides, Spectroscopy, Drug Development, CRO
Education
Palo Alto:Syntex Labs
Post Doctoral, Organic Chemistry / Synthetic Methodology
Purdue University
PhD, Organic Chemistry
University of Missouri-Kansas City
BS, Chemistry
Alexza Pharmaceuticals March 2009 - March 2011
Alexza Pharmaceuticals August 2001 - February 2009
Affymax Research Institute 1991 - 2001
Metafluor, Inc. 1986 - 1991
Skills
Drug Discovery, Analytical Chemistry, NMR, Chemistry, LC-MS, HPLC, Biotechnology, Chromatography, Medicinal Chemistry, Medical Devices, Laboratory, Technology Transfer, GMP, Organic Synthesis, R&D, Organic Chemistry, Formulation, IR, Drug Delivery, Purification, Cell, Peptides, Spectroscopy, Drug Development, CRO
Education
Palo Alto:Syntex Labs
Post Doctoral, Organic Chemistry / Synthetic Methodology
Purdue University
PhD, Organic Chemistry
University of Missouri-Kansas City
BS, Chemistry
Peter W. Schineller Peter W. Schineller's Alexza Pharmaceuticals Experience 2013 - 2013
Job Chief Commercial Officer
Industry Biotechnology
Experience
Agendia Inc. 2013 - Present
Alexza Pharmaceuticals 2013 - 2013
Ventana Medical Systems 2012 - 2013
Fidelis Consulting Group 2011 - 2012
Genoptix Medical Laboratory a Novartis Company 2010 - 2011
Cypress Bioscience 2008 - 2010
Verus Pharmaceuticals 2002 - 2008
Elan Biopharmaceuticals 2000 - 2002
Dura Pharmaceuticals 1998 - 2000
Abbott Laboratories 1987 - 1998
Skills
Sales Management, Diagnostics, Pharmaceuticals, Managed Care, Start-ups, Medical Devices, Product Development, Business Planning, Strategic Planning, Commercialization, Biotechnology, Forecasting, Negotiation, Planning, Product Launches, Oncology, Infectious Diseases, Due Diligence, Life Sciences, Hiring, Incentive Programs, Entrepreneur, Pediatrics, Territory, Healthcare
Education
State University of New York at Stony Brook
BA, Dual Major Political Science & History
Agendia Inc. 2013 - Present
Alexza Pharmaceuticals 2013 - 2013
Ventana Medical Systems 2012 - 2013
Fidelis Consulting Group 2011 - 2012
Genoptix Medical Laboratory a Novartis Company 2010 - 2011
Cypress Bioscience 2008 - 2010
Verus Pharmaceuticals 2002 - 2008
Elan Biopharmaceuticals 2000 - 2002
Dura Pharmaceuticals 1998 - 2000
Abbott Laboratories 1987 - 1998
Skills
Sales Management, Diagnostics, Pharmaceuticals, Managed Care, Start-ups, Medical Devices, Product Development, Business Planning, Strategic Planning, Commercialization, Biotechnology, Forecasting, Negotiation, Planning, Product Launches, Oncology, Infectious Diseases, Due Diligence, Life Sciences, Hiring, Incentive Programs, Entrepreneur, Pediatrics, Territory, Healthcare
Education
State University of New York at Stony Brook
BA, Dual Major Political Science & History
Sandie Anderson, PhD Sandie Anderson, PhD's Alexza Pharmaceuticals Experience October 2007 - March 2009
Job Driven to deliver, I shape early to full device & drug development, installing efficient systems for fast time to market
Industry Medical Devices
Experience
Leading pharmaceutical, medical device, and internet security companies 2009 - Present
United ID December 2008 - Present
Alexza Pharmaceuticals October 2007 - March 2009
ALZA Corporation / Johnson & Johnson 2005 - 2007
Procter & Gamble 1993 - 2005
Dow Chemical 1986 - 1993
Skills
FDA, Cross-functional Team..., Pharmaceutical Industry, Medical Devices, R&D, Product Development, Technology Transfer, Biotechnology, GMP, Quality System, Project Management, Process Improvement, Program Management, Gap Analysis, Regulatory Submissions, Technology Management, Global Alliance..., Team Building, IEC 60601, ISO 14971, Strategy, Start-ups, Leadership, Strategic Leadership, Organizational...
Education
Michigan State University 1989 — 1993
PhD
Ohio University 1980 — 1986
BS, MS
Bishops' High School 1972 — 1979
Leading pharmaceutical, medical device, and internet security companies 2009 - Present
United ID December 2008 - Present
Alexza Pharmaceuticals October 2007 - March 2009
ALZA Corporation / Johnson & Johnson 2005 - 2007
Procter & Gamble 1993 - 2005
Dow Chemical 1986 - 1993
Skills
FDA, Cross-functional Team..., Pharmaceutical Industry, Medical Devices, R&D, Product Development, Technology Transfer, Biotechnology, GMP, Quality System, Project Management, Process Improvement, Program Management, Gap Analysis, Regulatory Submissions, Technology Management, Global Alliance..., Team Building, IEC 60601, ISO 14971, Strategy, Start-ups, Leadership, Strategic Leadership, Organizational...
Education
Michigan State University 1989 — 1993
PhD
Ohio University 1980 — 1986
BS, MS
Bishops' High School 1972 — 1979
Huyen Dang Huyen Dang's Alexza Pharmaceuticals Experience 2011 - 2012
Job Sr. Scientist at Boston Scientific
Industry Medical Devices
Experience
Boston Scientific June 2013 - Present
CooperVision February 2012 - June 2013
Alexza Pharmaceuticals 2011 - 2012
Conor Medsystems /Cordis (J&J Company) May 2005 - August 2011
Guidant Corporation October 2001 - April 2005
American Peptide Company August 2000 - October 2001
Columbia Analytical Services July 1998 - August 2000
QUALITY CARE PHARMACEUTICAL May 1994 - April 1996
Skills
UV/Vis, Chemistry, FDA, GMP, Validation, HPLC, Quality Control, Quality System, R&D, Gas Chromatography, Six Sigma, V&V, CAPA, Laboratory, Organic Chemistry, Technology Transfer, Sop, Method Development, ISO, Assay Development, TLC, GC-MS, FTIR, Medical Devices
Education
Dominguez Hills State University 1995 — 1998
B.S, Chemistry
Golden West College 1992 — 1995
A.A, Accounting
Boston Scientific June 2013 - Present
CooperVision February 2012 - June 2013
Alexza Pharmaceuticals 2011 - 2012
Conor Medsystems /Cordis (J&J Company) May 2005 - August 2011
Guidant Corporation October 2001 - April 2005
American Peptide Company August 2000 - October 2001
Columbia Analytical Services July 1998 - August 2000
QUALITY CARE PHARMACEUTICAL May 1994 - April 1996
Skills
UV/Vis, Chemistry, FDA, GMP, Validation, HPLC, Quality Control, Quality System, R&D, Gas Chromatography, Six Sigma, V&V, CAPA, Laboratory, Organic Chemistry, Technology Transfer, Sop, Method Development, ISO, Assay Development, TLC, GC-MS, FTIR, Medical Devices
Education
Dominguez Hills State University 1995 — 1998
B.S, Chemistry
Golden West College 1992 — 1995
A.A, Accounting
Duane Yamasaki's Alexza Pharmaceuticals Experience April 2004 - June 2005
Job Medical Device Executive Product Development From the Lab through Acquisition.
Industry Medical Devices
Experience
Coagusense Inc. December 2008 - Present
Synergetic Engineering May 2004 - Present
Ventus Medical September 2007 - December 2008
Spinal Kinetics May 2006 - August 2007
Farallon Medical May 2005 - March 2006
Alexza Pharmaceuticals April 2004 - June 2005
TheraSense, Inc. (Abbott ) February 1999 - May 2004
Aclara BioScience October 1997 - February 1999
Bio Rad Labs June 1992 - April 1997
Colagen Corporation September 1989 - June 1992
Skills
Medical Devices, Validation, FMEA, Engineering, Design for Manufacturing, Medical Device Product..., Executive Management, Start-up Ventures, Product Development, Automation, Manufacturing..., Testing, ISO 13485, Cross-functional Team..., Software Documentation, SPC, Start-ups, Process Engineering, Commercialization, FDA, Solidworks, Design Control, Quality Control, Quality System, R, Manufacturing, R&D, Management, Product Launch, CAPA, GMP, Design of Experiments, Biotechnology, Leadership, Lean Manufacturing, V&V, Six Sigma, Product Management, Process Improvement, Biomedical Engineering, Quality Assurance, Materials, Pharmaceutical Industry, ISO
Education
California State University-Sacramento 1983 — 1989
BS
Coagusense Inc. December 2008 - Present
Synergetic Engineering May 2004 - Present
Ventus Medical September 2007 - December 2008
Spinal Kinetics May 2006 - August 2007
Farallon Medical May 2005 - March 2006
Alexza Pharmaceuticals April 2004 - June 2005
TheraSense, Inc. (Abbott ) February 1999 - May 2004
Aclara BioScience October 1997 - February 1999
Bio Rad Labs June 1992 - April 1997
Colagen Corporation September 1989 - June 1992
Skills
Medical Devices, Validation, FMEA, Engineering, Design for Manufacturing, Medical Device Product..., Executive Management, Start-up Ventures, Product Development, Automation, Manufacturing..., Testing, ISO 13485, Cross-functional Team..., Software Documentation, SPC, Start-ups, Process Engineering, Commercialization, FDA, Solidworks, Design Control, Quality Control, Quality System, R, Manufacturing, R&D, Management, Product Launch, CAPA, GMP, Design of Experiments, Biotechnology, Leadership, Lean Manufacturing, V&V, Six Sigma, Product Management, Process Improvement, Biomedical Engineering, Quality Assurance, Materials, Pharmaceutical Industry, ISO
Education
California State University-Sacramento 1983 — 1989
BS
Richard Tian's Alexza Pharmaceuticals Experience January 2007 - February 2009
Job Quality Professional
Industry Pharmaceuticals
Experience
Grifols May 2014 - Present
Grifols October 2011 - April 2014
Johnson & Johnson September 2009 - September 2011
Alexza Pharmaceuticals January 2007 - February 2009
United States Marine Corps 2001 - 2004
Skills
Validation, Biotechnology, GMP, HPLC, SOP, R&D, Quality System, FDA, Quality Control, Quality Assurance, CAPA, Medical Devices, Pharmaceutical Industry, Clinical Trials
Education
Boston University 2015 — 2017
Master of Science (M.S.), Project Management
University of California, Los Angeles 2014 — 2015
Project Management, 4.0
San Jose State University 2004 — 2008
Bachelor of Arts (B.A.), Psychology Neuroscience
De Anza College
Computer Science
Grifols May 2014 - Present
Grifols October 2011 - April 2014
Johnson & Johnson September 2009 - September 2011
Alexza Pharmaceuticals January 2007 - February 2009
United States Marine Corps 2001 - 2004
Skills
Validation, Biotechnology, GMP, HPLC, SOP, R&D, Quality System, FDA, Quality Control, Quality Assurance, CAPA, Medical Devices, Pharmaceutical Industry, Clinical Trials
Education
Boston University 2015 — 2017
Master of Science (M.S.), Project Management
University of California, Los Angeles 2014 — 2015
Project Management, 4.0
San Jose State University 2004 — 2008
Bachelor of Arts (B.A.), Psychology Neuroscience
De Anza College
Computer Science
Kenneth Gartner Kenneth Gartner's Alexza Pharmaceuticals Experience November 2014 - August 2015
Job Quality Control Analyst | Environmental Monitoring Specialist | Quality Assurance Specialist
Industry Pharmaceuticals
Experience
Alexza Pharmaceuticals November 2014 - August 2015
Alexza Pharmaceuticals February 2013 - November 2014
Impax Laboratories September 2011 - February 2013
In-N-Out Burger August 2003 - September 2011
The Response Group June 2010 - September 2010
Onsite Medical Service April 2009 - October 2009
Davis Fire Crew May 2008 - September 2008
Skills
Non-profits, Nonprofits, Teaching, Analysis, Customer Service, Microsoft Office, Supervisory Skills, Event Planning, Manufacturing, Training, Outlook, Leadership, Coaching, PowerPoint, Microsoft Word, Strategic Planning, Leadership Development, Public Speaking, GMP, Quality Control, Pharmaceutical Industry, Biotechnology, FDA, Medical Devices, Validation, SOP, Quality Assurance, CAPA, Research, Quality System, Microsoft Excel, Process Improvement, Change Control, GLP, R&D, Cross-functional Team..., 21 CFR Part 11, Life Sciences, Program Management, Management, Pharmaceutics, Microbiology, ISO, Testing
Education
UC Davis 2006 — 2009
BS, Biological Sciences
Foothill College 2004 — 2006
Biology/Biological Sciences, General
De Anza College 2003 — 2006
Biology/Biological Sciences, General
Fremont High School
Fremont High School
Fremont High School
Alexza Pharmaceuticals November 2014 - August 2015
Alexza Pharmaceuticals February 2013 - November 2014
Impax Laboratories September 2011 - February 2013
In-N-Out Burger August 2003 - September 2011
The Response Group June 2010 - September 2010
Onsite Medical Service April 2009 - October 2009
Davis Fire Crew May 2008 - September 2008
Skills
Non-profits, Nonprofits, Teaching, Analysis, Customer Service, Microsoft Office, Supervisory Skills, Event Planning, Manufacturing, Training, Outlook, Leadership, Coaching, PowerPoint, Microsoft Word, Strategic Planning, Leadership Development, Public Speaking, GMP, Quality Control, Pharmaceutical Industry, Biotechnology, FDA, Medical Devices, Validation, SOP, Quality Assurance, CAPA, Research, Quality System, Microsoft Excel, Process Improvement, Change Control, GLP, R&D, Cross-functional Team..., 21 CFR Part 11, Life Sciences, Program Management, Management, Pharmaceutics, Microbiology, ISO, Testing
Education
UC Davis 2006 — 2009
BS, Biological Sciences
Foothill College 2004 — 2006
Biology/Biological Sciences, General
De Anza College 2003 — 2006
Biology/Biological Sciences, General
Fremont High School
Fremont High School
Fremont High School
Anne Ravelo's Alexza Pharmaceuticals Experience March 2012 - June 2014
Job
Industry Medical Devices
Experience
Novartis August 2014 - Present
Alexza Pharmaceuticals March 2012 - June 2014
Alexza Pharmaceuticals July 2011 - March 2012
Alexza Pharmaceuticals July 2007 - July 2011
Nektar Therapeutics July 2006 - May 2007
Genentech February 2004 - November 2004
Quovera August 1999 - March 2001
Johnson & Johnson July 1997 - June 1999
Skills
Quality System, GMP, Cross-functional Team..., FDA, 21 CFR Part 11, Change Control, Business Process, Process Improvement, Strategy, Document Management, Training, SDLC, CAPA, Business Analysis, Requirements Analysis, Site Inspections, Situational Leadership, WBS, Business Process..., Software Requirements, Collaboration, SOP, Validation, Problem Solving
Education
Drexel University
Bachelor's Degree
Novartis August 2014 - Present
Alexza Pharmaceuticals March 2012 - June 2014
Alexza Pharmaceuticals July 2011 - March 2012
Alexza Pharmaceuticals July 2007 - July 2011
Nektar Therapeutics July 2006 - May 2007
Genentech February 2004 - November 2004
Quovera August 1999 - March 2001
Johnson & Johnson July 1997 - June 1999
Skills
Quality System, GMP, Cross-functional Team..., FDA, 21 CFR Part 11, Change Control, Business Process, Process Improvement, Strategy, Document Management, Training, SDLC, CAPA, Business Analysis, Requirements Analysis, Site Inspections, Situational Leadership, WBS, Business Process..., Software Requirements, Collaboration, SOP, Validation, Problem Solving
Education
Drexel University
Bachelor's Degree
Nony Bautista's Alexza Pharmaceuticals Experience 2006 - 2009
Job Principal Software Engineer/Consultant at innobatib
Industry Medical Devices
Experience
innobatib consulting 2009 - Present
Velomedix June 2011 - January 2014
ZOLL Circulation/ZOLL Medical November 2009 - May 2011
Alexza Pharmaceuticals 2006 - 2009
ZOLL Medical Corporation (acquired Revivant, Inc) 2002 - 2006
Ariba, Inc. (An SAP Company) 2000 - 2001
LifeScan, Inc ( a Johnson & Johnson company) 1996 - 2000
St. Jude Medical (acquired Ventritex) 1992 - 1996
Siemens Medical Systems (Ultrasound Group) 1988 - 1992
Skills
Medical Devices, FDA, Design Control, Validation, ISO 13485, R&D, Biomedical Engineering, Product Development, CAPA, Quality System, Cross-functional Team..., Start-ups, Manufacturing, V&V, Product Launch, Biotechnology, Software Development, Embedded Systems, Quality Assurance, Design of Experiments, Embedded Software, Commercialization, Pharmaceutical Industry, 21 CFR Part 11, GMP, ISO 14971, Software Engineering, Drug Delivery, Software Design, Product Lifecycle..., Software Documentation, Medical Imaging, Agile Methodologies, Rapid Prototyping, Clinical Trials, GxP, Healthcare
Education
University of California, Berkeley 1978 — 1982
BS, EECS
innobatib consulting 2009 - Present
Velomedix June 2011 - January 2014
ZOLL Circulation/ZOLL Medical November 2009 - May 2011
Alexza Pharmaceuticals 2006 - 2009
ZOLL Medical Corporation (acquired Revivant, Inc) 2002 - 2006
Ariba, Inc. (An SAP Company) 2000 - 2001
LifeScan, Inc ( a Johnson & Johnson company) 1996 - 2000
St. Jude Medical (acquired Ventritex) 1992 - 1996
Siemens Medical Systems (Ultrasound Group) 1988 - 1992
Skills
Medical Devices, FDA, Design Control, Validation, ISO 13485, R&D, Biomedical Engineering, Product Development, CAPA, Quality System, Cross-functional Team..., Start-ups, Manufacturing, V&V, Product Launch, Biotechnology, Software Development, Embedded Systems, Quality Assurance, Design of Experiments, Embedded Software, Commercialization, Pharmaceutical Industry, 21 CFR Part 11, GMP, ISO 14971, Software Engineering, Drug Delivery, Software Design, Product Lifecycle..., Software Documentation, Medical Imaging, Agile Methodologies, Rapid Prototyping, Clinical Trials, GxP, Healthcare
Education
University of California, Berkeley 1978 — 1982
BS, EECS
Steve Haylock, ASQ CQE & CQA's Alexza Pharmaceuticals Experience 2002 - 2004
Job Principal QA Product Technical Manager, IMP Quality OperationsUS at Genentech
Industry Biotechnology
Experience
Genentech, a member of the Roche Group February 2014 - Present
Genentech_a member of the Roche Group September 2004 - January 2014
Alexza Pharmaceuticals 2002 - 2004
Nektar Therapeutics (formerly Inhale Therapeutics) 2000 - 2002
LifeScan 1998 - 2000
Berlex Biosciences 1995 - 1998
Dade Behring Diagnostics (formerly Syva) 1991 - 1995
Los Angeles Department of Water and Power 1986 - 1991
Skills
CAPA, FDA, GMP, Validation, V&V, Quality System, Change Control, Design Control, Computer System..., Sop, Risk Management, Pharmaceutical Industry, Biotechnology, ISO 13485, ASQ, Certified Quality..., Medical Devices, Cleaning Validation, Method Transfer, Stability, ASQ, Certified Quality..., Supplier Quality, Water Quality, Water Treatment, Software Quality..., Combination Products, 21 CFR Part 11, Part 820, cGMP manufacturing, cGMP practices, ICH guidelines, QRM, Risk Assessment, Risk Based Testing, FMEA, Software Documentation, HACCP, Training, Quality by Design, DFMEA, GAMP, Validation Engineering, Computerized Systems, Purified Water, DQ, Cold Rooms, Environmental Chambers, Human Factors, Quality Auditing, HPLC, LIMS
Education
California State University-Long Beach 1984 — 1987
B. S. Chemical Engineering, Engineering
California State University-Los Angeles 1978 — 1983
B.S., Chemistry
Genentech, a member of the Roche Group February 2014 - Present
Genentech_a member of the Roche Group September 2004 - January 2014
Alexza Pharmaceuticals 2002 - 2004
Nektar Therapeutics (formerly Inhale Therapeutics) 2000 - 2002
LifeScan 1998 - 2000
Berlex Biosciences 1995 - 1998
Dade Behring Diagnostics (formerly Syva) 1991 - 1995
Los Angeles Department of Water and Power 1986 - 1991
Skills
CAPA, FDA, GMP, Validation, V&V, Quality System, Change Control, Design Control, Computer System..., Sop, Risk Management, Pharmaceutical Industry, Biotechnology, ISO 13485, ASQ, Certified Quality..., Medical Devices, Cleaning Validation, Method Transfer, Stability, ASQ, Certified Quality..., Supplier Quality, Water Quality, Water Treatment, Software Quality..., Combination Products, 21 CFR Part 11, Part 820, cGMP manufacturing, cGMP practices, ICH guidelines, QRM, Risk Assessment, Risk Based Testing, FMEA, Software Documentation, HACCP, Training, Quality by Design, DFMEA, GAMP, Validation Engineering, Computerized Systems, Purified Water, DQ, Cold Rooms, Environmental Chambers, Human Factors, Quality Auditing, HPLC, LIMS
Education
California State University-Long Beach 1984 — 1987
B. S. Chemical Engineering, Engineering
California State University-Los Angeles 1978 — 1983
B.S., Chemistry
Bryson Bennett's Alexza Pharmaceuticals Experience April 2002 - August 2005
Job Senior Scientist at CalicoLabs
Industry Biotechnology
Experience
CalicoLabs January 2015 - Present
Kadmon Pharmaceuticals December 2010 - October 2014
Princeton University March 2010 - December 2010
Princeton University September 2005 - March 2010
Alexza Pharmaceuticals April 2002 - August 2005
Zare Lab at Stanford September 1998 - December 2001
Skills
Lifesciences, Biotechnology, Molecular Biology, Cell Biology, HPLC, Microbiology, Analytical Chemistry, LC-MS, NMR, Biochemistry, Computational Biology, Immunology, Mass Spectrometry, Protein Purification, Pharmaceutical Industry
Education
Princeton University 2005 — 2010
PhD, Chemistry (Chemical Biology)
Stanford University 1997 — 2002
BS, Chemistry
CalicoLabs January 2015 - Present
Kadmon Pharmaceuticals December 2010 - October 2014
Princeton University March 2010 - December 2010
Princeton University September 2005 - March 2010
Alexza Pharmaceuticals April 2002 - August 2005
Zare Lab at Stanford September 1998 - December 2001
Skills
Lifesciences, Biotechnology, Molecular Biology, Cell Biology, HPLC, Microbiology, Analytical Chemistry, LC-MS, NMR, Biochemistry, Computational Biology, Immunology, Mass Spectrometry, Protein Purification, Pharmaceutical Industry
Education
Princeton University 2005 — 2010
PhD, Chemistry (Chemical Biology)
Stanford University 1997 — 2002
BS, Chemistry
Janet Tamada's Alexza Pharmaceuticals Experience May 2004 - April 2005
Job Senior Consultant for Medical Devices and Pharmaceuticals
Industry Medical Devices
Experience
J Tamada Consulting December 2012 - Present
ArKal Medical December 2007 - November 2012
ALZA Corporation, Johnson and Johnson May 2005 - October 2007
Alexza Pharmaceuticals May 2004 - April 2005
Cygnus, Inc. December 1991 - April 2004
Skills
Medical Devices, Combination Products, Drug Delivery, Diabetes, Pain Management, Continuous Glucose..., Transdermal, Inhalation, Biosensors, Microfluidics, Transport Phenomena, Separations, Polymer Characterization, Formulation, Design Control, PMA, IND, GCP, Biomedical Device Design, Team Leadership, Scientific Management, Project Management, Strategic Thinking, R&D, Biomedical Engineering, Commercialization, FDA, ISO 13485, Cross-functional Team..., Clinical Development, Sop
Education
Massachusetts Institute of Technology 1989 — 1991
NIH Postdoctoral Fellow
University of California, Berkeley 1984 — 1989
Ph.D.
California Institute of Technology 1980 — 1984
BS
J Tamada Consulting December 2012 - Present
ArKal Medical December 2007 - November 2012
ALZA Corporation, Johnson and Johnson May 2005 - October 2007
Alexza Pharmaceuticals May 2004 - April 2005
Cygnus, Inc. December 1991 - April 2004
Skills
Medical Devices, Combination Products, Drug Delivery, Diabetes, Pain Management, Continuous Glucose..., Transdermal, Inhalation, Biosensors, Microfluidics, Transport Phenomena, Separations, Polymer Characterization, Formulation, Design Control, PMA, IND, GCP, Biomedical Device Design, Team Leadership, Scientific Management, Project Management, Strategic Thinking, R&D, Biomedical Engineering, Commercialization, FDA, ISO 13485, Cross-functional Team..., Clinical Development, Sop
Education
Massachusetts Institute of Technology 1989 — 1991
NIH Postdoctoral Fellow
University of California, Berkeley 1984 — 1989
Ph.D.
California Institute of Technology 1980 — 1984
BS
Tamara Jovonovich's Alexza Pharmaceuticals Experience May 2004 - July 2005
Job Director of Product Development at Pernix Therapeutics
Industry Pharmaceuticals
Experience
Pernix Therapeutics January 2013 - Present
Cypress Pharmaceutical August 2011 - December 2012
Cypress Pharmaceutical June 2009 - August 2011
Fleming Pharmaceuticals 2005 - 2009
Alexza Pharmaceuticals May 2004 - July 2005
Skills
FDA, ANDA, Pharmaceutical Industry, HPLC, Biotechnology, GMP, Regulatory Submissions, Sop, Validation, NDA, Change Control, Lifesciences, CAPA, Regulatory Affairs
Education
Stanford University 2001 — 2003
post-doc, Biophysical Chemistry
University of Washington 1995 — 2000
PhD, Biophysical Chemistry
Pernix Therapeutics January 2013 - Present
Cypress Pharmaceutical August 2011 - December 2012
Cypress Pharmaceutical June 2009 - August 2011
Fleming Pharmaceuticals 2005 - 2009
Alexza Pharmaceuticals May 2004 - July 2005
Skills
FDA, ANDA, Pharmaceutical Industry, HPLC, Biotechnology, GMP, Regulatory Submissions, Sop, Validation, NDA, Change Control, Lifesciences, CAPA, Regulatory Affairs
Education
Stanford University 2001 — 2003
post-doc, Biophysical Chemistry
University of Washington 1995 — 2000
PhD, Biophysical Chemistry
Greg Wallace-Freedman's Alexza Pharmaceuticals Experience January 2002 - June 2003
Job Senior Software Engineer at Netflix
Industry Computer Software
Experience
Netflix June 2012 - Present
Thermo Fisher Scientific August 2011 - June 2012
BD Biosciences July 2010 - July 2011
Symyx Technologies June 2003 - May 2010
Alexza Pharmaceuticals January 2002 - June 2003
Symyx Technologies April 1996 - October 2001
Lawrence Berkeley National Laboratory 1994 - 1996
The Daily Californian 1990 - 1994
Skills
R&D, Agile Methodologies, Automation, NUnit, WPF, Software Design, Laboratory Automation, C#, Software Development, C++, Robotics, WinForms, .NET, XML, LINQ, Multithreading, Object Oriented Design, REST
Education
University of California, Berkeley 1989 — 1994
B.S., Naval Architecture & Offshore Engineering
Netflix June 2012 - Present
Thermo Fisher Scientific August 2011 - June 2012
BD Biosciences July 2010 - July 2011
Symyx Technologies June 2003 - May 2010
Alexza Pharmaceuticals January 2002 - June 2003
Symyx Technologies April 1996 - October 2001
Lawrence Berkeley National Laboratory 1994 - 1996
The Daily Californian 1990 - 1994
Skills
R&D, Agile Methodologies, Automation, NUnit, WPF, Software Design, Laboratory Automation, C#, Software Development, C++, Robotics, WinForms, .NET, XML, LINQ, Multithreading, Object Oriented Design, REST
Education
University of California, Berkeley 1989 — 1994
B.S., Naval Architecture & Offshore Engineering
Ramesh Damani's Alexza Pharmaceuticals Experience 2003 - 2008
Job CEO at Lifetech Advisors LLC
Industry Pharmaceuticals
Experience
Njoy Inc. February 2014 - Present
Lifetech Advisors LLC 2012 - Present
CardioCanary 2011 - Present
ArKal Medical 2009 - 2011
Alexza Pharmaceuticals 2003 - 2008
Alza Corporation 1992 - 2003
Education
University of California, Davis 1985 — 1987
MS, Engineering
Indian Institute of Technology, Madras 1981 — 1985
B Tech, Engineering
Njoy Inc. February 2014 - Present
Lifetech Advisors LLC 2012 - Present
CardioCanary 2011 - Present
ArKal Medical 2009 - 2011
Alexza Pharmaceuticals 2003 - 2008
Alza Corporation 1992 - 2003
Education
University of California, Davis 1985 — 1987
MS, Engineering
Indian Institute of Technology, Madras 1981 — 1985
B Tech, Engineering
Brad Kumagai's Alexza Pharmaceuticals Experience May 2005 - February 2009
Job Senior Reseach Associate at Theravance
Industry Medical Devices
Experience
Theravance August 2009 - Present
Alexza Pharmaceuticals May 2005 - February 2009
Vaxgen, Inc. August 2004 - April 2005
Millennium Pharmaceuticals January 2003 - June 2004
Cygnus, Inc. August 2000 - December 2002
Superstore Industries September 1999 - July 2000
Education
University of California, Davis 1999 — 2001
B.S., Biological Sciences
Theravance August 2009 - Present
Alexza Pharmaceuticals May 2005 - February 2009
Vaxgen, Inc. August 2004 - April 2005
Millennium Pharmaceuticals January 2003 - June 2004
Cygnus, Inc. August 2000 - December 2002
Superstore Industries September 1999 - July 2000
Education
University of California, Davis 1999 — 2001
B.S., Biological Sciences
Priscilla Bereza's Alexza Pharmaceuticals Experience 2004 - Present
Job QC Analytical Chemist at Alexza
Industry Pharmaceuticals
Experience
Alexza Pharmaceuticals 2004 - Present
Bioassay Laboratories April 2003 - September 2004
Cygnus, Inc April 2000 - October 2002
Education
Metropolitan State University of Denver 1993 — 1998
Alexza Pharmaceuticals 2004 - Present
Bioassay Laboratories April 2003 - September 2004
Cygnus, Inc April 2000 - October 2002
Education
Metropolitan State University of Denver 1993 — 1998
Edwin Kamemoto's Alexza Pharmaceuticals Experience April 2015 - Present
Job Regulatory Affairs at Alexza Pharmaceuticals
Industry Pharmaceuticals
Experience
Alexza Pharmaceuticals April 2015 - Present
Alexza Pharmaceuticals July 2012 - Present
Alexza Pharmaceuticals March 2006 - Present
Nektar Therapeutics 2001 - 2004
Education
Stanford University 1984 — 1988
Postdoctoral Fellow, Pharmacology
University of California, Los Angeles 1976 — 1982
PhD, Biochemistry
Alexza Pharmaceuticals April 2015 - Present
Alexza Pharmaceuticals July 2012 - Present
Alexza Pharmaceuticals March 2006 - Present
Nektar Therapeutics 2001 - 2004
Education
Stanford University 1984 — 1988
Postdoctoral Fellow, Pharmacology
University of California, Los Angeles 1976 — 1982
PhD, Biochemistry
Rhett V. Pascual, Ph.D.'s Alexza Pharmaceuticals Experience January 2013 - September 2014
Job Quality Assurance at Pharmaceutical Company
Industry Biotechnology
Experience
Alexza Pharmaceuticals January 2013 - September 2014
Bayer May 2005 - January 2012
Elan Pharmaceuticals February 2004 - May 2005
Skills
Sequencing, Biotechnology, Pharmaceutical Industry, Cell Culture, GMP, Quality Control, CAPA, Quality System, Quality Assurance, FDA, Medical Devices, Manufacturing, Laboratory, Microbiology
Education
University of California, Berkeley
Regulatory Affairs
University of California, Berkeley
BA, Neurobiology
University of California, Berkeley
PhD, Molecular & Cell Biology
Alexza Pharmaceuticals January 2013 - September 2014
Bayer May 2005 - January 2012
Elan Pharmaceuticals February 2004 - May 2005
Skills
Sequencing, Biotechnology, Pharmaceutical Industry, Cell Culture, GMP, Quality Control, CAPA, Quality System, Quality Assurance, FDA, Medical Devices, Manufacturing, Laboratory, Microbiology
Education
University of California, Berkeley
Regulatory Affairs
University of California, Berkeley
BA, Neurobiology
University of California, Berkeley
PhD, Molecular & Cell Biology
Tamara Herman's Alexza Pharmaceuticals Experience March 2014 - August 2014
Job Instructor volunteer at Science is Elementary (nonprofit)
Industry Biotechnology
Experience
Science is Elementary (non-profit) January 2012 - Present
Alexza Pharmaceuticals March 2014 - August 2014
Knwoledge Quest January 2012 - June 2014
Goodwill Industries International September 2008 - May 2012
Conor Medsystems 2006 - 2007
Stanford Research Institute March 2005 - June 2005
Alza September 2004 - January 2005
De Anza College March 2004 - September 2004
VA hospital July 2003 - November 2003
Syva (Dade Behring) April 1984 - October 2002
Skills
Chemistry, HPLC, Laboratory, Science, Data Analysis, Medical Devices, FDA, American Chemical...
Education
Prva beograska gimnazija Mosa Pijade
University of Belgrade
BS, Biology
Science is Elementary (non-profit) January 2012 - Present
Alexza Pharmaceuticals March 2014 - August 2014
Knwoledge Quest January 2012 - June 2014
Goodwill Industries International September 2008 - May 2012
Conor Medsystems 2006 - 2007
Stanford Research Institute March 2005 - June 2005
Alza September 2004 - January 2005
De Anza College March 2004 - September 2004
VA hospital July 2003 - November 2003
Syva (Dade Behring) April 1984 - October 2002
Skills
Chemistry, HPLC, Laboratory, Science, Data Analysis, Medical Devices, FDA, American Chemical...
Education
Prva beograska gimnazija Mosa Pijade
University of Belgrade
BS, Biology
Curtis Tom's Alexza Pharmaceuticals Experience 2002 - 2004
Job CTO at Tessaron Medical
Industry Medical Devices
Experience
Tessaron Medical March 2007 - Present
Voyage Medical January 2008 - December 2008
AMARANTE TECHNOLOGIES INC October 2005 - February 2007
Alexza Pharmaceutical October 2003 - October 2005
Alexza Pharmaceuticals 2002 - 2004
Broncus Technologies 2002 - 2002
MicroHeart 1999 - 2001
Skills
Medical Devices, Product Development, R&D, Design Control, Manufacturing, Intellectual Property, Start-ups, Engineering Management, System Design, Electrical Engineering, Embedded Systems, FDA, ISO 13485, Design for Manufacturing, Project Management, Quality System, Validation
Education
Pennsylvania State University-Great Valley Graduate Center 1991 — 1993
MSEE, engineering
Stevens Institute of Technology 1976 — 1981
BSEE, Engineering
Tessaron Medical March 2007 - Present
Voyage Medical January 2008 - December 2008
AMARANTE TECHNOLOGIES INC October 2005 - February 2007
Alexza Pharmaceutical October 2003 - October 2005
Alexza Pharmaceuticals 2002 - 2004
Broncus Technologies 2002 - 2002
MicroHeart 1999 - 2001
Skills
Medical Devices, Product Development, R&D, Design Control, Manufacturing, Intellectual Property, Start-ups, Engineering Management, System Design, Electrical Engineering, Embedded Systems, FDA, ISO 13485, Design for Manufacturing, Project Management, Quality System, Validation
Education
Pennsylvania State University-Great Valley Graduate Center 1991 — 1993
MSEE, engineering
Stevens Institute of Technology 1976 — 1981
BSEE, Engineering
Wolfgang Schmidt's Alexza Pharmaceuticals Experience January 2005 - June 2014
Job Senior Director Technical Operations at NJOY Electronic Cigarettes
Industry Biotechnology
Experience
NJOY Electronic Cigarettes June 2014 - Present
Alexza Pharmaceuticals January 2005 - June 2014
Skills
Biotechnology, CAPA, FDA, GMP, Medical Devices, Pharmaceutical Industry, Quality System, R&D, Sop, Technology Transfer, Validation, 21 CFR Part 11
Education
Duke University - Fuqua School of Business 2002 — 2004
MBA
University of Illinois at Urbana-Champaign 1991 — 1995
Ph.D., Chem. Eng.
SUNY at Buffalo 1989 — 1991
M.S., Chem. Eng.
University of Stellenbosch 1985 — 1988
B.S., Chem. Eng.
NJOY Electronic Cigarettes June 2014 - Present
Alexza Pharmaceuticals January 2005 - June 2014
Skills
Biotechnology, CAPA, FDA, GMP, Medical Devices, Pharmaceutical Industry, Quality System, R&D, Sop, Technology Transfer, Validation, 21 CFR Part 11
Education
Duke University - Fuqua School of Business 2002 — 2004
MBA
University of Illinois at Urbana-Champaign 1991 — 1995
Ph.D., Chem. Eng.
SUNY at Buffalo 1989 — 1991
M.S., Chem. Eng.
University of Stellenbosch 1985 — 1988
B.S., Chem. Eng.
Sai Dharmaraj's Alexza Pharmaceuticals Experience December 2013 - Present
Job QC Analyst II at Alexza Pharmeceuticals, Inc.
Industry Pharmaceuticals
Experience
Alexza Pharmaceuticals December 2013 - Present
Corium International March 2012 - November 2013
Komala Vilas June 2005 - April 2012
Corium International March 2010 - March 2012
Corium International August 2007 - December 2009
Skills
UV/Vis, Biotechnology, GMP, Gas Chromatography, HPLC, Chromatography, FTIR, Medical Devices, Raw Materials, Drug Delivery, FDA, GLP, R&D, Validation, Quality Control
Education
University of California, Riverside 2003 — 2007
Alexza Pharmaceuticals December 2013 - Present
Corium International March 2012 - November 2013
Komala Vilas June 2005 - April 2012
Corium International March 2010 - March 2012
Corium International August 2007 - December 2009
Skills
UV/Vis, Biotechnology, GMP, Gas Chromatography, HPLC, Chromatography, FTIR, Medical Devices, Raw Materials, Drug Delivery, FDA, GLP, R&D, Validation, Quality Control
Education
University of California, Riverside 2003 — 2007
Erfan Gunawan's Alexza Pharmaceuticals Experience July 2004 - February 2005
Job Experienced Finance Professional
Industry Accounting
Experience
Intuit January 2015 - Present
Logitech July 2013 - January 2015
Shutterfly January 2012 - July 2013
Mercury Media Holdings April 2010 - June 2011
Pittsburgh Glass Works, ULC July 2009 - March 2010
General Electric June 2008 - August 2008
Nektar Therapeutics March 2005 - May 2007
Alexza Pharmaceuticals July 2004 - February 2005
Skills
Forecasting, Financial Analysis, Cross-functional Team..., Management, Competitive Analysis, Data Analysis, Product Management, Analysis, Strategy, Budgets, Finance, Accounting, Process Improvement
Education
Carnegie Mellon University - Tepper School of Business
Master of Business Administration (MBA), Finance and Accounting
University of California, Berkeley
BS, Chemical Engineering
Intuit January 2015 - Present
Logitech July 2013 - January 2015
Shutterfly January 2012 - July 2013
Mercury Media Holdings April 2010 - June 2011
Pittsburgh Glass Works, ULC July 2009 - March 2010
General Electric June 2008 - August 2008
Nektar Therapeutics March 2005 - May 2007
Alexza Pharmaceuticals July 2004 - February 2005
Skills
Forecasting, Financial Analysis, Cross-functional Team..., Management, Competitive Analysis, Data Analysis, Product Management, Analysis, Strategy, Budgets, Finance, Accounting, Process Improvement
Education
Carnegie Mellon University - Tepper School of Business
Master of Business Administration (MBA), Finance and Accounting
University of California, Berkeley
BS, Chemical Engineering
Son Kuan's Alexza Pharmaceuticals Experience 2011 - 2014
Job Quality Professional in Biotechnology / Pharmaceuticals
Industry Biotechnology
Experience
DoubleDragon Consulting 2015 - Present
Alexza Pharmaceuticals 2011 - 2014
Ipsen 2011 - 2011
Zosano Pharma January 2009 - November 2010
Anesiva 2008 - 2009
TaiMed Biologics 2008 - 2009
Solstice Neurosciences (acquired from Elan Pharmaceuticals) 2004 - 2007
Elan Pharmaceuticals 2003 - 2004
Anosys 2001 - 2003
Matrix Pharmaceuticals (now Novartis) 1996 - 2001
Skills
Change Control, Assay Development, Auditing, Method Transfer, Deviations, ICH guidelines, GMP, Validation, Quality Control, Pharmaceutical Industry, Biotechnology, FDA, CAPA, Quality Assurance, R&D, Regulatory Requirements, Microbiology, SOP, Biopharmaceuticals
Education
Indiana University Bloomington
MS
Iowa State University
Ph.D
The Chinese University of Hong Kong
BS
DoubleDragon Consulting 2015 - Present
Alexza Pharmaceuticals 2011 - 2014
Ipsen 2011 - 2011
Zosano Pharma January 2009 - November 2010
Anesiva 2008 - 2009
TaiMed Biologics 2008 - 2009
Solstice Neurosciences (acquired from Elan Pharmaceuticals) 2004 - 2007
Elan Pharmaceuticals 2003 - 2004
Anosys 2001 - 2003
Matrix Pharmaceuticals (now Novartis) 1996 - 2001
Skills
Change Control, Assay Development, Auditing, Method Transfer, Deviations, ICH guidelines, GMP, Validation, Quality Control, Pharmaceutical Industry, Biotechnology, FDA, CAPA, Quality Assurance, R&D, Regulatory Requirements, Microbiology, SOP, Biopharmaceuticals
Education
Indiana University Bloomington
MS
Iowa State University
Ph.D
The Chinese University of Hong Kong
BS
Ward Tuttle's Alexza Pharmaceuticals Experience May 2005 - February 2009
Job Process Project Engineer at ALK Abelló
Industry Pharmaceuticals
Experience
ALK Abelló May 2009 - Present
Alexza Pharmaceuticals May 2005 - February 2009
Alza 2001 - 2005
AlZA Corporation, Mountain View, CA 2001 - 2005
Impax Laboratories November 1999 - February 2001
Skills
Process Validation, Validation, Technology Transfer, Medical Devices, Quality Systems, Equipment Selection, Equipment Installation, R&D, V&V, FDA, GMP, Lifesciences, Quality System, Biotechnology, Pharmaceutical Industry, Process Simulation, CAPA, Quality Assurance, Process Engineering, Design of Experiments, Software Documentation, Sop, Change Control, Chemistry
Education
University of California, Berkeley 1995 — 1998
Bachelor of Science, Chemical Engineering
Oregon State University 1993 — 1995
Chemical Engnineering
ALK Abelló May 2009 - Present
Alexza Pharmaceuticals May 2005 - February 2009
Alza 2001 - 2005
AlZA Corporation, Mountain View, CA 2001 - 2005
Impax Laboratories November 1999 - February 2001
Skills
Process Validation, Validation, Technology Transfer, Medical Devices, Quality Systems, Equipment Selection, Equipment Installation, R&D, V&V, FDA, GMP, Lifesciences, Quality System, Biotechnology, Pharmaceutical Industry, Process Simulation, CAPA, Quality Assurance, Process Engineering, Design of Experiments, Software Documentation, Sop, Change Control, Chemistry
Education
University of California, Berkeley 1995 — 1998
Bachelor of Science, Chemical Engineering
Oregon State University 1993 — 1995
Chemical Engnineering
Neeraj Pakala's Alexza Pharmaceuticals Experience March 2015 - Present
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 Alexza Pharmaceuticals Experience April 2013 - August 2014
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
Helen Avitabile's Alexza Pharmaceuticals Experience 2009 - October 2012
Job Associate Director, Analytical Research & Development, Quality Control function group at Novartis
Industry Pharmaceuticals
Experience
Novartis October 2012 - Present
Alexza Pharmaceuticals 2009 - October 2012
Johnson & Johnson West Coast ChemPharm - ALZA Corporation 2006 - 2007
ALZA Corporation 2003 - 2006
ALZA Corporation 1994 - 2001
ALZA Corporation 1987 - 1990
ALZA Corporation 1986 - 1987
RJ Reynolds - Del Monte Research Center 1983 - 1986
Skills
Six Sigma, Method Validation, Laboratory..., PAI, Analytical Techniques, Adaptable and Goal..., Documentation, Quality Systems, Quality Management, Department Management, Training, Regulatory Approvals, Quality Systems Design, Company Turn Around
Education
University of California, Berkeley
Novartis October 2012 - Present
Alexza Pharmaceuticals 2009 - October 2012
Johnson & Johnson West Coast ChemPharm - ALZA Corporation 2006 - 2007
ALZA Corporation 2003 - 2006
ALZA Corporation 1994 - 2001
ALZA Corporation 1987 - 1990
ALZA Corporation 1986 - 1987
RJ Reynolds - Del Monte Research Center 1983 - 1986
Skills
Six Sigma, Method Validation, Laboratory..., PAI, Analytical Techniques, Adaptable and Goal..., Documentation, Quality Systems, Quality Management, Department Management, Training, Regulatory Approvals, Quality Systems Design, Company Turn Around
Education
University of California, Berkeley
Roman Skowronski, MD, PhD's Alexza Pharmaceuticals Experience 2002 - 2005
Job at InteKrin Therapeutics
Industry Pharmaceuticals
Experience
InteKrin Therapeutics 2010 - Present
AcelRx Pharmaceuticals 2009 - 2010
ALZA / Johnson & Johnson PRD 2005 - 2008
Alexza Pharmaceuticals 2002 - 2005
ALZA Corporation 1994 - 2001
Education
Stanford University School of Medicine 1987 — 1989
Post-doctoral Fellowship
University of California, San Diego - School of Medicine 1986 — 1987
Post-doctoral Fellowship
MD, PhD
InteKrin Therapeutics 2010 - Present
AcelRx Pharmaceuticals 2009 - 2010
ALZA / Johnson & Johnson PRD 2005 - 2008
Alexza Pharmaceuticals 2002 - 2005
ALZA Corporation 1994 - 2001
Education
Stanford University School of Medicine 1987 — 1989
Post-doctoral Fellowship
University of California, San Diego - School of Medicine 1986 — 1987
Post-doctoral Fellowship
MD, PhD
Chaio-Wen Chen's Alexza Pharmaceuticals Experience January 2007 - May 2008
Job Preclinical Consultant at Consulting Firm
Industry Pharmaceuticals
Experience
Self-Employed March 2013 - Present
Santa Clara County, Mental Health Department February 2013 - Present
Anacor Pharmaceuticals July 2010 - January 2013
Anacor Pharmaceuticals May 2008 - July 2010
Alexza Pharmaceuticals January 2007 - May 2008
ALZA/JNJ 2005 - 2007
Johnson and Johnson Pharmaceutical 2005 - 2007
Roche Palo Alto April 2002 - June 2005
Development Center for Biotechnology 1996 - 2001
Skills
Toxicology, Drug Development, Drug Discovery, GLP, CRO, Biotechnology, Regulatory Submissions, IND, Pharmaceutical Industry, Lifesciences, In Vivo, FDA
Education
University of Alabama at Birmingham 1992 — 1996
PhD, Environmental Toxicology
Self-Employed March 2013 - Present
Santa Clara County, Mental Health Department February 2013 - Present
Anacor Pharmaceuticals July 2010 - January 2013
Anacor Pharmaceuticals May 2008 - July 2010
Alexza Pharmaceuticals January 2007 - May 2008
ALZA/JNJ 2005 - 2007
Johnson and Johnson Pharmaceutical 2005 - 2007
Roche Palo Alto April 2002 - June 2005
Development Center for Biotechnology 1996 - 2001
Skills
Toxicology, Drug Development, Drug Discovery, GLP, CRO, Biotechnology, Regulatory Submissions, IND, Pharmaceutical Industry, Lifesciences, In Vivo, FDA
Education
University of Alabama at Birmingham 1992 — 1996
PhD, Environmental Toxicology
Tony Tebbutt's Alexza Pharmaceuticals Experience 2007 - 2009
Job Author
Industry Writing and Editing
Experience
AGT Rx 2010 - 2012
Alexza Pharmaceuticals 2007 - 2009
UCB 1996 - 2006
SYNTEX S.A 1989 - 1995
Synpharm 1987 - 1989
Syntex Canada 1983 - 1987
Eli Lilly and Co. Canada 1974 - 1983
Skills
Pharmaceutical Industry, Product Launch, Medical Devices, Cross-functional Team..., New Business Development, Marketing Strategy, Business Strategy, Start-ups, Pharmaceutical Sales, Business Development, Sales, Strategy, Lifesciences, Marketing, Oncology, Biotechnology, Biopharmaceuticals, Business Planning, FDA, Clinical Development, Validation, Cardiology, Commercialization, GMP
Education
Santa Clara University
Bachelor of Business Administration (B.B.A.), Cum Laude
Stanford University Graduate School of Business
MBA
AGT Rx 2010 - 2012
Alexza Pharmaceuticals 2007 - 2009
UCB 1996 - 2006
SYNTEX S.A 1989 - 1995
Synpharm 1987 - 1989
Syntex Canada 1983 - 1987
Eli Lilly and Co. Canada 1974 - 1983
Skills
Pharmaceutical Industry, Product Launch, Medical Devices, Cross-functional Team..., New Business Development, Marketing Strategy, Business Strategy, Start-ups, Pharmaceutical Sales, Business Development, Sales, Strategy, Lifesciences, Marketing, Oncology, Biotechnology, Biopharmaceuticals, Business Planning, FDA, Clinical Development, Validation, Cardiology, Commercialization, GMP
Education
Santa Clara University
Bachelor of Business Administration (B.B.A.), Cum Laude
Stanford University Graduate School of Business
MBA
Sherri Biondi's Alexza Pharmaceuticals Experience March 2005 - May 2012
Job Director Device Development at Genentech
Industry Medical Devices
Experience
Genentech June 2012 - Present
Alexza Pharmaceuticals March 2005 - May 2012
Caliper Technologies 1999 - 2005
Affymetrix 1995 - 1999
Education
University of Pennsylvania 1990 — 1995
PhD, Chemical Engineering
Rensselaer Polytechnic Institute 1986 — 1990
BS, Chemical Engineering
Genentech June 2012 - Present
Alexza Pharmaceuticals March 2005 - May 2012
Caliper Technologies 1999 - 2005
Affymetrix 1995 - 1999
Education
University of Pennsylvania 1990 — 1995
PhD, Chemical Engineering
Rensselaer Polytechnic Institute 1986 — 1990
BS, Chemical Engineering
August Moretti's Alexza Pharmaceuticals Experience January 2005 - December 2011
Job CFO at Depomed
Industry Pharmaceuticals
Experience
Depomed, Inc. January 2012 - Present
Alexza Pharmaceuticals January 2005 - December 2011
Skills
Start-ups, Lifesciences, Financial Analysis, Sarbanes-Oxley Act, IPO, Due Diligence, Investor Relations, Revenue Recognition, Pharmaceutical Industry, Financial Modeling, Forecasting, Biotechnology, Venture Capital, Mergers, Corporate Development, Business Strategy, Legal, Valuation, Strategic Financial..., Private Equity, Mergers & Acquisitions, Entrepreneurship, Strategy, Executive Management, Business Planning, Cross-functional Team..., Corporate Finance, Financial Reporting, Technology Transfer, Auditing, Restructuring, M&A experience, Managerial Finance, SEC filings, Acquisition Integration, Corporate Governance, Commercialization, Private Placements, Venture Financing, Accounting, Cash Flow, Drug Development, Joint Ventures, Business Valuation, Biopharmaceuticals, Acquisitions, Clinical Development, Licensing, Investment Banking, Sarbanes-Oxley
Education
Harvard Law School 1972 — 1975
Juris Doctor (J.D.)
Princeton University 1968 — 1972
AB, Economics
Depomed, Inc. January 2012 - Present
Alexza Pharmaceuticals January 2005 - December 2011
Skills
Start-ups, Lifesciences, Financial Analysis, Sarbanes-Oxley Act, IPO, Due Diligence, Investor Relations, Revenue Recognition, Pharmaceutical Industry, Financial Modeling, Forecasting, Biotechnology, Venture Capital, Mergers, Corporate Development, Business Strategy, Legal, Valuation, Strategic Financial..., Private Equity, Mergers & Acquisitions, Entrepreneurship, Strategy, Executive Management, Business Planning, Cross-functional Team..., Corporate Finance, Financial Reporting, Technology Transfer, Auditing, Restructuring, M&A experience, Managerial Finance, SEC filings, Acquisition Integration, Corporate Governance, Commercialization, Private Placements, Venture Financing, Accounting, Cash Flow, Drug Development, Joint Ventures, Business Valuation, Biopharmaceuticals, Acquisitions, Clinical Development, Licensing, Investment Banking, Sarbanes-Oxley
Education
Harvard Law School 1972 — 1975
Juris Doctor (J.D.)
Princeton University 1968 — 1972
AB, Economics
Madelyn Morris's Alexza Pharmaceuticals Experience January 2007 - Present
Job Analytical Chemist II at Alexza Pharmaceuticals
Industry Pharmaceuticals
Experience
Alexza Pharmaceuticals January 2007 - Present
VaxGen 2004 - 2007
Education
Santa Clara University 1998 — 2002
Alexza Pharmaceuticals January 2007 - Present
VaxGen 2004 - 2007
Education
Santa Clara University 1998 — 2002
Jim Cassella's Alexza Pharmaceuticals Experience June 2004 - January 2015
Job Chief Development Officer at Concert Pharmaceuticals, Inc.
Industry Pharmaceuticals
Experience
Concert Pharmaceuticals, Inc. February 2015 - Present
Alexza Pharmaceuticals June 2004 - January 2015
Neurogen Corporation April 1989 - June 2004
Oberlin College August 1987 - April 1989
Yale University School of Medicine March 1983 - August 1987
Skills
Drug Development, Pharmacology, Central Nervous System, Strategy, Neuroscience, Clinical Research, Psychiatry, Clinical Development, Biotechnology, Lifesciences, Drug Discovery, Clinical Trials, CRO, Laboratory, FDA, Medical Devices, Pharmaceutical Industry, Biopharmaceuticals, Regulatory Submissions, Technology Transfer, GCP, Validation, Regulatory Affairs, GLP, R&D, Commercialization, Sop, GMP, Life Sciences, Assay Development
Education
Dartmouth College 1978 — 1983
PhD, Neuroscience
University of New Haven 1972 — 1976
BA, Psychology
Concert Pharmaceuticals, Inc. February 2015 - Present
Alexza Pharmaceuticals June 2004 - January 2015
Neurogen Corporation April 1989 - June 2004
Oberlin College August 1987 - April 1989
Yale University School of Medicine March 1983 - August 1987
Skills
Drug Development, Pharmacology, Central Nervous System, Strategy, Neuroscience, Clinical Research, Psychiatry, Clinical Development, Biotechnology, Lifesciences, Drug Discovery, Clinical Trials, CRO, Laboratory, FDA, Medical Devices, Pharmaceutical Industry, Biopharmaceuticals, Regulatory Submissions, Technology Transfer, GCP, Validation, Regulatory Affairs, GLP, R&D, Commercialization, Sop, GMP, Life Sciences, Assay Development
Education
Dartmouth College 1978 — 1983
PhD, Neuroscience
University of New Haven 1972 — 1976
BA, Psychology
Catherine McAuliffe's Alexza Pharmaceuticals Experience August 2005 - Present
Job Sr. Director Operations at Alexza Pharmaceuticals
Industry Pharmaceuticals
Experience
Alexza Pharmaceuticals August 2005 - Present
Affymax, Inc. 1996 - 2004
Zoecon/Sandoz 1989 - 1996
Education
University of San Francisco 1991 — 1993
MS, Environmental Management
San Jose State University 1986 — 1991
BS, Biology
Alexza Pharmaceuticals August 2005 - Present
Affymax, Inc. 1996 - 2004
Zoecon/Sandoz 1989 - 1996
Education
University of San Francisco 1991 — 1993
MS, Environmental Management
San Jose State University 1986 — 1991
BS, Biology
Ron Hale's Alexza Pharmaceuticals Experience Principal ScientistAffymax Research Institute1988 - 2001
Job Principal Scientist at Alexza Pharmaceuticals
Industry Pharmaceuticals
Experience
Alexza Pharmaceuticals Principal ScientistAffymax Research Institute1988 - 2001
Education
Georgia Institute of Technology 1966 — 1968
Alexza Pharmaceuticals Principal ScientistAffymax Research Institute1988 - 2001
Education
Georgia Institute of Technology 1966 — 1968
Peter Noymer's Alexza Pharmaceuticals Experience 2006 - 2013
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
Felicia Tsai's Alexza Pharmaceuticals Experience November 2004 - June 2009
Job Sr. Research Associate/Clinical Research Associate at Arkal Medical
Industry Pharmaceuticals
Experience
Arkal Medical June 2009 - Present
Roche Molecular Systems 2012 - 2013
Alexza Pharmaceuticals November 2004 - June 2009
Scion Pharmaceuticals January 2004 - November 2004
Education
Boston University School of Medicine
MA, Pharmacology
University of Washington
BS, Microbiology
Arkal Medical June 2009 - Present
Roche Molecular Systems 2012 - 2013
Alexza Pharmaceuticals November 2004 - June 2009
Scion Pharmaceuticals January 2004 - November 2004
Education
Boston University School of Medicine
MA, Pharmacology
University of Washington
BS, Microbiology
Kelly Childers's Alexza Pharmaceuticals Experience 2005 - 2006
Job Notary Public/Loan Signing Agent
Industry Banking
Experience
Alexza Pharmaceuticals 2005 - 2006
Affymax 1998 - 2001
Roche Bioscience 1995 - 1998
Education
San Diego State University-California State University 1990 — 1994
B.S., Biology
Alexza Pharmaceuticals 2005 - 2006
Affymax 1998 - 2001
Roche Bioscience 1995 - 1998
Education
San Diego State University-California State University 1990 — 1994
B.S., Biology
Chuck Franzino's Alexza Pharmaceuticals Experience May 2008 - February 2011
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
Khe Dinh's Alexza Pharmaceuticals Experience June 2013 - May 2015
Job Sr. Process Development Engineer at Novartis
Industry Pharmaceuticals
Experience
Novartis May 2015 - Present
Alexza Pharmaceuticals June 2013 - May 2015
Medicines360 March 2012 - March 2013
Alexza Pharmaceuticals June 2008 - March 2012
Novo Nordisk Delivery Technologies January 2008 - May 2008
novo nordisk delivery technologies 2006 - 2008
Bloom Energy 2006 - 2006
Headway Technologies March 2005 - December 2005
Peninsula Coating Services January 2001 - January 2005
Skills
Aerosol, Drug Delivery, GMP, HPLC, Morphology, Validation, formulation...
Education
San Jose State University 2007 — 2010
M.S, Chemical Engineering
San Jose State University 2001 — 2006
B.S, Chemical Engineering
Novartis May 2015 - Present
Alexza Pharmaceuticals June 2013 - May 2015
Medicines360 March 2012 - March 2013
Alexza Pharmaceuticals June 2008 - March 2012
Novo Nordisk Delivery Technologies January 2008 - May 2008
novo nordisk delivery technologies 2006 - 2008
Bloom Energy 2006 - 2006
Headway Technologies March 2005 - December 2005
Peninsula Coating Services January 2001 - January 2005
Skills
Aerosol, Drug Delivery, GMP, HPLC, Morphology, Validation, formulation...
Education
San Jose State University 2007 — 2010
M.S, Chemical Engineering
San Jose State University 2001 — 2006
B.S, Chemical Engineering
Kevin Lenn's Alexza Pharmaceuticals Experience January 2010 - November 2010
Job Compliance Director at Veracyte, Inc.
Industry Medical Devices
Experience
Veracyte, Inc. January 2015 - Present
Veracyte, Inc. August 2011 - December 2014
Veracyte, Inc. May 2010 - July 2011
NewLink Genetics February 2011 - March 2011
Novartis Vaccines and Diagnostics November 2010 - February 2011
Alexza Pharmaceuticals January 2010 - November 2010
Progenitor Cell Therapy November 2009 - January 2010
Cell Genesys 2006 - 2009
Cell Genesys 2003 - 2006
Cell Genesys 2001 - 2003
Skills
Senior Management, Team Building and..., Personnel Development, Project Management, Quality Control, Quality Assurance, Commissioning, Equipment, Utilities,..., Equipment, Utilities,..., Failure Investigation, Risk Management, Long Range Planning, Site Inspections (FDA,..., Biotechnology, FDA, GMP, Pharmaceutical Industry, Change Control, Biopharmaceuticals, CAPA, SOP, QMS
Education
University of California, Davis 1987 — 1991
B.S., Microbiology
Veracyte, Inc. January 2015 - Present
Veracyte, Inc. August 2011 - December 2014
Veracyte, Inc. May 2010 - July 2011
NewLink Genetics February 2011 - March 2011
Novartis Vaccines and Diagnostics November 2010 - February 2011
Alexza Pharmaceuticals January 2010 - November 2010
Progenitor Cell Therapy November 2009 - January 2010
Cell Genesys 2006 - 2009
Cell Genesys 2003 - 2006
Cell Genesys 2001 - 2003
Skills
Senior Management, Team Building and..., Personnel Development, Project Management, Quality Control, Quality Assurance, Commissioning, Equipment, Utilities,..., Equipment, Utilities,..., Failure Investigation, Risk Management, Long Range Planning, Site Inspections (FDA,..., Biotechnology, FDA, GMP, Pharmaceutical Industry, Change Control, Biopharmaceuticals, CAPA, SOP, QMS
Education
University of California, Davis 1987 — 1991
B.S., Microbiology
Jessica Filippi's Alexza Pharmaceuticals Experience March 2008 - February 2012
Job Independent Pharmaceuticals Professional
Industry Pharmaceuticals
Experience
Gilead Sciences February 2013 - Present
Alexza Pharmaceuticals March 2008 - February 2012
Genitope 2003 - 2007
Genzyme 2001 - 2002
Education
California State University-Hayward
B.A., Liberal Studies, with a minor in Mass Communications
Gilead Sciences February 2013 - Present
Alexza Pharmaceuticals March 2008 - February 2012
Genitope 2003 - 2007
Genzyme 2001 - 2002
Education
California State University-Hayward
B.A., Liberal Studies, with a minor in Mass Communications
Diana Segur's Alexza Pharmaceuticals Experience May 2011 - August 2011
Job QA Compliance Manager
Industry Biotechnology
Experience
InterMune, Inc. August 2012 - September 2012
Genentech, Inc. (Roche Pharmaceuticals) November 2011 - July 2012
Marion Weinreb and Associates January 2006 - 2012
Alexza Pharmaceuticals May 2011 - August 2011
Bayer HealthCare July 2010 - March 2011
Cepheid June 2007 - October 2008
VaxGen Inc. October 2005 - March 2006
Genentech Inc. November 1997 - March 2004
Systemix, Inc. (Novartis) October 1993 - December 1995
Molecular Devices March 1990 - January 1992
Skills
LIMS
Education
University of California, Berkeley 1980 — 1985
post grad courses, Molecular Biology
California Polytechnic State University-San Luis Obispo 1973 — 1978
B.S., Biological Sciences
InterMune, Inc. August 2012 - September 2012
Genentech, Inc. (Roche Pharmaceuticals) November 2011 - July 2012
Marion Weinreb and Associates January 2006 - 2012
Alexza Pharmaceuticals May 2011 - August 2011
Bayer HealthCare July 2010 - March 2011
Cepheid June 2007 - October 2008
VaxGen Inc. October 2005 - March 2006
Genentech Inc. November 1997 - March 2004
Systemix, Inc. (Novartis) October 1993 - December 1995
Molecular Devices March 1990 - January 1992
Skills
LIMS
Education
University of California, Berkeley 1980 — 1985
post grad courses, Molecular Biology
California Polytechnic State University-San Luis Obispo 1973 — 1978
B.S., Biological Sciences
Kalyani Sunkara's Alexza Pharmaceuticals Experience March 2008 - December 2008
Job
Industry Medical Devices
Experience
Genentech / Roche 2012 - Present
Terumo Cardiovascular Systems 2011 - 2012
Genentech 2010 - 2012
Engisystems, Inc. 2010 - 2012
Abbott Laboratories 2011 - 2011
Bio-Rad Laboratories 2011 - 2011
Genomic Health June 2009 - June 2010
Cardinal Health 2010 - 2010
Alexza Pharmaceuticals March 2008 - December 2008
Onyx Pharmaceuticals March 2008 - October 2008
Education
Project Management Institution
PMP, Project Management
University of Detroit Mercy
MSCIS, Computer Information Systems
Bharathidasan University
M.Ed, Education
Nagarjuna University
M.A, History
Osmania University
L.L.B, Law
Management
PGDBM, Post Graduate Diploma in Business Management
Bharathidasan University
B.Ed, Education
Nagarjuna University
B.A, Ecomomics, History, Politics
Polytechnic
D.Pharmacy, Pharmacy
ISO 9001: 2008 Lead Auditor
Genentech / Roche 2012 - Present
Terumo Cardiovascular Systems 2011 - 2012
Genentech 2010 - 2012
Engisystems, Inc. 2010 - 2012
Abbott Laboratories 2011 - 2011
Bio-Rad Laboratories 2011 - 2011
Genomic Health June 2009 - June 2010
Cardinal Health 2010 - 2010
Alexza Pharmaceuticals March 2008 - December 2008
Onyx Pharmaceuticals March 2008 - October 2008
Education
Project Management Institution
PMP, Project Management
University of Detroit Mercy
MSCIS, Computer Information Systems
Bharathidasan University
M.Ed, Education
Nagarjuna University
M.A, History
Osmania University
L.L.B, Law
Management
PGDBM, Post Graduate Diploma in Business Management
Bharathidasan University
B.Ed, Education
Nagarjuna University
B.A, Ecomomics, History, Politics
Polytechnic
D.Pharmacy, Pharmacy
ISO 9001: 2008 Lead Auditor
Michelle Bidaut's Alexza Pharmaceuticals Experience November 2006 - November 2007
Job Manager, Medical Communication at Depomed, Inc
Industry Pharmaceuticals
Experience
Depomed, Inc 2007 - Present
Alexza pharmaceuticals November 2006 - November 2007
FibroGen 2006 - 2006
Affymetrix 2005 - 2006
walgreen 2002 - 2005
Mayo Clinic 1999 - 2001
University of North texas Health Science Center 1996 - 1999
St. Louis University/Washington University School of Medicine 1989 - 1996
Education
Saint Louis University 1991 — 1993
MPH, Epidemiology
Saint Louis University 1984 — 1989
PhD, Pharmacology
Aix-Marseille Université 1970 — 1975
Diplome de pharmacien, Pharmacy
Depomed, Inc 2007 - Present
Alexza pharmaceuticals November 2006 - November 2007
FibroGen 2006 - 2006
Affymetrix 2005 - 2006
walgreen 2002 - 2005
Mayo Clinic 1999 - 2001
University of North texas Health Science Center 1996 - 1999
St. Louis University/Washington University School of Medicine 1989 - 1996
Education
Saint Louis University 1991 — 1993
MPH, Epidemiology
Saint Louis University 1984 — 1989
PhD, Pharmacology
Aix-Marseille Université 1970 — 1975
Diplome de pharmacien, Pharmacy
Louis Fries's Alexza Pharmaceuticals Experience February 2013 - Present
Job Senior Director of CMC Development at Alexza Pharmaceuticals
Industry Pharmaceuticals
Experience
Alexza Pharmaceuticals February 2013 - Present
CMC Regulatory Consulting July 2008 - Present
Novo Nordisk Delivery Technologies 2005 - 2008
Nektar Therapeutics 1999 - 2003
Matrix Pharmaceutical 1992 - 1999
Collagen Corp 1987 - 1992
Skills
FDA, Process Simulation, GMP, Biotechnology, V&V, Validation, CAPA, Pharmaceutical Industry, Medical Devices, Cross-functional Team..., Chemistry, 21 CFR Part 11, Regulatory Affairs, Commercialization, Quality System
Education
Lehigh University 1969 — 1971
MS, Chemical Engineering
Rutgers University-New Brunswick 1965 — 1969
BS, Chemical Engineering
Alexza Pharmaceuticals February 2013 - Present
CMC Regulatory Consulting July 2008 - Present
Novo Nordisk Delivery Technologies 2005 - 2008
Nektar Therapeutics 1999 - 2003
Matrix Pharmaceutical 1992 - 1999
Collagen Corp 1987 - 1992
Skills
FDA, Process Simulation, GMP, Biotechnology, V&V, Validation, CAPA, Pharmaceutical Industry, Medical Devices, Cross-functional Team..., Chemistry, 21 CFR Part 11, Regulatory Affairs, Commercialization, Quality System
Education
Lehigh University 1969 — 1971
MS, Chemical Engineering
Rutgers University-New Brunswick 1965 — 1969
BS, Chemical Engineering
Russell Crook's Alexza Pharmaceuticals Experience August 2007 - January 2009
Job Engineering Consultant
Industry Think Tanks
Experience
Booz Allen Hamilton January 2015 - Present
Surface Science Analytics,LLC 2007 - Present
Orbital ATK November 2012 - January 2015
Epalign, LTD March 2013 - August 2014
Ion Torrent by Life Technologies February 2013 - July 2013
ATK Space Structures and Services October 2010 - November 2012
Melior Innovations January 2010 - November 2011
Kevin Kennedy Associates Inc. 2007 - June 2011
ATK Aerospace Group January 2007 - October 2010
Alexza Pharmaceuticals August 2007 - January 2009
Skills
Design of Experiments, Simulations, Composites, Systems Engineering, Product Development, R&D, Finite Element Analysis, Matlab, Polymers, Modeling, Fortran, Modeling and Simulation, MS Project, Earned Value Management, Polymer Composites, Adhesion and Surface..., Green Belt, Python, Adhesives, Mathematical Modeling, Structural Analysis, Program Development, Schedule Analysis, Fracture Mechanics, Abaqus, Polymer Chemistry, polymer formulation, Constitutive Modeling, Quantitative Analysis, MathCAD, Polymer Characterization, Polymer Physics, Adhesion, Elastomers, Image Analysis, Remote Sensing, Response Surface..., Visual Studio, Adobe Creative Suite, VBA, Excel, Silicone, polymer synthesis, Simulation, Image Simulation, Radiometry, Zemax OpticStudio, Formulation Development, OpenCV, Machine Learning
Education
Texas A&M University 1986 — 1991
Ph.D.
Texas A&M University 1983 — 1986
M.S.
Wayne State University 1981 — 1982
Bachelor's degree
Wayne State University 1977 — 1981
B.A.
Booz Allen Hamilton January 2015 - Present
Surface Science Analytics,LLC 2007 - Present
Orbital ATK November 2012 - January 2015
Epalign, LTD March 2013 - August 2014
Ion Torrent by Life Technologies February 2013 - July 2013
ATK Space Structures and Services October 2010 - November 2012
Melior Innovations January 2010 - November 2011
Kevin Kennedy Associates Inc. 2007 - June 2011
ATK Aerospace Group January 2007 - October 2010
Alexza Pharmaceuticals August 2007 - January 2009
Skills
Design of Experiments, Simulations, Composites, Systems Engineering, Product Development, R&D, Finite Element Analysis, Matlab, Polymers, Modeling, Fortran, Modeling and Simulation, MS Project, Earned Value Management, Polymer Composites, Adhesion and Surface..., Green Belt, Python, Adhesives, Mathematical Modeling, Structural Analysis, Program Development, Schedule Analysis, Fracture Mechanics, Abaqus, Polymer Chemistry, polymer formulation, Constitutive Modeling, Quantitative Analysis, MathCAD, Polymer Characterization, Polymer Physics, Adhesion, Elastomers, Image Analysis, Remote Sensing, Response Surface..., Visual Studio, Adobe Creative Suite, VBA, Excel, Silicone, polymer synthesis, Simulation, Image Simulation, Radiometry, Zemax OpticStudio, Formulation Development, OpenCV, Machine Learning
Education
Texas A&M University 1986 — 1991
Ph.D.
Texas A&M University 1983 — 1986
M.S.
Wayne State University 1981 — 1982
Bachelor's degree
Wayne State University 1977 — 1981
B.A.
David McKinney's Alexza Pharmaceuticals Experience September 2012 - Present
Job Sr. Director, Manufacturing at Alexza Pharmaceuticals
Industry Pharmaceuticals
Experience
Alexza Pharmaceuticals September 2012 - Present
Talon Therapeutics (formerly Hana Biosciences) April 2008 - September 2012
Johnson & Johnson June 2001 - April 2008
ALZA Corporation June 1996 - June 2001
Bayer Corporation 1989 - 1996
Bayer Corporation 1980 - 1989
Hollister-Stier Laboratories 1979 - 1980
Hollister-Stier Laboratories 1977 - 1979
Hollister-Stier Laboratories 1976 - 1977
Skills
Aseptic Processing, GMP, CAPA, Biopharmaceuticals, Validation, Sop, Technology Transfer, Biotechnology, Quality System, Pharmaceutical Industry, Contract Manufacturing, 21 CFR Part 11, GLP, GxP, FDA, Quality Assurance, SOP, Change Control, Manufacturing, Medical Devices, Regulatory Affairs
Education
Georgia State University 1978 — 1979
Microbiology
Wheaton College 1971 — 1975
B.S., Biology
Wheaton Central
Bachelor of Science (BS), Biology, General
Alexza Pharmaceuticals September 2012 - Present
Talon Therapeutics (formerly Hana Biosciences) April 2008 - September 2012
Johnson & Johnson June 2001 - April 2008
ALZA Corporation June 1996 - June 2001
Bayer Corporation 1989 - 1996
Bayer Corporation 1980 - 1989
Hollister-Stier Laboratories 1979 - 1980
Hollister-Stier Laboratories 1977 - 1979
Hollister-Stier Laboratories 1976 - 1977
Skills
Aseptic Processing, GMP, CAPA, Biopharmaceuticals, Validation, Sop, Technology Transfer, Biotechnology, Quality System, Pharmaceutical Industry, Contract Manufacturing, 21 CFR Part 11, GLP, GxP, FDA, Quality Assurance, SOP, Change Control, Manufacturing, Medical Devices, Regulatory Affairs
Education
Georgia State University 1978 — 1979
Microbiology
Wheaton College 1971 — 1975
B.S., Biology
Wheaton Central
Bachelor of Science (BS), Biology, General
Rich Faucher's Alexza Pharmaceuticals Experience October 2012 - March 2013
Job Experienced Strategic and Business Development Consultant, Innovation Strategy
Industry Management Consulting
Experience
Independent Contractor June 2015 - Present
Babson College, F.W. Olin Graduate School of Business October 2013 - June 2015
United States Marine Forces Reserve March 1985 - June 2015
Delta Project Management October 2012 - March 2013
Alexza Pharmaceuticals October 2012 - March 2013
XOMA 2005 - 2012
US Marines 2007 - 2008
ESP & Alarms, Inc. (now ESP Pros, Inc.) 2003 - 2005
Wafernet, llc 2000 - 2002
Quaker Oats/Gatorade 1999 - 2000
Skills
Manufacturing, Operations Management, Supply Chain Management, Six Sigma, Logistics, Supply Chain, Warehousing, Lean Manufacturing, Cross-functional Team..., Process Engineering, Contract Management, Change Management, Strategic Planning, Problem Solving, Product Development, Supplier Management, Process Development, Process Improvement, GMP, Inventory Management, Purchasing, Life Sciences, Forecasting, Biotechnology, Budgeting, Program Management, Validation, Troubleshooting, SAP, Contract Negotiation, Pharmaceuticals, Team Building, Security, cGMP, SOP, Customer Relations, Financial Analysis, Quality Assurance, Continuous Improvement, Compliance, Analysis, Electronics, Vendor Management, Executive Management, Risk Management, Mergers, Management Consulting, Kaizen, P&L Responsibility, Operational Excellence
Education
Babson College - Franklin W. Olin Graduate School of Business 2013 — 2015
Master of Business Administration (MBA), Entrepreneurial and Small Business Operations, 3.6
United States Marine Corps Command and Staff College 2011 — 2013
Command and Staff, Military National Resource Strategy and Policy
The Basic School 1989 — 1990
Basic Officer and Field Artillery, Military Leadership and Command
Bridgewater State University 1984 — 1988
Bachelor of Science (B.S.), Aviation Management
Independent Contractor June 2015 - Present
Babson College, F.W. Olin Graduate School of Business October 2013 - June 2015
United States Marine Forces Reserve March 1985 - June 2015
Delta Project Management October 2012 - March 2013
Alexza Pharmaceuticals October 2012 - March 2013
XOMA 2005 - 2012
US Marines 2007 - 2008
ESP & Alarms, Inc. (now ESP Pros, Inc.) 2003 - 2005
Wafernet, llc 2000 - 2002
Quaker Oats/Gatorade 1999 - 2000
Skills
Manufacturing, Operations Management, Supply Chain Management, Six Sigma, Logistics, Supply Chain, Warehousing, Lean Manufacturing, Cross-functional Team..., Process Engineering, Contract Management, Change Management, Strategic Planning, Problem Solving, Product Development, Supplier Management, Process Development, Process Improvement, GMP, Inventory Management, Purchasing, Life Sciences, Forecasting, Biotechnology, Budgeting, Program Management, Validation, Troubleshooting, SAP, Contract Negotiation, Pharmaceuticals, Team Building, Security, cGMP, SOP, Customer Relations, Financial Analysis, Quality Assurance, Continuous Improvement, Compliance, Analysis, Electronics, Vendor Management, Executive Management, Risk Management, Mergers, Management Consulting, Kaizen, P&L Responsibility, Operational Excellence
Education
Babson College - Franklin W. Olin Graduate School of Business 2013 — 2015
Master of Business Administration (MBA), Entrepreneurial and Small Business Operations, 3.6
United States Marine Corps Command and Staff College 2011 — 2013
Command and Staff, Military National Resource Strategy and Policy
The Basic School 1989 — 1990
Basic Officer and Field Artillery, Military Leadership and Command
Bridgewater State University 1984 — 1988
Bachelor of Science (B.S.), Aviation Management
Tatjana Naranda's Alexza Pharmaceuticals Experience July 2013 - Present
Job VP Business Development and Alliance Management at Alexza Pharmaceuticals
Industry Pharmaceuticals
Experience
Alexza pharmaceuticals July 2013 - Present
Alexza Pharmaceuticals July 2012 - July 2013
Alexza Pharmaceuticals February 2009 - July 2012
Alexza Pharmaceuticals October 2005 - 2009
Receptron Inc 1995 - 2005
Education
Golden Gate University 1998 — 2010
MBA
Autonomous University, Madrid Spain 1985 — 1990
Ph.D., Molecular Biology
University of Zagreb 1984 — 1985
Master of Science (MS), Biochemistry
University of Zagreb, Croatia 1980 — 1984
Bachelor of Science (BS), Organic Chemistry
Alexza pharmaceuticals July 2013 - Present
Alexza Pharmaceuticals July 2012 - July 2013
Alexza Pharmaceuticals February 2009 - July 2012
Alexza Pharmaceuticals October 2005 - 2009
Receptron Inc 1995 - 2005
Education
Golden Gate University 1998 — 2010
MBA
Autonomous University, Madrid Spain 1985 — 1990
Ph.D., Molecular Biology
University of Zagreb 1984 — 1985
Master of Science (MS), Biochemistry
University of Zagreb, Croatia 1980 — 1984
Bachelor of Science (BS), Organic Chemistry
Justin Sweeley's Alexza Pharmaceuticals Experience August 2007 - May 2009
Job Process Development Engineer II at TOLMAR Inc.
Industry Pharmaceuticals
Experience
TOLMAR Inc. March 2015 - Present
Colorado State University 2009 - Present
OPX Biotechnologies, Inc. June 2012 - October 2012
Alexza Pharmaceuticals August 2007 - May 2009
Mammoth Brewing Company August 2006 - June 2007
Skills
HPLC, Protein Chemistry, Aseptic Technique, Cell Culture, Fluorescence Microscopy, SDS-PAGE, GMP, Design of Experiments, Medical Devices, UV/Vis, Cell Biology, Molecular Biology, Process Simulation, Biotechnology, Fermentation, Life Sciences, Biochemistry, Research
Education
Colorado State University 2010 — 2015
PhD, Chemical Engineering
Colorado State University 2010 — 2014
Master of Science (M.S.), Chemical Engineering
University of Colorado at Boulder 2001 — 2005
Bachelor of Arts (B.A.), Molecular Cellular and Developmental Biology, Biochemistry, Chemistry
TOLMAR Inc. March 2015 - Present
Colorado State University 2009 - Present
OPX Biotechnologies, Inc. June 2012 - October 2012
Alexza Pharmaceuticals August 2007 - May 2009
Mammoth Brewing Company August 2006 - June 2007
Skills
HPLC, Protein Chemistry, Aseptic Technique, Cell Culture, Fluorescence Microscopy, SDS-PAGE, GMP, Design of Experiments, Medical Devices, UV/Vis, Cell Biology, Molecular Biology, Process Simulation, Biotechnology, Fermentation, Life Sciences, Biochemistry, Research
Education
Colorado State University 2010 — 2015
PhD, Chemical Engineering
Colorado State University 2010 — 2014
Master of Science (M.S.), Chemical Engineering
University of Colorado at Boulder 2001 — 2005
Bachelor of Arts (B.A.), Molecular Cellular and Developmental Biology, Biochemistry, Chemistry
Roselle Will's Alexza Pharmaceuticals Experience October 2011 - December 2011
Job QC Analyst III at Pharmacyclics
Industry Pharmaceuticals
Experience
Pharmacyclics April 2013 - Present
Alexza Pharmaceuticals October 2011 - December 2011
Affymax, Inc. April 2007 - July 2011
SuperGen, Inc. (Astex Pharmaceuticals) November 2000 - April 2007
AB Mauri Fleischmann's June 1989 - November 2000
Skills
21 CFR Part 11, FDA, CAPA, Analytical Chemistry, Validation, GLP, HPLC, UV/Vis Spectroscopy, Karl Fisher Titration, Data review and analysis, OOS and OOT..., MS office, proprietary..., cGMPs related to QC..., Stability..., Preventive maintenance,..., Sop, UV/Vis, GMP
Education
University of Santo Tomas
Bachelor of Science in Food Technology
Pharmacyclics April 2013 - Present
Alexza Pharmaceuticals October 2011 - December 2011
Affymax, Inc. April 2007 - July 2011
SuperGen, Inc. (Astex Pharmaceuticals) November 2000 - April 2007
AB Mauri Fleischmann's June 1989 - November 2000
Skills
21 CFR Part 11, FDA, CAPA, Analytical Chemistry, Validation, GLP, HPLC, UV/Vis Spectroscopy, Karl Fisher Titration, Data review and analysis, OOS and OOT..., MS office, proprietary..., cGMPs related to QC..., Stability..., Preventive maintenance,..., Sop, UV/Vis, GMP
Education
University of Santo Tomas
Bachelor of Science in Food Technology
Siddiq M.'s Alexza Pharmaceuticals Experience June 2011 - Present
Job Sr. Manager, Facilities & Calibration at Alexza Pharmaceuticals
Industry Research
Experience
Alexza Pharmaceuticals June 2011 - Present
ACCO Engineered Systems December 2008 - June 2011
Cell Genesys January 2007 - November 2008
Cell Genesys September 2004 - January 2007
Monster Mechanical December 1997 - September 2004
US Navy June 1993 - June 1997
Skills
FDA GMP, EMA, Auditing, Facilities Management, HVAC, SOP development, Root Cause Analysis, Investigative Reporting, CAPA, CMMS, CCMS, Building Automation, Operations Management, Digital Photography, Biotechnology, GMP, BMS/BAS, IOPQ, Validation
Education
California State University-Hayward 2007 — 2015
Bachelor of Science (B.Sc.)
Pipe Trades Joint Apprenticeship Training 1997 — 2002
Alexza Pharmaceuticals June 2011 - Present
ACCO Engineered Systems December 2008 - June 2011
Cell Genesys January 2007 - November 2008
Cell Genesys September 2004 - January 2007
Monster Mechanical December 1997 - September 2004
US Navy June 1993 - June 1997
Skills
FDA GMP, EMA, Auditing, Facilities Management, HVAC, SOP development, Root Cause Analysis, Investigative Reporting, CAPA, CMMS, CCMS, Building Automation, Operations Management, Digital Photography, Biotechnology, GMP, BMS/BAS, IOPQ, Validation
Education
California State University-Hayward 2007 — 2015
Bachelor of Science (B.Sc.)
Pipe Trades Joint Apprenticeship Training 1997 — 2002
Monica Joya's Alexza Pharmaceuticals Experience April 2010 - October 2010
Job Senior Medical Device Engineer at Intuity Medical, Inc.
Industry Electrical/Electronic Manufacturing
Experience
Intuity Medical, Inc. May 2014 - Present
Intuity Medical April 2012 - May 2014
San Jose State University 2009 - May 2012
Alexza Pharmaceuticals April 2010 - October 2010
Hewlett-Packard July 2006 - May 2009
Hewlett-Packard 2003 - 2004
Hewlett-Packard May 2001 - August 2001
Skills
Testing, Embedded Systems, Firmware, Software Documentation, Electrical Engineering, PCB design, Debugging, Hardware Architecture, Hardware, Manufacturing, VHDL, Verilog, Electronics, PCB Design, Project Management
Education
San Jose State University
Bachelor of Science, Electrical Engineering
Intuity Medical, Inc. May 2014 - Present
Intuity Medical April 2012 - May 2014
San Jose State University 2009 - May 2012
Alexza Pharmaceuticals April 2010 - October 2010
Hewlett-Packard July 2006 - May 2009
Hewlett-Packard 2003 - 2004
Hewlett-Packard May 2001 - August 2001
Skills
Testing, Embedded Systems, Firmware, Software Documentation, Electrical Engineering, PCB design, Debugging, Hardware Architecture, Hardware, Manufacturing, VHDL, Verilog, Electronics, PCB Design, Project Management
Education
San Jose State University
Bachelor of Science, Electrical Engineering
Huiwen Lin's Alexza Pharmaceuticals Experience February 2008 - February 2009
Job Consultant at Alexza Pharmaceuticals
Industry Pharmaceuticals
Experience
Alexza Pharmaceuticals February 2008 - February 2009
GSK April 2005 - June 2006
Taipei Veterans General Hospital, Chest Department, Taipei, Taiwan March 2002 - March 2005
Education
Chinese Culture University 1991 — 2006
BS, Forestry
Chinese Culture University 1996 — 1998
Master, Biotechnology
Alexza Pharmaceuticals February 2008 - February 2009
GSK April 2005 - June 2006
Taipei Veterans General Hospital, Chest Department, Taipei, Taiwan March 2002 - March 2005
Education
Chinese Culture University 1991 — 2006
BS, Forestry
Chinese Culture University 1996 — 1998
Master, Biotechnology
Aarti Verma's Alexza Pharmaceuticals Experience May 2014 - April 2015
Job Associate Director, PV Case Management at Pharmacyclics
Industry Pharmaceuticals
Experience
Pharmacyclics April 2015 - Present
Alexza Pharmaceuticals May 2014 - April 2015
Elan Pharmaceuticals October 2011 - April 2014
InterMune February 2011 - September 2011
Elan July 2009 - February 2011
Teva Pharmaceuticals April 2009 - July 2009
Omnicare Clinical Research May 2006 - April 2009
Skills
Pharmacovigilance, Clinical Trials, Risk Management, Safety Operations, Clinical Research, FDA, CRO, Therapeutic Areas, MedDRA, Drug Safety, EDC, Regulatory Submissions, GCP, Biotechnology, Clinical Development
Education
Cedar Crest College
BSN, RN
Convent of Jesus & Mary
Pharmacyclics April 2015 - Present
Alexza Pharmaceuticals May 2014 - April 2015
Elan Pharmaceuticals October 2011 - April 2014
InterMune February 2011 - September 2011
Elan July 2009 - February 2011
Teva Pharmaceuticals April 2009 - July 2009
Omnicare Clinical Research May 2006 - April 2009
Skills
Pharmacovigilance, Clinical Trials, Risk Management, Safety Operations, Clinical Research, FDA, CRO, Therapeutic Areas, MedDRA, Drug Safety, EDC, Regulatory Submissions, GCP, Biotechnology, Clinical Development
Education
Cedar Crest College
BSN, RN
Convent of Jesus & Mary
Xun Cheng's Alexza Pharmaceuticals Experience March 2014 - September 2014
Job Associate Director, Analytical Chemistry at Pharmacyclics
Industry Biotechnology
Experience
Pharmacyclics September 2014 - Present
Alexza Pharmaceuticals March 2014 - September 2014
Gilead Sciences February 2013 - March 2014
Gilead Sciences January 2011 - January 2013
Affymax February 2008 - January 2011
Affymax March 2005 - January 2008
Skills
HPLC, LC-MS, Method Development, Analytical Chemistry, Biotechnology, Characterization, GLP, Purification, GMP, GC-MS, Chromatography, FDA, UV/Vis, Validation, Gas Chromatography, Drug Development
Education
University of Illinois at Chicago 2000 — 2005
Ph.D., Analytical Chemistry
The University of Chicago 1997 — 2000
M.S., Organic Chemistry
University of Science and Technology of China 1992 — 1997
B.S., Polymer Chemistry
Pharmacyclics September 2014 - Present
Alexza Pharmaceuticals March 2014 - September 2014
Gilead Sciences February 2013 - March 2014
Gilead Sciences January 2011 - January 2013
Affymax February 2008 - January 2011
Affymax March 2005 - January 2008
Skills
HPLC, LC-MS, Method Development, Analytical Chemistry, Biotechnology, Characterization, GLP, Purification, GMP, GC-MS, Chromatography, FDA, UV/Vis, Validation, Gas Chromatography, Drug Development
Education
University of Illinois at Chicago 2000 — 2005
Ph.D., Analytical Chemistry
The University of Chicago 1997 — 2000
M.S., Organic Chemistry
University of Science and Technology of China 1992 — 1997
B.S., Polymer Chemistry
Carlo Chelone's Alexza Pharmaceuticals Experience April 2007 - January 2009
Job
Industry Information Technology and Services
Experience
Genentech (formerly InterMune) January 2014 - Present
Ingenuity Web Apps January 2010 - January 2014
Alexza Pharmaceuticals April 2007 - January 2009
Skills
System Administration, Software Documentation, Biotechnology, Help Desk Support, Linux, DNS, VPN, Cloud Computing, Windows, Cross-functional Team..., Management, Windows Server, Troubleshooting, Microsoft Office, Pharmaceutical Industry, Vendor Management
Education
College of San Mateo 1992 — 2009
Music
Genentech (formerly InterMune) January 2014 - Present
Ingenuity Web Apps January 2010 - January 2014
Alexza Pharmaceuticals April 2007 - January 2009
Skills
System Administration, Software Documentation, Biotechnology, Help Desk Support, Linux, DNS, VPN, Cloud Computing, Windows, Cross-functional Team..., Management, Windows Server, Troubleshooting, Microsoft Office, Pharmaceutical Industry, Vendor Management
Education
College of San Mateo 1992 — 2009
Music
Jeffrey McKinney's Alexza Pharmaceuticals Experience September 2001 - November 2003
Job Principal McKinney Law Group
Industry Law Practice
Experience
McKinney Law Group March 2007 - Present
Active Life Scientific 2009 - 2010
Altair Nanotechnologies March 2007 - September 2008
Sheppard Mullin Richter & Hampton LLP December 2004 - March 2007
Burnes Doane Swecker Mathis November 2004 - December 2005
Alexza Pharmaceuticals September 2001 - November 2003
Burns Doane December 2000 - September 2001
Townsend and Townsend August 1999 - December 2000
Morrison & Foerster LLP June 1996 - July 1999
Zeneca Pharmaceuticals September 1991 - July 1994
Skills
Start-ups, Patents, Intellectual Property, Leadership, Chemistry, Licensing, Due Diligence, Mergers & Acquisitions, Patent Prosecution, Trade Secrets, Venture Capital, Trademarks, Joint Ventures, Negotiation, Patentability, Technology Transfer, Contract Negotiation, Prosecution, Biotechnology, Trademark Infringement, Copyright Law
Education
Stanford University Law School 1994 — 1997
J.D., law
Stanford University 1989 — 1991
Postdoc, Organic Synthesis, DNA Cleavage
The Ohio State University 1984 — 1989
Ph.D., Organic and Organometallic Chemistry
Miami University 1982 — 1984
Chemistry
Hanover College 1978 — 1982
B.A., English Literature
McKinney Law Group March 2007 - Present
Active Life Scientific 2009 - 2010
Altair Nanotechnologies March 2007 - September 2008
Sheppard Mullin Richter & Hampton LLP December 2004 - March 2007
Burnes Doane Swecker Mathis November 2004 - December 2005
Alexza Pharmaceuticals September 2001 - November 2003
Burns Doane December 2000 - September 2001
Townsend and Townsend August 1999 - December 2000
Morrison & Foerster LLP June 1996 - July 1999
Zeneca Pharmaceuticals September 1991 - July 1994
Skills
Start-ups, Patents, Intellectual Property, Leadership, Chemistry, Licensing, Due Diligence, Mergers & Acquisitions, Patent Prosecution, Trade Secrets, Venture Capital, Trademarks, Joint Ventures, Negotiation, Patentability, Technology Transfer, Contract Negotiation, Prosecution, Biotechnology, Trademark Infringement, Copyright Law
Education
Stanford University Law School 1994 — 1997
J.D., law
Stanford University 1989 — 1991
Postdoc, Organic Synthesis, DNA Cleavage
The Ohio State University 1984 — 1989
Ph.D., Organic and Organometallic Chemistry
Miami University 1982 — 1984
Chemistry
Hanover College 1978 — 1982
B.A., English Literature
Bertha deLanda, CIP's Alexza Pharmaceuticals Experience August 2008 - March 2009
Job Clinical Regulatory Affairs Manager, Pediatric Endocrinology
Industry Research
Experience
Stanford University School of Medicine February 2015 - Present
Stanford University August 2012 - January 2015
Stanford University April 2009 - August 2012
AAHRPP 2009 - 2012
Alexza Pharmaceuticals August 2008 - March 2009
Applied Biosystems December 2005 - August 2008
Yoh Scientific May 2005 - November 2005
Glenmoor Elementary School June 1997 - June 2005
Celera Diagnostics April 2004 - May 2005
Roche Molecular Systems January 2003 - December 2004
Skills
Training, FDA, Drug Discovery, HPLC, Clinical Development, Biotechnology, Lifesciences, GLP, Purification, Technology Transfer, Public Speaking, Molecular Biology, Assay Development, Biochemistry, Cell Culture, DNA, Genetics, Genomics, GMP, PCR, Quality Assurance, Science, Life Sciences, GCP, ELISA, Drug Development, Technical Documentation, Experienced Trainer, Quality Control, Quality Management
Education
University of California, Berkeley 1983 — 1987
BA Biology, Organismal
Immaculate Conception Academy 1979 — 1983
High School
St Edwards Elementary 1977 — 1979
Stanford University
Stanford University School of Medicine February 2015 - Present
Stanford University August 2012 - January 2015
Stanford University April 2009 - August 2012
AAHRPP 2009 - 2012
Alexza Pharmaceuticals August 2008 - March 2009
Applied Biosystems December 2005 - August 2008
Yoh Scientific May 2005 - November 2005
Glenmoor Elementary School June 1997 - June 2005
Celera Diagnostics April 2004 - May 2005
Roche Molecular Systems January 2003 - December 2004
Skills
Training, FDA, Drug Discovery, HPLC, Clinical Development, Biotechnology, Lifesciences, GLP, Purification, Technology Transfer, Public Speaking, Molecular Biology, Assay Development, Biochemistry, Cell Culture, DNA, Genetics, Genomics, GMP, PCR, Quality Assurance, Science, Life Sciences, GCP, ELISA, Drug Development, Technical Documentation, Experienced Trainer, Quality Control, Quality Management
Education
University of California, Berkeley 1983 — 1987
BA Biology, Organismal
Immaculate Conception Academy 1979 — 1983
High School
St Edwards Elementary 1977 — 1979
Stanford University
Thomas Cutler's Alexza Pharmaceuticals Experience April 2003 - March 2009
Job Sr. Design Engineer at Novartis
Industry Medical Devices
Experience
Novartis October 2012 - Present
Freeslate Inc. November 2011 - October 2012
Onda Corporation December 2010 - November 2011
Pacific Biosciences April 2009 - December 2010
Alexza Pharmaceuticals April 2003 - March 2009
Affymax 1998 - 2003
Skills
Lathe, Biotechnology, Milling, Solidworks, GMP, Soldering
Education
University of California, Santa Cruz 1986 — 1992
BA, Biochemistry
Novartis October 2012 - Present
Freeslate Inc. November 2011 - October 2012
Onda Corporation December 2010 - November 2011
Pacific Biosciences April 2009 - December 2010
Alexza Pharmaceuticals April 2003 - March 2009
Affymax 1998 - 2003
Skills
Lathe, Biotechnology, Milling, Solidworks, GMP, Soldering
Education
University of California, Santa Cruz 1986 — 1992
BA, Biochemistry
Marc Glazer's Alexza Pharmaceuticals Experience December 2008 - February 2010
Job Sr. Manager, Chemistry at Ion Torrent by Life Technologies
Industry Medical Devices
Experience
Ion Torrent by Life Technologies September 2014 - Present
Ion Torrent Systems (by Life Technologies) February 2012 - September 2014
BD Biosciences February 2010 - April 2012
Alexza Pharmaceuticals December 2008 - February 2010
Alexza Pharmaceuticals December 2006 - December 2008
Alexza Pharmaceuticals November 2004 - December 2006
Cell Biosciences September 2003 - November 2004
Aspira Biosystems April 2002 - September 2003
McKinsey & Company August 1994 - May 1996
Skills
Design Control, IVD, Regulatory Affairs, Medical Devices, Chemistry, FDA, Biotechnology, Materials Science, Surface Chemistry, Product Development
Education
Stanford University 1996 — 2002
PhD, Materials Science
Stanford University 1996 — 2002
Masters, Chemical Engineering
The University of Texas at Austin 1990 — 1994
Bachelors, Mechanical Engineering
Ion Torrent by Life Technologies September 2014 - Present
Ion Torrent Systems (by Life Technologies) February 2012 - September 2014
BD Biosciences February 2010 - April 2012
Alexza Pharmaceuticals December 2008 - February 2010
Alexza Pharmaceuticals December 2006 - December 2008
Alexza Pharmaceuticals November 2004 - December 2006
Cell Biosciences September 2003 - November 2004
Aspira Biosystems April 2002 - September 2003
McKinsey & Company August 1994 - May 1996
Skills
Design Control, IVD, Regulatory Affairs, Medical Devices, Chemistry, FDA, Biotechnology, Materials Science, Surface Chemistry, Product Development
Education
Stanford University 1996 — 2002
PhD, Materials Science
Stanford University 1996 — 2002
Masters, Chemical Engineering
The University of Texas at Austin 1990 — 1994
Bachelors, Mechanical Engineering
Peter Wickman P.E.'s Alexza Pharmaceuticals Experience 2007 - 2009
Job Engineering Consultant at ForSight VISION5
Industry Medical Devices
Experience
ForSight VISION5 February 2015 - Present
Teleflex Incorporated February 2014 - December 2014
Volcano Corporation April 2013 - December 2013
Terumo Cardiovascular Systems October 2012 - April 2013
Medtronic January 2012 - October 2012
Abbott Vascular April 2011 - October 2011
Conor Medsystems (Cordis) June 2009 - May 2011
Alexza Pharmaceuticals 2007 - 2009
Cepheid 2005 - 2007
Advanced Bionics January 2005 - December 2005
Skills
Solidworks, Cobalt, Machining, Medical Devices, R&D, Manufacturing, Diagnostics, GLP, Validation, V&V, FDA, Design Control, ISO 13485, Six Sigma, Quality System, FMEA, Hardware Diagnostics, SPC, SolidWorks
Education
San Jose State University
M.S., Chemical Engineering
Oregon State University
B.S., Chemical Engineering
University of Oregon
B.S., Biology, Chemistry
ForSight VISION5 February 2015 - Present
Teleflex Incorporated February 2014 - December 2014
Volcano Corporation April 2013 - December 2013
Terumo Cardiovascular Systems October 2012 - April 2013
Medtronic January 2012 - October 2012
Abbott Vascular April 2011 - October 2011
Conor Medsystems (Cordis) June 2009 - May 2011
Alexza Pharmaceuticals 2007 - 2009
Cepheid 2005 - 2007
Advanced Bionics January 2005 - December 2005
Skills
Solidworks, Cobalt, Machining, Medical Devices, R&D, Manufacturing, Diagnostics, GLP, Validation, V&V, FDA, Design Control, ISO 13485, Six Sigma, Quality System, FMEA, Hardware Diagnostics, SPC, SolidWorks
Education
San Jose State University
M.S., Chemical Engineering
Oregon State University
B.S., Chemical Engineering
University of Oregon
B.S., Biology, Chemistry
Frank Contreras's Alexza Pharmaceuticals Experience January 2013 - August 2014
Job Manufacturing Associate at Conor Medsystems
Industry Pharmaceuticals
Experience
Alexza Pharmaceuticals January 2013 - August 2014
DSM April 2010 - January 2013
Conor Medsystems August 2009 - April 2010
DePuy Spine January 2003 - February 2009
DePuy Spine December 1999 - January 2003
OREAD January 1997 - January 1999
MATRIX PHARMACEUTICALS January 1994 - January 1997
SYNTEX LABORATORIES January 1993 - January 1994
SYNTEX LABORATORIES January 1989 - January 1993
Education
Evergreen Valley College 1984 — 1986
Fire Science
Silver CreekHigh School 1980 — 1984
Evergreen Valley College
Fire Science
Diploma
Alexza Pharmaceuticals January 2013 - August 2014
DSM April 2010 - January 2013
Conor Medsystems August 2009 - April 2010
DePuy Spine January 2003 - February 2009
DePuy Spine December 1999 - January 2003
OREAD January 1997 - January 1999
MATRIX PHARMACEUTICALS January 1994 - January 1997
SYNTEX LABORATORIES January 1993 - January 1994
SYNTEX LABORATORIES January 1989 - January 1993
Education
Evergreen Valley College 1984 — 1986
Fire Science
Silver CreekHigh School 1980 — 1984
Evergreen Valley College
Fire Science
Diploma
Ed Balancio's Alexza Pharmaceuticals Experience 2004 - 2009
Job Supervisor Device Manufacturing at Arkal Medical
Industry Medical Devices
Experience
Arkal Medical January 2011 - Present
Arkal Medical May 2009 - 2010
Alexza Pharmaceuticals 2004 - 2009
Alexza Pharmaceuticals 2004 - 2009
Alexza 2004 - 2009
Alza September 1998 - March 2004
Johnson & Johnson / Alza Corporation 1998 - 2004
Santa Clara County 2000 - 2001
Unilab Corp. 1994 - 1998
Skills
CAPA, V&V, FDA, GMP, ISO 13485, Medical Devices, Validation, Six Sigma
Education
Evergreen Valley College
Correction Officer Academy
University of Santo Tomas
BS Mechanical Engineering
Arkal Medical January 2011 - Present
Arkal Medical May 2009 - 2010
Alexza Pharmaceuticals 2004 - 2009
Alexza Pharmaceuticals 2004 - 2009
Alexza 2004 - 2009
Alza September 1998 - March 2004
Johnson & Johnson / Alza Corporation 1998 - 2004
Santa Clara County 2000 - 2001
Unilab Corp. 1994 - 1998
Skills
CAPA, V&V, FDA, GMP, ISO 13485, Medical Devices, Validation, Six Sigma
Education
Evergreen Valley College
Correction Officer Academy
University of Santo Tomas
BS Mechanical Engineering
Da Wang's Alexza Pharmaceuticals Experience March 2014 - Present
Job Analytical R&D Scientist at Alexza Pharmaceuticals
Industry Biotechnology
Experience
Alexza Pharmaceuticals March 2014 - Present
Novartis Institutes for BioMedical Research (NIBR) November 2011 - Present
Novartis Vaccines and Diagnostics November 2008 - December 2011
Chiron/Novartis November 1998 - November 2008
Skills
HPLC-MS, supercritical Fluid..., UPLC, Empower, MassLynx, AKTA, Unicorn, Computer System..., Cleaning Validation, GMP, Protein Purification, Purification, HPLC, Mass Spectrometry, Chiral Chromatography
Education
Northwestern Polytechnic University 2002 — 2004
Master of Science (MS), Computer Science
University of the Pacific 1995 — 1998
Master's degree, Chemistry
Alexza Pharmaceuticals March 2014 - Present
Novartis Institutes for BioMedical Research (NIBR) November 2011 - Present
Novartis Vaccines and Diagnostics November 2008 - December 2011
Chiron/Novartis November 1998 - November 2008
Skills
HPLC-MS, supercritical Fluid..., UPLC, Empower, MassLynx, AKTA, Unicorn, Computer System..., Cleaning Validation, GMP, Protein Purification, Purification, HPLC, Mass Spectrometry, Chiral Chromatography
Education
Northwestern Polytechnic University 2002 — 2004
Master of Science (MS), Computer Science
University of the Pacific 1995 — 1998
Master's degree, Chemistry
Ashraf (Ashley) Ahmed's Alexza Pharmaceuticals Experience August 2013 - September 2014
Job Director, Regulatory Affairs, CMC at Medivation Inc.
Industry Biotechnology
Experience
Medivation Inc. September 2014 - Present
Alexza Pharmaceuticals August 2013 - September 2014
Genentech August 2008 - August 2013
Genentech January 2006 - July 2008
Gilead Sciences May 2004 - January 2006
Gilead Sciences February 2003 - April 2004
Gilead Sciences April 2002 - January 2003
Alpha Therapeutic Corporation September 2000 - January 2002
Skills
Regulatory Affairs, FDA, Quality Assurance, Pharmaceutical Industry, Cross-functional Team..., Project Management, CMC, Biotechnology, NDA, Regulatory Submissions, Regulations, GMP, Drug Development, Biopharmaceuticals, SOP, IND
Education
Specialized Certificate as ISO 9001: 2000 Lead Auditor
UC San Diego
Physiology and Neuroscience
Medivation Inc. September 2014 - Present
Alexza Pharmaceuticals August 2013 - September 2014
Genentech August 2008 - August 2013
Genentech January 2006 - July 2008
Gilead Sciences May 2004 - January 2006
Gilead Sciences February 2003 - April 2004
Gilead Sciences April 2002 - January 2003
Alpha Therapeutic Corporation September 2000 - January 2002
Skills
Regulatory Affairs, FDA, Quality Assurance, Pharmaceutical Industry, Cross-functional Team..., Project Management, CMC, Biotechnology, NDA, Regulatory Submissions, Regulations, GMP, Drug Development, Biopharmaceuticals, SOP, IND
Education
Specialized Certificate as ISO 9001: 2000 Lead Auditor
UC San Diego
Physiology and Neuroscience
Mara Clarke's Alexza Pharmaceuticals Experience November 2005 - July 2006
Job Technical Manager PepsiCo
Industry Food & Beverages
Experience
PepsiCo October 2009 - Present
NicePak September 2007 - October 2009
Par Pharmaceutical October 2006 - January 2007
Alexza Pharmaceuticals November 2005 - July 2006
Bay Bioanalytical Laboratory July 2001 - November 2005
Skills
GMP, Quality Assurance, Quality Control, Testing, Food Science, LIMS, Validation, Chromatography, Analytical Chemistry, Sop, Manufacturing
Education
University of California, Davis 1996 — 2001
Science
PepsiCo October 2009 - Present
NicePak September 2007 - October 2009
Par Pharmaceutical October 2006 - January 2007
Alexza Pharmaceuticals November 2005 - July 2006
Bay Bioanalytical Laboratory July 2001 - November 2005
Skills
GMP, Quality Assurance, Quality Control, Testing, Food Science, LIMS, Validation, Chromatography, Analytical Chemistry, Sop, Manufacturing
Education
University of California, Davis 1996 — 2001
Science
Rick Maze's Alexza Pharmaceuticals Experience October 2012 - Present
Job Scientist
Industry Medical Devices
Experience
Alexza Pharmaceuticals October 2012 - Present
LifeScan March 2005 - December 2011
Medluminal November 2003 - February 2005
Amira Medical 1999 - 2002
Chiron Diagnostics 1995 - 1998
Ciba Corning Diagnostics 1985 - 1995
Skills
Design Control
Education
San Jose State University
Bachelor of Arts, Biological Science with Concentration in Molecular Biology
Alexza Pharmaceuticals October 2012 - Present
LifeScan March 2005 - December 2011
Medluminal November 2003 - February 2005
Amira Medical 1999 - 2002
Chiron Diagnostics 1995 - 1998
Ciba Corning Diagnostics 1985 - 1995
Skills
Design Control
Education
San Jose State University
Bachelor of Arts, Biological Science with Concentration in Molecular Biology
Justin Virgili's Alexza Pharmaceuticals Experience 2003 - 2004
Job Director of Materials Engineering at Tactus Technology
Industry Consumer Electronics
Experience
Tactus Technology September 2014 - Present
Tactus Technology May 2014 - August 2014
The Dow Chemical Company 2012 - April 2014
The Dow Chemical Company 2010 - 2012
UC Berkeley 2004 - 2009
Alexza Pharmaceuticals 2003 - 2004
PolyFuel June 2002 - October 2002
Thomas Weisel Partners June 2001 - August 2001
3M Pharmaceuticals June 2000 - August 2000
Education
University of California, Berkeley 2004 — 2009
Ph.D, Chemical Engineering
Stanford University 1998 — 2002
B.S, Chemical Engineering and Biological Sciences
Tactus Technology September 2014 - Present
Tactus Technology May 2014 - August 2014
The Dow Chemical Company 2012 - April 2014
The Dow Chemical Company 2010 - 2012
UC Berkeley 2004 - 2009
Alexza Pharmaceuticals 2003 - 2004
PolyFuel June 2002 - October 2002
Thomas Weisel Partners June 2001 - August 2001
3M Pharmaceuticals June 2000 - August 2000
Education
University of California, Berkeley 2004 — 2009
Ph.D, Chemical Engineering
Stanford University 1998 — 2002
B.S, Chemical Engineering and Biological Sciences
Monique DeSalvo's Alexza Pharmaceuticals Experience April 2014 - September 2014
Job
Industry Internet
Experience
Notion June 2015 - Present
Alexza Pharmaceuticals April 2014 - September 2014
Janssen Alzheimer Immunotherapy June 2010 - March 2014
Adams and Reese LLP May 2007 - February 2010
Docusource Litigation Support July 2006 - April 2007
CC's Community Coffee House January 2005 - June 2006
Gulf States Optical Laboratories, Inc. January 2003 - December 2004
Skills
Quality Assurance, 21 CFR Part 11, Document Management, Sop, FDA, Biotechnology, Pharmaceutical Industry, GxP, GCP, Software Documentation, Microsoft Office, Customer Service, Biopharmaceuticals, Change Control, Documentum, SharePoint, Protocol, Photoshop, Troubleshooting, Awesomeness, Access Database, Visio, Inkscape, HTML, Records Management, User Acceptance Testing, CSS, Data Entry, Email, Administrative Functions, EDMS, Adobe Acrobat Pro, Oracle Agile PLM, WordPress, MailChimp
Education
San Francisco State University 2011 — 2011
University of New Orleans 1999 — 2001
General Studies
Notion June 2015 - Present
Alexza Pharmaceuticals April 2014 - September 2014
Janssen Alzheimer Immunotherapy June 2010 - March 2014
Adams and Reese LLP May 2007 - February 2010
Docusource Litigation Support July 2006 - April 2007
CC's Community Coffee House January 2005 - June 2006
Gulf States Optical Laboratories, Inc. January 2003 - December 2004
Skills
Quality Assurance, 21 CFR Part 11, Document Management, Sop, FDA, Biotechnology, Pharmaceutical Industry, GxP, GCP, Software Documentation, Microsoft Office, Customer Service, Biopharmaceuticals, Change Control, Documentum, SharePoint, Protocol, Photoshop, Troubleshooting, Awesomeness, Access Database, Visio, Inkscape, HTML, Records Management, User Acceptance Testing, CSS, Data Entry, Email, Administrative Functions, EDMS, Adobe Acrobat Pro, Oracle Agile PLM, WordPress, MailChimp
Education
San Francisco State University 2011 — 2011
University of New Orleans 1999 — 2001
General Studies
Saina Hajizadeh's Alexza Pharmaceuticals Experience February 2008 - January 2009
Job Mechanical Engineer at HewlettPackard
Industry Mechanical or Industrial Engineering
Experience
Hewlett-Packard 2011 - Present
Canesta April 2009 - November 2010
Alexza Pharmaceuticals February 2008 - January 2009
Education
San Jose State University 2010 — 2012
M.S., Engineering Management
San Jose State University 2002 — 2007
B.S., Mechanical Engineering
Hewlett-Packard 2011 - Present
Canesta April 2009 - November 2010
Alexza Pharmaceuticals February 2008 - January 2009
Education
San Jose State University 2010 — 2012
M.S., Engineering Management
San Jose State University 2002 — 2007
B.S., Mechanical Engineering
Vien Lam's Alexza Pharmaceuticals Experience QC Chemist 2Aerogen1998 - 2003
Job QC Scientist 1 at Alexza Pharmaceuticals
Industry Pharmaceuticals
Experience
Alexza Pharmaceuticals QC Chemist 2Aerogen1998 - 2003
Skills
GMP, Validation, Microsoft Office, cGMP, Quality Systems, GLP, HPLC, Pharmaceuticals, CAPA, Computer System..., Cleaning Validation, ISO, Excel, Medical Devices, Agile
Education
University of California, Davis 1996 — 1998
BS, Biochemistry
Alexza Pharmaceuticals QC Chemist 2Aerogen1998 - 2003
Skills
GMP, Validation, Microsoft Office, cGMP, Quality Systems, GLP, HPLC, Pharmaceuticals, CAPA, Computer System..., Cleaning Validation, ISO, Excel, Medical Devices, Agile
Education
University of California, Davis 1996 — 1998
BS, Biochemistry
Jasmine Han's Alexza Pharmaceuticals Experience 2005 - 2008
Job Research Scientist at Impax Laboratories
Industry Pharmaceuticals
Experience
Impax Laboratories 2011 - Present
ADDS Pharmaceuticals 2010 - 2011
Exelixis 2008 - 2010
Alexza Pharmaceuticals 2005 - 2008
ALZA Corporation 2002 - 2005
Skills
Biotechnology, Validation, GMP, Drug Delivery, SOP
Education
San Jose State University
MS, Chemical Engineering
University of California, Berkeley
BS, Bioengineering
Impax Laboratories 2011 - Present
ADDS Pharmaceuticals 2010 - 2011
Exelixis 2008 - 2010
Alexza Pharmaceuticals 2005 - 2008
ALZA Corporation 2002 - 2005
Skills
Biotechnology, Validation, GMP, Drug Delivery, SOP
Education
San Jose State University
MS, Chemical Engineering
University of California, Berkeley
BS, Bioengineering
Priscilla Kunz's Alexza Pharmaceuticals Experience October 2004 - February 2012
Job Chemist III at Intersect ENT
Industry Pharmaceuticals
Experience
Intersect ENT March 2012 - Present
Alexza Pharmaceuticals October 2004 - February 2012
Bioassay 2002 - 2004
Cygnus Pharmaceuticals, Inc 2000 - 2002
Oral B 1999 - 2000
Skills
Documentation, Compliance, Laboratory Experience, cGMP, CAPA, HPLC, Medical Devices, Biotechnology, Microsoft Office, Excel, GMP, Laboratory, GLP, Microsoft Excel, Quality Control, Software Documentation, Sop, UV/Vis, Gas Chromatography, SOP, Validation
Education
Metropolitan State College of Denver 1993 — 1997
BS, Environmental Science
Intersect ENT March 2012 - Present
Alexza Pharmaceuticals October 2004 - February 2012
Bioassay 2002 - 2004
Cygnus Pharmaceuticals, Inc 2000 - 2002
Oral B 1999 - 2000
Skills
Documentation, Compliance, Laboratory Experience, cGMP, CAPA, HPLC, Medical Devices, Biotechnology, Microsoft Office, Excel, GMP, Laboratory, GLP, Microsoft Excel, Quality Control, Software Documentation, Sop, UV/Vis, Gas Chromatography, SOP, Validation
Education
Metropolitan State College of Denver 1993 — 1997
BS, Environmental Science
Leo Le's Alexza Pharmaceuticals Experience November 2006 - November 2007
Job Cash Management Operations at Presidio Bank
Industry Financial Services
Experience
Presidio Bank October 2012 - Present
Online Banking Analyst May 2011 - October 2012
Alexza Pharmaceuticals November 2006 - November 2007
Jeff Gregg Lab, UC Davis Medical Center Medical Pathology January 2005 - July 2006
Education
San Francisco State University
Bachelor of Arts (B.A.), Economics
University of California, Davis
Bachelor of Science (BS), Biochemistry and Molecular Biology
Presidio Bank October 2012 - Present
Online Banking Analyst May 2011 - October 2012
Alexza Pharmaceuticals November 2006 - November 2007
Jeff Gregg Lab, UC Davis Medical Center Medical Pathology January 2005 - July 2006
Education
San Francisco State University
Bachelor of Arts (B.A.), Economics
University of California, Davis
Bachelor of Science (BS), Biochemistry and Molecular Biology
Merck
Johnson & Johnson
GlaxoSmithKline
Bristol Myers Squibb
Eli Lilly and Company
Novartis
Abbott Laboratories
AstraZeneca