Intarcia Therapeutics
Industry: Company
DescriptionIntarcia Therapeutics is an American biopharmaceutical company based in Boston, MA and incorporated under the laws of Delaware. It was founded in 1995 under the name "BioMedicines" and changed to its present name in 2004. CEO: Kurt C. Graves (Apr 2012–) Headquarters: Boston, MA VP: James P. Brady (Human Resources) Founded: 1995 CFO: James Ahlers* Subsidiary: Phoundry Pharmaceuticals, Inc.
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Intarcia Therapeutics Employees
City College of San Francisco August 2015 - Present
Intarcia Therapeutics October 2014 - Present
thenosemilk.com December 2014 - August 2015
TechSpot January 2015 - May 2015
City College of San Francisco August 2014 - December 2014
Monogram Biosciences February 2012 - October 2014
RailsBridge June 2014 - September 2014
UCSF Medical Center October 2012 - March 2013
Sigma Systems, Inc 2012 - 2012
UC Davis September 2011 - December 2011
Skills
C++, MySQL, Unix, Linux, CGI scripts, HTML, CSS, Ruby, Git, Github, Heroku, Shell Scripting, Facebook, PCR, Cell, Gel Electrophoresis, Microscopy, Cell Culture, DNA extraction, Protein Purification, Science, Microsoft Excel, Neuroscience, Lifesciences, Biotechnology, Molecular Biology, Staining, Bilingual, Life Sciences, Laboratory, SDS-PAGE, Microsoft Works, Excel, Teaching, Viral load, Materials Management, Purchasing, Raw Materials, Material Handling, Hazardous Materials
Education
Free Code Camp 2015 — 2015
Certificate in Full Stack Web Development, Computer Software Engineering
University of California, Davis 2008 — 2011
Bachelor of Science, Biological Sciences
City College of San Francisco
RailsBridge
open hatch
Intarcia Therapeutics July 2013 - Present
NeurogesX, Inc. March 2008 - December 2012
NeurogesX, Inc. June 2005 - March 2008
SRI International August 2004 - June 2005
Advanced Polymer Systems (now AP Pharma) February 1996 - March 1997
Oral-B Laboratories October 1994 - January 1996
The Clorox Company February 1992 - October 1994
Dow Corning Corporation June 1988 - February 1992
Skills
Project Management, V&V, Strategic Planning, Logistics Management, Product Development, IND, GMP, Regulatory Submissions, Supply Chain Management, Vendor Management, Clinical Trials, Cross-functional Team..., Leadership, Change Management, Strategy, Quality Assurance, Supply Chain
Education
Pepperdine University 2012 — 2013
MBA
University of Illinois at Urbana-Champaign 1985 — 1988
B.S.
Intarcia Therapeutics February 2015 - Present
Zosano Pharma January 2014 - January 2015
ZP Group LLC July 2013 - December 2013
Genentech 2006 - 2012
Genentech 2004 - 2006
Nektar Therapeutics 1995 - 2003
Skills
GMP, CPIM, CSCP, SAP R/3, Data Analysis, Project Management, SQL*Plus, Microsoft Excel, Microsoft Word, PowerPoint, Visio, Google Docs, DMAIC, Risk Assessment, Kaizen, 5S, Process Improvement, Public Speaking, Business Objects, Experimental Design, GLP, Trackwise, Google Apps, Microsoft Office, Pivot Tables, Inventory Management, Warehouse Safety, Office Safety, Materials Handling, Cross-functional Team..., Leadership, Pharmaceutical Industry, FDA, Medical Devices, Manufacturing, Lean Manufacturing, Validation, 21 CFR Part 11, Biotechnology
Education
California State University-Stanislaus 1992 — 1995
Bachelor of Science (B.S.), Biology, General
West Valley College 1990 — 1992
Associate of Arts (A.A.), Liberal Arts and Sciences, General Studies and Humanities
Intarcia Therapeutics July 2013 - Present
GenQuest BioScience, Inc. October 2012 - June 2013
Boehringer Ingelheim March 2011 - September 2012
Amgen October 2006 - March 2011
Genentech January 2005 - October 2006
CMC Broadcasting Company, Incorporated August 1997 - December 2004
Skills
Aseptic Processing, GMP, Validation, CAPA, V&V, Sop, Pharmaceutical Industry, FDA, Biotechnology, LIMS, Aseptic Technique, Cleaning Validation, 21 CFR Part 11, GLP, Chromatography, Troubleshooting, Change Control, Purification, Technology Transfer, Manufacturing, Quality System, cGMP manufacturing, Biopharmaceuticals, GxP, ISO 13485, Trackwise, Clean Rooms, Vaccines, Medical Devices, Quality Control, Sterilization, FDA GMP, Autoclave, Clinical Trials, Environmental Monitoring, Technical Writing, HPLC, Fermentation, Quality Assurance, Regulatory Affairs, SOP
Education
San Francisco State University
Bachelor of Arts (B.A.), Broadcast and Eletronic Communication Arts
City College of San Francisco
M and G Jewelers August 2015 - Present
Peter F. Drucker and Masatoshi Ito Graduate School of Management October 2014 - April 2015
Intarcia Therapeutics January 2014 - August 2014
Sanmina April 2013 - August 2013
Sendx Medical, Inc. September 2011 - September 2012
Pacific Biosciences April 2008 - April 2011
Genencor, A Danisco Division September 2007 - April 2008
Medtronic February 2007 - July 2007
Skills
DNA sequencing, Data Analysis, Lifesciences, LIMS, Molecular Biology, Biotechnology, Medical Devices, Laboratory
Education
Hult International Business School 2012 — 2013
Master of Business Administration (M.B.A.), Business Administration, Management and Operations
University of California, Santa Barbara 2003 — 2006
BS, Biological sciences
Intarcia Therapeutics February 2013 - Present
Skills
Microsoft Office, Microsoft Excel, Microsoft Word, Customer Service, PowerPoint, English, Windows, Research, Outlook, Teaching, Photoshop, Public Speaking, HTML, Strategic Planning, Budgets
Education
Dartmouth College
Milton Academy
Intarcia Therapeutics August 2010 - Present
Radius May 2011 - Present
Achillion June 2012 - Present
Pulmatrix Inc. June 2010 - Present
Vertex Pharmaceuticals July 2007 - October 2009
Novartis Pharmaceuticals AG, Switzerland 2003 - 2007
Novartis Pharmaceuticals January 1999 - August 2003
AstraZeneca 1991 - 1999
Merck & Co., Inc 1989 - 1991
Skills
Biotechnology, Mergers, Clinical Development, Business Strategy, Licensing, Commercialization, Talent Management, Regulatory Strategy, Global Strategy, Strategic Leadership, Pharmaceuticals, Pharmacoeconomics, Pharmaceutical Industry, Market Access, Strategic Alliances, Biopharmaceuticals, Regulatory Affairs, Managed Care, Venture Capital, Start-ups, Corporate Development, Due Diligence, R&D, Clinical Trials, Product Launch, Cross-functional Team..., Leadership, Drug Development, Lifesciences, Mergers & Acquisitions, Pharmaceutical Sales, Strategy, FDA, Medical Devices, Acquisition Integration, CRO, Cardiology, Competitive Analysis, Competitive Intelligence, Drug Discovery, Executive Management, Immunology, Infectious Diseases, Life Sciences, Medical Affairs, Neurology, Oncology, Pharmaceutics, Sales Effectiveness, Technology Transfer
Education
University of Michigan - Stephen M. Ross School of Business 1995 — 1995
Executive Education
University of Pennsylvania - The Wharton School 1994 — 1994
Executive Education
Hillsdale College 1986 — 1990
Bachelor of Science, Biology & Chemistry
Cranbrook Kingswood College Prep 1983 — 1986
Intarcia Therapeutics January 2015 - Present
Biogen Idec March 2013 - January 2015
Merck Research Labs February 2010 - March 2013
Kennedy-Donovan Center January 2008 - January 2010
Marquette University 2000 - 2007
Skills
Calendaring, Access, Google Analytics, Executive..., Comfortable working..., Analysis, C-Level Executive..., Supervisory Skills, Business Travel, Meeting Planning, Expense Management, Office Administration, Human Resources, Business Partner Support, Analytical Skills, Team Building, Flexibility, Positivity, Outlook, Microsoft Office, Database Administration, Oral & Written..., Minute Taking, Administrative..., Event Planning, Training, Travel Arrangements, Management, Program Management, SharePoint
Education
Marquette University 2004 — 2007
Mathematics
Milwaukee Area Technical College 1998 — 2001
Associate of Arts (A.A.), Business Administration and Management, General
Eastern Virginia Medical School January 2013 - May 2015
California Pacific Medical Center - Circulatory Support Systems March 2011 - December 2012
Genentech March 2008 - December 2009
Genentech, Inc. June 2006 - March 2008
Intarcia Therapeutics September 2005 - April 2006
Almac Group - Clinical Technologies Services March 2001 - August 2005
Education
Eastern Virginia Medical School 2013 — 2015
Master, Physician Assistant
Skyline College
Associate of Arts and Sciences (A.A.S.), Allied Health
Skyline College
Associate of Arts and Sciences (A.A.S.), Natural Sciences
University of California, Davis 1997 — 2000
BSc, Physiology
Jinan University, China 1996 — 1996
Chinese Mandarin Language Studies
Intarcia Therapeutics March 2015 - Present
Intarcia Therapeutics August 2013 - March 2015
PerkinElmer May 2010 - July 2013
Interleukin Genetics January 2008 - May 2010
Surface Logix, Inc. April 2006 - December 2007
Vertex Pharmaceuticals, Inc. December 2000 - April 2006
Harvard Medical School January 2000 - December 2000
Brigham and Women's Hospital 1997 - 1999
University of Wisconsin-Madison 1996 - 1997
Skills
Clinical Development, IVD Development, Biotechnology, Drug Discovery, Pharmacology, Immunology, Assay Development, Drug Development, Clinical Trials, Infectious Diseases, Lifesciences, Biochemistry, In Vivo, Biomarkers, Protein Chemistry, Oncology, Pharmaceutical Industry, Life Sciences
Education
Banaras Hindu University 1991 — 1996
PhD, Biotechnology-Biochemistry
Intarcia Therapeutics October 2014 - Present
Biogen Idec February 2014 - Present
Organogenesis October 2011 - February 2014
Siemens Healthcare August 2007 - October 2011
Skills
Program Management, Lean Manufacturing, Cross-functional Team..., Manufacturing, Pharmaceutical Industry, GMP, Project Management, R&D, Biotechnology, FDA, Strategy, Validation, Quality Assurance
Education
Bryant University 2004 — 2007
MBA, Business
Syracuse University 1998 — 2002
B.S., Biochemistry
Intarcia Therapeutics March 2015 - Present
Experian Data Quality June 2014 - March 2015
Experian Data Quality February 2013 - May 2014
Experian Data Quality April 2012 - February 2013
Experian Data Quality November 2009 - April 2012
Experian Data Quality December 2008 - November 2009
CSC May 2008 - November 2008
Skills
CRM, Enterprise Software, Process Improvement, Leadership, Cross-functional Team..., Strategy, Management, E-commerce, Software Project..., Customer Experience, Project Management, Team Management, Salesforce.com, Cloud Computing, Solution Selling, Professional Services, SaaS, Technical Support, Business Analysis, Data Analysis, Requirements Analysis, JavaScript, Customer Retention, SQL, Customer Service, Software Implementation, People Development, Change Management, Operations Management, Java, Agile Methodologies, Net Promoter Score, Digital Strategy, User Experience, Customer Experience..., Marketing Automation, Customer Loyalty..., Digital Marketing, Presenter, Program Management, Product Management, Product Marketing, Go-to-market Strategy, Service Design, Customer Journey Mapping, User Experience Design, Product Launch, Voice of the Customer, Customer Experience..., Customer Insight
Education
University of Rochester 2004 — 2008
B.A., Economics
Intarcia Therapeutics January 2015 - Present
Idenix Pharmaceuticals November 2005 - December 2014
Bristol-Myers Squibb September 2004 - November 2005
Cubist Pharmaceuticals September 2001 - September 2004
Skills
Scientific Background..., Clinical Background..., Pharmaceutical..., Pharmaceutics, Scientific Background, Therapeutic Areas, GCP, Clinical Development, Drug Development, Pharmaceutical Industry, Clinical Trials, IND, Sop, FDA, Clinical Research, Clinical Monitoring, Medical Writing, CRO, Clinical Operations, Pharmacology, Clinical Study Design, Trial Management
Education
Northeastern University
Master's degree, Pharmacology
University of New Hampshire
Bachelor's degree, Cell, Developmental and Molecular Biology
Intarcia Therapeutics July 2013 - Present
Janssen Alzheimer Immunotherapy Research and Development September 2009 - April 2013
Elan Pharmaceuticals October 2000 - September 2009
Watson Pharmaceuticals May 1994 - October 2000
Skills
Biotechnology, 21 CFR Part 11, GLP, GMP, IND, GxP, Pharmaceutical Industry, Quality Assurance, Biopharmaceuticals, Change Control, CAPA, FDA, GCP
Education
Marylhurst University 2010 — 2011
MBA, Sustainability
University of San Diego 1991 — 1994
BA, Biochemistry
Pharmatech Associates April 2014 - November 2014
Fourstep Automation, Inc. May 2013 - March 2014
Hyde Engineering & Consultants June 2004 - April 2013
Genentech 2012 - 2013
Novartis 2011 - 2012
Intarcia Therapeutics June 2009 - 2010
Bayer 2007 - 2009
Chiron Corporation 2004 - 2007
Swat Engineering Group June 2003 - June 2004
Quasar Engineering Services July 2002 - June 2003
Skills
GMP, Validation, Biotechnology, Engineering, Manufacturing, Project Management, Change Control, Commissioning, Automation, Root Cause Analysis, Biopharmaceuticals, V&V, Quality System, Cleaning Validation, ISO 13485, Cross-functional Team..., Quality Assurance, 21 CFR Part 11, Six Sigma, CAPA, Technology Transfer, Chromatography, GAMP, Sop, Process Engineering, R&D, FDA, Computer System..., FMEA, Process Simulation, Aseptic Processing, GxP, Design of Experiments, SOP
Education
San Jose State University 1974 — 1980
B.S. Industrial Engineering, Industrial Technology
Intarcia Therapeutics July 2014 - Present
Intarcia Therapeutics June 2013 - July 2014
Intarcia Therapeutics 2013 - 2014
CKC Engineering September 2007 - April 2013
CKC Engineering July 2007 - December 2009
ZosanaPharma 2007 - 2009
Nektar Therapeutics 2006 - 2007
Nektar Therapeutics (formerly Inhale Therapeutic Systems, Inc.) 2006 - 2007
International Process Solutions February 2005 - June 2006
Johnson Controls @ LLNL June 2001 - February 2002
Skills
Engineering, GMP, Instrumentation, Biotechnology, Solidworks, Project Management, Manufacturing, Automation, Quality System, Validation, Troubleshooting, Product Development, Medical Devices, AutoCAD, R&D, Lean Manufacturing, Continuous Improvement, Process Improvement, Engineering Management, Mechanical Engineering, Calibration, Design for Manufacturing
Education
California State Polytechnic University-Pomona 1997 — 2001
Bachelor of Science (B.S.), Mechanical Engineering
De Anza College
Associate of Arts (A.A.), General Studies
Intarcia Therapeutics October 2011 - Present
Boehringer Ingelheim February 2011 - October 2011
AMGEN November 2006 - March 2011
Alza/Johnson and Johnson April 2001 - August 2006
ALZA 1991 - 2001
Skills
GMP, Calibration, Facilities Management, Project Planning, CAPA, Preventive Maintenance, FDA, Biopharmaceuticals, Maximo, Engineering, Manufacturing, V&V, Validation, Quality System, Technology Transfer, Sop, Biotechnology, Troubleshooting, Aseptic Processing, Pharmaceutical Industry, 21 CFR Part 11, GLP, Change Control, GxP, Regulatory Affairs, Cleaning Validation, Computer System..., SOP
Education
De Anza College 2008 — 2013
Health, Medical Terminology, Exercise Science, Automotive Electronics.
Miller Institute Spokane WA. (Affiliated Arizona State University) 1982 — 1984
Associate of Science (A.S.), Electronics and Computer Technology
Intarcia Therapeutics August 2006 - Present
Alza 1994 - 2006
Extended Length Flex Corp February 1992 - August 1993
Apple Computer February 1991 - August 1991
General Electric June 1986 - January 1991
Skills
Drug Delivery, Materials Science, Design Control, Technology Transfer, Polymers, FDA, Medical Devices, Materials, Design for Manufacturing, Characterization, Thin Films, R&D, Coatings, Design of Experiments, Plastics, Biotechnology, V&V
Education
Purdue University 1988 — 1990
MS, Engineering
Drexel University 1981 — 1986
BS, Materials Engineering
Intarcia Therapeutics April 2015 - Present
Education
Harvard University 2000 — 2006
Ph.D.
North Dakota State University 1995 — 2000
BS
Justus-Liebig-Universität Giessen 1999 — 1999
Intarcia Therapeutics April 2015 - Present
Genzyme June 2006 - April 2015
Thomson Financial 2001 - 2006
netNumina 2000 - 2001
Linkage, Inc. 1996 - 1996
Skills
Talent Management, Team Building, Succession Planning, Change Management, Employee Relations, Executive Coaching, Strategy, Organizational..., Organizational..., Performance Management, Leadership Development, Career Development, Project Management, Management, Organizational Design, Leadership, Onboarding, Employee Engagement, Talent Acquisition, E-Learning
Education
Harvard University 1995 — 1997
MTS
Marietta College 1988 — 1992
BA, History, Literature, Leadership Studies
University of Cambridge 1991 — 1991
European history
University of Edinburgh 1991 — 1991
European history
Intarcia Therapeutics October 2013 - Present
Bay Area FasTrak/ACS Xerox March 2012 - March 2014
Google June 2013 - October 2013
Celerity August 2011 - December 2011
Syndicus, Inc. April 2010 - February 2011
Kelly Scientific Resources May 2008 - May 2009
Skills
Quality Assurance, Quality Control, Microsoft Excel, Visio, Analysis, Data Analysis, GMP, Process Improvement, Databases, Software Documentation, Microsoft Access, SQL, Visual Basic, Visual C#, Microsoft Project
Education
Kaplan University 2008 — 2010
MBA, Business
California State University-East Bay 2004 — 2008
Bachelor of Sciences, Biochemistry
Diablo Valley College 1997 — 2003
Associate, Arts; Liberal Arts
Intarcia Therapeutics February 2015 - Present
Publicis Touchpoint Solutions, Inc. July 2012 - December 2014
Jazz Pharmaceuticals June 2011 - July 2012
Elan Pharmaceuticals March 2008 - January 2011
Quintiles 2004 - 2008
Cyberonics 2002 - 2003
Skills
Managed Care, Neurology, Clinical Research, Cardiology, Pharmaceutical Industry, Pharmaceutical Sales, Oncology, Healthcare, Hospitals, Medical Devices
Education
The University of Texas Medical Branch at Galveston 1997 — 2001
BSN, Nursing
Intarcia Therapeutics August 2014 - Present
NovaBay Pharmaceuticals May 2014 - July 2014
Doyle Research Group - Materials Science and Engineering September 2013 - April 2014
Joint BioEnergy Institute June 2013 - December 2013
Five Prime Therapeutics January 2013 - June 2013
Doyle Research Group, University of California, Berkeley January 2013 - May 2013
Skills
Teamwork, Research, Matlab, Chemistry, Python, IR spectroscopy, Gel Electrophoresis, C++, SPICE, Microsoft Excel, MS Excel, Analytical Skills, real-time PCR, Biopython, Chemical Engineering, Electrochemistry, Visual C#, Design of Experiments, Optimization, Aspen Plus, Process Control, Atomic Absorption..., PolyMath Software, MS Power Point, Mass & Energy Balance, Optimizations, Interpersonal Skill, MS Word, electroplating, coatings, thin films, electrodeposition, Distillation, Purification, Medical Devices, HPLC, GC
Education
University of California, Berkeley
Bachelor of Science (BS), Chemical Engineering
Intarcia Therapeutics December 2014 - Present
Amylin Pharmaceuticals September 2008 - April 2014
Berlex Pharmaceuticals 1993 - 2007
SmithKline Beecham 1989 - 1993
Skills
GMP, Regulatory Affairs, Chemistry, R&D, Drug Development, IND, Pharmaceutical Industry, LIMS, FDA, Validation, Biotechnology, Analytical Chemistry, HPLC
Education
University of California, Santa Cruz 1982 — 1989
Ph.D., Chemistry
University of Vermont 1976 — 1982
Bachelor of Science (BS), Master of Science (MS), Chemistry
Intarcia Therapeutics October 2014 - April 2015
NCC Group, Inc. August 2012 - October 2014
Phase2Careers December 2010 - December 2012
YNPNsfba May 2009 - September 2012
San Mateo County Library September 2010 - August 2012
Asian & Pacific Islander American Health Forum March 2007 - July 2010
BZ Web October 2006 - December 2006
Wheel Group February 2005 - February 2006
Skills
Benefits Administration, Employee Relations, Recruiting, Organizational..., New Hire Orientations, Resume Writing, Interviews, Non-profits, Career Counseling, Human Resources, Volunteer Management, Management, Employee Benefits, Nonprofits, Talent Management, Personnel Management, Onboarding, Social Media, Benefits Negotiation, Leadership, Deferred Compensation, Volunteer Training, Job Search Strategies, Policy, Job Fairs, Employment Law, Employee Engagement, Volunteer Coordination, Small Business, Fundraising, Public Speaking, Employee Orientations, New Hire Orientation, Employee Orientation, Conference Coordination, Career Advising, Mock Interviews, Career Development..., ADP HRB, HRIS
Education
University of California, Los Angeles 1993 — 1997
BA
UCSC Extension Silicon Valley 2013 - Present
SOS Consulting Inc. 2005 - Present
Klinera Global Services 2012 - 2013
Durect 2006 - January 2012
Institute for OneWorld Health 2008 - 2012
Institute for OneWorld Health 2008 - December 2011
PDL BioPharma December 2007 - 2008
PDL BioPharma 2007 - 2008
Affymax September 2006 - January 2007
Intarcia Therapeutics 2001 - March 2006
Skills
Clinical Trials, Regulatory Affairs, Oncology, Clinical Research, Project Management, Clinical Trial..., Clinical, CTMS, GCP, CRO, Drug Development, Clinical Development, Regulatory Submissions, Pharmaceutical Industry, Medical Imaging, Infectious Diseases, Clinical Monitoring, Clinical Data Management, Sop, Lifesciences, FDA
Education
St. Thomas University 1989 — 1990
MHM, Health Management
University of Mumbai 1979 — 1987
MSc, Medical Microbiology
Wilson College, Mumbai, India 1979 — 1984
Bachelor of Science (B.Sc.), Microbiology, General
T2 Green Consulting, LLC Clinical ScientistCelgeneOctober 2014 - Present
Intarcia Therapeutics July 2012 - October 2014
sanofi-aventis 2008 - May 2009
Covance June 1999 - June 2000
Skills
Oncology, Clinical Research, Diabetes, Clinical Trials, Clinical Development, Pharmaceutical Industry, FDA, CRO, CTMS, Regulatory Affairs, GCP, Drug Development, Regulatory Submissions, Infectious Diseases, EDC, Vaccines, Clinical Monitoring, Biotechnology, Cardiology, Neurology, IND, Therapeutic Areas, Management, Clinical Data Management, Lifesciences, Dermatology, Medical Writing, Endocrinology, SOP, Disaster Response, Life Sciences
Education
Fairleigh Dickinson University-Florham Campus
MBA, Pharmaceutical Management
Fairleigh Dickinson University-Florham Campus
BS/MS, Biology/Chemistry/Human Physiology
Georgetown University
PhD: Completion Pending, Pharmacology
Genomic Health December 2007 - Present
Intarcia Therapeutics November 2004 - April 2007
Fluidigm April 2002 - September 2004
Recombinant Capital January 1999 - March 2002
Skills
Biotechnology, Product Management, Oncology, Market Research, Product Development, Business Development, Infectious Diseases, Leadership, Marketing, Marketing Communications, Lifesciences, Genomics, Product Launch, Commercialization, Personalized Medicine, Urology, Cancer
Education
University of Southern California 1996 — 1998
Masters
Princeton University 1992 — 1996
BA
Corona del Mar High School 1988 — 1992
Intarcia Therapeutics March 2015 - Present
Novartis January 2009 - March 2015
Nektar Therapeutics April 2004 - December 2008
Matrix Integrated Systems May 2000 - April 2004
Kvaerner - San Ramon, CA October 1995 - May 2000
PLC Programming Services September 1994 - October 1995
Kvaerner - Pgh, PA May 1989 - September 1994
Skills
Automation, GMP, Engineering, Pharmaceutical Industry, Control Systems Design, Cross-functional Team..., Manufacturing, Quality System, Troubleshooting, GAMP, 21 CFR Part 11, Wonderware, Validation, Instrumentation, PLC, CAPA, Project Management, Process Improvement, Commissioning, Management, FDA, SCADA
Education
University of Pittsburgh 1985 — 1989
B.S.E.E., Electrical Engineering
Intarcia Therapeutics July 2014 - Present
The Quantic Group, Ltd July 2011 - Present
Genentech 2009 - 2011
Gilead Sciences July 2007 - July 2009
MedImmune 2003 - 2007
The University of Chicago 1997 - 2000
Skills
Project Management, Automation, Maximo, Program Management, Quality Assurance, CAPA, V&V, Validation, Computer System..., GAMP, S88, S95, Emerson DeltaV, PI Data Historian, OSIsoft PI, Data Historian, SAP Project Management, Pharmaceutical Industry, FDA, GMP, Biotechnology, 21 CFR Part 11, SOP, Change Control, Biopharmaceuticals
Education
University of Chicago
Ph.D., Linguistics / Slavic Linguistics
University of California, Los Angeles
MLS, Information Systems
New York University 1988 — 1988
Cert., Filmmaking
Hinsdale Central High School
University of California, Santa Barbara
BA, CSLit
Univerzita Karlova v Praze
Fullbright Dissertation Research Fellow, History / Linguistics / Czech
ProTrials Research, Inc. April 2013 - Present
ProTrials Research, Inc. December 2011 - March 2013
FibroGen 2010 - 2011
Children's Hospital Oakland Research Institute 2008 - 2011
Intarcia Therapeutics 2001 - 2006
Clinimetrics 1999 - 2001
Scios 1998 - 1999
Abgenix 1996 - 1998
Dade-Behring Diagnostics, Syva Co. 1992 - 1996
Skills
Biotechnology, Clinical Development, Project Management, FDA, Clinical Trials, Oncology, GCP, Drug Development, Lifesciences, Pharmaceutical Industry, Infectious Diseases, CRO
Education
University of California, Davis
Incarcia Therapeutics, Inc. 2007 - Present
Intarcia Therapeutics 2007 - Present
ALZA/J&J January 2002 - June 2007
Bayer 1983 - 1988
Skills
Quality Assurance, Microbiology, CAPA, GMP, FDA, Sop, Pharmaceutical Industry
Education
Saint Mary's College of California
BS, Biology
Intarcia Therapeutics February 2014 - Present
Rx Access 360 August 2012 - February 2014
Alkermes January 2009 - February 2012
Cephalon April 2008 - December 2008
Idenix January 2006 - December 2007
Nabi Biopharmaceuticals 2003 - 2005
Nabi Biopharmaceuticals 1999 - 2002
Nabi Biopharmaceuticals 1997 - 1999
ROBERTS PHARMACEUTICAL CORPORATION January 1994 - December 1996
Skills
Oncology, Hematology, Gastroenterology, Cardiology, Transplant, Reimbursement, Healthcare Reimbursement, Hospital Reimbursement, Medicare/Medicaid..., Managed Care, Pharmaceutical Industry, Pharmacoeconomics, Pricing Strategy, Distribution Strategy, Managed Care Stategy, Part B, Part D, HUB Support Services, Contract Strategy, Third Party Logistics, Medicare Part D, National Accounts, Strategic Planning, Hospitals, Biotechnology, Cross-functional Team..., Pharmaceutical Sales, Product Launch, Sales Operations
Education
Fenton High School 1984 — 1998
Lake Superior State University 1988 — 1992
Bachelor Science, Business Administration
Intarcia Therapeutics February 2013 - Present
Boehringer Ingelheim October 2011 - February 2013
Boehringer Ingelheim March 2011 - November 2011
Amgen March 2007 - March 2011
ALZA Corporation 2002 - 2007
United Airlines December 1998 - September 2001
RenoAir May 1997 - December 1998
Horizon Air January 1995 - May 1997
WestAir December 1993 - January 1995
Skills
GMP, Manufacturing, Aseptic Processing, Sop, Troubleshooting, Lean Manufacturing, Process Engineering, Pharmaceutical Industry, Medical Devices, Aircraft, Facilities Management, Aircraft Maintenance, Biopharmaceuticals, 21 CFR Part 11, Change Control, Biotechnology, Calibration, Preventive Maintenance, CAPA, Maintenance & Repair, Validation, V&V, ISO, Quality System, Quality Assurance, ISO 13485, Quality Auditing, FDA
Education
Portland Community College 1989 — 1993
Aircraft Maintenance Technology
Intarcia Therapeutics August 2013 - Present
Intarcia June 2006 - August 2013
ALZA Corporation 2004 - 2006
Skills
Pharmaceutical Industry, Pharmaceutical Research, Pharmaceutical..., Biotechnology, GMP, FDA, Lifesciences
Education
Computer Technology Academy 1999 — 2000
Certificate, IT
De Anza College 1998 — 2000
AA, computer
Intarcia Therapeutics May 2013 - Present
SDC Clinical October 2012 - April 2013
AVEO Pharmaceuticals October 2010 - October 2012
Covidien April 2009 - October 2010
Synta Pharmaceuticals March 2008 - March 2009
Altus Pharmaceuticals 2007 - 2008
Parexel Int 2000 - 2004
PAREXEL 2000 - 2004
Skills
CDISC, Clinical Trials, Clinical Data Management, CRO, Oncology, 21 CFR Part 11, EDC, Clinical Development, Oracle Clinical, Pharmaceutical Industry, CTMS, Biotechnology, Clinical Research, Data Management, FDA, ICH-GCP
Education
University of Massachusetts at Lowell 2002 — 2004
MBA
University of Massachusetts Lowell 1995 — 2000
BA, History
Intarcia Therapeutics 2006 - 2008
ALZA Corporation 2001 - 2006
Education
University of California, Los Angeles 1991 — 1996
Bachelor of Science (B.S.), Chemical Engineering
UC Davis
PhD, Chemical Engineering
Intarcia Therapeutics, Inc. May 2015 - Present
Intarcia Therapeutics August 2014 - May 2015
Experien Group March 2013 - August 2014
Abbott Vascular Devices July 2007 - February 2013
Bio-Rad Laboratories July 2005 - June 2007
Lawrence Berkeley National Laboratory May 2004 - May 2005
UC Berkeley November 2003 - January 2005
Skills
Regulatory Affairs, Regulatory Submissions, Lifesciences, Biotechnology, Medical Devices, Molecular Biology, GMP, Clinical Trials, R&D, Sop, CAPA, Life Sciences
Education
Northeastern University 2008 — 2011
M.S., Regulatory Affairs
University of California, Berkeley 2003 — 2005
B.A., Molecular and Cell Biology
Intarcia Therapeutics January 2015 - Present
Abbott Vascular Devices February 2009 - January 2015
Cell Genesys June 2008 - October 2008
Genitope Corporation April 2006 - May 2008
ALZA Corporation October 2004 - April 2006
Pharmatech Validation Services, Inc. March 2004 - October 2004
Pharmatech Validation Services, Inc. March 2002 - March 2004
Cascade Controls July 2000 - December 2001
Skills
Validation, CAPA, Computer System..., V&V, Sop, Change Control, FMEA, GMP, FDA, 21 CFR Part 11
Education
California Polytechnic State University-San Luis Obispo 1997 — 2000
Bachelor of Science, Mechanical Engineering, Mechatronics Concentration
Intarcia Therapeutics 2007 - May 2013
Cygnus, Inc. 1998 - 2006
Chiron Corporation 1990 - 1998
Townsend & Townsend 1989 - 1990
DuPont 1986 - 1989
Education
University of Pennsylvania Law School 1984 — 1987
Doctor of Law (JD)
University of California, San Diego 1973 — 1977
B.A., Anthropology/Biology
Intarcia Therapeutics 2014 - Present
Intarcia Therapeutics 2014 - 2014
Hyperion Therapeutics 2013 - 2014
Vertex Pharmaceuticals 2012 - 2013
Cubist Pharmaceuticals 2008 - 2012
MGI Pharma, Eisai 2006 - 2008
Dyax 2001 - 2006
Transkaryotic Therapies 1999 - 2001
Virus Research Institute, Avant Immunotherapeutics 1997 - 1999
Genzyme 1996 - 1997
Skills
Quality Assurance, Biologics, Regulatory Affairs, Clinical Research, Biotechnology, IND, FDA, Clinical Development, Strategy, Pharmaceutical Industry, Regulatory Submissions, Clinical Trials, Biopharmaceuticals, Vaccines, GLP, Drug Development
Education
Kellogg School of Management
RAPS Executive Development Program June 2013
Saint Anselm College
BA, Biology
Intarcia Therapeutics December 2007 - Present
Nanostellar Inc. October 2004 - December 2007
Education
California State University-Hayward - School of Business and Economics 2008 — 2011
Bachelors, Accounting
Heald College 2005 — 2008
Associate of Arts, Accounting
RRD International, LLC July 2006 - December 2014
Intarcia Therapeutics January 2000 - July 2006
Quintiles Consulting September 1997 - December 1999
FDA June 1987 - September 1997
Education
University of Maryland - Robert H. Smith School of Business 1993 — 1995
MBA
University of Colorado School of Medicine 1973 — 1977
MD
Grinnell College 1969 — 1973
BA, Biology
Aimmune Therapeutics, Inc. March 2015 - Present
Gilead Sciences April 2012 - March 2015
Intarcia Therapeutics 2009 - December 2012
Intarcia Therapeutics, Inc. June 2009 - 2011
SUGEN, Inc. (subsidiary of Pharmacia) 2003 - July 2006
Skills
Clinical Trials, Endocrinology, Therapeutic Areas, Infectious Diseases, Clinical Development, Biotechnology, Clinical Research, CTMS, Regulatory Submissions, Pharmaceutical Industry, Type 2 Diabetes, GCP, CRO, Clinical Operations, Drug Development, FDA, Lifesciences, Molecular Biology, Clinical Monitoring
Education
San Francisco State University 1987 — 1994
BSN, Nursing
KLL Consulting 2012 - Present
Intarcia Therapeutics August 2008 - March 2012
Nuvelo 2004 - 2008
Tularik 2003 - 2004
Metabolex 1994 - 2003
Scios 1991 - 1994
University of Texas Southwestern Medical School 1980 - 1991
Skills
Board Certified..., Board Certified..., Internal Medicine, Diabetes, Drug Development, Clinical Development, Medical Research, Translational Medicine, Medicine, Biotechnology, Clinical Research, Clinical Trials, Medical Affairs, GCP, Oncology, Infectious Diseases
Education
The University of Texas Southwestern Medical School 1972 — 1976
MD, Medicine
The University of Texas at Austin 1969 — 1972
BA, Biology
Edwards Lifesciences December 2011 - Present
Abraxis BioScience March 2009 - June 2011
Valeant Pharmaceuticals 2007 - 2009
Intarcia Therapeutics August 2002 - August 2006
Onebody August 2000 - August 2002
Education
California State University-East Bay 1997 — 2000
English, Literature
Intarcia Therapeutics November 2013 - Present
ARIAD Pharmaceuticals, Inc. November 2009 - November 2013
GiantLoop Network August 2001 - May 2003
CMGI January 1998 - July 2001
Summa Four June 1994 - January 1997
Wang Laboratories August 1980 - November 1989
Skills
PowerPoint, Microsoft Word, Start-ups, Due Diligence, Corporate Law, Outlook, Contract Negotiation, Project Management, Marketing Communications
Education
Rasmussen College-Minnesota 1977 — 1978
Legal Secretarial Certificate, Legal
Intarcia Therapeutics, Inc. August 2015 - Present
Intarcia Therapeutics August 2014 - Present
Dynavax Technologies February 2012 - August 2014
Dynavax Technologies July 2010 - February 2012
Dynavax Technologies Corporation August 2008 - July 2010
Skills
Project Management, Clinical Development, Drug Development, IND, Biopharmaceuticals, FDA, GMP, Vaccines, Regulatory Submissions, Regulatory Requirements, Regulatory Affairs, GCP, Sop, CRO, Biotechnology, CTMS, Clinical Trials, Oncology
Education
San Francisco State University, College of Business 1998 — 2002
B.S., Business Management
University of California, Berkeley
Certification in Project Management
University of California, Berkeley
Certificate in Project Human Resource Management
University of California, Berkeley
Certificate in Regulatory Affairs
Intarcia Therapeutics March 2012 - Present
SUNY Health Science Center at Brooklyn 1994 - Present
sanofi-aventis January 2011 - June 2011
sanofi-aventis June 2008 - January 2011
Novartis Pharmaceuticals Corporation November 1998 - June 2008
Novartis 1998 - 2008
Skills
Internal Medicine, Endocrinology, Diabetes, Hypertension, Clinical Development, Osteoporosis, Clinical Research, Clinical Trials, Protocol Development
Education
State University of New York Downstate Medical Center College of Medicine 1990 — 1992
Endocrinology Fellowship
Emory University 1983 — 1986
Internship and Residency
Howard University College of Medicine 1979 — 1983
MD, Medicine
The Johns Hopkins University 1975 — 1979
BA, Biology
Intarcia Therapeutics March 2015 - Present
Thermo Fisher Scientific (Life Technologies) July 2011 - March 2015
Life Technologies November 2010 - July 2011
Skills
HPLC, Mass Spectrometry, GLP, DNA, Validation, Quality Control, Biotechnology, Capillary..., Laboratory, Microsoft Office, ISO 13485, GDP, Vietnamese, GMP, PCR, Cpr Certified, 6S, Life Sciences, SOP, Purification, Finnish Language, Trackwise, Karl Fisher, RNA, Biochemistry
Education
University of California, San Diego
BS, Biochemistry and Cell Biology, Minor in Management Science