PowderJect Vaccines
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PowderJect Vaccines Employees
Walker Downey & Associates 2004 - Present
Powderject Vaccines 2002 - 2004
Becton Dickinson 1994 - 2002
Searle Pharmaceutical (Mont-Saint-Guibert, Belgium) 1989 - 1994
Baxter Healthcare 1985 - 1989
Skills
Project Management, Medical Devices, FDA, Regulatory Affairs, Biotechnology, Lifesciences, Pharmaceutical Industry, Clinical Trials, Clinical Development, GLP, R&D, Drug Development, GMP, Validation, Clinical Research, Medical Writing, Medical Device..., Biocompatibility, IND, Toxicology, GCP, Drug Discovery, CRO, Regulatory Submissions, Pharmacology, Pharmacokinetics, Molecular Biology, Oncology, Immunology, In Vivo, Biopharmaceuticals, Regulatory Requirements, 21 CFR Part 11, Vaccines, Clinical Study Design, Formulation, In Vitro, Medical Affairs, Hardware Diagnostics, Infectious Diseases, Protein Chemistry, Biologics, Sop, Technology Transfer, Drug Safety, Therapeutic Areas, Protocol, Commercialization, Life Sciences
Education
Cornell University
MS/PhD, Nutritional Toxicology and Preventive Medicine
Cellara May 2015 - Present
Swift Manufacturing & Engineering, Inc. January 2011 - Present
Cellara 2015 - 2015
CareFusion March 2011 - July 2012
Reidar Aamotsbakken January 2010 - March 2011
Design Concepts October 2008 - December 2009
University of Wisconsin - Madison November 2005 - October 2008
Gammex RMI May 2003 - October 2005
TREK Diagnostic Systems May 2001 - May 2003
Powderject Vaccines November 1998 - May 2001
Skills
Medical Devices, Technology Transfer, Quality Assurance, Reliability, Product Launch, R&D, Biomedical Engineering, Invitro Diagnostics, Tissue Mimicking..., Epoxy Formulations, Blood Contacting..., Biomaterials, Vapor Transmission, Troubleshooting, Transdermal Delivery, Drug Delivery, Stem Cell Devices, Cardiovascular Devices, Process Development, Biotechnology, Product Development, Cross-functional Team..., ISO 13485, Process Improvement, Design Control, Engineering, Program Management, Start-ups, Problem Solving, Project Planning, Team Leadership, FDA, Process Validation, Leadership, Fluids, Blood, Medical Device R&D, ISO, Solidworks, Commercialization, Design for Manufacturing, Rapid Prototyping, Laboratory, V&V, Process Simulation
Education
The University of Memphis 1996 — 1998
MS, Biomedical Engineering
The University of Tennessee Health Science Center 1996 — 1998
MS, Biomedical Engineering
Middle Tennessee State University 1992 — 1996
BS, Chemistry
Walker Downey & Associates January 2013 - Present
Walker Downey & Associates December 2012 - Present
Philips Medical Systems February 2004 - December 2012
PowderJect Vaccines 2003 - 2004
Teleflex Medical 1999 - 2002
Becton Dickinson September 1997 - August 1999
International Paper 1989 - 1996
Skills
Medical Devices, FDA, ISO 14971, ISO 13485, Design Control, Post Market Surveillance, Quality System, CAPA, Regulatory Affairs, Complaint Management, Regulatory Requirements, Validation, Lifesciences, GLP, Quality Auditing, V&V, ISO, Quality Assurance, 21 CFR Part 11, Life Sciences
Education
North Carolina State University
Bachelor of Science (BS), Food Science
Covance January 2013 - Present
GE Healthcare Research Park Headquarters April 2011 - January 2013
Roche March 2009 - April 2011
GE Healthcare April 2007 - February 2009
Promega August 2004 - April 2007
PowderJect Vaccines January 1996 - May 2004
UC Santa Cruz August 1986 - January 1996
University of California Santa Cruz 1986 - 1996
UC Davis September 1984 - August 1986
Skills
Biosafety, Medical Devices, Safety Management..., Manufacturing, Chemistry, Research, Quality Auditing, Biotechnology, GMP, EHS, Six Sigma, R&D, Pharmaceutical Industry, Lifesciences, Quality System, Risk Assessment, Hazardous Waste..., Validation, Industrial Hygiene, Process Improvement
Education
University of California, Santa Cruz 1990 — 1992
Professional, Environmental, Health and Safety
California Polytechnic State University-San Luis Obispo 1979 — 1984
BS, Pre Vet Medicine
Aptos High School 1975 — 1979
GE, High School
WiCell May 2013 - Present
WiCell 2010 - Present
WiCell 2007 - 2010
Gala Biotech January 2006 - April 2007
Covance November 2004 - December 2005
PowderJect Vaccines 2000 - 2004
Skills
Strategic Planning, Stem Cells, Project Management, Biotechnology, Management, Cell, PMP, Budgets, Team Building, Process Improvement, Clinical Research
Education
University of Wisconsin-Madison - School of Business 2011 — 2013
Executive MBA
Augustana College 1987 — 1992
BA, Biology
Boston Scientific August 2013 - Present
Boston Scientific November 2011 - August 2013
Boston Scientific September 2001 - November 2011
PowderJect Vaccines 1999 - 2001
Cygnus 1994 - 1999
Syntex 1994 - 1995
SYVA Co. 1989 - 1994
US Army 1987 - 1989
Skills
Change Control, ISO 13485, Quality System, CAPA, Continuous Improvement, Minitab, FDA, Design Control, Process Improvement, Six Sigma, Medical Devices, ISO 14971, Design of Experiments, R&D, Validation, V&V, Regulatory Affairs, SPC, Manufacturing, GMP, 21 CFR Part 11, Quality Assurance, Calibration, Root Cause Analysis, Lean Manufacturing, Quality Control, DMAIC
Education
California State University-Dominguez Hills
Master of Science (MS), Quality Assurance
California State University-Sacramento
Bachelor of Arts (BA), Government
SinuSys Corp. April 2015 - Present
AcelRx Pharmaceuticals, Inc. 2006 - March 2015
Anesiva 2004 - 2008
Roche Palo Alto 2004 - 2008
imedd Inc 2004 - 2005
PowderJect Vaccines 2000 - 2002
ALZA Corporation 1996 - August 2000
Syntex/Roche/Oread 1987 - 1995
Cooper Laboratories Inc. 1985 - 1987
Skills
Pharmaceuticals, R&D, Formulation Development, Dissolution, Formulation, Pharmaceutical Industry, Drug Development, Biotechnology, Validation, Pharmaceutics, FDA, Technology Transfer, GMP, Drug Discovery, Clinical Development, Biopharmaceuticals, Life Sciences
Education
The University of Kansas 1983 — 1985
MS, Pharmaceutical Chemistry
National Wildlife Health Center, USGS August 2008 - Present
Third Wave Technologies October 2006 - April 2008
Scientific Protein Laboratories June 2004 - October 2006
PowderJect Vaccines June 2001 - June 2004
US Air Force 1987 - 1994
Skills
GMP
Education
Western Illinois University 1999 — 2001
MS, Biology
Cornell College 1994 — 1997
BS, Molecular Biology
Food Research Institute at the University of Wisconsin-Madison August 2014 - Present
Deltanoid Pharmaceuticals 2009 - August 2014
Deltanoid Pharmaceuticals 2004 - 2009
PowderJect Vaccines 2003 - 2004
Third Wave Technologies 2000 - 2003
Cato Research 1997 - 2000
Duke University 1994 - 1997
UC Berkeley 1993 - 1993
Skills
Biotechnology, Product Development, Regulations, FDA, Lifesciences, Clinical Trials, Molecular Biology, Pharmaceutical Industry, GMP, Clinical Development, Technology Transfer, Drug Development, Project Management, Analytical Chemistry, Chemistry, Clinical Research, Drug Discovery, HPLC, Validation, CRO, Assay Development, ELISA, GLP, Biopharmaceuticals, Biochemistry, Protein Chemistry, Immunology, Laboratory, Medical Writing, Sop, Cell Culture, Life Sciences, SOP
Education
University of Wisconsin-Madison 1987 — 1992
Ph.D., Biochemistry
University of Illinois at Urbana-Champaign 1983 — 1987
Bachelor of Science, Chemistry
Bristol-Myers Squibb November 2013 - July 2014
Noramco November 2011 - September 2013
Siemens Healthcare Diagnostics June 2008 - February 2010
Phenomenex 2006 - 2008
Powderject Vaccines 2001 - 2006
Aventis Behring 1997 - 2001
Millenium Chemicals 1989 - 1997
Skills
CAPA, GMP, Validation, Quality System, Quality Assurance, Analytical Methods..., Quality Control, HPLC, GC-MS, GC-FID, ELISA, ELISPOT, Gel Electrophoresis, Laboratory, Sop, GLP, Technology Transfer, FDA, 21 CFR Part 11, V&V, Change Control, Vaccines, Chromatography, Chemical Engineering
Education
Illinois Institute of Technology 1987 — 2004
PHD, Engineering
Kansas State University October 2014 - Present
UU 2004 - 2005
PowderJect Vaccines 1999 - 2002
megabios 1997 - 1999
Skills
Bionanotechnology, Therapeutic DNA and RNA...
Education
The Johns Hopkins University 1989 — 1994
University of Rochester 1986 — 1988
MS, biophysical chemistry
PATH Director of ResearchPowderject plc1998 - 2004
PowderJect Vaccines January 1998 - December 2003
Skills
R&D, Lifesciences, Vaccines, Biotechnology, Protein Chemistry, Technology Transfer, Infectious Diseases, Immunology, Clinical Development
Education
Mississippi State University 1987 — 1991
Ph.D., Immunology
Promega November 2004 - Present
PowderJect 1997 - 2004
PowderJect Vaccines 1990 - 2004
Agracetus 1990 - 1994
Education
Colorado State University 1985 — 1989
BS, Biology
Sucampo Pharmaceuticals, Inc. 2012 - 2013
Savient Pharmaceuticals, Inc. 2011 - 2012
TMAC/URL Pharma August 2008 - October 2011
TMAC/Novartis Vaccines November 2007 - December 2008
Novartis Vaccines February 2002 - 2007
PowderJect Vaccines February 2000 - November 2002
University Of Wisconsin Oncology Center February 1996 - March 1998
Skills
Oncology, Infectious Diseases, Medical Affairs, Immunology, Pharmaceutical Industry, Neurology, Clinical Research, Clinical Trials, Clinical Development, Vaccines, Medical Devices, Endocrinology, Managed Care, Pharmaceutics, Therapeutic Areas, Psychiatry, Gastroenterology, Medicine, Cardiology, Rheumatology, Diabetes, Hospitals, Biotechnology, Urology, Nephrology, Pharmaceutical Sales, Dermatology, Regulatory Affairs, Pulmonology, Hospital Sales, CRO, Healthcare
Education
Universidad Nacional Autónoma de México 1980 — 1984
medicine, medicine
Promega March 2013 - Present
SAFC 2004 - March 2013
PowderJect Vaccines 2002 - 2004
PPD 2000 - 2002
Merial, a Sanofi Company 1998 - 2000
Skills
GMP, HPLC, Quality Control, Laboratory, GLP, PCR, Validation, FDA, Sop, Biotechnology, Chromatography, Pharmaceutical Industry, GC-FID, Gel Electrophoresis, Method Development, Assay Development, Molecular Biology, Employee Training
Education
University of Wisconsin-Madison 2006 — 2008
Masters, Biotechnology
Missouri State University 1991 — 1995
Bachelors, Chemistry
Takeda Pharmaceuticals October 2014 - Present
Pfizer/Wyeth January 2005 - May 2014
PowderJect Vaccines 1999 - 2005
Veterinary Infectious Disease Organization January 1995 - January 1999
Insect Biotech Canada January 1990 - January 1995
Queen's University January 1988 - January 1990
Skills
Assay Development, Protein Chemistry, Vaccines, DNA, Antibodies, Clinical Trials, Research, Drug Discovery, Drug Development, Clinical Development, Lifesciences, Biotechnology, Pharmaceutical Industry, GLP
Education
University of Saskatchewan 1984 — 1988
Ph.D, Biochemistry
Arrowhead Research Corporation October 2014 - Present
Covance Laboratories June 2004 - June 2014
PowderJect Vaccines July 1998 - May 2004
Skills
Vaccines, GLP, Toxicology, CRO, Drug Development, Lifesciences, Biotechnology, Drug Discovery, Pharmaceutical Industry, Sop, In Vivo, Validation, Clinical Development, Molecular Biology, Cell Culture, FDA, Western Blotting, ELISA, GMP, Regulatory Affairs, Project Management, Flow Cytometry, GCP, In Vitro, Pharmacokinetics, Biopharmaceuticals, DNA, Regulatory Submissions, Pharmacology, IND
Education
University of Wisconsin-Madison 2002 — 2004
MS, Biotechnology
Texas A&M University 1994 — 1998
BS, Genetics/Biochemistry
FluGen, Inc May 2011 - Present
Herber Consulting January 2008 - Present
Platypus Technologies, LLC January 2006 - May 2011
PowderJect Vaccines 1998 - 2005
McArdle Laboratory for Cancer Research 1990 - 1998
Veterinary Science Dept, UW-Madison 1987 - 1989
Skills
Data Analysis, Technical Writing, Project Planning, Strategic Thinking, Assay Development, Cell, Vaccines, Lifesciences, Budgets, Medical Devices, FDA, R&D, Biotechnology, Cell Culture, Biochemistry, Validation, Drug Discovery, Product Development, CRO, Clinical Development, Genetics, Molecular Biology, Laboratory, Technology Transfer, Cell Biology, Hardware Diagnostics
Education
Clarke University 1982 — 1986
BS, Chemstry
Mirus Bio LLC February 2005 - Present
Mirus Bio Corporation 2005 - 2008
PowderJect Vaccines March 1983 - December 2004
Agracetus 1983 - 1995
Oakwood Lutheran Homes, Inc. 1982 - 1983
Skills
Accounting, General Ledger, Payroll, Accounts..., Navision, QuickBooks, Accounts Payable, Budgets, ADP Payroll, Microsoft Excel, Hyperion Enterprise, Auditing, Variance Analysis, Financial Analysis, Process Improvement, Financial Reporting, Internal Controls, Cash Management, Management, Financial Modeling, Forecasting, Managerial Finance, Revenue Recognition, Analysis, Accruals, Fixed Assets, Cash Flow Forecasting, Great Plains Software, Cost Accounting, Biopharmaceuticals, Year-end Close
Education
Madison Area Technical College
Accounting/Payroll Systems
University of Wisconsin-Platteville
Math
Gilda's Club of Madison May 2011 - Present
UW-SMPH November 2010 - Present
Helix Diagnostics Inc. 2012 - 2012
Covance 2006 - 2010
Covance Laboratories 2006 - 2010
PowderJect Vaccines 1995 - 2004
Agracetus Inc. 1983 - 1996
Skills
Integrity, Science, Communication, Biotechnology, Clinical Development, Molecular Biology, Toxicology, Medical Devices, Animal Models, Clinical Trials, GLP, Drug Development, Clinical Research, Vaccines, Biochemistry, Lifesciences
Education
University of California at SanFrancisco 1978 — 1983
post doctoral, Biochemistry, molecular biology
The University of Georgia 1969 — 1978
MS, PhD, Biochemistry, enzymology
Emory University 1964 — 1969
BA, Chemistry
NIH @ CSR (Center for Scientific Review) March 2008 - August 2015
NIH @ NIDCR November 2003 - February 2008
Wyeth Pharmaceuticals now Pfizer 1999 - 2003
PowderJect Vaccines January 1999 - March 2000
University of Pennsylvania 1994 - 1999
Skills
Program Management, Immunology, Vaccines, Drug Discovery, Lifesciences, Clinical Development, Medical Research, Molecular Biology, DNA, Biotechnology, Cell Biology, Clinical Research, Data Analysis, Life Sciences
Education
University of Pennsylvania 1994 — 1999
Post-doctorate fellowship, Mucosal Immunology
All India Institute of Medical Sciences 1990 — 1994
PhD, Biology
Jawaharlal Nehru University 1987 — 1989
MSc, Life Sciences
Delhi University 1984 — 1987
Bsc, Zoology
University of Washington 2005 - Present
PowderJect Vaccines October 1998 - May 2004
Skills
Research, Cell Culture, Molecular Biology
Education
Mississippi State University 1988 — 1991
Master's degree, Molecular Biology, 3.5
Mississippi State University
Mississippi State University, Molecular Biology, Master