CMC ICOS Biologics
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CMC ICOS Biologics Employees
CMC ICOS August 2011 - Present
CMC Icos Biologics March 2006 - Present
Amgen October 2003 - March 2006
Genentech 2001 - 2003
Skills
GMP, Cell Culture, Manufacturing, Biopharmaceuticals, Technology Transfer, Sop, Aseptic Technique, Biotechnology, V&V, Process Simulation, CAPA, Continuous Improvement, Vaccines, Pharmaceutical Industry, Quality System, Purification, Lifesciences, Change Control, Start-ups, 21 CFR Part 11, FDA, Validation
Education
Collegio San Juan de Letran 1982 — 1986
BA, Economics
Brigham Young University
Technical Wiritng Course
University of the Philippines
Basic Computer Skills
CMC ICOS Biologics October 2011 - Present
BioGenesis Nutraceuticals February 2010 - June 2011
Apple Inc. August 2008 - February 2010
Evergreen Print Solutions October 2006 - August 2008
Emerald Books September 1995 - June 2006
American Art & Graphics May 1990 - June 1995
Skills
Warehouse Management, Problem Solving, Inventory Management, Supply Chain Management, Microsoft Office, Customer Service, Team Leadership, Purchasing, SAP, Microsoft Excel, Mac, Leadership, Software Documentation, Mac OS X, Microsoft Word, GMP, Loss Prevention, OS X, Warehousing, Mac OS, Operations Management, Inventory Control, Data Entry, Sop, iPod, iWork, iTunes, Human Resources, Supply Chain, Forklift Operator, iPhoto, Retail, Communication Skills, Cycle Counting, Document Review, ERP Software, Industrial Safety, International Shipping, Pharmaceutical Industry, Shipping, Team-oriented, Time Management, 21 CFR Part 11, Biopharmaceuticals, Biotechnology, Employee Training, iLife, cGMP manufacturing, cGMP practices, Inventory Accuracy
Education
U of N 1998 — 1999
BLS Certificate
Shoreline Community College 1989 — 1990
Woodway High School 1985 — 1988
Diploma, High School/Secondary Diplomas and Certificates
Aerojet Rocketdyne March 2015 - Present
American Red Cross Snohomish County November 2014 - Present
CMC Biologics January 2012 - October 2014
CMC ICOS Biologics June 2008 - December 2011
Intermec Technologies April 2008 - May 2008
Nastech Pharmaceutical 2004 - 2008
Ostex International Inc. 2001 - 2004
Blue Nile 2000 - 2001
US Fish and Wildlife Service 1998 - 2000
National Marine Fishery Service 1994 - 1998
Skills
Validation, Cell Culture, Purification, GLP, Pharmaceutical Industry, Technology Transfer, Sop, Biotechnology, FDA, Inventory Control, GMP, ELISA, CAPA, Aseptic Processing, Quality System
Education
Unity College 1988 — 1993
Bachelor's Degree, Wildlife Biology and Managment
CMC ICOS Biologics December 2008 - Present
ICOS Corporation June 1997 - December 2008
CellPro June 1994 - June 1997
Skills
Biotechnology, Protein Chemistry, HPLC, GMP, Testing, Wet Chemistry, Validation, Biopharmaceuticals, GLP, Immunoassays, Cleaning Validation
Education
University of Washington 1990 — 1992
Bachellor of Science, Molecular Biology
San Diego State University-California State University 1987 — 1989
Seattle Children's Research Institute December 2014 - Present
CMC ICOS Biologics 2010 - January 2015
Cardinal Health 2009 - 2010
Novartis 2005 - 2009
Skills
GMP, Sop, Software Documentation, Validation, Chromatography, Biotechnology, Purification, Protein Chemistry, Biopharmaceuticals, CAPA, FDA, Technology Transfer, Change Control, Pharmaceutical Industry, 21 CFR Part 11, Quality Control, SOP
Education
University of Minnesota-Morris 2001 — 2005
BA, Biology
CSU- Moss Landing
Genzyme January 2014 - Present
CMC ICOS Biologics January 2012 - December 2013
Hospira (Adelaide) May 2007 - December 2011
Novozymes (GroPep Limited) May 2000 - May 2007
Intracel Corporation Bartels division January 1998 - September 1999
Skills
GMP, Validation, Biotechnology, Cleaning Validation, FDA, Technology Transfer, 21 CFR Part 11, V&V, Biopharmaceuticals, Project Management, Quality System, ISO, Change Control, Aseptic Processing, CAPA, Computer System..., GxP, GLP, GAMP, Sop, LIMS, Cell Culture, Trackwise, Purification, SOP, TrackWise
Education
San Jose State University
B.Sc, Biology
University of South Australia
Graduate, Project Management
CMC Biologics June 2015 - Present
Amgen January 2010 - May 2015
CMC Icos Biologics September 2008 - May 2009
ZymoGenetics April 2004 - September 2004
Corixa Corporation March 2001 - November 2003
University of Washington October 1998 - June 1999
Skills
Analytical Chemistry, Medicinal Chemistry, Process Development, Biochemistry, Purification, Process Simulation, Protein Expression, Organic Synthesis, Fluorescence..., ELISA, SDS-PAGE, Biotechnology, Chemistry, Protein Chemistry
Education
Seattle University
Bachelors, Biochemistry
University of Washington
Masters, Organic Chemistry
Alder Biopharmaceuticals June 2011 - Present
CMC Icos Biologics July 2010 - August 2011
Amgen August 2001 - July 2009
Amgen Inc. November 2008 - March 2009
Amgen January 2008 - July 2008
Skills
Biotechnology, Cell Culture, GMP, GLP, Biopharmaceuticals, Lifesciences, Chromatography, FDA, Quality System, Technology Transfer, HPLC, Purification, Protein Purification, Pharmaceutical Industry, Validation, Fermentation, CAPA, Change Control
Education
Purdue University 2012 — 2012
Certificate, Lean Six Sigma Green Belt
Western Washington University 1999 — 2001
BS, Biology
CMC Biologics A/S January 2010 - Present
CMC Icos Biologics October 2003 - Present
US Navy October 2003 - Present
CMC Biologics January 2003 - Present
Bio-Rad Laboratories March 2000 - October 2003
Bio-Rad Laboratories January 2000 - January 2003
Quinton Instruments / Kendall Healthcare September 1989 - April 2000
Quinton Instruments / Kendall Healthcare January 1989 - January 2000
Skills
GMP, Chromatography, Fermentation, Purification, cGMP, Validation, Biotechnology, Protein Purification, Process Validation, Monoclonal Antibodies, HPLC, Cell Culture, Biopharmaceuticals, Technology Transfer, SOP, CAPA, R&D, UV-Vis, Life Sciences, Diagnostics, Process Development, FDA, Mass Spectrometry, GLP, Quality Systems, Medical Devices, Microbiology, Western Blotting, Pharmaceuticals, ISO
Education
Naval Training Center, Treasure Island Engineering Propulsion Systems 1985 — 1986
Associate's degree, Engineering Propulsion Systems
Naval Training Center Treasure Island 1984 — 1986
Associate, Engineering Propulsion Systems
Lake Washington Institute of Technology
Seattle Genetics November 2009 - Present
Kim's Cafe April 2009 - Present
CMC ICOS Biologics September 1999 - April 2009
ICOS Corporation 1999 - 2009
Amgen September 1989 - September 1999
Sierracin Advanced Programs Group February 1984 - May 1987
Skills
cold chain distribution, package development, testing and validation..., Validation, Biotechnology, Molecular Biology, Transportation, Biochemistry, Cold Chain, ELISA, Pharmaceutical Industry, CRO, Clinical Trials, Assay Development, Clinical Development, Lifesciences, FDA, Drug Discovery, Packaging, GLP, GMP, Monoclonal Antibodies, Biopharmaceuticals, CTMS, Infectious Diseases, GCP, Sop, Drug Development, Life Sciences, Technology Transfer, Oncology, SOP
Education
Caltech 1987 — 1989
Biochemistry and Molecular Biology
California State University-Northridge 1983 — 1987
B.Sc., Biochemistry
Dendreon June 2013 - Present
Fred Hutchinson Cancer Research Center January 2011 - August 2012
CMC ICOS Biologics June 2008 - January 2011
GenPrime, Inc. May 2007 - February 2008
Skills
Cell Culture, Research, Biotechnology, Biochemistry, Life Sciences, Lifesciences
Education
Tulane University 2012 — 2013
Master of Science (MS), Cell/Cellular and Molecular Biology
Gonzaga University 2004 — 2008
B.S. in Biology, Concentration in Entrepreneurship
Eastside Catholic High School 2001 — 2004
Diploma
Analytics Pros November 2014 - Present
Analytics Pros July 2014 - December 2014
Analytics Pros February 2014 - July 2014
Analytics Pros October 2012 - February 2014
CMC Biologics June 2011 - October 2012
CMC ICOS Biologics December 2007 - August 2011
ICOS Corporation 2006 - 2007
Seattle Biomedical Research Institute July 2005 - October 2006
Epigenomics, Inc July 2004 - July 2005
University of Washington Department of Chemistry January 2003 - June 2004
Skills
Google Analytics, Google Tag Manager, JavaScript, Conversion Optimization, Optimizely, Strategic Planning, Analytics Solution..., Biotechnology, PCR, Flow Cytometry, Cell Culture, Lifesciences, Molecular Biology, CSS3, Optimization, CSS, Data Analysis, GTM, Project Management
Education
Seattle Pacific University 2001 — 2005
B.S., Biochemistry
CMC ICOS Biologics August 2004 - Present
ICOS Corporation 2004 - 2007
University of Washington 2003 - 2004
InterGenetics Incorporated 2001 - 2003
Skills
Monoclonal Antibodies, Lifesciences, Biotechnology, Assay Development, Drug Discovery, Biopharmaceuticals, Cell Culture, Technology Transfer, HPLC, GMP, Protein Chemistry, ELISA, Life Sciences, Antibodies, GLP, Protein Purification, Molecular Biology, Pharmaceutical Industry, Biochemistry, Validation, FDA, Cell, SOP, Chromatography, Molecular Cloning, Molecular Genetics, Cell Biology
Education
University of Central Oklahoma 1992 — 2000
BS, Chemistry
University of Central Oklahoma
CMC Biologics August 2013 - Present
CMC Biologics A/S January 2012 - August 2013
CMC ICOS Biologics 2010 - 2012
CMC ICOS Biologics 2007 - 2010
ICOS Corporation 2005 - 2007
ICOS Corporation 1992 - 2005
Pfizer 1988 - 1992
Skills
Pharmaceutical Industry, Assay Development, Monoclonal Antibodies, Analytical Chemistry, Sop, Quality Control, Drug Discovery, FDA, R&D, Quality System, Protein Chemistry, Molecular Biology, Change Control, CAPA, Laboratory, Microbiology, Drug Development, SOP
Education
University of Houston
Master of Science (MS), Organic Chemistry
University of Houston
Master of Science (BS), Chemistry
CMC Biologics 2011 - January 2013
CMC ICOS Biologics 2007 - 2010
ICOS 2006 - 2007
ICOS 2000 - 2006
Skills
Biopharmaceuticals, Biotechnology, Technology Transfer, GMP, Lifesciences, Drug Development, FDA, Manufacturing, Contract Manufacturing, Cross-functional Team..., Project Management, Analytical Methods..., Change Control, Quality Control, Life Sciences
Education
University of Washington 2004 — 2005
Certificate, Project Management
Auburn University 1991 — 1997
Bachelor's of Science
Juno Therapeutics April 2014 - Present
CMC ICOS Biologics May 2010 - April 2014
NNE Pharmaplan August 2008 - May 2010
Bayer Pharmaceuticals 2007 - 2008
Bayer HealthCare 2006 - 2007
Berlex Laboratories 2002 - 2007
Berlex Incorporated 2002 - 2006
Amgen 2001 - 2002
immunex 1992 - 2002
Skills
Validation, Biotechnology, Technology Transfer, Project Management, Project Planning, GMP, Automation, Pharmaceutical Industry, FDA, Biopharmaceuticals, V&V, Change Control, CAPA
Education
Marquette University 1987 — 1992
BS, Mechanical Engineering
CMC ICOS Biologics March 2010 - Present
Education
Queen's University Belfast 1999 — 2003
11 Compliance Consulting October 2012 - Present
CMC ICOS Biologics March 2011 - October 2012
Seattle Genetics September 2010 - March 2011
Genzyme 2002 - July 2010
Avecia 2001 - 2002
XOMA 2000 - 2001
Cookson Electronics 1997 - 2000
Skills
MasterControl..., GMP, GLP, Sop, 21 CFR Part 11, FDA, Validation, Biotechnology, Biopharmaceuticals, Change Control, CAPA, Computer System..., Pharmaceutical Industry, Technology Transfer
Education
CCRI
Northeastern University
Oncothyreon, Inc. July 2012 - Present
Saltigo Redmond June 2011 - August 2012
Saltigo Redmond December 2008 - December 2011
Saltigo Redmond February 2008 - December 2008
ICOS January 2006 - February 2008
CMC ICOS BIOLOGICS 2007 - 2008
ICOS February 1999 - January 2006
Skills
Validation, GLP, FDA, Technology Transfer, Project Management, Technical Writing, Quality Control, Quality System..., Analytical Chemistry, Clinical Trials, 21 CFR Part 11, V&V, Quality Assurance, GMP, CRO, Deviations, Computer System..., Lifesciences, R&D, Quality Auditing, Regulatory Submissions, Clinical Development
Education
University of Washington 2007 — 2008
Certificate, Editing
California State University-Northridge 1977 — 1978
Elementary Education
KBI Biopharma January 2015 - Present
KBI Biopharma January 2014 - December 2014
KBI Biopharma May 2012 - December 2013
KBI Biopharma October 2010 - May 2012
Tensility International Corporation May 2009 - 2010
Irvine Pharmaceutical Services May 2008 - January 2009
CMC ICOS Biologics November 2005 - May 2008
Human Genome Sciences 1999 - 2005
Skills
GMP, Technology Transfer, Biotechnology, Chromatography, GLP, Purification, Pharmaceutical Industry, SOP, Protein Chemistry, FDA, R&D
Education
Virginia Polytechnic Institute and State University 1993 — 1998
B.S., Biochemistry
The Johns Hopkins University
Biotechnology
Alder Biopharmaceuticals January 2011 - Present
Hyde Engineering and Consulting September 2010 - January 2011
CMC Icos Biologics November 2007 - July 2010
ICOS March 1998 - November 2007
Amgen August 1987 - February 1998
Skills
Validation, Process Validation, Manufacturing, Cleaning Validation, Fermentation, Protein Purification, Cell Culture, Technology Transfer, cGMP, GLP, sterilization validation, Contamination control, Biopharmaceuticals
Education
University of California, Davis 1983 — 1987
Bachelor's, Genetics
Takeda Vaccines Inc. December 2014 - Present
CMC Biologics August 2011 - November 2014
CMC Biologics May 2009 - July 2011
CMC ICOS Biologics March 2006 - April 2009
Targeted Genetics Corporation 1996 - 2006
Skills
Biopharmaceuticals, Biotechnology, Lifesciences, Business Development, Project Planning, GMP, CMC, GLP, Change Control
Education
University of Washington 2007 — 2008
Certificate in Project Managment
University of Washington 2002 — 2003
Certificate in Biomedical Regulatory Affairs, Biomedical/Medical Engineering
Seattle University 1989 — 1992
BSc, Biology
Bill & Melinda Gates Foundation September 2013 - Present
CMC ICOS Biologics February 2008 - August 2013
ICOS Corporation October 1995 - February 2008
US FDA June 1991 - October 1995
NeoRx Corporation April 1986 - April 1989
Education
University of Washington 1980 — 1986
PhD, Organic Chemistry/Natural Products Chemistry
University of Maine 1975 — 1979
BS, Chemistry
CMC ICOS Biologics November 2007 - Present
ICOS November 2001 - November 2007
Advanced Tissue Sciences November 1995 - September 2001
Hyclone Laboratories December 1993 - September 1995
Skills
Quality Control, Biopharmaceuticals, GMP, GLP, Biotechnology, Validation, CAPA, FDA, Sop, HPLC, Analytical Method..., Quality System, 21 CFR Part 11
Education
University of California, Santa Barbara 1986 — 1990
BA, Aquatic Biology
Greater Seattle Area January 2009 - Present
CMC ICOS December 2007 - January 2009
CMC ICOS Biologics 2007 - 2009
Lilly ICOS November 2006 - December 2007
ICOS Corporation January 2003 - November 2006
XOMA Corporation December 1989 - January 1995
Skills
Biotechnology, Life Sciences, GMP, Purification
Education
University of California, Los Angeles 1979 — 1982
Post Doc, Biochemistry
Colorado State University 1973 — 1979
MS, PhD, Biochemistry
Saint Michael's College 1964 — 1968
BA, Biology
CMC ICOS Biologics July 1999 - Present
Ostex International 1992 - 1999
Oncogen 1985 - 1991
Skills
Biotechnology, Biopharmaceuticals, Validation, Technology Transfer, GMP, Life Sciences, FDA, Purification, SOP, Pharmaceutical Industry, Protein Chemistry
Education
University of Colorado Boulder 1979 — 1981
MCD Biology
University of Oregon 1976 — 1979
BA, Biology, General
. June 2011 - Present
CMC ICOS Biologics June 2005 - May 2011
Roche Palo Alto July 1995 - 2001
Syntex February 1994 - June 1995
Education
Danmarks Farmaceutiske Universitet 1988 — 1993
Master of Science (M.S.), Pharmaceutical Sciences
Modumetal, Inc. April 2015 - Present
Amgen May 2013 - December 2014
Amgen April 2012 - May 2013
Dendreon Corporation December 2010 - September 2011
CMC ICOS Biologics January 2008 - December 2010
CMC ICOS Biologics / ICOS Corporation January 2008 - December 2010
ICOS Corporation January 2005 - January 2008
ECOLAB Inc April 2002 - January 2005
Sienna Technologies Inc June 2001 - December 2001
Skills
HPLC, GMP, Chromatography, Analytical Chemistry, Protein Chemistry, ELISA, Validation, Research, Chemistry, cGMP, SDS-PAGE, Quality Systems, Method Transfer, GLP, ICH guidelines, UPLC, Assay Development, UV/Vis, SOP, Biotechnology
Education
Brigham Young University - Hawaii 1998 — 2001
BS, Chemistry
Brigham Young University
Bachelor of Science, Chemistry
Illinois Institute of Technology
Masters, Analytical Chemistry
Illinois Institute of Technology
Master's Degree, Analytical Chemistry
Waters Corporation
Institute for Health Metrics and Evaluation December 2012 - Present
Institute for Health Metrics and Evaluation January 2011 - December 2012
CMC Icos Biologics November 2010 - December 2010
Technical Digest Services April 2007 - December 2009
Berlex LLC July 2002 - August 2006
Berlex LLC July 2002 - March 2004
Immunex Corporation April 1997 - July 2002
Skills
Biotechnology, GMP, Automation, Data Analysis, Statistics, Research, Microsoft Office, JavaScript, PowerPoint, Sop, R, Validation, Databases, Software Documentation
Education
University of Maryland Baltimore County 2008 — 2009
MS, Information Systems, 4.0
University of Washington 2005 — 2006
BS, Biochemistry
CMC ICOS Biologics, Inc. 2012 - Present
CMC ICOS Biologics, Inc 2010 - 2012
CMC ICOS Biologics 2008 - 2010
Progenitor Cell Therapy 2007 - 2008
Skills
Biotechnology, Biopharmaceuticals, Lifesciences
Education
Linköping University 1980 — 1983
B.Sc., Chemistry
brionyx April 2009 - Present
Spacelabs Healthcare 2014 - 2015
Product Creation Studio May 2011 - April 2014
CMC ICOS Biologics 2010 - 2010
The Allen Institute for Brain Science November 2008 - April 2009
Pathway Medical January 2008 - October 2008
CardioMetrix, Inc. August 2006 - December 2007
Cardiac Dimensions October 2003 - August 2006
Modified Polymer Components, Inc. April 1997 - March 2002
Skills
R&D, Medical Devices, Engineering, ISO 13485, Design Control, Product Development, Program Management, Project Management, Product Management, Cross-functional Team..., Biomedical Engineering, Quality System, Quality Management, Design of Experiments, Design for Manufacturing, Entrepreneurship, Start-ups, Start-up Ventures, Biotechnology, Commercialization, V&V, FMEA, FDA, FDA GMP, GMP, Product Launch, Interventional..., Surgical Pathology, Anatomic Pathology, Forensic Pathology, Catheters, Manufacturing, Manufacturing..., Operations Management, Solidworks, Engineering Management, Testing, Mechanical Product..., CAPA, Rapid Prototyping, SolidWorks
Education
Stanford University School of Medicine 1996 — 1998
MS, Biomechanical Engineering
San Jose State University 1993 — 1997
BS, Systems Physiology/Chemistry
Stanford University School of Medicine 1993 — 1997
PA, Forensic and Surgical Pathology as well as Clinical Medicine
Dendreon May 2012 - Present
CMC Biologics January 2010 - April 2012
CMC ICOS Biologics December 2008 - January 2010
ICOS March 1999 - December 2008
Immunex April 1995 - March 1999
Skills
Biopharmaceuticals, Validation, Technology Transfer, GMP, Biotechnology, Fermentation, Change Control, CAPA, Process Engineering, Process Improvement, FDA, 21 CFR Part 11, Quality System, Aseptic Processing, Process Simulation, Cell Culture, GxP, Monoclonal Antibodies, Sterilization, cGMP manufacturing, cGMP practices, R&D, Project Management, Inventory Control, Calibration, Process Automation, Cleaning Validation, Cold Storage, Control Systems Design, Engineering Management, Sop, Lifesciences, Purification, Filtration, Cold Chain Management, Cryopreservation, Biorepository, GLP, Chromatography, Life Sciences, SOP
Education
Bellingham Technical College
Fred Hutch October 2015 - Present
Jackson Rahl Comics LLC July 2013 - Present
CMC ICOS Biologics September 2011 - October 2015
Biopharmaceutical Manufacturing & Academic Resource Center (BioMARC) August 2010 - August 2011
Colorado State University March 2004 - August 2010
Skills
Project Management, Aseptic Technique, Equipment Onboarding, Biopharmaceuticals, GMP, Biotechnology, Calibration, Fermentation, Speed Reading, Purification, Cell Culture, Protein Purification, GLP, Technology Transfer, Monoclonal Antibodies, Lyophilization, Filtration, Chromatography, UF/DF, Sterilization, PCR, SDS-PAGE
Education
Colorado State University 2003 — 2006
Bachelor's degree, Philosophy of Science and Ethics