Baxter Hemoglobin Therapeutics
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Baxter Hemoglobin Therapeutics Employees
Employee
Years
Job
Industry
Shibu George Shibu George's Baxter Hemoglobin Therapeutics Experience 1999 - 2003
Job Scientist at KBI Biopharma
Industry Biotechnology
Experience
KBI Biopharma May 2014 - Present
Merck March 2009 - May 2014
Insmed Therapeutic Proteins July 2004 - March 2009
Insmed 2004 - 2009
Cargill 2003 - 2004
Baxter hemoglobin therapeutics 1999 - 2003
Baxter 1999 - 2003
Hauser 1996 - 1998
Skills
HPLC, SDS-PAGE, Protein Purification, Filtration, Analysis, Protein Folding, GLP, Purification, GMP, Biotechnology, Technology Transfer, Sop, Chromatography, Fermentation, UV/Vis, Pharmaceutical Industry
Education
Mangalore University 1988 — 1992
Pharmacy (B. Pharm), Pharmaceutical Sciences
KBI Biopharma May 2014 - Present
Merck March 2009 - May 2014
Insmed Therapeutic Proteins July 2004 - March 2009
Insmed 2004 - 2009
Cargill 2003 - 2004
Baxter hemoglobin therapeutics 1999 - 2003
Baxter 1999 - 2003
Hauser 1996 - 1998
Skills
HPLC, SDS-PAGE, Protein Purification, Filtration, Analysis, Protein Folding, GLP, Purification, GMP, Biotechnology, Technology Transfer, Sop, Chromatography, Fermentation, UV/Vis, Pharmaceutical Industry
Education
Mangalore University 1988 — 1992
Pharmacy (B. Pharm), Pharmaceutical Sciences
Micah Shagoury Micah Shagoury's Baxter Hemoglobin Therapeutics Experience July 2001 - January 2002
Job Operations Management | Business Strategy Professional
Industry Biotechnology
Experience
KBI Biopharma May 2014 - Present
Merck April 2009 - December 2013
Insmed, Inc. April 2007 - April 2009
Insmed Therapeutic Proteins July 2006 - April 2007
Insmed Therapeutic Proteins September 2004 - July 2006
Baxter, Hemoglobin Therapeutics July 2001 - January 2002
Skills
Validation, GMP, Quality Assurance, Change Control, Manufacturing, Biotechnology, Six Sigma, CAPA, Technology Transfer, Cross-functional Team..., Project Management, Pharmaceutical Industry, Fermentation, Management, Process Improvement, Purification, Lean Manufacturing, Operations Management, Finite Scheduling, Financial Modeling, Process Scheduler, Facility Fit, Finance, Budget Management, Capital Budgeting, Microsoft Dynamics GP
Education
University of Colorado Boulder - Leeds School of Business 2011 — 2013
MBA
University of New Hampshire 1999 — 2001
Masters in Education, Secondary Science
University of New Hampshire 1995 — 1999
Bachelor of Science (B.S.), Biology
KBI Biopharma May 2014 - Present
Merck April 2009 - December 2013
Insmed, Inc. April 2007 - April 2009
Insmed Therapeutic Proteins July 2006 - April 2007
Insmed Therapeutic Proteins September 2004 - July 2006
Baxter, Hemoglobin Therapeutics July 2001 - January 2002
Skills
Validation, GMP, Quality Assurance, Change Control, Manufacturing, Biotechnology, Six Sigma, CAPA, Technology Transfer, Cross-functional Team..., Project Management, Pharmaceutical Industry, Fermentation, Management, Process Improvement, Purification, Lean Manufacturing, Operations Management, Finite Scheduling, Financial Modeling, Process Scheduler, Facility Fit, Finance, Budget Management, Capital Budgeting, Microsoft Dynamics GP
Education
University of Colorado Boulder - Leeds School of Business 2011 — 2013
MBA
University of New Hampshire 1999 — 2001
Masters in Education, Secondary Science
University of New Hampshire 1995 — 1999
Bachelor of Science (B.S.), Biology
Adam W. York Adam W. York's Baxter Hemoglobin Therapeutics Experience May 2001 - August 2003
Job Staff Scientist at Thermo Fisher Scientific
Industry Research
Experience
Thermo Fisher Scientific January 2014 - Present
Princeton University December 2012 - January 2014
Rutgers University August 2012 - December 2012
New Jersey Center for Biomaterials August 2010 - August 2012
University of Southern Mississippi August 2004 - May 2010
Baxter Hemoglobin Therapeutics May 2001 - August 2003
Skills
Polymer Chemistry, Polymer Characterization, GPC, ASEC-MALLS, SLS, DLS, Zeta Potential, NMR, UV-Vis, Fluorescence, Cell Culture, Gel Electrophoresis, TGA, CD Spectroscopy, Organic Nanoparticle..., Epifluorescent..., RAFT Polymerization, Bioconjugation Methods, Flow Cytometry, Microsoft Office, ChemDraw, ImageJ, qRT-PCR, Nanofabrication, Polymer Science, Nanobiotechnology, Nanoparticles, Nanotechnology, Polymers, Biomaterials, Chemistry, UV/Vis
Education
University of Southern Mississippi 2004 — 2010
Ph.D, Polymer Science and Engineering
University of Colorado 1999 — 2004
Bachelor of Science, Chemical Engineering
Thermo Fisher Scientific January 2014 - Present
Princeton University December 2012 - January 2014
Rutgers University August 2012 - December 2012
New Jersey Center for Biomaterials August 2010 - August 2012
University of Southern Mississippi August 2004 - May 2010
Baxter Hemoglobin Therapeutics May 2001 - August 2003
Skills
Polymer Chemistry, Polymer Characterization, GPC, ASEC-MALLS, SLS, DLS, Zeta Potential, NMR, UV-Vis, Fluorescence, Cell Culture, Gel Electrophoresis, TGA, CD Spectroscopy, Organic Nanoparticle..., Epifluorescent..., RAFT Polymerization, Bioconjugation Methods, Flow Cytometry, Microsoft Office, ChemDraw, ImageJ, qRT-PCR, Nanofabrication, Polymer Science, Nanobiotechnology, Nanoparticles, Nanotechnology, Polymers, Biomaterials, Chemistry, UV/Vis
Education
University of Southern Mississippi 2004 — 2010
Ph.D, Polymer Science and Engineering
University of Colorado 1999 — 2004
Bachelor of Science, Chemical Engineering
Erik Rosendal Erik Rosendal's Baxter Hemoglobin Therapeutics Experience 1996 - 2003
Job Sr. Consultant II at Hyde Engineering + Consulting
Industry Biotechnology
Experience
Hyde Engineering + Consulting September 2011 - Present
PharmaSolutions, Inc. 2002 - Present
Emergent BioSolutions 2009 - August 2011
Biokinetics Inc. 2007 - 2008
Insmed 2004 - 2007
Validation Technologies, Inc. 2003 - 2004
Baxter Hemoglobin Therapeutics 1996 - 2003
Somatogen 1990 - 1996
Skills
GMP, Technology Transfer, Validation, Biotechnology, FDA, Biopharmaceuticals, Pharmaceutical Industry, GLP, CAPA, Lifesciences, Change Control, Quality System, Commissioning and..., Fill and Finish, Isolation Technology, Project Management, Cleaning Validation, Protocol Development, Autoclave Validation, EMEA /EudraLex..., Process Engineering, Process Development, Design of Experiments, Microbiology, Fermentation, V&V, Protocol, Process Simulation, Cell Culture, Manufacturing, Sop, 21 CFR Part 11, Protein Chemistry, Downstream Processing
Education
University of Colorado Boulder 1978 — 1983
Saguaro High School 1974 — 1978
Hyde Engineering + Consulting September 2011 - Present
PharmaSolutions, Inc. 2002 - Present
Emergent BioSolutions 2009 - August 2011
Biokinetics Inc. 2007 - 2008
Insmed 2004 - 2007
Validation Technologies, Inc. 2003 - 2004
Baxter Hemoglobin Therapeutics 1996 - 2003
Somatogen 1990 - 1996
Skills
GMP, Technology Transfer, Validation, Biotechnology, FDA, Biopharmaceuticals, Pharmaceutical Industry, GLP, CAPA, Lifesciences, Change Control, Quality System, Commissioning and..., Fill and Finish, Isolation Technology, Project Management, Cleaning Validation, Protocol Development, Autoclave Validation, EMEA /EudraLex..., Process Engineering, Process Development, Design of Experiments, Microbiology, Fermentation, V&V, Protocol, Process Simulation, Cell Culture, Manufacturing, Sop, 21 CFR Part 11, Protein Chemistry, Downstream Processing
Education
University of Colorado Boulder 1978 — 1983
Saguaro High School 1974 — 1978
William Swigert William Swigert's Baxter Hemoglobin Therapeutics Experience May 2001 - October 2003
Job Pharmaceutical Production Supervisor
Industry Biotechnology
Experience
TOLMAR Inc. February 2015 - Present
Allergan April 2012 - March 2015
GlaxoSmithKline November 2007 - April 2012
validant Consulting February 2007 - October 2007
Insmed Therapeutic Proteins June 2004 - February 2007
Baxter May 2001 - November 2003
Baxter Hemoglobin Therapeutics May 2001 - October 2003
Skills
GMP, Validation, FDA, Purification, Fermentation, Sterilization, Biotechnology, Biopharmaceuticals, Root Cause Analysis, Technology Transfer, Sop, Aseptic Processing, Manufacturing, Change Control, V&V, Process Simulation, Vaccines, Formulation, Lyophilization, Fill, cGMP, FMEA, Process Validation, Chromatography, Aseptic Technique, Cleaning Validation, Deviations, Protein Purification, Filtration, Trackwise, ISO 13485, cGMP manufacturing, Lean Manufacturing, Lean Operations, Lean Management, 21 CFR Part 11, GLP, SOP
Education
University of Colorado 1996 — 2000
BA, Biochemistry & Molecular Biology
TOLMAR Inc. February 2015 - Present
Allergan April 2012 - March 2015
GlaxoSmithKline November 2007 - April 2012
validant Consulting February 2007 - October 2007
Insmed Therapeutic Proteins June 2004 - February 2007
Baxter May 2001 - November 2003
Baxter Hemoglobin Therapeutics May 2001 - October 2003
Skills
GMP, Validation, FDA, Purification, Fermentation, Sterilization, Biotechnology, Biopharmaceuticals, Root Cause Analysis, Technology Transfer, Sop, Aseptic Processing, Manufacturing, Change Control, V&V, Process Simulation, Vaccines, Formulation, Lyophilization, Fill, cGMP, FMEA, Process Validation, Chromatography, Aseptic Technique, Cleaning Validation, Deviations, Protein Purification, Filtration, Trackwise, ISO 13485, cGMP manufacturing, Lean Manufacturing, Lean Operations, Lean Management, 21 CFR Part 11, GLP, SOP
Education
University of Colorado 1996 — 2000
BA, Biochemistry & Molecular Biology
Justin Neway, Ph.D. Justin Neway, Ph.D.'s Baxter Hemoglobin Therapeutics Experience July 1990 - February 1997
Job VP & General Manager, Process Production Operations, Dassault Systèmes BIOVIA, and Senior Fellow, BIOVIA Science Council
Industry Pharmaceuticals
Experience
Dassault Systèmes April 2014 - Present
Accelrys, Inc October 2012 - April 2014
Aegis Analytical Corporation February 1997 - October 2012
Baxter Hemoglobin Therapeutics July 1990 - February 1997
Novartis Vaccines and Diagnostics November 1986 - July 1990
Wyeth Biosciences December 1982 - November 1986
Skills
Biotechnology, Manufacturing, FDA, Data Analysis, Technology Transfer, Science, Biopharmaceuticals, Pharmaceuticals, GMP, Pharmaceutical Industry, Lifesciences, 21 CFR Part 11, Validation, Process Simulation, Launching Start-ups, Venture Capital, Business Development, Intellectual Property, Public Speaking, Marketing Communications, Global Business..., Strategic Leadership, Cross-functional Team..., Product Marketing, Process Development, Patents, cGMP, Life Sciences, Microbiology, Purification, Chromatography, Operational Excellence, Technical Presentations, Technical Leadership, Strategic Thinking, Biotechnology Industry, Fermentation Process..., Upstream Processing, Downstream Processing
Education
The Aji Network 1995 — 1997
BPC, Business Professionals Course
University of Illinois at Urbana-Champaign 1979 — 1982
Ph.D., Biochemistry
University of Calgary 1975 — 1977
M.Sc., Biochemistry
University of Calgary 1971 — 1975
B.Sc., Microbiology
Bishop Grandin High School 1970 — 1971
Pretoria Boys High School (PBHS) 1966 — 1969
Dassault Systèmes April 2014 - Present
Accelrys, Inc October 2012 - April 2014
Aegis Analytical Corporation February 1997 - October 2012
Baxter Hemoglobin Therapeutics July 1990 - February 1997
Novartis Vaccines and Diagnostics November 1986 - July 1990
Wyeth Biosciences December 1982 - November 1986
Skills
Biotechnology, Manufacturing, FDA, Data Analysis, Technology Transfer, Science, Biopharmaceuticals, Pharmaceuticals, GMP, Pharmaceutical Industry, Lifesciences, 21 CFR Part 11, Validation, Process Simulation, Launching Start-ups, Venture Capital, Business Development, Intellectual Property, Public Speaking, Marketing Communications, Global Business..., Strategic Leadership, Cross-functional Team..., Product Marketing, Process Development, Patents, cGMP, Life Sciences, Microbiology, Purification, Chromatography, Operational Excellence, Technical Presentations, Technical Leadership, Strategic Thinking, Biotechnology Industry, Fermentation Process..., Upstream Processing, Downstream Processing
Education
The Aji Network 1995 — 1997
BPC, Business Professionals Course
University of Illinois at Urbana-Champaign 1979 — 1982
Ph.D., Biochemistry
University of Calgary 1975 — 1977
M.Sc., Biochemistry
University of Calgary 1971 — 1975
B.Sc., Microbiology
Bishop Grandin High School 1970 — 1971
Pretoria Boys High School (PBHS) 1966 — 1969
Patricia Rustanius Patricia Rustanius's Baxter Hemoglobin Therapeutics Experience August 1990 - January 2001
Job Principal Contractor at Columbine Quality Consulting, LLC
Industry Biotechnology
Experience
Columbine Quality Consulting, LLC August 2014 - Present
N30 Pharmaceuticals June 2008 - July 2014
Agilent Technologies July 2002 - June 2008
Proligo, Inc. January 2001 - July 2002
Baxter Hemoglobin Therapeutics August 1990 - January 2001
Skills
GMP, Biopharmaceuticals, Pharmaceutical Industry, Validation, FDA, Biotechnology, CAPA, GLP, Drug Development, Regulatory Submissions, Quality Control, Lifesciences, Cleaning Validation, Regulatory Affairs, GCP, HPLC, Quality Assurance, LIMS, V&V, Quality System, Aseptic Processing, Change Control, GxP, 21 CFR Part 11, Regulatory Requirements, IND, Technology Transfer, SOP, Chemistry, Chromatography, Manufacturing, Project Management, Testing, Management, Cell, Analytical Chemistry, Medical Devices, R&D, Clinical Trials, Clinical Research, Purification, Drug Discovery, Microbiology, Clinical Development, Life Sciences
Education
Colorado State University
Master of Science (M.S.), Agricultural Biotech
Washington State University
Bachelor of Science (B.S.), Biology/Biological Sciences, General
Columbine Quality Consulting, LLC August 2014 - Present
N30 Pharmaceuticals June 2008 - July 2014
Agilent Technologies July 2002 - June 2008
Proligo, Inc. January 2001 - July 2002
Baxter Hemoglobin Therapeutics August 1990 - January 2001
Skills
GMP, Biopharmaceuticals, Pharmaceutical Industry, Validation, FDA, Biotechnology, CAPA, GLP, Drug Development, Regulatory Submissions, Quality Control, Lifesciences, Cleaning Validation, Regulatory Affairs, GCP, HPLC, Quality Assurance, LIMS, V&V, Quality System, Aseptic Processing, Change Control, GxP, 21 CFR Part 11, Regulatory Requirements, IND, Technology Transfer, SOP, Chemistry, Chromatography, Manufacturing, Project Management, Testing, Management, Cell, Analytical Chemistry, Medical Devices, R&D, Clinical Trials, Clinical Research, Purification, Drug Discovery, Microbiology, Clinical Development, Life Sciences
Education
Colorado State University
Master of Science (M.S.), Agricultural Biotech
Washington State University
Bachelor of Science (B.S.), Biology/Biological Sciences, General
Angie Nunn Angie Nunn's Baxter Hemoglobin Therapeutics Experience 1997 - 2003
Job Product Quality QC Manager at Amgen
Industry Biotechnology
Experience
Amgen September 2013 - Present
Amgen September 2003 - September 2013
Baxter/Somatogen October 1997 - September 2003
Baxter 1997 - 2003
Baxter Hemoglobin Therapeutics 1997 - 2003
Baxter International/Baxter Hemoglobin Therapeutics 1997 - 2003
Skills
LIMS, Biotechnology, GMP, Quality Control, Quality Assurance, Chromatography, CAPA, Purification, Cell Culture, Regulatory Affairs, Quality Auditing, Six Sigma, Management, Project Management, Regulatory Inspections, Data Mining, Customer Relations, Staff Development, Program Development, FDA, SOP, Validation, Sop
Education
Northeastern University 2011 — 2014
Master's degree, Regulatory Affairs for Drugs, Biologics, and Medical Devices
University of Colorado Boulder 1992 — 1997
BA, Environmental, Population, and Organismic Biology
Project Management Institute
PMP, certified Project Management Professional
Amgen September 2013 - Present
Amgen September 2003 - September 2013
Baxter/Somatogen October 1997 - September 2003
Baxter 1997 - 2003
Baxter Hemoglobin Therapeutics 1997 - 2003
Baxter International/Baxter Hemoglobin Therapeutics 1997 - 2003
Skills
LIMS, Biotechnology, GMP, Quality Control, Quality Assurance, Chromatography, CAPA, Purification, Cell Culture, Regulatory Affairs, Quality Auditing, Six Sigma, Management, Project Management, Regulatory Inspections, Data Mining, Customer Relations, Staff Development, Program Development, FDA, SOP, Validation, Sop
Education
Northeastern University 2011 — 2014
Master's degree, Regulatory Affairs for Drugs, Biologics, and Medical Devices
University of Colorado Boulder 1992 — 1997
BA, Environmental, Population, and Organismic Biology
Project Management Institute
PMP, certified Project Management Professional
Andrew Lowell's Baxter Hemoglobin Therapeutics Experience December 2001 - January 2004
Job Associate Director at KBI Biopharma
Industry Biotechnology
Experience
KBI Biopharma September 2015 - Present
National Renewable Energy Laboratory (NREL) September 2007 - September 2015
Insmed, Inc. July 2004 - March 2007
Baxter Hemoglobin Therapeutics December 2001 - January 2004
Leprino Foods July 2001 - December 2001
Lonza January 1999 - July 2001
Skills
Fermentation, Process Simulation, Microbiology, Technology Transfer, Protein Purification, Brewing, Chromatography, Pharmaceutical Industry
Education
University of New Hampshire 1997 — 2001
BS, Microbiology
KBI Biopharma September 2015 - Present
National Renewable Energy Laboratory (NREL) September 2007 - September 2015
Insmed, Inc. July 2004 - March 2007
Baxter Hemoglobin Therapeutics December 2001 - January 2004
Leprino Foods July 2001 - December 2001
Lonza January 1999 - July 2001
Skills
Fermentation, Process Simulation, Microbiology, Technology Transfer, Protein Purification, Brewing, Chromatography, Pharmaceutical Industry
Education
University of New Hampshire 1997 — 2001
BS, Microbiology
Jeanette Leach's Baxter Hemoglobin Therapeutics Experience February 1993 - December 2003
Job Independent Biotech Consultant
Industry Biotechnology
Experience
Independent Biotech Consultant January 2010 - Present
Alder Biopharmaceuticals January 2008 - December 2009
Scios, Johnson & Johnson August 2004 - December 2007
Baxter Hemoglobin Therapeutics February 1993 - December 2003
Syntex 1990 - February 1993
Panlabs 1983 - 1990
Skills
Process Development, cGMP, Product Development, CMC, SPC, Process Transfer, Process Scaleup, Fermentation, Process Validation, Project Management, Start-ups, Technical Transfer, Upstream & Downstream..., Experimental Design, Phase I/II/III and..., Technology Transfer, GMP, Process Simulation, Biopharmaceuticals, V&V, Biotechnology, Assay Development, Monoclonal Antibodies, Protein Purification, Lifesciences, Protein Chemistry, Chromatography, GLP, FDA, Validation, Pharmaceutical Industry, Life Sciences
Education
Cornell University
PhD, Plant Pathology with minors in Biochemistry and Genetics
Oregon State University
BSc, Botany
Independent Biotech Consultant January 2010 - Present
Alder Biopharmaceuticals January 2008 - December 2009
Scios, Johnson & Johnson August 2004 - December 2007
Baxter Hemoglobin Therapeutics February 1993 - December 2003
Syntex 1990 - February 1993
Panlabs 1983 - 1990
Skills
Process Development, cGMP, Product Development, CMC, SPC, Process Transfer, Process Scaleup, Fermentation, Process Validation, Project Management, Start-ups, Technical Transfer, Upstream & Downstream..., Experimental Design, Phase I/II/III and..., Technology Transfer, GMP, Process Simulation, Biopharmaceuticals, V&V, Biotechnology, Assay Development, Monoclonal Antibodies, Protein Purification, Lifesciences, Protein Chemistry, Chromatography, GLP, FDA, Validation, Pharmaceutical Industry, Life Sciences
Education
Cornell University
PhD, Plant Pathology with minors in Biochemistry and Genetics
Oregon State University
BSc, Botany
Kalli Anderson's Baxter Hemoglobin Therapeutics Experience 2000 - 2004
Job Quality Assurance Manager at BDC Laboratories
Industry Medical Devices
Experience
BDC Laboratories August 2014 - Present
Dohmen Life Science Services (Formally Reglera) April 2011 - August 2014
Anacor Compliance Services, Inc May 2010 - April 2011
Cochlear May 2008 - April 2010
Insmed Therapeutic Proteins April 2006 - April 2008
Sirna Therapeutics, Inc. February 2004 - April 2006
Baxter Hemoglobin Therapeutics 2000 - 2004
Skills
Quality Assurance, Quality System, V&V, Validation, Pharmaceutical Industry, GMP, Biotechnology, Quality Control, SOP, Manufacturing, Medical Devices, FDA, ISO 13485, Quality Management, Change Control, CAPA
Education
Colorado Mesa University 1996 — 2000
Bachelor of Science, Biology, Chemistry, Molecular Genetics
BDC Laboratories August 2014 - Present
Dohmen Life Science Services (Formally Reglera) April 2011 - August 2014
Anacor Compliance Services, Inc May 2010 - April 2011
Cochlear May 2008 - April 2010
Insmed Therapeutic Proteins April 2006 - April 2008
Sirna Therapeutics, Inc. February 2004 - April 2006
Baxter Hemoglobin Therapeutics 2000 - 2004
Skills
Quality Assurance, Quality System, V&V, Validation, Pharmaceutical Industry, GMP, Biotechnology, Quality Control, SOP, Manufacturing, Medical Devices, FDA, ISO 13485, Quality Management, Change Control, CAPA
Education
Colorado Mesa University 1996 — 2000
Bachelor of Science, Biology, Chemistry, Molecular Genetics
Rose Lopez's Baxter Hemoglobin Therapeutics Experience 2000 - 2003
Job Sr. Director of Quality and GMP Operations at Neumedicines Inc.
Industry Biotechnology
Experience
Neumedicines Inc. April 2014 - Present
Merck September 2009 - December 2013
RMC Pharmaceutical Solutions February 2008 - July 2009
Amgen 2004 - 2007
Baxter Hemoglobin Therapeutics 2000 - 2003
SCIREX Corporation 1997 - 2000
Geneva Pharmaceuticals 1995 - 1997
Colorado State University 1994 - 1994
Skills
GMP, Biotechnology, Quality Management, Technology Transfer, Compliance, Operational Excellence, Operations Management, FDA, Quality System, V&V, Quality Assurance, Commercialization, 21 CFR Part 11, CAPA, Biotechnology Industry, Pharmaceutical Industry, Change Control, Sop, GLP, Regulatory Affairs, Aseptic Processing, Quality Auditing, Computer System..., Regulatory Submissions, Clinical Development, Lifesciences, SOP, Life Sciences
Education
Colorado State University 1986 — 1989
Bachelor of Science (BS), Biological Sciences
Neumedicines Inc. April 2014 - Present
Merck September 2009 - December 2013
RMC Pharmaceutical Solutions February 2008 - July 2009
Amgen 2004 - 2007
Baxter Hemoglobin Therapeutics 2000 - 2003
SCIREX Corporation 1997 - 2000
Geneva Pharmaceuticals 1995 - 1997
Colorado State University 1994 - 1994
Skills
GMP, Biotechnology, Quality Management, Technology Transfer, Compliance, Operational Excellence, Operations Management, FDA, Quality System, V&V, Quality Assurance, Commercialization, 21 CFR Part 11, CAPA, Biotechnology Industry, Pharmaceutical Industry, Change Control, Sop, GLP, Regulatory Affairs, Aseptic Processing, Quality Auditing, Computer System..., Regulatory Submissions, Clinical Development, Lifesciences, SOP, Life Sciences
Education
Colorado State University 1986 — 1989
Bachelor of Science (BS), Biological Sciences
Doug Looker's Baxter Hemoglobin Therapeutics Experience 1997 - 2003
Job Large and Small Molecule CMC and Preclinical at Independent Consultant
Industry Pharmaceuticals
Experience
Large and Small Molecule CMC and Preclinical August 2014 - Present
N30 Pharmaceuticals July 2007 - July 2014
Regulatory, CMC and Pharmacology 2006 - 2007
Sanford Rose and Associates, Executive Search 2004 - 2006
Baxter 2003 - 2004
Baxter Hemoglobin Therapeutics 1997 - 2003
Somatogen, Inc - 1987 - 1997
Skills
Infectious Diseases, Pharmaceuticals, Biotechnology, GMP, R&D, Pharmaceutical Industry, FDA, Clinical Development, Life Sciences, Technology Transfer, Biopharmaceuticals, IND, Formulation, Drug Discovery, Molecular Biology, Drug Development, Clinical Trials, Protein Chemistry, Lifesciences, Cell Culture, GLP, Validation, Protein Expression, Microbiology
Education
Saint Louis University School of Medicine
Doctor of Philosophy (Ph.D.)
Large and Small Molecule CMC and Preclinical August 2014 - Present
N30 Pharmaceuticals July 2007 - July 2014
Regulatory, CMC and Pharmacology 2006 - 2007
Sanford Rose and Associates, Executive Search 2004 - 2006
Baxter 2003 - 2004
Baxter Hemoglobin Therapeutics 1997 - 2003
Somatogen, Inc - 1987 - 1997
Skills
Infectious Diseases, Pharmaceuticals, Biotechnology, GMP, R&D, Pharmaceutical Industry, FDA, Clinical Development, Life Sciences, Technology Transfer, Biopharmaceuticals, IND, Formulation, Drug Discovery, Molecular Biology, Drug Development, Clinical Trials, Protein Chemistry, Lifesciences, Cell Culture, GLP, Validation, Protein Expression, Microbiology
Education
Saint Louis University School of Medicine
Doctor of Philosophy (Ph.D.)
Michele Surey's Baxter Hemoglobin Therapeutics Experience 1988 - 2003
Job Law Firm Manager
Industry Management Consulting
Experience
Baxter Hemoglobin Therapeutics 1988 - 2003
Education
University of Colorado Denver 2006 — 2007
Business Administration
University of Colorado Boulder 2001 — 2005
BA, Humanities
Baxter Hemoglobin Therapeutics 1988 - 2003
Education
University of Colorado Denver 2006 — 2007
Business Administration
University of Colorado Boulder 2001 — 2005
BA, Humanities
Carolyn Jacobs's Baxter Hemoglobin Therapeutics Experience 2001 - 2003
Job Owner at GMP by CynJay, LLC
Industry Biotechnology
Experience
GMP by CynJay, LLC January 2013 - Present
VRL Laboratories April 2011 - January 2013
LABS, Inc January 2009 - April 2011
LABS, Inc. January 2004 - January 2009
Baxter Hemoglobin Therapeutics 2001 - 2003
Gambro BCT now Terumo BCT April 1992 - April 2001
Skills
FDA, GMP, Compliance, Microbiology, Quality Management, Validation, GLP, Laboratory, Design Control, R&D, Regulatory Affairs, V&V, Quality Control, Quality Auditing, Cell, Sop, Root Cause Analysis, Sterilization, Biotechnology, Infectious Diseases, Medical Devices, Quality System, ISO 13485, Quality Assurance, Hardware Diagnostics, Lifesciences
Education
Colorado State University
BS, Microbiology, Chemistry, Theatre
GMP by CynJay, LLC January 2013 - Present
VRL Laboratories April 2011 - January 2013
LABS, Inc January 2009 - April 2011
LABS, Inc. January 2004 - January 2009
Baxter Hemoglobin Therapeutics 2001 - 2003
Gambro BCT now Terumo BCT April 1992 - April 2001
Skills
FDA, GMP, Compliance, Microbiology, Quality Management, Validation, GLP, Laboratory, Design Control, R&D, Regulatory Affairs, V&V, Quality Control, Quality Auditing, Cell, Sop, Root Cause Analysis, Sterilization, Biotechnology, Infectious Diseases, Medical Devices, Quality System, ISO 13485, Quality Assurance, Hardware Diagnostics, Lifesciences
Education
Colorado State University
BS, Microbiology, Chemistry, Theatre
Tom Belval's Baxter Hemoglobin Therapeutics Experience 1998 - 2001
Job Principal Engineer at Amgen
Industry Biotechnology
Experience
Amgen PD scientistSomatogen1992 - 2002
Baxter Hemoglobin Therapeutics 1998 - 2001
Education
Rice University 1979 — 1984
Amgen PD scientistSomatogen1992 - 2002
Baxter Hemoglobin Therapeutics 1998 - 2001
Education
Rice University 1979 — 1984
Richard Mauro's Baxter Hemoglobin Therapeutics Experience March 2001 - January 2003
Job Biotechnology Professional
Industry Biotechnology
Experience
Vestas Blades A/S July 2011 - October 2012
Geotech Environmental Equipment, Inc. October 2010 - June 2011
Inverness Medical - Biostar November 2006 - June 2008
EppendorfAG-5prime, Inc. November 2005 - February 2006
Cardinal Health-Nuclear Manufacturing Services August 2004 - November 2005
Baxter Hemoglobin Therapeutics March 2001 - January 2003
Hauser Chemical Research, Inc. December 2000 - March 2001
Skills
HPLC, GMP, Validation, Chromatography, UV/Vis, Microbiology, Analytical Chemistry, ELISA, Purification, Sop, Cell Culture, Protein Chemistry, Laboratory, CAPA, Biotechnology, Quality System, Quality Assurance, ISO 13485, Life Sciences, FDA
Education
Hahnemann University of the Health Sciences 1996 — 1998
Cardiovascular Perfusion
Metropolitan State University of Denver 1992 — 1998
BS, Biology, Chemisty
Vestas Blades A/S July 2011 - October 2012
Geotech Environmental Equipment, Inc. October 2010 - June 2011
Inverness Medical - Biostar November 2006 - June 2008
EppendorfAG-5prime, Inc. November 2005 - February 2006
Cardinal Health-Nuclear Manufacturing Services August 2004 - November 2005
Baxter Hemoglobin Therapeutics March 2001 - January 2003
Hauser Chemical Research, Inc. December 2000 - March 2001
Skills
HPLC, GMP, Validation, Chromatography, UV/Vis, Microbiology, Analytical Chemistry, ELISA, Purification, Sop, Cell Culture, Protein Chemistry, Laboratory, CAPA, Biotechnology, Quality System, Quality Assurance, ISO 13485, Life Sciences, FDA
Education
Hahnemann University of the Health Sciences 1996 — 1998
Cardiovascular Perfusion
Metropolitan State University of Denver 1992 — 1998
BS, Biology, Chemisty
Antonio Neri's Baxter Hemoglobin Therapeutics Experience June 1999 - June 2000
Job Medical Epidemiologist at Centers for Disease Control and Prevention
Industry Health, Wellness and Fitness
Experience
Centers for Disease Control and Prevention January 2011 - Present
Centers for Disease Control June 2009 - December 2010
Centers for Disease Control and Prevention July 2007 - June 2009
Centers for Disease Control and Prevention July 2005 - July 2007
University of Colorado Health Sciences Center July 2004 - July 2005
Baxter Hemoglobin Therapeutics June 1999 - June 2000
United States Forest Service - Baker River Hotshots May 1998 - August 1998
Larimer County Search and Rescue 1995 - 1998
Denver Department of Public Safety May 1994 - May 1995
Alpine Rescue Team 1993 - 1995
Skills
Public Health, Epidemiology, Global Health, Prevention, Built Environment, Environmental Health, Program Evaluation, International Health, Infectious Diseases, Health Education, Disaster Response, Community Health
Education
Emory University School of Medicine 2007 — 2008
MPH, Epidemiology
Rosalind Franklin University of Medicine and Science 2000 — 2004
MD
Colorado State University 1995 — 1998
BS, Microbiology
Centers for Disease Control and Prevention January 2011 - Present
Centers for Disease Control June 2009 - December 2010
Centers for Disease Control and Prevention July 2007 - June 2009
Centers for Disease Control and Prevention July 2005 - July 2007
University of Colorado Health Sciences Center July 2004 - July 2005
Baxter Hemoglobin Therapeutics June 1999 - June 2000
United States Forest Service - Baker River Hotshots May 1998 - August 1998
Larimer County Search and Rescue 1995 - 1998
Denver Department of Public Safety May 1994 - May 1995
Alpine Rescue Team 1993 - 1995
Skills
Public Health, Epidemiology, Global Health, Prevention, Built Environment, Environmental Health, Program Evaluation, International Health, Infectious Diseases, Health Education, Disaster Response, Community Health
Education
Emory University School of Medicine 2007 — 2008
MPH, Epidemiology
Rosalind Franklin University of Medicine and Science 2000 — 2004
MD
Colorado State University 1995 — 1998
BS, Microbiology