Grifols Therapeutics Inc.
Industry: Company
DescriptionFounded: 2004 Parent organization: Grifols Shared Services North America, Inc.
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Grifols Therapeutics Inc. Employees
Grifols Therapeutics, Inc January 2014 - Present
Grifols March 2007 - Present
Bayer Pharmaceuticals January 2002 - March 2006
Bayer Pharmaceuticals January 1998 - January 2002
Skills
PMP Certified, Change Control, Process Improvement, Cross-functional Team..., Quality Assurance, 21 CFR Part 11, PMP, Software Documentation, Quality Management, SDLC, Computer System..., Process Simulation, FDA, Management, GxP, SAP, Continuous Improvement, Sop, CAPA, GMP, Quality System, V&V, Aseptic Processing, LIMS, GLP, Validation, Regulatory Requirements, TrackWise, Biopharmaceuticals, GAMP, SOP
Education
Indiana University Bloomington 1978 — 1982
BS, Biology, General
Allegiant Health August 2015 - Present
Kedrion Melville Inc. July 2013 - August 2015
Grifols Therapeutics Inc. July 2011 - July 2013
Talecris Biotherapeutics, Inc. August 2005 - July 2011
Precision Pharma Services, Inc. May 2002 - August 2005
North Shore LIJ Health System August 1994 - May 2002
MediGene, Inc 1990 - 1994
Memorial Sloan-Kettering Cancer Center 1986 - 1990
Skills
Compliance, Regulatory Affairs, Quality Assurance, Drug Development, Biomedical Research, cGMP/cGLP, Quality Auditing, Aseptic Processing, API Manufacturing, Clinical Trials, Clinical Diagnostics, IND/PAS, Biopharmaceuticals, GMP, Validation, FDA, Laboratory, 21 CFR Part 11, Biotechnology, SOP, Quality System
Education
Mount Holyoke College 1982 — 1986
Bachelor's degree, Biology
Hofstra University School of Law 1989 — 1990
Law
Novartis Influenza Vaccines April 2013 - Present
Novartis Vaccines and Diagnostics October 2012 - April 2013
Grifols Therapeutics Inc. February 2012 - September 2012
Grifols Therapeutics Inc./Talecris Biotherapeutics 2009 - 2012
Talecris Biotherapeutics, Inc. 2007 - 2009
Talecris Biotherapeutics, Inc. 2005 - 2007
Talecris Biotherapeutics, Inc./Bayer Healthcare 2003 - 2005
Bayer HealthCare 2002 - 2003
Skills
Nucleic Acid Testing, Manual and kit based..., BSL-1, 2, & 3, Polyacrylamide gel..., Cell Culture, Viral Titrations, Nanodrop..., GXP compliance, RT-PCR on AB7300 &..., Gel Electrophoresis, RT-PCR, GMP, Sop, GxP, Quality Assurance, PCR, Change Control, Validation, LIMS, FDA, Lifesciences, Software Documentation, Assay Development, Molecular Biology, Laboratory
Education
University of North Carolina at Wilmington 1997 — 1999
Bachelor of Science (BS), Marine Biology
Grifols Therapeutics Inc April 2015 - Present
Grifols Therapeutics Inc. July 2013 - Present
Grifols, Inc. (formerly Talecris Biotherapeutics) May 2004 - April 2013
Grifols, Inc. 2000 - 2013
Bayer HealthCare 2000 - 2003
Yonkers Industries, Inc. 1989 - 1996
Skills
FDA, Pharmaceutical Industry, Biotechnology, GMP, Software Documentation, Quality Assurance, Supervisory Skills, Document Management, Validation, Regulatory Affairs, Sop, Change Control, Clinical Trials, 21 CFR Part 11, GxP, Quality Auditing, V&V, Quality System, SOP
Education
East Carolina University 1971 — 1972
Art / History
Grifols Therapeutics Inc. July 2014 - Present
Ocera Therapeutics July 2013 - June 2014
Tranzyme Pharma March 2012 - July 2013
PRA International December 2010 - March 2012
Gilead Sciences January 2008 - December 2010
Triangle/Gilead 2001 - 2010
Cato Research Ltd. 1995 - 2000
Skills
IND, Drug Development, Clinical Development, Clinical Trials, CRO, Therapeutic Areas, Protocol, Clinical Monitoring, Clinical Research, Infectious Diseases, NDA, Pharmaceutical Industry, Pharmacology, CTMS, Regulatory Submissions, Medicine, GCP, EDC, ICH-GCP, Medical Writing, Oncology, Neurology, Regulatory Affairs, Clinical Pharmacology, Medical Affairs
Education
State University of New York at Buffalo - School of Medicine & Biomedical Sciences 1978 — 1982
M.D., Medicine
Grifols Therapeutics Inc June 2011 - Present
Talecris Biotherapeutics, Inc. April 2010 - June 2011
Talecris Biotherapeutics, Inc. March 2006 - June 2010
Eli Lilly and Company 2002 - 2006
Aventis Behring October 1994 - June 2002
Mayo Clinic November 1991 - September 1994
Skills
Pharmaceutical Industry, FDA, Biotechnology, Lifesciences, Program Management, GMP, Validation, Biopharmaceuticals, Technology Transfer, Clinical Trials, Regulatory Affairs, CAPA, Change Control, Infectious Diseases, 21 CFR Part 11, Quality System, Cell Culture, Drug Development, Protein Chemistry, Drug Discovery, HPLC, Biochemistry, V&V, Vaccines, SOP
Education
University of Iowa 1985 — 1991
Ph.D, Biochemistry
University of Indianapolis 1981 — 1985
B.S., Math/Chemistry
Perry Meridian High School 1977 — 1981
Retired, Inc September 2013 - Present
Grifols Therapeutics, Inc. April 2005 - Present
Bayer Biological 2002 - 2004
Bayer Biological 1997 - 2002
Bayer Biological 1993 - 1997
Skills
Leadership Development
Education
Northwestern State University
BS, Medical Technology
Apptimize, Inc. November 2013 - Present
Perseid Therapeutics January 2013 - May 2013
Grifols Therapeutics, Inc November 2011 - September 2012
Life Technologies September 2010 - September 2011
Univ of NC at Chapel Hill and NC State Univ August 2007 - August 2010
Dr. Hamel Lab, Undergraduate Biological Chemical Engineering Lab, MIT July 2006 - August 2007
Synthetic Biology UROP, MIT June 2005 - August 2005
Skills
Cell Culture, Biotechnology, Lifesciences, Molecular Biology, In Vitro, Cell Biology, Tissue Culture, Cell, Purification, Flow Cytometry, ELISA, Gel Electrophoresis, Fermentation, PCR, Biochemistry, Biopharmaceuticals, DNA, Stem Cells, Mammalian Cell Culture, Aseptic Technique, Science, Biomedical Engineering, Aseptic Processing, Bioreactor, Immunohistochemistry, R&D, GLP, Laboratory, Centrifugation, Technology Transfer, Biomaterials, Antibodies, Protein Purification, Process Simulation, Fluorescence Microscopy, Western Blotting, FACS, Chromatography, SDS-PAGE, Protein Expression, Microscopy, High Throughput...
Education
Joint Program in Biomedical Eng. at NC State University and University of NC at Chapel Hill 2007 — 2009
Biomedical Engineering
Massachusetts Institute of Technology 2002 — 2006
BS, Chemical Engineering
Grifols Therapeutics Inc. June 2011 - Present
Grifols 2011 - Present
Bayer MaterialScience October 1990 - April 2005
BAYER CORPORATION 1990 - 2005
Skills
Biotechnology
Education
Lamar University 1991 — 1993
Masters of Engineering
United States Military Academy at West Point 1980 — 1984
BS
Grifols Therapeutics Inc. 2011 - Present
RTI International 2007 - 2010
Huntingdon Life Sciences 2003 - 2007
Huntingdon Life Sciences 2000 - 2003
Phoenix International Life Sciences 1999 - 1999
Phoenix International Life Sciences 1997 - 1999
L.A.B. Pharmacological Research International Inc 1997 - 1997
Skills
GLP, Quality Assurance, Bioanalytical, GCLP, CRO, Bioanalysis, Computer System..., 21 CFR Part 11, Sop, Pharmaceutical Industry, Mass Spectrometry, LIMS, R&D, FDA, GMP, HPLC, Chromatography, Biopharmaceuticals, Validation, Analytical Chemistry, Regulatory Submissions, Drug Development, Regulatory Affairs, Technology Transfer, Biotechnology, SOP
Education
Concordia University
B.Sc., Chemistry
Grifols Therapeutics Inc. April 2005 - Present
Smurfit-Stone July 1989 - November 2004
US Navy May 1983 - May 1989
Skills
Continuous Improvement, Process Improvement, Lean Manufacturing, Manufacturing, GMP, Commissioning, Validation, Troubleshooting, Supply Chain, Root Cause Analysis, Cross-functional Team..., Process Engineering, Customer Service, Engineering, Factory, Operations Management, Team Building, Project Management
Education
Old Dominion University
Grifols Therapeutics Inc. January 2014 - Present
Peer-reviewed Scientific Journals 2011 - Present
National Institute of Environmental Health Sciences November 2010 - January 2014
Cornell University 2004 - 2010
Cornell University 2004 - 2010
Cornell University 2002 - 2004
Cornell University 2001 - 2002
Stump Hill Farm, Exotic Animal Education Center 2001 - 2002
Skills
Protein Chemistry, Biochemistry, Protein Expression, Molecular Biology, Cell Biology, Experimental Design, Western Blotting, Protein Purification, Biotechnology, Bioinformatics, Cell Culture, Animal Nutrition, Protein Engineering, HPLC, Molecular Cloning, Process Development, Scientific Writing, Phytase, Microscopy, Microsoft Office, PowerPoint, Microsoft Excel, BPR (Batch Production..., DoE (Design of..., ELISA, HCP (host cell proteins), TFF (Tangential Flow..., Depth Filtration, Ultrafiltration, Diafiltration, Clarification, Plasma, Mentoring, Enzyme Kinetics, Immunoprecipitation, Surface Plasmon..., Recombinant DNA..., Signal Transduction, Cell Signaling, Small Molecules, Radioactive Materials, Functional Genomics, University Teaching, Oral & Written..., Large and Small Animal...
Education
Cornell University 2007 — 2011
Doctor of Philosophy (PhD), Animal Science
Cornell University 2004 — 2007
Master of Science (MS), Animal Science
Cornell University 1999 — 2003
Bachelor of Science (BS), Animal Science
Grifols Inc. June 2013 - Present
Grifols Therapeutics Inc. June 2011 - June 2013
Talecris Biotherapeutics Inc August 2010 - June 2011
Talecris Biotherapeutics Inc October 2007 - August 2010
Talecris Biotherapeutics September 2005 - October 2007
Acucote Incorporated December 1991 - September 2005
Skills
Supply Chain, Inventory Management, Logistics, 3PL, Process Improvement, Cross-functional Team..., Customer Service, SAP, Team Leadership, Logistics Management, Shipping, International Logistics, Distribution Center..., Purchasing, Leadership, Supply Chain Management, Sales, GMP, Forecasting, Sales Operations, Customs Regulations, Materials Management, Management, Six Sigma, Pricing, Operations Management, Pharmaceutical Industry
Education
Strayer University (VA) 2008 — 2012
MBA, International Business
2005 - 2008 Strayer University 2005 — 2008
Bachelor of Science, International Business Management
Strayer University 2005 — 2007
BS, International Business Management
Elon University 1994 — 2005
Bachelor of Arts, Spanish
Grifols Therapeutics Inc. October 2010 - Present
Pfizer March 2004 - January 2008
Pharmacia July 2001 - March 2004
GlaxoSmithKline 1998 - 2001
GlaxoWellcome 1995 - 1998
Burroughs Wellcome 1979 - 1995
Skills
Toxicology, GLP, Drug Discovery, Drug Metabolism, DMPK, Protocol, In Vitro, Bioanalysis
Education
Lake Superior State University
Grifols Therapeutics Inc. 2002 - Present
C.R. Bard Access Systems September 2000 - December 2001
Nature's Sunshine Products October 1996 - September 2000
Den-Mat Corporation December 1990 - September 1996
Skills
Pharmaceutics, Root Cause Analysis, Blow Molding, Product Launch, Corrugated, Automation, Testing, Project Management, Engineering, Packaging Engineering
Education
California Polytechnic State University-San Luis Obispo 1992 — 1996
BS, Industrial Technology with Packaging Minor
Ambassador College 1976 — 1979
Bachelor of Arts (B.A.)
Grifols Therapeutics, Inc March 2004 - Present
Biovail Pharmaceuticals 2001 - 2004
DES & Associates 1998 - 2000
Skills
Pharmaceutical Industry, Cross-functional Team..., Supply Chain Management, Supply Chain, Materials Management, Process Improvement, Continuous Improvement, Medical Devices, Six Sigma, Lean Manufacturing, Manufacturing, Strategic Sourcing, SAP, Production Planning, Product Launch, Operations Management, Business Process..., 21 CFR Part 11, Change Management, ERP
Education
Eastern Washington University 1980 — 1983
Bachelor of Science (BS), Business Administration, Management and Operations
EWU 1979 — 1983
Bachelor of Science (BS), Business Administration and Management, General
bioMerieux, Inc. January 2015 - Present
Grifols Therapeutics, Inc. January 2006 - January 2015
Skills
Pharmaceutical Industry, Customer Service, Biotechnology, Cross-functional Team..., Process Improvement, Research, GMP, Training, Quality Assurance, Medical Devices, CAPA, 21 CFR Part 11, SOP, Validation, Biopharmaceuticals, FDA
Education
University of North Carolina at Chapel Hill
BA, Psychology
Wake Technical Community College
Associate's degree, Industrial Pharmaceutical Technology
Grifols Therapeutics Inc. April 2006 - Present
IBM January 1996 - March 2006
Skills
Instructional Design, E-learning Development, Instructor-led Training, Internal Audit, Validation, SOP, 21 CFR Part 11, Change Control, Training, Sop, E-Learning, Software Documentation, CAPA, FDA, Management, GMP, V&V, Quality Assurance, Cross-functional Team..., Pharmaceutical Industry, Process Improvement, Biotechnology
Education
SUNY Cortland 1992 — 1995
Master of Science (M.S.), Health Education
Elmira College 1980 — 1984
Bachelor of Science (B.S.), Criminal Justice
Grifols Therapeutics Inc June 2011 - Present
Talecris Biotheratpeutics August 2005 - June 2011
Bayer HealthCare 2001 - 2005
Skills
Production Planning, SAP, Vendor Management, GMP, Management, MS Project, Pharmaceutical Industry, Sop, Cross-functional Team..., Supply Chain, Sales Plan, Logistics
Education
NCSU 1985 — 1989
Biochemistry
North Carolina State University 1985 — 1989
BS, Biochemistry
Grifols Therapeutics Inc 1993 - Present
Skills
Cleaning Validation, CAPA, GMP, V&V, FDA, Change Control
Education
University of Kentucky 1984 — 1992
Ph.D., Microbiology
Pennsylvania State University 1984 — 1987
Microbiology, General
Grifols Therapeutics, Inc. February 1998 - Present
Education
Duke University
Master's, Immunohematology
Grifols Therapeutics Inc September 2014 - Present
Grifols Therapeutics Inc April 2013 - August 2014
Grifols, Inc/ Talecris June 2012 - April 2013
Talecris Biotherapeutics, Inc. 2007 - 2012
Talecris Biotherapeutics, Inc. 2002 - 2007
Bayer/Talecris 1999 - 2002
Education
New Jersey Institute of Technology 1994 — 1995
MS, Chemical Engineering
Regional Engineering College, Rourkela, Orissa, India 1985 — 1989
Chemical Engineering
Pfeiffer University
Master of Business Administration (MBA)
Grifols Therapeutics, Inc. February 2008 - Present
Ethicon/Ortho-Clinical Diagnostics (Johnson & Johnson) 1987 - 2007
Education
North Carolina State University
Ph.D., Biomathematics
Grifols Therapeutics, Inc. November 2012 - Present
Biosurgery U.S February 2007 - November 2012
Boehringer Ingelheim Pharmaceuticals, Inc April 2003 - February 2007
Ventiv Health, Bayer Contract May 2001 - March 2003
Promoware, Inc June 1994 - June 2001
Connaught Laboratories, Inc November 1991 - June 1994
American Cyanamid Co June 1989 - July 1991
Skills
Urology, Nephrology, Rheumatology, Pharmaceutical Sales, Cardiology, Buy & Bill, Neurology, Pulmonology, Oncology, Managed Care, Pharmaceutical Industry, Sales Effectiveness, Hypertension, Orthopedic, ENT, Biotechnology, Medical Devices, Selling, Gastroenterology, Endocrinology
Education
University of Illinois at Urbana-Champaign 1985 — 1989
B.S., Agricultural Economics
Grifols Therapeutics, Inc. October 2006 - Present
Athersys 2003 - 2006
GlaxoSmithKline 1990 - 2003
Skills
Drug Discovery, Biotechnology, GLP, Oncology, Lifesciences, Pharmaceutical Industry, Biopharmaceuticals, Pharmacology, Technology Transfer, In Vitro, Assay Development, Protein Chemistry, In Vivo, Drug Development, Clinical Development, ELISA, Life Sciences, Validation, HPLC, Immunology, Infectious Diseases, Immunoassays, Cell, CRO, IND, Purification, High Throughput..., Chromatography
Education
Case Western Reserve University 1984 — 1990
PhD, Physiology and Biophysics
Grifols Therapeutics Inc. December 2009 - Present
Talecris Biotherapeutics, Inc. May 2007 - December 2009
Skills
GMP, CAPA, Trackwise, FDA, Aseptic Processing
Education
Longwood University 1982 — 1986
B.S., Biological Sciences
School name:
Kedrion Melville, Inc. July 2013 - July 2015
Grifols Therapeutics Inc. April 2005 - July 2013
Precision Pharma Services, Inc February 2004 - April 2005
ALK-Abello, Inc (formerly Center Laboratories, Inc January 2000 - February 2004
Center Laboratories, Inc August 1995 - January 2000
Del Laboratories, Inc April 1993 - August 1995
Altana, Inc April 1990 - March 1993
Ayerst Laboratories and Lederle Laboratories June 1983 - April 1990
University Position January 1978 - January 1983
Skills
GMP, Regulatory Affairs, FDA, Quality System, Pharmaceutical Industry, Sop, Technology Transfer, Regulatory Requirements, 21 CFR Part 11
Education
Saint Bonaventure University
Bachelors of Science
University of Massachusetts
Master of Science, Microbiology
Grifols Therapeutics Inc. January 2011 - Present
GlaxoSmithKline April 1999 - August 2010
GlaxoSmithKline August 1994 - March 1999
GlaxoSmithKline May 1989 - July 1994
Skills
Sales, Sales Operations, Pharmaceutical Sales, Pharmaceutical Industry, Urology, Business Planning, Marketing, Cardiology, Selling, Strategic Planning, Training, Pulmonology, Management, Diabetes, Hospitals, Endocrinology, Hospital Sales
Education
University of Jamestown 1981 — 1982
BA, Business Administration
Grifols Therapeutics Inc. June 2011 - Present
Talecris Biotherapeutics, Inc. April 2005 - May 2011
Bayer HealthCare 2002 - 2005
Skills
Program Management, Pharmaceutical Industry, Validation, Biotechnology, GMP, Biopharmaceuticals, Lifesciences, Sop, FDA, Change Control, Technology Transfer
Education
University of California, Berkeley 1990 — 1991
University of Maryland College Park 1975 — 1979
BS, Zoology
Grifols Therapeutics, Inc. January 2015 - Present
Grifols Therapeutics, Inc. August 2011 - Present
Grifols April 2008 - Present
Talecris Biotherapeutics January 2000 - April 2008
Bayer HealthCare January 1994 - January 2000
Miles Laboratories January 1983 - January 1994
Cutter Laboratories January 1978 - January 1983
Skills
Quality System, Validation, GMP, Manufacturing, FDA, Regulatory Affairs, Aseptic Processing, Software Documentation, Change Control, Biotechnology, GxP, Pharmaceutical Industry, Drug Development, Management, SDLC, Analytical Skills, CAPA, 21 CFR Part 11, Biochemistry, Biopharmaceuticals, Failure Analysis, V&V, FDA GMP
Education
Barton College
BS, Business
Grifols Therapeutics, Inc. February 2001 - Present
Skills
Validation, GMP, Pharmaceutical Industry, CAPA, Change Control, Troubleshooting, Sop, SOP, Quality System, 21 CFR Part 11, Aseptic Processing, FDA, Root Cause Analysis, Construction Management, GAMP, Quality Assurance, Process Simulation, Biotechnology, V&V, Technology Transfer, Software Documentation, Contract Negotiation, Filtration, Manufacturing, Purification, Project Planning, Cross-functional Team..., Project Engineering, GLP, Biopharmaceuticals, Construction, Lean Manufacturing
Education
East Carolina University
BS, Industrial Technology - Construction Manangement
Grifols Therapeutics Inc. December 2005 - Present
Skills
Strategic Planning, Software Project..., Contract Negotiation, Microsoft Word, Microsoft Excel, GMP, Operations Management, Process Improvement, Cross-functional Team..., Customer Service, Coaching, Negotiation, Account Management, Healthcare, Research, Microsoft Office, Team Building, Pharmaceutical Industry, Regulatory Affairs, Project Management, PowerPoint, New Business Development, Hospitals, Medical Devices, Environmental..., LAL, ISI Toolbox, Immunogenicity, Government Pricing, Process Transfer, Depth Filtration, Speaker Programs, Waste Management
Education
Northwestern University 1983 — 1987
Bachelor of Science (BS), Chemical Engineering
Grifols Therapeutics, Inc. March 1996 - Present
Education
Mount Olive College 1990 — 1995
BS, Recreation & Leisure Studies
Grifols Therapeutics Inc. March 2013 - Present
Grifols May 2002 - March 2013
Talecris Biotherapeutics December 2002 - June 2011
Skills
CAPA, 21 CFR Part 11, Biopharmaceuticals, GMP, FDA, GLP, Change Control, Validation, Aseptic Processing, V&V, GxP, Technology Transfer, Sop, Quality System, Regulatory Affairs
Education
Elizabethtown College 1969 — 1973
BS/BA, Biology/Chemistry
Hershey Medical Center, Pennsylvania State University
MS, Microbiology