Diosynth Biotechnology
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Diosynth Biotechnology Employees
Eli Lilly and Company May 2006 - Present
KBI BioPharma, Inc. 2005 - 2006
Tanox 2004 - 2005
Diosynth Biotechnology 2001 - 2004
Covance Biotechnology 1999 - 2001
Scios, Inc. 1996 - 1999
California Biotechnology 1988 - 1996
Education
Marquette University 1983 — 1987
BS, Biomedical Engineering
Catalent Pharma Solutions August 2014 - Present
bioMerieux September 2011 - March 2014
bioMerieux October 2010 - September 2011
Biogen Idec July 2007 - October 2010
Amgen September 2003 - June 2007
Diosynth Biotechnology 1999 - 2003
Skills
CAPA, cGMP, Process Validation, FDA, GMP, 21 CFR Part 11, Aseptic Processing, Biopharmaceuticals, Biotechnology, Change Control, Chromatography, Continuous Improvement, Cross-functional Team..., GLP, GxP, Leadership, Lifesciences, Management, Manufacturing, Medical Devices, Pharmaceutical Industry, Quality Assurance, Quality Auditing, Quality Control, Quality System, Regulatory Affairs, SOP, Sop, Technology Transfer, V, Vaccines, Validation, Life Sciences
Education
Campbell University 2000 — 2002
MBA, Business
North Carolina State University
BS, Pre Medical
KBI Biopharma, Inc. June 2007 - Present
Diosynth Biotechnology July 2001 - June 2007
Diosynth RTP, Inc. 1998 - July 2001
Bristol Myers Squibb Diagnostics (now Bracco Diagnostics) 1987 - 1994
Pfizer 1979 - 1986
Skills
Employee Relations, Policy, Compliance, Coaching, Start-ups, Compensation, Performance Management, Employee Benefits, Talent Acquisition, HRIS, Benefits Administration, Interviewing, HR Policies, Strategic Planning, Management, Recruiting, Deferred Compensation, Program Management, Human Resources, Interviews, GMP, Biotechnology, Workforce Planning, Pharmaceutical Industry
Education
Caldwell University
BA, Sociology
KBI Biopharma, Inc. May 2004 - Present
Diosynth Biotechnology 1999 - 2004
North American Vaccine November 1999 - July 2000
Genetic Therapy, Inc. March 1988 - November 1999
Skills
Technology Transfer, Biopharmaceuticals, Validation, Project Management, Sop, FDA, GMP, Quality Assurance, Lifesciences, Biotechnology, V&V
Education
Penn State University 1977 — 1981
B.S., Biology and Education
Merck December 2014 - Present
Merck June 2012 - December 2014
Talecris Biotherapeutics/Grifols July 2008 - June 2012
RTI International June 2009 - August 2009
Hydro Service and Supplies July 2007 - July 2008
Biolex Therapeutics January 2008 - May 2008
North Carolina State University August 2006 - May 2008
Biogen Idec September 2007 - December 2007
Diosynth Biotechnology August 2006 - December 2006
Baylor College of Medicine February 2003 - July 2006
Skills
LIMS, Cell Culture, PCR, Western Blotting, Validation, Protein Purification, ELISA, Quality Assurance, CAPA, SDS-PAGE, Affinity Chromatography, Trackwise, Agarose Gel..., Fluorescence Microscopy, Root Cause Analysis, 21 CFR Part 11, Deviation Management, Investigation Author..., Microsoft Office, DNA isolation,..., Immunoblotting, Kinetic Turbidimetric..., Microbial Bioburden..., Gene cloning and..., Animal cell culture..., Restriction Mapping, Brightfield Microscopy, Working knowledge of..., SAP, Werum PAS-X, Quality Control, cGMP practices, Environmental Monitoring, Project Management
Education
North Carolina State University 2008 — 2010
Master, Business Administration; Biosciences Management and Product Innovation Management
North Carolina State University 2006 — 2008
Master, Microbial Biotechnology
Texas A&M University 1998 — 2002
Bachelor of Science, Genetics
Parkway South High School 1994 — 1998
BioPontisAlliance for Rare Disease September 2013 - Present
BioPontis Alliance LLC June 2009 - Present
Sagacity Partners LLC February 2007 - June 2009
Diosynth Biotechnology 2004 - 2007
Hemocellular Therapeutics (name changed to Entegrion) 2002 - 2004
Bertek Phamraceuticals 2001 - 2002
Bayer Pharmaceuticals, Bayer Corporation 1984 - 2001
Skills
Biotechnology, Lifesciences, Technology Transfer, Commercialization, Pharmaceutical Industry, Product Launch, Product Development, Strategic Planning, Drug Discovery, Cross-functional Team..., Biopharmaceuticals, Strategy, Start-ups, Clinical Development, R&D, Drug Development, Mergers & Acquisitions, Infectious Diseases, Clinical Trials, Business Development, Cell, Protein Chemistry, Pharmacology, Medical Devices, Neurology, IND, Clinical Research, Corporate Development, Life Sciences
Education
Stony Brook University 1970 — 1974
BS
Diosynth Biotechnology September 2009 - Present
Performance Fibers January 2006 - February 2010
ConAgra July 2005 - January 2006
Black & Decker January 2003 - July 2005
Texas Workers' Compensation Commission January 2000 - January 2003
Texas Workers' Compensation Commission January 1990 - January 2000
HEART OF TEXAS MENTAL HEALTH MENTAL RETARDATION CENTER January 1989 - January 1990
Education
Lenoir Memorial Hospital School of Nursing R
Tarleton State University
BA, English
Biothermal LLC October 2010 - Present
Biothermal LLC 2003 - Present
Hospira 2010 - 2011
Sandoz 2009 - 2009
NNE Pharmaplan 2008 - 2008
Organon Technika 2008 - 2008
MedImmune 2007 - 2007
Valsource 2003 - 2005
Diosynth Biotechnology 2002 - 2003
Diosynth 2000 - 2003
Skills
Quality Control, Change Control, Technology Transfer, Biotechnology, CAPA, Lifesciences, Quality System, Sop, Management, Lean Manufacturing, Manufacturing, Validation, Pharmaceutical Industry, FDA, Leadership, Quality Assurance, GMP, V&V, Six Sigma, Computer System..., 21 CFR Part 11, Regulatory Affairs, GxP, ISO 13485
Education
Kennedy Western University 2004 — 2008
Bachelor of Science, Engineering: Mechanical
Biopharmaceutical Consulting April 2014 - Present
Olympus Biotech America June 2013 - August 2014
Rentschler Biotechnologie September 2011 - August 2012
Laureate Pharma October 2009 - November 2010
CARBOGEN AMCIS 2008 - 2008
Cardinal Health 2004 - 2006
BioReliance/Invitrogen May 2003 - May 2004
Diosynth Biotechnology 1999 - 2003
Life Technologies 1984 - 1999
Skills
Biotechnology, Biopharmaceuticals, Lifesciences, Technology Transfer, Pharmaceutical Industry, Commercialization, GMP, Medical Devices, Vaccines, FDA, Molecular Biology, GLP, Validation, Contract Manufacturing, Cell Culture, Clinical Development, Process Improvement, Drug Discovery, Drug Development, Regulatory Affairs, CRO, Leadership, Sop, Biochemistry, Oncology, Clinical Trials, Microbiology, Infectious Diseases, R&D, Cell, 21 CFR Part 11, Protein Chemistry, Laboratory, Genomics, Immunology, CAPA, Chromatography, ELISA, Regulatory Submissions, DNA, Biologics, Hardware Diagnostics, Assay Development, HPLC, Cell Biology, Cancer, Immunoassays, PCR, Life Sciences, SOP
Education
The Johns Hopkins University - Carey Business School 1994 — 1998
MBA
State University of New York College at Fredonia
B.S.
Tangerine Travel LTD July 2012 - Present
Ingenuity Systems September 2011 - April 2012
Central and South America 2007 - 2010
Pyxant Labs Inc. 2005 - 2007
Pyxant Labs Inc. 2005 - 2005
Diosynth Biotechnology 2001 - 2004
Skills
GMP, Validation, Software Documentation, Biotechnology, GLP, Lifesciences, Quality Assurance, FDA, Sop, HPLC, Project Management, Program Development, Project Planning, Program Management, Customer Service, Travel Management, Business Travel, Travel Planning, Account Management, Customer Retention, Sales Management, Laboratory, ELISA, Data Analysis, Biochemistry
Education
Penn State University 1998 — 2001
M.S., Biochemisty, Microbiology and Molecular Biology (BMMB)
Cornell College 1995 — 1998
BA, Biochemisty and Molecular Biology
Merck March 2012 - Present
Time Warner Cable February 2010 - March 2012
Accentuate Staffing January 2010 - June 2010
Merck & Co June 2008 - August 2009
Diosynth Biotechnology June 2007 - December 2007
United States Army Reserves August 2005 - December 2006
GlaxoSmithKline Pharmaceutical Company June 2005 - August 2005
Skills
Chemistry, Customer Service, HPLC, LC-MS, LIMS, Laboratory, Microsoft Office, NMR, Sales, Sop, GMP, Organic Chemistry, Biotechnology, GC-MS, SOP, Software Documentation
Education
North Carolina Central University 2003 — 2009
Bachelors of Science, Chemistry
MedImmune April 2011 - Present
AlphaVax 2004 - 2010
Diosynth Biotechnology 2002 - 2003
Skills
Chromatography, Protein Chemistry, Biotechnology, Technology Transfer, GMP, Biopharmaceuticals, Formulation, Analytical Chemistry, Purification, Assay Development, Vaccines, Monoclonal Antibodies, Spectroscopy, Fluorescence, Characterization, Design of Experiments, Process Simulation, Lyophilization, FTIR, Biophysics, Nanoparticles, Product Development, HPLC, Biochemistry, IND, Peptides, Protein Purification, CMC, GLP, Drug Delivery
Education
University of Colorado Boulder
PhD, Chemical Engineering
University of Illinois at Urbana-Champaign
BS, Chemical Engineering
Amgen 2011 - Present
Amgen 2006 - 2011
Amgen 2005 - 2006
Amgen 2003 - 2006
Diosynth Biotechnology 2000 - 2003
Genzyme 1994 - 2000
Skills
Biopharmaceuticals, Technology Transfer, GMP, Biotechnology, Process Simulation, V&V, Lean Manufacturing, Pharmaceutical Industry, Purification, Manufacturing, Fermentation, Process Engineering, Chromatography, Change Control, CAPA, Protein Chemistry, Biochemistry, R&D, Cell Culture, Sop, Lifesciences, Quality System, Validation, Quality Control, GLP, 21 CFR Part 11, LIMS, Drug Development, Monoclonal Antibodies, IND, Clinical Development, Life Sciences, SOP
Education
University of Minnesota-Twin Cities
Microbial Engineering/Chemical Engineering
Center for Creative Leadership
Executive Leadership Development
UCLA Anderson School of Management
Women's Leadership Institute
Fujifilm Diosynth Biotechnologies April 2009 - Present
Fujifilm Diosynth Biotechnology 2005 - Present
FUJIFILM Diosynth Biotechnologies U.S.A., Inc. 1999 - Present
Diosynth Biotechnology/ Merck 2005 - 2009
Diosynth Biotechnology October 2002 - September 2005
Diosynth Biotechnology (formerly Covance Biotechnology Services, Inc.) November 1999 - October 2002
Novartis May 1996 - December 1998
Zenith Laboratories, Inc. December 1984 - May 1996
Skills
Chromatography, Technology Transfer, HPLC, GMP, cGMP practices, UV/Vis, SOP authoring, SOP development, Quality Control, Analytical Method..., Chemstation, Gel Electrophoresis, SDS-PAGE, Analytical Methods...
Education
Gujarat University
Master of Science (M.S.), Organic Chemistry
St. Xavier's College
Bachelor of Science (B.S.), Chemistry
Fujifilm Diosynth Biotechnologies May 2006 - Present
Diosynth Biotechnology May 2003 - May 2006
Skills
Technology Transfer, Quality by Design, Project Management, Biopharmaceuticals, Chromatography, Validation, HPLC, GMP, Fermentation Process..., Biotechnology, Sop, FDA, Fermentation
Education
North Carolina State University 1993 — 1998
Ph.D., Microbiology
SUNY Fredonia 1989 — 1993
Bachelor of Science (B.S.), Biology/Biological Sciences, General
Fujifilm Diosynth Biotechnologies June 2009 - June 2014
Diosynth Biotechnology May 2007 - June 2009
Diosynth August 2004 - May 2007
Diosynth July 2001 - July 2004
Cytomedix June 1998 - July 2001
Duke University Medical Center September 1996 - August 1998
Skills
SAS JMP enthusiast, Fluent Spanish, Yellow Belt LSS, GMP, Technology Transfer, Yellow Belt, Validation, Biopharmaceuticals, Change Control, Cleaning Validation, Quality Assurance, Vaccines, LIMS, Biotechnology, Manufacturing, Quality System, Aseptic Processing, GxP, Purification, CAPA, FDA, Deviations, 21 CFR Part 11, Sop, GLP, V&V, Computer System..., Laboratory, SOP
Education
North Carolina State University - College of Management 1997 — 2000
MBA, Operations Management
Georgia State University 1994 — 1996
BS, Medical Technology
Duke University 1983 — 1987
AB, Comparative Area Studies
Advent Engineering Services, INC. September 2013 - Present
ADVENT Consulting Canada, Inc. August 2010 - September 2013
ADVENT Engineering Services, Inc. April 2010 - August 2010
Diosynth Biotechnology 2007 - 2010
ShareFile May 2007 - December 2007
IBM May 2006 - May 2007
Spirent Communications August 2005 - May 2006
Skills
Commissioning, Computer System..., Validation, PLC
Education
North Carolina State University 2003 — 2010
Bachelor of Science, Electrical Engineering, Nanotechnology, Soft Electronics
Biogen Idec August 2014 - Present
Fujifilm Diosynth Biotechnologies July 2012 - August 2014
FUJIFILM Diosynth Biotechnologies January 2010 - July 2012
Diosynth Biotechnology January 2009 - January 2010
Skills
GMP, Sop, Chromatography, Purification, CAPA, Cleaning Validation, Software Documentation, GLP
Education
Appalachian State University 2004 — 2006
Bachelor of Science, Ecology and Environmental Biology, 3.64
Sandhills Community College 2001 — 2004
Associate in Science, Science
University of North Carolina December 2008 - Present
Diosynth Biotechnology June 2008 - December 2008
GlaxoSmithKline January 2008 - June 2008
MannKind Corporation August 2005 - November 2007
Amgen June 2004 - May 2005
Skills
Cell, Assay Development, Molecular Biology, Biotechnology, Drug Discovery, PCR, ELISA, Protein Chemistry, Biochemistry, Cell Biology, High Throughput..., Western Blotting, Tissue Culture, Protein Purification, GMP, Validation, Project Management, In Vitro, Cell Based Assays, Protein Expression, Enzyme Kinetics, Purification, Enzyme Assays, Lifesciences, pro
Education
Western Carolina University 2012 — 2015
Master's degree, Project Management
Southeastern Louisiana University 2001 — 2003
MS, Biology
Southeastern Louisiana University 1994 — 2000
BS, Chemistry
Southeastern Louisiana University 1994 — 2000
BS, Biology
Biomanufacturing Training and Education Center at NC State University August 2007 - Present
Diosynth Biotechnology August 2000 - August 2007
Skills
Biotechnology, Biopharmaceuticals, GMP, HPLC, Technology Transfer, Process Optimization, Process Simulation, Pharmaceutical Industry, Downstream Processing, Lifesciences, Chemical Engineering, Sop, Validation, Cell Culture, Process Engineering, Quality Control, CAPA, FDA, V&V, Chromatography, R&D, Fermentation, GLP, Chemistry, Vaccines, Microbiology, Biochemistry, Purification, Planning & Organizing...
Education
University of Minnesota-Twin Cities 1987 — 1993
Ph.D., Chemical Engineering
North Carolina State University 1982 — 1986
BS, Chemical Engineering
Novo Nordisk A/S 2012 - Present
Novo Nordisk A/S 2010 - 2011
Diosynth Biotechnology 2008 - 2010
Diosynth Biotechnology 2006 - 2008
Celerant Consulting 2002 - 2006
Variagenics, Inc 1999 - 1999
Skills
Quality Assurance, Validation, Six Sigma, Change Control, Quality System, CAPA, Sop, GMP, Pharmaceutical Industry, Process Simulation, Testing, Manufacturing, 21 CFR Part 11, Lean Manufacturing, GxP, Biotechnology, Cross-functional Team..., Quality Control
Education
Tufts University 1997 — 2001
Bachelor of Science Engineering, Biochemistry and Engineering Science - Chemical Engineering
FUJIFILM Diosynth Biotechnologies April 2011 - Present
Merck September 2010 - April 2011
TransTech Pharma December 2009 - October 2010
Diosynth Biotechnology August 2007 - December 2009
Diosynth Biotechnology 2005 - 2007
Diosynth 2000 - September 2005
Indiana University, Medical Ctr 1996 - 1999
University of California, Irvine 1993 - 1996
Skills
Biopharmaceuticals, Biotechnology, Protein Chemistry, GMP, Microbiology, Analytical Chemistry, Formulation, In Vivo, Pharmaceutics, IND, Contract Manufacturing, Biologics, Technology Transfer, Project Management, Lifesciences, Pharmaceutical Industry, Contract Negotiation, Manufacturing, Chromatography, Purification, Drug Development, FDA, GLP, Life Sciences, Monoclonal Antibodies, Vaccines, Validation
Education
University of North Carolina at Chapel Hill - Kenan-Flagler Business School 2004 — 2006
MBA
University of California, Irvine 1993 — 1996
postdoc, biochemistry
Technical University of Wroclaw 1992 — 1992
Ph.D., Chemistry
Technical University of Wroclaw 1978 — 1983
MSc, Eng., Biotechnology/Bioorganic Chemistry
Biogen Idec July 2010 - Present
Integrated Process Technologies, Inc April 2008 - July 2010
Diosynth Biotechnology August 2006 - April 2008
Diosynth Biotechnology June 2001 - August 2006
Covance Biotechnology Services August 1999 - June 2001
Tosco Corporation 1997 - 1999
Skills
Technology Transfer, GMP, Process Equipment, Manufacturing..., Manufacturing, Troubleshooting, Problem Solving
Education
University of Michigan 1991 — 1995
BSE
Fujifilm Diosynth Biotechnologies July 2011 - Present
Catalent Pharma Solutions October 2010 - July 2011
Diosynth Biotechnology October 2000 - October 2010
Skills
Chromatography, HPLC, Protein Chemistry, Mass Spectrometry, UV/Vis, Assay Development, Fermentation, Purification, Biopharmaceuticals, Eggplant, Validation
Education
North Carolina State University 1993 — 1998
Stiefel, a GSK company January 2011 - Present
Stiefel Laboratories October 2006 - January 2011
Erimos Pharmaceuticals April 2005 - October 2006
Diosynth 2000 - 2005
Diosynth Biotechnology 2000 - 2005
Skills
Pharmaceutical Industry, Regulatory Affairs, Regulatory Submissions, FDA, Biopharmaceuticals, Drug Development, Clinical Development, GMP, Validation, Biotechnology, Technology Transfer, Sop, Change Control, GxP, CAPA, 21 CFR Part 11, Clinical Trials, GLP, CRO, GCP, Team Leadership, Strategic Planning, People Development
Education
University of North Carolina at Chapel Hill 1994 — 1997
M.S., Biological Chemistry
Southwestern University 1990 — 1994
Chemistry
Kemwell Biopharma March 2014 - Present
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company August 2009 - February 2014
Tunnell Consulting December 2007 - August 2009
Diosynth Biotechnology May 1998 - December 2007
Skills
Biopharmaceuticals, Technology Transfer, Pharmacovigilance, Clinical Development, Biotechnology, Protein Chemistry, Pharmacology, Pharmaceutical Industry, Drug Development, Protein Purification, Oncology, GMP, Clinical Trials, Biochemistry, Pharmaceutics, IND, CTMS, Vaccines, Regulatory Affairs, Sop, LIMS, CAPA, GLP, Lifesciences, Monoclonal Antibodies, Validation, Chromatography, Fermentation, R&D, Regulatory Submissions, 21 CFR Part 11, GxP, Cell Culture, FDA, Commercialization, Analytical Chemistry, Formulation, Purification, Change Control, GCP, Drug Discovery, Medical Devices, Assay Development, Clinical Research, CRO
Education
University of Connecticut 1987 — 1994
Ph.D., Pharmaceutical Sciences
Pfizer January 2008 - Present
Wyeth Biotech June 2006 - December 2007
Wyeth Biotech March 2004 - June 2006
Integrated Project Services May 2002 - March 2004
Diosynth Biotechnology December 2000 - May 2002
Skills
21 CFR Part 11, GMP, Validation, Change Control, Sop, CAPA, Aseptic Processing, FDA, Technical Writing, LIMS
Education
Temple University 2010 — 2013
MS, Quality Assurance and Regulatory Affairs
University of Phoenix 2004 — 2007
MBA
Elon University 1995 — 2000
BS, Biology
Fujifilm Diosynth Biotechnologies April 2011 - Present
Merck August 2007 - April 2011
Diosynth Biotechnology 2007 - January 2009
PDL BioPharma August 1999 - June 2007
Skills
Mammalian Cell Culture, Biopharmaceuticals, Technology Transfer, Monoclonal Antibodies, Chromatography, Bioreactor, Purification, Biotechnology, GMP, Protein Chemistry, Protein Purification, Validation, Fermentation, Team Leadership, Cell Culture, FDA GMP, Drug Discovery, Vaccines, ELISA, GLP, Downstream Processing, HPLC, Assay Development, Cell, SDS-PAGE, Biochemistry
Education
University of Maryland University College 2005 — 2007
MS, Biotechnology
Pennsylvania State University-University Park 1996 — 1999
Bachelor's degree, Biotechnology
Novartis Vaccines and Diagnostics 2012 - Present
Pfizer BioTherapeutics (formerly Wyeth Vaccines) 2004 - 2011
Diosynth Biotechnology 1999 - 2004
Education
University of North Carolina at Chapel Hill 1995 — 1999
BS, Chemistry - Biochemistry
Fukoku Life International (America) Inc. January 2012 - Present
Sembrador Capital de Riesgo SA February 2011 - July 2011
Sidoti & Company, LLC October 2006 - January 2010
Diosynth Biotechnology 2002 - 2003
Diosynth Biotechnology 1998 - 2002
Diosynth Biotechnology 1996 - 1998
Skills
Financial Modeling, Equity Research, DCF, Venture Capital, Financial Statement..., Valuation, Equities, Bloomberg, Financial Analysis, Equity Valuation, Biotechnology, Capital Markets, Securities, Portfolio Management, Investments
Education
The University of Manchester 2003 — 2004
MSc, Finance
University of North Carolina at Chapel Hill 2002 — 2003
Economics, Accounting, Finance
Virginia Polytechnic Institute and State University 1991 — 1995
BS, Chemical Engineering
Ampfuul LLC August 2015 - Present
Metabolon April 2011 - August 2015
Ampfuul LLC 2007 - April 2011
Precision BioSciences 2010 - 2011
BioPontis Alliance 2009 - 2011
Diosynth Biotechnology 2004 - 2007
Syngenta Biotechnology 2001 - 2004
Syngenta Crop Protection 1999 - 2001
Novartis (Basel, Switzerland) 1997 - 1999
Ciba-Geigy (Basel, Switzerland) 1990 - 1997
Skills
Life Sciences, Biotechnology, Technology Transfer, Pharmaceutical Industry, Commercialization, Biopharmaceuticals, Drug Discovery, Biochemistry, Molecular Biology, R&D, Leadership, Protein Chemistry, Lifesciences, Business Development, Analysis, Drug Development, Biomarkers, Cell Culture, Start-ups, Hardware Diagnostics, Chemistry, Biomarker Discovery, Toxicology, Research, Oncology, Cross-functional Team..., Clinical Development, Organic Chemistry, Cell Biology, Cell
Education
Duke University - The Fuqua School of Business 2001 — 2002
MBA, Finance, Venture
Université Louis Pasteur (Strasbourg I) 1984 — 1988
PhD, Chemistry
Université Louis Pasteur (Strasbourg I) 1979 — 1984
DEA, Biochemsitry
Université Louis Pasteur (Strasbourg I) 1979 — 1984
DEA, Biochemsitry
Lycee Albert Schweitzer
Fujifilm Diosynth Biotechnologies August 2013 - Present
Fujifilm Diosynth Biotechnologies August 2009 - Present
Diosynth Biotechnology August 2006 - 2009
Diosynth Biotechnology April 2003 - August 2006
Bayer Biological Products 1998 - 2002
Skills
Technology Transfer, Biotechnology, Contract Manufacturing, Biopharmaceuticals, Chromatography, Fermentation, Sop, Protein Chemistry, R&D, Cell, Cell Culture, V&V, Validation, Purification, Manufacturing, GMP, Protein Purification, FDA, Development Of Employees, Lifesciences, Collaborative Problem..., GLP, Customer Satisfaction, Leadership, Team Leadership, Management, Change Control, Collaboration, HPLC, Pharmaceutical Industry, Cross-functional Team...
Education
Georgia Institute of Technology 1993 — 1999
PhD, Chemical Engineering/Bioengineering
Hospira April 2013 - Present
Hospira January 2012 - April 2013
Kepner-Tregoe July 2010 - January 2012
Talecris Plasma Resources April 2008 - July 2010
i3, a UnitedHealth Group Company February 2008 - April 2008
Amgen November 2005 - October 2007
Diosynth Biotechnology February 2002 - November 2005
Wake Technical Community College and Vance Granville Community College 2001 - 2004
Medic Computer Systems 2001 - 2002
Therapy Edge 2000 - 2001
Skills
Sop, GMP, CAPA, Biotechnology, FDA, Validation, Quality System, Change Control, Pharmaceutical Industry, 21 CFR Part 11, Medical Devices, GLP, Quality Assurance, Biopharmaceuticals, Process Improvement, Employee Training, Lifesciences, Regulatory Affairs, Training, Computer System..., Quality Management, Software Documentation, Manufacturing, GxP, Regulatory Requirements, Root Cause Analysis, Aseptic Processing, LIMS, SOP, Life Sciences
Education
University of St. Francis 2003 — 2005
MS, Training and Development
University of North Carolina at Wilmington 1994 — 1997
BS, Biology
Takeda Vaccines January 2015 - Present
Takeda Vaccines June 2013 - January 2015
Amgen November 2011 - May 2013
Biolex Therapeutics October 2006 - October 2011
Diosynth Biotechnology 1998 - 2006
Bayer Biologics January 1996 - March 1998
North American Biologicals 1994 - 1996
Skills
Upstream process..., Downstream process..., Formulation process..., Cross functional..., Clinical manufacturing, CMC aspects of business..., Plasma proteins, Recombinant proteins, Process..., Post-approval process..., Novel expression systems, Disposable..., Flexible manufacturing..., Mammalian expression..., Yeast expression systems, Bacterial expression..., Regulatory filings, Contract manufacturing, Managment of..., Recruitment and..., Drug substance..., Drug product..., International business..., Intellectual property, Monoclonal antibodies, Protein fragments, Fusion protiens, Protein folding, Protein purification, Process Simulation, Protein Chemistry, Formulation, Protein Purification, Upstream, Contract Manufacturing, Monoclonal Antibodies, Manufacturing, Drug Development, Intellectual Property, Purification, Lifesciences, Biopharmaceuticals, Technology Transfer, Clinical Manufacturing, GMP, Pharmaceutical Industry, Commercialization, Cell Culture, Life Sciences, recombinant DNA...
Education
Florida Atlantic University 1989 — 1994
MS, Biology
Pfizer September 2004 - Present
Pfizer (formerly Wyeth) September 2004 - December 2010
Diosynth Biotechnology 2000 - 2004
VI Technologies (Vitex) 1997 - 2000
Skills
GMP, Chromatography, LIMS, Technology Transfer, Manufacturing, Validation, Sop, Biotechnology, CAPA, Pharmaceutical Industry, Regulatory Submissions, FDA, Microsoft Office, Vaccines, Change Control, GLP, V&V, Technical Writing, Project Management, Purification, Cleaning Validation, Biopharmaceuticals, Aseptic Processing, Computer System..., SOP
Education
Stony Brook University
Argos Therapeutics July 2014 - Present
Merck January 2010 - July 2014
BioTechLogic, Inc. November 2006 - December 2009
Diosynth Biotechnology 1998 - 2006
Apex Bioscience August 1997 - August 1998
Skills
GMP, Validation, Biopharmaceuticals, Biotechnology, Technology Transfer, FDA, SOP, Pharmaceutical Industry, CAPA, Change Control, Deviation Management
Education
North Carolina State University 1992 — 1996
BS, Chemical Engineering
Hospira September 2011 - Present
Purdue Pharma November 2010 - July 2011
Becton, Dickinson and Company July 2009 - October 2010
Amgen Rhode Island October 2005 - October 2007
Biogen Idec RTP February 2004 - September 2005
Diosynth Biotechnology July 2001 - February 2004
Covance Biotechnology September 1998 - June 2001
U.S. Navy November 1988 - August 1992
Skills
GMP, CAPA, Quality Assurance, Validation, 21 CFR Part 11, FDA, GLP, GxP, Sop, Change Control, Quality Control, LIMS, Computer System..., Aseptic Processing, V&V, SOP
Education
University of North Carolina at Charlotte 1994 — 1998
BS, Biology
Fujifilm Diosynth Biotechnologies July 2013 - Present
KBI Biopharma 2013 - 2013
Fujifilm Diosynth Biotechnologies 2012 - 2012
Diosynth Biotechnology 2007 - 2012
Diosynth Biotechnology 2005 - 2007
Diosynth Biotechnology 2004 - 2005
Diosynth Biotechnology 2000 - 2004
Covance 1999 - 2000
Bayer Pharmaceuticals 1998 - 1999
Skills
GMP, Change Control, Sop, Validation, Biopharmaceuticals, CAPA
Education
Campbell University 1994 — 1998
FUJIFILM Diosynth Biotechnologies August 2014 - Present
FUJIFILM Diosynth Biotechnologies February 2014 - August 2014
Fujifilm Diosynth Biotechnologies November 2012 - February 2014
Fujifilm Diosynth Biotechnologies November 2011 - November 2012
Diosynth Biotechnology November 2007 - October 2011
Talecris Biotherapeutics August 2006 - October 2007
Diosynth January 2002 - August 2006
Covance May 1999 - December 2002
Education
North Carolina State University 1994 — 1998
Bachelor of Science (BS), Food Science and Technology
Fujifilm Diosynth Biotechnologies April 2011 - Present
Merck March 2009 - April 2011
Diosynth Biotechnology 2001 - 2008
Duke University April 1997 - May 2001
Skills
Technology Transfer, Purification, Chromatography, Biopharmaceuticals, Validation, GMP, Protein Chemistry, Processes Development, Biotechnology, Regulatory Submissions, Fermentation, GLP, Monoclonal Antibodies, HPLC, Protein Purification, Assay Development, recombinant DNA..., Vaccines, SDS-PAGE, ELISA
Education
North Carolina State University 1991 — 1997
PhD
GlaxoSmithKline April 2007 - Present
Diosynth Biotechnology January 2002 - March 2007
Education
University of North Carolina at Chapel Hill 1997 — 2001
1995 — 1996
MS, Catalysis and Biocatalysis
1990 — 1995
B.S., Chemistry
Biogen Idec November 2003 - Present
Diosynth Biotechnology 2001 - 2003
Roche Diagnostics 2000 - 2001
Education
University of California, Davis 1994 — 1999
inVentiv Health Clinical April 2015 - Present
Quintiles November 2014 - April 2015
Quintiles February 2012 - April 2014
Quintiles May 2009 - February 2012
Copernicus Group 2006 - 2007
Copernicus Group IRB 2006 - 2007
Diosynth Biotechnology 2001 - 2006
Skills
Clinical Trials, Pharmaceutical Industry, IRB, FDA, SOP, Biotechnology, CRO, Clinical Research, CTMS, ICH-GCP, EDC, GCP, Regulatory Affairs, GMP, Regulatory Submissions, Biopharmaceuticals, Validation, Clinical Development
Education
North Carolina State University 1996 — 2000
Bachelor of Science (B.S.), Zoology/Animal Biology
Adaptimmune December 2014 - Present
MGReg Consulting, LLC November 2012 - Present
Savant HWP 2012 - 2013
CROfessionals October 2011 - November 2012
MedImmune September 2009 - September 2011
Argos Therapeutics July 2007 - July 2009
Stiefel Laboratories 2006 - 2007
Erimos Pharmaceuticals LLC, Raleigh, NC 2004 - 2006
Diosynth Biotechnology 1996 - 2004
University of North Carolina at Chapel Hill July 1993 - October 1996
Skills
Biotechnology, Regulatory Affairs, Technology Transfer, Pharmaceutical Industry, GMP, Regulatory Submissions, FDA, Clinical Development, Lifesciences, IND, Biopharmaceuticals, Sop
Education
University of Notre Dame 1979 — 1983
BS, Biochemistry
West Virginia University 1983 — 1987
Doctor of Philosophy (PhD), Pharmacology and Toxicology
Sutro Biopharma, Inc. September 2011 - Present
Itero Biopharmaceticals May 2008 - September 2011
Nuvelo, Inc January 2002 - March 2008
Diosynth Biotechnology June 2001 - December 2001
Covance July 1996 - December 2001
Khepri Pharmaceuticals 1993 - 1996
Genentech December 1990 - July 1993
Genencor International September 1984 - December 1990
Genentech January 1982 - September 1984
Skills
Protein Chemistry, Biochemistry, Biotechnology, Purification, Technology Transfer, Biopharmaceuticals, Chromatography, Process Simulation, Drug Discovery, Cell Culture, Pharmaceutical Industry, GMP, Antibodies, Assay Development, Protein Purification, ELISA, Monoclonal Antibodies, GLP, Lifesciences, Life Sciences
Education
Kansas State University 1979 — 1981
MS, Biochemistry
Bethany College 1973 — 1977
BS, Biology and chemistry
bioAD solutions January 2015 - Present
Bluestream Labs April 2014 - November 2014
AVEO Pharmaceuticals September 2011 - April 2014
Shire HGT December 2006 - March 2012
Diosynth Biotechnology 2000 - 2006
Wyeth Vaccines September 1997 - April 2000
NIEHS August 1995 - August 1997
NIH/NIEHS 1995 - 1997
Skills
HPLC, Protein Chemistry, GMP, Analytical Chemistry, LC-MS, ELISA, Technology Transfer, Mass Spectrometry, Validation, SDS-PAGE, Assay Development, Biopharmaceuticals, Immunoassays, Biotechnology, Monoclonal Antibodies, Drug Development, Formulation, Antibodies, V&V, Vaccines, IND, Analytical Methods...
Education
Marquette University
Ph.D., Analytical -Biophysical Chemistry
University of Jaffna
Bachelor of Science (BSc), Chemistry
University of Jaffna
University of Jaffna
KBI Biopharma June 2014 - Present
KBI Biopharma November 2011 - June 2014
KBI BioPharma February 2010 - November 2011
Diosynth Biotechnology June 2007 - February 2010
Skills
GMP, Biopharmaceuticals, GLP, Biotechnology, Protein Chemistry, Sop, HPLC, Chromatography, LIMS, Technology Transfer
Education
Campbell University 2003 — 2007
B.S., Pharmaceutical Science
SC Johnson March 2015 - Present
University of North Carolina at Chapel Hill July 2013 - March 2015
Duke Translational Medicine Institute August 2014 - September 2014
North Carolina State University August 2008 - July 2013
Diosynth Biotechnology September 2007 - August 2008
University of Mount Union May 2006 - April 2007
University of Mount Union May 2005 - May 2006
Skills
Mammalian Cell Culture, Mouse Models, Necropsy, RNA isolation, qRT-PCR, Nanodrop, RNAi, protein isolation, BCA Protein Assay, Western Blotting, ELISA, Confocal Microscopy, Hemocytometer, cytospin, Sircol Collagen Assay, intraperitoneal..., pulmonary fibroblast..., TCID50 Assay, UV/Vis, Osmolality, GraphPad Prism, Adobe Acrobat, Microsoft Office, Adobe Illustrator 5, GMP
Education
North Carolina State University 2008 — 2013
Doctor of Philosophy (PhD), Cellular and Molecular Toxicology
University of Mount Union 2003 — 2007
Bachelor of Science (BS), Biochemistry
Digital Recorders, Inc. May 2014 - Present
Beocare Inc, September 2009 - February 2010
APExhaust Products, Inc. November 2008 - May 2009
West Brothers Transportation August 2007 - August 2008
Diosynth Biotechnology December 2002 - August 2007
Diosynth Biotechnology/ Merck 2002 - 2007
Wyeth Vaccines July 1997 - December 2002
Skills
Cash Management, Budgeting, Process Improvement, Financial Control, Forecasting, Financial Analysis, Inventory Control
Education
Fairleigh Dickinson University 1980 — 1982
Pharmaceutical Marketing
Rutgers University-New Brunswick 1973 — 1979
BS, Accounting
KBI Biopharma August 2013 - Present
Shire Pharmaceuticals October 2012 - August 2013
Biogen Idec November 2009 - February 2012
Biogen Idec Inc. November 2006 - November 2009
Diosynth Biotechnology March 2003 - August 2006
Diosynth Biotechnology Services December 1999 - February 2003
CBER, USFDA 1995 - 1999
American Red Cross and the National Institutes of Health, Bethesda 1990 - 1994
Skills
Protein Chemistry, Biotechnology, LIMS, Biopharmaceuticals, Analytical Chemistry, GMP, Validation, Technology Transfer, Pharmaceutical Industry, FDA, 21 CFR Part 11, Sop, Chromatography, HPLC, Computer System..., Microbiology, Quality System, ELISA, GLP, GxP, Quality Management, Protein Purification, Assay Development, Change Control, Molecular Biology, Monoclonal Antibodies, IND, Cell, SOP, Stability Testing, Biologics
Education
Osmania University
Ph.D., Biochemistry
Biogen Idec January 2007 - Present
Diosynth 2001 - 2007
Diosynth Biotechnology 2000 - 2007
DPS Engineering January 2000 - September 2001
Skills
Purification, Chromatography, Downstream Processing, Technology Transfer, Contract Manufacturing, Ultrafiltration, cGMP, Commissioning, Filtration, Biotechnology, Fermentation, Cell Culture, Process Engineering, Biopharmaceuticals, Centrifugation, Troubleshooting
Education
Queen's University Belfast 1989 — 1992
BEng, Chemical Engineering
Thermo Fisher Scientific September 2011 - Present
Novartis August 2009 - May 2010
GlaxoSmithKline November 2006 - December 2008
Diosynth Biotechnology July 2000 - October 2006
Education
Campbell University 2005 — 2007
BAS, Business Administration
Central Carolina Community College 2004 — 2005
AAS, Operations Management
PPD, Inc. August 2010 - Present
PPD, Inc. July 2005 - August 2010
Diosynth Biotechnology November 2001 - June 2005
UNC Wilmington December 1999 - November 2001
aaiPharma, Inc. July 1998 - November 1999
aaiPharma, Inc. June 1996 - July 1998
aaiPharma, Inc. October 1990 - June 1996
UNC Wilmington September 1982 - September 1989
Skills
Auditing, Quality Management, Process Improvement, Continuous Improvement, Cross-functional Team..., GMP, 21 CFR Part 11, Quality Assurance, Change Control, Sop, Analysis, Business Process
Education
University of North Carolina at Wilmington 1986 — 1987
Bachelor of Arts, Philosophy & Religion
University of North Carolina at Wilmington 1982 — 1986
Bachelor of Arts, Psychology
Jacobs Engineering February 2010 - Present
Jacobs Engineering August 2006 - April 2009
Engineering-Field Assignment January 2008 - March 2008
Conveyor Technologies May 2006 - August 2006
Diosynth Biotechnology May 2005 - September 2005
Skills
Matlab, Solidworks, AutoCAD, Microstation, SmartPlant, PipeFlo, Engineering, Process Simulation, Project Engineering, MathCAD, Mechanical Engineering, Instrumentation, Manufacturing, Engineering Design, SolidWorks
Education
North Carolina State University 2001 — 2006
B.S., Mechanical Engineering
FUJIFILM Diosynth Biotechnologies April 2011 - Present
Merck January 2005 - April 2011
Diosynth Biotechnology May 2000 - January 2005
OSI Pharmaceuticals, Inc. December 1996 - April 2000
OSI Pharmaceuticals, Inc. May 1993 - December 1996
OSI Pharmaceuticals, Inc. May 1988 - April 1993
BiosChile S.A. September 1987 - May 1988
Pontificia Universidad Católica de Chile March 1985 - September 1987
Skills
cGMP, Drug Discovery, Biopharmaceuticals, SDS-PAGE, Protein Chemistry, Biotechnology, Biochemistry, Cell Based Assays, PCR, Technology Transfer, Validation, SOP, Cell Culture, Molecular Biology, FDA, GLP, Microbiology, Monoclonal Antibodies, Pharmaceuticals, Life Sciences, Analytical Chemistry, Western Blotting, GMP, LIMS, Quality Systems, High Throughput..., 21 CFR Part 11, R&D, CRO, ELISA, HPLC, Sop, Change Control, Pharmaceutical Industry, Aseptic Technique, Laboratory, Assay Development, In Vitro
Education
Pontificia Universidad Católica de Chile 1985 — 1987
Universidad de Concepción 1979 — 1987
Biochemist
Medicago USA October 2011 - Present
Novartis August 2011 - October 2011
GlaxoSmithKline July 2010 - June 2011
Novartis September 2009 - June 2010
GlaxoSmithKline March 2008 - September 2009
Biolex Therapeutics June 2007 - December 2007
Diosynth Biotechnology March 2004 - June 2007
Diosynth Biotechnology October 2000 - March 2004
GlaxoSmithKline June 1999 - October 2000
Skills
21 CFR Part 11, Internal Audit, Quality Assurance, Databases, GMP, Sop, GLP, Biotechnology, CAPA, LIMS, Change Control, Validation, Aseptic Processing, FDA, Quality Control, Biopharmaceuticals, Technology Transfer, V&V, SOP
Education
Elizabeth City State University
BS, Biology
Eisai December 2013 - Present
Self employed January 2011 - Present
Eisai April 2012 - November 2013
CURACYTE AG January 2006 - January 2012
DIOSYNTH BIOTECHNOLOGY 2003 - 2006
Apex Bioscience Inc 1997 - 2003
APEX BIOSCIENCE INC January 1994 - January 1997
Skills
Biopharmaceuticals, Validation, Pharmaceuticals, Biotechnology, Technology Transfer, Pharmaceutical Industry, Process Simulation, V&V, Manufacturing, Chromatography, Sop, CAPA, Change Control, Quality System, FDA, Quality Assurance, GMP, SOP
Education
North Carolina State University
Master of Science, Microbiology
North Carolina State University
Bachelor of Science; Bachelor of Science, Chemical Engineering; Biochemistry
SFS 1980 — 1986
HS Diploma
Merck January 2015 - Present
Fujifilm Diosynth Biotechnologies May 2008 - November 2014
Diosynth Biotechnology- a part of Schering Plough 2007 - 2008
Diosynth Biotechnology May 2004 - 2007
EMD Pharmaceuticals March 2002 - May 2004
Bayer January 2000 - March 2002
Bayer Animal Helath 1994 - 2000
Bayer 1979 - 1994
Skills
Clinical GMP, Environmental Monitoring, Quality Systems, Pharmaceutical..., Clean Room Management, Facility Validation, Method Development and..., Quality System, Quality Assurance, V&V, GMP, Microbiology, Aseptic Processing, Biotechnology, Quality Control, Aseptic Technique, Pharmaceutical Industry, BPF, Biopharmaceuticals, Technology Transfer, FDA, 21 CFR Part 11, SOP, Validation
Education
Friends University 1995 — 1996
MS, Total Quality Management
Washinton State University
Bachelor's Degree, Bacteriology and Public Health
The Marshall Residence March 2014 - Present
Hospira March 2013 - February 2014
Hospira December 2011 - March 2013
Grifols September 2008 - August 2011
Diosynth Biotechnology 2001 - 2008
Diosynth Biotechnology June 1999 - March 2001
Diosynth 1998 - 1999
Toxin Technology August 1996 - August 1998
Skills
GMP, Biotechnology, Sop, Pharmaceutical Industry, Training, Purification, Biopharmaceuticals, 21 CFR Part 11, Change Control, Quality Assurance, Chromatography, GxP, Aseptic Processing, ELISA, Aseptic Technique, Protein Purification, Formulation, Technical Writing, Downstream Processing, Filtration
Education
Rochester Institute of Technology 1991 — 1996
BS, Biotechnology
Fujifilm Diosynth Biotechnologies Lead Production TechnicianCovance2001 - 2012
Diosynth Biotechnology 2001 - 2012
Covance 2001 - 2012
Education
Campbell University
Kempsville High School