Biolex Therapeutics
Description
Address: 158 Credle St, Pittsboro, NC 27312 Phone: (919) 542-9901: : : : Place name: : : Website: Category: Own this business?
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Biolex Therapeutics Employees
Employee
Years
Job
Industry
Billy Houghteling Billy Houghteling's Biolex Therapeutics Experience October 1999 - February 2002
Job Senior Licensing Manager at Syngenta
Industry Executive Office
Experience
Syngenta September 2013 - Present
North Carolina State University September 2010 - January 2013
North Carolina State University September 2010 - January 2013
North Carolina State University July 2007 - August 2010
North Carolina State University March 2002 - June 2007
Biolex Therapeutics October 1999 - February 2002
Washington University School of Medicine May 1998 - September 1999
Skills
Molecular Biology, Lifesciences, Biotechnology, Technology Transfer, Biochemistry, Commercialization, R&D, Licensing
Education
Ball State University 1996 — 1998
MS, Plant Molecular Biology
Siena Heights University 1992 — 1996
BS, Biology
Syngenta September 2013 - Present
North Carolina State University September 2010 - January 2013
North Carolina State University September 2010 - January 2013
North Carolina State University July 2007 - August 2010
North Carolina State University March 2002 - June 2007
Biolex Therapeutics October 1999 - February 2002
Washington University School of Medicine May 1998 - September 1999
Skills
Molecular Biology, Lifesciences, Biotechnology, Technology Transfer, Biochemistry, Commercialization, R&D, Licensing
Education
Ball State University 1996 — 1998
MS, Plant Molecular Biology
Siena Heights University 1992 — 1996
BS, Biology
Kevin Cox Kevin Cox's Biolex Therapeutics Experience August 2000 - August 2011
Job Director, Technical Service BioEnergy at Novozymes
Industry Biotechnology
Experience
Novozymes July 2014 - Present
Novozymes January 2012 - June 2014
Novozymes August 2011 - January 2012
Biolex Therapeutics August 2000 - August 2011
Novartis Crop Protection 1998 - 2000
Skills
Biotechnology, Product Launch, R&D, Product Development, Renewable Energy, Leadership, Commercialization, Management Of..., Strategy Development, Biochemistry, Technical Leadership, Technical Analysis, Organizational..., Lifesciences, Cross-functional Team..., Protein Chemistry, Team Motivation, Biofuels, Public Speaking, Industrial Enzymes, Team Building, Life Sciences, Protein Expression, Global management, Molecular Biology, Growth mindset, Service Development, Customer Support, Microbiology, Strategic Thinking, Intellectual Property, Judgement and Decision..., Scientific Presentations, Alternative Energy, Ethanol, Product Optimization, Service Management, Organizational..., Organizational..., People Management, Collaborative Leadership, Customer Engagement, Vaccines, Budget Management, Change Management, Technology Transfer, Pharmaceutical Industry, Biopharmaceuticals, GMP, DNA
Education
North Carolina State University 1995 — 1998
MS, Botany
North Carolina State University 1990 — 1995
Bachelor of Science (BS), Conservation
Novozymes July 2014 - Present
Novozymes January 2012 - June 2014
Novozymes August 2011 - January 2012
Biolex Therapeutics August 2000 - August 2011
Novartis Crop Protection 1998 - 2000
Skills
Biotechnology, Product Launch, R&D, Product Development, Renewable Energy, Leadership, Commercialization, Management Of..., Strategy Development, Biochemistry, Technical Leadership, Technical Analysis, Organizational..., Lifesciences, Cross-functional Team..., Protein Chemistry, Team Motivation, Biofuels, Public Speaking, Industrial Enzymes, Team Building, Life Sciences, Protein Expression, Global management, Molecular Biology, Growth mindset, Service Development, Customer Support, Microbiology, Strategic Thinking, Intellectual Property, Judgement and Decision..., Scientific Presentations, Alternative Energy, Ethanol, Product Optimization, Service Management, Organizational..., Organizational..., People Management, Collaborative Leadership, Customer Engagement, Vaccines, Budget Management, Change Management, Technology Transfer, Pharmaceutical Industry, Biopharmaceuticals, GMP, DNA
Education
North Carolina State University 1995 — 1998
MS, Botany
North Carolina State University 1990 — 1995
Bachelor of Science (BS), Conservation
John R. Gasdaska John R. Gasdaska's Biolex Therapeutics Experience January 1999 - July 2012
Job Director of Analytics at Modern Meadow
Industry Biotechnology
Experience
Modern Meadow May 2015 - Present
Professional Consultant May 2014 - May 2015
Synthon Pharmaceuticals April 2012 - May 2014
Biolex Therapeutics January 1999 - July 2012
University of Arizona 1996 - 1998
University of Arizona 1992 - 1996
DuPont 1987 - 1991
Skills
Biotechnology, Protein Chemistry, Biopharmaceuticals, Protein Purification, Biochemistry, Analytical Chemistry, Validation, Project Management, Managment of CROs, Analytical method..., GLP, Assay validation, Supervisory Experience, ELISA, R&D, Team Leadership, Assay Development, Immunoassays, Analytics, Document Management, Technical Leadership, Bioanalytical Chemistry, Analytical Development, Technical Management, Leadership Experience, Research Project..., Bioanalytical..., Highly Analytical, cGMP, Process Development, Management of CMOs, Assay qualification, Pharmaceutical..., QC, Budget Management, Managing Technical...
Education
Emory University 1982 — 1986
PhD, Chemistry
Vanderbilt University 1978 — 1982
BA, Chemistry
Modern Meadow May 2015 - Present
Professional Consultant May 2014 - May 2015
Synthon Pharmaceuticals April 2012 - May 2014
Biolex Therapeutics January 1999 - July 2012
University of Arizona 1996 - 1998
University of Arizona 1992 - 1996
DuPont 1987 - 1991
Skills
Biotechnology, Protein Chemistry, Biopharmaceuticals, Protein Purification, Biochemistry, Analytical Chemistry, Validation, Project Management, Managment of CROs, Analytical method..., GLP, Assay validation, Supervisory Experience, ELISA, R&D, Team Leadership, Assay Development, Immunoassays, Analytics, Document Management, Technical Leadership, Bioanalytical Chemistry, Analytical Development, Technical Management, Leadership Experience, Research Project..., Bioanalytical..., Highly Analytical, cGMP, Process Development, Management of CMOs, Assay qualification, Pharmaceutical..., QC, Budget Management, Managing Technical...
Education
Emory University 1982 — 1986
PhD, Chemistry
Vanderbilt University 1978 — 1982
BA, Chemistry
Erminio Alesii Erminio Alesii's Biolex Therapeutics Experience January 2008 - May 2008
Job Senior Specialist, Operations / Process Specialist for Varicella Bulk Facility (VBF) Virus Suite at Merck
Industry Pharmaceuticals
Experience
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
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
Peter Radtke, Ph.D. Peter Radtke, Ph.D.'s Biolex Therapeutics Experience July 2005 - February 2008
Job Biotechnology Consultant
Industry Biotechnology
Experience
Biotechnology Consultant January 2005 - Present
JustNeem, LLC April 2007 - Present
Grifols September 2011 - February 2013
Talecris Biotherapeutics, Inc. April 2009 - August 2010
Biolex Therapeutics July 2005 - February 2008
Bayer Health Care February 1997 - June 2005
Johann Wolfgang Goethe Universitaet November 1993 - January 1997
The Scripps Research Institute September 1988 - November 1993
Behringwerke AG Marburg January 1987 - August 1988
Behringwerke AG Marburg March 1983 - January 1987
Education
The Philipp University of Marburg 1979 — 1987
Ph.D., Biochemistry
Biotechnology Consultant January 2005 - Present
JustNeem, LLC April 2007 - Present
Grifols September 2011 - February 2013
Talecris Biotherapeutics, Inc. April 2009 - August 2010
Biolex Therapeutics July 2005 - February 2008
Bayer Health Care February 1997 - June 2005
Johann Wolfgang Goethe Universitaet November 1993 - January 1997
The Scripps Research Institute September 1988 - November 1993
Behringwerke AG Marburg January 1987 - August 1988
Behringwerke AG Marburg March 1983 - January 1987
Education
The Philipp University of Marburg 1979 — 1987
Ph.D., Biochemistry
Jennifer Lockhart Jennifer Lockhart's Biolex Therapeutics Experience January 2005 - December 2011
Job Science Editor at The Plant Cell
Industry Biotechnology
Experience
The Plant Cell November 2012 - Present
Oxford Science Editing Ltd. June 2012 - Present
Bioedit April 2012 - Present
Biolex Therapeutics January 2005 - December 2011
BASF Plant Science March 2004 - December 2004
Syngenta Biotechnology, Inc October 2000 - December 2003
North Carolina State University August 1991 - March 1993
University of North Carolina at Chapel Hill August 1989 - August 1991
Skills
Molecular Biology, Plant Physiology, Plant Transformation, Plant Tissue Culture, Technical Writing and..., Plant Development
Education
University of Maryland College Park 1984 — 1989
PhD, Plant Science
University of Pennsylvania 1980 — 1984
BA, Biology
The Plant Cell November 2012 - Present
Oxford Science Editing Ltd. June 2012 - Present
Bioedit April 2012 - Present
Biolex Therapeutics January 2005 - December 2011
BASF Plant Science March 2004 - December 2004
Syngenta Biotechnology, Inc October 2000 - December 2003
North Carolina State University August 1991 - March 1993
University of North Carolina at Chapel Hill August 1989 - August 1991
Skills
Molecular Biology, Plant Physiology, Plant Transformation, Plant Tissue Culture, Technical Writing and..., Plant Development
Education
University of Maryland College Park 1984 — 1989
PhD, Plant Science
University of Pennsylvania 1980 — 1984
BA, Biology
Marc A. Roman Marc A. Roman's Biolex Therapeutics Experience February 2009 - April 2010
Job QA Manager, US Distribution at GlaxoSmithKline LLC. (formerly Novartis Vaccines)
Industry Biotechnology
Experience
GlaxoSmthKline LLC (formerly Novartis Vaccines) August 2012 - Present
Novartis Vaccines and Diagnostics July 2010 - August 2012
Biolex Therapeutics February 2009 - April 2010
Biolex Therapeutics February 2007 - March 2009
Biolex Therapeutics October 2005 - February 2007
Wyeth Biotech October 2004 - October 2005
Wyeth Biotech May 2003 - October 2004
Wyeth Pharmaceuticals September 2002 - December 2002
Hoffmann-La Roche Inc. February 2000 - September 2002
Hoffmann-La Roche Inc. April 1998 - February 2000
Skills
GMP, Quality System, FDA, Validation, Vaccines, Quality Assurance, Manufacturing, Change Control, Biopharmaceuticals, Quality Control, cGMP, Quality Systems, CAPA, Sop, Quality Auditing, 21 CFR Part 11, Protein Chemistry, GLP, V&V, Purification, GxP, Aseptic Processing, Technology Transfer, Pharmaceutical Industry, R&D, Software Documentation, Chromatography, Recalls, Good Distribution..., Cold Chain, SOP
Education
Kean University 1990 — 1999
BA, Biology
Spalding University
GlaxoSmthKline LLC (formerly Novartis Vaccines) August 2012 - Present
Novartis Vaccines and Diagnostics July 2010 - August 2012
Biolex Therapeutics February 2009 - April 2010
Biolex Therapeutics February 2007 - March 2009
Biolex Therapeutics October 2005 - February 2007
Wyeth Biotech October 2004 - October 2005
Wyeth Biotech May 2003 - October 2004
Wyeth Pharmaceuticals September 2002 - December 2002
Hoffmann-La Roche Inc. February 2000 - September 2002
Hoffmann-La Roche Inc. April 1998 - February 2000
Skills
GMP, Quality System, FDA, Validation, Vaccines, Quality Assurance, Manufacturing, Change Control, Biopharmaceuticals, Quality Control, cGMP, Quality Systems, CAPA, Sop, Quality Auditing, 21 CFR Part 11, Protein Chemistry, GLP, V&V, Purification, GxP, Aseptic Processing, Technology Transfer, Pharmaceutical Industry, R&D, Software Documentation, Chromatography, Recalls, Good Distribution..., Cold Chain, SOP
Education
Kean University 1990 — 1999
BA, Biology
Spalding University
Bipin Dalmia Bipin Dalmia's Biolex Therapeutics Experience 2008 - May 2012
Job Vice President, US Business Development at Ferring Pharmaceuticals
Industry Pharmaceuticals
Experience
Ferring Pharmaceuticals May 2012 - Present
Biolex Therapeutics 2008 - May 2012
Biolex Therapeutics 2003 - 2008
Syngenta 2000 - 2003
Novartis 1998 - 2000
Pioneer Hi-Bred International Inc 1997 - 1998
Pioneer Hi-Bred International Inc 1994 - 1997
Skills
Mergers & Acquisitions, Biopharmaceuticals, Licensing, Biotechnology, Technology Transfer, Life Sciences, Intellectual Property, Commercialization, Cross-functional Team..., Due Diligence, Strategic Planning, Product Development, Infectious Diseases, Corporate Development, Strategic Thinking, Business Planning, Negotiation, Technology Evaluation, Pharmaceuticals, Strategy Development, New Business Development, Problem Solving, Program Management, Contract Management, Marketing Strategy, Contract Negotiation, Market Research, Portfolio Management, Competitive Intelligence
Education
Drake University 1995 — 1998
MBA, Business Administration
Iowa State University 1987 — 1994
MS, PhD, Chemical Engineering
Birla Institute of Technology and Science, Pilani 1983 — 1987
B.E., Chemical Engineering
Ferring Pharmaceuticals May 2012 - Present
Biolex Therapeutics 2008 - May 2012
Biolex Therapeutics 2003 - 2008
Syngenta 2000 - 2003
Novartis 1998 - 2000
Pioneer Hi-Bred International Inc 1997 - 1998
Pioneer Hi-Bred International Inc 1994 - 1997
Skills
Mergers & Acquisitions, Biopharmaceuticals, Licensing, Biotechnology, Technology Transfer, Life Sciences, Intellectual Property, Commercialization, Cross-functional Team..., Due Diligence, Strategic Planning, Product Development, Infectious Diseases, Corporate Development, Strategic Thinking, Business Planning, Negotiation, Technology Evaluation, Pharmaceuticals, Strategy Development, New Business Development, Problem Solving, Program Management, Contract Management, Marketing Strategy, Contract Negotiation, Market Research, Portfolio Management, Competitive Intelligence
Education
Drake University 1995 — 1998
MBA, Business Administration
Iowa State University 1987 — 1994
MS, PhD, Chemical Engineering
Birla Institute of Technology and Science, Pilani 1983 — 1987
B.E., Chemical Engineering
Kiyomi Carter Kiyomi Carter's Biolex Therapeutics Experience May 2005 - April 2010
Job Director of Project Management at Medicago
Industry Biotechnology
Experience
Medicago December 2011 - Present
Medicago-USA January 2011 - November 2011
Biolex Therapeutics May 2005 - April 2010
Eli Lilly January 1994 - December 2004
Skills
Management, GMP, Drug Discovery, Cross-functional Team..., Clinical Trials, Budgets, Strategic Alliances, Leadership, Biopharmaceuticals, Project Management, Biotechnology, Strategy, Risk Management, Vaccines, Clinical Development, Product Management, Risk Assessment, Strategic Planning, Drug Development, Biochemistry, Lifesciences, GLP, Technology Transfer, Validation, Pharmaceutical Industry, CRO, R&D, FDA, Life Sciences, 21 CFR Part 11, Protein Chemistry, HPLC, Molecular Biology
Education
Texas A&M University-Corpus Christi 1979 — 1981
BS, Biology
Medicago December 2011 - Present
Medicago-USA January 2011 - November 2011
Biolex Therapeutics May 2005 - April 2010
Eli Lilly January 1994 - December 2004
Skills
Management, GMP, Drug Discovery, Cross-functional Team..., Clinical Trials, Budgets, Strategic Alliances, Leadership, Biopharmaceuticals, Project Management, Biotechnology, Strategy, Risk Management, Vaccines, Clinical Development, Product Management, Risk Assessment, Strategic Planning, Drug Development, Biochemistry, Lifesciences, GLP, Technology Transfer, Validation, Pharmaceutical Industry, CRO, R&D, FDA, Life Sciences, 21 CFR Part 11, Protein Chemistry, HPLC, Molecular Biology
Education
Texas A&M University-Corpus Christi 1979 — 1981
BS, Biology
Vincent Wingate's Biolex Therapeutics Experience September 2004 - April 2012
Job
Industry Pharmaceuticals
Experience
Vector Core, Gene Therapy Center, UNC Chapel Hill, NC September 2014 - Present
Synthon Pharmaceuticals April 2012 - May 2014
Biolex Therapeutics September 2004 - April 2012
Vector Research 2003 - 2004
Bayer Cropscience 1999 - 2003
Rhone-Poulenc Ag Company 1996 - 1999
Rhone-Poulenc Ag Company 1992 - 1996
Education
The Open University
Ph. D, Biochemistry
University of Oxford
Postgraduate Certificate in Education, Education
University of Oxford
B.A. Honors, Biochemistry
Vector Core, Gene Therapy Center, UNC Chapel Hill, NC September 2014 - Present
Synthon Pharmaceuticals April 2012 - May 2014
Biolex Therapeutics September 2004 - April 2012
Vector Research 2003 - 2004
Bayer Cropscience 1999 - 2003
Rhone-Poulenc Ag Company 1996 - 1999
Rhone-Poulenc Ag Company 1992 - 1996
Education
The Open University
Ph. D, Biochemistry
University of Oxford
Postgraduate Certificate in Education, Education
University of Oxford
B.A. Honors, Biochemistry
Carmine J DeFilippis, P.E.'s Biolex Therapeutics Experience 2005 - 2006
Job Senior Project Manager
Industry Pharmaceuticals
Experience
Various Bio/Pharmaceutical Companies 2010 - Present
AMGEN, INC 2006 - 2009 2006 - 2009
Biolex Therapeutics 2005 - 2006
Pfizer Vaccines 2002 - 2005
BE&K ENGINEERING 2000 - 2001
NOVARTIS PHARMACEUTICALS CORPORATION 1985 - 1999
Skills
Start-ups, Forecasting, Due Diligence, Logistics, Construction, Cross-functional Team..., Validation, Compliance, Project Management, Capital Planning, Projects, Capital Project Planning, Pre-construction, Management, PMP, Project Engineering, Contract Negotiation, Strategy, Change Control, Leadership, Operations Management, Manufacturing, Pharmaceutical Industry, Business Planning, Risk Management, Budgets, FDA, Engineering, Computer System..., 21 CFR Part 11, Team Building, Technology Transfer, Process Engineering, V&V, CAPA, GxP, Biopharmaceuticals
Education
New Jersey Institute of Technology
BSME, Mechanical Engineering
Rutgers, The State University of New Jersey-Newark
MBA, Business
Various Bio/Pharmaceutical Companies 2010 - Present
AMGEN, INC 2006 - 2009 2006 - 2009
Biolex Therapeutics 2005 - 2006
Pfizer Vaccines 2002 - 2005
BE&K ENGINEERING 2000 - 2001
NOVARTIS PHARMACEUTICALS CORPORATION 1985 - 1999
Skills
Start-ups, Forecasting, Due Diligence, Logistics, Construction, Cross-functional Team..., Validation, Compliance, Project Management, Capital Planning, Projects, Capital Project Planning, Pre-construction, Management, PMP, Project Engineering, Contract Negotiation, Strategy, Change Control, Leadership, Operations Management, Manufacturing, Pharmaceutical Industry, Business Planning, Risk Management, Budgets, FDA, Engineering, Computer System..., 21 CFR Part 11, Team Building, Technology Transfer, Process Engineering, V&V, CAPA, GxP, Biopharmaceuticals
Education
New Jersey Institute of Technology
BSME, Mechanical Engineering
Rutgers, The State University of New Jersey-Newark
MBA, Business
Jason Sterling's Biolex Therapeutics Experience April 2005 - December 2007
Job Senior Scientist at GSK
Industry Biotechnology
Experience
GSK March 2015 - Present
Novartis Vaccines and Diagnostics May 2014 - February 2015
Catalent Pharma Solutions November 2012 - April 2014
KBI BioPharma October 2009 - November 2012
Liquidia Technologies January 2008 - September 2009
Biolex Therapeutics April 2005 - December 2007
Education
The University of Georgia 1996 — 2004
Ph.D., Biochemistry and Molecular Biology
McGill University 1992 — 1996
B.Sc., Biology
GSK March 2015 - Present
Novartis Vaccines and Diagnostics May 2014 - February 2015
Catalent Pharma Solutions November 2012 - April 2014
KBI BioPharma October 2009 - November 2012
Liquidia Technologies January 2008 - September 2009
Biolex Therapeutics April 2005 - December 2007
Education
The University of Georgia 1996 — 2004
Ph.D., Biochemistry and Molecular Biology
McGill University 1992 — 1996
B.Sc., Biology
Scot Shepard's Biolex Therapeutics Experience October 2006 - October 2011
Job Biologics Process Design at Takeda Vaccines
Industry Biotechnology
Experience
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
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
Rachel Loranger's Biolex Therapeutics Experience January 2000 - Present
Job Upstream Research Coordinator at Biolex Therapeutics
Industry Biotechnology
Experience
Biolex Therapeutics January 2000 - Present
Education
Michigan State University 1993 — 1999
Bachelor of Science, Botany and Plant Pathology
Biolex Therapeutics January 2000 - Present
Education
Michigan State University 1993 — 1999
Bachelor of Science, Botany and Plant Pathology
Jessica Mercer's Biolex Therapeutics Experience 2006 - November 2009
Job QA Manager Quality Systems at Novartis V&D
Industry Biotechnology
Experience
Novartis Vaccines February 2015 - Present
Novartis Vaccines and Diagnostics January 2013 - Present
Novartis V&D November 2009 - January 2013
Biolex Therapeutics 2006 - November 2009
Wyeth Biotech June 2000 - February 2007
Charm Sciences 1999 - 2000
Skills
Chromatography, GMP, Biochemistry, LIMS, Validation, GLP, Sop, HPLC, Technology Transfer, Vaccines, Biopharmaceuticals, Analytical Chemistry, Monoclonal Antibodies, Protein Chemistry, Purification, Analytical Method..., Quality System, Trackwise, IND, Assay Development, Quality Control, Regulatory Submissions, Biotechnology, 21 CFR Part 11, FDA, Change Control, Aseptic Processing, V&V, GxP
Education
University of New Hampshire 1994 — 1998
Bioscience and Technology, Bioscience and technology
Novartis Vaccines February 2015 - Present
Novartis Vaccines and Diagnostics January 2013 - Present
Novartis V&D November 2009 - January 2013
Biolex Therapeutics 2006 - November 2009
Wyeth Biotech June 2000 - February 2007
Charm Sciences 1999 - 2000
Skills
Chromatography, GMP, Biochemistry, LIMS, Validation, GLP, Sop, HPLC, Technology Transfer, Vaccines, Biopharmaceuticals, Analytical Chemistry, Monoclonal Antibodies, Protein Chemistry, Purification, Analytical Method..., Quality System, Trackwise, IND, Assay Development, Quality Control, Regulatory Submissions, Biotechnology, 21 CFR Part 11, FDA, Change Control, Aseptic Processing, V&V, GxP
Education
University of New Hampshire 1994 — 1998
Bioscience and Technology, Bioscience and technology
Adam Veller's Biolex Therapeutics Experience November 2006 - December 2007
Job Clinical Manufacturing Scientist at Pfizer
Industry Biotechnology
Experience
Pfizer February 2012 - Present
Pfizer Pharmaceuticals February 2011 - February 2012
Pfizer July 2009 - February 2011
Biolex Therapeutics November 2006 - December 2007
Diosynth May 1999 - November 2006
Skills
cGMP, Technology Transfer, Purification, Vaccines, GLP, Clinical Development, Chromatography, Validation, SOP, Protein Purification, CAPA, Monoclonal Antibodies, Manufacturing, Continuous Improvement, GMP, Biotechnology, Process Simulation, Biopharmaceuticals, FDA, Column Chromatography, LIMS, Sop, 21 CFR Part 11, Drug Discovery, GxP, ELISA, Pharmaceutical Industry, Formulation, HPLC, SDS-PAGE, Aseptic Technique, Fermentation, Filtration, Change Control, Analytical Chemistry, Lifesciences, Protein Chemistry, Assay Development, Drug Development, Aseptic Processing, Cleaning Validation, IND, Cell, Computer System..., Downstream Processing, V&V, Biochemistry, Cell Culture, Regulatory Submissions, Microbiology
Education
Illinois State University 1988 — 1992
Bachelors of Science in Biology, Chemistry minor
Pfizer February 2012 - Present
Pfizer Pharmaceuticals February 2011 - February 2012
Pfizer July 2009 - February 2011
Biolex Therapeutics November 2006 - December 2007
Diosynth May 1999 - November 2006
Skills
cGMP, Technology Transfer, Purification, Vaccines, GLP, Clinical Development, Chromatography, Validation, SOP, Protein Purification, CAPA, Monoclonal Antibodies, Manufacturing, Continuous Improvement, GMP, Biotechnology, Process Simulation, Biopharmaceuticals, FDA, Column Chromatography, LIMS, Sop, 21 CFR Part 11, Drug Discovery, GxP, ELISA, Pharmaceutical Industry, Formulation, HPLC, SDS-PAGE, Aseptic Technique, Fermentation, Filtration, Change Control, Analytical Chemistry, Lifesciences, Protein Chemistry, Assay Development, Drug Development, Aseptic Processing, Cleaning Validation, IND, Cell, Computer System..., Downstream Processing, V&V, Biochemistry, Cell Culture, Regulatory Submissions, Microbiology
Education
Illinois State University 1988 — 1992
Bachelors of Science in Biology, Chemistry minor
Surendran Rajendran's Biolex Therapeutics Experience 2008 - 2009
Job Senior Biochemcial Research Scientist
Industry Biotechnology
Experience
Amgen December 2009 - December 2011
Biolex Therapeutics 2008 - 2009
Roche Molecular Diagnostics 2007 - 2008
Shakti Pharma, Inc 2006 - 2007
Roche Pharmaceuticals, Palo Alto, CA February 2002 - September 2006
UTMB January 2000 - January 2002
UTMB January 1992 - January 2000
Central Food Technological Research Institute January 1990 - January 1992
Central Food Technological Research Institute January 1985 - January 1990
Skills
Purification, Protein Chemistry, Therapeutics, Kinetics, HCV, Characterization, HTS, ADME, Drug Discovery, Drug Metabolism, Protein Engineering, Protein Purification, Antibodies, In Vitro, Biomarkers, Biochemistry, ELISA, Flow Cytometry, Fluorescence, Clinical Development, IND, Affinity, Proteomics, GLP, Mass Spectrometry, Molecular Biology, Pharmacology, SDS-PAGE, DNA, HPLC
Education
Central Food Technological Research Institute 1985 — 1990
Ph.D., Biochemistry
University of Madras 1979 — 1985
B.S.; M.S.; M.Phil., Biochemistry
Amgen December 2009 - December 2011
Biolex Therapeutics 2008 - 2009
Roche Molecular Diagnostics 2007 - 2008
Shakti Pharma, Inc 2006 - 2007
Roche Pharmaceuticals, Palo Alto, CA February 2002 - September 2006
UTMB January 2000 - January 2002
UTMB January 1992 - January 2000
Central Food Technological Research Institute January 1990 - January 1992
Central Food Technological Research Institute January 1985 - January 1990
Skills
Purification, Protein Chemistry, Therapeutics, Kinetics, HCV, Characterization, HTS, ADME, Drug Discovery, Drug Metabolism, Protein Engineering, Protein Purification, Antibodies, In Vitro, Biomarkers, Biochemistry, ELISA, Flow Cytometry, Fluorescence, Clinical Development, IND, Affinity, Proteomics, GLP, Mass Spectrometry, Molecular Biology, Pharmacology, SDS-PAGE, DNA, HPLC
Education
Central Food Technological Research Institute 1985 — 1990
Ph.D., Biochemistry
University of Madras 1979 — 1985
B.S.; M.S.; M.Phil., Biochemistry
Amy Rigney's Biolex Therapeutics Experience August 2008 - March 2011
Job Chief Operations Officer at SPRI Clinical Trials Global
Industry Biotechnology
Experience
SPRI Clinical Trials - Global January 2014 - Present
SPRI Clinical Trials - Global February 2013 - December 2013
SPRI Clinical Trials - Global January 2011 - January 2013
Biolex Therapeutics August 2008 - March 2011
Talecris Biotherapeutics May 2007 - August 2008
i3 Research April 2006 - May 2007
Gilead Sciences December 2001 - March 2006
Triangle Pharmaceuticals August 1999 - December 2001
Skills
Infectious Diseases, CRO, Clinical Trials, CTMS, Biotechnology, GCP, Cross-functional Team..., Clinical Research, Cardiology, Oncology, Gastroenterology, Pharmaceutical Industry, FDA, Clinical Development, Clinical Operations, Medical Devices, EDC
Education
Boston University
M.Ed., Counseling
University of Maryland College Park
B.S., Psychology
SPRI Clinical Trials - Global January 2014 - Present
SPRI Clinical Trials - Global February 2013 - December 2013
SPRI Clinical Trials - Global January 2011 - January 2013
Biolex Therapeutics August 2008 - March 2011
Talecris Biotherapeutics May 2007 - August 2008
i3 Research April 2006 - May 2007
Gilead Sciences December 2001 - March 2006
Triangle Pharmaceuticals August 1999 - December 2001
Skills
Infectious Diseases, CRO, Clinical Trials, CTMS, Biotechnology, GCP, Cross-functional Team..., Clinical Research, Cardiology, Oncology, Gastroenterology, Pharmaceutical Industry, FDA, Clinical Development, Clinical Operations, Medical Devices, EDC
Education
Boston University
M.Ed., Counseling
University of Maryland College Park
B.S., Psychology
Brian Hoppe's Biolex Therapeutics Experience October 2008 - June 2009
Job Technical Lead at BristolMyers Squibb
Industry Biotechnology
Experience
Bristol-Myers Squibb December 2012 - Present
Bristol-Myers Squibb June 2011 - December 2012
Shire HGT June 2009 - June 2011
Biolex Therapeutics October 2008 - June 2009
Diosynth June 2007 - October 2008
Lonza Biologics December 2006 - June 2007
Skills
Project Coordination, UFDF, bulk fill, Aseptic Processing, Aseptic Technique, Process Automation, column packing, Syncade, Delta V, Technical Documentation, SOP development, SOP authoring, Project Management, Column Packing, Validation, Sop, GMP, CAPA, Purification, Biotechnology, FDA, Protein Purification, Filtration, Chromatography, Biopharmaceuticals
Education
University of New Hampshire 2004 — 2006
Masters, Nutritional Sciences
Michigan State University 2001 — 2003
BS Dietetics
Michigan State University 2001 — 2003
Bristol-Myers Squibb December 2012 - Present
Bristol-Myers Squibb June 2011 - December 2012
Shire HGT June 2009 - June 2011
Biolex Therapeutics October 2008 - June 2009
Diosynth June 2007 - October 2008
Lonza Biologics December 2006 - June 2007
Skills
Project Coordination, UFDF, bulk fill, Aseptic Processing, Aseptic Technique, Process Automation, column packing, Syncade, Delta V, Technical Documentation, SOP development, SOP authoring, Project Management, Column Packing, Validation, Sop, GMP, CAPA, Purification, Biotechnology, FDA, Protein Purification, Filtration, Chromatography, Biopharmaceuticals
Education
University of New Hampshire 2004 — 2006
Masters, Nutritional Sciences
Michigan State University 2001 — 2003
BS Dietetics
Michigan State University 2001 — 2003
Jyothi Gade's Biolex Therapeutics Experience July 2007 - September 2009
Job Specialist, Quality at Merck Sharp & Dohme
Industry Pharmaceuticals
Experience
Merck Sharp & Dohme August 2011 - Present
Novartis Vaccines and Diagnostics December 2009 - April 2011
Biolex Therapeutics July 2007 - September 2009
Biolex Therapeutics May 2006 - June 2007
Biolex Therapeutics July 2004 - April 2006
Srinivasa Clinical Laboratory January 1998 - October 1999
Skills
GLP, CAPA, Sop, GMP, LIMS, Quality Assurance, Validation, Quality Control
Education
Swami Ramanand Teerth Marathwada University 1995 — 1997
M.Sc, Microbiology
Osmania University 1991 — 1994
B.Sc, Microbiology, Chemistry & Zoology
Merck Sharp & Dohme August 2011 - Present
Novartis Vaccines and Diagnostics December 2009 - April 2011
Biolex Therapeutics July 2007 - September 2009
Biolex Therapeutics May 2006 - June 2007
Biolex Therapeutics July 2004 - April 2006
Srinivasa Clinical Laboratory January 1998 - October 1999
Skills
GLP, CAPA, Sop, GMP, LIMS, Quality Assurance, Validation, Quality Control
Education
Swami Ramanand Teerth Marathwada University 1995 — 1997
M.Sc, Microbiology
Osmania University 1991 — 1994
B.Sc, Microbiology, Chemistry & Zoology
LaShawn Richardson's Biolex Therapeutics Experience June 2007 - December 2007
Job QA Senior Specialist at Medicago USA
Industry Pharmaceuticals
Experience
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
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
Chip Peele's Biolex Therapeutics Experience November 2000 - April 2012
Job Scientist I at Bayer CropScience
Industry Biotechnology
Experience
Bayer CropScience September 2014 - Present
Synthon Pharmaceuticals April 2012 - May 2014
Biolex Therapeutics November 2000 - April 2012
North Carolina State University 1994 - 2000
Skills
Biotechnology, Molecular Biology, Protein Chemistry, DNA, Biochemistry, PCR, Protein Purification, Monoclonal Antibodies, Laboratory, GMP, Protein Expression, Genetics
Education
North Carolina State University 1990 — 1995
BS, Biochemistry, Biological Sciences, Chemistry
Bayer CropScience September 2014 - Present
Synthon Pharmaceuticals April 2012 - May 2014
Biolex Therapeutics November 2000 - April 2012
North Carolina State University 1994 - 2000
Skills
Biotechnology, Molecular Biology, Protein Chemistry, DNA, Biochemistry, PCR, Protein Purification, Monoclonal Antibodies, Laboratory, GMP, Protein Expression, Genetics
Education
North Carolina State University 1990 — 1995
BS, Biochemistry, Biological Sciences, Chemistry
Jeff Frye's Biolex Therapeutics Experience February 2007 - May 2010
Job Account Manager at STERIS Corporation
Industry Biotechnology
Experience
STERIS Corporation September 2010 - Present
Biolex Therapeutics February 2007 - May 2010
Biolex August 2005 - February 2007
Wyeth June 2003 - August 2005
Diosynth (Covance) July 1999 - June 2003
Wyeth March 1992 - July 1999
Skills
Technology Transfer, GMP, Validation, Biotechnology, Biopharmaceuticals, FDA, Change Control
Education
North Carolina Wesleyan College
BS, Business Administration
STERIS Corporation September 2010 - Present
Biolex Therapeutics February 2007 - May 2010
Biolex August 2005 - February 2007
Wyeth June 2003 - August 2005
Diosynth (Covance) July 1999 - June 2003
Wyeth March 1992 - July 1999
Skills
Technology Transfer, GMP, Validation, Biotechnology, Biopharmaceuticals, FDA, Change Control
Education
North Carolina Wesleyan College
BS, Business Administration