Biolex Company
Industry: Pharmaceutical company
DescriptionBiolex Therapeutics was a biotechnology firm in the Research Triangle of North Carolina that was founded in 1997 and raised $190 million from investors. It filed for Chapter 7 bankruptcy on July 5, 2012. Headquarters: Rhode Island
Biolex List of Employees There's an exhaustive list of past and present employees! Get comprehensive information on the number of employees at Biolex. You can filter them based on skills, years of employment, job, education, department, and prior employment.
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Biolex Employees
Employee
Years
Job
Industry
J. P. DeVoe J. P. DeVoe's Biolex Experience February 2006 - July 2006
Job Experienced Senior Engineer focusing on Biomanufacturing Design, Development, and Technology Transfer
Industry Biotechnology
Experience
NNE Pharmaplan July 2014 - Present
Amgen June 2010 - June 2014
Amgen July 2006 - June 2010
Biolex February 2006 - July 2006
Wyeth Vaccines August 2003 - February 2006
Bayer Biological Products June 2001 - August 2003
Rohm and Haas 2000 - 2001
Skills
Validation, Technology Transfer, Process Simulation, Chromatography, Process Engineering, Purification, Plant Design, Equipment Commissioning, Process Automation, Project Management, Process Piping Design, P&ID, GAMP, UF/DF, CIP, SIP, Clean Utilities, Cross-functional Team..., PI Data Historian, Filtration, Process Optimization, Process Monitoring, Six Sigma, Lean Manufacturing, Debottlenecking, Change Control, Cleaning Validation, Emerson DeltaV, Start-ups, Biopharmaceuticals
Education
North Carolina State University 1994 — 2000
BS, Chemical Engineering
NNE Pharmaplan July 2014 - Present
Amgen June 2010 - June 2014
Amgen July 2006 - June 2010
Biolex February 2006 - July 2006
Wyeth Vaccines August 2003 - February 2006
Bayer Biological Products June 2001 - August 2003
Rohm and Haas 2000 - 2001
Skills
Validation, Technology Transfer, Process Simulation, Chromatography, Process Engineering, Purification, Plant Design, Equipment Commissioning, Process Automation, Project Management, Process Piping Design, P&ID, GAMP, UF/DF, CIP, SIP, Clean Utilities, Cross-functional Team..., PI Data Historian, Filtration, Process Optimization, Process Monitoring, Six Sigma, Lean Manufacturing, Debottlenecking, Change Control, Cleaning Validation, Emerson DeltaV, Start-ups, Biopharmaceuticals
Education
North Carolina State University 1994 — 2000
BS, Chemical Engineering
Edward Hannon Edward Hannon's Biolex Experience 2004 - 2006
Job Materials Specialist at Covance Genomics Lab
Industry Biotechnology
Experience
Covance Genomics Lab November 2011 - October 2013
The Cobalt Group 2007 - 2011
Biolex 2004 - 2006
ALZA Corporation May 1995 - June 2000
Nycomed January 1992 - May 1995
Skills
Cross-functional Team..., Facilities Management, Project Management, Process Improvement, Team Building, Vendor Management, Digital Marketing, Online Advertising, Team Leadership, Customer Service, Manufacturing, Account Management, Operations Management, GMP, Change Management
Education
University of San Francisco 2002 — 2004
Org. Behavior, Business
Covance Genomics Lab November 2011 - October 2013
The Cobalt Group 2007 - 2011
Biolex 2004 - 2006
ALZA Corporation May 1995 - June 2000
Nycomed January 1992 - May 1995
Skills
Cross-functional Team..., Facilities Management, Project Management, Process Improvement, Team Building, Vendor Management, Digital Marketing, Online Advertising, Team Leadership, Customer Service, Manufacturing, Account Management, Operations Management, GMP, Change Management
Education
University of San Francisco 2002 — 2004
Org. Behavior, Business
Anne McKay Anne McKay's Biolex Experience February 2008 - May 2010
Job President at Anne McKay Inc.
Industry Biotechnology
Experience
Anne McKay Inc. June 2010 - Present
Ocera Therapeutics January 2014 - Present
Biolex February 2008 - May 2010
BWA Consulting September 2003 - January 2008
Triangle Pharmaceuticals October 1996 - May 2003
Burroughs Wellcome January 1980 - June 1995
Education
MSU 1972 — 1976
BS, Animal Science
Anne McKay Inc. June 2010 - Present
Ocera Therapeutics January 2014 - Present
Biolex February 2008 - May 2010
BWA Consulting September 2003 - January 2008
Triangle Pharmaceuticals October 1996 - May 2003
Burroughs Wellcome January 1980 - June 1995
Education
MSU 1972 — 1976
BS, Animal Science
David Spencer David Spencer's Biolex Experience November 2001 - April 2012
Job CEO at Biotechnology Enterprise Management
Industry Biotechnology
Experience
Biotechnology Enterprise Management, LLC April 2012 - Present
ProteoVec, Inc. April 2015 - May 2015
ProteoVec October 2013 - March 2015
Spirovation, Inc. July 2013 - June 2014
Biolex November 2001 - April 2012
Bayer July 2000 - October 2001
Bayer April 1995 - June 2000
Bayer July 1994 - March 1995
Bayer July 1991 - June 1994
Bayer July 1987 - June 1991
Skills
R&D management, Preclinical and..., Project Management, Product Management /..., GMP manufacturing, Investor Relations, Management of..., German fluency, Portfolio strategy and..., KOL interactions, R&D, Clinical Development, GMP, Pharmaceutical Industry, Drug Discovery, Commercialization, Clinical Trials, Immunology, Strategy, Oncology, CRO, Biopharmaceuticals, Biotechnology
Education
Indiana University Bloomington 1977 — 1981
Ph.D., Physiological Psychology
University of California, Los Angeles 1971 — 1975
Bachelor of Arts (BA), Psychopharmacology
Biotechnology Enterprise Management, LLC April 2012 - Present
ProteoVec, Inc. April 2015 - May 2015
ProteoVec October 2013 - March 2015
Spirovation, Inc. July 2013 - June 2014
Biolex November 2001 - April 2012
Bayer July 2000 - October 2001
Bayer April 1995 - June 2000
Bayer July 1994 - March 1995
Bayer July 1991 - June 1994
Bayer July 1987 - June 1991
Skills
R&D management, Preclinical and..., Project Management, Product Management /..., GMP manufacturing, Investor Relations, Management of..., German fluency, Portfolio strategy and..., KOL interactions, R&D, Clinical Development, GMP, Pharmaceutical Industry, Drug Discovery, Commercialization, Clinical Trials, Immunology, Strategy, Oncology, CRO, Biopharmaceuticals, Biotechnology
Education
Indiana University Bloomington 1977 — 1981
Ph.D., Physiological Psychology
University of California, Los Angeles 1971 — 1975
Bachelor of Arts (BA), Psychopharmacology
Amy Ranta Amy Ranta's Biolex Experience April 2007 - November 2009
Job Senior Specialist, Quality Assurance at Astrazeneca
Industry Pharmaceuticals
Experience
AstraZeneca August 2013 - Present
Bristol-Myers Squibb (Amylin Pharmaceuticals) September 2009 - August 2013
Biolex April 2007 - November 2009
bioMerieux 2005 - 2007
Pharmacia/Pfizer 2002 - 2005
Diosynth 1999 - 2002
Skills
Purification, Manufacturing, Medical Devices, GMP, Sop, Validation, CAPA, Aseptic Processing, Change Control, Pharmaceutical Industry, Biopharmaceuticals, 21 CFR Part 11, V&V, Technology Transfer, Biotechnology, Change Management, Quality System, Cleaning Validation
Education
Fayetteville State University 1995 — 1998
bachelor of science, biology
Mott Community College 1992 — 1993
general
AstraZeneca August 2013 - Present
Bristol-Myers Squibb (Amylin Pharmaceuticals) September 2009 - August 2013
Biolex April 2007 - November 2009
bioMerieux 2005 - 2007
Pharmacia/Pfizer 2002 - 2005
Diosynth 1999 - 2002
Skills
Purification, Manufacturing, Medical Devices, GMP, Sop, Validation, CAPA, Aseptic Processing, Change Control, Pharmaceutical Industry, Biopharmaceuticals, 21 CFR Part 11, V&V, Technology Transfer, Biotechnology, Change Management, Quality System, Cleaning Validation
Education
Fayetteville State University 1995 — 1998
bachelor of science, biology
Mott Community College 1992 — 1993
general
Craig Greiner's Biolex Experience June 2005 - December 2007
Job Engineer at John Deere
Industry Defense & Space
Experience
John Deere February 2013 - Present
RD2 Engineering November 2011 - Present
John Deere March 2012 - February 2013
Entegee March 2012 - February 2013
iRobot January 2008 - October 2011
Biolex June 2005 - December 2007
McGowan Institute for Regenerative Medicine January 2002 - June 2005
Skills
Product Development, Finite Element Analysis, Program Management, Solidworks, Mechanical Engineering, Robotics, Cross-functional Team..., Project Management, CAD, Rapid Prototyping, Integration, Technical Leadership, Technology Transfer, Proposal Writing, Team Leadership, Manufacturing, Testing, Engineering Management, Simulations, Design Engineering, Contract Management, New Business Development, Security Clearance, Project Engineering, MS Project, CFD, Engineering, Systems Engineering, R&D, Automation, Embedded Systems, Electronics, Six Sigma, Product Design, Design for Manufacturing, Pro Engineer, Maritime Robotics, Computational Fluid..., Research and Development, Marine Technologies, Small Volume..., Prototyping, simulation, Tableau, Business Analytics
Education
University of Pittsburgh 2001 — 2005
B.S., BioEngineering
John Deere February 2013 - Present
RD2 Engineering November 2011 - Present
John Deere March 2012 - February 2013
Entegee March 2012 - February 2013
iRobot January 2008 - October 2011
Biolex June 2005 - December 2007
McGowan Institute for Regenerative Medicine January 2002 - June 2005
Skills
Product Development, Finite Element Analysis, Program Management, Solidworks, Mechanical Engineering, Robotics, Cross-functional Team..., Project Management, CAD, Rapid Prototyping, Integration, Technical Leadership, Technology Transfer, Proposal Writing, Team Leadership, Manufacturing, Testing, Engineering Management, Simulations, Design Engineering, Contract Management, New Business Development, Security Clearance, Project Engineering, MS Project, CFD, Engineering, Systems Engineering, R&D, Automation, Embedded Systems, Electronics, Six Sigma, Product Design, Design for Manufacturing, Pro Engineer, Maritime Robotics, Computational Fluid..., Research and Development, Marine Technologies, Small Volume..., Prototyping, simulation, Tableau, Business Analytics
Education
University of Pittsburgh 2001 — 2005
B.S., BioEngineering
Eric Hastings's Biolex Experience March 2009 - August 2009
Job at
Industry Biotechnology
Experience
Biogen January 2015 - Present
Biogen Idec July 2011 - January 2015
Novartis Vaccines and Diagnostics August 2009 - August 2011
Biolex March 2009 - August 2009
Wyeth Biotech 2004 - 2008
Bayer HealthCare 1999 - 2004
Skills
Validation, LIMS, GMP, FDA, Pharmaceutical Industry, Sop, CAPA, Biotechnology, GLP, Lifesciences, Change Control, Trackwise, Microbiology, Analytical Chemistry, Aseptic Processing, 21 CFR Part 11, Quality Control
Education
North Carolina State University 1991 — 1998
BS, Microbiology; Genetics
Biogen January 2015 - Present
Biogen Idec July 2011 - January 2015
Novartis Vaccines and Diagnostics August 2009 - August 2011
Biolex March 2009 - August 2009
Wyeth Biotech 2004 - 2008
Bayer HealthCare 1999 - 2004
Skills
Validation, LIMS, GMP, FDA, Pharmaceutical Industry, Sop, CAPA, Biotechnology, GLP, Lifesciences, Change Control, Trackwise, Microbiology, Analytical Chemistry, Aseptic Processing, 21 CFR Part 11, Quality Control
Education
North Carolina State University 1991 — 1998
BS, Microbiology; Genetics
Glen Williams Glen Williams's Biolex Experience 2005 - September 2011
Job Biotechnology executive with specialization in all aspects of CMC at Biotechnology Consulting
Industry Biotechnology
Experience
Biotechnology Consulting September 2015 - Present
Synageva BioPharma Corp. September 2012 - 2015
Caliber Biotherapeutics, LLC June 2011 - August 2012
Biolex 2005 - September 2011
Biogen Idec January 1996 - September 2005
GlaxoSmithKline 1995 - 1996
Burroughs Wellcome Company 1990 - 1995
Burroughs Wellcome 1985 - 1990
The Dow Chemical Company 1980 - 1985
Skills
Biopharmaceuticals, Life Sciences, GMP, Operations Management, Molecular Biology, FDA, Pharmaceutical Industry, Technology Transfer, Vaccines, Cell Culture, Validation, Quality Assurance, Biotechnology, Manufacturing, Leadership, SOP, Process Simulation, Project Planning, CAPA
Education
Central Michigan University 1981 — 1985
MBA, Masters of Business Administration
The Ohio State University 1976 — 1980
BSME, Mechanical Engineering
Biotechnology Consulting September 2015 - Present
Synageva BioPharma Corp. September 2012 - 2015
Caliber Biotherapeutics, LLC June 2011 - August 2012
Biolex 2005 - September 2011
Biogen Idec January 1996 - September 2005
GlaxoSmithKline 1995 - 1996
Burroughs Wellcome Company 1990 - 1995
Burroughs Wellcome 1985 - 1990
The Dow Chemical Company 1980 - 1985
Skills
Biopharmaceuticals, Life Sciences, GMP, Operations Management, Molecular Biology, FDA, Pharmaceutical Industry, Technology Transfer, Vaccines, Cell Culture, Validation, Quality Assurance, Biotechnology, Manufacturing, Leadership, SOP, Process Simulation, Project Planning, CAPA
Education
Central Michigan University 1981 — 1985
MBA, Masters of Business Administration
The Ohio State University 1976 — 1980
BSME, Mechanical Engineering
Cale Halbleib Cale Halbleib's Biolex Experience July 2005 - May 2010
Job Director, Biopharmaceutical Development at KBI Biopharma
Industry Pharmaceuticals
Experience
KBI Biopharma December 2014 - Present
KBI Biopharma November 2011 - December 2014
KBI Biopharma July 2010 - November 2011
Biolex July 2005 - May 2010
Bayer HealthCare March 2004 - July 2005
Karo Bio AB May 2002 - December 2003
Panvera Corporation February 2000 - May 2002
Skills
ELISA, Capillary..., Circular Dichroism, IEF, HPLC, SDS-PAGE, Mass Spectrometry, Gel Electrophoresis, Fluorescence
Education
University of Wisconsin-Madison 1994 — 1999
PhD, Biochemistry
University of Missouri-Columbia 1990 — 1994
BS, Chemical Engineering
KBI Biopharma December 2014 - Present
KBI Biopharma November 2011 - December 2014
KBI Biopharma July 2010 - November 2011
Biolex July 2005 - May 2010
Bayer HealthCare March 2004 - July 2005
Karo Bio AB May 2002 - December 2003
Panvera Corporation February 2000 - May 2002
Skills
ELISA, Capillary..., Circular Dichroism, IEF, HPLC, SDS-PAGE, Mass Spectrometry, Gel Electrophoresis, Fluorescence
Education
University of Wisconsin-Madison 1994 — 1999
PhD, Biochemistry
University of Missouri-Columbia 1990 — 1994
BS, Chemical Engineering
Meredith Kalman Meredith Kalman's Biolex Experience May 2006 - August 2006
Job Senior Consultant at Deloitte
Industry Management Consulting
Experience
Deloitte August 2014 - Present
Deloitte July 2012 - August 2014
AT&T May 2011 - August 2011
Accenture June 2007 - July 2010
Biolex May 2006 - August 2006
Education
Emory University - Goizueta Business School 2010 — 2012
MBA, General Management and Strategy
Bucknell University 2003 — 2007
BS, Biomedical Engineering
Deloitte August 2014 - Present
Deloitte July 2012 - August 2014
AT&T May 2011 - August 2011
Accenture June 2007 - July 2010
Biolex May 2006 - August 2006
Education
Emory University - Goizueta Business School 2010 — 2012
MBA, General Management and Strategy
Bucknell University 2003 — 2007
BS, Biomedical Engineering
Jon Curme Jon Curme's Biolex Experience September 2008 - July 2009
Job Senior Research Associate at KBI Biopharma
Industry Pharmaceuticals
Experience
KBI Biopharma April 2013 - Present
Grifols May 2011 - February 2013
Talecris Biotherapeutics, Inc. July 2009 - May 2011
Biolex September 2008 - July 2009
Skills
HPLC, Chromatography, Purification, Analytical Chemistry, GLP, Protein Chemistry, Protein Purification, Mass Spectrometry, UV/Vis, Biotechnology, GMP, Chemistry, Biopharmaceuticals, NMR, LC-MS, Assay Development, ELISA, SDS-PAGE, Organic Chemistry, Lifesciences, Western Blotting, Biochemistry
Education
North Carolina State University 2006 — 2008
Masters, Chemistry
Sewanee-The University of the South 2002 — 2006
BS, Chemistry
KBI Biopharma April 2013 - Present
Grifols May 2011 - February 2013
Talecris Biotherapeutics, Inc. July 2009 - May 2011
Biolex September 2008 - July 2009
Skills
HPLC, Chromatography, Purification, Analytical Chemistry, GLP, Protein Chemistry, Protein Purification, Mass Spectrometry, UV/Vis, Biotechnology, GMP, Chemistry, Biopharmaceuticals, NMR, LC-MS, Assay Development, ELISA, SDS-PAGE, Organic Chemistry, Lifesciences, Western Blotting, Biochemistry
Education
North Carolina State University 2006 — 2008
Masters, Chemistry
Sewanee-The University of the South 2002 — 2006
BS, Chemistry
Cliff Becher Cliff Becher's Biolex Experience 2005 - 2007
Job Manager, Quality Assurance at FUJIFILM Diosynth Biotechnologies
Industry Biotechnology
Experience
FUJIFILM Diosynth Biotechnologies March 2015 - Present
FUJIFILM Diosynth Biotechnologies March 2015 - Present
bioMerieux February 2010 - Present
Tunnell December 2009 - February 2010
Tengion Labs January 2008 - June 2009
Biolex 2005 - 2007
Wyeth Vaccines 2001 - 2005
TRI Technologies Ldta. / Republic Medical, Inc. 2000 - 2001
Skills
GLP, GCP, cGMP, Continuous Improvement, Quality Systems, GMP, Change Management, Validation, GxP, Problem Solving, Cross-functional Team..., CAPA, Auditing, Staff Development, Staff Management, Compliance, Technical Writing, Staff Training, Training &..., Product Life Cycle..., FDA, Change Control, Medical Devices, Supplier Quality, Quality Engineering, ISO 13485, Root Cause Analysis, Quality Auditing, QSR, Quality System, Software Documentation, Quality Assurance, Quality Control, Regulatory Affairs, 21 CFR Part 11, V&V, Sop, Quality Management, Computer System..., LIMS, SOP
Education
Temple University
Certification, QA/RA New Drug Developement
Wright State University
BS, Biology
FUJIFILM Diosynth Biotechnologies March 2015 - Present
FUJIFILM Diosynth Biotechnologies March 2015 - Present
bioMerieux February 2010 - Present
Tunnell December 2009 - February 2010
Tengion Labs January 2008 - June 2009
Biolex 2005 - 2007
Wyeth Vaccines 2001 - 2005
TRI Technologies Ldta. / Republic Medical, Inc. 2000 - 2001
Skills
GLP, GCP, cGMP, Continuous Improvement, Quality Systems, GMP, Change Management, Validation, GxP, Problem Solving, Cross-functional Team..., CAPA, Auditing, Staff Development, Staff Management, Compliance, Technical Writing, Staff Training, Training &..., Product Life Cycle..., FDA, Change Control, Medical Devices, Supplier Quality, Quality Engineering, ISO 13485, Root Cause Analysis, Quality Auditing, QSR, Quality System, Software Documentation, Quality Assurance, Quality Control, Regulatory Affairs, 21 CFR Part 11, V&V, Sop, Quality Management, Computer System..., LIMS, SOP
Education
Temple University
Certification, QA/RA New Drug Developement
Wright State University
BS, Biology
Torrence Gill's Biolex Experience October 2000 — August 2001
Job Molecular Entomologist
Industry Applied Research
Experience
CREC - Citrus Research and Education Center with University of Florida January 2015 — Present
USDA-ARS May 2010 — January 2015
Penn State University January 2008 — May 2010
Biolex October 2000 — August 2001
Skills
Entomology, Western Blotting, PCR, RT-PCR, Protein Purification, Insect Feeding Bioassays, RNA isolation, VIGs, Plant Transformation, Field Work, Antibody Production, Insect Colony..., Zymogram, Chitinase Activity Assay, Retic Lysate Assay, Insect Physiology, Science, Insect, Gene Silencing, Biotechnology, Statistics, Molecular Biology, Ecology, Genetics, Purification, Antibodies, RNA Isolation, Life Sciences, Research, Biochemistry
Education
University of Kentucky 2001 — 2007
Ph.D, Molecular Entomology
North Carolina Agricultural and Technical State University 1996 — 2000
Bachelors, Animal Science
CREC - Citrus Research and Education Center with University of Florida January 2015 — Present
USDA-ARS May 2010 — January 2015
Penn State University January 2008 — May 2010
Biolex October 2000 — August 2001
Skills
Entomology, Western Blotting, PCR, RT-PCR, Protein Purification, Insect Feeding Bioassays, RNA isolation, VIGs, Plant Transformation, Field Work, Antibody Production, Insect Colony..., Zymogram, Chitinase Activity Assay, Retic Lysate Assay, Insect Physiology, Science, Insect, Gene Silencing, Biotechnology, Statistics, Molecular Biology, Ecology, Genetics, Purification, Antibodies, RNA Isolation, Life Sciences, Research, Biochemistry
Education
University of Kentucky 2001 — 2007
Ph.D, Molecular Entomology
North Carolina Agricultural and Technical State University 1996 — 2000
Bachelors, Animal Science
Ingrid Felton's Biolex Experience April 2005 - August 2006
Job Scientist II Process Development Downstream Purification at FUJIFILM Diosynth Biotechnologies
Industry Biotechnology
Experience
Novartis Vaccines and Diagnostics July 2011 - August 2012
BD Diagnostics/ Women's Health and Cancer February 2009 - March 2011
BD Diagnostics/Tripath August 2006 - January 2009
Biolex April 2005 - August 2006
Biolex January 2005 - April 2005
Eli Lilly & Company June 2001 - December 2004
Inspire Pharmaceuticals January 2000 - May 2001
Inspire Pharmaceuticals January 1999 - January 2000
Skills
GLP, Technology Transfer, ELISA, Purification, GMP, Protein Purification, Biotechnology, Assay Development, Protein Chemistry, Cell Culture, SDS-PAGE, Chromatography, Cell
Education
North Carolina State University
Bachelor of Science
Novartis Vaccines and Diagnostics July 2011 - August 2012
BD Diagnostics/ Women's Health and Cancer February 2009 - March 2011
BD Diagnostics/Tripath August 2006 - January 2009
Biolex April 2005 - August 2006
Biolex January 2005 - April 2005
Eli Lilly & Company June 2001 - December 2004
Inspire Pharmaceuticals January 2000 - May 2001
Inspire Pharmaceuticals January 1999 - January 2000
Skills
GLP, Technology Transfer, ELISA, Purification, GMP, Protein Purification, Biotechnology, Assay Development, Protein Chemistry, Cell Culture, SDS-PAGE, Chromatography, Cell
Education
North Carolina State University
Bachelor of Science
Daniel Siegle's Biolex Experience October 2007 - December 2007
Job Data. Science.
Industry Biotechnology
Experience
Biogen Idec October 2008 - March 2011
Diosynth January 2008 - October 2008
Biolex October 2007 - December 2007
Human Genome Sciences November 2006 - July 2007
Alaskan Observers, Inc. July 1999 - March 2006
Biogen, Inc January 2001 - August 2002
Skills
GMP, Biopharmaceuticals, Technology Transfer, Aseptic Processing, R, Aseptic Technique, Assay Development, Validation, Pharmaceutical Industry, Protein Chemistry, Downstream Processing, Cleaning Validation, Apache Spark, Python, Machine Learning, Data Analysis
Education
North Carolina Central University 2008 — 2015
MS, Pharmaceutical Sciences
University of North Carolina at Chapel Hill 1995 — 1999
BS, Biology
Biogen Idec October 2008 - March 2011
Diosynth January 2008 - October 2008
Biolex October 2007 - December 2007
Human Genome Sciences November 2006 - July 2007
Alaskan Observers, Inc. July 1999 - March 2006
Biogen, Inc January 2001 - August 2002
Skills
GMP, Biopharmaceuticals, Technology Transfer, Aseptic Processing, R, Aseptic Technique, Assay Development, Validation, Pharmaceutical Industry, Protein Chemistry, Downstream Processing, Cleaning Validation, Apache Spark, Python, Machine Learning, Data Analysis
Education
North Carolina Central University 2008 — 2015
MS, Pharmaceutical Sciences
University of North Carolina at Chapel Hill 1995 — 1999
BS, Biology
Ken West's Biolex Experience January 1998 - May 1999
Job Medical Device Executive
Industry Medical Devices
Experience
Technology Commercialization Group (TCG) May 1999 - Present
ROTEM - TEM Systems, Inc. July 2008 - January 2013
Curasan, Inc. January 2004 - July 2008
VetInsite September 2005 - April 2007
Biolex January 1998 - May 1999
Embrex May 1988 - August 1995
FMC 1979 - 1988
Skills
Start-ups, Medical Devices, Strategic Planning, Business Strategy, Business Development, Biotechnology, Strategy, Strategic Partnerships, Business Planning, Marketing, Management, Marketing Strategy, Entrepreneurship, Mergers & Acquisitions, Venture Capital, CRM, Mergers, Due Diligence, Commercialization, Sales
Education
University of Pennsylvania - The Wharton School 1978 — 1979
MBA
Cornell University 1974 — 1978
BS
Technology Commercialization Group (TCG) May 1999 - Present
ROTEM - TEM Systems, Inc. July 2008 - January 2013
Curasan, Inc. January 2004 - July 2008
VetInsite September 2005 - April 2007
Biolex January 1998 - May 1999
Embrex May 1988 - August 1995
FMC 1979 - 1988
Skills
Start-ups, Medical Devices, Strategic Planning, Business Strategy, Business Development, Biotechnology, Strategy, Strategic Partnerships, Business Planning, Marketing, Management, Marketing Strategy, Entrepreneurship, Mergers & Acquisitions, Venture Capital, CRM, Mergers, Due Diligence, Commercialization, Sales
Education
University of Pennsylvania - The Wharton School 1978 — 1979
MBA
Cornell University 1974 — 1978
BS
Susanne Rallis's Biolex Experience September 2009 - December 2009
Job Associate Operations Specialist at Quintiles
Industry Hospital & Health Care
Experience
Quintiles March 2015 - Present
SPRI Clinical Trials September 2014 - Present
Theorem Clinical Research October 2014 - February 2015
DSA November 2013 - July 2014
Drug Safety Alliance November 2010 - April 2012
Drug Safety Alliance December 2009 - April 2010
Dr Cynthia Gregg September 2004 - March 2010
Biolex September 2009 - December 2009
Fresenius Medical Care September 2007 - June 2009
Cary Academy August 1999 - August 2008
Skills
GCP, Drug Safety, Regulatory Affairs, Clinical Trials, Oncology, Pharmaceutical Industry, Clinical Research, Clinical Development, CRO, Case Management, Pharmacovigilance, Healthcare, Leadership
Education
Loyola University New Orleans 2007 — 2009
MSN, Master's of Health Care Systems Management, 4.0
University of North Carolina at Chapel Hill 2005 — 2006
Certificate, Clinical Research Associate
University of North Alabama
BSN, Nursing, 3.8
Quintiles March 2015 - Present
SPRI Clinical Trials September 2014 - Present
Theorem Clinical Research October 2014 - February 2015
DSA November 2013 - July 2014
Drug Safety Alliance November 2010 - April 2012
Drug Safety Alliance December 2009 - April 2010
Dr Cynthia Gregg September 2004 - March 2010
Biolex September 2009 - December 2009
Fresenius Medical Care September 2007 - June 2009
Cary Academy August 1999 - August 2008
Skills
GCP, Drug Safety, Regulatory Affairs, Clinical Trials, Oncology, Pharmaceutical Industry, Clinical Research, Clinical Development, CRO, Case Management, Pharmacovigilance, Healthcare, Leadership
Education
Loyola University New Orleans 2007 — 2009
MSN, Master's of Health Care Systems Management, 4.0
University of North Carolina at Chapel Hill 2005 — 2006
Certificate, Clinical Research Associate
University of North Alabama
BSN, Nursing, 3.8
Debbie Lydiard,'s Biolex Experience January 2007 - December 2009
Job Scientist at Novartis Vaccines and Diagnostics
Industry Biotechnology
Experience
Novartis Vaccines and Diagnostics February 2013 - Present
Talecris Biotherapeutics December 2009 - February 2013
Biolex January 2007 - December 2009
Diosynth April 2000 - January 2007
North Carolina State University 1996 - 2000
Genetics Institute 1992 - 1996
Skills
Protein Purification, Chromatography, Design of Experiments, JMP, UF/DF, Filtration, Statistics, Laboratory Skills, Protein Chemistry, HPLC, Purification, Validation, Laboratory, Technology Transfer, V&V, Aseptic Processing, R&D, Biopharmaceuticals, Cell Culture, GLP, Biotechnology, Change Control, SDS-PAGE, FDA, Downstream Processing, GMP, 21 CFR Part 11, Sop
Education
North Carolina State University 1996 — 2000
MS, Chemical Engineering
Tufts University 1988 — 1992
BS, Chemical Engineering
Novartis Vaccines and Diagnostics February 2013 - Present
Talecris Biotherapeutics December 2009 - February 2013
Biolex January 2007 - December 2009
Diosynth April 2000 - January 2007
North Carolina State University 1996 - 2000
Genetics Institute 1992 - 1996
Skills
Protein Purification, Chromatography, Design of Experiments, JMP, UF/DF, Filtration, Statistics, Laboratory Skills, Protein Chemistry, HPLC, Purification, Validation, Laboratory, Technology Transfer, V&V, Aseptic Processing, R&D, Biopharmaceuticals, Cell Culture, GLP, Biotechnology, Change Control, SDS-PAGE, FDA, Downstream Processing, GMP, 21 CFR Part 11, Sop
Education
North Carolina State University 1996 — 2000
MS, Chemical Engineering
Tufts University 1988 — 1992
BS, Chemical Engineering
Lee Shirkey's Biolex Experience May 2007 - December 2007
Job Sr. Industry Consultant, SAS Center for Health Analytics and Insights
Industry Computer Software
Experience
SAS July 2015 - Present
PierianDx May 2014 - July 2015
GlaxoSmithKline June 2013 - May 2014
GlaxoSmithKline July 2012 - July 2013
BD May 2010 - July 2012
BD Technologies May 2009 - August 2009
Biolex May 2007 - December 2007
Biolex October 2005 - May 2007
Biolex March 2005 - October 2005
Biolex February 2005 - March 2005
Skills
Biotechnology, Pharmaceutical Industry, Lifesciences, Cross-functional Team..., R&D, Market Research, Technology Transfer, Medical Devices, Life Sciences, Biopharmaceuticals, Commercialization, Drug Delivery, Protein Purification, Vaccines, Business Strategy, Product Development, Clinical Development, Drug Discovery, Clinical Trials, Purification, Marketing Strategy, Financial Modeling, New Business Development, Business Analysis, Corporate Development, Licensing, Visual Control, Pharmaceutics, Business Intelligence, Mobile Technology, Healthcare Information..., Licensing Negotiations, Assay Development, Drug Development, Monoclonal Antibodies, Immunology, Bioinformatics, Genomics, Genome Sequencing, Start-ups, Entrepreneurship, Molecular Diagnostics, NGS, Personalized Medicine
Education
University of North Carolina at Chapel Hill - Kenan-Flagler Business School 2008 — 2010
MBA, Entrepreneurship
Penn State University 2003 — 2004
M.S., Biotechnology
James Madison University 1999 — 2003
B.S., Integrated Science and Technology-Biotechnology Concentration
Memphis University School 1994 — 1999
SAS July 2015 - Present
PierianDx May 2014 - July 2015
GlaxoSmithKline June 2013 - May 2014
GlaxoSmithKline July 2012 - July 2013
BD May 2010 - July 2012
BD Technologies May 2009 - August 2009
Biolex May 2007 - December 2007
Biolex October 2005 - May 2007
Biolex March 2005 - October 2005
Biolex February 2005 - March 2005
Skills
Biotechnology, Pharmaceutical Industry, Lifesciences, Cross-functional Team..., R&D, Market Research, Technology Transfer, Medical Devices, Life Sciences, Biopharmaceuticals, Commercialization, Drug Delivery, Protein Purification, Vaccines, Business Strategy, Product Development, Clinical Development, Drug Discovery, Clinical Trials, Purification, Marketing Strategy, Financial Modeling, New Business Development, Business Analysis, Corporate Development, Licensing, Visual Control, Pharmaceutics, Business Intelligence, Mobile Technology, Healthcare Information..., Licensing Negotiations, Assay Development, Drug Development, Monoclonal Antibodies, Immunology, Bioinformatics, Genomics, Genome Sequencing, Start-ups, Entrepreneurship, Molecular Diagnostics, NGS, Personalized Medicine
Education
University of North Carolina at Chapel Hill - Kenan-Flagler Business School 2008 — 2010
MBA, Entrepreneurship
Penn State University 2003 — 2004
M.S., Biotechnology
James Madison University 1999 — 2003
B.S., Integrated Science and Technology-Biotechnology Concentration
Memphis University School 1994 — 1999
Jeff Regan's Biolex Experience September 2000 - April 2012
Job Senior Scientist, Analytical Development at Envisia Therapeutics
Industry Biotechnology
Experience
Envisia Therapeutics July 2014 - Present
Synthon Pharmaceuticals April 2012 - May 2014
Biolex September 2000 - April 2012
University of North Carolina, Department of Genetics August 1998 - September 2000
Skills
ELISA, SDS-PAGE, Western Blotting, Enzyme Assays, Design of Experiments, MALDI-MS, Protein Chemistry, Purification, Protein Purification, Biopharmaceuticals, Assay Development, Biotechnology
Education
Indiana University Bloomington 1993 — 1997
Bachelor of Science, Biology
Envisia Therapeutics July 2014 - Present
Synthon Pharmaceuticals April 2012 - May 2014
Biolex September 2000 - April 2012
University of North Carolina, Department of Genetics August 1998 - September 2000
Skills
ELISA, SDS-PAGE, Western Blotting, Enzyme Assays, Design of Experiments, MALDI-MS, Protein Chemistry, Purification, Protein Purification, Biopharmaceuticals, Assay Development, Biotechnology
Education
Indiana University Bloomington 1993 — 1997
Bachelor of Science, Biology
Bill Welsh's Biolex Experience 2005 - 2006
Job Downstream GMP Process Transfer Leader/Manufacturing Sciences/Biogen Idec
Industry Biotechnology
Experience
Biogen Idec Inc October 2013 - Present
BioMérieux, Inc August 2012 - August 2013
North Carolina State University January 2011 - August 2012
Biogen Idec August 2006 - January 2011
Biolex 2005 - 2006
Wyeth 1999 - 2005
Wyeth Research 1999 - 2005
Wyeth Vaccines 1999 - 2005
STC Laboratories 1994 - 1999
Skills
Biopharmaceuticals, Biotechnology, Change Control, Chromatography, Engineering, FDA, GLP, GMP, HPLC, LIMS, Leadership, Lifesciences, Pharmaceutical Industry, Process Simulation, Protein Chemistry, Purification, Quality Assurance, Quality Control, Quality System, Sop, Technology Transfer, Training, Vaccines, Validation, Life Sciences, V&V, Fermentation, SOP, CAPA
Education
University of Manitoba 1980 — 1993
Biogen Idec Inc October 2013 - Present
BioMérieux, Inc August 2012 - August 2013
North Carolina State University January 2011 - August 2012
Biogen Idec August 2006 - January 2011
Biolex 2005 - 2006
Wyeth 1999 - 2005
Wyeth Research 1999 - 2005
Wyeth Vaccines 1999 - 2005
STC Laboratories 1994 - 1999
Skills
Biopharmaceuticals, Biotechnology, Change Control, Chromatography, Engineering, FDA, GLP, GMP, HPLC, LIMS, Leadership, Lifesciences, Pharmaceutical Industry, Process Simulation, Protein Chemistry, Purification, Quality Assurance, Quality Control, Quality System, Sop, Technology Transfer, Training, Vaccines, Validation, Life Sciences, V&V, Fermentation, SOP, CAPA
Education
University of Manitoba 1980 — 1993
Rhonda McKoy's Biolex Experience December 2005 - June 2006
Job Quality Analyst at Baxter International Inc.
Industry Biotechnology
Experience
Baxter International Inc. May 2015 - Present
Dendreon May 2011 - May 2015
Amgen June 2006 - May 2011
Biolex December 2005 - June 2006
Biogen idec April 2004 - August 2005
Biogen Idec October 2000 - May 2004
Laboratory Corporation of America June 1998 - September 2000
Laboratory Corporation of America, April 1996 - June 1998
Skills
GMP, Validation, Sop, Chromatography, Biotechnology, Aseptic Processing, GLP, FDA, Aseptic Technique, Purification, HPLC, CAPA, Downstream Processing, Biopharmaceuticals, Manufacturing, Quality Control, V&V, Cell, Quality Assurance, Microbiology, LIMS, Change Control, 21 CFR Part 11, Laboratory, Filtration, Software Documentation, Sterilization, Quality, Employee Training, Pharmaceutical Industry, SOP
Education
University of North Carolina at Chapel Hill 1989 — 1993
Biology/Biological Sciences, General
Baxter International Inc. May 2015 - Present
Dendreon May 2011 - May 2015
Amgen June 2006 - May 2011
Biolex December 2005 - June 2006
Biogen idec April 2004 - August 2005
Biogen Idec October 2000 - May 2004
Laboratory Corporation of America June 1998 - September 2000
Laboratory Corporation of America, April 1996 - June 1998
Skills
GMP, Validation, Sop, Chromatography, Biotechnology, Aseptic Processing, GLP, FDA, Aseptic Technique, Purification, HPLC, CAPA, Downstream Processing, Biopharmaceuticals, Manufacturing, Quality Control, V&V, Cell, Quality Assurance, Microbiology, LIMS, Change Control, 21 CFR Part 11, Laboratory, Filtration, Software Documentation, Sterilization, Quality, Employee Training, Pharmaceutical Industry, SOP
Education
University of North Carolina at Chapel Hill 1989 — 1993
Biology/Biological Sciences, General
Teresa Sterling, CPA, CGMA's Biolex Experience January 2001 - August 2007
Job .....
Industry Accounting
Experience
Advanced Energy & NC GreenPower February 2014 - July 2015
Advanced Energy & NC GreenPower February 2013 - February 2014
Advanced Energy & NC GreenPower February 2012 - February 2013
Advanced Energy & NC GreenPower July 2009 - February 2012
Lunsford & Strickland, P.A. August 2008 - April 2009
KPMG Audit August 2007 - July 2008
Biolex January 2001 - August 2007
Skills
Accounting, Financial Statements, Account Reconciliation, Internal Controls, Sarbanes-Oxley Act, Auditing, Financial Analysis, Financial Reporting, Accounts Payable, Journal Entries, Payroll, Fixed Assets, CPA
Education
North Carolina State University - College of Management 2006 — 2007
Masters, Accounting
North Carolina State University - College of Management 2002 — 2005
BS, Accounting
Advanced Energy & NC GreenPower February 2014 - July 2015
Advanced Energy & NC GreenPower February 2013 - February 2014
Advanced Energy & NC GreenPower February 2012 - February 2013
Advanced Energy & NC GreenPower July 2009 - February 2012
Lunsford & Strickland, P.A. August 2008 - April 2009
KPMG Audit August 2007 - July 2008
Biolex January 2001 - August 2007
Skills
Accounting, Financial Statements, Account Reconciliation, Internal Controls, Sarbanes-Oxley Act, Auditing, Financial Analysis, Financial Reporting, Accounts Payable, Journal Entries, Payroll, Fixed Assets, CPA
Education
North Carolina State University - College of Management 2006 — 2007
Masters, Accounting
North Carolina State University - College of Management 2002 — 2005
BS, Accounting
Tamara Monesmith's Biolex Experience January 1999 - February 2002
Job Senior Director, Manufacturing Science & Technology at Argos Therapeutics
Industry Biotechnology
Experience
Argos Therapeutics January 2015 - Present
Argos Therapeutics January 2008 - Present
Argos Therapeutics April 2007 - January 2008
Argos Therapeutics August 2002 - April 2007
Argos Therapeutics February 2002 - July 2002
Biolex January 1999 - February 2002
Education
North Carolina State University 1996 — 1999
MS, Biological Engineering
University of Arizona 1989 — 1994
BS, Chemical Engineering
Argos Therapeutics January 2015 - Present
Argos Therapeutics January 2008 - Present
Argos Therapeutics April 2007 - January 2008
Argos Therapeutics August 2002 - April 2007
Argos Therapeutics February 2002 - July 2002
Biolex January 1999 - February 2002
Education
North Carolina State University 1996 — 1999
MS, Biological Engineering
University of Arizona 1989 — 1994
BS, Chemical Engineering
Ron Uhing's Biolex Experience 2001 - 2003
Job Quality Consultant
Industry Pharmaceuticals
Experience
GSK April 2015 - Present
Baxter International Inc. June 2014 - March 2015
Hospira September 2013 - December 2013
Ricerca Biosciences April 2008 - July 2013
Argos Therapeutics 2003 - 2005
Biolex 2001 - 2003
Covance Biotechnology Services 1998 - 2000
Skills
cGMP, SOP, HPLC, Quality Assurance, Chromatography, Methods Development, Process Development, Sop, V&V, CAPA, GMP, Immunoassays, ELISA, Protein Purification, Fermentation, Protein Chemistry, Cell Culture, Purification, FDA, Analytical Chemistry, Pharmaceutical Industry, Assay Development, Technology Transfer, LIMS, Biopharmaceuticals, Change Control, Drug Development, IND, Biochemistry, Gas Chromatography, Chemistry, LC-MS, 21 CFR Part 11, SDS-PAGE, Cell, Organic Chemistry, Molecular Biology, Clinical Development, Clinical Trials, GLP, Quality Control, Vaccines, Organic Synthesis, CRO, Quality Auditing
Education
Benedictine College
Bachelor of Arts (BA), Biology, General
Iowa State University
Ph.D., Biochemistry
GSK April 2015 - Present
Baxter International Inc. June 2014 - March 2015
Hospira September 2013 - December 2013
Ricerca Biosciences April 2008 - July 2013
Argos Therapeutics 2003 - 2005
Biolex 2001 - 2003
Covance Biotechnology Services 1998 - 2000
Skills
cGMP, SOP, HPLC, Quality Assurance, Chromatography, Methods Development, Process Development, Sop, V&V, CAPA, GMP, Immunoassays, ELISA, Protein Purification, Fermentation, Protein Chemistry, Cell Culture, Purification, FDA, Analytical Chemistry, Pharmaceutical Industry, Assay Development, Technology Transfer, LIMS, Biopharmaceuticals, Change Control, Drug Development, IND, Biochemistry, Gas Chromatography, Chemistry, LC-MS, 21 CFR Part 11, SDS-PAGE, Cell, Organic Chemistry, Molecular Biology, Clinical Development, Clinical Trials, GLP, Quality Control, Vaccines, Organic Synthesis, CRO, Quality Auditing
Education
Benedictine College
Bachelor of Arts (BA), Biology, General
Iowa State University
Ph.D., Biochemistry
Christy Webb's Biolex Experience November 2007 - August 2009
Job Independent Consultant at Self Employed
Industry Biotechnology
Experience
Self Employed October 2014 - Present
Synageva BioPharma Corp. February 2013 - October 2014
Novartis Vaccines and Diagnostics August 2012 - February 2013
Novartis Vaccines and Diagnostics August 2009 - August 2012
Biolex November 2007 - August 2009
Salix Pharmaceuticals March 2004 - November 2007
Wyeth Biotech November 2001 - March 2004
Purdue Pharma May 2001 - November 2001
DSM Pharmaceuticals April 1996 - April 2001
Education
Campbell University 2002 — 2005
MS, Clinical Research, Completed coursework
Campbell University 1991 — 1995
BS, Biology, minor in Chemistry
Self Employed October 2014 - Present
Synageva BioPharma Corp. February 2013 - October 2014
Novartis Vaccines and Diagnostics August 2012 - February 2013
Novartis Vaccines and Diagnostics August 2009 - August 2012
Biolex November 2007 - August 2009
Salix Pharmaceuticals March 2004 - November 2007
Wyeth Biotech November 2001 - March 2004
Purdue Pharma May 2001 - November 2001
DSM Pharmaceuticals April 1996 - April 2001
Education
Campbell University 2002 — 2005
MS, Clinical Research, Completed coursework
Campbell University 1991 — 1995
BS, Biology, minor in Chemistry
Aaron Stewart's Biolex Experience February 2005 - November 2005
Job Maintenance Planner at Novartis Vaccines
Industry Biotechnology
Experience
Novartis Vaccines March 2014 - Present
KBI Biopharma July 2012 - March 2014
Merck August 2011 - July 2012
Eisai Inc. November 2010 - August 2011
Eisai May 2008 - November 2010
Wyeth November 2005 - May 2008
Biolex February 2005 - November 2005
Wyeth October 2001 - February 2005
Skills
Metrology, Sop, GMP, Preventive Maintenance, Validation, Calibration, CAPA, Change Control, FDA, Lean Manufacturing, Computer System..., Manufacturing, Continuous Improvement, Pharmaceutical Industry, 21 CFR Part 11, Quality System, Instrumentation, Aseptic Processing, Six Sigma
Education
Campbell University 2002 — 2004
BAS, Applied Science
Novartis Vaccines March 2014 - Present
KBI Biopharma July 2012 - March 2014
Merck August 2011 - July 2012
Eisai Inc. November 2010 - August 2011
Eisai May 2008 - November 2010
Wyeth November 2005 - May 2008
Biolex February 2005 - November 2005
Wyeth October 2001 - February 2005
Skills
Metrology, Sop, GMP, Preventive Maintenance, Validation, Calibration, CAPA, Change Control, FDA, Lean Manufacturing, Computer System..., Manufacturing, Continuous Improvement, Pharmaceutical Industry, 21 CFR Part 11, Quality System, Instrumentation, Aseptic Processing, Six Sigma
Education
Campbell University 2002 — 2004
BAS, Applied Science
Kyle Chenet's Biolex Experience July 2005 - February 2007
Job CEO at Lq3 Pharmaceuticals
Industry Biotechnology
Experience
Lq3 Pharmaceuticals July 2014 - Present
Liquidia Technologies October 2009 - July 2014
Liquidia Technologies March 2007 - November 2009
Biolex July 2005 - February 2007
GlaxoSmithKline July 2002 - July 2005
Skills
Technology Transfer, Business Development, Corporate Development, Biotechnology, Lifesciences, Commercialization, Drug Development, Biopharmaceuticals, Start-ups, R&D, Entrepreneurship, Drug Discovery, Clinical Development, Medical Devices, Life Sciences
Education
Stanford University Graduate School of Business 2000 — 2002
MBA
University of Michigan 1990 — 1995
BSE, Mechanical Engineering
Lq3 Pharmaceuticals July 2014 - Present
Liquidia Technologies October 2009 - July 2014
Liquidia Technologies March 2007 - November 2009
Biolex July 2005 - February 2007
GlaxoSmithKline July 2002 - July 2005
Skills
Technology Transfer, Business Development, Corporate Development, Biotechnology, Lifesciences, Commercialization, Drug Development, Biopharmaceuticals, Start-ups, R&D, Entrepreneurship, Drug Discovery, Clinical Development, Medical Devices, Life Sciences
Education
Stanford University Graduate School of Business 2000 — 2002
MBA
University of Michigan 1990 — 1995
BSE, Mechanical Engineering
Mary Boguslaski's Biolex Experience 2006 - 2007
Job Managing Member at M.G.Boguslaski, LLC
Industry Legal Services
Experience
M.G.Boguslaski, LLC October 2012 - Present
Life Sciences Law, PLLC April 2005 - March 2013
Biolex 2006 - 2007
Talecris Biotherapeutics 2005 - 2006
Bayer Biological Products 1998 - 2005
Bayer HealthCare 1983 - 2005
BAYER CORPORATION 1983 - 2005
Skills
Pharmaceutical Industry, Regulatory Affairs, Corporate Law, Trade Secrets, Intellectual Property, Biopharmaceuticals, Licensing, Due Diligence, Technology Transfer, Chemistry, Patents, Biotechnology, FDA, Commercialization, Pharmaceutics, Life Sciences, Medical Devices
Education
University of Notre Dame 1980 — 1983
Doctor of Law (J.D.), Law
University of Notre Dame Law School 1980 — 1983
Doctor of Law (J.D.), Law
UCSF 1965 — 1971
Doctor of Philosophy (Ph.D.), Medicinal and Pharmaceutical Chemistry
University of Michigan 1960 — 1965
Bachelor of Science (B.S.), Pharmacy
M.G.Boguslaski, LLC October 2012 - Present
Life Sciences Law, PLLC April 2005 - March 2013
Biolex 2006 - 2007
Talecris Biotherapeutics 2005 - 2006
Bayer Biological Products 1998 - 2005
Bayer HealthCare 1983 - 2005
BAYER CORPORATION 1983 - 2005
Skills
Pharmaceutical Industry, Regulatory Affairs, Corporate Law, Trade Secrets, Intellectual Property, Biopharmaceuticals, Licensing, Due Diligence, Technology Transfer, Chemistry, Patents, Biotechnology, FDA, Commercialization, Pharmaceutics, Life Sciences, Medical Devices
Education
University of Notre Dame 1980 — 1983
Doctor of Law (J.D.), Law
University of Notre Dame Law School 1980 — 1983
Doctor of Law (J.D.), Law
UCSF 1965 — 1971
Doctor of Philosophy (Ph.D.), Medicinal and Pharmaceutical Chemistry
University of Michigan 1960 — 1965
Bachelor of Science (B.S.), Pharmacy
R. Edward Branson's Biolex Experience 2001 - 2006
Job Biotechnology CMC Consultant
Industry Biotechnology
Experience
R Edward Branson Associates LLC August 2010 - Present
R. E. Branson 2009 - Present
Wake Forest Institute for Regenerative Medicine September 2011 - May 2013
Intercell USA 2010 - December 2010
MannKind Corporation 2006 - 2009
Biolex 2001 - 2006
Covance April 1999 - November 2000
R. Edward Branson Associates 1997 - 1999
Cephalon, Inc 1993 - 1996
Bio-Response, Inc 1987 - 1990
Skills
Organizational..., Biopharmaceuticals, cGMP, Technology Transfer, GMP, Operations Management, Manufacturing, FDA, Process Improvement, Process Validation, Team Building, Change Management, Start-ups, Commissioning, Biotechnology, SOP, Process Development, Auditing, Strategic Planning, GLP, Budgeting, Cross-functional Team..., Medical Devices, Problem Solving, Cell Culture, Team Leadership, Documentation, Process Optimization, CMC, GTP, V&V, Project Management, FDA GMP, Sop, Software Documentation, Pharmaceutical Industry, Regulatory Affairs, Quality System, CAPA, Quality Assurance, Change Control, 21 CFR Part 11, Lifesciences, R&D, Clinical Trials, GxP, Quality Control, Life Sciences
Education
University of North Carolina at Chapel Hill
PhD Biochemistry, Protein structure
R Edward Branson Associates LLC August 2010 - Present
R. E. Branson 2009 - Present
Wake Forest Institute for Regenerative Medicine September 2011 - May 2013
Intercell USA 2010 - December 2010
MannKind Corporation 2006 - 2009
Biolex 2001 - 2006
Covance April 1999 - November 2000
R. Edward Branson Associates 1997 - 1999
Cephalon, Inc 1993 - 1996
Bio-Response, Inc 1987 - 1990
Skills
Organizational..., Biopharmaceuticals, cGMP, Technology Transfer, GMP, Operations Management, Manufacturing, FDA, Process Improvement, Process Validation, Team Building, Change Management, Start-ups, Commissioning, Biotechnology, SOP, Process Development, Auditing, Strategic Planning, GLP, Budgeting, Cross-functional Team..., Medical Devices, Problem Solving, Cell Culture, Team Leadership, Documentation, Process Optimization, CMC, GTP, V&V, Project Management, FDA GMP, Sop, Software Documentation, Pharmaceutical Industry, Regulatory Affairs, Quality System, CAPA, Quality Assurance, Change Control, 21 CFR Part 11, Lifesciences, R&D, Clinical Trials, GxP, Quality Control, Life Sciences
Education
University of North Carolina at Chapel Hill
PhD Biochemistry, Protein structure
Scott Hallam's Biolex Experience 2003 - 2006
Job Director of External Manufacturing Operations and Sourcing
Industry Biotechnology
Experience
Celldex Therapeutics April 2015 - Present
NPS Pharmaceuticals May 2011 - April 2015
MannKind Corporation August 2008 - April 2011
NC BioNetwork August 2006 - August 2008
Biolex 2003 - 2006
Stryker Biotech 2002 - 2003
Covance Biotechnologies 1999 - 2000
Sanofi Pasteur 1991 - 1999
Skills
CAPA, GMP, Technology Transfer, Manufacturing, FDA, Lifesciences, Purification, Biopharmaceuticals, Product Development, Validation, Biotechnology, Sop, LIMS, GLP, Change Control, Quality System, 21 CFR Part 11
Education
East Stroudsburg University of Pennsylvania 1987 — 1991
Bachelor of Science (BS), biology, marine science
Celldex Therapeutics April 2015 - Present
NPS Pharmaceuticals May 2011 - April 2015
MannKind Corporation August 2008 - April 2011
NC BioNetwork August 2006 - August 2008
Biolex 2003 - 2006
Stryker Biotech 2002 - 2003
Covance Biotechnologies 1999 - 2000
Sanofi Pasteur 1991 - 1999
Skills
CAPA, GMP, Technology Transfer, Manufacturing, FDA, Lifesciences, Purification, Biopharmaceuticals, Product Development, Validation, Biotechnology, Sop, LIMS, GLP, Change Control, Quality System, 21 CFR Part 11
Education
East Stroudsburg University of Pennsylvania 1987 — 1991
Bachelor of Science (BS), biology, marine science
Yongliang Fan's Biolex Experience October 2008 - May 2009
Job Research Associate at Duke University
Industry Biotechnology
Experience
Duke University November 2010 - Present
Syngenta Biotechnology Inc. August 2009 - October 2010
KBI BioPharma May 2009 - August 2009
Biolex October 2008 - May 2009
NC State University February 2005 - October 2008
University of Georgia July 2004 - February 2005
NC State University July 1999 - July 2004
Skills
Proteomics, endosymbiont, bacteria, Protein Chemistry, SDS-PAGE, Assay Development, Biochemistry, HPLC, Western Blotting, Science, Life Sciences, qPCR, In Vitro, Purification, Biotechnology
Education
Shanghai Institute of Entomology, the Chinese Academy of Sciences 1992 — 1996
Ph.D., Entomology and Biochemistry
Shanxi University 1985 — 1988
MSc, zoology
Shanxi Agricultural University 1981 — 1985
BSc, Crop Protection
Duke University November 2010 - Present
Syngenta Biotechnology Inc. August 2009 - October 2010
KBI BioPharma May 2009 - August 2009
Biolex October 2008 - May 2009
NC State University February 2005 - October 2008
University of Georgia July 2004 - February 2005
NC State University July 1999 - July 2004
Skills
Proteomics, endosymbiont, bacteria, Protein Chemistry, SDS-PAGE, Assay Development, Biochemistry, HPLC, Western Blotting, Science, Life Sciences, qPCR, In Vitro, Purification, Biotechnology
Education
Shanghai Institute of Entomology, the Chinese Academy of Sciences 1992 — 1996
Ph.D., Entomology and Biochemistry
Shanxi University 1985 — 1988
MSc, zoology
Shanxi Agricultural University 1981 — 1985
BSc, Crop Protection
Patricia Gallagher's Biolex Experience 2004 - 2006
Job Method Valdiation Manager at Argos Therapeutics
Industry Biotechnology
Experience
Argos Therapeutics December 2014 - Present
BD Diagnostics March 2008 - Present
BD Diagnostics Tripath March 2006 - March 2008
Biolex 2004 - 2006
University of North Carolina at Chapel Hill 1992 - 2003
Skills
GMP, Manufacturing, GLP, CAPA, FDA, Validation, Microsoft Office, Lifesciences, Biotechnology, Lean Six Sigma, Design of Experiments, Analytical Method..., Manufacturing Process..., Medical Devices, Biophamaceutical..., Quality Management, Microbiology, V&V, Protein Purification, Assay Development, Sop, HPLC, ELISA, Purification, Protein Chemistry
Education
UNC Chapel Hill 1986 — 1992
PhD, Biochemistry and Molecular Biology
Penn State University 1979 — 1981
Bachelor of Science (BS), Biochemistry and Molecular Biology
Argos Therapeutics December 2014 - Present
BD Diagnostics March 2008 - Present
BD Diagnostics Tripath March 2006 - March 2008
Biolex 2004 - 2006
University of North Carolina at Chapel Hill 1992 - 2003
Skills
GMP, Manufacturing, GLP, CAPA, FDA, Validation, Microsoft Office, Lifesciences, Biotechnology, Lean Six Sigma, Design of Experiments, Analytical Method..., Manufacturing Process..., Medical Devices, Biophamaceutical..., Quality Management, Microbiology, V&V, Protein Purification, Assay Development, Sop, HPLC, ELISA, Purification, Protein Chemistry
Education
UNC Chapel Hill 1986 — 1992
PhD, Biochemistry and Molecular Biology
Penn State University 1979 — 1981
Bachelor of Science (BS), Biochemistry and Molecular Biology
Beth mcLaurin's Biolex Experience 2005 - 2009
Job unemployed
Industry Biotechnology
Experience
n/a - currently unemployed February 2014 - Present
Novartis (contractor) August 2013 - February 2014
Pfizer December 2009 - August 2013
Biolex 2005 - 2009
Education
Campbell University 2012 — 2015
Bachelor's Degree, Applied Sciences and Clinical Research, GPA 3.76
Central Carolina Community College
Associate in Applied Science BioQuality Technology
Central Carolina Community College
Associate in Applied Science Bioprocess Technology
n/a - currently unemployed February 2014 - Present
Novartis (contractor) August 2013 - February 2014
Pfizer December 2009 - August 2013
Biolex 2005 - 2009
Education
Campbell University 2012 — 2015
Bachelor's Degree, Applied Sciences and Clinical Research, GPA 3.76
Central Carolina Community College
Associate in Applied Science BioQuality Technology
Central Carolina Community College
Associate in Applied Science Bioprocess Technology
Gregory Pittman's Biolex Experience April 2006 - July 2010
Job Senior Manager Quality Control @ Biogen
Industry Biotechnology
Experience
Biogen Idec January 2013 - Present
Biogen Idec August 2011 - January 2013
Smith & Nephew July 2010 - July 2011
Biolex April 2006 - July 2010
Biogen Idec March 1997 - March 2006
Education
University of North Carolina at Chapel Hill
BS, Chemistry / Biochemistry
Biogen Idec January 2013 - Present
Biogen Idec August 2011 - January 2013
Smith & Nephew July 2010 - July 2011
Biolex April 2006 - July 2010
Biogen Idec March 1997 - March 2006
Education
University of North Carolina at Chapel Hill
BS, Chemistry / Biochemistry
Amy Morrison's Biolex Experience April 2007 - April 2010
Job Manufacturing Scientist II at Biogen Idec
Industry Biotechnology
Experience
Biogen Idec January 2011 - Present
KBI BioPharma September 2010 - December 2010
KBI BioPharma May 2010 - August 2010
Biolex April 2007 - April 2010
University of North Carolina at Chapel Hill January 2004 - April 2007
Skills
Protein Purification, Technology Transfer, cGMP manufacturing, Process Validation, Project Management, ELISA, Western Blotting, PCR, HPLC, Assay Development, Biotechnology, SDS-PAGE, Protein Chemistry
Education
Penn State University 1997 — 2003
PhD
State University of New York College at Plattsburgh 1994 — 1997
BS
Biogen Idec January 2011 - Present
KBI BioPharma September 2010 - December 2010
KBI BioPharma May 2010 - August 2010
Biolex April 2007 - April 2010
University of North Carolina at Chapel Hill January 2004 - April 2007
Skills
Protein Purification, Technology Transfer, cGMP manufacturing, Process Validation, Project Management, ELISA, Western Blotting, PCR, HPLC, Assay Development, Biotechnology, SDS-PAGE, Protein Chemistry
Education
Penn State University 1997 — 2003
PhD
State University of New York College at Plattsburgh 1994 — 1997
BS
Kate Shirkey's Biolex Experience August 2006 - February 2008
Job Nurse Anesthetist at Duke Regional Hospital
Industry Hospital & Health Care
Experience
Duke Regional Hospital June 2015 - Present
Duke University Medical Center October 2011 - December 2012
Duke University Medical Center September 2010 - October 2011
KBI Biopharma February 2008 - May 2009
Biolex August 2006 - February 2008
Skills
Anesthesia, Airway Management, Regional Anesthesia, ACLS, Epic Systems, Hospitals, Critical Care, BLS, PALS, Patient Safety, Inpatient, ICU, Pediatrics, Patient Education, Acute Care, Healthcare, EMR, Nursing
Education
Duke University 2013 — 2015
MSN, Nurse Anesthesia
University of North Carolina at Chapel Hill 2009 — 2010
BSN, Nursing- Accelerated Program
University of North Carolina at Chapel Hill 2004 — 2006
BS, Biochemistry
Duke Regional Hospital June 2015 - Present
Duke University Medical Center October 2011 - December 2012
Duke University Medical Center September 2010 - October 2011
KBI Biopharma February 2008 - May 2009
Biolex August 2006 - February 2008
Skills
Anesthesia, Airway Management, Regional Anesthesia, ACLS, Epic Systems, Hospitals, Critical Care, BLS, PALS, Patient Safety, Inpatient, ICU, Pediatrics, Patient Education, Acute Care, Healthcare, EMR, Nursing
Education
Duke University 2013 — 2015
MSN, Nurse Anesthesia
University of North Carolina at Chapel Hill 2009 — 2010
BSN, Nursing- Accelerated Program
University of North Carolina at Chapel Hill 2004 — 2006
BS, Biochemistry
Jeff Frye's Biolex Experience August 2005 - February 2007
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
Dana Geyer's Biolex Experience July 2007 - March 2012
Job Senior Accountant at United Therapeutics
Industry Biotechnology
Experience
United Therapeutics March 2013 - Present
United Therapeutics March 2012 - February 2013
Biolex July 2007 - March 2012
Philip Post & Associates March 2005 - July 2007
Ryan Homes November 2003 - February 2005
Skills
General Ledger, Accounting, Auditing, Accounts Payable, Financial Reporting, Fixed Assets, Variance Analysis, Microsoft Excel, Accounts Receivable, GAAP, Internal Controls
Education
Strayer University 2010 — 2012
MS, Accounting
Kent State University 1999 — 2003
BBA, Accounting
United Therapeutics March 2013 - Present
United Therapeutics March 2012 - February 2013
Biolex July 2007 - March 2012
Philip Post & Associates March 2005 - July 2007
Ryan Homes November 2003 - February 2005
Skills
General Ledger, Accounting, Auditing, Accounts Payable, Financial Reporting, Fixed Assets, Variance Analysis, Microsoft Excel, Accounts Receivable, GAAP, Internal Controls
Education
Strayer University 2010 — 2012
MS, Accounting
Kent State University 1999 — 2003
BBA, Accounting
Les Smith's Biolex Experience October 2005 - April 2010
Job Biotechnology Professional
Industry Biotechnology
Experience
KBI Biopharma August 2011 - Present
KBI BioPharma June 2010 - August 2011
Biolex October 2005 - April 2010
Diosynth 1998 - 2005
Education
University of North Carolina at Chapel Hill 1994 — 1998
Bachelors, Chemistry
KBI Biopharma August 2011 - Present
KBI BioPharma June 2010 - August 2011
Biolex October 2005 - April 2010
Diosynth 1998 - 2005
Education
University of North Carolina at Chapel Hill 1994 — 1998
Bachelors, Chemistry
Margaret Carol Midgette's Biolex Experience 2006 - 2007
Job Mushroom Hill Mycotechnology, Owner
Industry Biotechnology
Experience
Mushroom Hill Mycotechnology July 2014 - Present
Diosynth Biotechnology/Organon/ Merck/Fujifilm April 2007 - May 2014
Biolex 2006 - 2007
Bayer 2004 - 2006
AAI Pharma July 1999 - July 2004
Campbell University School of Pharmacy July 1994 - July 1999
Skills
cGMP, HPLC, GMP, SOP, Validation, Technology Transfer, Biotechnology, Quality Assurance, Documentation, SDS-PAGE, GLP, Compliance, Excel, Biochemistry, Sop, Western Blotting, Laboratory, Quality Control, Microsoft Excel
Education
UNC WIlmington 1991 — 1993
Master of Science (M.S.), Biology/Biological Sciences, General
Fayetteville State University
Bachelor of Science (B.S.), Biology, General
Mushroom Hill Mycotechnology July 2014 - Present
Diosynth Biotechnology/Organon/ Merck/Fujifilm April 2007 - May 2014
Biolex 2006 - 2007
Bayer 2004 - 2006
AAI Pharma July 1999 - July 2004
Campbell University School of Pharmacy July 1994 - July 1999
Skills
cGMP, HPLC, GMP, SOP, Validation, Technology Transfer, Biotechnology, Quality Assurance, Documentation, SDS-PAGE, GLP, Compliance, Excel, Biochemistry, Sop, Western Blotting, Laboratory, Quality Control, Microsoft Excel
Education
UNC WIlmington 1991 — 1993
Master of Science (M.S.), Biology/Biological Sciences, General
Fayetteville State University
Bachelor of Science (B.S.), Biology, General
Hannah Maynor's Biolex Experience 2000 - 2002
Job Director at LabCorp
Industry Hospital & Health Care
Merck
Johnson & Johnson
GlaxoSmithKline
Bristol Myers Squibb
Eli Lilly and Company
Novartis
Abbott Laboratories
AstraZeneca