Diosynth Company
Diosynth List of Employees There's an exhaustive list of past and present employees! Get comprehensive information on the number of employees at Diosynth. You can filter them based on skills, years of employment, job, education, department, and prior employment.
Diosynth Salaries. You can even request information on how much does Diosynth pay if you want to. Learn about salaries, pros and cons of working for Diosynth directly from the past employees.
Find People by Employers You can rekindle an old relationship, reconnect with a long-lost friend, former boss, business acquaintance who might be useful in your new line of work. With our employee database, the possibilities are endless. All you have to do is type in a couple of keywords and we'll bring you the exact information you wanted!
144 Diosynth employees in database. Find out everything there's to know about Diosynth employees. We offer you a great deal of unbiased information from the internal database, personal records, and many other details that might be of interest to you.
Diosynth Employees
Employee
Years
Job
Industry
David Ownby David Ownby's Diosynth Experience 2000 - 2007
Job Principal Scientist, Group Leader at FUJIFILM Diosynth Biotechnologies
Industry Biotechnology
Experience
FUJIFILM Diosynth Biotechnologies 2013 - Present
Grifols, Inc. November 2007 - 2013
Diosynth 2000 - 2007
Bayer 1997 - 2000
Abbott Laboratories 1994 - 1997
Skills
Biopharmaceuticals, Technology Transfer, Biotechnology, Purification, Protein Purification, Chromatography, Mammalian Cell Culture, Technical Project..., Protein Chemistry, GMP, Assay Development, Lifesciences, FDA, Downstream Processing
Education
The University of Texas at Austin 1991 — 1993
Postdoctoral Fellow, Zoology
University of Colorado at Boulder 1984 — 1990
Ph.D., Biophysical Chemistry
The University of Georgia 1979 — 1984
B.S., Chemistry
FUJIFILM Diosynth Biotechnologies 2013 - Present
Grifols, Inc. November 2007 - 2013
Diosynth 2000 - 2007
Bayer 1997 - 2000
Abbott Laboratories 1994 - 1997
Skills
Biopharmaceuticals, Technology Transfer, Biotechnology, Purification, Protein Purification, Chromatography, Mammalian Cell Culture, Technical Project..., Protein Chemistry, GMP, Assay Development, Lifesciences, FDA, Downstream Processing
Education
The University of Texas at Austin 1991 — 1993
Postdoctoral Fellow, Zoology
University of Colorado at Boulder 1984 — 1990
Ph.D., Biophysical Chemistry
The University of Georgia 1979 — 1984
B.S., Chemistry
Angela K Dunston, MBA, ASQ CQA, ASQ CMQ/OE Angela K Dunston, MBA, ASQ CQA, ASQ CMQ/OE's Diosynth Experience February 2003 - March 2005
Job Vice President, Compliance at Global GxP Solutions
Industry Management Consulting
Experience
Global GxP Solutions November 2014 - Present
PharmaPact Consulting Services January 2009 - November 2014
SQA Services July 2010 - August 2014
Nektar Therapeutics April 2007 - January 2009
Amgen April 2005 - January 2007
Diosynth February 2003 - March 2005
GlaxoSmithKline May 2001 - February 2003
Bristol-Myers Squibb October 1996 - September 2000
Skills
GMP, FDA, CAPA, Validation, Quality Assurance, Root Cause Analysis, Quality System, Change Control, Supplier Quality, Internal Audit, Cross Functional Team..., Business Analysis, Process Improvement, GxP, Corrective Actions, Preventative Actions, Regulatory Compliance, Strategic Planning, Change Management, SOP Development, Pharmaceutical Industry, Quality Management, 21 CFR Part 11, GLP, Medical Devices, Quality Control, SOP, Technology Transfer, V
Education
Strayer University (DC)
MBA, Management
American Society for Quality
Certified Pharmaceutical Gmp Professional (Pending June 2015)
American Society for Quality
Certified Quality Auditor
American Society for Quality
Certified Manager of Quality/Organizational Excellence
Strayer University-Alabama
Executive Graduate Certificate, Public Accounting
Campbell University
Bachelor, Health Science
Wake Technical Community College
Associates, Industrial Pharmaceutical Technology
Global GxP Solutions November 2014 - Present
PharmaPact Consulting Services January 2009 - November 2014
SQA Services July 2010 - August 2014
Nektar Therapeutics April 2007 - January 2009
Amgen April 2005 - January 2007
Diosynth February 2003 - March 2005
GlaxoSmithKline May 2001 - February 2003
Bristol-Myers Squibb October 1996 - September 2000
Skills
GMP, FDA, CAPA, Validation, Quality Assurance, Root Cause Analysis, Quality System, Change Control, Supplier Quality, Internal Audit, Cross Functional Team..., Business Analysis, Process Improvement, GxP, Corrective Actions, Preventative Actions, Regulatory Compliance, Strategic Planning, Change Management, SOP Development, Pharmaceutical Industry, Quality Management, 21 CFR Part 11, GLP, Medical Devices, Quality Control, SOP, Technology Transfer, V
Education
Strayer University (DC)
MBA, Management
American Society for Quality
Certified Pharmaceutical Gmp Professional (Pending June 2015)
American Society for Quality
Certified Quality Auditor
American Society for Quality
Certified Manager of Quality/Organizational Excellence
Strayer University-Alabama
Executive Graduate Certificate, Public Accounting
Campbell University
Bachelor, Health Science
Wake Technical Community College
Associates, Industrial Pharmaceutical Technology
Shandalyn Matson Shandalyn Matson's Diosynth Experience November 2000 - August 2007
Job Manager, Human Resources at Novartis Vaccines and Diagnostics
Industry Biotechnology
Experience
Novartis Vaccines and Diagnostics December 2009 - Present
Novartis Vaccines August 2007 - July 2011
Diosynth November 2000 - August 2007
Merisel November 1999 - October 2000
Skills
Recruiting, Human Resources, Applicant Tracking..., HRIS, Employee Benefits, Training, Interviews, Workforce Planning, Vendor Management, Screening, Management, Biotechnology, Project Management, Program Management, Temporary Placement, SAP, Project Planning, Pharmaceutical Industry, Start-ups, Talent ma, Compensations, Organizational..., Deferred Compensation, Performance Management, Leadership, Talent Management, Personnel Management, Internet Recruiting
Education
Peace College
BA, Business Administration, Minor in Human Resources
Novartis Vaccines and Diagnostics December 2009 - Present
Novartis Vaccines August 2007 - July 2011
Diosynth November 2000 - August 2007
Merisel November 1999 - October 2000
Skills
Recruiting, Human Resources, Applicant Tracking..., HRIS, Employee Benefits, Training, Interviews, Workforce Planning, Vendor Management, Screening, Management, Biotechnology, Project Management, Program Management, Temporary Placement, SAP, Project Planning, Pharmaceutical Industry, Start-ups, Talent ma, Compensations, Organizational..., Deferred Compensation, Performance Management, Leadership, Talent Management, Personnel Management, Internet Recruiting
Education
Peace College
BA, Business Administration, Minor in Human Resources
Patrick Asplund Patrick Asplund's Diosynth Experience 2001 - 2003
Job Principal Engineer at Cook Pharmica
Industry Pharmaceuticals
Experience
Cook Pharmica 2010 - Present
Cook Pharmica 2007 - 2010
Cook Pharmica 2006 - 2007
Cook Pharmica 2004 - 2006
Human Genome Sciences 2003 - 2004
Diosynth 2001 - 2003
Raytheon 1988 - 1991
Skills
Engineering, Chromatography, Filtration, SOP, cGMP, Biotechnology, GMP, Technology Transfer, Process Validation, Process Engineering, Manufacturing, Biopharmaceuticals, Troubleshooting, Contract Manufacturing, Commissioning, Automation, Problem Solving, Team Building, Change Management, Calibration, Excel, Word, Change Control, Cell Culture, V&V, Process Simulation
Education
Penn State University 1995 — 1999
PhD, Bioengineering Program/Department of Chemical Engineering
Penn State University 1991 — 1994
MS, Bioengineering Program/Department of Chemical Engineering
Michigan State University 1983 — 1988
BS, Mechanical Engineering
Cook Pharmica 2010 - Present
Cook Pharmica 2007 - 2010
Cook Pharmica 2006 - 2007
Cook Pharmica 2004 - 2006
Human Genome Sciences 2003 - 2004
Diosynth 2001 - 2003
Raytheon 1988 - 1991
Skills
Engineering, Chromatography, Filtration, SOP, cGMP, Biotechnology, GMP, Technology Transfer, Process Validation, Process Engineering, Manufacturing, Biopharmaceuticals, Troubleshooting, Contract Manufacturing, Commissioning, Automation, Problem Solving, Team Building, Change Management, Calibration, Excel, Word, Change Control, Cell Culture, V&V, Process Simulation
Education
Penn State University 1995 — 1999
PhD, Bioengineering Program/Department of Chemical Engineering
Penn State University 1991 — 1994
MS, Bioengineering Program/Department of Chemical Engineering
Michigan State University 1983 — 1988
BS, Mechanical Engineering
Lara Marxreiter Lara Marxreiter's Diosynth Experience May 2006 - September 2006
Job Contracts Negotiator at DoD
Industry Military
Experience
United States Department of Defense April 2012 - Present
United States Department of Defense February 2010 - April 2012
Children's National Medical Center September 2007 - January 2010
University of North Carolina at Chapel Hill August 2006 - May 2007
Diosynth May 2006 - September 2006
Pfizer May 2005 - August 2005
US EPA July 2004 - January 2005
Education
The George Washington University 2007 — 2010
Master of Science (MS), Biochemistry and Molecular Genetics
Marine Biological Laboratory 2009 — 2009
Embryology and Neuroscience
North Carolina State University 2002 — 2006
Bachelor of Science (BS), Biochemistry; Minor in Genetics
United States Department of Defense April 2012 - Present
United States Department of Defense February 2010 - April 2012
Children's National Medical Center September 2007 - January 2010
University of North Carolina at Chapel Hill August 2006 - May 2007
Diosynth May 2006 - September 2006
Pfizer May 2005 - August 2005
US EPA July 2004 - January 2005
Education
The George Washington University 2007 — 2010
Master of Science (MS), Biochemistry and Molecular Genetics
Marine Biological Laboratory 2009 — 2009
Embryology and Neuroscience
North Carolina State University 2002 — 2006
Bachelor of Science (BS), Biochemistry; Minor in Genetics
Sandra Ferree Sandra Ferree's Diosynth Experience January 2007 - September 2009
Job Process Engineer
Industry Biotechnology
Experience
Makerbot Industries May 2013 - April 2015
Novartis Vaccines and Diagnostics March 2011 - May 2013
Integrated Process Technologies, Inc. September 2009 - March 2011
Diosynth January 2007 - September 2009
NC State BTEC June 2005 - December 2006
Skills
GMP, Fermentation, Aseptic Processing, Process Simulation, Validation, V&V, CAPA, 21 CFR Part 11, Technology Transfer, Change Control, Biopharmaceuticals, Sop, Quality System, Biotechnology, FDA, SOP
Education
North Carolina State University 2002 — 2006
CHE, Chemical Engineering, Political Science
Makerbot Industries May 2013 - April 2015
Novartis Vaccines and Diagnostics March 2011 - May 2013
Integrated Process Technologies, Inc. September 2009 - March 2011
Diosynth January 2007 - September 2009
NC State BTEC June 2005 - December 2006
Skills
GMP, Fermentation, Aseptic Processing, Process Simulation, Validation, V&V, CAPA, 21 CFR Part 11, Technology Transfer, Change Control, Biopharmaceuticals, Sop, Quality System, Biotechnology, FDA, SOP
Education
North Carolina State University 2002 — 2006
CHE, Chemical Engineering, Political Science
Clara Smith Clara Smith's Diosynth Experience March 2001 - September 2005
Job Principal Scientist, Analytical Development at Diosynth Biotechnologies
Industry Biotechnology
Experience
Fujifilm Diosynth Biotechnologies March 2012 - Present
Fujifilm Diosynth Biotechnologies April 2011 - March 2012
Merck May 2010 - April 2011
Diosynth Biotechnolgy, then Schering Plough December 2006 - May 2010
Lonza Biologics October 2005 - November 2006
Diosynth March 2001 - September 2005
Glaxo Smith Kline June 1999 - March 2001
Skills
Biopharmaceuticals, Technology Transfer, Protein Chemistry, Chromatography, Biotechnology, HPLC, Monoclonal Antibodies, SDS-PAGE, Assay Development, ELISA, GMP, Validation, Analytical Chemistry, Mass Spectrometry, Assay Qualification, Impurity..., UPLC, Biosimilars, Vaccines, LC-MS, Proteomics, Life Sciences
Education
Northwestern University 1997 — 1998
MS, Biotechnology
Florida State University 1993 — 1997
BS, Biochemistry
Fujifilm Diosynth Biotechnologies March 2012 - Present
Fujifilm Diosynth Biotechnologies April 2011 - March 2012
Merck May 2010 - April 2011
Diosynth Biotechnolgy, then Schering Plough December 2006 - May 2010
Lonza Biologics October 2005 - November 2006
Diosynth March 2001 - September 2005
Glaxo Smith Kline June 1999 - March 2001
Skills
Biopharmaceuticals, Technology Transfer, Protein Chemistry, Chromatography, Biotechnology, HPLC, Monoclonal Antibodies, SDS-PAGE, Assay Development, ELISA, GMP, Validation, Analytical Chemistry, Mass Spectrometry, Assay Qualification, Impurity..., UPLC, Biosimilars, Vaccines, LC-MS, Proteomics, Life Sciences
Education
Northwestern University 1997 — 1998
MS, Biotechnology
Florida State University 1993 — 1997
BS, Biochemistry
Katie Dutch Katie Dutch's Diosynth Experience May 2007 - December 2008
Job Product Development Engineer R&D Anesthesia at Teleflex Medical
Industry Medical Devices
Experience
Teleflex Medical March 2012 - Present
Teleflex Medical October 2010 - March 2012
Teleflex Medical February 2009 - October 2010
Diosynth May 2007 - December 2008
Closure Medical May 2006 - August 2006
Skills
Microsoft Office, Solidworks, Microsoft Excel, Technical Writing, Medical Devices, R&D, Quality System, Regulatory Affairs, Product Development, GMP, ISO
Education
North Carolina State University 2003 — 2008
BS, Biomedical Engineering - Biomaterials and Tissue Engineering
Teleflex Medical March 2012 - Present
Teleflex Medical October 2010 - March 2012
Teleflex Medical February 2009 - October 2010
Diosynth May 2007 - December 2008
Closure Medical May 2006 - August 2006
Skills
Microsoft Office, Solidworks, Microsoft Excel, Technical Writing, Medical Devices, R&D, Quality System, Regulatory Affairs, Product Development, GMP, ISO
Education
North Carolina State University 2003 — 2008
BS, Biomedical Engineering - Biomaterials and Tissue Engineering
Samuel Duke Samuel Duke's Diosynth Experience October 1998 - March 2006
Job King Fisher of Men
Industry Fishery
Experience
Paradise Fishing June 2014 - Present
Merck March 2006 - June 2014
Diosynth October 1998 - March 2006
Motorola July 1995 - October 1998
Skills
Electricians, Engineering, Facilities Management, Manufacturing, Preventive Maintenance, Testing, Validation, CAPA, GMP, HVAC, FDA, Six Sigma, SOP, Quality System, Fishing, Change Control, Commissioning
Education
North Carolina State University 2003 — 2004
Diploma, Facilities Engineering Management
Paradise Fishing June 2014 - Present
Merck March 2006 - June 2014
Diosynth October 1998 - March 2006
Motorola July 1995 - October 1998
Skills
Electricians, Engineering, Facilities Management, Manufacturing, Preventive Maintenance, Testing, Validation, CAPA, GMP, HVAC, FDA, Six Sigma, SOP, Quality System, Fishing, Change Control, Commissioning
Education
North Carolina State University 2003 — 2004
Diploma, Facilities Engineering Management
Melissa (Hannold) Swanson Melissa (Hannold) Swanson's Diosynth Experience 2003 - 2007
Job Senior Research Associate at KBI BioPharma
Industry Pharmaceuticals
Experience
KBI Biopharma March 2007 - Present
Diosynth 2003 - 2007
Skills
Biotechnology, GMP, Protein Chemistry, Biopharmaceuticals
Education
North Carolina State University 1999 — 2003
BS, Biological Sciences
KBI Biopharma March 2007 - Present
Diosynth 2003 - 2007
Skills
Biotechnology, GMP, Protein Chemistry, Biopharmaceuticals
Education
North Carolina State University 1999 — 2003
BS, Biological Sciences
David Oates David Oates's Diosynth Experience January 2001 - August 2002
Job Network Engineer
Industry Information Technology and Services
Experience
Cisco Systems March 2010 - Present
INX 2010 - 2012
British Telecom November 2006 - March 2010
Subex Tech September 2006 - November 2006
CTG March 2006 - November 2006
Silver Fox Farms May 1985 - April 2006
Best Buy Inc December 2004 - December 2005
Best Buy, Inc. August 2001 - November 2004
Diosynth January 2001 - August 2002
Skills
Cisco Technologies, Switches, Routers, TCP/IP, Troubleshooting, WAN, Data Center, Networking, CCNA, VoIP, VMware, LAN-WAN, Servers, Cisco Routers, OSPF, Network Engineering, BGP, F5 BigIP
Education
Strayer University 2012 — 2014
Master of Science (MS), Information Systems Network Management, 4.0
Mount Olive College 1997 — 2000
Bachelor of Science, Biology, 3.5
Hobbton High School 1993 — 1997
High School Diploma, General education
North Carolina State University
Classes, Environmental Engineering and Economics, 3.5
Cisco Systems March 2010 - Present
INX 2010 - 2012
British Telecom November 2006 - March 2010
Subex Tech September 2006 - November 2006
CTG March 2006 - November 2006
Silver Fox Farms May 1985 - April 2006
Best Buy Inc December 2004 - December 2005
Best Buy, Inc. August 2001 - November 2004
Diosynth January 2001 - August 2002
Skills
Cisco Technologies, Switches, Routers, TCP/IP, Troubleshooting, WAN, Data Center, Networking, CCNA, VoIP, VMware, LAN-WAN, Servers, Cisco Routers, OSPF, Network Engineering, BGP, F5 BigIP
Education
Strayer University 2012 — 2014
Master of Science (MS), Information Systems Network Management, 4.0
Mount Olive College 1997 — 2000
Bachelor of Science, Biology, 3.5
Hobbton High School 1993 — 1997
High School Diploma, General education
North Carolina State University
Classes, Environmental Engineering and Economics, 3.5
Edwin Cosme Edwin Cosme's Diosynth Experience 2000 - 2003
Job CEO at Biothermal LLC
Industry Biotechnology
Experience
Biothermal LLC October 2010 - Present
Biothermal LLC 2003 - Present
Hospira 2010 - 2011
Sandoz 2009 - 2009
NNE Pharmaplan 2008 - 2008
Organon Technika 2008 - 2008
MedImmune 2007 - 2007
Valsource 2003 - 2005
Diosynth Biotechnology 2002 - 2003
Diosynth 2000 - 2003
Skills
Quality Control, Change Control, Technology Transfer, Biotechnology, CAPA, Lifesciences, Quality System, Sop, Management, Lean Manufacturing, Manufacturing, Validation, Pharmaceutical Industry, FDA, Leadership, Quality Assurance, GMP, V&V, Six Sigma, Computer System..., 21 CFR Part 11, Regulatory Affairs, GxP, ISO 13485
Education
Kennedy Western University 2004 — 2008
Bachelor of Science, Engineering: Mechanical
Biothermal LLC October 2010 - Present
Biothermal LLC 2003 - Present
Hospira 2010 - 2011
Sandoz 2009 - 2009
NNE Pharmaplan 2008 - 2008
Organon Technika 2008 - 2008
MedImmune 2007 - 2007
Valsource 2003 - 2005
Diosynth Biotechnology 2002 - 2003
Diosynth 2000 - 2003
Skills
Quality Control, Change Control, Technology Transfer, Biotechnology, CAPA, Lifesciences, Quality System, Sop, Management, Lean Manufacturing, Manufacturing, Validation, Pharmaceutical Industry, FDA, Leadership, Quality Assurance, GMP, V&V, Six Sigma, Computer System..., 21 CFR Part 11, Regulatory Affairs, GxP, ISO 13485
Education
Kennedy Western University 2004 — 2008
Bachelor of Science, Engineering: Mechanical
Coleen Burke Coleen Burke's Diosynth Experience October 2007 - October 2009
Job Sr. Manager, QA at Fujifilm Diosynth Biotechnologies
Industry Pharmaceuticals
Experience
Fujifilm Diosynth Biotechnologies May 2013 - Present
Fujifilm Diosynth Biotechnologies October 2009 - May 2013
Diosynth October 2007 - October 2009
Catalent April 2007 - October 2007
Cardinal Health 2004 - 2007
Magellan Laboratories 1998 - 2004
O'Brien & Gere April 1989 - July 1998
Nanco Laboratories 1987 - 1989
Skills
FDA, Biotechnology, Software Documentation, Cleaning Validation, GMP, Validation, Medical Devices, Quality System, Quality Assurance, 21 CFR Part 11, Pharmaceutical Industry, Sop, HPLC, CAPA, GLP, V&V, Change Control, Biopharmaceuticals, Technology Transfer, Analytical Chemistry, Quality Auditing, Chemistry, Process Improvement, LIMS
Education
State University of New York College at Geneseo 1983 — 1987
BA, Mathematics
Fujifilm Diosynth Biotechnologies May 2013 - Present
Fujifilm Diosynth Biotechnologies October 2009 - May 2013
Diosynth October 2007 - October 2009
Catalent April 2007 - October 2007
Cardinal Health 2004 - 2007
Magellan Laboratories 1998 - 2004
O'Brien & Gere April 1989 - July 1998
Nanco Laboratories 1987 - 1989
Skills
FDA, Biotechnology, Software Documentation, Cleaning Validation, GMP, Validation, Medical Devices, Quality System, Quality Assurance, 21 CFR Part 11, Pharmaceutical Industry, Sop, HPLC, CAPA, GLP, V&V, Change Control, Biopharmaceuticals, Technology Transfer, Analytical Chemistry, Quality Auditing, Chemistry, Process Improvement, LIMS
Education
State University of New York College at Geneseo 1983 — 1987
BA, Mathematics
eric hodgden eric hodgden's Diosynth Experience May 2006 - September 2008
Job I&C Engineer at CRB
Industry Biotechnology
Experience
CRB Consulting Engineers February 2008 - Present
Diosynth May 2006 - September 2008
Wyeth May 2007 - September 2007
US Army April 1999 - April 2003
Education
North Carolina State University 2005 — 2008
BS, Chemical Engineering
CRB Consulting Engineers February 2008 - Present
Diosynth May 2006 - September 2008
Wyeth May 2007 - September 2007
US Army April 1999 - April 2003
Education
North Carolina State University 2005 — 2008
BS, Chemical Engineering
Renee Robbins Nygard Renee Robbins Nygard's Diosynth Experience November 1999 - March 2003
Job Accounting Assistant at Leith Management Co.
Industry Biotechnology
Experience
Leith Management Co. February 2011 - Present
Fujifilm Diosynth Biotechnologies (Experis) March 2012 - June 2012
Triangle Building Services, Inc. July 2010 - January 2012
Biogen Idec February 2008 - August 2008
Biogen Idec March 2004 - February 2008
Embrex March 2003 - February 2004
Diosynth November 1999 - March 2003
Covance Biotechnology Services, Inc. September 1998 - November 1999
Covance Biotechnology Services, Inc. September 1997 - September 1998
Pharmacia & Upjohn April 1995 - January 1997
Skills
GMP, Quality Assurance, Biopharmaceuticals, Validation, Biotechnology, LIMS, Pharmaceutical Industry, Change Control, GxP, Technology Transfer, GLP, CAPA, Quality System, SOP, HPLC, V&V, Purification, Team Building, Computer System..., Aseptic Technique, Aseptic Processing, Vaccines, TrackWise, Continuous Improvement, Auditing, PowerPoint, Coaching, Fermentation, Documentation, cGMP, Compliance, Writing, Problem Solving, Pharmaceuticals, E-Verify, FDA, 21 CFR Part 11
Education
Campbell University 2009 — 2011
Bachelor of Applied Science
American Society for Quality 2005 — 2005
certification, Quality Auditor
Wake Technical Community College 1997 — 1997
A.A.S., Industrial Pharmaceutical Technology
Leith Management Co. February 2011 - Present
Fujifilm Diosynth Biotechnologies (Experis) March 2012 - June 2012
Triangle Building Services, Inc. July 2010 - January 2012
Biogen Idec February 2008 - August 2008
Biogen Idec March 2004 - February 2008
Embrex March 2003 - February 2004
Diosynth November 1999 - March 2003
Covance Biotechnology Services, Inc. September 1998 - November 1999
Covance Biotechnology Services, Inc. September 1997 - September 1998
Pharmacia & Upjohn April 1995 - January 1997
Skills
GMP, Quality Assurance, Biopharmaceuticals, Validation, Biotechnology, LIMS, Pharmaceutical Industry, Change Control, GxP, Technology Transfer, GLP, CAPA, Quality System, SOP, HPLC, V&V, Purification, Team Building, Computer System..., Aseptic Technique, Aseptic Processing, Vaccines, TrackWise, Continuous Improvement, Auditing, PowerPoint, Coaching, Fermentation, Documentation, cGMP, Compliance, Writing, Problem Solving, Pharmaceuticals, E-Verify, FDA, 21 CFR Part 11
Education
Campbell University 2009 — 2011
Bachelor of Applied Science
American Society for Quality 2005 — 2005
certification, Quality Auditor
Wake Technical Community College 1997 — 1997
A.A.S., Industrial Pharmaceutical Technology
Lauren (Alexander) Mello's Diosynth Experience January 2008 - February 2010
Job at
Industry Biotechnology
Experience
Pearl Therapeutics March 2014 - Present
KBI BioPharma February 2010 - March 2014
Diosynth January 2008 - February 2010
Skills
Biopharmaceuticals, Protein Chemistry, Chromatography, GMP, HPLC, Biotechnology, Technology Transfer, Assay Development, UV/Vis, Microbiology, GLP, Quality Control, Aseptic Technique, Analytical Chemistry, Fermentation, LIMS, SDS-PAGE, ELISA, Protein Purification, Capillary..., Western Blotting, Analytical Method..., Glycobiology, DLS, Differential Scanning..., Formulation, Particle Size Analysis, Binding Assays, Monoclonal Antibodies, MS Excel Pivot Tables, Microsoft Excel, Data Analysis
Education
North Carolina State University 2004 — 2007
B.S., Chemistry, Food Science
Wake Technical Community College 2002 — 2004
Associate's Degree, Culinary Arts/Chef Training
Pearl Therapeutics March 2014 - Present
KBI BioPharma February 2010 - March 2014
Diosynth January 2008 - February 2010
Skills
Biopharmaceuticals, Protein Chemistry, Chromatography, GMP, HPLC, Biotechnology, Technology Transfer, Assay Development, UV/Vis, Microbiology, GLP, Quality Control, Aseptic Technique, Analytical Chemistry, Fermentation, LIMS, SDS-PAGE, ELISA, Protein Purification, Capillary..., Western Blotting, Analytical Method..., Glycobiology, DLS, Differential Scanning..., Formulation, Particle Size Analysis, Binding Assays, Monoclonal Antibodies, MS Excel Pivot Tables, Microsoft Excel, Data Analysis
Education
North Carolina State University 2004 — 2007
B.S., Chemistry, Food Science
Wake Technical Community College 2002 — 2004
Associate's Degree, Culinary Arts/Chef Training
Diana Tysinger Diana Tysinger's Diosynth Experience 2007 - 2007
Job Process Engineer at Merck
Industry Pharmaceuticals
Experience
Grifols 2008 - 2013
Diosynth 2007 - 2007
Skills
GMP, Validation, Cleaning Validation, FDA, Chemical Engineering, Technology Transfer, Process Simulation, Biotechnology, Pharmaceutical Industry, Sop, R&D, CAPA, Protein Purification, Protein Chemistry, Biopharmaceuticals, Aseptic Processing, Chromatography, UF/DF, Nanofiltration, Downstream Processing, V&V, Purification, 21 CFR Part 11, Filtration, UV/Vis, Root Cause Analysis, Pilot Plant, Centrifugation, HPLC, LIMS, Ultrafiltration, Fermentation, Analytical Chemistry, Design of Experiments
Education
North Carolina State University 2004 — 2008
Bachelor of Science (B.S.), Chemical Engineering
Grifols 2008 - 2013
Diosynth 2007 - 2007
Skills
GMP, Validation, Cleaning Validation, FDA, Chemical Engineering, Technology Transfer, Process Simulation, Biotechnology, Pharmaceutical Industry, Sop, R&D, CAPA, Protein Purification, Protein Chemistry, Biopharmaceuticals, Aseptic Processing, Chromatography, UF/DF, Nanofiltration, Downstream Processing, V&V, Purification, 21 CFR Part 11, Filtration, UV/Vis, Root Cause Analysis, Pilot Plant, Centrifugation, HPLC, LIMS, Ultrafiltration, Fermentation, Analytical Chemistry, Design of Experiments
Education
North Carolina State University 2004 — 2008
Bachelor of Science (B.S.), Chemical Engineering
Amy Ranta's Diosynth Experience 1999 - 2002
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
Luis Giron Luis Giron's Diosynth Experience 2006 - July 2007
Job Product Marketing Manager at Lenovo
Industry Marketing and Advertising
Experience
Lenovo October 2014 - Present
IBM March 2013 - September 2014
Siemens Industry US June 2010 - November 2012
Capstrat March 2010 - June 2010
Lenovo May 2008 - August 2008
Diosynth 2006 - July 2007
Diosynth 2004 - 2006
Diosynth 2000 - 2004
Skills
Product Marketing, Market Research, Business Development, Cross-functional Team..., Marketing Strategy, Product Development, Start-ups, Business Planning, Business Strategy, Entrepreneurship, Leadership, Market Analysis, Marketing, Marketing Communications, Salesforce.com
Education
Duke University - The Fuqua School of Business 2007 — 2009
MBA, Marketing
North Carolina State University 1996 — 2000
BS, Microbiology
Lenovo October 2014 - Present
IBM March 2013 - September 2014
Siemens Industry US June 2010 - November 2012
Capstrat March 2010 - June 2010
Lenovo May 2008 - August 2008
Diosynth 2006 - July 2007
Diosynth 2004 - 2006
Diosynth 2000 - 2004
Skills
Product Marketing, Market Research, Business Development, Cross-functional Team..., Marketing Strategy, Product Development, Start-ups, Business Planning, Business Strategy, Entrepreneurship, Leadership, Market Analysis, Marketing, Marketing Communications, Salesforce.com
Education
Duke University - The Fuqua School of Business 2007 — 2009
MBA, Marketing
North Carolina State University 1996 — 2000
BS, Microbiology
Charlie Neal, Jr.'s Diosynth Experience 2001 - 2007
Job President/Owner at Neal and Company, Inc.
Industry Pharmaceuticals
Experience
Neal and Company, Inc. November 2010 - Present
Biothermal Validation, LLC October 2009 - December 2010
Sandoz Inc United States 2009 - 2010
NNE Pharmaplan US December 2007 - September 2009
Diosynth 2001 - 2007
TheraTech, Inc. (later Watson) 1993 - 1997
Bristol Myers 1980 - 1989
3M 1978 - 1980
Skills
Validation, FDA, V&V, Quality Assurance, Business Development, Quality System, Biotechnology, Medical Devices, Pharmaceutical Industry, CAPA, Biopharmaceuticals, Process Simulation, Quality Auditing, Computer System..., 21 CFR Part 11, GMP, Manufacturing, Technology Transfer, Process Engineering, Equipment Qualification, Management, LIMS, Technology Management, Project Management, Change Control, Chromatography, Sop, Lifesciences, Contract Manufacturing, Quality Management, GAMP
Education
Louisiana Tech University 1973 — 1978
Bachelor of Science (B.S.), Biomedical Engineering
Neal and Company, Inc. November 2010 - Present
Biothermal Validation, LLC October 2009 - December 2010
Sandoz Inc United States 2009 - 2010
NNE Pharmaplan US December 2007 - September 2009
Diosynth 2001 - 2007
TheraTech, Inc. (later Watson) 1993 - 1997
Bristol Myers 1980 - 1989
3M 1978 - 1980
Skills
Validation, FDA, V&V, Quality Assurance, Business Development, Quality System, Biotechnology, Medical Devices, Pharmaceutical Industry, CAPA, Biopharmaceuticals, Process Simulation, Quality Auditing, Computer System..., 21 CFR Part 11, GMP, Manufacturing, Technology Transfer, Process Engineering, Equipment Qualification, Management, LIMS, Technology Management, Project Management, Change Control, Chromatography, Sop, Lifesciences, Contract Manufacturing, Quality Management, GAMP
Education
Louisiana Tech University 1973 — 1978
Bachelor of Science (B.S.), Biomedical Engineering
Pete Gillespie Pete Gillespie's Diosynth Experience 1996 - 1999
Job Principal Engineer at Grifols
Industry Pharmaceuticals
Experience
Grifols March 2009 - Present
Novartis Vaccines and Diagnostics December 2008 - March 2009
BiogenIdec January 1999 - December 2008
Covance Biotechnology Services 1996 - 1999
Diosynth 1996 - 1999
Covance Biotechnology now Diosynth September 1996 - December 1998
GlaxoWellcome January 1993 - August 1996
Skills
Biopharmaceuticals, CAPA, GMP, Change Control, Cell Culture, Aseptic Processing, Technology Transfer, Biotechnology, Validation, FDA, Fermentation, Plant Maintenance, Computer System..., GLP, Laboratory, Medical Devices, Cleaning Validation, Vaccines, Protein Chemistry, 21 CFR Part 11, Quality Assurance, GAMP, Quality Auditing, R&D, Metrology, Operations Management, Quality System, Factory, Pharmaceutical Industry, V&V, Chromatography, Trackwise, Facilities Management, GxP, Process Simulation, Sop, Cross-functional..., Quality Control, Cross-functional Team..., Purification, Downstream Processing, Filtration, Root Cause Analysis, WebDAV, Ultrafiltration, LIMS
Education
Maine Maritime Academy 1982 — 1986
BS Marine Engineering
Grifols March 2009 - Present
Novartis Vaccines and Diagnostics December 2008 - March 2009
BiogenIdec January 1999 - December 2008
Covance Biotechnology Services 1996 - 1999
Diosynth 1996 - 1999
Covance Biotechnology now Diosynth September 1996 - December 1998
GlaxoWellcome January 1993 - August 1996
Skills
Biopharmaceuticals, CAPA, GMP, Change Control, Cell Culture, Aseptic Processing, Technology Transfer, Biotechnology, Validation, FDA, Fermentation, Plant Maintenance, Computer System..., GLP, Laboratory, Medical Devices, Cleaning Validation, Vaccines, Protein Chemistry, 21 CFR Part 11, Quality Assurance, GAMP, Quality Auditing, R&D, Metrology, Operations Management, Quality System, Factory, Pharmaceutical Industry, V&V, Chromatography, Trackwise, Facilities Management, GxP, Process Simulation, Sop, Cross-functional..., Quality Control, Cross-functional Team..., Purification, Downstream Processing, Filtration, Root Cause Analysis, WebDAV, Ultrafiltration, LIMS
Education
Maine Maritime Academy 1982 — 1986
BS Marine Engineering
Lisa Saxon Lisa Saxon's Diosynth Experience 2006 - 2006
Job
Industry Biotechnology
Experience
Biogen Idec June 2014 - Present
Novartis Vaccines and Diagnostics April 2012 - June 2014
Novartis Vaccines and Diagnostics December 2009 - April 2012
Novartis Vaccines and Diagnostics May 2007 - December 2009
Diosynth 2006 - 2006
Wyeth 2004 - 2006
North Carolina Healthy Start Foundation 2002 - 2004
Nortel Networks 1997 - 2002
Skills
Manufacturing, Project Engineering, GMP, International Project..., Staff Supervision, Engineering, Biotechnology, Long term International..., Long Term, Assignment, 21 CFR Part 11, Pharmaceutical Industry, Process Optimization, Process Simulation, Project Management, SAP, Validation, CAPA, Aseptic Processing
Education
North Carolina State University
BS, Chemical and Biomolecular Engineering
Biogen Idec June 2014 - Present
Novartis Vaccines and Diagnostics April 2012 - June 2014
Novartis Vaccines and Diagnostics December 2009 - April 2012
Novartis Vaccines and Diagnostics May 2007 - December 2009
Diosynth 2006 - 2006
Wyeth 2004 - 2006
North Carolina Healthy Start Foundation 2002 - 2004
Nortel Networks 1997 - 2002
Skills
Manufacturing, Project Engineering, GMP, International Project..., Staff Supervision, Engineering, Biotechnology, Long term International..., Long Term, Assignment, 21 CFR Part 11, Pharmaceutical Industry, Process Optimization, Process Simulation, Project Management, SAP, Validation, CAPA, Aseptic Processing
Education
North Carolina State University
BS, Chemical and Biomolecular Engineering
Lois Dinterman Lois Dinterman's Diosynth Experience January 1996 - June 2001
Job Manager, Quality Assurance and Regulatory Compliance at Tenax Therapeutics, Inc. (formerly Oxygen Biotherapeutics, Inc.)
Industry Biotechnology
Experience
Tenax Therapeutics, Inc. (formerly Oxygen Biotherapeutics, Inc.) June 2012 - Present
Clinical Research Management June 2011 - February 2012
SAIC January 2009 - June 2011
BWA Consulting, LLC December 2008 - December 2009
Tunnell Consulting, Inc. May 2008 - December 2008
Lonza Walkersville, Inc. August 2004 - January 2008
USP Chapter <1046> ad hock Advisory Panel 2007 - 2008
Argos Therapeutics March 2001 - July 2004
Diosynth January 1996 - June 2001
Wyeth Biotech June 1991 - January 1996
Skills
FDA, GMP, GLP, GCP, Clinical Trials, Validation, Technology Transfer, Biotechnology, Quality Control, Quality Assurance, CAPA, Sop, Purification, Protein Chemistry, Lifesciences, Microbiology, Vaccines, Life Sciences, Regulatory Submissions, Biopharmaceuticals, Pharmaceutical Industry, Cell, R&D, Quality System, V&V, Computer System..., CMC, Regulatory Complicane, Fermentation Process..., Project Management, IND & CTD
Education
Hood College 1978 — 1980
BA, Biology
Tenax Therapeutics, Inc. (formerly Oxygen Biotherapeutics, Inc.) June 2012 - Present
Clinical Research Management June 2011 - February 2012
SAIC January 2009 - June 2011
BWA Consulting, LLC December 2008 - December 2009
Tunnell Consulting, Inc. May 2008 - December 2008
Lonza Walkersville, Inc. August 2004 - January 2008
USP Chapter <1046> ad hock Advisory Panel 2007 - 2008
Argos Therapeutics March 2001 - July 2004
Diosynth January 1996 - June 2001
Wyeth Biotech June 1991 - January 1996
Skills
FDA, GMP, GLP, GCP, Clinical Trials, Validation, Technology Transfer, Biotechnology, Quality Control, Quality Assurance, CAPA, Sop, Purification, Protein Chemistry, Lifesciences, Microbiology, Vaccines, Life Sciences, Regulatory Submissions, Biopharmaceuticals, Pharmaceutical Industry, Cell, R&D, Quality System, V&V, Computer System..., CMC, Regulatory Complicane, Fermentation Process..., Project Management, IND & CTD
Education
Hood College 1978 — 1980
BA, Biology
Stephen M. Perry's Diosynth Experience June 2001 - July 2003
Job President & CEO, Kymanox
Industry Pharmaceuticals
Experience
Kymanox August 2004 - Present
Human Genome Sciences July 2003 - June 2004
Diosynth June 2001 - July 2003
Diosynth January 2001 - June 2001
Covance January 2000 - January 2001
Abbott Laboratories July 1999 - January 2000
Abbott Laboratories June 1997 - July 1999
Meissner+Wurst May 1996 - August 1996
Skills
Technology Transfer, Validation, Process Engineering, Biotechnology, GMP, Training, Purification, FDA, Project Management, Process Simulation, Medical Devices, Lifesciences, Quality System, Commercialization, Manufacturing, Change Control, R&D, Pharmaceutics, Technical Leadership, Pharmaceutical Industry, Sop, 21 CFR Part 11, Biopharmaceuticals, V&V, Engineering, CAPA, Life Sciences
Education
Purdue University 1998 — 1999
University of Notre Dame 1993 — 1997
BS
Kymanox August 2004 - Present
Human Genome Sciences July 2003 - June 2004
Diosynth June 2001 - July 2003
Diosynth January 2001 - June 2001
Covance January 2000 - January 2001
Abbott Laboratories July 1999 - January 2000
Abbott Laboratories June 1997 - July 1999
Meissner+Wurst May 1996 - August 1996
Skills
Technology Transfer, Validation, Process Engineering, Biotechnology, GMP, Training, Purification, FDA, Project Management, Process Simulation, Medical Devices, Lifesciences, Quality System, Commercialization, Manufacturing, Change Control, R&D, Pharmaceutics, Technical Leadership, Pharmaceutical Industry, Sop, 21 CFR Part 11, Biopharmaceuticals, V&V, Engineering, CAPA, Life Sciences
Education
Purdue University 1998 — 1999
University of Notre Dame 1993 — 1997
BS
Nadia Ward Nadia Ward's Diosynth Experience January 2001 - June 2002
Job Account Manager at bioMérieux
Industry Pharmaceuticals
Experience
bioMérieux September 2008 - Present
Pfizer March 2003 - September 2008
Diosynth January 2001 - June 2002
Skills
Pharmaceutical Industry, Medical Devices, Biotechnology, Chromatography, Lifesciences
Education
Duke University 1998 — 2000
Chemistry
Florida Atlantic University 1995 — 1998
Bachelor of Science (BS), Chemistry
bioMérieux September 2008 - Present
Pfizer March 2003 - September 2008
Diosynth January 2001 - June 2002
Skills
Pharmaceutical Industry, Medical Devices, Biotechnology, Chromatography, Lifesciences
Education
Duke University 1998 — 2000
Chemistry
Florida Atlantic University 1995 — 1998
Bachelor of Science (BS), Chemistry
Elaine Snowhill Elaine Snowhill's Diosynth Experience February 2000 - August 2002
Job Independent Consultant and Organizational Advisor Mediation | Facilitation | Coaching | Advocacy
Industry Alternative Dispute Resolution
Experience
Life Technologies September 2002 - October 2011
Diosynth February 2000 - August 2002
Novartis November 1983 - December 1999
Skills
Biopharmaceuticals, Biotechnology, Lifesciences, Pharmaceutical Industry, Clinical Development, Technology Transfer, Mediation, Conflict Resolution, Team Building, Facilitators, Program Facilitation, Collaborative Problem..., Commercialization, Program Management, Drug Discovery, Medical Devices, R&D, Validation, Drug Development, FDA, Regulatory Affairs, Cross-functional Team..., Cell, Cell Biology, Integration, Quality Assurance, Organizational..., Leadership, Change Management, Facilitation, Life Sciences
Education
University of Oregon School of Law
M.S., Conflict & Dispute Resolution
Stanford University Graduate School of Business
Stanford Executive Business Program
University of Utah
Ph.D., Pharmacology
Lewis and Clark College
B.A., Psychology
Life Technologies September 2002 - October 2011
Diosynth February 2000 - August 2002
Novartis November 1983 - December 1999
Skills
Biopharmaceuticals, Biotechnology, Lifesciences, Pharmaceutical Industry, Clinical Development, Technology Transfer, Mediation, Conflict Resolution, Team Building, Facilitators, Program Facilitation, Collaborative Problem..., Commercialization, Program Management, Drug Discovery, Medical Devices, R&D, Validation, Drug Development, FDA, Regulatory Affairs, Cross-functional Team..., Cell, Cell Biology, Integration, Quality Assurance, Organizational..., Leadership, Change Management, Facilitation, Life Sciences
Education
University of Oregon School of Law
M.S., Conflict & Dispute Resolution
Stanford University Graduate School of Business
Stanford Executive Business Program
University of Utah
Ph.D., Pharmacology
Lewis and Clark College
B.A., Psychology
Kristi Borge Kristi Borge's Diosynth Experience June 2007 - May 2010
Job QA Inspector at Coty/Kelly Services
Industry Pharmaceuticals
Experience
Kelly Services/Coty July 2012 - Present
Diosynth June 2007 - May 2010
Pfizer February 2005 - May 2007
Kelly Services/Wyeth September 2004 - February 2005
Skills
LIMS, Access, Active Learning, Trackwise, Outlook, Lotus Notes, Optical Comparator, Light Boxes, Pipetting, Freezers, Assays, Measurement Systems, B2B software, Microsoft Office, Microsoft Excel, Microsoft Word, PowerPoint, Laboratory Equipment, Laboratory Safety, Laboratory Skills, Autoclave
Education
Sandhills Community College 2002 — 2004
Sandhills Community College 2002 — 2003
Lee County Senior High School 1998 — 2002
Diploma, Diploma
Lee County Senior High School 1998 — 2002
High School Diploma, College/University Preparatory and Advanced High School/Secondary Diploma Program
Kelly Services/Coty July 2012 - Present
Diosynth June 2007 - May 2010
Pfizer February 2005 - May 2007
Kelly Services/Wyeth September 2004 - February 2005
Skills
LIMS, Access, Active Learning, Trackwise, Outlook, Lotus Notes, Optical Comparator, Light Boxes, Pipetting, Freezers, Assays, Measurement Systems, B2B software, Microsoft Office, Microsoft Excel, Microsoft Word, PowerPoint, Laboratory Equipment, Laboratory Safety, Laboratory Skills, Autoclave
Education
Sandhills Community College 2002 — 2004
Sandhills Community College 2002 — 2003
Lee County Senior High School 1998 — 2002
Diploma, Diploma
Lee County Senior High School 1998 — 2002
High School Diploma, College/University Preparatory and Advanced High School/Secondary Diploma Program
Tunisia Harrison Tunisia Harrison's Diosynth Experience August 2001 - December 2001
Job Manufacturing Process Engineer at Pfizer
Industry Pharmaceuticals
Experience
Pfizer August 2011 - Present
Pfizer April 2003 - August 2011
Diosynth August 2001 - December 2001
Skills
CAPA, FDA, GMP, Technology Transfer, Sop, 21 CFR Part 11, Quality System, Manufacturing Operations, Aseptic Processing, Biotechnology, Continuous Improvement, LIMS, Pharmaceutical Industry, Quality Assurance, SOP, Software Documentation
Education
UNC Chapel Hill 1997 — 2001
Bachelor of Arts (B.A.), Journalism
Pfizer August 2011 - Present
Pfizer April 2003 - August 2011
Diosynth August 2001 - December 2001
Skills
CAPA, FDA, GMP, Technology Transfer, Sop, 21 CFR Part 11, Quality System, Manufacturing Operations, Aseptic Processing, Biotechnology, Continuous Improvement, LIMS, Pharmaceutical Industry, Quality Assurance, SOP, Software Documentation
Education
UNC Chapel Hill 1997 — 2001
Bachelor of Arts (B.A.), Journalism
Wendy Summers Wendy Summers's Diosynth Experience 1999 - December 2006
Job Associate Director, Head of External Manufacturing QA Americas at UCB
Industry Pharmaceuticals
Experience
UCB March 2014 - Present
UCB Pharma 2011 - Present
UCB Pharma 2011 - July 2012
Catalent Pharma Solutions January 2011 - July 2011
Biogen Idec November 2007 - December 2010
GlaxoSmithKline 2006 - 2007
Diosynth 1999 - December 2006
Skills
GMP, Supply Chain, Validation, Quality System, FDA, Change Control, Regulations, HPLC, GLP, Pharmaceutical Industry, Biopharmaceuticals, GAMP, Analytical Chemistry, Cleaning Validation, Biotechnology, Manufacturing, Aseptic Processing, Drug Development, Testing, Supply Chain Management, Chromatography, Computer System..., Quality Auditing, Microbiology, Supplier Quality, Vaccines, LIMS, Laboratory, Contract Manufacturing, Regulatory Submissions, Technology Transfer, Regulatory Requirements, Chemistry, Community Service, SOP, Quality Assurance, CAPA, 21 CFR Part 11, Pharmaceutics, GxP, Quality Management, Cross-functional Team...
Education
Campbell University 2006 — 2013
M.S.
American Society of Quality 2007 — 2012
certification
American Society of Quality 2006 — 2012
certification
Campbell University 1995 — 1998
B.S.
International Register of Certified Auditors (IRCA)
certification - Pharmaceutical GMP Auditor Certification
UCB March 2014 - Present
UCB Pharma 2011 - Present
UCB Pharma 2011 - July 2012
Catalent Pharma Solutions January 2011 - July 2011
Biogen Idec November 2007 - December 2010
GlaxoSmithKline 2006 - 2007
Diosynth 1999 - December 2006
Skills
GMP, Supply Chain, Validation, Quality System, FDA, Change Control, Regulations, HPLC, GLP, Pharmaceutical Industry, Biopharmaceuticals, GAMP, Analytical Chemistry, Cleaning Validation, Biotechnology, Manufacturing, Aseptic Processing, Drug Development, Testing, Supply Chain Management, Chromatography, Computer System..., Quality Auditing, Microbiology, Supplier Quality, Vaccines, LIMS, Laboratory, Contract Manufacturing, Regulatory Submissions, Technology Transfer, Regulatory Requirements, Chemistry, Community Service, SOP, Quality Assurance, CAPA, 21 CFR Part 11, Pharmaceutics, GxP, Quality Management, Cross-functional Team...
Education
Campbell University 2006 — 2013
M.S.
American Society of Quality 2007 — 2012
certification
American Society of Quality 2006 — 2012
certification
Campbell University 1995 — 1998
B.S.
International Register of Certified Auditors (IRCA)
certification - Pharmaceutical GMP Auditor Certification
Magnus Persmark Magnus Persmark's Diosynth Experience January 2003 - June 2005
Job Product Manager, Cellbased Assays at Invitrogen
Industry Biotechnology
Experience
Life Technologies 2007 - Present
Invitrogen July 2005 - August 2009
Diosynth January 2003 - June 2005
Diosynth June 2001 - December 2002
GlaxoSmithKline March 1997 - June 2001
Skills
Biotechnology, Drug Discovery, Lifesciences, Cell Biology, Molecular Biology, Immunology, Cell Culture, Genomics, Biochemistry, Biopharmaceuticals, Assay Development
Education
The Faculty of Engineering at Lund University 1984 — 1991
PhD, Biotechnology
Life Technologies 2007 - Present
Invitrogen July 2005 - August 2009
Diosynth January 2003 - June 2005
Diosynth June 2001 - December 2002
GlaxoSmithKline March 1997 - June 2001
Skills
Biotechnology, Drug Discovery, Lifesciences, Cell Biology, Molecular Biology, Immunology, Cell Culture, Genomics, Biochemistry, Biopharmaceuticals, Assay Development
Education
The Faculty of Engineering at Lund University 1984 — 1991
PhD, Biotechnology
Dawn Kanupp's Diosynth Experience June 2000 - July 2004
Job Associate Staff Quality Engineer
Industry Biotechnology
Experience
bioMerieux August 2011 - Present
Eisai April 2009 - April 2011
Wyeth Biotech July 2004 - April 2009
Diosynth June 2000 - July 2004
Glaxo Wellcome Inc. June 1999 - June 2000
Skills
GMP, Quality System, Calibration, Auditing, Documentum, Preventive Maintenance, GCPs, Work Orders, Quality Assurance, Vaccines, Manufacturing, CAPA, Change Control, FDA, 21 CFR Part 11, Validation, Pharmaceutical Industry, Aseptic Processing, Computer System..., GxP, Technology Transfer, Sop, LIMS, SOP
Education
Temple University 2003 — 2006
MS, Quality Assurance/Regulatory Affairs
Bowling Green State University 1993 — 1997
BS, Biology
bioMerieux August 2011 - Present
Eisai April 2009 - April 2011
Wyeth Biotech July 2004 - April 2009
Diosynth June 2000 - July 2004
Glaxo Wellcome Inc. June 1999 - June 2000
Skills
GMP, Quality System, Calibration, Auditing, Documentum, Preventive Maintenance, GCPs, Work Orders, Quality Assurance, Vaccines, Manufacturing, CAPA, Change Control, FDA, 21 CFR Part 11, Validation, Pharmaceutical Industry, Aseptic Processing, Computer System..., GxP, Technology Transfer, Sop, LIMS, SOP
Education
Temple University 2003 — 2006
MS, Quality Assurance/Regulatory Affairs
Bowling Green State University 1993 — 1997
BS, Biology
Yolanda Watson's Diosynth Experience January 2004 - September 2004
Job Quality Assurance Associate at Dendreon
Industry Biotechnology
Experience
Dendreon November 2012 - Present
Dendreon August 2010 - November 2012
Pfizer (formally Wyeth) September 2004 - August 2010
Diosynth January 2004 - September 2004
Diosynth January 2001 - September 2004
Purification January 2001 - January 2004
Skills
LIMS, Validation, Protocol, Cleaning Validation, Software Documentation, Quality Control, Troubleshooting, Technical Writing, Process Engineering, Research, File Management, Spreadsheets, WebDAV, IQ, Fermentation, Sop, GMP, CAPA, V&V, Change Control, Vaccines, Biotechnology, Quality Assurance, Aseptic Technique, HPLC, Purification, Protein Chemistry, Cell, Clean Rooms, Centrifugation, GLP, SOP, 21 CFR Part 11
Education
NC A&T State University 1995 — 1999
Bachelor of Science, Chemical Engineering
North Carolina Agricultural and Technical State University 1995 — 1999
B.S., Chemical Engineering
Dendreon November 2012 - Present
Dendreon August 2010 - November 2012
Pfizer (formally Wyeth) September 2004 - August 2010
Diosynth January 2004 - September 2004
Diosynth January 2001 - September 2004
Purification January 2001 - January 2004
Skills
LIMS, Validation, Protocol, Cleaning Validation, Software Documentation, Quality Control, Troubleshooting, Technical Writing, Process Engineering, Research, File Management, Spreadsheets, WebDAV, IQ, Fermentation, Sop, GMP, CAPA, V&V, Change Control, Vaccines, Biotechnology, Quality Assurance, Aseptic Technique, HPLC, Purification, Protein Chemistry, Cell, Clean Rooms, Centrifugation, GLP, SOP, 21 CFR Part 11
Education
NC A&T State University 1995 — 1999
Bachelor of Science, Chemical Engineering
North Carolina Agricultural and Technical State University 1995 — 1999
B.S., Chemical Engineering
donald milden donald milden's Diosynth Experience April 1995 - May 2003
Job Shift Lead Biogen Idec
Industry Biotechnology
Experience
Biogen January 2007 - Present
Biogen January 2006 - Present
Amgen 2002 - 2006
Diosynth April 1995 - May 2003
Skills
cGMP, Biotechnology, Aseptic Technique, SOP, Validation, GMP, Sop, Biopharmaceuticals, Process Improvement, CAPA, Cell Culture, GLP, Purification, 21 CFR Part 11, Quality Assurance, Change Control, Lifesciences, Vaccines, Pharmaceutical Industry, Aseptic Processing, LIMS, V&V, Cleaning Validation, Downstream Processing, FDA, Technology Transfer, Fermentation, HPLC, Chromatography, Gas Chromatography, Pharmaceutics, GAMP, Protein Purification, CIP, Computer System..., GxP, Process Simulation, Trackwise, Deviations, Medical Devices, FDA GMP, cGMP manufacturing, Quality System, Manufacturing, Quality Control, IND, TrackWise, Life Sciences
Education
New Catholic High School 1970 — 1974
Johnson C. Smith University - JCSU
Biogen January 2007 - Present
Biogen January 2006 - Present
Amgen 2002 - 2006
Diosynth April 1995 - May 2003
Skills
cGMP, Biotechnology, Aseptic Technique, SOP, Validation, GMP, Sop, Biopharmaceuticals, Process Improvement, CAPA, Cell Culture, GLP, Purification, 21 CFR Part 11, Quality Assurance, Change Control, Lifesciences, Vaccines, Pharmaceutical Industry, Aseptic Processing, LIMS, V&V, Cleaning Validation, Downstream Processing, FDA, Technology Transfer, Fermentation, HPLC, Chromatography, Gas Chromatography, Pharmaceutics, GAMP, Protein Purification, CIP, Computer System..., GxP, Process Simulation, Trackwise, Deviations, Medical Devices, FDA GMP, cGMP manufacturing, Quality System, Manufacturing, Quality Control, IND, TrackWise, Life Sciences
Education
New Catholic High School 1970 — 1974
Johnson C. Smith University - JCSU
Kim Batts's Diosynth Experience June 2007 - April 2010
Job Supply Chain Coordinator at Fujifilm Diosynth Biotechnologies
Industry Biotechnology
Experience
Fujifilm Diosynth Biotechnologies November 2011 - Present
Merck (Diosynth Biotechnology) May 2010 - November 2011
Diosynth June 2007 - April 2010
Wyeth Biotech October 2004 - June 2007
Wyeth Biotech March 2002 - October 2004
Wyeth Biotech October 2000 - May 2002
Abbott Laboratories September 1998 - October 2000
Abbott Laboratories September 1995 - September 1998
Skills
Microbiology, Fermentation, Testing, GMP, Biopharmaceuticals, LIMS, 21 CFR Part 11, Biotechnology, GLP, Change Control, Sop, Pharmaceutical Industry, CAPA, Formulation, Quality Control, Regulatory Affairs, Vaccines, Validation, Analytical Chemistry, Aseptic Processing, FDA, Laboratory, Quality System, Quality Assurance, SOP
Education
UMUC 2004 — 2006
Courses in Microbiology, Ethics, and Bioinformatics, Biotechnology
North Carolina Wesleyan College 1990 — 1995
BS, Biology
Fujifilm Diosynth Biotechnologies November 2011 - Present
Merck (Diosynth Biotechnology) May 2010 - November 2011
Diosynth June 2007 - April 2010
Wyeth Biotech October 2004 - June 2007
Wyeth Biotech March 2002 - October 2004
Wyeth Biotech October 2000 - May 2002
Abbott Laboratories September 1998 - October 2000
Abbott Laboratories September 1995 - September 1998
Skills
Microbiology, Fermentation, Testing, GMP, Biopharmaceuticals, LIMS, 21 CFR Part 11, Biotechnology, GLP, Change Control, Sop, Pharmaceutical Industry, CAPA, Formulation, Quality Control, Regulatory Affairs, Vaccines, Validation, Analytical Chemistry, Aseptic Processing, FDA, Laboratory, Quality System, Quality Assurance, SOP
Education
UMUC 2004 — 2006
Courses in Microbiology, Ethics, and Bioinformatics, Biotechnology
North Carolina Wesleyan College 1990 — 1995
BS, Biology
Christopher P Moore Christopher P Moore's Diosynth Experience August 2004 - May 2007
Job Experienced Biotechnology and Process/Cleaning Validation Professional
Industry Biotechnology
Experience
Fujifilm Diosynth Biotechnologies June 2009 - June 2014
Diosynth Biotechnology May 2007 - June 2009
Diosynth August 2004 - May 2007
Diosynth July 2001 - July 2004
Cytomedix June 1998 - July 2001
Duke University Medical Center September 1996 - August 1998
Skills
SAS JMP enthusiast, Fluent Spanish, Yellow Belt LSS, GMP, Technology Transfer, Yellow Belt, Validation, Biopharmaceuticals, Change Control, Cleaning Validation, Quality Assurance, Vaccines, LIMS, Biotechnology, Manufacturing, Quality System, Aseptic Processing, GxP, Purification, CAPA, FDA, Deviations, 21 CFR Part 11, Sop, GLP, V&V, Computer System..., Laboratory, SOP
Education
North Carolina State University - College of Management 1997 — 2000
MBA, Operations Management
Georgia State University 1994 — 1996
BS, Medical Technology
Duke University 1983 — 1987
AB, Comparative Area Studies
Fujifilm Diosynth Biotechnologies June 2009 - June 2014
Diosynth Biotechnology May 2007 - June 2009
Diosynth August 2004 - May 2007
Diosynth July 2001 - July 2004
Cytomedix June 1998 - July 2001
Duke University Medical Center September 1996 - August 1998
Skills
SAS JMP enthusiast, Fluent Spanish, Yellow Belt LSS, GMP, Technology Transfer, Yellow Belt, Validation, Biopharmaceuticals, Change Control, Cleaning Validation, Quality Assurance, Vaccines, LIMS, Biotechnology, Manufacturing, Quality System, Aseptic Processing, GxP, Purification, CAPA, FDA, Deviations, 21 CFR Part 11, Sop, GLP, V&V, Computer System..., Laboratory, SOP
Education
North Carolina State University - College of Management 1997 — 2000
MBA, Operations Management
Georgia State University 1994 — 1996
BS, Medical Technology
Duke University 1983 — 1987
AB, Comparative Area Studies
Megan Trogdon's Diosynth Experience July 2007 - June 2008
Job QA Lead Investigator at Almac Group
Industry Biotechnology
Experience
Almac Group March 2015 - Present
bioMerieux August 2014 - March 2015
bioMerieux January 2014 - August 2014
Biomerieux June 2011 - January 2014
Biogen Idec June 2008 - June 2011
Diosynth July 2007 - June 2008
Wyeth January 2007 - July 2007
Skills
Quality Control, GMP, Knowledge of regulatory..., Team Leadership, Cross-functional Team..., Excellent written and..., Outstanding Communicator, Outstanding..., Communication, Problem Solving, Outstanding, Regulatory Requirements, GLP, LIMS, Microbiology, Analytical Chemistry, Validation, Technology Transfer, FDA, Laboratory, Quality System, Biotechnology
Education
University of North Carolina at Wilmington 2002 — 2006
Bachelor of Science (B.S.), Biology, General
Almac Group March 2015 - Present
bioMerieux August 2014 - March 2015
bioMerieux January 2014 - August 2014
Biomerieux June 2011 - January 2014
Biogen Idec June 2008 - June 2011
Diosynth July 2007 - June 2008
Wyeth January 2007 - July 2007
Skills
Quality Control, GMP, Knowledge of regulatory..., Team Leadership, Cross-functional Team..., Excellent written and..., Outstanding Communicator, Outstanding..., Communication, Problem Solving, Outstanding, Regulatory Requirements, GLP, LIMS, Microbiology, Analytical Chemistry, Validation, Technology Transfer, FDA, Laboratory, Quality System, Biotechnology
Education
University of North Carolina at Wilmington 2002 — 2006
Bachelor of Science (B.S.), Biology, General
Ellen Wofford Ellen Wofford's Diosynth Experience 2005 - 2007
Job Sr. Regulatory SpecialistLicensing at Grifols
Industry Biotechnology
Experience
Grifols February 2015 - Present
Grifols (former Talecris Plasma Resources) September 2010 - Present
Talecris Plasma Resources (Now Grifols) November 2007 - September 2010
Diosynth 2005 - 2007
Glaxosmithkline 2003 - 2005
Skills
•PPTA Viral Mark..., State Licensing, PPTA Certification, cGMP, FDA, SOP, CAPA, Quality Systems, GCP, Regulatory Affairs, GMP, Pharmaceuticals, Biotechnology, Quality Assurance, Compliance, Documentation, Auditing, 21 CFR Part 11, Document Management, Validation, Regulatory Requirements, Documentum, Quality Management, Problem Solving, Manufacturing, Quality Auditing, LIMS, Regulatory Submissions, Access, Computer System..., Continuous Improvement, Biopharmaceuticals, Excel, Microsoft Office, Healthcare, Quality System, Sop, Software Documentation, Microsoft Excel, V&V, GxP, Quality Control, Technology Transfer, Aseptic Processing, Trackwise, Cleaning Validation, Vaccines
Education
California State University-Dominguez Hills
MSQA, Quality Assurance
University of Phoenix 2002 — 2005
BSHCS, Health Care
Grifols February 2015 - Present
Grifols (former Talecris Plasma Resources) September 2010 - Present
Talecris Plasma Resources (Now Grifols) November 2007 - September 2010
Diosynth 2005 - 2007
Glaxosmithkline 2003 - 2005
Skills
•PPTA Viral Mark..., State Licensing, PPTA Certification, cGMP, FDA, SOP, CAPA, Quality Systems, GCP, Regulatory Affairs, GMP, Pharmaceuticals, Biotechnology, Quality Assurance, Compliance, Documentation, Auditing, 21 CFR Part 11, Document Management, Validation, Regulatory Requirements, Documentum, Quality Management, Problem Solving, Manufacturing, Quality Auditing, LIMS, Regulatory Submissions, Access, Computer System..., Continuous Improvement, Biopharmaceuticals, Excel, Microsoft Office, Healthcare, Quality System, Sop, Software Documentation, Microsoft Excel, V&V, GxP, Quality Control, Technology Transfer, Aseptic Processing, Trackwise, Cleaning Validation, Vaccines
Education
California State University-Dominguez Hills
MSQA, Quality Assurance
University of Phoenix 2002 — 2005
BSHCS, Health Care
Dan Rosado's Diosynth Experience January 2001 - March 2011
Job Engineer II at FUJIFILM Diosynth Biotechnologies
Industry Biotechnology
Experience
Fujifilm Diosynth Biotechnologies July 2013 - Present
FUJIFILM Diosynth Biotechnologies March 2011 - July 2013
Diosynth January 2001 - March 2011
LabCorp April 1998 - December 2000
Skills
SDS-PAGE, ELISA, Protein Chemistry, Cell Culture, Fermentation, Assay Development, Cell Biology
Education
North Carolina State University 1992 — 1997
BS, Microbiology
Fujifilm Diosynth Biotechnologies July 2013 - Present
FUJIFILM Diosynth Biotechnologies March 2011 - July 2013
Diosynth January 2001 - March 2011
LabCorp April 1998 - December 2000
Skills
SDS-PAGE, ELISA, Protein Chemistry, Cell Culture, Fermentation, Assay Development, Cell Biology
Education
North Carolina State University 1992 — 1997
BS, Microbiology
Johanna Sikes Johanna Sikes's Diosynth Experience April 2004 - December 2004
Job Rooftop Manager at Hibernian Company, Inc./Solas
Industry Hospitality
Experience
Hibernian Company, Inc./Solas November 2012 - Present
Hibernian Company, Inc./Solas August 2008 - Present
Solas July 2008 - Present
an Cuisines October 2006 - March 2008
GlaxoSmithKline RTP August 2007 - November 2007
AAI Pharmaceuticals November 2006 - August 2007
Cirrus Pharmaceuticals January 2005 - October 2006
Diosynth April 2004 - December 2004
Skills
Outstanding Customer..., Attention To Detail, Organizational Structure, Leadership, Microsoft Office, Budgets, Microsoft Excel, Sales, Strategic Planning, Project Management, PowerPoint, Outlook, Human Resources, Customer Service, Analytical Chemistry, Food & Beverage, Restaurants, Training
Education
NC State University 2000 — 2004
BS) Biochemistry(BA), ChemistryBiology
North Carolina State University 2000 — 2004
Bachelor's degree, Biochemistry
Hibernian Company, Inc./Solas November 2012 - Present
Hibernian Company, Inc./Solas August 2008 - Present
Solas July 2008 - Present
an Cuisines October 2006 - March 2008
GlaxoSmithKline RTP August 2007 - November 2007
AAI Pharmaceuticals November 2006 - August 2007
Cirrus Pharmaceuticals January 2005 - October 2006
Diosynth April 2004 - December 2004
Skills
Outstanding Customer..., Attention To Detail, Organizational Structure, Leadership, Microsoft Office, Budgets, Microsoft Excel, Sales, Strategic Planning, Project Management, PowerPoint, Outlook, Human Resources, Customer Service, Analytical Chemistry, Food & Beverage, Restaurants, Training
Education
NC State University 2000 — 2004
BS) Biochemistry(BA), ChemistryBiology
North Carolina State University 2000 — 2004
Bachelor's degree, Biochemistry
Jayant Aphale Jayant Aphale's Diosynth Experience 2000 - 2003
Job SVP, Technical Operations at Sarepta Therapeutics
Industry Biotechnology
Experience
Sarepta Therapeutics (formerly AVI BioPharma) December 2011 - Present
Apex CMC Advisors, LLC January 2011 - January 2012
GSK January 2010 - November 2010
Enobia Pharma June 2008 - January 2010
Acambis February 2006 - May 2008
Wyeth October 2003 - February 2006
Diosynth 2000 - 2003
Roche Diagnostics 1996 - 2000
Skills
Technology Transfer, Scale Up, FDA, Oligonucleotides, Biotechnology, Vaccines, Commercialization, Pharmaceutical Industry, Lifesciences, Business Process..., Project Portfolio..., Earned Value Management, Government Contracting
Education
University of North Carolina at Chapel Hill - Kenan-Flagler Business School 2001 — 2003
MBA, Strategy, finance, marketing
The Ohio State University 1987 — 1992
Ph. D., Molecular biology, fermentation technology, downstream processing
King George HS, Bombay
King George HS, Bombay
Sarepta Therapeutics (formerly AVI BioPharma) December 2011 - Present
Apex CMC Advisors, LLC January 2011 - January 2012
GSK January 2010 - November 2010
Enobia Pharma June 2008 - January 2010
Acambis February 2006 - May 2008
Wyeth October 2003 - February 2006
Diosynth 2000 - 2003
Roche Diagnostics 1996 - 2000
Skills
Technology Transfer, Scale Up, FDA, Oligonucleotides, Biotechnology, Vaccines, Commercialization, Pharmaceutical Industry, Lifesciences, Business Process..., Project Portfolio..., Earned Value Management, Government Contracting
Education
University of North Carolina at Chapel Hill - Kenan-Flagler Business School 2001 — 2003
MBA, Strategy, finance, marketing
The Ohio State University 1987 — 1992
Ph. D., Molecular biology, fermentation technology, downstream processing
King George HS, Bombay
King George HS, Bombay
Jessica Bridges Weaver's Diosynth Experience October 2005 - April 2007
Job Scientist II, Bioprocess Services for BTEC at North Carolina State University
Industry Biotechnology
Experience
North Carolina State University July 2012 - Present
North Carolina State University December 2010 - July 2012
North Carolina State University April 2007 - December 2010
Diosynth October 2005 - April 2007
RBC Bank March 2001 - October 2005
Skills
Aseptic Technique, Centrifugation, Chromatography, Cell Culture, Protein Purification, AKTA, Explorer,..., TFF, Continous Flow..., Mammalian Cell Culture, Fermentation, Fermentation Process..., Space planning, Client Relations Skills, GLP, cGMP practices, Gel Electrophoresis, ELISA, SDS-PAGE, Microbiology, Biotechnology
Education
Western Carolina University 2015 — 2016
Graduate Certificate, Project Management
North Carolina State University
Master of Food Science, Bioprocessing
North Carolina State University
Bachelor of Science (B.S.), Biological Engineering
North Carolina State University July 2012 - Present
North Carolina State University December 2010 - July 2012
North Carolina State University April 2007 - December 2010
Diosynth October 2005 - April 2007
RBC Bank March 2001 - October 2005
Skills
Aseptic Technique, Centrifugation, Chromatography, Cell Culture, Protein Purification, AKTA, Explorer,..., TFF, Continous Flow..., Mammalian Cell Culture, Fermentation, Fermentation Process..., Space planning, Client Relations Skills, GLP, cGMP practices, Gel Electrophoresis, ELISA, SDS-PAGE, Microbiology, Biotechnology
Education
Western Carolina University 2015 — 2016
Graduate Certificate, Project Management
North Carolina State University
Master of Food Science, Bioprocessing
North Carolina State University
Bachelor of Science (B.S.), Biological Engineering
Eyuphan Karca Eyuphan Karca's Diosynth Experience June 2001 - December 2002
Job Supply Operations Manager at Novartis
Industry Pharmaceuticals
Experience
Novartis August 2012 - Present
Novartis October 2008 - July 2012
Schering Plough March 2007 - October 2008
Organon USA Inc. January 2003 - March 2007
Organon 2003 - 2005
Diosynth June 2001 - December 2002
Labcorp Inc. September 2000 - June 2001
Skills
Pharmaceutical Industry, Clinical Development, GMP, Clinical Trials, Sop, Biotechnology, Oncology, GCP, CRO, Regulatory Affairs, Validation, CTMS, SAP
Education
Fairleigh Dickinson University 2004 — 2007
MBA, Pharmaceutical Management
East Carolina University 1996 — 2000
B.S., Biochemistry
Novartis August 2012 - Present
Novartis October 2008 - July 2012
Schering Plough March 2007 - October 2008
Organon USA Inc. January 2003 - March 2007
Organon 2003 - 2005
Diosynth June 2001 - December 2002
Labcorp Inc. September 2000 - June 2001
Skills
Pharmaceutical Industry, Clinical Development, GMP, Clinical Trials, Sop, Biotechnology, Oncology, GCP, CRO, Regulatory Affairs, Validation, CTMS, SAP
Education
Fairleigh Dickinson University 2004 — 2007
MBA, Pharmaceutical Management
East Carolina University 1996 — 2000
B.S., Biochemistry
Andrew Dunbar, EIT Andrew Dunbar, EIT's Diosynth Experience May 2009 - August 2009
Job Mechanical Engineer at Siemens Healthcare
Industry Mechanical or Industrial Engineering
Experience
Siemens Healthcare September 2013 - Present
Charles P King, CPA January 2013 - April 2013
Farm Design January 2012 - July 2012
Sperry Product Innovation January 2011 - June 2011
Foster-Miller January 2010 - August 2010
Diosynth May 2009 - August 2009
Skills
Solidworks, Pro Engineer, Engineering, Rapid Prototyping, Design for Manufacturing, Matlab, CAD, Surfacing, Creo, Tolerance Analysis, Manufacturing, Machining, Microsoft Office, Engineering Management, Mechanical Engineering, Injection Molding
Education
Northeastern University 2008 — 2013
B.S. Mechanical Engineering, Mechanical Engineering
Siemens Healthcare September 2013 - Present
Charles P King, CPA January 2013 - April 2013
Farm Design January 2012 - July 2012
Sperry Product Innovation January 2011 - June 2011
Foster-Miller January 2010 - August 2010
Diosynth May 2009 - August 2009
Skills
Solidworks, Pro Engineer, Engineering, Rapid Prototyping, Design for Manufacturing, Matlab, CAD, Surfacing, Creo, Tolerance Analysis, Manufacturing, Machining, Microsoft Office, Engineering Management, Mechanical Engineering, Injection Molding
Education
Northeastern University 2008 — 2013
B.S. Mechanical Engineering, Mechanical Engineering
Maurica Lawrence Maurica Lawrence's Diosynth Experience August 2000 - June 2003
Job Fermentation Manager at Mycosynthetix
Industry Biotechnology
Experience
Mycosynthetix October 2008 - Present
AMGEN July 2003 - January 2008
Diosynth August 2000 - June 2003
OSI Pharmaceuticals September 1993 - March 2000
Alamance Community College, Graham, NC 1991 - 1993
Alamance Community College, Graham, NC 1991 - 1993
Skills
Lean Manufacturing, Pharmaceutical Industry, Lifesciences, Team Leadership, Process Simulation, Quality System, Strategic Planning, Quality Assurance, Change Control, Chromatography, CAPA, Biopharmaceuticals, Cell Culture, Aseptic Processing, Aseptic Technique, Downstream Processing
Education
Kaplan University 2007 — 2009
BS, Communication-Technical Writing
Alamance Community College 1991 — 1993
Associate of Applied Science, Biotechnology
City University of New York-Herbert H. Lehman College 1970 — 1973
NA, Physical Education
Erasmus Hall 1967 — 1970
Academic, Academic Diploma
Mycosynthetix October 2008 - Present
AMGEN July 2003 - January 2008
Diosynth August 2000 - June 2003
OSI Pharmaceuticals September 1993 - March 2000
Alamance Community College, Graham, NC 1991 - 1993
Alamance Community College, Graham, NC 1991 - 1993
Skills
Lean Manufacturing, Pharmaceutical Industry, Lifesciences, Team Leadership, Process Simulation, Quality System, Strategic Planning, Quality Assurance, Change Control, Chromatography, CAPA, Biopharmaceuticals, Cell Culture, Aseptic Processing, Aseptic Technique, Downstream Processing
Education
Kaplan University 2007 — 2009
BS, Communication-Technical Writing
Alamance Community College 1991 — 1993
Associate of Applied Science, Biotechnology
City University of New York-Herbert H. Lehman College 1970 — 1973
NA, Physical Education
Erasmus Hall 1967 — 1970
Academic, Academic Diploma
Arbella Jones Arbella Jones's Diosynth Experience June 2001 - May 2010
Job Environmental Monitoring Technician
Industry Pharmaceuticals
Experience
Merck September 2013 - Present
NSI Solutions September 2013 - September 2013
Becton Dickinson October 2010 - December 2012
Diosynth June 2001 - May 2010
BIOGEN IDEC October 2000 - April 2001
Grifols August 1998 - August 1999
Covidien Healthcare January 1999 - March 1999
Skills
LIMS, Quality Control, Microbiology, Manufacturing, Troubleshooting, Environmental Monitoring, GMP, Calibration, Biotechnology, CAPA, FDA, Pharmaceutical Industry, Quality System, Biopharmaceuticals, 21 CFR Part 11, HPLC, SOP, Sop
Education
Campbell University 2004 — 2010
Bachelor of Applied Science, Industrial Pharmaceutical Technology
Wake Technical Community College 1993 — 1996
Associate in Applied Science, Industrial Pharmaceutical Technology
Southern Nash Sr. High School 1989 — 1992
High school diploma
Merck September 2013 - Present
NSI Solutions September 2013 - September 2013
Becton Dickinson October 2010 - December 2012
Diosynth June 2001 - May 2010
BIOGEN IDEC October 2000 - April 2001
Grifols August 1998 - August 1999
Covidien Healthcare January 1999 - March 1999
Skills
LIMS, Quality Control, Microbiology, Manufacturing, Troubleshooting, Environmental Monitoring, GMP, Calibration, Biotechnology, CAPA, FDA, Pharmaceutical Industry, Quality System, Biopharmaceuticals, 21 CFR Part 11, HPLC, SOP, Sop
Education
Campbell University 2004 — 2010
Bachelor of Applied Science, Industrial Pharmaceutical Technology
Wake Technical Community College 1993 — 1996
Associate in Applied Science, Industrial Pharmaceutical Technology
Southern Nash Sr. High School 1989 — 1992
High school diploma
Jozef Orpiszewski's Diosynth Experience 2000 - September 2005
Job
Industry Biotechnology
Experience
FUJIFILM Diosynth Biotechnologies April 2011 - Present
Merck September 2010 - April 2011
TransTech Pharma December 2009 - October 2010
Diosynth Biotechnology August 2007 - December 2009
Diosynth Biotechnology 2005 - 2007
Diosynth 2000 - September 2005
Indiana University, Medical Ctr 1996 - 1999
University of California, Irvine 1993 - 1996
Skills
Biopharmaceuticals, Biotechnology, Protein Chemistry, GMP, Microbiology, Analytical Chemistry, Formulation, In Vivo, Pharmaceutics, IND, Contract Manufacturing, Biologics, Technology Transfer, Project Management, Lifesciences, Pharmaceutical Industry, Contract Negotiation, Manufacturing, Chromatography, Purification, Drug Development, FDA, GLP, Life Sciences, Monoclonal Antibodies, Vaccines, Validation
Education
University of North Carolina at Chapel Hill - Kenan-Flagler Business School 2004 — 2006
MBA
University of California, Irvine 1993 — 1996
postdoc, biochemistry
Technical University of Wroclaw 1992 — 1992
Ph.D., Chemistry
Technical University of Wroclaw 1978 — 1983
MSc, Eng., Biotechnology/Bioorganic Chemistry
FUJIFILM Diosynth Biotechnologies April 2011 - Present
Merck September 2010 - April 2011
TransTech Pharma December 2009 - October 2010
Diosynth Biotechnology August 2007 - December 2009
Diosynth Biotechnology 2005 - 2007
Diosynth 2000 - September 2005
Indiana University, Medical Ctr 1996 - 1999
University of California, Irvine 1993 - 1996
Skills
Biopharmaceuticals, Biotechnology, Protein Chemistry, GMP, Microbiology, Analytical Chemistry, Formulation, In Vivo, Pharmaceutics, IND, Contract Manufacturing, Biologics, Technology Transfer, Project Management, Lifesciences, Pharmaceutical Industry, Contract Negotiation, Manufacturing, Chromatography, Purification, Drug Development, FDA, GLP, Life Sciences, Monoclonal Antibodies, Vaccines, Validation
Education
University of North Carolina at Chapel Hill - Kenan-Flagler Business School 2004 — 2006
MBA
University of California, Irvine 1993 — 1996
postdoc, biochemistry
Technical University of Wroclaw 1992 — 1992
Ph.D., Chemistry
Technical University of Wroclaw 1978 — 1983
MSc, Eng., Biotechnology/Bioorganic Chemistry
Daniel Siegle's Diosynth Experience January 2008 - October 2008
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
Roger Kriegl MS MBA PMP's Diosynth Experience July 2000 - May 2002
Job Senior Manager API Contract Manufacturing at Sanofi
Industry Biotechnology
Experience
Sanofi - CEPiA April 2014 - Present
Self October 2012 - April 2014
Baxter BioScience October 2007 - October 2012
Baxter/Epic Therapeutics January 2006 - October 2007
Baxter August 2003 - December 2005
Baxter May 2002 - December 2005
Diosynth July 2000 - May 2002
Pfizer 1995 - July 2000
American Cyanamid 1989 - 1993
Skills
Process Improvement, Program Management, Quality Assurance, Six Sigma, Project Management, Management, MS Project, Product Development, Manufacturing, Lean Manufacturing, Business Development, Budgets, Project Planning, Integration, Process Simulation, Logistics, GMP, R&D, Proposal Writing, Cross-functional Team..., Medical Devices, Clinical Trials, Strategy, Biotechnology, FDA, Pharmaceutical Industry, Technology Transfer, Biopharmaceuticals
Education
University of Nebraska-Lincoln 1996 — 1998
MBA, International Business
New York Medical College 1989 — 1993
MS, Microbiology and Immunology
University at Albany, SUNY 1986 — 1989
BS, Combined
State University of New York at New Paltz 1985 — 1986
Transfer, Biology
Sanofi - CEPiA April 2014 - Present
Self October 2012 - April 2014
Baxter BioScience October 2007 - October 2012
Baxter/Epic Therapeutics January 2006 - October 2007
Baxter August 2003 - December 2005
Baxter May 2002 - December 2005
Diosynth July 2000 - May 2002
Pfizer 1995 - July 2000
American Cyanamid 1989 - 1993
Skills
Process Improvement, Program Management, Quality Assurance, Six Sigma, Project Management, Management, MS Project, Product Development, Manufacturing, Lean Manufacturing, Business Development, Budgets, Project Planning, Integration, Process Simulation, Logistics, GMP, R&D, Proposal Writing, Cross-functional Team..., Medical Devices, Clinical Trials, Strategy, Biotechnology, FDA, Pharmaceutical Industry, Technology Transfer, Biopharmaceuticals
Education
University of Nebraska-Lincoln 1996 — 1998
MBA, International Business
New York Medical College 1989 — 1993
MS, Microbiology and Immunology
University at Albany, SUNY 1986 — 1989
BS, Combined
State University of New York at New Paltz 1985 — 1986
Transfer, Biology
Axline, Cheryln's Diosynth Experience November 2010 - Present
Job Prodcution Manger Downstream
Industry Biotechnology
Experience
Diosynth November 2010 - Present
Diosynth Biotechnology Inc. 1999 - November 2010
Skills
GMP, Biopharmaceuticals, Technology Transfer, Chromatography, Biotechnology, Filtration, Sop, Validation, Purification, Fermentation, Change Control, GLP, Aseptic Processing, 21 CFR Part 11, LIMS, CAPA, HPLC, FDA, SOP
Education
Fayetteville State University 1994 — 1998
Batchelor of Science, Biology/Chemistry
Diosynth November 2010 - Present
Diosynth Biotechnology Inc. 1999 - November 2010
Skills
GMP, Biopharmaceuticals, Technology Transfer, Chromatography, Biotechnology, Filtration, Sop, Validation, Purification, Fermentation, Change Control, GLP, Aseptic Processing, 21 CFR Part 11, LIMS, CAPA, HPLC, FDA, SOP
Education
Fayetteville State University 1994 — 1998
Batchelor of Science, Biology/Chemistry
Devon Allen's Diosynth Experience 2000 - 2005
Job Sr. Director, R&D Strategy, GlaxoSmithKline
Industry Pharmaceuticals
Experience
Stiefel, a GSK company January 2011 - Present
Stiefel Laboratories October 2006 - January 2011
Erimos Pharmaceuticals April 2005 - October 2006
Diosynth 2000 - 2005
Diosynth Biotechnology 2000 - 2005
Skills
Pharmaceutical Industry, Regulatory Affairs, Regulatory Submissions, FDA, Biopharmaceuticals, Drug Development, Clinical Development, GMP, Validation, Biotechnology, Technology Transfer, Sop, Change Control, GxP, CAPA, 21 CFR Part 11, Clinical Trials, GLP, CRO, GCP, Team Leadership, Strategic Planning, People Development
Education
University of North Carolina at Chapel Hill 1994 — 1997
M.S., Biological Chemistry
Southwestern University 1990 — 1994
Chemistry
Stiefel, a GSK company January 2011 - Present
Stiefel Laboratories October 2006 - January 2011
Erimos Pharmaceuticals April 2005 - October 2006
Diosynth 2000 - 2005
Diosynth Biotechnology 2000 - 2005
Skills
Pharmaceutical Industry, Regulatory Affairs, Regulatory Submissions, FDA, Biopharmaceuticals, Drug Development, Clinical Development, GMP, Validation, Biotechnology, Technology Transfer, Sop, Change Control, GxP, CAPA, 21 CFR Part 11, Clinical Trials, GLP, CRO, GCP, Team Leadership, Strategic Planning, People Development
Education
University of North Carolina at Chapel Hill 1994 — 1997
M.S., Biological Chemistry
Southwestern University 1990 — 1994
Chemistry
Jean Elade Eloi's Diosynth Experience 2002 - 2004
Job Director, Program Management, KBI BioPharma Inc.
Industry Biotechnology
Experience
Hope for Haiti Foundation June 2012 - June 2014
Hope Community Church June 2009 - May 2012
Invitrogen Corporatiom April 2007 - 2009
Invitrogen Corporation 2004 - 2007
Diosynth 2002 - 2004
Skills
Technology Transfer, Biotechnology, Biopharmaceuticals, FDA, GMP, Validation, Project Management, Lifesciences, Sop, 21 CFR Part 11, Change Control, Clinical Development, Pharmaceutical Industry, Process Simulation, Vaccines, Cross-functional Team..., Regulatory Affairs, GLP, Microsoft Office, Medical Devices
Education
University of Maryland College Park 1994 — 1998
Hope for Haiti Foundation June 2012 - June 2014
Hope Community Church June 2009 - May 2012
Invitrogen Corporatiom April 2007 - 2009
Invitrogen Corporation 2004 - 2007
Diosynth 2002 - 2004
Skills
Technology Transfer, Biotechnology, Biopharmaceuticals, FDA, GMP, Validation, Project Management, Lifesciences, Sop, 21 CFR Part 11, Change Control, Clinical Development, Pharmaceutical Industry, Process Simulation, Vaccines, Cross-functional Team..., Regulatory Affairs, GLP, Microsoft Office, Medical Devices
Education
University of Maryland College Park 1994 — 1998
David Fetterolf's Diosynth Experience 1996 - 2002
Job Senior Consultant, Technical Operations at BioTechLogic, Inc
Industry Biotechnology
Experience
BioTechLogic, Inc. January 2004 - Present
Pfizer January 2002 - January 2004
Diosynth 1996 - 2002
Covance Biotechnology Services 1996 - 2000
Skills
Biopharmaceuticals, GMP, Technology Transfer, FDA, Validation, CAPA, Biotechnology, Sop, Pharmaceutical Industry, Aseptic Processing, Contract Manufacturing, Change Control, 21 CFR Part 11, Vaccines, Lifesciences, Statistical Tools, Root Cause Analysis, Medical Devices, Drug Development, GLP, Process Simulation
Education
Elon University - Martha and Spencer Love School of Business 2000 — 2003
Master's, Business Administration and Management, General
Penn State University 1989 — 1995
Bachelor of Science (B.S.), Chemical Engineering
BioTechLogic, Inc. January 2004 - Present
Pfizer January 2002 - January 2004
Diosynth 1996 - 2002
Covance Biotechnology Services 1996 - 2000
Skills
Biopharmaceuticals, GMP, Technology Transfer, FDA, Validation, CAPA, Biotechnology, Sop, Pharmaceutical Industry, Aseptic Processing, Contract Manufacturing, Change Control, 21 CFR Part 11, Vaccines, Lifesciences, Statistical Tools, Root Cause Analysis, Medical Devices, Drug Development, GLP, Process Simulation
Education
Elon University - Martha and Spencer Love School of Business 2000 — 2003
Master's, Business Administration and Management, General
Penn State University 1989 — 1995
Bachelor of Science (B.S.), Chemical Engineering
Debbie Lydiard,'s Diosynth Experience April 2000 - January 2007
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
Kirk Hayenga's Diosynth Experience July 1996 - January 2002
Job Sr. Director at Nuvelo
Industry Biotechnology
Experience
Nuvelo January 2002 - Present
Diosynth July 1996 - January 2002
Diosynth Biotechnology 1996 - 2002
Covance 1996 - 2000
Khepri Pharmaceuticals July 1993 - July 1996
Education
Kansas State University 1979 — 1981
MS, Biochemistry
Bethany College 1973 — 1977
BS, Chemistry and Biology
Nuvelo January 2002 - Present
Diosynth July 1996 - January 2002
Diosynth Biotechnology 1996 - 2002
Covance 1996 - 2000
Khepri Pharmaceuticals July 1993 - July 1996
Education
Kansas State University 1979 — 1981
MS, Biochemistry
Bethany College 1973 — 1977
BS, Chemistry and Biology
Tsu-Shun Lee's Diosynth Experience 1999 - 2001
Job Director, Manufacturing Science and Technology at Allergan
Industry Biotechnology
Experience
Allergan December 2014 - Present
Allergan February 2008 - December 2014
sanofi pasteur July 2006 - 2008
Wyeth 2001 - 2006
Diosynth 1999 - 2001
Skills
Technology Transfer, Biotechnology, V&V, GMP, Process Simulation, Biopharmaceuticals, Validation, Project Planning, Project Coordination, Team Leadership, Cross-functional Team..., Analytical Chemistry, Fermentation, Quality by Design, Cell, Quality Assurance, GLP, Purification, FDA, Aseptic Processing, Sop, SOP
Education
University of Maryland College Park 1992 — 1997
Ph.D., Chemical Engineering
National Tsing Hua University 1986 — 1990
Bachelor of Science (BS), Chemical Engineering
Allergan December 2014 - Present
Allergan February 2008 - December 2014
sanofi pasteur July 2006 - 2008
Wyeth 2001 - 2006
Diosynth 1999 - 2001
Skills
Technology Transfer, Biotechnology, V&V, GMP, Process Simulation, Biopharmaceuticals, Validation, Project Planning, Project Coordination, Team Leadership, Cross-functional Team..., Analytical Chemistry, Fermentation, Quality by Design, Cell, Quality Assurance, GLP, Purification, FDA, Aseptic Processing, Sop, SOP
Education
University of Maryland College Park 1992 — 1997
Ph.D., Chemical Engineering
National Tsing Hua University 1986 — 1990
Bachelor of Science (BS), Chemical Engineering
Samantha (Morin) Chase's Diosynth Experience 2002 - 2004
Job Independent Quality Consultant and Business Owner
Industry Biotechnology
Experience
Full Circle Pilates October 2013 - Present
Biotech/ Pharma/ CRO/ Medical Device Companies November 2012 - Present
The EMMES Corporation March 2010 - November 2012
Biotech, Pharmaceutical and Medical Device Companies November 2009 - April 2010
Invitrogen November 2007 - July 2009
Alpha-Tech 2006 - 2007
Wyeth 2004 - 2006
Diosynth 2002 - 2004
Covance Biotechnology Services 1999 - 2002
Skills
Quality Assurance
Education
University of North Carolina at Chapel Hill 1995 — 1997
BS, Biology
North Carolina State University 1993 — 1995
Full Circle Pilates October 2013 - Present
Biotech/ Pharma/ CRO/ Medical Device Companies November 2012 - Present
The EMMES Corporation March 2010 - November 2012
Biotech, Pharmaceutical and Medical Device Companies November 2009 - April 2010
Invitrogen November 2007 - July 2009
Alpha-Tech 2006 - 2007
Wyeth 2004 - 2006
Diosynth 2002 - 2004
Covance Biotechnology Services 1999 - 2002
Skills
Quality Assurance
Education
University of North Carolina at Chapel Hill 1995 — 1997
BS, Biology
North Carolina State University 1993 — 1995
Renee Yanagawa's Diosynth Experience October 2007 - Present
Job Validation Engineer at FujiFilm Diosynth Biotechnologies
Industry Biotechnology
Experience
Fujifilm Diosynth Biotechnologies April 2014 - Present
Diosynth October 2007 - Present
Diosynth RTP Inc October 2005 - October 2007
Covance / Diosynth February 2000 - October 2005
Skills
GMP, Sop, Filtration, Centrifugation, Manufacturing, Biopharmaceuticals, 21 CFR Part 11, Change Control, FDA, Biotechnology, Bioreactor, Aseptic Technique, UV, UV/Vis, Cell Culture, Cleaning Validation, Fermentation, Technology Transfer, Validation, Protein Chemistry
Education
North Carolina State University
Chemistry
Fujifilm Diosynth Biotechnologies April 2014 - Present
Diosynth October 2007 - Present
Diosynth RTP Inc October 2005 - October 2007
Covance / Diosynth February 2000 - October 2005
Skills
GMP, Sop, Filtration, Centrifugation, Manufacturing, Biopharmaceuticals, 21 CFR Part 11, Change Control, FDA, Biotechnology, Bioreactor, Aseptic Technique, UV, UV/Vis, Cell Culture, Cleaning Validation, Fermentation, Technology Transfer, Validation, Protein Chemistry
Education
North Carolina State University
Chemistry
Paula Knabb's Diosynth Experience 2009 - March 2011
Job Quality Assurance Engineer at ProPharma Group
Industry Biotechnology
Experience
ProPharma Group July 2013 - Present
Quintiles February 2012 - October 2012
ProPharma Group August 2011 - February 2012
Diosynth 2009 - March 2011
Diosynth April 2004 - March 2009
Diosynth January 2003 - April 2004
Diosynth July 2001 - January 2003
Education
University of Florida 1990 — 1994
Bachelor of Science, Microbiology and Cell Science
NC State University
ProPharma Group July 2013 - Present
Quintiles February 2012 - October 2012
ProPharma Group August 2011 - February 2012
Diosynth 2009 - March 2011
Diosynth April 2004 - March 2009
Diosynth January 2003 - April 2004
Diosynth July 2001 - January 2003
Education
University of Florida 1990 — 1994
Bachelor of Science, Microbiology and Cell Science
NC State University
Brent Cope's Diosynth Experience November 2007 - July 2009
Job Scientist II at Fujifilm Diosynth Biotechnologies
Industry Biotechnology
Experience
Fujifilm Diosynth Biotechnologies January 2015 - Present
Fujifilm Diosynth Biotechnologies February 2013 - January 2015
Fujifilm Diosynth Biotechnologies April 2011 - February 2013
Fujifilm Diosynth Biotechnologies July 2009 - April 2011
Diosynth November 2007 - July 2009
Talecris Biotherapeutics September 2007 - November 2007
Biogen Idec May 2007 - September 2007
Biogen Idec May 2006 - August 2006
Biogen Idec May 2005 - August 2005
Skills
Chromatography, Validation, GMP, Purification, GLP, Protein Purification, SDS-PAGE, HPLC
Education
Campbell University 2005 — 2007
Master's Degree, Biotechnology
Campbell University 2001 — 2005
Bachelor's Degree, Pharmaceutical Science
Fujifilm Diosynth Biotechnologies January 2015 - Present
Fujifilm Diosynth Biotechnologies February 2013 - January 2015
Fujifilm Diosynth Biotechnologies April 2011 - February 2013
Fujifilm Diosynth Biotechnologies July 2009 - April 2011
Diosynth November 2007 - July 2009
Talecris Biotherapeutics September 2007 - November 2007
Biogen Idec May 2007 - September 2007
Biogen Idec May 2006 - August 2006
Biogen Idec May 2005 - August 2005
Skills
Chromatography, Validation, GMP, Purification, GLP, Protein Purification, SDS-PAGE, HPLC
Education
Campbell University 2005 — 2007
Master's Degree, Biotechnology
Campbell University 2001 — 2005
Bachelor's Degree, Pharmaceutical Science
Melinda Larr's Diosynth Experience September 2000 - December 2002
Job QA Associate at Biogen
Industry Biotechnology
Experience
Biogen Idec July 2004 - Present
Purdue Pharma December 2002 - July 2004
Diosynth September 2000 - December 2002
Alpharma, INC May 1998 - September 2000
Skills
GMP, CAPA, 21 CFR Part 11, LIMS, Sop, GxP, Trackwise, Biopharmaceuticals, Biotechnology, Quality System, Aseptic Processing, Pharmaceutical Industry, SOP
Education
Campbell University 1994 — 1997
BS, Biology
Campbell University 1994 — 1997
Master of Science, Clinical Research
Biogen Idec July 2004 - Present
Purdue Pharma December 2002 - July 2004
Diosynth September 2000 - December 2002
Alpharma, INC May 1998 - September 2000
Skills
GMP, CAPA, 21 CFR Part 11, LIMS, Sop, GxP, Trackwise, Biopharmaceuticals, Biotechnology, Quality System, Aseptic Processing, Pharmaceutical Industry, SOP
Education
Campbell University 1994 — 1997
BS, Biology
Campbell University 1994 — 1997
Master of Science, Clinical Research
Dana Perrin's Diosynth Experience 1998 - 2003
Job Volunteer
Industry Information Technology and Services
Experience
Biogen Idec August 2003 - March 2015
Diosynth 1998 - 2003
Skills
Computer Hardware..., Computer Repair, Troubleshooting, Data Analysis, Home Networking, Unicorn, Purification, Biopharmaceuticals, Biotechnology, Monoclonal Antibodies, GMP, Protein Purification, Cell, Chromatography, Protein Chemistry, HPLC, Technology Transfer, SOP, Mammalian Cell Culture, Cell Culture, GLP, Research, SDS-PAGE, Assay Development, Downstream Processing, Column Chromatography, Lifesciences, Aseptic Processing
Education
Seton Hall University 1993 — 1996
Master of Science, Biology
Biogen Idec August 2003 - March 2015
Diosynth 1998 - 2003
Skills
Computer Hardware..., Computer Repair, Troubleshooting, Data Analysis, Home Networking, Unicorn, Purification, Biopharmaceuticals, Biotechnology, Monoclonal Antibodies, GMP, Protein Purification, Cell, Chromatography, Protein Chemistry, HPLC, Technology Transfer, SOP, Mammalian Cell Culture, Cell Culture, GLP, Research, SDS-PAGE, Assay Development, Downstream Processing, Column Chromatography, Lifesciences, Aseptic Processing
Education
Seton Hall University 1993 — 1996
Master of Science, Biology
Jennifer Whitaker's Diosynth Experience January 2002 - August 2006
Job QA Senior Manager at FUJIFILM Diosynth Biotechnologies
Industry Biotechnology
Experience
FUJIFILM Diosynth Biotechnologies August 2014 - Present
FUJIFILM Diosynth Biotechnologies February 2014 - August 2014
Fujifilm Diosynth Biotechnologies November 2012 - February 2014
Fujifilm Diosynth Biotechnologies November 2011 - November 2012
Diosynth Biotechnology November 2007 - October 2011
Talecris Biotherapeutics August 2006 - October 2007
Diosynth January 2002 - August 2006
Covance May 1999 - December 2002
Education
North Carolina State University 1994 — 1998
Bachelor of Science (BS), Food Science and Technology
FUJIFILM Diosynth Biotechnologies August 2014 - Present
FUJIFILM Diosynth Biotechnologies February 2014 - August 2014
Fujifilm Diosynth Biotechnologies November 2012 - February 2014
Fujifilm Diosynth Biotechnologies November 2011 - November 2012
Diosynth Biotechnology November 2007 - October 2011
Talecris Biotherapeutics August 2006 - October 2007
Diosynth January 2002 - August 2006
Covance May 1999 - December 2002
Education
North Carolina State University 1994 — 1998
Bachelor of Science (BS), Food Science and Technology
Aaron Allen's Diosynth Experience September 2002 - October 2004
Job Principal Engineer at Novartis
Industry Biotechnology
Experience
Novartis Vaccines January 2015 - Present
Novartis September 2008 - February 2015
Jacobs Engineering Group November 2007 - September 2008
IDEA Engineering of NC 2006 - 2007
Fluid Flow of the Carolinas November 2005 - August 2006
Biogen Idec December 2004 - September 2005
Diosynth September 2002 - October 2004
Covance Biotechnology Services April 1997 - September 2002
Skills
Validation, Commissioning, Process Engineering, Downstream Processing, Biotechnology, Technology Transfer, Engineering Process, Biopharmaceuticals
Education
University of California, Santa Barbara 1990 — 1994
BS, Chemical Engineering
Novartis Vaccines January 2015 - Present
Novartis September 2008 - February 2015
Jacobs Engineering Group November 2007 - September 2008
IDEA Engineering of NC 2006 - 2007
Fluid Flow of the Carolinas November 2005 - August 2006
Biogen Idec December 2004 - September 2005
Diosynth September 2002 - October 2004
Covance Biotechnology Services April 1997 - September 2002
Skills
Validation, Commissioning, Process Engineering, Downstream Processing, Biotechnology, Technology Transfer, Engineering Process, Biopharmaceuticals
Education
University of California, Santa Barbara 1990 — 1994
BS, Chemical Engineering
Sahar G. Dabliz's Diosynth Experience 2000 - 2006
Job Sr Director, Corporate Compliance at PL Developments
Industry Pharmaceuticals
Experience
PL Developments November 2009 - Present
Compliance Strategies, Inc. October 2007 - Present
Various Biotech & Pharma January 1990 - July 2006
Diosynth 2000 - 2006
Skills
FDA, Biotechnology, Quality System, Quality Auditing, Pharmaceutics, Program Management, Auditing, GMP, Biopharmaceuticals, Technology Transfer, Validation, Sop, Pharmaceutical Industry, CAPA, Change Control
Education
Massachusetts College of Pharmacy and Health Sciences 1981 — 1986
B.S., Pharmacy
Massachusetts College of Pharmacy and Health Sciences 1981 — 1986
Bachelor's degree, Pharmacy
PL Developments November 2009 - Present
Compliance Strategies, Inc. October 2007 - Present
Various Biotech & Pharma January 1990 - July 2006
Diosynth 2000 - 2006
Skills
FDA, Biotechnology, Quality System, Quality Auditing, Pharmaceutics, Program Management, Auditing, GMP, Biopharmaceuticals, Technology Transfer, Validation, Sop, Pharmaceutical Industry, CAPA, Change Control
Education
Massachusetts College of Pharmacy and Health Sciences 1981 — 1986
B.S., Pharmacy
Massachusetts College of Pharmacy and Health Sciences 1981 — 1986
Bachelor's degree, Pharmacy
Philip Ropp's Diosynth Experience 2006 - 2009
Job Director Downstream Development at Fujifilm Diosynth Biotechnologies
Industry Biotechnology
Experience
Fujifilm Diosynth Biotechnologies April 2013 - Present
FujiFilm Diosynth Biotechnologies April 2009 - March 2013
Diosynth 2006 - 2009
Diosynth 1997 - 2006
Skills
Technology Transfer, Purification, Biotechnology, Biopharmaceuticals, Chromatography, Protein Purification, Protein Chemistry, GMP, Downstream Processing, HPLC, Fermentation, ELISA, Assay Development, SDS-PAGE, GLP, Monoclonal Antibodies, Cell Culture, Validation, Vaccines
Education
University of North Carolina at Chapel Hill 1983 — 1989
PhD, Biochemistry
Eastern Michigan University 1979 — 1983
Bachelor of Science (BS), Biochemistry
Fujifilm Diosynth Biotechnologies April 2013 - Present
FujiFilm Diosynth Biotechnologies April 2009 - March 2013
Diosynth 2006 - 2009
Diosynth 1997 - 2006
Skills
Technology Transfer, Purification, Biotechnology, Biopharmaceuticals, Chromatography, Protein Purification, Protein Chemistry, GMP, Downstream Processing, HPLC, Fermentation, ELISA, Assay Development, SDS-PAGE, GLP, Monoclonal Antibodies, Cell Culture, Validation, Vaccines
Education
University of North Carolina at Chapel Hill 1983 — 1989
PhD, Biochemistry
Eastern Michigan University 1979 — 1983
Bachelor of Science (BS), Biochemistry
Ken Herko's Diosynth Experience September 1998 - December 2002
Job Associate Director at MedImmune
Industry Biotechnology
Experience
MedImmune June 2004 - Present
Bristol-Myers Squibb January 2003 - June 2004
Diosynth September 1998 - December 2002
Smith Kline Beecham April 1992 - August 1998
Skills
Biotechnology, Technology Transfer, Biopharmaceuticals, GMP, Validation, Pharmaceutical Industry, Lifesciences, Vaccines, FDA, Sop, Purification, Monoclonal Antibodies, Chromatography, GLP, Cell Culture, 21 CFR Part 11, Clinical Development, Protein Purification, CAPA, Aseptic Processing, Microbiology, Cleaning Validation, Drug Development, Immunology, IND, HPLC, GxP, Assay Development, Antibodies, LIMS, ELISA, Protein Chemistry, Change Control, Regulatory Submissions, Biologics, Drug Discovery
Education
Pennsylvania State University-Great Valley Graduate Center 1995 — 1997
Masters in Management, Health Care Administration
Penn State University 1987 — 1991
BS, Microbiolgy
MedImmune June 2004 - Present
Bristol-Myers Squibb January 2003 - June 2004
Diosynth September 1998 - December 2002
Smith Kline Beecham April 1992 - August 1998
Skills
Biotechnology, Technology Transfer, Biopharmaceuticals, GMP, Validation, Pharmaceutical Industry, Lifesciences, Vaccines, FDA, Sop, Purification, Monoclonal Antibodies, Chromatography, GLP, Cell Culture, 21 CFR Part 11, Clinical Development, Protein Purification, CAPA, Aseptic Processing, Microbiology, Cleaning Validation, Drug Development, Immunology, IND, HPLC, GxP, Assay Development, Antibodies, LIMS, ELISA, Protein Chemistry, Change Control, Regulatory Submissions, Biologics, Drug Discovery
Education
Pennsylvania State University-Great Valley Graduate Center 1995 — 1997
Masters in Management, Health Care Administration
Penn State University 1987 — 1991
BS, Microbiolgy
Adam Veller's Diosynth Experience May 1999 - November 2006
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
Debra Weigl's Diosynth Experience April 2001 - April 2003
Job Quality Assurance Project Manager at Clorox
Industry Pharmaceuticals
Experience
Clorox September 2013 - Present
CSA-Soliance July 2011 - August 2013
Tunnell Consulting, Inc. August 2008 - June 2011
Human Genome Sciences May 2003 - October 2007
Diosynth April 2001 - April 2003
GlaxoSmithKline July 1992 - March 2001
GlaxoWellcome 1992 - 2001
Abbott Laboratories July 1985 - June 1992
Skills
Biopharmaceuticals, GMP, Process Validation, Process Management, Protein Chemistry, Method Validation, Technology Transfer, Project Management, Process Characterization, Compliance, HPLC, Validation, Biotechnology, Operational Excellence, Process Simulation, FDA, GLP, Sop, Pharmaceutical..., Quality Management, 21 CFR Part 11, Pharmaceutical Industry, Drug Development, Change Control, Regulatory Submissions, V&V, IND, Quality Assurance, CAPA, Quality System, GxP, SOP
Education
University of Wisconsin-Madison
BS, Bacteriology
The University of Texas at Austin
Certificate, Process Management
Clorox September 2013 - Present
CSA-Soliance July 2011 - August 2013
Tunnell Consulting, Inc. August 2008 - June 2011
Human Genome Sciences May 2003 - October 2007
Diosynth April 2001 - April 2003
GlaxoSmithKline July 1992 - March 2001
GlaxoWellcome 1992 - 2001
Abbott Laboratories July 1985 - June 1992
Skills
Biopharmaceuticals, GMP, Process Validation, Process Management, Protein Chemistry, Method Validation, Technology Transfer, Project Management, Process Characterization, Compliance, HPLC, Validation, Biotechnology, Operational Excellence, Process Simulation, FDA, GLP, Sop, Pharmaceutical..., Quality Management, 21 CFR Part 11, Pharmaceutical Industry, Drug Development, Change Control, Regulatory Submissions, V&V, IND, Quality Assurance, CAPA, Quality System, GxP, SOP
Education
University of Wisconsin-Madison
BS, Bacteriology
The University of Texas at Austin
Certificate, Process Management
Chris Gullette, PMP's Diosynth Experience May 2007 - May 2010
Job Sr. Process Engineer at Liquidia Technologies
Industry Biotechnology
Experience
Fujifilm Diosynth Biotechnologies April 2014 - October 2014
FUJIFILM Diosynth Biotechnologies U.S.A. May 2007 - April 2014
Diosynth May 2007 - May 2010
Diosynth April 2006 - May 2007
Diosynth April 2004 - May 2006
Diosynth October 2001 - April 2004
US Navy July 1992 - October 2001
Skills
Pumps, GMP, Technology Transfer, Validation, Biopharmaceuticals, Biotechnology, Fermentation, FDA, Testing, Change Control, Sop, Chromatography, Filtration, 21 CFR Part 11, Process Simulation, Design of Experiments, CAPA, V&V, Quality System, Cell Culture, JMP, Project Management, PowerPoint, Written & Oral..., Centrifugation, Homogenizer, UF/DF, Cleaning Validation, Process Improvement, Process Engineering, Process Optimization, Software Documentation, Laboratory, Manufacturing, SOP, Aseptic Processing, Purification
Education
North Carolina State University 2002 — 2007
BS, Biochemistry and Molecular Biology
Fujifilm Diosynth Biotechnologies April 2014 - October 2014
FUJIFILM Diosynth Biotechnologies U.S.A. May 2007 - April 2014
Diosynth May 2007 - May 2010
Diosynth April 2006 - May 2007
Diosynth April 2004 - May 2006
Diosynth October 2001 - April 2004
US Navy July 1992 - October 2001
Skills
Pumps, GMP, Technology Transfer, Validation, Biopharmaceuticals, Biotechnology, Fermentation, FDA, Testing, Change Control, Sop, Chromatography, Filtration, 21 CFR Part 11, Process Simulation, Design of Experiments, CAPA, V&V, Quality System, Cell Culture, JMP, Project Management, PowerPoint, Written & Oral..., Centrifugation, Homogenizer, UF/DF, Cleaning Validation, Process Improvement, Process Engineering, Process Optimization, Software Documentation, Laboratory, Manufacturing, SOP, Aseptic Processing, Purification
Education
North Carolina State University 2002 — 2007
BS, Biochemistry and Molecular Biology
Matt Pingel's Diosynth Experience January 2006 - November 2007
Job Engineer at QSPEC Solutions
Industry Biotechnology
Experience
QSPEC Solutions December 2007 - Present
Diosynth January 2006 - November 2007
Diosynth RTP, Inc. 2000 - 2007
Diosynth January 2001 - January 2006
Covance September 2000 - January 2001
Johnson Controls June 1997 - September 2000
GlaxoSmithKline 1996 - 2000
Johnson Controls October 1996 - June 1997
Education
Iowa State University 1990 — 1996
QSPEC Solutions December 2007 - Present
Diosynth January 2006 - November 2007
Diosynth RTP, Inc. 2000 - 2007
Diosynth January 2001 - January 2006
Covance September 2000 - January 2001
Johnson Controls June 1997 - September 2000
GlaxoSmithKline 1996 - 2000
Johnson Controls October 1996 - June 1997
Education
Iowa State University 1990 — 1996
Stephen C. Field Sr.'s Diosynth Experience June 2000 - May 2002
Job Research Scientist at Pfizer BioTx PharmSci
Industry Biotechnology
Experience
Pfizer October 2009 - March 2011
Wyeth Research May 2004 - November 2009
Wyeth Research May 2004 - June 2007
Diosynth RTP (formerly Covance Biotechnology) June 2000 - May 2004
Diosynth June 2000 - May 2002
Alcoa January 2000 - May 2000
Skills
cGMP, GMP, Purification, Chromatography, LIMS, Technology Transfer, Validation, Biotechnology, SOP, HPLC, Protein Purification, Vaccines, SDS-PAGE, Process Development, Clinical Development, Biopharmaceuticals, Gel Electrophoresis, Protein Chemistry, Change Control, Regulatory Submissions, Sop, Laboratory, Assay Development, Process Simulation, R, Manufacturing, 21 CFR Part 11
Education
Concord University 1997 — 1998
BS, Biology, Chemistry
Marshall University 1991 — 1995
Pre-Med
Pfizer October 2009 - March 2011
Wyeth Research May 2004 - November 2009
Wyeth Research May 2004 - June 2007
Diosynth RTP (formerly Covance Biotechnology) June 2000 - May 2004
Diosynth June 2000 - May 2002
Alcoa January 2000 - May 2000
Skills
cGMP, GMP, Purification, Chromatography, LIMS, Technology Transfer, Validation, Biotechnology, SOP, HPLC, Protein Purification, Vaccines, SDS-PAGE, Process Development, Clinical Development, Biopharmaceuticals, Gel Electrophoresis, Protein Chemistry, Change Control, Regulatory Submissions, Sop, Laboratory, Assay Development, Process Simulation, R, Manufacturing, 21 CFR Part 11
Education
Concord University 1997 — 1998
BS, Biology, Chemistry
Marshall University 1991 — 1995
Pre-Med
Josephine Ramos's Diosynth Experience June 2000 - September 2001
Job Biotechnology ProfessionalCell Culture Expert
Industry Biotechnology
Experience
Immunomic Therapeutics, Inc. November 2014 - Present
Kalon Biotherapeutics, LLC May 2013 - November 2013
PPD January 2012 - January 2013
Biogen Idec February 2010 - January 2012
Transform Pharmaceuticals September 2008 - December 2009
BioProcessors August 2007 - December 2007
Xcellerex September 2006 - August 2007
Peregrine Pharmaceuticals January 2005 - September 2005
Diosynth June 2000 - September 2001
Skills
Biotechnology, Cell Culture, Technology Transfer, Lifesciences, GMP, Biopharmaceuticals, GLP, Pharmaceutical Industry, HPLC, Molecular Biology, Validation, High Throughput..., Chromatography, Sop, ELISA, Assay Development, Cell, Laboratory, Immunology, R, Vaccines, SOP, Life Sciences
Education
Northeastern University 2011 — 2016
Master of Business Administration (MBA), Health/Health Care Administration/Management
University of New England 1997 — 2000
Bachelor of Science (BS), Biological Sciences
Immunomic Therapeutics, Inc. November 2014 - Present
Kalon Biotherapeutics, LLC May 2013 - November 2013
PPD January 2012 - January 2013
Biogen Idec February 2010 - January 2012
Transform Pharmaceuticals September 2008 - December 2009
BioProcessors August 2007 - December 2007
Xcellerex September 2006 - August 2007
Peregrine Pharmaceuticals January 2005 - September 2005
Diosynth June 2000 - September 2001
Skills
Biotechnology, Cell Culture, Technology Transfer, Lifesciences, GMP, Biopharmaceuticals, GLP, Pharmaceutical Industry, HPLC, Molecular Biology, Validation, High Throughput..., Chromatography, Sop, ELISA, Assay Development, Cell, Laboratory, Immunology, R, Vaccines, SOP, Life Sciences
Education
Northeastern University 2011 — 2016
Master of Business Administration (MBA), Health/Health Care Administration/Management
University of New England 1997 — 2000
Bachelor of Science (BS), Biological Sciences
Phil Campbell's Diosynth Experience November 1998 - January 2006
Job Sr Associate Scientist at Amgen
Industry Biotechnology
Experience
Amgen January 2006 - Present
Diosynth November 1998 - January 2006
Bayer February 1998 - November 1998
Skills
HPLC, Biotechnology, Chromatography, ELISA, Technology Transfer, GMP, Sop, SDS-PAGE, Monoclonal Antibodies, Mass Spectrometry, Protein Chemistry, Western Blotting, Purification, Protein Purification, Filtration, SOP, Biopharmaceuticals
Education
University of North Carolina at Wilmington 2003 — 2006
BS, Biology
University of Cincinnati 2001 — 2003
NA, Undeclared
Brookville High School 1985 — 1989
Amgen January 2006 - Present
Diosynth November 1998 - January 2006
Bayer February 1998 - November 1998
Skills
HPLC, Biotechnology, Chromatography, ELISA, Technology Transfer, GMP, Sop, SDS-PAGE, Monoclonal Antibodies, Mass Spectrometry, Protein Chemistry, Western Blotting, Purification, Protein Purification, Filtration, SOP, Biopharmaceuticals
Education
University of North Carolina at Wilmington 2003 — 2006
BS, Biology
University of Cincinnati 2001 — 2003
NA, Undeclared
Brookville High School 1985 — 1989
Judy Fredlin's Diosynth Experience 2003 - 2004
Job Associate Scientist III at Biogen Idec
Industry Biotechnology
Experience
Biogen Idec July 2012 - Present
Grifols (formerly Talecris Biotherapeutics, Inc.) November 2010 - July 2012
Talecris Biotherapeutics, Inc. July 2008 - November 2010
Talecris Biotherapeutics September 2004 - July 2008
Diosynth 2003 - 2004
Abgenix 2000 - 2003
Microgenics 1998 - 2000
Skills
Capillary..., HPLC, Biotechnology, ELISA, Validation, Sop, Protein Chemistry, Drug Discovery, Process Simulation, Western Blotting, SDS-PAGE, Trackwise, Technology Transfer, Chromatography, GMP, Biopharmaceuticals, FDA, Software Documentation, Pharmaceutical Industry, LIMS, Aseptic Processing, Assay Development, GLP, Monoclonal Antibodies
Education
University of California, Santa Barbara 1993 — 1997
Bachelor of Science (B.S.), Zoology
Irvington
Biogen Idec July 2012 - Present
Grifols (formerly Talecris Biotherapeutics, Inc.) November 2010 - July 2012
Talecris Biotherapeutics, Inc. July 2008 - November 2010
Talecris Biotherapeutics September 2004 - July 2008
Diosynth 2003 - 2004
Abgenix 2000 - 2003
Microgenics 1998 - 2000
Skills
Capillary..., HPLC, Biotechnology, ELISA, Validation, Sop, Protein Chemistry, Drug Discovery, Process Simulation, Western Blotting, SDS-PAGE, Trackwise, Technology Transfer, Chromatography, GMP, Biopharmaceuticals, FDA, Software Documentation, Pharmaceutical Industry, LIMS, Aseptic Processing, Assay Development, GLP, Monoclonal Antibodies
Education
University of California, Santa Barbara 1993 — 1997
Bachelor of Science (B.S.), Zoology
Irvington
Justin Aldridge's Diosynth Experience November 2005 - May 2007
Job Staff Associate, PQM at Biogen
Industry Pharmaceuticals
Experience
Biogen August 2015 - Present
Grifols April 2015 - Present
Grifols October 2012 - Present
Talecris Biotherapeutics December 2008 - October 2012
Talecris Biotherapeutics, Inc. May 2007 - December 2008
Diosynth November 2005 - May 2007
Skills
Biotechnology, GMP
Education
Duke University 2001 — 2005
PhD, Pharmacology/Toxicology
North Carolina State University 1997 — 2001
BS, Biochemistry
Biogen August 2015 - Present
Grifols April 2015 - Present
Grifols October 2012 - Present
Talecris Biotherapeutics December 2008 - October 2012
Talecris Biotherapeutics, Inc. May 2007 - December 2008
Diosynth November 2005 - May 2007
Skills
Biotechnology, GMP
Education
Duke University 2001 — 2005
PhD, Pharmacology/Toxicology
North Carolina State University 1997 — 2001
BS, Biochemistry
Jim Kennamer's Diosynth Experience 2000 - 2004
Job Vice President, Manufacturing at Grifols Therapeutics
Industry Pharmaceuticals
Experience
Grifols Therapeutics March 2007 - Present
Stratagene March 2004 - March 2007
Diosynth Biotechnology Inc. 2000 - 2004
Diosynth 2000 - 2004
Roche Applied Sciences 1988 - 2000
Education
Oklahoma State University 1981 — 1986
PhD, Biochemistry
Grifols Therapeutics March 2007 - Present
Stratagene March 2004 - March 2007
Diosynth Biotechnology Inc. 2000 - 2004
Diosynth 2000 - 2004
Roche Applied Sciences 1988 - 2000
Education
Oklahoma State University 1981 — 1986
PhD, Biochemistry
Tanya Adderson-Davidson's Diosynth Experience 2001 - 2003
Job Validation Specialist
Industry Pharmaceuticals
Experience
Catalent Pharma Solutions May 2013 - Present
CTG September 2012 - March 2013
Maternity Leave September 2011 - September 2012
Yoh @ Novartis January 2010 - September 2011
Kelly Services June 2009 - January 2010
Invensys Validation Technologies 2007 - 2009
Wyeth Biotech 2003 - 2006
Diosynth 2001 - 2003
Perigon 2000 - 2001
Baxter 1999 - 2000
Skills
CAPA, Computer System..., Validation, Change Control, 21 CFR Part 11, Cleaning Validation, GMP, LIMS, Vaccines, FDA, Regulatory Affairs, Pharmaceutical Industry, Quality Control, Quality System, Technology Transfer, Medical Devices, Sop, GxP, Biotechnology, ISO 13485, Quality Assurance, GAMP, Process Engineering
Education
Tulane University 1996 — 1998
BS, Biomedical Engineering
Xavier University of Louisiana 1993 — 1998
BS, Physics
Catalent Pharma Solutions May 2013 - Present
CTG September 2012 - March 2013
Maternity Leave September 2011 - September 2012
Yoh @ Novartis January 2010 - September 2011
Kelly Services June 2009 - January 2010
Invensys Validation Technologies 2007 - 2009
Wyeth Biotech 2003 - 2006
Diosynth 2001 - 2003
Perigon 2000 - 2001
Baxter 1999 - 2000
Skills
CAPA, Computer System..., Validation, Change Control, 21 CFR Part 11, Cleaning Validation, GMP, LIMS, Vaccines, FDA, Regulatory Affairs, Pharmaceutical Industry, Quality Control, Quality System, Technology Transfer, Medical Devices, Sop, GxP, Biotechnology, ISO 13485, Quality Assurance, GAMP, Process Engineering
Education
Tulane University 1996 — 1998
BS, Biomedical Engineering
Xavier University of Louisiana 1993 — 1998
BS, Physics
Cheryl Kitchen's Diosynth Experience December 2004 - November 2011
Job QA Manager
Industry Pharmaceuticals
Experience
Diosynth December 2004 - November 2011
Cardinal Health 2000 - 2004
Cangene Corporation March 1998 - December 2000
Skills
Quality Systems, FDA, cGMP, Validation, GMP, Quality Assurance, SOP, Biotechnology, Documentation, Auditing, Continuous Improvement, Compliance, Problem Solving, Start-ups, Life Sciences, 21 CFR Part 11, Change Control, Quality Auditing
Education
The University of Winnipeg 1982 — 1988
BSc (4 year), Biology/Biochemistry
Diosynth December 2004 - November 2011
Cardinal Health 2000 - 2004
Cangene Corporation March 1998 - December 2000
Skills
Quality Systems, FDA, cGMP, Validation, GMP, Quality Assurance, SOP, Biotechnology, Documentation, Auditing, Continuous Improvement, Compliance, Problem Solving, Start-ups, Life Sciences, 21 CFR Part 11, Change Control, Quality Auditing
Education
The University of Winnipeg 1982 — 1988
BSc (4 year), Biology/Biochemistry
Daniel Doub's Diosynth Experience QA Technical SpecialistDiosynth RTP2000 - Present
Job QA Technical Specialist
Industry Biotechnology
Experience
Diosynth QA Technical SpecialistDiosynth RTP2000 - Present
Fujifilm Diosynth Biotechnologies 2000 - Present
Education
East Carolina University 1996 — 1999
Diosynth QA Technical SpecialistDiosynth RTP2000 - Present
Fujifilm Diosynth Biotechnologies 2000 - Present
Education
East Carolina University 1996 — 1999
Kathy Patton's Diosynth Experience April 2002 - July 2009
Job Senior Scientist at Fujifilm Diosynth Biotechnologies
Industry Biotechnology
Experience
Fujifilm Diosynth Biotechnologies April 2011 - Present
Merck July 2009 - March 2011
Diosynth April 2002 - July 2009
Covance April 1999 - April 2002
Covance September 1997 - April 1999
Mallinckrodt Veterinary December 1993 - July 1997
Skills
Biotechnology, GMP, Chromatography, Biopharmaceuticals, Technology Transfer, Protein Chemistry, Validation, SOP, HPLC, GLP, Protein Purification, FDA, Purification, Pharmaceutical Industry, Life Sciences
Education
Kansas State University 1991 — 1993
Bachelors, Biology
University of Northern Colorado 1988 — 1991
Shawnee Mission South High School 1985 — 1988
Fujifilm Diosynth Biotechnologies April 2011 - Present
Merck July 2009 - March 2011
Diosynth April 2002 - July 2009
Covance April 1999 - April 2002
Covance September 1997 - April 1999
Mallinckrodt Veterinary December 1993 - July 1997
Skills
Biotechnology, GMP, Chromatography, Biopharmaceuticals, Technology Transfer, Protein Chemistry, Validation, SOP, HPLC, GLP, Protein Purification, FDA, Purification, Pharmaceutical Industry, Life Sciences
Education
Kansas State University 1991 — 1993
Bachelors, Biology
University of Northern Colorado 1988 — 1991
Shawnee Mission South High School 1985 — 1988
Wesley Daughtridge's Diosynth Experience 1999 - 2003
Job QA Manager at Pioneer Surgical Orthobiologics
Industry Medical Devices
Experience
Pioneer Surgical Technology December 2004 - Present
Diosynth 1999 - 2003
Education
North Carolina State University
BS, Microbiology
Pioneer Surgical Technology December 2004 - Present
Diosynth 1999 - 2003
Education
North Carolina State University
BS, Microbiology
Mark Chavez's Diosynth Experience September 2000 - November 2007
Job Senior Principal Scientist at FUJIFILM Diosynth Biotechnologies, U.S.A.
Industry Biotechnology
Experience
Fujifilm Diosynth Biotechnologies March 2011 - Present
Merck November 2009 - March 2011
Schering-Plough November 2007 - November 2009
Diosynth September 2000 - November 2007
Bayer Corporation, Biological Products Division 1998 - 2000
Geo-Centers 1993 - 1997
National Institutes of Health 1990 - 1993
Skills
Monoclonal Antibodies, Biopharmaceuticals, Design of Experiments, Technology Transfer, PEGylation, Chromatography, Scale Up, UF/DF, Validation, Protein Purification, GMP, Protein Chemistry, HPLC, Biotechnology, Downstream Processing, GLP, Change Control, Purification, Vaccines, Fermentation, Assay Development
Education
The University of New Mexico
Doctor of Philosophy (Ph.D.), Biophysical Chemistry
Fujifilm Diosynth Biotechnologies March 2011 - Present
Merck November 2009 - March 2011
Schering-Plough November 2007 - November 2009
Diosynth September 2000 - November 2007
Bayer Corporation, Biological Products Division 1998 - 2000
Geo-Centers 1993 - 1997
National Institutes of Health 1990 - 1993
Skills
Monoclonal Antibodies, Biopharmaceuticals, Design of Experiments, Technology Transfer, PEGylation, Chromatography, Scale Up, UF/DF, Validation, Protein Purification, GMP, Protein Chemistry, HPLC, Biotechnology, Downstream Processing, GLP, Change Control, Purification, Vaccines, Fermentation, Assay Development
Education
The University of New Mexico
Doctor of Philosophy (Ph.D.), Biophysical Chemistry
Brian Hoppe's Diosynth Experience June 2007 - October 2008
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
Kathryn Simon's Diosynth Experience February 2010 - January 2013
Job Site Head Regulatory & Compliance at Merck
Industry Biotechnology
Experience
Merck January 2013 - Present
Diosynth February 2010 - January 2013
Diosynth May 2009 - February 2010
Diosynth December 2007 - May 2009
MedImmune 2004 - 2006
Nalge Nunc International 1999 - 2001
Skills
Technology Transfer, Biopharmaceuticals, Biotechnology, Vaccines, Validation, Sop, FDA, CAPA, Aseptic Processing, Change Control, Lifesciences, Contract Manufacturing, Monoclonal Antibodies, V&V, Pharmaceutical Industry, Purification, GLP, Regulatory Affairs, Fermentation, Quality System, Chromatography, LIMS
Education
Virginia Polytechnic Institute and State University 1992 — 1996
PhD, Biochemistry
George Mason University 1988 — 1992
BS, Biology
Merck January 2013 - Present
Diosynth February 2010 - January 2013
Diosynth May 2009 - February 2010
Diosynth December 2007 - May 2009
MedImmune 2004 - 2006
Nalge Nunc International 1999 - 2001
Skills
Technology Transfer, Biopharmaceuticals, Biotechnology, Vaccines, Validation, Sop, FDA, CAPA, Aseptic Processing, Change Control, Lifesciences, Contract Manufacturing, Monoclonal Antibodies, V&V, Pharmaceutical Industry, Purification, GLP, Regulatory Affairs, Fermentation, Quality System, Chromatography, LIMS
Education
Virginia Polytechnic Institute and State University 1992 — 1996
PhD, Biochemistry
George Mason University 1988 — 1992
BS, Biology
Dale Allen's Diosynth Experience September 2007 - January 2011
Job Production Manager, Upstream at Fujifilm Diosynth Biotechnologies
Industry Pharmaceuticals
Experience
Fujifilm Diosynth Biotechnologies October 2014 - Present
Fujifilm Diosynth Biotechnologies January 2011 - Present
Diosynth September 2007 - January 2011
Diosynth January 2006 - September 2007
Nabi Biopharmaceuticals January 1998 - January 2006
Nabi Biopharmaceuticals January 1996 - January 1998
Skills
GMP, Cell Culture, Manufacturing, Sop, Biopharmaceuticals, Biotechnology, Validation, Chromatography, Pharmaceutical Industry, Protein Purification, lean six sigma tools, CAPA, Six Sigma, FDA, Technology Transfer, R&D, Vaccines, Software Documentation, Purification, Change Control, Pharmaceutics, Quality System, LIMS
Education
Maryville College 1988 — 1992
BA
Fujifilm Diosynth Biotechnologies October 2014 - Present
Fujifilm Diosynth Biotechnologies January 2011 - Present
Diosynth September 2007 - January 2011
Diosynth January 2006 - September 2007
Nabi Biopharmaceuticals January 1998 - January 2006
Nabi Biopharmaceuticals January 1996 - January 1998
Skills
GMP, Cell Culture, Manufacturing, Sop, Biopharmaceuticals, Biotechnology, Validation, Chromatography, Pharmaceutical Industry, Protein Purification, lean six sigma tools, CAPA, Six Sigma, FDA, Technology Transfer, R&D, Vaccines, Software Documentation, Purification, Change Control, Pharmaceutics, Quality System, LIMS
Education
Maryville College 1988 — 1992
BA
Gerry Farrell's Diosynth Experience July 2007 - January 2010
Job Vice President, Technical Operations at Fujifilm Diosynth Biotechnologies
Industry Biotechnology
Experience
Fujifilm Diosynth Biotechnologies Texas, LLC January 2015 - Present
Fujifilm Diosynth Biotechnologies June 2013 - December 2014
Fujifilm Diosynth Biotechnologies April 2011 - May 2013
Merck January 2010 - April 2011
Diosynth July 2007 - January 2010
Diosynth July 2004 - July 2007
Diosynth April 2001 - July 2004
Skills
Technology Transfer, GMP, Biotechnology, Validation, cGMP, Manufacturing, Operations Management, Process Development, Research Project..., LSS, Research, FDA, Project Management, Purification, Process Simulation, Biopharmaceuticals, Analytical Chemistry, CAPA, Sop, Vaccines, Cell Culture, Change Control, Fermentation, Chromatography, HPLC
Education
Dublin City University 1988 — 1992
PhD, Chemistry
Fujifilm Diosynth Biotechnologies Texas, LLC January 2015 - Present
Fujifilm Diosynth Biotechnologies June 2013 - December 2014
Fujifilm Diosynth Biotechnologies April 2011 - May 2013
Merck January 2010 - April 2011
Diosynth July 2007 - January 2010
Diosynth July 2004 - July 2007
Diosynth April 2001 - July 2004
Skills
Technology Transfer, GMP, Biotechnology, Validation, cGMP, Manufacturing, Operations Management, Process Development, Research Project..., LSS, Research, FDA, Project Management, Purification, Process Simulation, Biopharmaceuticals, Analytical Chemistry, CAPA, Sop, Vaccines, Cell Culture, Change Control, Fermentation, Chromatography, HPLC
Education
Dublin City University 1988 — 1992
PhD, Chemistry
Kelly Wiltberger's Diosynth Experience 2000 - 2002
Job Associate Director, Cell Culture Development at Biogen Idec
Industry Biotechnology
Experience
Biogen Idec February 2012 - Present
Biogen Idec February 2009 - February 2012
Biogen Idec January 2006 - February 2009
Biogen Idec January 2003 - January 2006
Biogen January 2002 - January 2003
Diosynth 2000 - 2002
Skills
Cell Culture, Cell Culture Scale Up, Biotechnology, Technology Transfer, Process Development, Manufacturing, Project Management, Protein Purification, GMP
Education
University of North Carolina at Chapel Hill - Kenan-Flagler Business School 2005 — 2007
MBA
University of Rochester 1995 — 1999
B.S., Chemical Engineering
Biogen Idec February 2012 - Present
Biogen Idec February 2009 - February 2012
Biogen Idec January 2006 - February 2009
Biogen Idec January 2003 - January 2006
Biogen January 2002 - January 2003
Diosynth 2000 - 2002
Skills
Cell Culture, Cell Culture Scale Up, Biotechnology, Technology Transfer, Process Development, Manufacturing, Project Management, Protein Purification, GMP
Education
University of North Carolina at Chapel Hill - Kenan-Flagler Business School 2005 — 2007
MBA
University of Rochester 1995 — 1999
B.S., Chemical Engineering
John Foy`'s Diosynth Experience August 2007 - May 2009
Job President and CEO at Fujifilm Diosynth Biotechnologies, Texas LLC
Industry Biotechnology
Experience
Fujifilm Diosynth Biotechnologies, Texas LLC December 2014 - Present
Fujifilm Diosynth Biotechnologies May 2009 - December 2014
Diosynth August 2007 - May 2009
Diosynth February 2006 - August 2007
Diosynth 2002 - 2006
Diosynth 2000 - 2002
Skills
Biopharmaceuticals, Business Development, Technology Transfer, GMP, Project Planning, Biotechnology, Validation, FDA, 21 CFR Part 11, Contract Manufacturing, Pharmaceutical Industry, Sop
Education
University of North Carolina at Greensboro 1997 — 1999
MBA
Lehigh University 1987 — 1991
BSME, Mechanical Engineering
Fujifilm Diosynth Biotechnologies, Texas LLC December 2014 - Present
Fujifilm Diosynth Biotechnologies May 2009 - December 2014
Diosynth August 2007 - May 2009
Diosynth February 2006 - August 2007
Diosynth 2002 - 2006
Diosynth 2000 - 2002
Skills
Biopharmaceuticals, Business Development, Technology Transfer, GMP, Project Planning, Biotechnology, Validation, FDA, 21 CFR Part 11, Contract Manufacturing, Pharmaceutical Industry, Sop
Education
University of North Carolina at Greensboro 1997 — 1999
MBA
Lehigh University 1987 — 1991
BSME, Mechanical Engineering
Jamie Canelas's Diosynth Experience March 2000 - March 2004
Job Owner / President at Synergy HomeCare of the Triangle
Industry Hospital & Health Care
Experience
Synergy HomeCare of the Triangle April 2010 - Present
Ethicon, Inc a division of Johnson & Johnson March 2004 - October 2009
Diosynth March 2000 - March 2004
BELL & HOWELL MAIL & MESSAGING TECHNOLOGIES August 1996 - March 2000
Skills
FDA, Supply Chain Management, Medical Devices, Biopharmaceuticals, Operations Management, ERP, GMP, CAPA, Contract Manufacturing, V&V, Management, Strategic Sourcing, Materials Management, Leadership, Strategy, Process Improvement, Operational Excellence, ISO 13485, Procurement, Supply Chain, Quality Control, Continuous Improvement, Lean Manufacturing, Process Engineering, Technology Transfer, Quality Assurance, Change Management, Change Control, Budgets, Project Planning, Quality System, Manufacturing, Biotechnology, Cross-functional Team..., Forecasting, Six Sigma, Purchasing, Strategic Planning, Global Sourcing, Inventory Management, Validation
Education
Wake Forest University School of Business 1994 — 1997
MBA, Operations Management
Northeastern University 1985 — 1990
BS, Electrical Engineering Technology
Synergy HomeCare of the Triangle April 2010 - Present
Ethicon, Inc a division of Johnson & Johnson March 2004 - October 2009
Diosynth March 2000 - March 2004
BELL & HOWELL MAIL & MESSAGING TECHNOLOGIES August 1996 - March 2000
Skills
FDA, Supply Chain Management, Medical Devices, Biopharmaceuticals, Operations Management, ERP, GMP, CAPA, Contract Manufacturing, V&V, Management, Strategic Sourcing, Materials Management, Leadership, Strategy, Process Improvement, Operational Excellence, ISO 13485, Procurement, Supply Chain, Quality Control, Continuous Improvement, Lean Manufacturing, Process Engineering, Technology Transfer, Quality Assurance, Change Management, Change Control, Budgets, Project Planning, Quality System, Manufacturing, Biotechnology, Cross-functional Team..., Forecasting, Six Sigma, Purchasing, Strategic Planning, Global Sourcing, Inventory Management, Validation
Education
Wake Forest University School of Business 1994 — 1997
MBA, Operations Management
Northeastern University 1985 — 1990
BS, Electrical Engineering Technology
Deborah Hermes's Diosynth Experience January 2000 - July 2002
Job Lead QC Associate II at Fujifilm Diosynth Biotechnologies
Industry Pharmaceuticals
Experience
Fujifilm Diosynth Biotechnologies August 2014 - Present
Fujifilm Diosynth Biotechnologies February 2011 - August 2014
Merck July 2002 - February 2011
Diosynth January 2000 - July 2002
Skills
GMP, Validation, Quality Assurance, Sop, Quality Control, SOP, Biotechnology, Biopharmaceuticals, Change Control, FDA
Education
State University of New York College at Potsdam 1992 — 1997
BS, Chemistry and Secondary Education
Fujifilm Diosynth Biotechnologies August 2014 - Present
Fujifilm Diosynth Biotechnologies February 2011 - August 2014
Merck July 2002 - February 2011
Diosynth January 2000 - July 2002
Skills
GMP, Validation, Quality Assurance, Sop, Quality Control, SOP, Biotechnology, Biopharmaceuticals, Change Control, FDA
Education
State University of New York College at Potsdam 1992 — 1997
BS, Chemistry and Secondary Education
Brian Folsom's Diosynth Experience January 2001 - July 2003
Job Senior Staff Scientist at Beckman Coulter
Industry Biotechnology
Experience
Beckman Coulter June 2006 - Present
Power3 Medical Products July 2004 - January 2006
Diosynth January 2001 - July 2003
Energy Biosystems March 1995 - January 2001
Envirogen Inc March 1990 - March 1995
U.S. Environmental Protection Agency March 1988 - March 1990
Eawag March 1986 - March 1988
University of Minnesota March 1984 - February 1986
Skills
Validation, Biotechnology, Process Validation, cGMP, Medical Devices, R&D, Life Sciences, CAPA, Protein Chemistry, Cell Culture, Biochemistry, GMP, Validations, Technology Transfer, Science, Purification, Chromatography, Problem Solving, Microsoft Office, Process Improvement, Cell, Design Control, V&V, Lifesciences, Sop, Laboratory, Assay Development, GLP, FDA, Biopharmaceuticals
Education
Washington State University 1979 — 1984
PhD, biochemistry
Macalester College 1974 — 1978
BA, Chemistry, Biology
Beckman Coulter June 2006 - Present
Power3 Medical Products July 2004 - January 2006
Diosynth January 2001 - July 2003
Energy Biosystems March 1995 - January 2001
Envirogen Inc March 1990 - March 1995
U.S. Environmental Protection Agency March 1988 - March 1990
Eawag March 1986 - March 1988
University of Minnesota March 1984 - February 1986
Skills
Validation, Biotechnology, Process Validation, cGMP, Medical Devices, R&D, Life Sciences, CAPA, Protein Chemistry, Cell Culture, Biochemistry, GMP, Validations, Technology Transfer, Science, Purification, Chromatography, Problem Solving, Microsoft Office, Process Improvement, Cell, Design Control, V&V, Lifesciences, Sop, Laboratory, Assay Development, GLP, FDA, Biopharmaceuticals
Education
Washington State University 1979 — 1984
PhD, biochemistry
Macalester College 1974 — 1978
BA, Chemistry, Biology
Richard Bachelder's Diosynth Experience 2001 - 2002
Job Account Executive, Pace Analytical Life Sciences
Industry Pharmaceuticals
Experience
Pace Analytical Life Sciences February 2015 - Present
Norwich Pharma Services January 2014 - December 2014
Norwich Pharma Services April 2013 - January 2014
ICON Development Solutions May 2010 - April 2013
Ebewe Parenta Pharmaceuticals December 2007 - April 2009
Wyeth 2002 - 2007
Diosynth 2001 - 2002
Mallinckrodt 1999 - 2001
Education
State University of New York College at Oneonta 1996 — 1999
BS, Chemistry
Herkimer County Community College 1993 — 1995
AAS, Accounting
Pace Analytical Life Sciences February 2015 - Present
Norwich Pharma Services January 2014 - December 2014
Norwich Pharma Services April 2013 - January 2014
ICON Development Solutions May 2010 - April 2013
Ebewe Parenta Pharmaceuticals December 2007 - April 2009
Wyeth 2002 - 2007
Diosynth 2001 - 2002
Mallinckrodt 1999 - 2001
Education
State University of New York College at Oneonta 1996 — 1999
BS, Chemistry
Herkimer County Community College 1993 — 1995
AAS, Accounting
Jaymi Fallon's Diosynth Experience 1997 - 2006
Job Scientist at Amgen
Industry Biotechnology
Experience
Amgen February 2006 - Present
Diosynth Biotechnology/ Merck November 1997 - January 2006
Diosynth 1997 - 2006
Skills
HPLC, Protein Chemistry, Biotechnology, GMP, Drug Development, Mass Spectrometry, FDA, ELISA, Lifesciences, Formulation, Biopharmaceuticals, Chromatography, LC-MS, Formulation Development, Healthcare, Protein Characterization, Public Health, Root Cause Analysis, Life Sciences, Therapeutics, Change Management, Lean Healthcare, Project Management, Project Planning, Strategy, Management, Career Development, Regulatory Submissions, Biotechnology Industry, Biotherapeutics, Biosimilars, NextGen, Hiring
Education
University of California, Los Angeles - School of Public Health 2009 — 2011
Master of Public Health (MPH), Management & Policy
North Carolina State University 1991 — 1995
BS, Biology
Sherwood HIgh School
Amgen February 2006 - Present
Diosynth Biotechnology/ Merck November 1997 - January 2006
Diosynth 1997 - 2006
Skills
HPLC, Protein Chemistry, Biotechnology, GMP, Drug Development, Mass Spectrometry, FDA, ELISA, Lifesciences, Formulation, Biopharmaceuticals, Chromatography, LC-MS, Formulation Development, Healthcare, Protein Characterization, Public Health, Root Cause Analysis, Life Sciences, Therapeutics, Change Management, Lean Healthcare, Project Management, Project Planning, Strategy, Management, Career Development, Regulatory Submissions, Biotechnology Industry, Biotherapeutics, Biosimilars, NextGen, Hiring
Education
University of California, Los Angeles - School of Public Health 2009 — 2011
Master of Public Health (MPH), Management & Policy
North Carolina State University 1991 — 1995
BS, Biology
Sherwood HIgh School
Ronald Mercer's Diosynth Experience 1999 - 2003
Job Quality Assurance Specialist at Argos Therapeutics
Industry Biotechnology
Experience
Argos Therapeutics July 2003 - Present
Diosynth 1999 - 2003
FMC 1996 - 1998
Skills
GMP, CAPA, Sop, Biotechnology, Pharmaceutical Industry, Clinical Trials, Quality Assurance, HPLC, Regulatory Affairs, Quality System, IND, GLP, LIMS, GCP, FDA, Change Control, 21 CFR Part 11
Education
East Carolina University
BS, Chemistry
Argos Therapeutics July 2003 - Present
Diosynth 1999 - 2003
FMC 1996 - 1998
Skills
GMP, CAPA, Sop, Biotechnology, Pharmaceutical Industry, Clinical Trials, Quality Assurance, HPLC, Regulatory Affairs, Quality System, IND, GLP, LIMS, GCP, FDA, Change Control, 21 CFR Part 11
Education
East Carolina University
BS, Chemistry
Divya Parekh's Diosynth Experience 1999 - November 2014
Job I Coach Professionals To Achieve Confidence ➡ Speaker ➡ Author ➡ Confidence Catalyst Coach ➡ Workshop Facilitator
Industry Professional Training & Coaching
Experience
The DP Group 2013 - Present
ICA, Australia 2011 - Present
Diosynth 1999 - November 2014
The Moxie Solution 2009 - 2013
Skills
Leadership, Coaching, Public Speaking, Leadership Development, Training, Career Development, Career Counseling, Strategy, Team Building, Strategic Planning, Mentoring, Entrepreneurship, Published Author, Executive Coaching, Personal Development, Workshop Facilitation
Education
International Coach Federation 2011 — 2012
Associate Certified Coach, Personal and Professional Development
ICA 2009 — 2010
Certified Professional Coach, Career/Transition Coaching
California State University-Fullerton 1994 — 1996
MS, Biochemistry
The DP Group 2013 - Present
ICA, Australia 2011 - Present
Diosynth 1999 - November 2014
The Moxie Solution 2009 - 2013
Skills
Leadership, Coaching, Public Speaking, Leadership Development, Training, Career Development, Career Counseling, Strategy, Team Building, Strategic Planning, Mentoring, Entrepreneurship, Published Author, Executive Coaching, Personal Development, Workshop Facilitation
Education
International Coach Federation 2011 — 2012
Associate Certified Coach, Personal and Professional Development
ICA 2009 — 2010
Certified Professional Coach, Career/Transition Coaching
California State University-Fullerton 1994 — 1996
MS, Biochemistry
Jolanda Westerlaken's Diosynth Experience March 2002 - May 2005
Job Director Global Regulatory AffairsCMC, CoE Biologics at UCB
Industry Pharmaceuticals
Experience
UCB January 2015 - Present
UCB January 2013 - Present
UCB Pharma April 2010 - December 2012
Wyeth Biotech June 2005 - April 2010
Diosynth March 2002 - May 2005
Univeristy of Nijmegen 1996 - 2001
Skills
Biotechnology, Regulatory Affairs, regulatory strategy, Clinical Trials, Medical Devices, Manufacturing, Biopharmaceuticals, Strategy, CMC, Biologics, R&D, Pharmaceutical Industry, IND, CMC Regulatory Affairs, eCTD, Regulatory Submissions, Drug Development, Clinical Development
Education
Radboud University Nijmegen 1996 — 2001
PhD, medical sciences
Wageningen Universiteit en Researchcentrum 1990 — 1996
Master of Science (MSc), Bioprocess technologie
UCB January 2015 - Present
UCB January 2013 - Present
UCB Pharma April 2010 - December 2012
Wyeth Biotech June 2005 - April 2010
Diosynth March 2002 - May 2005
Univeristy of Nijmegen 1996 - 2001
Skills
Biotechnology, Regulatory Affairs, regulatory strategy, Clinical Trials, Medical Devices, Manufacturing, Biopharmaceuticals, Strategy, CMC, Biologics, R&D, Pharmaceutical Industry, IND, CMC Regulatory Affairs, eCTD, Regulatory Submissions, Drug Development, Clinical Development
Education
Radboud University Nijmegen 1996 — 2001
PhD, medical sciences
Wageningen Universiteit en Researchcentrum 1990 — 1996
Master of Science (MSc), Bioprocess technologie
Frank Dumas's Diosynth Experience 2000 - 2006
Job Technical Supervisor at Talecris
Industry Pharmaceuticals
Experience
Talecris 2007 - Present
Diosynth 2000 - 2006
Education
Fayetteville State University 1989 — 1994
B.S., Biology
Talecris 2007 - Present
Diosynth 2000 - 2006
Education
Fayetteville State University 1989 — 1994
B.S., Biology
Julian Oputa's Diosynth Experience September 2007 - November 2010
Job Scientist I at Fujifilm Diosynth Biotechnologies
Industry Biotechnology
Experience
Fujifilm Diosynth Biotechnologies April 2014 - Present
Fujifilm Diosynth Biotechnologies June 2012 - April 2014
Fujifilm Diosynth Biotechnologies June 2011 - June 2012
Fujifilm Diosynth Biotechnologies November 2010 - June 2011
Diosynth September 2007 - November 2010
BRITE, North Carolina Central University August 2003 - August 2006
Skills
GMP, Protein Chemistry, SDS-PAGE, UV/Vis, Purification, Assay Development, Quality Assurance, Technology Transfer, Biochemistry, Quality Control, Laboratory, Trackwise, DNA, Fluorescence, recombinant DNA..., Agarose Gel..., GLP, RT-PCR, HPLC, LIMS, Electrophoresis, Biotechnology, ELISA, 21 CFR Part 11, real-time PCR, Deviations, Chromatography, Western Blotting, Aseptic Processing, Biopharmaceuticals, Aseptic Technique, Cell Culture, Sop, Validation, Fermentation, Microbiology, SOP
Education
North Carolina Central University 2001 — 2006
BS, Chemistry
Fujifilm Diosynth Biotechnologies April 2014 - Present
Fujifilm Diosynth Biotechnologies June 2012 - April 2014
Fujifilm Diosynth Biotechnologies June 2011 - June 2012
Fujifilm Diosynth Biotechnologies November 2010 - June 2011
Diosynth September 2007 - November 2010
BRITE, North Carolina Central University August 2003 - August 2006
Skills
GMP, Protein Chemistry, SDS-PAGE, UV/Vis, Purification, Assay Development, Quality Assurance, Technology Transfer, Biochemistry, Quality Control, Laboratory, Trackwise, DNA, Fluorescence, recombinant DNA..., Agarose Gel..., GLP, RT-PCR, HPLC, LIMS, Electrophoresis, Biotechnology, ELISA, 21 CFR Part 11, real-time PCR, Deviations, Chromatography, Western Blotting, Aseptic Processing, Biopharmaceuticals, Aseptic Technique, Cell Culture, Sop, Validation, Fermentation, Microbiology, SOP
Education
North Carolina Central University 2001 — 2006
BS, Chemistry
John McNeilly's Diosynth Experience 2001 - 2007
Job Senior Process Engineer at Biogen Idec
Industry Biotechnology
Experience
Biogen Idec January 2007 - Present
Diosynth 2001 - 2007
Diosynth Biotechnology 2000 - 2007
DPS Engineering January 2000 - September 2001
Skills
Purification, Chromatography, Downstream Processing, Technology Transfer, Contract Manufacturing, Ultrafiltration, cGMP, Commissioning, Filtration, Biotechnology, Fermentation, Cell Culture, Process Engineering, Biopharmaceuticals, Centrifugation, Troubleshooting
Education
Queen's University Belfast 1989 — 1992
BEng, Chemical Engineering
Biogen Idec January 2007 - Present
Diosynth 2001 - 2007
Diosynth Biotechnology 2000 - 2007
DPS Engineering January 2000 - September 2001
Skills
Purification, Chromatography, Downstream Processing, Technology Transfer, Contract Manufacturing, Ultrafiltration, cGMP, Commissioning, Filtration, Biotechnology, Fermentation, Cell Culture, Process Engineering, Biopharmaceuticals, Centrifugation, Troubleshooting
Education
Queen's University Belfast 1989 — 1992
BEng, Chemical Engineering
Robert Westney, M.S., RAC, CMQ/OE's Diosynth Experience August 1999 - May 2003
Job President, Director of Quality and Operations at Cryologics, Inc.
Industry Biotechnology
Experience
Cryologics, Inc. October 2010 - Present
Westney & Associates Consulting, LLC December 2010 - Present
ImClone Systems March 2006 - October 2010
Charles River Laboratories August 2005 - January 2006
MedImmune Vaccines June 2003 - August 2005
Diosynth August 1999 - May 2003
Certified Laboratories January 1998 - July 1999
Millennium Microbiology July 1996 - December 1997
Vitex July 1995 - July 1996
Alpharma May 1991 - July 1995
Skills
GMP, Aseptic Processing, Quality System, Microbiology, Environmental Monitoring, Regulatory Requirements, CAPA, Change Control, FDA, Quality Auditing, Biotechnology, Pharmaceutical Industry, Aseptic Technique, Quality Assurance, Quality Control, Dietary Supplements, Auditing, Consultants, Medical Devices, Pharmaceutical..., Vaccines, Deviations, Fermentation, Regulatory Submissions, Trackwise, Supplements, Manufacturing, Contract Manufacturing, Sterilization, Laboratory, FDA GMP, Biopharmaceuticals, USP, Lifesciences, Life Sciences
Education
Temple University 2004 — 2006
M.S., Quality Assurance/Regulatory Affairs
University of Vermont 1982 — 1987
B.A.
Cryologics, Inc. October 2010 - Present
Westney & Associates Consulting, LLC December 2010 - Present
ImClone Systems March 2006 - October 2010
Charles River Laboratories August 2005 - January 2006
MedImmune Vaccines June 2003 - August 2005
Diosynth August 1999 - May 2003
Certified Laboratories January 1998 - July 1999
Millennium Microbiology July 1996 - December 1997
Vitex July 1995 - July 1996
Alpharma May 1991 - July 1995
Skills
GMP, Aseptic Processing, Quality System, Microbiology, Environmental Monitoring, Regulatory Requirements, CAPA, Change Control, FDA, Quality Auditing, Biotechnology, Pharmaceutical Industry, Aseptic Technique, Quality Assurance, Quality Control, Dietary Supplements, Auditing, Consultants, Medical Devices, Pharmaceutical..., Vaccines, Deviations, Fermentation, Regulatory Submissions, Trackwise, Supplements, Manufacturing, Contract Manufacturing, Sterilization, Laboratory, FDA GMP, Biopharmaceuticals, USP, Lifesciences, Life Sciences
Education
Temple University 2004 — 2006
M.S., Quality Assurance/Regulatory Affairs
University of Vermont 1982 — 1987
B.A.
Ty Mew's Diosynth Experience October 1999 - October 2001
Job President at Ofni Systems
Industry Pharmaceuticals
Experience
Ofni Systems October 1999 - Present
Covance October 1999 - October 2001
Diosynth October 1999 - October 2001
Serentec 1997 - 1999
Skills
21 CFR Part 11, Computer System..., MS Office Automation, Database Design, Clinical Data Management, FDA, Validation, CDISC, Software Validation, ePro, GxP, Electronic Signatures, Microsoft Office, CSV, Pharmaceutical Industry, GMP, e-PRO, Biopharmaceuticals, CAPA, Change Control, Life Sciences, Biotechnology, Testing, GCP, SOP, Quality System
Education
North Carolina State University 1990 — 1995
ChE, Chemical/Biochemical Engineering
Ofni Systems October 1999 - Present
Covance October 1999 - October 2001
Diosynth October 1999 - October 2001
Serentec 1997 - 1999
Skills
21 CFR Part 11, Computer System..., MS Office Automation, Database Design, Clinical Data Management, FDA, Validation, CDISC, Software Validation, ePro, GxP, Electronic Signatures, Microsoft Office, CSV, Pharmaceutical Industry, GMP, e-PRO, Biopharmaceuticals, CAPA, Change Control, Life Sciences, Biotechnology, Testing, GCP, SOP, Quality System
Education
North Carolina State University 1990 — 1995
ChE, Chemical/Biochemical Engineering
Crystal Orr's Diosynth Experience November 2007 - January 2009
Job QC Microbiology Lab Technologist at BD Rx
Industry Biotechnology
Experience
BD Rx July 2012 - Present
Diosynth November 2007 - January 2009
Catalent Pharmaceutical Services January 2007 - August 2007
BioMerieux, Inc June 2005 - January 2007
Food and Dairy December 2002 - January 2004
Laboratory Corporation of America October 1998 - December 2002
North Carolina State Public Health Laboratories September 1997 - October 1998
Skills
GMP, Biochemistry, Biotechnology, Lifesciences, Cell Culture, Pharmaceutical Industry, HPLC, Microbiology, Laboratory, PCR, Biopharmaceuticals, Cell, Protein Chemistry, GLP, Quality Assurance, LIMS, Validation, Life Sciences
Education
North Carolina State University 1993 — 1997
BS, Microbiology and Zoology
BD Rx July 2012 - Present
Diosynth November 2007 - January 2009
Catalent Pharmaceutical Services January 2007 - August 2007
BioMerieux, Inc June 2005 - January 2007
Food and Dairy December 2002 - January 2004
Laboratory Corporation of America October 1998 - December 2002
North Carolina State Public Health Laboratories September 1997 - October 1998
Skills
GMP, Biochemistry, Biotechnology, Lifesciences, Cell Culture, Pharmaceutical Industry, HPLC, Microbiology, Laboratory, PCR, Biopharmaceuticals, Cell, Protein Chemistry, GLP, Quality Assurance, LIMS, Validation, Life Sciences
Education
North Carolina State University 1993 — 1997
BS, Microbiology and Zoology
Mike J. Vincent's Diosynth Experience 2000 - 2003
Job Application Specialist Southeast Fluid Management Technologies at Sartorius Stedim Biotech
Industry Biotechnology
Experience
Sartorius Stedim Biotech July 2014 - Present
Merial July 2005 - July 2014
BD 2003 - 2005
Diosynth 2000 - 2003
Regeneron Pharmaceuticals 1999 - 2000
Skills
Research, Antibodies, GMP, GCP, Biopharmaceuticals, GLP, Bioreactor, Purification, Industrial Microbiology, Biotechnology, Technology Transfer, Vaccines, LIMS, Technical Transfers, Cell Culture, Aseptic Processing, Fermentation, Chromatography, Protein Chemistry, Filtration, Assay Development, Validation
Education
Frank G. Zarb School of Business, Hofstra University 2014 — 2016
Master of Business Administration (MBA), Strategic Management
Georgia Gwinnett College 2011 — 2012
Business, Business-Project Management
Hudson Valley Community College 1998 — 1998
Emergency Medicine, Emergency Medicine
State University of New York at Albany 1993 — 1998
Biology, Biology
Midwood HS 1989 — 1993
Science Regents Honors, Science Math
Sartorius Stedim Biotech July 2014 - Present
Merial July 2005 - July 2014
BD 2003 - 2005
Diosynth 2000 - 2003
Regeneron Pharmaceuticals 1999 - 2000
Skills
Research, Antibodies, GMP, GCP, Biopharmaceuticals, GLP, Bioreactor, Purification, Industrial Microbiology, Biotechnology, Technology Transfer, Vaccines, LIMS, Technical Transfers, Cell Culture, Aseptic Processing, Fermentation, Chromatography, Protein Chemistry, Filtration, Assay Development, Validation
Education
Frank G. Zarb School of Business, Hofstra University 2014 — 2016
Master of Business Administration (MBA), Strategic Management
Georgia Gwinnett College 2011 — 2012
Business, Business-Project Management
Hudson Valley Community College 1998 — 1998
Emergency Medicine, Emergency Medicine
State University of New York at Albany 1993 — 1998
Biology, Biology
Midwood HS 1989 — 1993
Science Regents Honors, Science Math
Gretchen Rizor's Diosynth Experience 2009 - 2011
Job InstantGMP Support Associate
Industry Pharmaceuticals
Experience
InstantGMP 2012 - Present
Diosynth 2009 - 2011
Biogen Idec 2009 - 2009
Hospira 2008 - 2009
Catalent 2008 - 2008
Organon Teknika 2007 - 2008
Skills
GMP, Quality Assurance, CAPA, Quality Control, LIMS, Pharmaceutical Industry, Environmental Monitoring, 21 CFR Part 11, FDA, Aseptic Processing, GLP, Change Control, Microbiology, Sop, Quality Auditing, Aseptic Technique, Software Documentation, dietary supplement..., Software Validation..., Software Quality..., SOP
Education
University of North Carolina at Chapel Hill
Biology, Anthropology
InstantGMP 2012 - Present
Diosynth 2009 - 2011
Biogen Idec 2009 - 2009
Hospira 2008 - 2009
Catalent 2008 - 2008
Organon Teknika 2007 - 2008
Skills
GMP, Quality Assurance, CAPA, Quality Control, LIMS, Pharmaceutical Industry, Environmental Monitoring, 21 CFR Part 11, FDA, Aseptic Processing, GLP, Change Control, Microbiology, Sop, Quality Auditing, Aseptic Technique, Software Documentation, dietary supplement..., Software Validation..., Software Quality..., SOP
Education
University of North Carolina at Chapel Hill
Biology, Anthropology
Rick Wylie's Diosynth Experience December 2008 - Present
Job Lead QC Associate at Diosynth
Industry Biotechnology
Experience
Diosynth December 2008 - Present
Wyeth Biotech March 2004 - December 2008
Education
North Carolina Central University 1988 — 1994
Bachelor of Science, Biology
Diosynth December 2008 - Present
Wyeth Biotech March 2004 - December 2008
Education
North Carolina Central University 1988 — 1994
Bachelor of Science, Biology
Brett Gibbs's Diosynth Experience September 2000 - October 2006
Job Maintenance Technician
Industry Pharmaceuticals
Experience
Grifols September 2012 - Present
GlaxoSmithKline November 2008 - September 2012
Diosynth September 2000 - October 2006
Education
East Carolina University 1994 — 1996
BS, Industrial Technology
Grifols September 2012 - Present
GlaxoSmithKline November 2008 - September 2012
Diosynth September 2000 - October 2006
Education
East Carolina University 1994 — 1996
BS, Industrial Technology
Luther Anderson, Jr.'s Diosynth Experience June 2000 - October 2006
Job QC Raw Materials ( Sample Management ) at Novartis
Industry Pharmaceuticals
Glenn Smeal's Diosynth Experience November 1998 - February 2004
Job QA Manager at KBI Biopharma
Industry Biotechnology
Experience
KBI Biopharma August 2014 - Present
KBI BioPharma July 2010 - Present
Diosynth Biotechnology/ Merck February 2004 - July 2010
Diosynth November 1998 - February 2004
Bayer Pharmaceuticals October 1997 - November 1998
Skills
Project Management, Leadership, FDA, Testing, Deviations, Clinical Research, Biopharmaceuticals, GMP, Sop, Validation, Chromatography, Change Control, HPLC
Education
University of North Carolina at Wilmington 1991 — 1995
Bachelors of Science, Biology/Chemistry
KBI Biopharma August 2014 - Present
KBI BioPharma July 2010 - Present
Diosynth Biotechnology/ Merck February 2004 - July 2010
Diosynth November 1998 - February 2004
Bayer Pharmaceuticals October 1997 - November 1998
Skills
Project Management, Leadership, FDA, Testing, Deviations, Clinical Research, Biopharmaceuticals, GMP, Sop, Validation, Chromatography, Change Control, HPLC
Education
University of North Carolina at Wilmington 1991 — 1995
Bachelors of Science, Biology/Chemistry
Mary Moss, MPH's Diosynth Experience January 2006 - May 2009
Job Medical Writer at PMG Research
Industry Health, Wellness and Fitness
Experience
PMG Research October 2013 - Present
PMG Research October 2012 - September 2013
PMG Research October 2011 - September 2012
US EPA August 2011 - September 2011
Be Active North Carolina January 2011 - April 2011
Diosynth Biotechnology/ Merck May 2009 - May 2010
Diosynth January 2006 - May 2009
Hal Price Biotechnology Consulting Service February 2004 - May 2006
Diosynth March 2005 - January 2006
Koonce, Wooten & Haywood LLP May 2004 - March 2005
Skills
Quality Assurance, Sop, Validation, GMP, Pharmaceutical Industry, Clinical Research, Access, Training, GCP, Clinical Trials, CTMS, Software Documentation, ICH-GCP, SOP, FDA
Education
University of North Carolina at Greensboro 2008 — 2011
Masters, Public Health in Community Health Education
Radford University 2001 — 2003
Bachelor of Science, Psychology, Minor in General Management
PMG Research October 2013 - Present
PMG Research October 2012 - September 2013
PMG Research October 2011 - September 2012
US EPA August 2011 - September 2011
Be Active North Carolina January 2011 - April 2011
Diosynth Biotechnology/ Merck May 2009 - May 2010
Diosynth January 2006 - May 2009
Hal Price Biotechnology Consulting Service February 2004 - May 2006
Diosynth March 2005 - January 2006
Koonce, Wooten & Haywood LLP May 2004 - March 2005
Skills
Quality Assurance, Sop, Validation, GMP, Pharmaceutical Industry, Clinical Research, Access, Training, GCP, Clinical Trials, CTMS, Software Documentation, ICH-GCP, SOP, FDA
Education
University of North Carolina at Greensboro 2008 — 2011
Masters, Public Health in Community Health Education
Radford University 2001 — 2003
Bachelor of Science, Psychology, Minor in General Management
Jerry Ballance's Diosynth Experience May 2007 - March 2010
Job BioProcess Technician, Durham Vaccine Bulk Facility at Merck at Merck
Industry Biotechnology
Experience
Merck August 2010 - Present
Diosynth May 2007 - March 2010
Eisai Inc. November 2006 - May 2007
Education
Central Carolina Community College
Associates, Veterinary Medical Technology
North Carolina Wesleyan College
incomplete, Business Administration
Merck August 2010 - Present
Diosynth May 2007 - March 2010
Eisai Inc. November 2006 - May 2007
Education
Central Carolina Community College
Associates, Veterinary Medical Technology
North Carolina Wesleyan College
incomplete, Business Administration
Lori Simmons's Diosynth Experience May 2003 - February 2008
Job Training Manager at Diosynth Biotechnology/ Merck
Industry Biotechnology
Experience
Fujifilm Diosynth Biotechnologies (formerly Merck) February 2008 - Present
Diosynth May 2003 - February 2008
Diosynth (formerly Covance) November 2000 - May 2003
Covance December 1999 - November 2000
AAIPharma Services Corp. April 1997 - December 1999
Skills
GMP, Management Development, Biotechnology, Pharmaceutical Industry, Quality Assurance, Software Documentation, Sop, Validation, Six Sigma, FDA, Cross-functional Team..., Training, Quality System, Lean Manufacturing, CAPA, Biopharmaceuticals, Quality Auditing
Education
North Carolina State University 1988 — 1994
BS, Chemical Engineering
Fujifilm Diosynth Biotechnologies (formerly Merck) February 2008 - Present
Diosynth May 2003 - February 2008
Diosynth (formerly Covance) November 2000 - May 2003
Covance December 1999 - November 2000
AAIPharma Services Corp. April 1997 - December 1999
Skills
GMP, Management Development, Biotechnology, Pharmaceutical Industry, Quality Assurance, Software Documentation, Sop, Validation, Six Sigma, FDA, Cross-functional Team..., Training, Quality System, Lean Manufacturing, CAPA, Biopharmaceuticals, Quality Auditing
Education
North Carolina State University 1988 — 1994
BS, Chemical Engineering
Les Smith's Diosynth Experience 1998 - 2005
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
Gregory Worsley's Diosynth Experience 2005 - 2007
Job MA IV Biogen IDEC
Industry Biotechnology
Experience
Biogen Idec February 2011 - Present
Diosynth 2005 - 2007
Skills
Biotechnology, Biopharmaceuticals, GMP, Aseptic Processing, Fermentation, Validation
Education
North Carolina State University
Biogen Idec February 2011 - Present
Diosynth 2005 - 2007
Skills
Biotechnology, Biopharmaceuticals, GMP, Aseptic Processing, Fermentation, Validation
Education
North Carolina State University
Natalie Upchurch's Diosynth Experience 2007 - 2011
Job Sr. Supervisor Quality Assurance
Industry Biotechnology
Experience
Biogen Idec 2011 - Present
Diosynth 2007 - 2011
Education
North Carolina State University
BS Electrical Engineering
Biogen Idec 2011 - Present
Diosynth 2007 - 2011
Education
North Carolina State University
BS Electrical Engineering
Kimberly Gillis's Diosynth Experience November 2000 - March 2009
Job Manufacturing Compliance Manager at KBI Biopharma
Industry Biotechnology
Experience
KBI Biopharma December 2012 - Present
KBI Biopharma March 2009 - December 2012
Diosynth November 2000 - March 2009
Education
Salisbury University 1994 — 1998
BS, Biology
KBI Biopharma December 2012 - Present
KBI Biopharma March 2009 - December 2012
Diosynth November 2000 - March 2009
Education
Salisbury University 1994 — 1998
BS, Biology
Jim Allgood's Diosynth Experience 2001 - 2003
Job Quality Engineer
Industry Pharmaceuticals
Experience
Polyzen 2013 - Present
Pfizer (formerly Wyeth Vaccines) 2003 - 2013
Diosynth 2001 - 2003
LabCorp Center for Molecular Biology and Pathology 1997 - 2001
Skills
21 CFR Part 11, FDA, GMP, Validation, Quality System, V&V, Change Control, Aseptic Processing, Cleaning Validation, Sop, Computer System..., Technology Transfer, Biopharmaceuticals
Education
North Carolina State University 1992 — 1996
BS, Chemical Engineering and BS, Biochemistry
Polyzen 2013 - Present
Pfizer (formerly Wyeth Vaccines) 2003 - 2013
Diosynth 2001 - 2003
LabCorp Center for Molecular Biology and Pathology 1997 - 2001
Skills
21 CFR Part 11, FDA, GMP, Validation, Quality System, V&V, Change Control, Aseptic Processing, Cleaning Validation, Sop, Computer System..., Technology Transfer, Biopharmaceuticals
Education
North Carolina State University 1992 — 1996
BS, Chemical Engineering and BS, Biochemistry
Rebecca Steen-Marshall's Diosynth Experience 1998 - 1999
Job Domestic Engineer Manager
Industry Facilities Services
Experience
The Marshall Residence March 2014 - Present
Hospira March 2013 - February 2014
Hospira December 2011 - March 2013
Grifols September 2008 - August 2011
Diosynth Biotechnology 2001 - 2008
Diosynth Biotechnology June 1999 - March 2001
Diosynth 1998 - 1999
Toxin Technology August 1996 - August 1998
Skills
GMP, Biotechnology, Sop, Pharmaceutical Industry, Training, Purification, Biopharmaceuticals, 21 CFR Part 11, Change Control, Quality Assurance, Chromatography, GxP, Aseptic Processing, ELISA, Aseptic Technique, Protein Purification, Formulation, Technical Writing, Downstream Processing, Filtration
Education
Rochester Institute of Technology 1991 — 1996
BS, Biotechnology
The Marshall Residence March 2014 - Present
Hospira March 2013 - February 2014
Hospira December 2011 - March 2013
Grifols September 2008 - August 2011
Diosynth Biotechnology 2001 - 2008
Diosynth Biotechnology June 1999 - March 2001
Diosynth 1998 - 1999
Toxin Technology August 1996 - August 1998
Skills
GMP, Biotechnology, Sop, Pharmaceutical Industry, Training, Purification, Biopharmaceuticals, 21 CFR Part 11, Change Control, Quality Assurance, Chromatography, GxP, Aseptic Processing, ELISA, Aseptic Technique, Protein Purification, Formulation, Technical Writing, Downstream Processing, Filtration
Education
Rochester Institute of Technology 1991 — 1996
BS, Biotechnology
Chuck Luce's Diosynth Experience October 2001 - May 2010
Job Consultant at ProPharma Group
Industry Pharmaceuticals
Experience
ProPharma Group October 2011 - Present
Lonza Hopkinton 2011 - 2012
Diosynth October 2001 - May 2010
Skills
Contract Manufacturing, Biotechnology, GMP, cGMP, Validation, Technology Transfer, 21 CFR Part 11, Biochemistry, Biopharmaceuticals, CAPA, CRO, Cell Culture, Change Control, Chromatography, Drug Development, FDA, GLP, GxP, LIMS, Lifesciences, Manufacturing, Pharmaceutical Industry, Pharmaceutics, Purification, Quality Management, R, Regulatory Requirements, SOP, Sop, V, Vaccines
Education
North Carolina State University 1998 — 2001
Bachelor of Science, Biochemistry
North Carolina State University 1998 — 2001
Bachelor of Arts, Chemistry
ProPharma Group October 2011 - Present
Lonza Hopkinton 2011 - 2012
Diosynth October 2001 - May 2010
Skills
Contract Manufacturing, Biotechnology, GMP, cGMP, Validation, Technology Transfer, 21 CFR Part 11, Biochemistry, Biopharmaceuticals, CAPA, CRO, Cell Culture, Change Control, Chromatography, Drug Development, FDA, GLP, GxP, LIMS, Lifesciences, Manufacturing, Pharmaceutical Industry, Pharmaceutics, Purification, Quality Management, R, Regulatory Requirements, SOP, Sop, V, Vaccines
Education
North Carolina State University 1998 — 2001
Bachelor of Science, Biochemistry
North Carolina State University 1998 — 2001
Bachelor of Arts, Chemistry
Windy Johnson's Diosynth Experience February 2000 - March 2001
Job QA Associate III at Biogen Idec
Industry Biotechnology
Experience
Biogen Idec March 2001 - Present
Diosynth February 2000 - March 2001
Pfizer January 1998 - February 2000
Education
University of North Carolina at Pembroke 1991 — 1993
Biogen Idec March 2001 - Present
Diosynth February 2000 - March 2001
Pfizer January 1998 - February 2000
Education
University of North Carolina at Pembroke 1991 — 1993
Kenneth Yimbu's Diosynth Experience September 2007 - December 2008
Job Service Technician at Chapel Hill Transit
Industry Transportation/Trucking/Railroad
Experience
Chapel Hill Transit December 2014 - Present
Triangle Transit March 2009 - December 2014
Diosynth September 2007 - December 2008
East Carolina University Division of Health Sciences April 2006 - June 2007
Skills
Microsoft Office, Microsoft Excel, Microsoft Word, Customer Service, PowerPoint, English, Windows, Research, Outlook, Photoshop, Public Speaking, Access
Education
East Carolina University 2003 — 2007
Bachelor of Science (BS), Biology, General
Wake Forest-Rolesville High School 2000 — 2001
Chapel Hill Transit December 2014 - Present
Triangle Transit March 2009 - December 2014
Diosynth September 2007 - December 2008
East Carolina University Division of Health Sciences April 2006 - June 2007
Skills
Microsoft Office, Microsoft Excel, Microsoft Word, Customer Service, PowerPoint, English, Windows, Research, Outlook, Photoshop, Public Speaking, Access
Education
East Carolina University 2003 — 2007
Bachelor of Science (BS), Biology, General
Wake Forest-Rolesville High School 2000 — 2001
Hyo (Nikki) Chang's Diosynth Experience February 2001 - July 2005
Job Staff Process Engineer at FUJIFILM Diosynth Biotechnologies
Industry Biotechnology
Experience
FUJIFILM Diosynth Biotechnologies July 2005 - Present
Diosynth February 2001 - July 2005
Covance Biotechnology Services September 1999 - February 2001
Bayer HealthCare January 1999 - May 1999
North Carolina State University 1998 - 1999
Education
North Carolina State University
Bachelor of Arts (BA)
North Carolina State University
Bachelor of Science (BS)
FUJIFILM Diosynth Biotechnologies July 2005 - Present
Diosynth February 2001 - July 2005
Covance Biotechnology Services September 1999 - February 2001
Bayer HealthCare January 1999 - May 1999
North Carolina State University 1998 - 1999
Education
North Carolina State University
Bachelor of Arts (BA)
North Carolina State University
Bachelor of Science (BS)