DSM Pharmaceuticals
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DSM Pharmaceuticals Employees
Patheon June 2014 - Present
Zumba Fitness LLC June 2012 - Present
DSM PHARMACEUTICALS May 2012 - May 2014
East Carolina University January 2011 - December 2011
Time Financing Services August 2009 - December 2010
Craven Community College December 2007 - May 2009
Patel, M.D., Incorporated December 2006 - December 2007
Physiotherapy Associates May 2006 - October 2006
Westport Chiropractic September 2005 - May 2006
Baker Chiropractic Center November 2004 - September 2005
Skills
Teamwork, Molecular Biology, Data Analysis, UV/Vis, HPLC, Dissolution Testing, Data Reviewer, Karl Fisher, Gas Chromatography, autosampler, Bilingual, Subject Matter Experts, Mentoring Of Staff, Organic Chemistry, Cell Biology, Account Management, Chemistry, Financial Analysis, Technical Writing, Chromatography, Technical Support, Physics, Accounts Payable, Accounts Receivable, Medical Billing, Administration, calculations, Marine Biology, Office Administration, Telephone Skills, Invoicing, Laboratory, Titration, Lifesciences, Analytical Chemistry, Scientific Writing, Wet Chemistry, Statistics, Validation, Spectrophotometry, Science, Microscopy, Gel Electrophoresis, Biology, Troubleshooting, Aseptic Technique, GMP, Cell, Sop, Life Sciences
Education
East Carolina University 2010 — 2011
Bachelor of Science (B.S.), Biology, General
Craven Community College 2007 — 2009
Associate of Science (A.S.), Biology, General
Craven Community College 2007 — 2009
Associate of Arts (A.A.), Liberal Arts and Sciences/Liberal Studies
Havelock High School 1999 — 2002
Pronamic Industries February 2014 - Present
DSM Pharmaceuticals June 2000 - January 2014
Catalytica Pharmaceuticals August 1997 - June 2000
Glaxo-Wellcome Pharmaceuticals February 1996 - July 1997
Skills
Licensed Forklift..., Word Processing/Typing..., Microsoft Office..., Proficient in Windows..., Mechanical Drafting, Pharmaceutical Industry, GMP, Process Improvement, Teamwork, Product Development, English, Sop, Manufacturing, Photoshop, Inventory Management, FDA, Continuous Improvement, Microsoft Office, Microsoft Excel, Microsoft Word, CAPA, Quality Assurance, Software Documentation, Validation, Leadership, Quality Control, Technology Transfer, Biotechnology, Supervisory Skills, Mechanical Drawings, SOP
Education
East Carolina University 1978 — 1980
Special Education and Teaching
Roanoke High School 1975 — 1978
Diploma, College Prep
Patheon March 2014 - Present
DSM Pharmaceuticals April 2013 - March 2014
DSM Pharmaceuticals September 2010 - April 2013
DSM Pharmaceuticals June 2007 - September 2010
C.A. Lewis Industrial June 2006 - June 2007
Skills
Pharmaceutical Industry, Project Management, Validation, Pharmaceutical..., Pharmaceutical Packaging, Sterilization, Sterile Products, Sop, Aseptic Processing, FDA, Technology Transfer, GLP, 21 CFR Part 11, Cleaning Validation, Pharmaceutics, Change Control, Analytical Chemistry, SOP, Computer System..., Biotechnology, CAPA, GMP, Quality Assurance, Quality System
Education
Pitt Community College 2002 — 2006
Associate's degree, Building Construction Technology
J.H. Rose High School 1999 — 2002
AAIPharma Services Corp. December 2014 - Present
DSM Pharmaceuticals October 2013 - January 2014
DSM Pharmaceuticals December 2010 - January 2014
The NutraSweet Company April 2008 - September 2010
The NutraSweet Company October 2005 - April 2008
Austin industrial @ The Nutrasweet company August 2003 - October 2005
Skills
Quality Control, Industrial Safety, cGMP practices, cGMP manufacturing, Aseptic Technique, Sop, GMP, Contract Manufacturing, Pharmaceutical..., HACCP, FDA, CAPA, V&V, Cleaning Validation, Packaging, 5S, Software Documentation, TPM, Process Control, Clean Rooms, Continuous Improvement, Root Cause Analysis, Lean Manufacturing, Quality System, Validation, Manufacturing, Process Improvement, SOP
Education
Aiken Technical College 2000 — 2003
Associate's degree, Machine Tool Technology/Machinist
Aiken county career center 1999 — 2000
Certificate, Machine Tool Technology/Machinist
South Aiken High School 1997 — 2000
Diploma
Metrics, Inc. July 2006 - Present
Sandoz 2003 - 2006
DSM Pharmaceuticals June 2000 - June 2003
GlaxoSmithKline 2002 - 2003
Skills
Pharmaceutical Industry, Pharmaceutics, Formulation, Laboratory, Dissolution, Organic Chemistry, UV, Quality by Design, Drug Development, Mass Spectrometry, CRO, LC-MS, NMR, GC-MS, Wet Chemistry
Education
Bridgeport ,ct.
Pitt Community College
CP Engineers & Architecture CPM/HVAC Consulting EngineerNYCT2015 - 2015
NYCT 2015 - 2015
DSM Pharmaceuticals April 2013 - August 2014
Jacobs Engineering January 2007 - February 2013
Washington Group International (now part of URS Corporation) February 2002 - January 2007
DMJM Harris 2006 - 2007
DMJM Harris 2006 - 2007
metcalf & eddy aecom 1999 - 2003
metcalf & eddy aecom 1999 - 2003
metcalf & eddy aecom 1999 - 2003
Skills
Commissioning, Project Engineering, P&ID, Engineering, HVAC, Instrumentation, DCS, Piping, Process Control, HAZOP, PLC, Process Engineering, Primavera P6, AutoCAD, Automation, Construction, Inspection, SCADA, Validation, Construction Management, Process Simulation, Factory
Education
Kharkiv State Academy of Railway Transport 1965 — 1970
Master Degree, Construction machinery & equipment
Cook Children's Health Care System August 2014 - Present
Southlake Focus Group May 2013 - August 2014
HEALTHPOINT Biotherapeutics February 2011 - March 2013
Lake Region Medical, Inc January 2010 - February 2011
Paddock Laboratories, Inc July 2004 - September 2009
DSM Pharmaceuticals January 2000 - July 2004
Catalytica Pharmaceuticals January 1997 - January 2000
Glaxo Wellcome Pharmaceuticals June 1994 - January 1997
Burroughs Wellcome Pharmaceuticals May 1990 - June 1994
Education
East Carolina University 1990 — 1996
BS
New Horizons
Wethersfiled High School
Wethersfiled High School
Wethersfiled High School
Pearl Theraputics January 2011 - Present
GlaxoSmithKline February 2008 - January 2011
Talecris Biotherapeutics February 2009 - March 2010
Inhaled Product Development February 2008 - February 2009
DSM Pharmaceuticals May 2007 - January 2008
Goodys Family Clothing April 2003 - June 2007
Skills
HPLC, Pharmaceutical Industry, GLP, Chromatography, GMP, Analytical Chemistry, Laboratory, Protein Chemistry
Education
East Carolina University 2002 — 2006
Bachelor of Science (BS), Biology, General
GXP CONSULTING February 2010 - Present
Oxigene November 2007 - December 2009
Novartis Vaccines and Diagnostics November 2004 - October 2007
Yamanouchi Pharma Technologies March 2003 - October 2004
DSM Pharmaceuticals March 2002 - December 2002
Colgate Palmolive September 2000 - February 2002
Global Pharma Inc May 1998 - August 2000
Apotex Inc. November 1996 - April 1998
Skills
GMP, CAPA, FDA, Validation, Regulatory Affairs, Sop, Quality System, Pharmaceutical Industry, GLP, Biotechnology, GxP, Quality Control, Clinical Development, Clinical Trials, Pharmaceutics, GCP, Quality Auditing, Regulatory Requirements, Drug Development, Quality Assurance, SOP
Education
Business conference
McMaster University
Hons BSc Biochemistry, BSc Chemistry, Biochemistry, Chemistry
ENCO Pharmaceutical Development, Inc. 2012 - Present
Coty March 2010 - July 2011
DSM Pharmaceuticals 2003 - 2004
Skills
GMP, Sop, 21 CFR Part 11, Analytical Chemistry, Cross-functional Team..., FDA, GLP, HPLC, Quality Assurance, Quality System, Regulatory Affairs, SOP, Technology Transfer, Validation, R&D
Education
North Carolina State University 1995 — 2000
BS, Animal Science, Zoology, Business Management
D. H. Griffin Used Equipment January 2014 - Present
D. H. Griffin Used Equipment April 2005 - January 2014
DSM Pharmaceuticals August 1993 - April 2005
Skills
Market Research, Inventory Management, Sales Management, Sales Operations, Microsoft Office, Microsoft Excel, Microsoft Word, Management, Negotiation, Contract Negotiation, Purchasing, Sales, Customer Service, Key Account Management
Education
East Carolina University 1989 — 1993
Bachelor's degree, Biotechnology
Patheon March 2014 - Present
DSM Pharmaceuticals April 2012 - March 2014
DSM Pharmaceuticals 2007 - April 2012
Syfan Mfg 2005 - 2007
Skills
Supply Chain Management, Logistics, Supply Chain, SAP, Pharmaceutical Industry, Process Improvement, Inventory Management, Microsoft Office, Microsoft Excel, Customer Service, Materials Management, Logistics Management, Procurement, Warehousing, Sop, Six Sigma, GMP, Forecasting, Project Management, Continuous Improvement
Education
Wake Technical Community College 2003 — 2005
Associate's degree, Bus. Admin/HR
Martin Community College 2001 — 2003
Associate's degree, Equine Technologies
The Estée Lauder Companies Inc. July 2010 - Present
The Estée Lauder Companies Inc. October 2007 - July 2010
Avon February 2005 - September 2007
Associated Hygienic Products, LLC September 2003 - January 2005
DSM Pharmaceuticals August 2002 - September 2003
Procter & Gamble January 2000 - July 2000
Skills
Packaging, Project Management, Cosmetics, Consumer Products, Timelines, Luxury Goods, Packaging Engineering, Skin Care, Personal Care, Pharmaceutical Industry, Beauty Industry, Product Innovation, Fragrance
Education
Michigan State University 1997 — 2001
Bachelor of Science (B.S.), Packaging Science
NACCO Materials Handling Group September 2007 - Present
NACCO Materials Handling Group April 2006 - September 2007
NACCO Materials Handling Group September 2004 - April 2006
NACCO Materials Handling Group April 2002 - September 2004
DSM Pharmaceuticals August 1999 - April 2002
Wattam's Creek, L.L.C. March 1997 - April 2002
Grady-White Boats 1996 - 1997
Cliffstar Corporation 1995 - 1996
Skills
Account Management, Time Management, Strategic Planning, Sales Management, Sales, Purchasing, Pricing, Account Reconciliation, Accounts Payable, Analysis, B2B, Business Planning, Continuous Improvement, Finance, Forecasting, Contract Negotiation, Internal Audit, Inventory Management, Invoicing, Logistics, Key Account Management, Management, Manufacturing, Marketing, Material Handling, New Business Development, Operations Management, Process Improvement, Payroll, Parts, Product Development, Sales Process, Sales Operations, Supply Chain Management, Team Building
Education
State University of New York College at Fredonia 1991 — 1995
BS Accounting, Accounting
GlaxoSmithKline January 2012 - Present
GlaxoSmithKline 2003 - 2011
GlaxoWellcome 2000 - 2002
DSM Pharmaceuticals 1999 - 2000
Cataltyica Pharmaceuticals 1997 - 1999
Burroughs Wellcome 1988 - 1997
Skills
Validation, Pharmaceutical Industry, Change Control, GMP, CAPA, Sop, V&V, FDA, GxP, 21 CFR Part 11, Technology Transfer, SOP
Education
East Carolina University - College of Business
Business
Pfizer September 2015 - Present
Hospira November 2012 - August 2015
Kelly Scientific Resources March 2012 - November 2012
Irix Manufacturing Inc. June 2006 - February 2012
DSM Pharmaceuticals February 1992 - June 2006
Skills
Manufacturing Operations, Continuous Improvement, CAPA, GMP, Documentation, SOP, Investigations, Performance Management, Trackwise, Sop, Software Documentation, Validation, Process Improvement, Manufacturing, FDA, Aseptic Processing, TrackWise, Quality Assurance
Education
Farmville Central High 1968 — 1972
HS Diploma, College Preparatory
East Carolina University
A few Basic Courses
Pitt Community College
Some Basic courses
Priorities Limited February 2003 - Present
Snyder, Inc. June 2000 - Present
DSM Pharmaceuticals 2000 - 2003
GlaxoWellcome 1995 - 1998
Association for Quality and Participation 1994 - 1996
Burroughs Wellcome Co. 1992 - 1995
Burroughs Wellcome Co. 1983 - 1992
Burroughs Wellcome Co. 1978 - 1983
Burroughs Wellcome Co. 1970 - 1978
Skills
Leadership Development, Interview Coaching, Facilitation, Validation, Training & Development, Auditing, Personality Assessment, Team Leadership, Strategic Planning, Workshop Facilitation, Facilities Management, Curriculum Development, Leading Meetings, Communication Skills, Training Delivery, Training, Employee Training, Project Management, Coaching, Team Building, Employee Engagement, Organizational..., Program Management, Job Coaching, Quality Assurance, Management, Process Improvement, Continuous Improvement, Manufacturing, Instructional Design, Executive Coaching, Quality System, Business Process..., FDA, Pharmaceutical Industry, Change Management, GMP, Performance Management, Learning Management, Cross-functional Team..., Facilitators, Performance Improvement, Human Resources, Leadership, Instructor-led Training, Project Planning, Recruiting, Learning Management..., Succession Planning, Organizational...
Education
East Carolina University - College of Business 1965 — 1978
Bachelor of Science Business Administration, Management Science
Patheon Manufacturing Services January 2014 - Present
DSM Pharmaceuticals January 2012 - January 2014
DSM Pharmaceuticals January 2009 - January 2012
Fieldcrest Cannon January 1977 - February 1991
Skills
Clinical Research, Manufacturing, Pharmaceutical Industry, SOP, Biotechnology, GMP, Life Sciences, Regulatory Affairs, Medical Devices, Technology Transfer, CAPA, 21 CFR Part 11, Process Improvement, Continuous Improvement, FDA, Change Control, Management, Supervisory Skills
Education
East Carolina University 1975 — 1978
2 years, Business Adminstration
Medgate July 2011 - Present
DSM Pharmaceuticals July 2002 - June 2011
General Chemical January 2001 - June 2002
Bausch & Lomb 1998 - 2001
Skills
EHS, Ergonomics, Risk Assessment, Industrial Hygiene, Process Improvement, Quality Assurance, Occupational Health, Continuous Improvement, FDA, Industrial Safety, Hazard Analysis, Process Safety, Software Project..., Compliance, Safety Management..., Environmental Awareness, Technical Writing, Software Documentation, Training, GMP, Auditing, Budgets
Education
University of South Florida 2009 — 2011
MPH, Public Health
Ohio University 1992 — 1997
BSIH, Industrial Hygiene
Mayne Pharma March 2015 - Present
The Boat Doc January 2012 - Present
IBX Appraisals January 2005 - Present
Mark's Marine Incorporated June 1994 - Present
Patheon November 2014 - February 2015
Patheon March 2014 - February 2015
DSM Pharmaceuticals July 2012 - 2014
PotashCorp August 2010 - July 2012
PotashCorp July 2010 - July 2012
Skills
Maintenance & Repair, Marine Industry, Marine Electronics, Marinas, Instrumentation, PLC, Customer Service, Troubleshooting, Maintenance Management, Continuous Improvement, Predictive Maintenance, SCADA, Process Control, Microsoft Excel, Process Automation, DCS, Sales, Hydraulic Systems, Automation, HMIs, Electricians, Allen Bradley, Valves, Preventive Maintenance, Plant Maintenance, Electricity, Pneumatics, Root Cause Analysis, Variable Frequency..., Manufacturing, Pumps, Air Compressors, Marine Survey, Small Boat Operations, Mercury Test Tools, Scales, Equipment Installation, Equipment Integration, Project Management, Kaizen, Calibration, Planned Preventative..., Maintenance Engineering, Reliability Centered..., Factory, Electronic..., Fiberglass, Wireless Networking
Education
D.H. Conley High School 1992 — 1996
Diploma
Nationwide Insurance automotive claims school
Automotive damage assessment and reapir
North Carolina Insurance Property and Casualty School
NC claims adjuster license, Property and Casualty claims
Pitt Community College
Plc
Universal Technical Institute-Auto, Motorcycle, & Marine Mechanics Institute Division-Orlando
Marine mechanics
Aenova July 2014 - Present
Norwich Pharma Services March 2014 - July 2014
Norwich Pharma Services June 2011 - March 2014
The Peoples Company July 2010 - June 2011
AuroSource January 2010 - July 2010
The Peoples Company August 2009 - April 2010
NCEast Business Solutions April 2009 - December 2009
DSM Pharmaceuticals February 2000 - January 2009
DSM Pharmaceuticals 2000 - 2009
DSM Pharmaceutical Products 2003 - 2008
Skills
Pharmaceutical Industry, Technology Transfer, FDA, Validation, Pharmaceutical Packaging, Pharmaceutical..., GMP, Business Development, Manufacturing, Pharmaceutics, Contract Manufacturing, CAPA, Contract Negotiation, Regulatory Affairs, Biopharmaceuticals, Drug Discovery, Analytical Chemistry, Sop, Biotechnology, Commercialization, Product Development, Drug Development, R&D, Lifesciences, Formulation, GLP, Clinical Development, 21 CFR Part 11, Regulatory Submissions, V&V, CRO, Chemistry, Medical Devices, Clinical Trials, Quality System, HPLC, Chromatography, Regulatory Requirements, Vaccines, Change Control, Generic Programming, Oncology, Cross-functional Team..., Life Sciences, SOP
Education
East Carolina University - College of Business 1976 — 1980
BSBA, Marketing
MLP GxP Solutions, LLC, Inc. March 2012 - Present
Innovative Consultants GXP July 2011 - Present
Exemplar Compliance August 2014 - November 2014
The Quantic Group, Ltd March 2012 - July 2014
King Pharmaceuticals a wholly owned subsidiary of Pfizer August 2010 - July 2011
Apotex Inc. February 2010 - August 2010
Talecris Plasma Resources January 2008 - November 2009
Erimos Pharmaceuticals LLC, Raleigh, NC 2006 - 2008
DSM Pharmaceuticals 2002 - 2006
Alpharma USPD November 1999 - July 2002
Skills
Sop, GMP, Pharmaceutical Industry, CAPA, Root Cause Analysis, Quality Assurance, Quality System, Quality Management, Regulatory Requirements, Regulatory Affairs, 21 CFR, Pharmaceutical..., Pharmaceutical Sciences, FDA, Change Control, Document Management, Quality Control, Reviews, Troubleshooting, Specifications, Deviation Management, GxP, HPLC, Quality Auditing, Aseptic Processing, Pharmaceutics, Deviations, Validation, Drug Development, Biotechnology, 21 CFR Part 11, Analytical Chemistry, Biopharmaceuticals, CRO, Clinical Development, Clinical Trials, GAMP, IND, GLP, LIMS, Laboratory, Lifesciences, Protocol, Regulatory Submissions, Technology Transfer, Manufacturing, GCP, V, Cleaning Validation, SOP
Education
State University of New York College at Buffalo 1988 — 1991
BS
State University of New York at Buffalo 1988 — 1991
Bachelor of Science
Merck August 2013 - Present
Hospira 2012 - 2013
DSM Pharmaceuticals December 2011 - October 2012
Eisai June 2005 - April 2011
Eisai August 2001 - May 2006
Wright Chemical Corporation September 1999 - August 2001
Skills
Formulation Development, Technology Transfer, Process Validation, Analytical Chemistry, HPLC, cGMP, UV-Vis, R&D, Process Development
Education
North Carolina State University 1996 — 1999
MS, Textile Chemistry
North Carolina State University 1992 — 1996
BS, Textile Chemistry
CSCS Management August 2015 - Present
SwissCaps USA, Inc. 2012 - Present
DSM Pharmaceuticals 2008 - July 2012
DSM Pharmaceuticals and Biologics 2004 - 2007
DSM September 2001 - 2004
Alpha Therapeutic 1999 - 2001
Bayer 1994 - 1999
Bayer AG 1987 - 1994
Skills
SOP, cGMP, Biotechnology, Validation, Technology Transfer, Supply Chain..., Business Strategy, Business Planning, Sop, GMP, Pharmaceutical Industry, Formulation, Pharmaceutics, FDA, Commercialization, Lifesciences, Manufacturing, Biopharmaceuticals, Regulatory Affairs, Cross-functional Team..., CAPA, Aseptic Processing, Process Simulation, Lean Manufacturing, Contract Manufacturing, Continuous Improvement, GLP, R&D, Medical Devices, Quality System, Life Sciences, 21 CFR Part 11, Drug Development, ISO 13485, Change Control, Chemistry, Vaccines, Analytical Chemistry, V&V, Drug Delivery, Quality Assurance
Education
RWTH Aachen University 1976 — 1987
Priv. Doz. Dr. Ing.
Fachhochschule Düsseldorf 1972 — 1974
Ing. grad.
Fachoberschule Moenchengladbach 1969 — 1972
Elementary School Wegberg 1958 — 1968
Patheon November 2013 - Present
DSM Pharmaceuticals August 2013 - Present
Chinese Academy of Sciences August 1993 - July 1997
Dalian Institute of Chemical Physics, Chinese Academy of Sciences August 1990 - July 1993
Skills
Analytical Chemistry, Engineering Statistics, Knowledge Management,..., Design of Experiment..., Process and formulation..., Biopharmaceuticals, ICH Conference, Design of Experiments, Data Mining, Risk Management, Quality by Design, NMR, LIMS, HPLC, Customer Oriented, Project Support, Analytical Method..., GMP, R&D, CAPA, Pharmaceutical Industry, Technology Transfer, Pharmaceutics, Drug Development, Chromatography, Organic Chemistry, LC-MS, Organic Synthesis, FTIR
Education
Auburn University 1997 — 2001
Ph.D., Chemistry
Chinese Academy of Science 1990 — 1993
MS, Catalysis
University of Science and Technology of China 1985 — 1990
BS, Chemistry
UnitedHealth Group November 2004 - Present
DSM Pharmaceuticals 2000 - 2004
Catalytica Pharmaceuticals 1997 - 2000
GlaxoWellcome 1995 - 1997
BurroughsWellcome 1991 - 1995
Eveready Battery Company 1983 - 1990
Skills
Human Resources, Employee Relations, Talent Management, Workforce Planning, Deferred Compensation, Onboarding, Performance Management, Employee Engagement, Succession Planning, Employee Benefits, HRIS, Compensation & Benefit, Organizational Design, Benefits Administration, Organizational..., Compensation Structure..., Compensation Structures, Organizational..., HR Transformation, HR Consulting
Education
University of North Carolina at Greensboro 1971 — 1974
East Carolina University - College of Business 1991 — 1991
Psychology
Patheon October 2014 - Present
Patheon March 2014 - September 2014
DSM Pharmaceuticals April 2011 - March 2014
DSM Pharmaceuticals August 2008 - April 2011
DSM Pharmaceuticals June 2007 - July 2008
DSM Pharmaceuticals June 2002 - June 2007
DSM Pharmaceuticals December 2000 - June 2002
Catalytica Pharmaceuticals January 1998 - December 2000
Weyerhaeuser 1989 - 1998
Department of Treasury October 1984 - October 1988
Skills
SAP, Pharmaceutical Industry, Forecasting, Cross-functional Team..., Supply Chain Management, Process Improvement, Strategic Planning, New Business Development, Supply Chain, Continuous Improvement, Project Planning, Business Planning, Logistics, Procurement, Team Leadership, Management, Inventory Management, Contract Negotiation, Budgets, Leadership, Change Management, Purchasing, Capital Budgeting, Project Accounting, Account Reconciliation, Account Management, Customer Engagement, Customer Oriented, Collaborative Problem..., Financial Analysis, Accounting, Business Process...
Education
North Carolina Agricultural and Technical State University 1980 — 1984
B.S., Accounting
Patheon December 2013 - Present
Mallinckrodt May 2007 - December 2013
Cardinal Health August 2006 - May 2007
Catalent Pharma Solutions 2006 - 2007
Biogen Idec 2004 - 2006
DSM Pharmaceuticals 2001 - 2004
Schein Pharmaceuticals 1996 - 2001
Skills
SPC, Aseptic Processing, Process Validation, cGMP, Cell Culture, Six Sigma, Validation, Biotechnology, CAPA, Computer System..., Change Control, SOP, 21 CFR Part 11, Quality Systems, Cleaning Validation, Documentation, Technology Transfer, Auditing, Quality Auditing, Risk Assessment, Document Management, Continuous Improvement, Software Validation, FMEA, Quality Assurance, GMP, Compliance, Lean Manufacturing, V&V, LIMS, Quality System, GxP, Sop, FDA, Pharmaceutical Industry, Software Documentation, Biopharmaceuticals, ISO 13485, Regulatory Requirements, GAMP, Testing, Sterilization, GLP, Laboratory, FDA GMP, cGMP manufacturing, Deviations, Quality Control, USP, Quality by Design
Education
Arizona State University 1994 — 1997
BSc, Biology
Westfield High School 1979 — 1983
Hospira August 2011 - Present
DSM Pharmaceuticals April 2006 - June 2011
DSM Pharmaceuticals April 2002 - April 2006
Skills
Quality Investigations, Technical Writing, CAPA, Impact Assessment, Root Cause Analysis, cGMP, Documentation, Protocol Writing, Quality by Design, Environmental Monitoring, Aseptic Technique, Environmental Control, Contamination Control, Aseptic Processing, Deviation Management, Trackwise, Documentation Practices, cGLP, Pharmaceutical..., GMP, HPLC, Validation, Quality Control, 21 CFR Part 11, GxP, Sop, Cleaning Validation, Change Control, V&V, Quality System, GLP, Software Documentation, TrackWise, SOP
Education
University of Alabama
Business Administration
East Carolina University
BioAgilytix Labs, Inc. September 2013 - Present
Grifols September 2009 - September 2013
AlphaVax Human Vaccines August 2008 - September 2009
Talecris Biotherapeutics, Inc. November 2007 - August 2008
DSM Pharmaceuticals October 2006 - October 2007
SBI Crime Lab 2005 - 2005
Skills
GMP, GLP, Validation, Sop, CAPA, Cell Culture, Microbiology, Assay Development, Cell, In Vitro, Quality Assurance, Laboratory, Aseptic Technique, Regulatory Submissions, Environmental Monitoring, Biopharmaceuticals, Biotechnology, Titration, LIMS, SDS-PAGE, FDA, Chromatography, Protein Chemistry, HPLC, Technology Transfer, SOP
Education
East Carolina University 2003 — 2006
BS, Biology
Plymouth High School
Hospira February 2013 - Present
Visiting Nurse & Hospice of Fairfield County March 2012 - August 2012
Apria Healthcare June 2010 - February 2012
Medical Instill Technologies, Inc. 2009 - 2010
DSM Pharmaceuticals 2002 - 2008
Skills
FDA, Teamwork, Microsoft Office, Word, Pharmaceuticals, Sales, Quality Assurance, Quality Control, Microbiology, Durable Medical..., Individual Work, Business Development, Change Control, GMP, Leadership, Management, Marketing, Product Development, Pharmaceutical Industry, Project Management, Validation, Quality System
Education
East Carolina University - College of Business 2003 — 2003
MBA, Business Administration
East Carolina University 1998 — 2002
BS, Biology
Novartis Vaccines & Diagnostics August 2012 - Present
Novartis Vaccines and Diagnostics October 2007 - August 2012
Sanofi Pasteur June 2006 - September 2007
DSM Pharmaceuticals October 2003 - June 2006
DSM Pharmaceuticals 1999 - 2003
Catalytica Pharmaceuticals / Glaxo Wellcome 1995 - 1999
Burroughs Wellcome 1993 - 1995
Abbott Laboratories 1989 - February 1993
Abbott Laboratories July 1988 - October 1989
Abbott Laboratories 1987 - 1988
Skills
Managment of Capital..., Sterile Process..., Filling &..., Sterile Facility..., Process Engineering, Engineering, Project Engineering, Validation, Manufacturing
Education
North Carolina State University 1984 — 1987
BSEE, Engineering
LeMaitre Vascular 2013 - Present
Bionostics, Inc. 2006 - 2013
GlycoDesign Inc. 2002 - 2004
DSM Pharmaceuticals 1999 - 2002
R.P. Scherer 1997 - 1999
London International US Holdings 1994 - 1996
Bayer Pharmaceuticals 1974 - 1994
Skills
Biotechnology, Mergers & Acquisitions, Medical Devices, Pharmaceutical Industry, FDA, Cross-functional Team..., Business Development, Product Development, Start-ups, Business Planning, Strategy, Marketing Strategy, Product Launch, Venture Capital, Commercialization, R&D, Lifesciences, Technology Transfer, Drug Discovery, Strategic Planning, Operational Excellence, Rapid Growth, Due Diligence, Business Strategy, Manufacturing, Mergers, Turn Around Management, P&L Management, Life Sciences
Education
Colgate University 1968 — 1972
BA, English, Business
Quinnapiac University/Yale University
Procept Partners, LLC January 2009 - Present
Sullivan University College of Pharmacy June 2010 - October 2011
Stiefel Laboratories November 2006 - December 2008
Baxter Healthcare July 2005 - November 2006
DSM Pharmaceuticals August 2004 - July 2005
DSM Pharmaceuticals December 2002 - August 2004
Wyeth Biotech December 2001 - December 2002
Wyeth Biotech May 1999 - December 2001
Skills
Product Development, Process Improvement, Aseptic Processing, Regulatory Submissions, GxP, Project Portfolio..., Stage-Gate, Process Excellence, Six Sigma, Value Stream Mapping, Activity Based..., Multivariate Statistics, Quality by Design, SAS, R (statistics), C, Python, Linux, CAPA, Cross-functional Team..., FDA, Formulation, GMP, Pharmaceutical Industry, Quality Assurance, Quality System, Technology Transfer, V, Validation
Education
Elon University - Martha and Spencer Love School of Business 2008 — 2010
MBA
Indiana University - Kelley School of Business 2009 — 2010
Management Consulting
Purdue University 1995 — 1999
PhD, Industrial Pharmacy / Pharmaceutics
University of Louisville 1988 — 1993
B.S., Chemical Engineering
Sandoz / Novartis April 2007 - January 2010
Stubbs & Perdue, PA November 2006 - April 2007
DSM Pharmaceuticals May 2006 - November 2006
Womble Carlyle Sandridge & Rice PLLC March 2005 - May 2006
DSM Pharmaceuticals August 2003 - March 2005
Kessler Law Firm January 2002 - April 2002
Ratner & Prestia May 1999 - September 1999
American Cyanamid June 1991 - August 1997
American Cyanamid 1990 - 1997
EniMont Americas 1987 - 1989
Education
University of Phoenix 2010 — 2011
Masters, Secondary Education
Seton Hall University School of Law 1997 — 2000
JD, Law, Concentrating in Intellectual Property and Criminal Law
Rutgers University-New Brunswick 1989 — 1991
Post-Grad, Microbiology; Virology
Columbia University College of Physicians and Surgeons 1982 — 1984
Masters, Pathology
University of Pennsylvania 1978 — 1982
BS, Biochemistry, Political Science
Becton
Becton
The Law Offices Of J. Ghita Harris, PLLC May 2010 - Present
The Brown Law Firm, P.C. July 2008 - April 2010
Leiner Health Products November 2007 - April 2008
Purdue Pharma December 2002 - August 2004
DSM Pharmaceuticals August 2001 - December 2002
Varian January 2000 - August 2001
AAIPharma Services Corp. January 1997 - January 2000
Skills
Training, Regulatory Affairs, Pharmaceutical Industry, FDA, Technology Transfer, GMP, Civil Litigation, Public Speaking, Criminal Law, Quality Assurance, Legal Writing, Biotechnology, Validation, Intellectual Property, Patents, Trials
Education
North Carolina Central University School of Law 2004 — 2007
JD, Law
University of North Carolina at Chapel Hill
BA, Chemistry
Cardinal Health May 2014 - Present
Cardinal Health February 2008 - Present
Carolina BioOncology Institute (parttime) April 2008 - April 2011
DSM Pharmaceuticals 1995 - 2007
DSM Pharmaceuticals 1995 - 2007
Skills
Aseptic Processing, CAPA, Customer Service, DMAIC, FDA, GMP, Leadership, Lean Manufacturing, Management, Manufacturing, Pharmaceutical Industry, Process Improvement, Quality Assurance, Quality System, Recruiting, Six Sigma, Sop, Team Building, Technical Writing, Technology Transfer, Troubleshooting, Validation, Change Control, Cross-functional Team..., Root Cause Analysis, V&V, 21 CFR Part 11, GxP, Quality Control, SOP
Education
East Carolina University 1990 — 1994
Business economics, Business/Managerial Economics
Patheon June 2014 - Present
DSM 2012 - 2014
DSM Pharmaceuticals June 2011 - May 2012
Skills
GMP, R, Pharmaceutical Industry, SOP, FDA, Validation, CAPA, Quality System, Change Control, GLP, 21 CFR Part 11, LIMS, Continuous Improvement, Quality Control, Process Improvement, V
Education
East Carolina University
Biology, Microbiology, Marine Biology, Business
Pernix Therapeutics March 2014 - Present
Norwich Pharmaceuticals January 2011 - February 2014
FrontLine Pharmaceuticals, LLC January 2010 - January 2011
Patheon Inc. February 2008 - December 2009
DSM Pharmaceuticals, Inc October 2007 - February 2008
DSM Pharmaceuticals June 2002 - October 2007
DSM Pharmaceuticals June 2001 - January 2002
Cytogen Corporation May 2000 - June 2001
Innovex 1995 - 2000
Algos January 1998 - January 1999
Skills
Contract Manufacturing, Strategic Planning, Team Building, P&L, Pharmaceuticals, Biotechnology, Business Planning, Start-ups, New Business Development, Negotiation, Marketing Strategy, Pharmaceutical Industry, Business Development, Income Statement, Commercialization, Mergers & Acquisitions, Mergers, Strategy, Marketing, Leadership, Account Management, Cross-functional Team..., Pharmaceutics, Sales Operations, Human Resources, Regulatory Affairs, FDA, Healthcare, Technology Transfer, Product Launch, Project Management, Manufacturing, GMP, P&L Management, Biopharmaceuticals, Drug Development, Clinical Development, Management, Life Sciences, Sales, Sales Management, Product Development, Pharmaceutical Sales, Managed Care, Oncology
Education
Muhlenberg College 1974 — 1978
B.S, Biology
Muhlenberg College 1974 — 1978
Bachelor of Science (B.S.), Biology/Biological Sciences, General
DSM Pharmaceuticals November 1994 - Present
DSM Pharmaceuticals November 1994 - Present
DSM November 1994 - Present
DSM November 1994 - Present
Skills
Process Improvement, Manufacturing, Microsoft Office, GMP, Product Development, Pharmaceutical Industry, Change Management, Customer Service, Six Sigma, Lean Manufacturing
Education
Brazosport College 2010 — 2015
Engineering/Industrial Management
XALT Energy November 2010 - Present
MidMichigan Innovation Center January 2004 - October 2010
DSM Pharmaceuticals 2002 - 2004
Dow Chemical January 1992 - March 2002
Skills
Lean Manufacturing, New Business Development, Angel Investing, Community Leadership, Agricultural Chemicals, Training, Entrepreneurship, Six Sigma, Manufacturing, Product Development, Strategic Planning, Change Management, Operations Management, Process Improvement, Team Building, Continuous Improvement, Contract Negotiation, Automotive, Process Engineering, Business Strategy, SPC, Leadership, Commercialization, Program Management, Start-ups, Quality Management, Root Cause Analysis, Engineering, SAP, Strategy, Polymers, Process Simulation, Process Optimization, Design of Experiments, Manufacturing..., Supply Chain, DMAIC, R&D, Chemical Engineering, Cross-functional Team...
Education
South Dakota School of Mines and Technology 1977 — 1981
BS
South Dakota School of Mines and Technology
Engineer's Degree
AAIPharma Services Corp. October 2013 - Present
AAIPharma Services Corp. January 2012 - October 2013
AAIPharma Services Corp. August 2010 - January 2012
AAIPharma Services Corp. April 2008 - August 2010
DSM Pharmaceuticals August 2004 - April 2008
United States Marine Corps August 1997 - August 2001
Skills
Pharmaceutical Industry, Sop, FDA, GMP, Validation, CRO, Biotechnology, 21 CFR Part 11, Clinical Trials, Clinical Development, Oncology, GCP, Technology Transfer, Change Control, CTMS, Cross-functional Team..., CAPA, Drug Development, EDC, Medical Devices, SOP
Education
East Carolina University - College of Business 2005 — 2007
BSBA, Finance
Pitt Community College 2004 — 2005
Associate of Arts (A.A.), Business Administration and Management, General
Univar May 2015 - Present
Univar March 2015 - Present
Southeastern Laboratories, Inc. June 2006 - February 2015
DSM Pharmaceuticals February 2006 - June 2006
Hospira March 2005 - February 2006
Skills
Key Account Management, Sales Operations, Sales Force Development, Ingredients, Chemistry, New Business Development, Sales Management, Account Management, Food Industry, Waste Management, Key Account Development, Sales Presentations, Adhesives, Sales Process, Direct Sales, Outside Sales, Plastics, B2B, GMP, Manufacturing, Pharmaceutical Industry, Quality Assurance, FDA
Education
East Carolina University 2010 — 2013
Master of Science (MS), Environmental Health
Mount Olive College 2002 — 2005
Bachelor of Science (B.S.), Chemistry
Merck July 2014 - Present
Merck, Sharp & Dohme, Corp. June 2013 - July 2014
Hospira April 2010 - June 2013
Hospira February 2007 - April 2010
DSM Pharmaceuticals October 1999 - February 2007
Hill PHOENIX April 1998 - October 1999
Cogentrix Energy, Inc. September 1997 - March 1998
RCG LLC Corporation March 1996 - August 1997
CMS Energy August 1990 - March 1996
Skills
Calibration, Process Control, cGMP, PLC, Electrical, FDA, Pharmaceuticals, Preventive Maintenance, GMP, Compliance, Troubleshooting, Validation, Diagnostics, Engineering, Manufacturing, Operation, Instrumentation, Inspection, Electronics, Automation, Quality Systems, Process Validation, Documentation, CAPA, Six Sigma, Supervisory Skills, 21 CFR Part 11, ISO, Root Cause Analysis, Continuous Improvement, Quality Assurance, Problem Solving, Quality Management, Lean Manufacturing, Technical Training, Process Improvement, Project Engineering, Technical Writing, Quality Auditing, Process Development, Risk Assessment, Process Engineering, Biotechnology, Computer System..., FMEA, Change Management, Project Management, Change Control, Team Leadership, Coaching
Education
East Carolina University 1985 — 1989
Completed a Bachelor of Science, Industrial Technology (Electronics)
Naturex May 2015 - Present
Avon Global Research and Development Center August 2010 - August 2014
Avon August 2010 - August 2014
DSM Pharmaceuticals March 2009 - May 2010
Global Laboratories Services, Inc May 2008 - February 2009
Education
East Carolina University 2004 — 2008
Bachelor of Arts (BA), Chemistry
East Carolina University 2004 — 2008
Bachelor, Chemistry
Metrics, Inc. January 2007 - Present
Metrics, Inc. May 2004 - January 2007
DSM Pharmaceuticals 2001 - 2004
DSM Pharmaceuticals 1998 - 2001
Procter & Gamble June 1997 - December 1998
DuPont September 1996 - June 1997
DuPont September 1994 - September 1996
Skills
Pharmaceutical Industry, GMP, CTM manufacturing, Pharmaceutical process..., Manufacturing, SOP, Sampling Raw Materials, Firefighting, Sop, Troubleshooting, R&D, SAP, Analysis, Leadership, Formulation, CAPA, Clinical Trials, Quality Assurance, V&V, Laboratory, Change Control, Software Documentation
Education
Pitt Community College 1992 — 1994
Associate of Arts and Sciences (AAS), Architectural Drafting and Architectural CAD/CADD
East Carolina University 1989 — 1992
None, Construction Management/Industrial Technology
Ajinomoto Althea, Inc. January 2015 - Present
Par Sterile Products (formerly JHP Pharmaceuticals) September 2010 - November 2014
Ben Venue Laboratories, A Boehringer Ingelheim Company 2007 - 2009
DSM Pharmaceuticals 2001 - 2007
Bausch & Lomb Pharmaceuticals 1996 - 2001
Education
Missouri State University 1980 — 1983
B.S. Chemistry
Lachman Consultants 2006 - 2014
Clarkston Consulting 2002 - 2006
DSM Pharmaceuticals 2000 - 2002
Haemonetics 1998 - 2000
GSK 1996 - 1998
Bayer 1982 - 1996
Skills
Pharmaceutical..., Validation, Quality Assurance, Quality System, FDA, GMP, CAPA, Pharmaceutical Industry, Software Documentation, 21 CFR Part 11, SOP, Pharmaceutics, Change Control, Manufacturing, Biotechnology, Technology Transfer, V&V
Education
Purdue University 1973 — 1975
Master of Science (M.S.), Analytical Chemistry
Chatham University 1970 — 1973
Batchelor of Science, Chemistry
Marken LLP May 2011 - Present
Patheon December 2007 - November 2010
Valeant Pharmaceuticals February 2003 - December 2007
DSM Pharmaceuticals February 2002 - March 2003
GlaxoSmithkline December 1989 - February 2002
Glaxo, GlaxoWellcome (now GSK) 1995 - 1997
Exxon Research & Engineering Company (now ExxonMobil) July 1978 - November 1989
Skills
Supply Chain, Restructuring, Procurement, Pharmaceutical Industry, Operational Risk, Biotechnology, FDA, Medical Devices, Cross-functional Team..., Strategic Planning, Lifesciences, Pharmaceutics, GMP, Product Development, Supply Chain Management, Logistics, Quality System, Manufacturing, Leadership, Strategy, R&D, Business Planning, Clinical Trials, Management, Regulatory Affairs, Biopharmaceuticals, Market Research, Life Sciences, Technology Transfer, Mergers & Acquisitions, Business Strategy, Operational Excellence, Project Management, Commercialization, Sop, Business Development, Forecasting, Product Launch, Quality Assurance, Start-ups, Program Management, Regulatory Requirements
Education
Worcester Polytechnic Institute 1974 — 1978
BSME, Mechanical Engineering
California Lutheran University
MBA, Finance
DSM Pharmaceuticals 2010 - 2011
Skills
Quality System, Six Sigma, Lean Manufacturing, Cross-functional Team..., Leadership, FDA, Root Cause Analysis
Education
North Carolina Agricultural and Technical State University 1989 — 1994
Bachelor of Science (BS), Industrial Technology/Technician
JB Solutions 2010 - Present
Stiefel, a GSK company 2006 - 2010
DSM Pharmaceuticals 2003 - 2006
Pfizer 1999 - 2003
Novartis 1992 - 1999
GlaxoSmithKline 1988 - 1991
Skills
Regulatory Affairs, Quality Assurance, Sop, Product Development, CAPA, Change Control, Pharmaceutics, Biopharmaceuticals, Clinical Development, Quality by Design, Chemistry, Six Sigma, Drug Discovery, GMP, FDA, Pharmaceutical Industry, Technology Transfer, Formulation, Manufacturing, Analytical Chemistry, GLP, LIMS, GxP, Regulatory Submissions, 21 CFR Part 11, Drug Development, Analytical Method..., Analytical Methods..., SOP
Education
Fairleigh Dickinson University 1993 — 1997
Master’s Degree, Chemistry
Fairleigh Dickinson University 1987 — 1993
Bachelor’s Degree, Chemistry
FMS Inc. 2013 - Present
YKWIT LLC August 2012 - Present
Merck 2013 - 2013
DSM Pharmaceuticals February 1999 - August 2012
Rubbermaid Commercial Products January 1997 - January 1998
Collins & Aikman January 1996 - January 1997
Skills
Aseptic Processing, Sop, GMP, Validation, Pharmaceutical Industry, Cleaning Validation, Lyophilization, Sterilization, Troubleshooting, Contract Manufacturing, Packaging, Manufacturing, FDA, CAPA, Quality Assurance, 21 CFR Part 11, Technology Transfer, V&V, Quality Control, SOP
Education
Pitt Community College 2011 — 2014
Industrial Management
Home January 2015 - Present
PMI 2009 - 2015
Self-Employed July 2009 - August 2009
Self-Employed April 2008 - March 2009
Catalent Pharma Solutions (formerly Cardinal Health) 2007 - 2008
Cardinal Health, SPS 2005 - 2007
Wyeth Biotech 2004 - 2005
DSM Pharmaceuticals 1998 - 2004
Schein 1993 - 1998
ZLB Bioplasma 1992 - 1993
Skills
Validation, FDA, Pharmaceutical Industry, Sterilization, Vaccines, Sop, GMP, Regulatory Requirements, 21 CFR Part 11, Technology Transfer, V&V, Change Control, Quality Control, Manufacturing, CAPA, Aseptic Processing
Education
Illinois Institute of Technology
MS, Microbiology
Michigan State University
BS, Microbiology
Patheon MFG July 2014 - Present
DSM Pharmaceuticals August 2010 - June 2014
Skills
Risk Management, Risk Assessment, Enterprise Risk..., Internal Audit, Auditing, Internal Controls, SOP, Sarbanes-Oxley Act, Quality System, SAP, Financial Reporting
Education
East Carolina University 1978 — 1980
BSBA, School of Business-Accounting
Sun Chemical November 2013 - Present
DSM August 2011 - November 2013
DSM Pharmaceuticals September 2009 - August 2012
Sunrise Wiring January 2004 - December 2008
Daffy's, Inc. July 1998 - December 2008
Skills
Microsoft Office, Outlook, Pharmaceutical Industry, PowerPoint, SAP, Management, Microsoft Excel, Process Improvement, Project Management, Training, Change Management, Human Resources, Employee Relations, Leadership, Administrative...
Education
Rutgers University-New Brunswick 1993 — 1998
BA, Psychology
Corning Life Sciences August 2013 - Present
DSM Pharmaceuticals February 2010 - May 2011
Sandoz Inc 2007 - 2009
Dupont Dacron June 1994 - December 2004
Skills
Bioprocessing, GMP, Sop, Pharmaceutical Industry, Formulation, GLP, Product Development, Validation, R&D, Quality Control, SOP, Analytical Chemistry, Quality Assurance
Education
East Carolina University 2010 — 2013
BS, Industrial Technology/Bioprocess Manufacturing
Pitt Community College 2005 — 2007
AAS, Biotechnology
Pitt Community College 1991 — 1993
AAS, Electronic Engineering Technology
Alliance Health, LLC October 2014 - Present
Fusion-io June 2013 - October 2014
Aflac May 2011 - June 2013
Amgen April 2008 - May 2011
Amgen January 2006 - April 2008
Amgen July 2003 - January 2006
DSM Pharmaceuticals March 2000 - July 2003
Catalytica Pharamceuticals December 1997 - March 2000
Glaxo Wellcome 1992 - December 1997
IBM 1985 - 1992
Education
North Carolina State University 1979 — 1984
BS
Rutgers University- Department of Life Sciences March 2014 - Present
Novartis Consumer Health March 2013 - February 2014
McNeil Consumer Inc., Johnson & Johnson December 2012 - March 2013
McNeil Consumer Inc., Johnson & Johnson November 2010 - December 2012
Merck February 2010 - November 2010
Merck, Formerly Schering Plough Corp April 2003 - February 2010
DSM Pharmaceuticals 2002 - 2003
Bristol-Myers Squibb 1993 - 2002
Skills
GMP, FDA, Quality System, Validation, Quality Assurance, Auditing, Process Improvement, Pharmaceutical Industry, CRO, Black Belt, Change Control, Six Sigma, Blackbelt: LeanSixSigma, Medical Devices, V&V, Change Management, Manufacturing, Process Engineering, 21 CFR Part 11, GAMP, Document Management, Inspection, Technology Transfer, Quality Control, GLP, Computer System..., GxP, Software Documentation, Quality Management, Consent Decree..., CAPA, Biopharmaceuticals, Regulatory Affairs, Regulatory Requirements, LIMS, Quality Auditing, Process Simulation, GCP, Pharmaceutics, Analytical Chemistry, Drug Development, HPLC, Biotechnology, Cleaning Validation, Chromatography, R&D, SOP
Education
Sardar Patel University 1988 — 1991
Ph.D, Organic Chemistry
Beach Enterprises December 2006 - Present
Evonik - North America May 2014 - August 2014
Sandoz - A Division of Novartis May 2011 - May 2014
DSM Pharmaceuticals January 2008 - April 2011
DSM Pharmaceuticals August 1999 - April 2011
Alpharma USPD October 1996 - August 1999
Actavis 1996 - 1999
Alpharma USPD December 1993 - October 1996
Barre National 1993 - 1996
Baxter Healthcare November 1991 - December 1993
Skills
GMP, Validation, FDA, Quality System, Pharmaceutical Industry, Technology Transfer, Sop, V&V, Change Control, Quality Assurance, CAPA, Computer System..., Manufacturing, 21 CFR Part 11, Cleaning Validation, Pharmaceutics, SPC, Automation, Aseptic Processing, Engineering
Education
North Carolina State University 1986 — 1991
Bachelor’s Degree, Mechanical Engineering
Cook Pharmica January 2014 - Present
Ben Venue Laboratories June 2013 - Present
Ben Venue Laboratories June 2011 - June 2013
Ben Venue Laboratories February 2010 - June 2011
Ben Venue Laboratories September 2009 - February 2010
Oakwood Laboratories March 2008 - September 2009
Ben Venue Laboratories November 2007 - March 2008
Ben Venue Laboratories June 2001 - November 2007
DSM Pharmaceuticals July 2000 - June 2001
DSM Pharmaceuticals 1995 - 2000
Skills
Pharmaceutical Industry, Process Simulation, Sop, GMP, Manufacturing, CAPA, FDA, Technology Transfer, Biotechnology, Aseptic Processing, Validation, Quality Assurance, Quality System, Process Improvement, Project Management, Change Control
Education
East Carolina University 1987 — 1990
Masters, Biology
University of North Carolina at Charlotte 1984 — 1986
BS, Biology
US Department of Health & Human Services August 2010 - Present
US Department of Health and Human Services September 2011 - February 2012
Irvine Pharmaceutical Services July 2007 - September 2008
Metrics Inc. March 2002 - August 2004
DSM Pharmaceuticals January 2001 - February 2002
Skills
Analytical Chemistry, Chemistry, FDA, Pharmaceutical Industry, Biotechnology, Lifesciences, Technical Writing, Sop, Quality Assurance, Software Documentation, Process Improvement, Data Analysis, Project Management, Marketing Communications, Access Database, Public Health Emergency..., Strategic Planning, Strategic Partnerships, Federal Government, Policy, New Business Development, Cross-functional Team..., Thought Leadership, Human Capital, Human Resources, Federal Agencies, Collaborative Problem..., Resilience, Dependable Team Player, Leadership, Strategy, Program Management, Analysis, Government, Public Speaking, Research
Education
East Carolina University - College of Business 2003 — 2005
MBA, Business
University of Kentucky 1998 — 2000
MS, Analytical Chemistry
East Carolina University 1994 — 1998
BS, Chemistry
Barnhill & Associates, Inc. December 2003 - Present
Marion Weinreb & Associates, Inc. December 2005 - Present
Smart Consulting Group, LLC March 2015 - March 2015
Jay@barnhillassociates.net July 2014 - March 2015
Compliance Architects® February 2014 - June 2014
QualComp Consulting Services April 2012 - February 2014
Compliance Architects® May 2011 - December 2011
Steris Laboratories, Inc 2003 - 2004
Andrx Pharmaceuticals, Inc 2003 - 2003
DSM Pharmaceuticals 2000 - 2003
Skills
Strategic Planning, Cleaning Validation, Aseptic Processing, Chromatography, Customer Service, Six Sigma, Product Development, Chemistry, GMP, Software Documentation, analytical chemistry, audit, batch record, environmental monitoring, Root Cause Analysis, Root Cause Problem..., HPLC, Dissolution, Change Control, Deviation Management, Project Management, Quality Assurance, Quality System..., GDP, GLP, LIMS, Lean Thinking, Biologics, Pharmaceutical..., Pharmaceutical Sciences, Pharmaceutical..., Medical Devices, Process Improvement, Failure Analysis, Investigation, Fishbone, 5 Why, Pharmaceutical Packaging, Interpreting Data, Laboratory, Process Validation, Analytical Method..., TrackWise, Compliance, Equipment Qualification, Technical Transfers, Parenteral, Vaccines, Consulting, Technical Writing
Education
Barton College
Bachelor’s Degree, Cell Biology
Bausch & Lomb November 2010 - Present
DSM Pharmaceuticals May 1994 - November 2010
DSM Pharmaceuticals Inc. July 2001 - February 2005
DSM Pharmaceuticals Inc. May 1994 - July 2001
Skills
Compliance, Compliance Audits, Auditing, Microbiology, Pharmaceuticals, Regulatory Requirements, Environmental Monitoring, Sterility Assurance, Aseptic Technique, Aseptic Processing, cGMP, Quality Auditing, Quality Assurance, Validation, Pharmaceutical Industry, GMP, Laboratory, CAPA, LIMS, ISO 13485, V&V, 21 CFR Part 11, FDA, GLP, Change Control, Technology Transfer, Cleaning Validation, Biopharmaceuticals
Education
East Carolina University 1991 — 1993
BS, Microbiology, Biotechnology
Purdue Pharma June 2007 - Present
DSM Pharmaceuticals June 2001 - June 2003
Skills
Dynamic Leadership..., Superior Work Ethic, Supervisory Skills, Customer Support, Job Coaching, Negotiation Skills
Education
East Carolina University 2005 — 2006
Masters Industrial Technology, Manufacturing Systems
East Carolina University 1984 — 1989
Degree: Bachelor of Science, Industrial Technology
State of North Carolina 2005 - 2005
DSM Pharmaceuticals 1998 - 2003
DSM Pharmaceuticals 1998 - 1999
a4 Health Systems 1997 - 1998
Glaxo Wellcome 1995 - 1996
Burroughs Wellcome Company 1986 - 1995
Burroughs Wellcome 1985 - 1990
Burroughs Wellcome 1971 - 1985
Education
North Carolina State University 1981 — 1985
M.E., Economics
University of South Florida 1965 — 1967
BA, Chemistry
University of North Carolina at Chapel Hill
Ph.D., Chemistry
DSM Pharmaceuticals 2000 - 2004
DSM Pharmaceuticals 1995 - 2004
DSM 1995 - 2004
GlaxoWellcome 1995 - 1997
Burroughs Wellcome 1973 - 1995
Skills
FDA, GMP, Sop, Validation, CAPA, V&V, 21 CFR Part 11, Pharmaceutical Industry, Manufacturing, Medical Devices, Six Sigma, Laboratory, Technology Transfer, Product Development, Continuous Improvement, Change Control, Quality Assurance, GLP, Quality System, GxP, R&D, HPLC, Analytical Chemistry, Biotechnology, Biopharmaceuticals, Process Simulation, Regulatory Affairs, Pharmaceutics, LIMS
Education
Edgecombe Community College 1987 — 1999
AAS, Industrial Management
East Carolina University
Syngenta February 2011 - Present
Nana Co Consulting January 2003 - February 2011
Syngenta Seeds April 2005 - November 2010
DSM Pharmaceuticals January 2003 - February 2005
SAP America Inc. July 1999 - January 2003
St. Lawrence Cement 1998 - 1999
Skills
SAP R/3, SAP APO, SAP WM, SAP, Materials Management, Business Process Design, Manufacturing, SAP MM, SAP Implementation, SAP ERP, Business Analysis, Business Process, Change Management, ERP, Integration, Management, Process Improvement, Project Management, Quality Management, Warehouse Management
Education
Queen's University
Bachelor of Applied Science, Civil Engineering
Mallinckrodt February 2013 - Present
Mallinckrodt Pharmaceuticals 2004 - 2014
Covidien October 2011 - February 2013
Covidien April 2011 - October 2011
Covidien August 2004 - April 2011
DSM Pharmaceuticals 2001 - 2004
Skills
ASQ Certified Quality..., Quality System, GMP, Change Control, Regulatory Affairs, Sop, 21 CFR Part 11, Design Control, CAPA, FDA, Validation, Quality Control, Quality Assurance, Aseptic Processing, Computer System..., CQA, V&V, ISO 13485, Medical Devices, Manufacturing, Minitab, GAMP, GxP, Cleaning Validation, Quality Auditing, LIMS, Trackwise, Biopharmaceuticals, Sterilization, Technology Transfer, Root Cause Analysis, GLP, Calibration, Pharmaceutical Industry, Biotechnology, ISO, cGMP practices, Quality Management, cGMP manufacturing, FDA GMP, 21 CFR, SOP
Education
Webster University 1999 — 2001
Masters of Arts, Computer Resources and Information Management
Texas State University-San Marcos 1993 — 1997
Bachelor of Science, Healthcare Administration (LTCA)
Halyard Healthcare October 2014 - Present
Validant July 2014 - October 2014
CVC Consulting September 2012 - June 2014
The Quantic Group April 2011 - August 2012
Botanical Laboratories December 2008 - April 2011
Leiner health Products February 2008 - October 2008
Sandoz April 2003 - January 2008
DSM Pharmaceuticals 1998 - 2003
Alpharma 1993 - 1998
Shering-Plough 1991 - 1993
Skills
Statistics, Agronomy, Cereal Chemistry, Compliance Management, Quality Engineering, Quality Assurance, Quality Auditing, Quality Systems, Quality System, Quality Control, Validation, FDA, Regulatory Affairs, Pharmaceutical Industry, Cleaning Validation, Change Control, 21 CFR Part 11, Sop, CAPA, V&V, GMP, Supplier Quality..., Project Management, Statistical Modeling
Education
North Dakota State University 1980 — 1984
Agonomy/Statistics
Pennsylvania State University-Erie Campus 1973 — 1980
BS, Biology, Genetics
Self Employed October 2014 - Present
Synageva BioPharma Corp. February 2013 - October 2014
Novartis Vaccines and Diagnostics August 2012 - February 2013
Novartis Vaccines and Diagnostics August 2009 - August 2012
Biolex November 2007 - August 2009
Salix Pharmaceuticals March 2004 - November 2007
Wyeth Biotech November 2001 - March 2004
Purdue Pharma May 2001 - November 2001
DSM Pharmaceuticals April 1996 - April 2001
Education
Campbell University 2002 — 2005
MS, Clinical Research, Completed coursework
Campbell University 1991 — 1995
BS, Biology, minor in Chemistry
Glaxosmithkline Sr. ScientistGlaxoSmithKlineApril 2007 - Present
Glaxosmithkline 2007 - Present
DSM Pharmaceuticals 2003 - 2005
DSM 2001 - 2005
Education
Acharya Nagarjuna University 1996 — 1998
Osmania University 1992 — 1995
B.Sc, Microbiology, Botony, Chemistry
Patheon January 2008 - Present
Patheon May 2001 - January 2008
DSM Pharmaceuticals October 1998 - May 2001
Skills
GMP, Change Control, FDA, Sop, CAPA, Manufacturing, Validation, Pharmaceutical Industry, Quality System, Quality Assurance, Quality Control, Technology Transfer
Education
East Carolina University 1996 — 2001
BS in Industrial Technology, Manufacturing
Pitt Community College 1991 — 1993
AAS in Electronics Engineering Technology, Electronics Engineering Technology
Patheon Inc January 2013 - Present
DSM Pharmaceuticals 1996 - Present
United States Marine Corps January 2001 - February 2010
Skills
GMP, Validation, Sop, Aseptic Processing, Technology Transfer, FDA, Pharmaceutical Industry, CAPA, Biotechnology, LIMS, GLP, Change Control, 21 CFR Part 11, Biopharmaceuticals, Quality System
Education
Fayetteville State University 1991 — 1996
BS, Biology
Novartis Vaccines and Diagnostics July 2013 - Present
Catalent Pharma Solutions March 2004 - July 2013
DSM May 1987 - March 2004
DSM Pharmaceuticals 1999 - 2004
Catalytica 1999 - 2001
Glaxo Wellcome June 1996 - September 1999
Burroughs Wellcome May 1992 - April 1996
Burroughs Wellcome May 1987 - May 1992
Skills
GMP, FDA, Validation, Sop, CAPA, Pharmaceutical Industry, Technology Transfer, GLP, Change Control, 21 CFR Part 11, GxP, Regulatory Affairs, IND, Computer System..., Cleaning Validation, Quality Assurance, Quality Auditing, Laboratory, Quality System, ANDA, Quality Control, Dissolution, HPLC, Aseptic Processing, V&V, Trackwise, LIMS, Biopharmaceuticals, Gas Chromatography, GAMP, Regulatory Requirements, Analytical Chemistry, Chromatography, CMC, Pharmaceutics, Regulatory Submissions, Formulation, SOP
Education
North Carolina Agricultural and Technical State University 1983 — 1987
B.S., Chemistry
DSM Pharmaceuticals May 2013 - Present
Catalent Pharma Solutions November 2009 - February 2013
Catalent Pharma Solutions September 2008 - November 2009
GlaxoSmithKline June 2003 - May 2008
GlaxoSmithKline August 1998 - June 2003
Skills
Root Cause Analysis, SMED, Resource Loading, Pharmaceutical..., Solid Dose, DPI, pMDI, Nasal, Six Sigma, DOE, FMEA, Risk Analysis, Continuous Improvement, Lean Manufacturing, SOP, Facility Engineering, Production and..., Operational Excellence, Lean Sigma Training..., Engineering, Sop, Design of Experiments, Solid Oral Dosage Forms, Manufacturing, GMP, Capital Equipment, V&V, Validation
Education
East Carolina University 1974 — 1979
Industrial Technology, Manufacturing
North Carolina State University 1990 — 1994
Patheon March 2012 - Present
Patheon, Inc September 2010 - Present
Quality Compliance & Innovative Solutions LLC July 2009 - December 2010
Sandoz June 2008 - July 2009
DSM Pharmaceuticals August 2001 - June 2008
McNeil Consumer Healthcare 1998 - 2001
Marsam Pharmaceuticals 1996 - 1998
PACO Pharmaceuticals Inc 1995 - 1997
Bristol-Myers Squibb February 1986 - May 1995
Warner Lambert June 1984 - February 1986
Skills
CAPA, FDA, GMP, Pharmaceutical Industry, Change Control, Validation, Technology Transfer
Education
Rutgers, The State University of New Jersey-New Brunswick
Hospira November 2012 - Present
IHL December 2011 - November 2012
DLS Biopharmaceutical Consulting, LLC February 2010 - March 2012
Hospira 2011 - 2012
Abraxis BioScience September 2008 - February 2010
DSM Pharmaceuticals April 2000 - August 2008
MedImmune 1997 - 2000
Genosys Biotechnologies December 1992 - April 1997
Skills
Organic Chemistry, Peptide Synthesis, Analytical Chemistry, Creative Writing, Chess Instruction, Pharmaceutical..., Biotechnology, Laboratory, FDA, Validation, Chromatography, Protein Chemistry, Pharmaceutics, Pharmaceutical Industry, Oncology, Chemistry, Quality System, HPLC, GLP, GMP, Change Control, Formulation, Biopharmaceuticals, Method Development, Drug Development, Purification, Technology Transfer, Instruction, Sop, Peptides
Education
University of Arizona 1982 — 1987
Ph.D., Organic Chemistry
University of Alabama at Birmingham 1979 — 1981
MS, Organic Chemistry
Georgia Institute of Technology 1974 — 1979
BS, Chemistry
HR Impact January 2015 - Present
Behavioral Center of Michigan & Samaritan Behavioral Center June 2014 - January 2015
DSM Pharmaceuticals September 2013 - April 2014
36th District Court July 2011 - March 2013
Vibra Hospital of Southeastern Michigan December 2008 - July 2011
AstraZeneca Pharmaceuticals 2000 - 2004
Mercy Hospital Detroit 1996 - 2000
Henry Ford Wyandotte Hospital 1994 - 1996
Skills
Deferred Compensation, Employee Relations, Healthcare, Labor Relations, Employee Engagement, Employee Benefits, Coaching, Strategic Planning, Payroll, HRIS, Organizational..., Human Resources, Healthcare Management, Team Building, Benefits Management, SHRM, SPHR, Union Avoidance, Recruiting, Affirmative Action, Talent Management, Talent Acquisition, Personnel Management, Succession Planning
Education
Spring Arbor University
Bachelor of Arts, Human Resources Management
University of Phoenix
Master of Arts, Organizational Management
Patheon July 2012 - Present
MKCS, Inc. April 2009 - July 2012
Catalent December 2008 - March 2009
DSM Pharmaceuticals December 2005 - December 2008
O'Neal, Inc. December 1996 - December 2005
Skills
Validation, GMP, Documentation, Pharmaceuticals, Microsoft Office, 21 CFR Part 11, Computer System..., Quality Assurance, Problem Solving, Testing, Compliance, Technology Transfer, Quality Auditing, GxP, Quality System, Quality Control, V&V, Pharmaceutical Industry, GLP, Software Documentation, CAPA, LIMS, Change Control, SAP, Automation, Aseptic Processing, Biopharmaceuticals, GAMP, Cleaning Validation, Biotechnology, Regulatory Affairs, Process Simulation, Root Cause Analysis
Education
North Carolina State University 1996 — 1998
Engineering
University of North Carolina at Chapel Hill 1986 — 1991
BA, English
Northeastern High
Northeastern High
Hospira March 2013 - Present
Hospira May 2012 - March 2013
DSM Pharmaceuticals August 2011 - May 2012
DSM Pharmaceuticals November 2009 - August 2011
DSM Pharmaceuticals March 2009 - November 2009
DSM Pharmaceuticals 2007 - 2009
Skills
Quality Control, Software Documentation, FDA, Manufacturing, Laboratory, Six Sigma, Process Improvement, Microbiology, Validation, Operational Excellence, GxP, Lean Manufacturing, Project Management, Management, Change Control, GMP, Environmental Monitoring, Problem Solving, Technology Transfer, Quality Assurance, Team Leadership, Sop, CAPA, Quality System, Pharmaceutical Industry, Pharmaceutical..., Continuous Improvement, 21 CFR Part 11, Lifesciences, SOP, LIMS, GLP, V, Life Sciences
Education
East Carolina University 1990 — 1994
BS, Biology
Patheon Manufacturing Services March 2014 - Present
DSM Pharmaceuticals July 1999 - March 2014
DSM 1985 - 2009
Alpharma 1996 - 1999
Burroughs Wellcome 1987 - 1989
Skills
Key Account Management, Customer Relations, Pharmaceuticals, Account Management, Sales Management, Quality Assurance, Manufacturing, Business Planning, Cross-functional Team..., Product Development, Biotechnology, Customer Service, Pharmaceutical Industry, Strategy, Marketing Strategy, New Business Development, Technology Transfer, Product Launch, Business Development, Business Strategy, Forecasting, Validation, SOP, GMP, FDA
Education
East Carolina University
Bachelor's degree, Biology, General
Eli Lilly and Company August 2014 - Present
Eli Lilly and Company October 2013 - July 2014
Eli Lilly March 2009 - September 2013
Eli Lilly and Company May 2012 - September 2012
Eli Lilly and Company March 2006 - March 2009
Eli Lilly and Company February 2002 - March 2006
DSM Pharmaceuticals August 1998 - February 2002
Skills
Pharmaceutical Industry, Validation, GMP, Biotechnology, FDA, Technology Transfer, Sop, CAPA, Change Control, Quality System, Root Cause Analysis, Process Engineering
Education
North Carolina State University 1993 — 1998
ChE, Engineering, Business
Piedmont Animal Health May 2014 - Present
Boehringer Ingelheim Roxane May 2012 - May 2014
Boehringer Ingelheim Roxane, Inc. May 2010 - May 2012
Boehringer Ingelheim Vetmedica November 2008 - March 2010
IDEXX September 2003 - November 2008
DSM Pharmaceuticals July 2000 - September 2003
Rhone-Poulenc Rorer 1990 - July 2000
Rhone-Poulenc Rorer 1984 - 1990
Skills
CAPA, GMP, FDA, Analytical Chemistry, Change Control, Chemistry, V&V, Validation, Quality Assurance, Quality System, Pharmaceutical Industry, Dissolution, Chromatography, Quality Control, Gas Chromatography
Education
Colby College
BS, Chemistry
Petzold Consultant October 2005 - Present
DSM Pharmaceuticals December 2000 - October 2005
Merck May 1997 - October 1998
Rhone Poulenc Rorer July 1980 - May 1997
Skills
Pharmacovigilance, Regulatory Affairs, Pharmaceuticals, Validation, Quality Systems, Quality Assurance, Compliance, Document Management, Auditing, GMP, Pharmaceutical Industry, Quality System, Analytical Chemistry, Change Control, 21 CFR Part 11, Pharmaceutics, GxP, CAPA, FDA, Technology Transfer, V&V, SOP
Education
Arcadia University 1993 — 1997
BS, Chemistry and Business Administration
University of Notre Dame
Duke Energy Corporation November 2014 - Present
Duke Energy Corporation July 2013 - October 2014
Progress Energy March 2010 - August 2013
Coty August 2007 - February 2010
DSM Pharmaceuticals March 2004 - July 2007
Skills
Team Building, Process Improvement, EHS, Root Cause Analysis, Industrial Hygiene, Occupational Health, Training, Strategic Planning, Industrial Safety, Continuous Improvement, Purchasing, Inventory Management, Risk Assessment, Management, Energy, Leadership, Team Leadership, Lean Manufacturing, Manufacturing, Change Management, Safety Management..., Quality Assurance, Six Sigma, Power Plants, Process Engineering, Supervisory Skills, Operations Management
Education
East Carolina University 2002 — 2007
MS, Environmental Health and Safety
OSHA
Arysta LifeScience February 2013 - September 2014
Arysta LifeScience January 2006 - December 2012
Hospira June 2004 - January 2006
DSM Pharmaceuticals 2002 - 2004
Education
Fayetteville State University 1984 — 1987
Bachelor of Science (BS), Chemistry
DSM Dyneema November 2010 - Present
Tylo Investments November 2010 - March 2013
DSM Pharmaceuticals 1992 - 2004
Burroughs Wellcome 1992 - 2003
Education
University of North Carolina at Chapel Hill 1990 — 1991
Graduate Studies in Analytical Chemistry
East Carolina University 1986 — 1990
Bachelor of Science (B.S.), Chemistry
City of Wilson February 2015 - Present
Wilson County June 2012 - February 2015
East Carolina University December 2010 - May 2012
DSM Pharmaceuticals December 2009 - December 2010
Skills
Laboratory, Environmental Health, Radiation Safety, Waste, Public Health, Radiation, Sop, Water Quality, Environmental Science, Environmental Awareness, Environmental Compliance, Industrial Hygiene, Epidemiology, Microbiology, Environmental Impact..., Data Analysis, Hazardous Waste..., Environmental..., Statistics, Water, Research, GMP, Pharmaceutical Industry
Education
East Carolina University 2006 — 2011
Masters, Environmental Health
East Carolina University 2002 — 2006
Bachelors, Environmental Health
KVK Tech, Inc. June 2014 - Present
KVK Tech Inc November 2011 - Present
Cispharma Inc May 2009 - November 2011
QPharma LLC February 2005 - December 2008
DSM Pharmaceuticals 1999 - 2004
Education
Andhra University 1979 — 1982
Ph.D., Pharmaceutical Chemistry
Patheon January 2014 - Present
DSM Pharmaceuticals February 2008 - Present
GlaxoSmithKline February 2006 - February 2008
DSM Pharmaceuticals Inc July 2000 - February 2006
Catalytica Pharmaceuticals 1997 - 2000
Skills
GMP, Manufacturing, Packaging, Continuous Improvement, Quality Assurance, Quality Control, Pharmaceutical Industry, Lean Manufacturing, Quality System, Product Development, Validation, Purchasing, Supply Chain Management, Technology Transfer, Medical Devices, Automation, Troubleshooting, Supply Chain, Cross-functional Team..., Production Planning, Six Sigma, FDA, Root Cause Analysis
Education
East Carolina University 1989 — 1991
BS, Industrial Technology
Wayne Community College 1987 — 1989
AAS, Aviation Maintenance Technology
Mustang Engineering April 2011 - Present
Fluor February 2010 - August 2010
Fluor October 2005 - January 2010
IRIX Pharmaceuticals 2004 - 2004
DSM Pharmaceuticals 2002 - 2003
Schweizerhall Manufacturing Co. 1999 - 2002
Skills
GMP, Chemicals, Chemical Engineering, Project Engineering, Engineering
Education
Clemson University - College of Business and Behavioral Science 1995 — 1998
MBA, Business Administration
Florida State University 1983 — 1989
B.S., Chemistry, Chemical Engineering
Perdue Farms November 2014 - Present
Perdue Farms March 2013 - Present
DSM Pharmaceuticals December 2009 - August 2012
USDA-FSIS April 2004 - February 2005
Education
University of Mount Olive 2013 — 2015
Bachelor of Business Administration (B.B.A.), Business Administration and Management, General
Kaplan University 2008 — 2009
none, Business Management
DSM Pharmaceuticals July 2012 - July 2013
Independent Contractor May 2011 - June 2012
Undergraduate Research (NCSU) August 2010 - May 2011
Skills
Microsoft Office, Microsoft Excel, Microsoft Word, HPLC, Gas Chromatography, UV, Karl Fisher, Raw Materials, Chemistry, Analytical Chemistry, UV/Vis, FTIR, Protein Chemistry
Education
North Carolina State University 2013 — 2018
Doctor of Philosophy (Ph.D.), Chemistry
North Carolina State University 2008 — 2011
Bachelor of Arts (BA), Chemistry
North Carolina State University 2008 — 2011
Bachelor of Science (BS), Applied Mathematics
ECU, School of Dental Medicine March 2013 - Present
DSM, Pharmaceuticals April 2012 - October 2012
Vidant Medical Group December 2009 - March 2012
WBTW June 2007 - December 2009
Skills
Benefits Administration, Employee Relations, Public Speaking, Customer Service, HRIS, Employee Benefits, HR Policies, Outlook, Background Checks, Job Fairs, Human Resources, Training, Talent Acquisition, Recruiting, Onboarding/Orientation, Interviews, New Hire Orientations, Onboarding
Education
Pitt Community College
Human Resource Management/Business
Patheon July 2013 - Present
DSM Pharmaceuticals March 2012 - July 2013
Carolina Medical Products June 2010 - August 2010
Skills
GMP, Quality Assurance, UV/Vis, Sop, Testing, GLP, HPLC, Chromatography, FTIR, Gas Chromatography, Laboratory, Pharmaceutical Industry, Spectrophotometry
Education
Campbell University 2008 — 2011
Master of Science in Pharmaceutical Sciences, Industrial Pharmacy
Manpower Inc. August 2009 - October 2009
DSM Pharmaceuticals October 2006 - May 2009
DSM Pharmaceuticals April 2004 - October 2006
DSM Pharmaceuticals March 2003 - February 2004
Catalytica Pharmaceuticals March 1999 - February 2003
Catalytica Pharmaceuticals July 1997 - February 1999
Glaxo Wellcome/Manpower Inc. March 1996 - June 1997
Education
East Carolina University
B.S., Chemistry
Purdue Pharma June 2008 - Present
DSM Pharmaceuticals July 2001 - February 2008
Skills
GLP, LC-MS, HPLC, Analytical Chemistry, Dissolution, Pharmaceutical Industry, LIMS, Sop, USP, Chemstation, Chromatography, GMP
Education
East Carolina University 1997 — 2001
Bachelor of Science, Biology and Chemistry
Mayne Pharma February 2015 - Present
DSM Pharmaceuticals January 2013 - February 2015
Skills
UV, Materials Science, Spectroscopy, AFM, Analytical Chemistry
Education
University of Florida 2015 — 2017
Master of Science (MS), Pharmaceutical Policy & Regulations
North Carolina Agricultural and Technical State University 2008 — 2011
Masters, Chemistry, 3.5
DSM Pharmaceuticals, Inc. December 2010 - Present
DSM Pharmaceuticals May 2007 - December 2010
Parks and RecreationPolice Athletic League January 2008 - June 2008
DSM Pharmaceuticals May 2002 - May 2007
East Carolina University March 2000 - May 2002
East Carolina University August 1998 - December 2001
Brody School of Medicine May 2000 - August 2000
Pitt County Environmental Health May 1999 - August 1999
United States Census Bureau May 1999 - August 1999
Education
East Carolina University 2002 — 2008
MS, Molecular Biology
East Carolina University 1998 — 2002
BS, Cell Biology
Banner Life Sciences April 2015 - Present
Fresenius Kabi USA June 2011 - March 2014
DSM Pharmaceuticals February 2003 - May 2011
DSM Pharmaceuticals August 2001 - February 2003
Organon January 1998 - August 2001
Organon Teknika July 1992 - December 1997
Organon Teknika August 1987 - July 1992
Skills
Aseptic Processing, Microbiology, Quality Assurance, Biotechnology, Quality System, FDA, Lean Manufacturing, Medical Devices, Lifesciences, Six Sigma, Clinical Research, Manufacturing, Continuous Improvement, GMP, Sterilization, CAPA, Change Control, SOP, Validation, Quality Control, Pharmaceutical Industry, Technology Transfer, 21 CFR Part 11, Biopharmaceuticals
Education
Albright College 1983 — 1987
BS, Biology
New Vision Childcare January 2007 - Present
D & A Fashions January 2004 - December 2007
DSM Pharmaceuticals October 1973 - October 2007
Skills
Entrepreneurship, Public Speaking, Customer Service, Retail, Event Planning, Social Media, Coaching, Fundraising, Microsoft Office, Leadership Development, Outlook, Training
Education
Covenant Theological Seminary 2011 — 2014
Pitt Community College
Computer
I-Cubed, A KPIT Company March 2013 - Present
Consert, Inc. September 2011 - January 2012
DSM Pharmaceuticals March 2011 - July 2011
Arclight Energy Marketing October 2007 - March 2009
TEAMM Pharmaceuticals April 2005 - March 2007
Constella Group February 2003 - March 2005
ABB Shared Service June 2002 - August 2003
MTS Systems - Material Testing Divsion October 1998 - June 2002
Skills
Accounting, Account Reconciliation, Accountants, Accountability, Financial Analysis, Financial Accounting, Financial Statements, Great Plains Software, NetSuite, Deltek, SAP R/3, QuickBooks, Costpoint, Government Contracting, Journal Entries, Microsoft Dynamics GP, General Ledger, Bank Reconciliation, Budgets
Education
Campbell University 2001 — 2003
MBA, Finance
Saint Augustines College 1990 — 1994
BS, Accounting
Sequence Inc. - Quality and Compliance Services June 2015 - Present
Sequence Inc. December 2011 - May 2015
DSM Pharmacueticals March 2004 - December 2011
DSM Pharmaceuticals July 2000 - March 2004
Grady White Boats June 1994 - July 2000
Grady-White Boats 1993 - 2000
Noland Company February 1991 - July 1994
Skills
Computer System..., Change Control, GxP, 21 CFR Part 11, CAPA, Validation, FDA, Sop, LIMS, Quality System, Quality Auditing, Quality Control, Software Documentation, Biopharmaceuticals, Pharmaceutical Industry, GMP, Technology Transfer, GAMP, V&V, Aseptic Processing, Cleaning Validation, Biotechnology, Regulatory Requirements, Pharmaceutics, Quality Assurance, Document Management, Medical Devices, Regulatory Affairs, GLP, ISO 13485, Process Simulation, Documentum, Lifesciences, Laboratory, Regulatory Submissions, Trackwise, Quality Management, R&D, SOP
Education
East Carolina University 1986 — 1988
Political Science
Pitt Community College 2001 — 2003
Business/Math Courses
Conley High School
DSM Pharmaceuticals January 2008 - May 2008
Ann's House of Nuts April 2003 - October 2003
Wal-Mart Supercenter November 1998 - April 2003
Education
East Carolina University 2008 — 2011
Bachelor of Science (BS), Industrial Technology, Dual Concentration: Bioprocess Manufacturing and Distribution & Logistics
Pitt Community College
Associates in Applied Science, Biotechnology
Hospira, Inc. June 2012 - Present
DSM Pharmaceuticals January 2008 - May 2008
Ann's House of Nuts April 2003 - October 2003
Wal-Mart Supercenter November 1998 - April 2003
Education
East Carolina University 2008 — 2011
East Carolina University 2008 — 2011
Bachelor of Science (BS), Industrial Technology; Bioprocess Manufacturing and Distribution & Logistics
Pitt Community College
Associate in Applied Science, Biotechnology
Cooney Pharma Consulting, LLC (www.cooneypharma.com) 2014 - Present
Cambridge Major Laboratories May 2012 - January 2014
Endo/Qualitest Pharmaceuticals August 2009 - 2011
Hospira February 2005 - September 2008
DSM Pharmaceuticals September 2000 - August 2004
American Cyanamid/Cytec Industries 1980 - 1994
Skills
GMP, Analytical Chemistry, Validation, Pharmaceutical Industry, Chemistry, FDA, Regulatory Affairs, Pharmaceutics, R&D, CAPA, Quality Control, Quality Assurance, Formulation, Project Management, Regulations, Regulatory Submissions, CMC, ICH Guidelines, APIs, Method Development, Process Optimization, Generic Drugs, Contract Manufacturing, cGMP Laboratory..., Parenteral Drugs, Operational Due..., Capital Budgeting, Laboratory Capital...
Education
Georgia Institute of Technology, Atlanta, GA 1994 — 1999
Ph.D., Analytical Chemistry
Charter Oak State College 1991 — 1994
B.S., Chemistry
Western Connecticut State University 1975 — 1979
B.A., Biology
Hospira August 2013 - Present
DSM Pharmaceuticals, Inc. July 2011 - August 2013
DSM Pharmaceuticals November 2000 - June 2011
Burroughs Wellcome May 1989 - 2000
Skills
cGMP manufacturing, Aseptic Processing, Technical Transfers, Problem Solving, SAP R/3, Technical Writing, Manufacturing, Visual Inspection, Quality System, Process Improvement, Production Process..., Parenterals, Process Optimization, Pharmaceutical Industry, GMP, Technology Transfer, FDA, Validation, V&V, LIMS, CAPA, GLP, Change Control, 21 CFR Part 11, Parenteral, Technical Support
Education
North Carolina State University 1987 — 1989
Masters, Nutrition/toxicology
Pfizer 2015 - Present
Hospira 2015 - 2015
BD Rx Pharmaceuticals 2012 - 2014
DSM Pharmaceuticals September 2006 - May 2010
3V INC April 2004 - August 2006
Kelly Scientific Resources July 2003 - December 2003
Nobex Corporation February 2001 - November 2002
U.S. Geological Survey (USGS) September 1999 - February 2001
Skills
UPLC, HPLC, Empower, Method Transfer, LIMS template reviewer, Data review/LIMS release, Quality Control, Laboratory, Quality Assurance, LIMS, Analytical Chemistry, GMP, Method Development, USP, UV/Vis, Dissolution, Microsoft Excel, Protein Chemistry, FTIR, Pharmaceutical Industry, GC-FID, Wet Chemistry
Education
North Carolina State University 1998 — 2000
Zoology/Pre-Vet Curriculum
East Carolina University
Bachelor, Chemistry
DSM Pharmaceuticals October 2011 - Present
Dyneema February 2006 - October 2011
Education
Pitt Community College 2000 — 2002
Information Systems/Networking Administration and Support, Networking
Synthon February 2009 - Present
UCB Pharma March 2007 - December 2009
Schwarz Biosciences February 2006 - November 2007
AAIPharma Services Corp. 2002 - January 2006
DSM Pharmaceuticals 2000 - 2002
DSM Pharmaceuticals 1999 - 2000
Cato Research 1997 - 1999
Cato Research 1994 - 1997
Cato Research 1993 - 1994
Skills
Regulatory Submissions, Pharmaceuticals, GMP, Change Management, Strategic Planning, Product Development, Writing, Business Strategy, Negotiation, Biotechnology, Budgeting, Product Management, Team Leadership, Quality Assurance, Due Diligence, Compliance, Medical Devices, Research, Pharmaceutical Industry
Education
Meredith College 1988 — 1992
Bachelor of Science, Biology
DSM Pharmaceuticals June 2012 - Present
DSM Sinochem Pharmaceuticals June 2011 - Present
Skills
Microsoft Office, Microsoft Excel, Microsoft Word, PowerPoint, Customer Service, Research, Teamwork, Social Media, English, Windows, Time Management
Education
East Carolina University 2010 — 2011
Bachelor of Science (BS), Biology
St. John's College 2006 — 2008
Associate of Science (AS), Biology/Chemstry
DSM Pharmaceuticals November 2011 - Present
Education
East Carolina University 2009 — 2012
BSBA, Business Management
Pitt Community College 2007 — 2009
Associate of Arts (AA), Pre-Business Administration
DSM Pharmaceuticals August 2011 - Present
DSM 2004 - August 2011
Burroughs Wellcome / GSK / Catalytica 1988 - 2003
Skills
Training, Construction Safety, Validation, Management, Project Management, NFPA, Continuous Improvement, Electrical Safety, Six Sigma
Education
Beaufort County Community College 1981 — 1983
Associates of Applied Science, Electrical Engineering Technology, 14
DSM Pharmaceuticals September 2011 - Present
DSM DPI October 1986 - August 2004
Skills
SAP, LIMS, Microsoft Excel, Microsoft Word, ACS All Church...
Education
North Carolina State University 1974 — 1979
Bachelor of Applied Science (BASc), Agronomy and Crop Science
Patheon Inc 2015 - Present
DSM Pharmaceuticals 2004 - 2015
DSM Pharmaceuticals Inc August 2000 - August 2004
Catalytica August 1997 - August 2000
Glaxo Welcome Inc August 1994 - August 1997
Burroughs Welcome August 1990 - August 1995
Skills
Pharmaceutical Industry, Microsoft Office, Team Leadership, Training, Microsoft Excel, GMP, Life Sciences, Microsoft Word, SOP, FDA, Leadership, Quality Assurance, Quality System, Quality Auditing, Quality Management, Quality Control, CAPA, Process Improvement, Change Control, 21 CFR Part 11, LIMS
Education
East Carolina University 1994 — 2000
Master of Business Administration (MBA), Business Administration and Management, General
East Carolina University 1987 — 1989
Bachelor of Science (B.S.), Biology, General
Lenoir Community College 1985 — 1987
Associate of Science (A.S.), Science
Codexis May 2007 - Present
InterMune 2006 - 2007
Celera Genomics 2005 - 2006
Norac 2002 - 2004
DSM Pharmaceuticals 2000 - 2002
Catalytica 1991 - 2000
University of Illinois at Urbana-Champaign 1990 - 1991
Education
Arizona State University
DSM Pharmaceuticals January 1979 - Present
Greenville January 1979 - January 2001
Skills
Project Management, Process Improvement, Product Development, Technology Transfer, FDA, Cross-functional Team..., SOP, Manufacturing, Continuous Improvement, Validation, CAPA, Change Control
Education
Pitt Community College
DSM Pharmaceuticals July 2012 - Present
Education
Elizabeth City State University
Metrics, Inc. September 2009 - Present
DSM Pharmaceuticals October 1990 - September 2009
DSM Pharm October 1990 - September 2009
Skills
Sop, HPLC, Pharmaceutical Industry, GMP, FDA, Validation, Analytical Chemistry, Gas Chromatography, LIMS, Change Control, 21 CFR Part 11, GLP, CAPA, SOP, Biotechnology, Formulation, Technology Transfer
Education
East Carolina University 1985 — 1989
Bachelor of Arts (B.A.), Geography
Pitt County Sheriff's Office October 2006 - Present
DSM Pharmaceuticals March 1998 - December 2003
Hoffmann La Roche August 1991 - August 1996
Skills
Chemistry, Analytical Chemistry, HPLC, Research, Data Analysis, Environmental Awareness, Science, UV/Vis, Environmental Science, Analysis, Organic Chemistry, Chromatography, Statistics, Laboratory, Mass Spectrometry
Education
Duquesne University
Master's degree, Biochemistry
University of Pittsburgh
Doctorate, Organic Chemistry