Amylin Ohio LLC
Industry: Company
DescriptionFounded: 2005 Parent organizations: AstraZeneca, Amylin Pharmaceuticals
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Amylin Ohio LLC Employees
AstraZeneca September 2015 - Present
AstraZeneca August 2014 - September 2015
Advanced Testing Laboratory November 2013 - August 2014
Advanced Testing Laboratory May 2011 - November 2013
Amylin Ohio, LLC September 2009 - June 2011
Amylin Pharmaceuticals, Inc March 2007 - September 2009
Amylin Pharmaceuticals, Inc October 2005 - March 2007
Focus Diagnostics October 2004 - October 2005
Focus Diagnostics September 2002 - October 2004
Focus Diagnostics February 2001 - September 2002
Skills
Validation, Deviations, Change Control, FMEA, Product Complaints, Internal Audit, Quality Auditing, CAPA, Quality Investigations, Laboratory, Calibration, Quality Assurance Review, Analytical Method..., Sop, GMP, Employee Training, Microbiology, GLP, Quality Assurance, Quality Management, ISO, Pharmaceutical Industry, SOP, FDA, Quality System
Education
San Diego State University-California State University 2008 — 2009
Adv. Certificate, Biomedical Quality Systems
University of California, Santa Barbara 1992 — 1997
B.S., Zoology
Johnson & Johnson February 2015 - Present
Alcon Laboratories, Inc. July 2013 - October 2014
Boehringer Ingelheim July 2011 - July 2013
Boehringer Ingelheim March 2009 - August 2011
Amylin Ohio LLC 2006 - 2008
Cephalon Inc. October 2003 - October 2006
Eisai Inc. 1997 - 2003
Lederle/Wyeth 1993 - 1997
Skills
GMP, Quality System, Change Control, Document Management, Records Management, CAPA, Quality Assurance, FDA, Training, Validation, Clinical Trials, Quality Control, Technology Transfer, Pharmaceutical Industry, Manufacturing, Computer System..., Regulatory Affairs, GAMP, Process Improvement, Product Development, Quality Management, Sop, 21 CFR Part 11, Software Documentation, Technical Writing, GxP, GLP, Regulatory Requirements, Biopharmaceuticals, Change Management, Regulatory Submissions
Education
Case Western Reserve University School of Medicine 2010 — 2012
University of North Carolina at Chapel Hill 1991 — 1992
BA
Patheon June 2015 - Present
Patheon Pharmaceuticals June 2011 - Present
Amylin Pharmaceuticals August 2008 - October 2010
Amylin Ohio LLC August 2008 - October 2010
Amylin Ohio LLC August 2008 - October 2010
Alkermes Inc May 2006 - May 2008
Alkermes Inc May 2006 - May 2008
Alkermes 2006 - 2008
Grandma's Gardens March 2004 - April 2006
Grandma's Gardens March 2004 - April 2006
Skills
CAPA, Cross-functional Team..., FDA, GLP, GMP, Quality Assurance
Education
University of Phoenix 2003 — 2006
Master Business Administration, Marketing
Wilmington College of Ohio 1987 — 1992
Bachelor of Science, Biology
Wilmington College of Ohio
Bachelor of Science, Biology
Wilmington College of Ohio
Bachelor of Science, Biology
University of Phoenix
MBA, Marketing
University of Phoenix
MBA, Marketing
Quality Compliance Partners, Inc. August 2012 - Present
Amylin Ohio, LLC 2007 - July 2012
Amylin Ohio, LLC January 2007 - January 2008
Akorn, Inc. October 2005 - January 2007
Salus Inc. January 2004 - October 2005
MS BioScience January 1998 - January 2004
Burns and McDonnell Engineers and Consultants January 1994 - January 1998
Skills
Cleaning Validation, Computer System..., GxP, Aseptic Processing, 21 CFR Part 11, V&V, Validation, Change Control, CAPA, GMP, FDA, Sop, GLP, GAMP, Pharmaceutical Industry, Technology Transfer, Quality System, Regulatory Affairs, Aseptic Technique, Quality Assurance, Quality Control, Biotechnology, SOP
Education
University of California, Davis 1972 — 1976
BSChE, Chemcial Engineering
Golden Gate University
Master of Business Administration (M.B.A.), MBA
Schneider Electric November 2010 - Present
cGMP Validation LLC November 2003 - November 2010
Amylin Ohio LLC October 2006 - October 2010
Skills
21 CFR Part 11, Automation, Change Control, Commissioning, Computer System..., DCS, Engineering, GAMP, GMP, Process Control, Process Simulation, Program Management, Project Engineering, Quality Assurance, Root Cause Analysis, V, Validation, V&V, Testing
Education
Northeastern University 1992 — 1997
BS, Chemical Engineering
The Timken Company August 2015 - Present
AstraZeneca February 2015 - June 2015
Amylin Pharmaceuticals - a wholly owned subsidiary of Bristol-Myers Squibb July 2013 - February 2015
Amylin Ohio, LLC December 2008 - July 2013
Amylin Pharmaceuticals June 2007 - December 2008
Midland Title Security Inc. April 2001 - June 2007
Skills
Microsoft Excel, Microsoft Office, Pharmaceutical Industry, Sop, Compliance, Software Documentation, Process Improvement, Microsoft Word, Records Management, Customer Service, Problem Solving, Concur, Validation, QuickBooks, Visio, SharePoint, Project Management, Account Reconciliation, Manufacturing, SAP, Human Resources, Payroll, JD Edwards, GMP, SOP
Education
DeVry University 2013 — 2016
Bachelor of Business Administration (B.B.A.), Accounting
Cincinnati State Technical and Community College 2006 — 2011
Accounting, Accounting
Miami University 2001 — 2004
AstraZeneca February 2014 - Present
Bristol-Myers Squibb January 2013 - February 2014
Amylin Ohio, LLC November 2010 - July 2012
Amylin Ohio, LLC 2012 - 2012
Amylin Ohio, LLC February 2007 - November 2010
Pfizer, Inc November 2005 - January 2007
Pfizer, Inc November 2004 - July 2005
Pfizer, Inc April 1996 - November 2004
Pfizer, Inc October 1990 - April 1996
Aldrich Chemical 1987 - 1990
Skills
Pharmaceutical Industry, GMP, Technology Transfer, Validation, V&V, Sop, Quality System, Biotechnology, Purification, Biopharmaceuticals
Education
University of Michigan 2006 — 2008
MEng, Pharmaceutical Engineering (in progress)
Central Michigan University 1981 — 1987
B.S., Chemistry/Biology
Amylin Ohio LLC Warehouse ManagerAmylin PharmaceuticalsOctober 2007 - Present
Givaudan Flavors December 1990 - September 2006
Education
Ohio University 1971 — 1975
Baxter International Inc. March 2014 - Present
Integra LifeSciences December 2012 - August 2013
Harlan Laboratories September 2011 - December 2012
Terumo Medical Corporation October 2008 - August 2009
Amylin Ohio LLC December 2006 - August 2008
Cardinal Health 2004 - 2006
Cardinal Health 2003 - 2005
Baxter Laboratories 2001 - 2003
Skills
FDA, Quality System, Validation, Change Control, CAPA, V&V, CRM, ISO 13485, Quality Assurance, Medical Devices, Quality Management
Education
Webster University 1999 — 2001
MBA, Business Administration
Columbia College Chicago 1997 — 1999
BS, Business Administration
Optwo LLC June 2014 - Present
Patheon June 2014 - Present
Boston Beer Company May 2013 - May 2014
Amylin Pharmaceuticals November 2011 - May 2013
Amylin Pharmaceuticals May 2011 - November 2011
Amylin Pharmaceuticals January 2010 - May 2011
Amylin Ohio LLC March 2009 - January 2010
Amylin Ohio LLC July 2007 - March 2009
Barr Pharmaceuticals 2003 - 2007
Stearn Extruded Textiles 1995 - 2000
Skills
GMP, Validation, Pharmaceutical Industry, 21 CFR, Packaging, Problem Solving, 5S, Waste Management, Materials Management, Hazardous Materials, Aseptic Technique, SOP development, Work Instruction..., Project Management, Material Handling, Development Coaching, FDA, Aseptic Processing, Instructional Design, Manufacturing, Leadership, CAPA, Quality System, Change Control, Sop, Process Improvement, Quality Control, Quality Assurance, GxP, Training, SOP, V&V
Education
Keller Graduate School of Management of DeVry University
Master's Degree, Business Administration and Management, General
DeVry
Bachelor's Degree, Technical Manager
TKF Consulting March 2010 - Present
Amylin Ohio LLC February 2007 - January 2010
Pfizer Pharmaceuticals March 2002 - February 2007
Jacobs Engineering 1996 - 2000
Education
University of Cincinnati
Amylin Process Engineering ManagerAmylin Pharmaceuticals2007 - Present
Amylin Ohio LLC 2007 - Present
Novo Nordisk 2004 - 2007
CSL Behring 2003 - 2004
Aventis-Behring 2001 - 2004
Skills
Quality System, GMP, Medical Devices, Change Control, Engineering, FDA, Continuous Improvement, Process Engineering, Pharmaceutical Industry, CAPA, Parenteral, Cross-functional Team..., Leadership, Validation, V&V, Process Improvement, Aseptic Processing, Sop, Process Simulation, Technology Transfer, SOP
Education
United States Naval Academy 1988 — 1992
AstraZeneca November 2013 - Present
Amylin Pharmaceuticals January 2008 - October 2013
Amylin Ohio LLC 2008 - October 2013
Forest Pharmaceuticals 1998 - 2008
Skills
GMP, SOP, Pharmaceuticals, FDA, Manufacturing, Packaging
Education
Miami University 1992 — 1996
bachelor of arts, geology
AstraZeneca June 2007 - Present
Amylin Pharmaceuticals Inc. Ohio 2007 - Present
Amylin Ohio LLC. July 2007 - June 2012
Amylin Ohio LLC July 2007 - June 2011
3M 1998 - 2006
Uno's Pizzaria 1994 - 1998
Skills
HRIS, Sop, Pharmaceutical Industry, Process Improvement, GMP, Cross-functional Team..., Six Sigma, Software Documentation, Validation, FDA, ISO, Quality System, Biotechnology, Change Control, Visio, Quality Assurance, Continuous Improvement, Human Resources, Project Management, Medical Devices, Quality Control
Education
Academy of Art University 2006 — 2012
Actavis plc (now Allergan plc) September 2015 - Present
Nestlé S.A. August 2010 - November 2013
Daxor Corparation November 2009 - August 2010
Amylin Pharmaceuticals June 2007 - October 2008
Amylin Ohio LLC 2007 - October 2008
Pfizer Pharmaceuticals December 2006 - June 2007
Alkermes April 2004 - December 2006
Alkermes 2005 - 2006
Abbott Laboratories January 2001 - April 2004
Bridgestone/Firestone July 1993 - December 2001
Skills
Six Sigma, Cross-functional Team..., Performance Management, Infrastructure, Multi-Site Operations, Negotiation, Project Planning, Leadership Development, Validation, GMP, Pharmaceutical Industry, Quality System, Medical Devices, FDA, Continuous Improvement, Sop, Lean Manufacturing, Quality Assurance, Root Cause Analysis, Biotechnology, Manufacturing, Aseptic Processing, Change Control, Management
Education
Tennessee Technological University 1985 — 1990
BS, Education
Chowan College 1983 — 1985
AA, Printing Technology
IFCO SYSTEMS December 2013 - Present
General Pet Supply April 2012 - June 2013
Undisclosed February 2011 - August 2011
Amylin Ohio LLC August 2007 - February 2011
Fort Dodge Animal Health 2006 - 2007
Cardinal Health 1999 - 2006
US Army 1988 - 2005
Skills
Shipping, Receiving, Warehousing, Distribution Center..., Transportation, Materials Management, Inventory Control, Warehouse Management, Inventory Management, Logistics, Supply Chain, Supply Chain Management, GMP, Management, Quality Control, FDA, Quality Assurance, Material Handling, Quality System, Training, Software Documentation, Continuous Improvement, ISO, Lean Manufacturing, Six Sigma, Manufacturing, Process Improvement, Operational Excellence
Education
St. Louis Community College 1992 — 1992
Certificate, Applied Machine Technology (Machinist)
Brooksource September 2014 - Present
Adecco Group February 2013 - August 2014
Brooksource August 2012 - January 2013
Eli Lilly and Company July 2011 - August 2012
Cummins Inc May 2011 - July 2011
WellPoint April 2010 - June 2011
Amylin Ohio, LLC September 2007 - November 2009
Lilly February 2001 - May 2007
Skills
Software Documentation, Visio, SharePoint, Project Management, Cross-functional Team..., Management, Microsoft Excel, Data Analysis, Leadership, Budgets, Six Sigma, Analysis, Project Planning, Change Management, Meeting/Event Planning,..., PowerPoint, Contract Management, Document Management, Quality Assurance, Access, Team Leadership, Excel, “Can Do” Attitude, Word, Microsoft Word, Contract Negotiation &..., Third Party Management, Health Outcomes Process..., MS Project, Macro's, Pivot Tables, Outsourcing, Alliance Coordination, Paralegal Experience, Six Sigma Yellow Belt, Office Management, Scientific Disclosures, Datavision, Libra, Vendor Management..., Business Development, Business Process..., Workflow Process Mapping, RFI, RFP, Project Coordination, Salesforce.com, Project Server, Business Requirements, Microsoft Project
Education
Indiana State University - School of Business 1982 — 1986
Indiana State University - Scott College of Business
Continuing Education, Business
Ivy Tech Community College
Continuing Education, Paralegal
AstraZeneca May 2013 - Present
Bristol-Myers Squibb / Amylin Pharmaceutical Inc. August 2010 - Present
Amylin Pharmaceuticals 2008 - Present
Amylin Ohio LLC December 2007 - Present
Macy's 2006 - 2008
Mercy Health Partners 2004 - 2006
Givaudan Flavors 1990 - 2004
Skills
Lifetime C.P.M..., Strategic Sourcing, Manufacturing, Lifetime, Quality Assurance, Purchasing, Procurement, Contract Management, Pharmaceutical Industry, Packaging, Supply Management, Management, Spend Analysis, Materials Management, Supply Chain Management, Cross-functional Team..., Continuous Improvement, Supply Chain, Global Sourcing, Lean Manufacturing
Education
University of Cincinnati 1988 — 2003
Associates, Raymond Walters, General Business
Bowling Green State University 1983 — 1984
Business
Leadership 21
Amylin Ohio, LLC June 2008 - October 2012
Amylin Pharmaceuticals Inc. Ohio 2008 - October 2012
Amylin Pharmaceuticals October 2010 - 2012
Amylin Pharmaceuticals 2008 - 2012
Pfizer April 2004 - May 2008
Skills
cGMP, SOP, GMP, Validation, Pharmaceuticals, Process Validation, Quality Systems, Documentation, Process Improvement, Sop, Change Control, Pharmaceutical Industry, V&V, Quality System, CAPA, LIMS, 21 CFR Part 11
Education
ITT Tech 1985 — 1986
None, Electrical Engineering Technology
Ivy Tech Community College 1981 — 1982
None, Commercial Photography
Hillsborough Community College 1976 — 1977
None, Biology
Indiana Central College 1970 — 1971
None, Biology
Astra Zeneca (Amylin Ohio LLC) November 2006 - Present
Bristol Myers Squibb/Amylin Ohio LLC August 2012 - January 2014
Amylin Ohio LLC October 2006 - August 2012
Akorn, Inc 2005 - 2006
APP Pharmaceuticals 2002 - 2005
Boehringer Ingelheim 1991 - 2002
Abbott Laboratories 1983 - 1991
IVAC (Eli Lilly) 1979 - 1983
Skills
Validation, Quality System, Quality Auditing, Microbiology, Medical Devices, FDA, Quality Assurance, Aseptic Processing, GMP, CAPA, Manufacturing, Quality Control, Change Control, 21 CFR Part 11, Sop, GxP, Clinical Trials, SOP
Education
Campbell University
Master of Business Administration (MBA)
San Diego State University
Bachelor of Science (B.S.), Microbiology
Cincinnati Children's Hospital Medical Center March 2013 - Present
Pfizer April 2012 - December 2012
Q Laboratories August 2011 - April 2012
Givaudan November 2010 - August 2011
Givaudan Flavors November 2010 - August 2011
U.K. Extension Campbell County July 2009 - November 2010
County Extension Agent for Agriculture and Natural Resources March 2009 - November 2010
Amylin Ohio LLC December 2007 - March 2009
Yellowstone Wolf Restoration Research August 2006 - December 2007
Ball State University 2004 - 2007
Skills
Microbiology, Aseptic Technique, Microsoft Office, Biotechnology, Sop, GLP, Research, GMP
Education
Western Kentucky University 2010 — 2012
Master of Science, In-Process Online; Biology
Ball State University 2004 — 2007
Bachelor of Science, Biology; Zoology and Wildlife Biology
OPX Biotechnologies, Inc. 2011 - 2014
Amgen Inc. December 2010 - September 2011
Amylin Ohio LLC May 2010 - August 2010
Cargill September 2009 - January 2010
Skills
Environmental Awareness, Aseptic Technique, Biotechnology, Fermentation, SOP, Validation, Laboratory
Education
Wright State University 2007 — 2009
B.S. Biological Science, Biology/Biological Sciences, General, 3.5
Sinclair Community College 2005 — 2006
Biology/Biological Sciences, General, 3.5
Garrett College 2002 — 2003
Associates in Applied Science, Adventure Sports, 3.8
AstraZeneca November 2014 - Present
AstraZeneca/Amyin May 2012 - November 2014
Baxter Healthcare June 2011 - May 2012
Amylin Ohio LLC March 2010 - August 2010
Skills
cGMP, Validation, GMP, Pharmaceutical Industry, FDA, Quality System, Design of Experiments
Education
Rose-Hulman Institute of Technology 2007 — 2011
Bachelor's degree, Chemical Engineering
Amylin Ohio LLC Automation Co-opAmylin Ohio LLCSeptember 2009 - September 2011
Education
University of Cincinnati 2007 — 2012