AMEC BioPharmaceuticals
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AMEC BioPharmaceuticals Employees
Chesapeake PERL February 2006 - September 2013
AMEC BioPharmaceuticals March 2004 - March 2007
Phoenix Imperative May 2000 - March 2007
Advanced Biotechnologies Inc. (ABI) September 1999 - May 2000
Bio Science Contract Production Corp. July 1998 - September 1999
ONCOR Inc. December 1991 - July 1998
Amvax Inc. July 1989 - December 1991
Skills
CAPA, GMP, Quality System, Biotechnology, Lifesciences, Sop, V&V, Validation, Change Control, Quality Assurance, FDA, Protein Chemistry, Vaccines, GLP, 21 CFR Part 11, GxP, Microbiology, Biopharmaceuticals, Software Documentation, Technology Transfer, LIMS, Aseptic Processing, Life Sciences
Education
Howard Community College
Laboratory Science Program
Ventana Medical Systems (a subsidary of Roche) March 2011 - Present
Byron Medical division of Mentor Corporation (a owned subsididary of Johnson & Johnson) August 2008 - April 2011
Xeridiem (formerly MRI Medical) 2011 - 2011
AMEC Biopharmaceuticals February 2006 - August 2008
Guidant 2004 - 2006
Allergan 1998 - 2004
Certified Facilities 1996 - 1998
Validation Systems, Inc. 1994 - 1996
Molecular Biosystems 1993 - 1994
Skyland Scientific 1992 - 1993
Skills
ISO 13485, Quality System, Cross-functional Team..., Quality Assurance, Validation, Change Control, Medical Devices, FDA, CAPA, Quality Auditing, Auditing, ISO, GMP, Quality Control, Sop, Leadership, V&V, Biotechnology, Continuous Improvement, Six Sigma, Lean Manufacturing, Manufacturing, Regulatory Requirements, SOP, Pharmaceutical Industry, 21 CFR Part 11, Technology Transfer, Regulatory Affairs, Life Sciences, GLP
Education
California State University-Dominguez Hills 1995 — 1997
MS, Quality Assurance
Harvey Mudd College 1985 — 1990
B.S, Applied Chemistry / General Engineering
Insight Numerics, LLC July 2014 - Present
Xymeo April 2012 - September 2014
Biogen Idec August 2012 - July 2014
Biogen Idec April 2011 - July 2014
Biogen Idec June 2007 - April 2011
Amec BioPharmaceuticals January 2006 - June 2007
IBM Corp. January 2001 - August 2001
Skills
Cross-functional Team..., Process Engineering, GMP, Management, Strategy, Entrepreneurship, Process Improvement, FDA, 21 CFR Part 11, Project Management, Biotechnology, Strategic Planning, Manufacturing, Technology Transfer, Biopharmaceuticals, Start-ups, Quality System, Process Simulation, Lifesciences, Engineering, Data Analysis, Quality Assurance, Business Strategy, Microsoft Excel, Computer System..., Six Sigma, Business Analysis, Problem Solving, Operations Management, Team Leadership, CAPA, V&V, Change Control, R&D, GAMP, GxP, cGMP, Excel, Change Management, Risk Management, Social Entrepreneurship, F&G, Oil & Gas Industry, Life Sciences
Education
Boston University Graduate School of Management 2010 — 2012
MBA, Strategy Management, and Operations & Technology Management
Clarkson University 2004 — 2006
ME, Civil / Environmental Engineering
Clarkson University 1999 — 2003
BS, Chemical Engineering
Genzyme November 2014 - Present
Genzyme January 2014 - October 2014
Ben Venue Laboratories, Inc. July 2013 - January 2014
Ben Venue Laboratories, Inc November 2010 - June 2013
Ben Venue Laboratories, Inc. April 2009 - October 2010
AMEC BioPharmaceuticals July 2007 - December 2008
Biogen Idec July 2007 - March 2008
Novartis Pharmaceuticals December 2001 - June 2002
Novartis Pharmaceuticals June 1999 - November 2001
Skills
Change Control, CAPA, Validation, GMP, Program Management, Sop, Quality Assurance, FDA, Aseptic Processing, 21 CFR Part 11, Pharmaceutical Industry, Quality Systems..., Six Sigma Tools and..., Annual Product Reviews..., Data Management, Biotechnology, Six Sigma, Lean Manufacturing, Cross-functional Team..., Manufacturing, Regulatory Requirements, Process Simulation, Trackwise, V&V, Computer System..., Quality System, GxP, Regulatory Affairs, Pharmaceutics, GLP, LIMS, Quality Auditing, Deviations, Quality Control, Site Inspections, Team Leadership, Laboratory, Technical Leadership, Problem Solving, Problem Management, USP, SOP, TrackWise
Education
The University of Akron 2002 — 2007
Doctor of Philosophy (PhD), Polymer Science
Kent State University 2011 — 2011
Certificate, Project Management
Villanova University 2010 — 2010
Master Certificate, Lean Six Sigma
Marmara University 1999 — 2002
MBA, Concentration in Marketing
Boğaziçi University 1994 — 1998
BS, Chemical Engineering
Kadikoy Anadolu High School 1987 — 1994
High School, Science
Commissioning Agents, Inc January 2013 - Present
ISPE 2003 - Present
Biotech Company 2012 - 2012
Biotech Company June 2011 - December 2011
Yonkers Industries, Inc February 2007 - November 2011
OSD Facility 2007 - January 2009
Client 2007 - 2008
AMEC BioPharmaceuticals 2005 - 2007
Key Club and Circle K International 1996 - 2005
Skills
General Utility..., FDA, Validation, GMP, V&V, Sop, Biotechnology, Change Control, Pharmaceutical Industry, Process Simulation, Quality Assurance, Quality System, CAPA, Process Engineering, Commissioning, GLP, Technical Writing, Software Documentation, Microbiology, LIMS, Aseptic Processing, Cross-functional Team..., Manufacturing, Project Management, Lifesciences, Cleaning Validation, Computer System..., 21 CFR Part 11, Testing, GAMP, GxP, SOP, Life Sciences, Technology Transfer
Education
North Carolina State University 2000 — 2005
BS, Industrial Engineering
Wake Forest-Rolesville High School 1996 — 2000
Mangan Inc. June 2011 - Present
Vantage Consulting Group October 2009 - 2011
BE&K BioPharm 2007 - 2008
PharmEng July 2005 - January 2007
Wyeth Biotech 2004 - 2006
AMEC BioPharmaceuticals 2004 - 2005
Merck 2000 - 2005
Merck 2003 - 2004
Merck 2003 - 2004
Merck 2002 - 2004
Skills
Validation, Computer System..., Quality Control, 21 CFR Part 11, CAPA, GMP, Biotechnology, Leadership, Sop, GAMP, V&V, Quality Assurance, FDA, Pharmaceutical Industry, Business Development, GxP, Change Control, Process Engineering, Quality System, SOP
Education
Nash Community College 1995 — 1998
Ass. Science, Information Systems
East Carolina University
B.S., Industrial Technology
Alexion Pharmaceuticals, Inc. May 2015 - Present
Amgen May 2006 - Present
Cardinal Health, SPS 2005 - 2006
AMEC BioPharmaceuticals 2001 - 2005
Day & Zimmermann 1999 - 2001
AAIPharma February 1997 - October 1999
Skills
Validation, Cleaning Validation, Project Management, Process Validation (PPQ), Quality Assurance, Regulatory Compliance, CAPA, Change Control, Biopharmaceuticals, 21 CFR Part 11, FDA, SOP, Technology Transfer
Education
University of North Carolina at Wilmington
ITT Engineered Valves September 2013 - Present
ITT Engineered Valves January 2010 - September 2013
ITT Pure Flo March 2007 - December 2009
PharmEng 2005 - 2007
AMEC BioPharmaceuticals 2003 - 2005
Skills
Technology Transfer, Sales, Process Engineering, Sales Operations, FDA, Process Optimization, Change Control, GMP, Manufacturing, Validation, V&V, Quality System, Biotechnology, Management, CAPA
Education
North Carolina State University 1998 — 2002
BS, Chemical Engineering
ZB Validation Solutions LLC February 2008 - Present
Z&B Validation Solutions LLC January 2007 - Present
amec inc. 2003 - 2008
AMEC BioPharmaceuticals 2003 - 2007
Skills
Quality Management, Quality Control, GMP, Change Control, Quality Assurance, Sop, Validation, V&V, Pharmaceutical Industry, Commissioning, Biotechnology, 21 CFR Part 11, FDA, Quality System, Technology Transfer, Process Simulation, Project Management, Lifesciences, Automation, Start-ups, Process Engineering, Piping, CAPA, Software Documentation, Construction, Document Management, Change Management, Regulatory Affairs, SOP
Education
Regis University 1975 — 1977
FDA/CDER/Office of Hematology and Oncology Products/Division of Oncology Products 2 October 2008 - Present
Meridian BioGroup, LLC March 2008 - October 2008
AMEC BioPharmaceuticals 2003 - 2008
AMEC 2000 - 2008
Phoenix Imperative March 2000 - March 2003
CapricornPharma February 1999 - March 2000
North American Vaccine November 1997 - February 1999
Cephalon 1992 - 1996
Pharmacia-ENI Diagnostics 1983 - 1992
Skills
Compliance, Biotechnology, Validation, cGMP, Quality Systems, Pharmaceuticals, Quality Assurance, Documentation, GMP, FDA, Regulatory Affairs, Auditing, Medical Devices, Cleaning Validation, SOP, Document Management
Education
Mary Washington College 1978 — 1982
Bachelor of Science, Biology
Medical College of Virginia, Virginia Commenwealth University 1980 — 1981
Medical Technology
Oxford International February 2013 - Present
PharmaMatrix, Inc January 2008 - March 2013
AMEC BioPharmaceuticals March 2001 - December 2007
ValiCor Associates, Inc. July 1997 - March 2001
Kemper Masterson, Inc. May 1991 - July 1997
Morrison Knudsen Corporation January 1989 - May 1991
Fluor Daniel April 1987 - November 1988
CooperVision-Cilco, Inc. August 1984 - April 1987
ASTRA Pharmaceutical Products, Inc., May 1981 - August 1984
Parke-Davis, February 1978 - May 1981
Skills
Quality System, GMP, Validation, Laboratory, Quality Assurance, CAPA, Sop, Commissioning, V&V, GAMP, Pharmaceutics, Computer System..., Testing, FDA, Pharmaceutical Industry, Medical Devices, Manufacturing, HVAC, Management, Process Engineering, Change Control, Biotechnology, Biopharmaceuticals, Project Planning, Calibration, Software Documentation, 21 CFR Part 11, Instrumentation, Budgets, Technology Transfer, Electronics, Start-ups, Sterilization, Quality Control
Education
Northeastern University 1975 — 1977
BSIT, Electronics
Northeastern University 1967 — 1975
ASEE, Electronics