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Karen Mitchell Location
Hale, GB
Karen Mitchell Work
Director of Performance and Operational Excellence @ (June 2024 - Present)
Senior Director, Technical Operations @ (February 2022 - June 2024)
Director Of Technical Operations and PMO @ (January 2021 - February 2022)
Senior Manager, Centre Of Excellence, Operational Excellence @ (November 2018 - October 2020)
Site PMO Head @ (March 2017 - October 2018)
Manufacturing Improvements Manager @ (October 2014 - March 2017)
Head, Business Diagnostics and Governance @ (October 2013 - October 2014)
Operational Excellence Master Black Belt @ (February 2010 - October 2013)
Technical Support Manager @ (January 2006 - January 2010)
Business Improvements Manager, Technology Development @ (August 2004 - January 2006)
Technologist @ (September 1998 - August 2004)
Karen Mitchell Education
North Carolina State University
Master Black Belt Certification (Lean Six Sigma)
2012-2012
The University of Manchester
Master of Science (M.Sc.) (Pharmaceutical Engineering)
2001-2006
Loughborough University
BSc (Chemistry)
1994-1998
Karen Mitchell Skills
21 CFR Part 11
Biopharmaceuticals
Business Process Improvement
CAPA
Change Control
Cleaning Validation
DFSS
DMAIC
Design of Experiments
Deviation Management
Equipment Qualification
FDA
FMEA
GMP
GxP
Leadership
Lean Manufacturing
Manufacturing
Manufacturing Operations
Operational Excellence
Pharmaceutical Industry
Process Improvement
Process Qualification
Project Management
Project Management Office (PMO)
Quality System
Root Cause Analysis
SOP
Six Sigma
Standard Operating Procedure (SOP)
Strategy
TRIZ
Technical Support
Technology Transfer
Training
V&V
Vaccines
Validation
Workshop Facilitation
Karen Mitchell Summary
Karen Mitchell, based in Hale, GB, is currently a Director of Performance and Operational Excellence at Ipsen. Karen Mitchell brings experience from previous roles at TriRx Pharmaceutical Services, LLC, Elanco and Seqirus. Karen Mitchell holds a 2012 - 2012 Master Black Belt Certification in Lean Six Sigma @ North Carolina State University. With a robust skill set that includes 21 CFR Part 11, Biopharmaceuticals, Business Process Improvement, CAPA, Change Control and more. Karen Mitchell has 2 emails and 1 mobile phone numbers on RocketReach.
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