Senior Director of Manufacturing @ (April 2022 - August 2023)
Director of Manufacturing, R1 Facility Small Volume Parenteral Filling @ (April 2021 - April 2022)
Director Of Manufacturing, SVP R1 @ (August 2018 - April 2021)
Operations Investigation Manager @ (May 2017 - August 2018)
SAP Manufacturing Implementation Lead @ (September 2016 - May 2017)
Senior Manufacturing Manager, Flex and VisIV @ (September 2015 - September 2016)
Production Manager, SVP @ (July 2013 - September 2015)
Focus Factory Manager @ (July 2012 - July 2013)
Production Preparation Supervisor @ (November 2011 - July 2012)
Warehouse Supervisor @ (August 2011 - November 2011)
Purchasing Agent and MRO Supervisor @ (January 2011 - November 2011)
Production Supervisor @ (January 2008 - January 2011)
Plant Manager @ Cargill Inc (May 2006 - January 2008)
Casting System Operator @ Roto Corporation (October 2001 - June 2002)
Ammunition Manager and Cannon Crewmember @ (December 1995 - January 2001)
Michael Hale Education
Kansas State University
BS (Operations and Supply Chain Management)
2003-2006
Barton County Community College
Associate's Degree (Environmental Safety and Compliance)
1995-2001
Michael Hale Skills
21 CFR Part 11
49CFR
Aseptic Processing
Aseptic Technique
Behavior Based Safety
Biopharmaceuticals
Business Process Improvement
CAPA
Change Control
Change Management
Cleaning Validation
Computer System Validation
Continuous Improvement
Contract Manufacturing
Corrective and Preventive Action (CAPA)
Cross-functional Team Leadership
FDA
FDA GMP
Formulation
GLP
GMP
Good Laboratory Practice (GLP)
Good Manufacturing Practice (GMP)
GxP
ISO 13485
LIMS
Leadership
Lean Manufacturing
Logistics Management
Lyophilization
Manufacturing
Manufacturing Operations
Medical Devices
OPEX
OSHA 10-Hour
OSHA 30-Hour
Operations Management
P&L Management
Pharmaceutical Industry
Pharmaceutics
Process Improvement
Production Management
Project Management
Quality Assurance
Quality Auditing
Quality Control
Quality System
Regulatory Affairs
Regulatory Requirements
SOP
Six Sigma
Standard Operating Procedure (SOP)
Statistical Process Control (SPC)
Technology Transfer
TrackWise
U.S. Food and Drug Administration (FDA)
V&V
Validation
Social Media
Microsoft Office
Cross Functional Team Leadership
Computer System
Product Development
u.s. Food and Drug Administration Fda
Standard Operating Procedure Sop
Corrective and Preventive Action Capa
Microsoft Word
Strategy
Microsoft Excel
Business Development
Standard Operating Procedure
u.s. Food and Drug Administration
Corrective and Preventive Action
Michael Hale Summary
Michael Hale, based in Cincinnati, OH, US, is currently a Senior Director, Manufacturing Operations at Alkermes. Michael Hale brings experience from previous roles at Emergent BioSolutions and Pfizer. Michael Hale holds a 2003 - 2006 BS in Operations and Supply Chain Management @ Kansas State University. With a robust skill set that includes 21 CFR Part 11, 49CFR, Aseptic Processing, Aseptic Technique, Behavior Based Safety and more. Michael Hale has 2 emails and 4 mobile phone numbers on RocketReach.
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