Michael Hale
- Role
- Senior Director, Manufacturing Operations at Alkermes
- Location
- Cincinnati, OH, US
- LinkedIn followers
- 500 followers
Manufacturing & ProductionView LinkedIn profile
About Michael Hale
Culture and quality driven, goal oriented leader with over 15 years of experience leading…
Experience
Senior Director, Manufacturing Operations
Aug 2023 — Present
Skills
- Business Process Improvement
- Iso 13485
- Six Sigma
- Fda
- Regulatory Requirements
- Technology Transfer
- Gxp
- Medical Devices
- Validation
- Cross-Functional Team Leadership
- Aseptic Processing
- V&V
- Formulation
- Computer System Validation
- Trackwise
- Cleaning Validation
- Corrective and Preventive Action (Capa)
- Standard Operating Procedure (Sop)
- Quality System
- Regulatory Affairs
- Sop
- Gmp
- Contract Manufacturing
- Capa
- Lyophilization
- Quality Control
- Process Improvement
- Aseptic Technique
- Change Control
- Lims
- 21 Cfr Part 11
- U.s. Food and Drug Administration (Fda)
- Lean Manufacturing
- Quality Auditing
- Glp
- Manufacturing
- Continuous Improvement
- Pharmaceutical Industry
- Quality Assurance
- Pharmaceutics
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