Stephen Mitnaul
- Role
- Senior Specialist - Large Molecule External Manufacturing, Technical Operations at Merck
- Location
- Philadelphia, PA, US
- LinkedIn followers
- 500 followers
About Stephen Mitnaul
WHO I AM: I am a dedicated and skilled professional who appreciates challenging work and…
Experience
Senior Specialist - Large Molecule External Manufacturing, Technical Operations
Jun 2020 — Present
I fulfill the run-the-business, technical needs of 3 drug substance processes performed at a contract manufacturing organization - all of which requiring process performance qualification; these areas include technical transfer, change management, quality risk assessment, deviation management, etc.
Skills
- Project Management
- Regulatory Interactions
- Sop
- Lean Six Sigma
- Communication
- Regulatory Submissions
- Analytical Skills
- Influence Others
- Cleaning Validation
- Controlled Temperature Unit Qualification
- Negotiation
- Leadership
- Change Management
- Vaccines
- Cross-Functional Team Leadership
- Validation
- Microsoft Office
- Fda
- Microsoft Project
- Adaptive Learning
- Team Management
- Pharmaceutical Industry
- Gmp
- Six Sigma
- Regulatory Filings
- Process Validation
- Sterilization
- Manufacturing
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