Phil Sticha Email & Phone Number
Director of Operations @ QTS Medical Device Outsourcing
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Phil Sticha Location
- Saint Paul, MN, US
Phil Sticha Work
- Director of Operations @ (April 2026 - Present)
- Vice President of Development Services @ (January 2018 - March 2026)
- Senior Director of Manufacturing @ (July 1996 - January 2018)
Phil Sticha Education
- University of Wisconsin-Stevens Point
BS (Biology)
Phil Sticha Skills
- API Manufacturing – Microbial Fermentation
- APS-Aseptic process simulations
- Aseptic Filling
- CDMO
- CMC program management
- Chemistry, Manufacturing, and Controls (CMC)
- Complex product formulations
- Cross functional leadership and collaboration
- External customer partnerships
- GMP regulations - US, EU, and ROW
- Lean Manufacturing
- Manufacturing tech transfer, scale up, and validation- PQ, PPQ
- Negotiation and execution of development and commercial contracts (DSA, MSA, CMA).
- PPQ
- Packaging operations
- Parenteral sterile injectables- PFS (Prefilled syringe) and vial
- Project timeline execution and management
- Project/ Program management – former head of project management
- RFP, Proposals, and SOW (Statement of Work)
- Root cause analysis and CAPA
- Staffing and team building
- Sterile filtration
- Terminal sterilization -Gamma, Heat, VHP
- Visual Inspection
- Manufacturing Operations Management
- Manufacturing Operations
- Clinical Development
- IND
- Strategy
- Continuous Improvement
- Pharmaceutical Industry
Phil Sticha Summary
- Phil Sticha, based in Saint Paul, MN, US, is currently a Director of Operations at QTS Medical Device Outsourcing. Phil Sticha brings experience from previous roles at Lifecore Biomedical. Phil Sticha holds a BS in Biology @ University of Wisconsin-Stevens Point. With a robust skill set that includes API Manufacturing – Microbial Fermentation, APS-Aseptic process simulations, Aseptic Filling , CDMO, CMC program management and more.
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