Heath Miller
Senior Manager, Equipment Validation and Metrology at REGENXBIO Inc.
- Role
- Senior Manager, Equipment Validation and Metrology at REGENXBIO
- Location
- Rockville, MD, US
- LinkedIn followers
- 500 followers
About Heath Miller
Senior biotechnology leader with nearly twenty years of extensive experience in metrology, validation, and quality oversight for advanced therapeutics. Equipment validation lead at Regenxbio, covering lab/process equipment and utility validation, shipping qualification for temperature-sensitive materials, and fill-finish sterilization strategies. Served as SME during FDA inspections and BLA submissions.I specialize in building high-performing teams, implementing risk-based lifecycle strategies, and aligning technical operations with organizational goals. My focus is driving compliance, efficiency, and reliability across GxP systems while enabling innovation at scale.Passionate about advancing gene therapy and biologics, I partner with leadership to embed quality into operations and deliver transformative therapies to patients.
Experience
Senior Manager, Equipment Validation and Metrology
Jun 2021 — Present
Education
University of Maryland Baltimore County
Bachelor's degree, Chemical Engineering w/ focus in Biotechnology
2001 — 2006
University of Maryland Baltimore County
Master's Degree, Chemical and Biochemical Engineering
2005 — 2007
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