Robert Feltz
Director, Analytical and Formulation Services at Sharp
- Role
- Director of Analytical and Formulation Services at Sharp Services
- Location
- Philadelphia, PA, US
- LinkedIn followers
- 500 followers
About Robert Feltz
Leading Sharp Clinical Services\' analytical research and formulation teams, I help…
Experience
Director of Analytical and Formulation Services
Aug 2022 — Present · Bethlehem, PA, US
I lead analytical R&D, formulation and manufacturing, and quality control operations within a global CDMO environment. I bridge the gap between technical operations, regulatory compliance, and strategic business growth.My role spans:Laboratory and GMP Operations Leadership Oversee laboratory and manufacturing functions including analytical method validation, release and stability testing, cleaning verification, and clinical manufacturing operations under GMP guidelines.Risk-Based Quality and Compliance StrategyDevelop and implement both global and site-wide policies for new product introduction, risk management, data integrity, and cleaning validation master plans aligned with global regulatory standards.Capital and Process Optimization Build ROI-justified CAPEX proposals for new systems and equipment intended to drive automation, cost efficiency, and data reliability across sites.Cross-Functional Program Management Partner with QA, packaging operations, and project management teams to streamline technology transfers, capacity planning, and regulatory readiness for diverse product portfolios.Technical Expertise and Continuous Improvement Apply advanced analytical knowledge to improve processes, reduce risk, and enhance operational throughput using data-driven approaches.
Education
Shepherd University
BS, Chemistry
2000 — 2004
Penn State University
MS, Chemistry
2004 — 2006
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