Lance Philipose
Director, Quality at Abzena
- Role
- Director, Quality at Abzena
- Location
- Philadelphia, PA, US
- LinkedIn followers
- 500 followers
About Lance Philipose
Biopharmaceutical Quality professional with expertise in FDA/global regulations and guidelines, specializing in GMP clinical and commercial Quality Operations, Systems, and Compliance.
Experience
Director, Quality
Apr 2022 — Present · Bristol, PA, US
Quality Leadership at a Contract Development and Manufacturing Organization (CDMO).• Responsible for QA Operations (small molecule and biologic conjugation) and GMP Services (e.g, Deviations, CAPA, Change Controls, OOS Investigations, Document Control, Training, Validation, Qualification, I.T Compliance) for Phase-1 to Phase-3 clinical drug substances. • Direct and indirect management of quality professionals responsible for day-to-day manufacturing, quality systems, and compliance. • Overhaul global quality procedures and implement an electronic Quality Management System (ZenQMS). • Eliminate batch and quality record backlog at multiple Abzena sites through creating efficient interim and long-term systems, training current teams, and onboarding subject matter experts.• Elevate quality culture of the site and global organization to ensure GMP clinical and commercial readiness.
Education
Temple University
Master of Science - MS, Regulatory Affairs and Quality Assurance
Temple University
Bachelor of Science - BS, Biochemistry
Central High School
Bachelor of Arts - BA
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