Specialist I, Manufacturing Technical Operations
Current• Manages deviations across all streams (upstream, downstream, formulation, and material planning), alongwith CAPA, analytical investigations, and risk assessments for lot disposition and daily operations, servingboth commercial and clinical clients.• Lead cross-functional investigations for deviations, determines root causes, and presents findings andrecommendations to the leadership team for Drug substance and Drug product.• 40+ closed Records including Major and Minor investigations pertaining to; low VCD for mammalian cell line for HEK293, GDP errors, Sample management, Inoculation times, OOS Buffers, Planova Filters, exceeding hold times, and Data Integrity.• Facilitates risk assessments with teams including, process development, manufacturing, quality control, quality assurance, and regulatory affairs.• Ensured quality event ownership through metric reviews, cross-functional escalation meetings, and establishing team best practices.• Presented deviations directly to Clients in order to facilitate their closure.• Aided in CAPA implementation of Electronic Batch Records for both manufacturing upstream and downstream.