Aspect Biosystems Benefits Overview

Develop, optimize, and qualify bioanalytical methods (ddPCR, qPCR, flow cytometry, ELISA, cell-based assays) to characterize bioprinted tissue therapeutics. Execute and troubleshoot assays, perform routine testing, author SOPs/protocols/reports, ensure GxP compliance, maintain instruments, and work cross-functionally to support product characterization and clinical readiness.

Lead and scale the QA organization and GxP compliance for bioprinted tissue therapeutics. Establish a phase-appropriate GMP QMS, oversee Document Control, CAPA, deviations, inspection readiness, regulatory interactions (FDA/EMA/Health Canada), QA oversight of GMP cell manufacturing, support QC and data integrity, and author/review quality sections for regulatory submissions.

Manage and scale corporate IT infrastructure for a clinical-stage biotech, securing Google Workspace, networks, endpoints and IDS, governing IT assets and vendors, driving safe AI use, enforcing cybersecurity posture, and providing technical support and documentation to enable secure, high-performing tools and processes.