Aspect Biosystems Benefits Overview

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.

Execute analytical and cell-based assays for characterization, release, and stability testing of biologics; support method qualification/validation per regulatory guidelines; record, analyze, and present data; troubleshoot methods; maintain analytical instruments; collaborate cross-functionally to support product development.