Teams at Encoded Therapeutics

Provides external quality assurance oversight for CDMOs and analytical laboratories supporting clinical and commercial gene therapy supplies. Reviews GMP documentation, batch records, specifications, testing protocols, deviations, CAPAs, and change controls. Authors quality procedures, monitors quality metrics, guides cross-functional compliance decisions, manages suppliers, and supports audits, regulatory inspections, technology transfers, and commercial readiness.

Designs and analyzes small-scale upstream process studies for AAV and plasmid manufacturing. Supports preclinical and clinical manufacturing across upstream, downstream, fill-finish, and drug-device processes; facilitates technology transfers to internal and external GMP sites; provides on-site manufacturing support; and develops tools for technology-transfer workflows. Requires expertise in cell culture, single-use bioreactors, cGMP, process sciences, and preferably gene therapy processes.

Lead Site Quality Assurance for a clinical manufacturing facility, overseeing CGMP compliance, quality operations, batch disposition, investigations, CAPA, change control, validation, regulatory inspections, supply chain quality, environmental monitoring, and data integrity. Build and mentor the local QA team, provide quality oversight for AAV and gene therapy manufacturing, support regulatory filings, and drive risk-based decisions and continuous improvement.