Jobs at LEXEO Therapeutics

Supports analytical development for AAV-based gene therapy programs by performing routine PCR-based, ELISA, and cell-based assays; maintaining cell cultures; preparing reagents; documenting and analyzing data; managing laboratory supplies; and communicating findings and assay risks to scientists. The role also assists with protocol interpretation, assay troubleshooting, laboratory organization, and cross-functional research activities.

Scientist II leading analytical development for AAV gene therapy programs. Designs, optimizes, qualifies, validates, and transfers cell-based potency and molecular assays, including qPCR and ddPCR. Generates and interprets data supporting GMP manufacturing, material release, regulatory submissions, and QC activities. Troubleshoots assay performance, manages technical risks, prepares reports and protocols, collaborates with CMC, Quality, CROs, and CDMOs, and provides scientific guidance across project teams.

Leads CMC Quality Control oversight for gene therapy programs, including external laboratory management, analytical method lifecycle activities, stability and release testing, investigations, specifications, reference standards, comparability, and regulatory submissions. Partners with Analytical Development, Technical Operations, Regulatory Affairs, Quality Assurance, and external vendors to support clinical development, process validation, and commercial readiness. Coordinates sample submissions, shipments, and testing activities while ensuring cGMP and global regulatory compliance.

Lead hands-on development, optimization, and scale-up of AAV manufacturing using Sf9/baculovirus and HEK systems. Drive process characterization, technology transfer, control strategy development, regulatory documentation, troubleshooting, and cross-functional collaboration to support clinical and late-stage CMC deliverables and mentor junior staff.

Lead and operationally oversee the Quality Management System, document control, and training functions. Serve as eQMS business owner (ZenQMS), manage SOP lifecycle, ensure GxP compliance, support audits/inspections, develop quality metrics, and partner cross-functionally. Mentor quality systems staff and drive continuous improvement across quality documentation and training programs to support gene therapy development and commercialization.