Tr1X Benefits Overview

Leads hands-on LNP formulation and process development for mRNA delivery and targeted LNP systems supporting an in vivo CAR-Treg platform. Optimizes formulations, mixing, purification, analytical characterization, stability, and biological performance. Develops scalable research processes, interprets formulation and in vivo data, supports CDMO technology transfer, prepares IND-enabling documentation, and defines long-term manufacturability strategy in collaboration with biology, manufacturing, and external partners.

Lead and build the quality organization for a clinical-stage cell therapy company, overseeing GxP quality systems, audits, regulatory compliance (FDA/EMA/ICH), clinical quality, vendor oversight, metrics, and continuous improvement. Partner cross-functionally with clinical and manufacturing teams, represent the company to regulators and external partners, and manage budgeting, staffing, and strategic quality initiatives to ensure product integrity and patient safety.