Travere Therapeutics Benefits Overview

Lead analytical method development, validation, specification setting, and transfer with CROs/CMOs for small molecule drug substances and products. Provide technical leadership, troubleshoot OOS/OOT, oversee IPC/release testing and impurity characterization, prepare regulatory analytical submission content, and ensure cGMP and international regulatory compliance while supporting cross-functional project teams.

Lead execution of CMC strategies for biologics, develop integrated project plans, manage risks and cross-functional alignment, support manufacturing, regulatory and supply readiness through clinical development and commercialization.

Lead Quality Control activities to ensure GMP and regulatory compliance for drug substance and drug product. Oversee specifications, batch release, stability programs, method transfers, OOS/OOT investigations, vendor audits, and support CMC/regulatory submissions and comparability assessments in collaboration with Analytical, CMC, QA, and CMOs.