Teams at Corcept Therapeutics

Provide strategic leadership of Quality Control and stability programs, oversee external contract lab studies, review and trend stability data, address OOS/OOT results with cross-functional teams, author stability/regulatory sections, support analytical method validation and batch analysis, and expand QC capabilities and infrastructure.

Support global pharmacokinetics (PK) and bioanalytical operations by tracking clinical PK samples and shipments, coordinating logistics with clinical operations and vendors, managing long-term storage, preparing PK reports, archiving temperature recorder data into the TMF, and assisting with SOPs and cross-functional communication to ensure regulatory and quality requirements are met.

Support analytical development for drug substance and product at CMOs: review development/manufacturing documents and raw data, assist with regulatory filing sections, draft SOPs, archive documents in Veeva, and provide administrative support for analytical development and QC activities.