Krystal Biotech Benefits Overview

Supports upstream process development for viral vector production by operating bench-scale bioreactors, performing mammalian cell culture, preparing media and buffers, designing experiments, analyzing data, maintaining equipment, and supporting scale-up and technology transfer to manufacturing. The role collaborates with manufacturing and MSAT teams, documents work in electronic lab notebooks, troubleshoots laboratory issues, and communicates findings to the process development team.

Supports quality systems and GMP manufacturing at a gene therapy facility. Responsibilities include preparing and updating manufacturing documentation, reviewing and approving manufacturing and quality control records, supporting SOP updates, ensuring cGXP compliance, assisting with FDA audit readiness, and driving continuous improvement of QA and compliance functions.

Perform complex analytical testing (finished product and stability) for clinical and commercial drug release; review data, support investigations (deviations, CAPA, CR), execute method validation/transfer, maintain QC documentation/equipment, manage materials, participate in audits, and keep QC labs audit-ready.