Jobs at Krystal Biotech

Supports quality assurance and document control systems in GMP manufacturing and laboratory environments. Reviews, processes, distributes, archives, and retrieves controlled documents and records; maintains inspection-ready document control rooms; supports audits and regulatory inspections; manages access-control logs and retention schedules; and performs administrative, office organization, shipping, visitor, and front-desk duties for the Astra location.

Administer and maintain GMP training systems and the Learning Management System. Develop and coordinate cGMP, GDP, SOP, and regulatory training; assign and track curricula; maintain accurate training records; monitor completion metrics; support investigations, CAPAs, and inspection readiness; and collaborate with Quality, Manufacturing, QC, Facilities, Supply Chain, and other departments.

Provides statistical leadership across clinical-stage programs, including trial design, endpoint and sample-size planning, analysis, Statistical Analysis Plans, regulatory submissions, clinical study reports, and post-marketing activities. Oversees CRO and vendor deliverables, interprets efficacy and safety data, supports FDA interactions, and ensures compliance with regulatory and clinical research standards.

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.