Jobs at Krystal Biotech

Support QA for gene therapy GMP manufacturing: produce and review GMP documentation, maintain quality systems, update SOPs, support FDA audit readiness, and ensure regulatory compliance for cGxP operations.

Lead clinical development from late preclinical through Phase 1-3 and post-approval, manage trial execution, regulatory interactions (IND/BLA/MAA), medical monitoring, data review, KOL engagement, publication strategy, and cross-functional collaboration to advance gene therapy programs to approval and commercialization.

Perform complex analytical testing (finished product and stability) for clinical/commercial release, review and report QC data, support investigations, method validation/transfer, document control, material and equipment management, audit readiness, and other QC projects.

Support and oversee QA functions for cGxP gene therapy manufacturing: produce and maintain GMP documentation, review and approve manufacturing and QC records, update SOPs, ensure regulatory compliance, and support FDA audit readiness.

Support clinical operations by managing clinical supplies, ensuring protocol and regulatory compliance, training and monitoring investigative sites per GCP/ICH, assisting with budgets/invoices, maintaining TMF documentation, reviewing site SOPs, and performing site visits (qualification, initiation, monitoring, closeout). Travel up to 50% during peak periods.