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 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.

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.

Support QA systems for gene therapy manufacturing: create and maintain GMP documentation, review and approve manufacturing and QC records, update SOPs, support FDA audit readiness, and ensure regulatory compliance and continuous QA improvement.