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.

Coordinate end-to-end finished-product logistics for temperature-controlled pharmaceutical shipments, managing cold chain and specialty couriers, preparing global export documentation, liaising with 3PLs, resolving logistics exceptions, supporting GMP/GDP compliance, monitoring serialization alerts, and tracking performance and invoices.

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.

Lead troubleshooting and optimization of GMP upstream manufacturing processes by integrating process engineering, automation, and data analytics. Serve as technical liaison between Manufacturing, Automation, and Facilities to support equipment qualification, process validation, control systems (PLCs/HMIs/SCADA), predictive maintenance, batch records, and continuous improvement initiatives.

Lead commercial analytics for rare disease products by translating strategy into KPIs and dashboards, synthesizing diverse datasets into executive insights, monitoring performance, enabling launch readiness, establishing data governance, and partnering cross-functionally with Commercial, Finance, Market Access, and Patient Services to optimize access and patient experience.

Lead clinical development from late preclinical through Phase 1-3 and post-approval, manage trial design and execution, regulatory interactions (IND/BLA/MAA), medical monitoring and safety, collaborate cross-functionally and with KOLs, support recruitment, publications, and commercialization activities.

Lead design, execution, and oversight of Phase I-III clinical trials for gene therapy programs. Manage protocol development, site selection, CRO and investigator relationships, regulatory interactions, patient recruitment strategy, data review, budgets, and cross-functional collaboration. Provide clinical and scientific guidance, prepare regulatory/study documents, and mentor clinical research staff.

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.

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.