Specialist, Logistics and Customs Compliance

Specialist, Logistics and Customs Compliance

Lexington, MA

Kiniksa Pharmaceuticals is a commercial‑stage biopharmaceutical company developing and commercializing novel therapies for diseases with unmet need, with a focus on cardiovascular indications. With deep expertise in immunology and inflammation, Kiniksa is advancing a growing portfolio of approved and investigational medicines, anchored by its lead product, ARCALYST®, the first and only FDA‑approved therapy for recurrent pericarditis. Grounded in rigorous science and bold innovation, the company fosters a highly collaborative, patient‑first culture led by accomplished life sciences leaders.

At Kiniksa, talented individuals are trusted and empowered to make a real impact—shaping the future of medicine while improving the lives of patients who need it most.

Reporting to the Manager, Supply Chain Operations, the Specialist, Logistics and Customs Compliance will be responsible for supporting global logistics, storage, and customs compliance activities across Kiniksa’s clinical, commercial, and research supply chains. This role will execute and support domestic and international shipments of temperature‑controlled, GMP pharmaceutical materials, while ensuring shipment documentation, customs entries, product classifications, broker interactions, and import/export records are managed accurately and in accordance with applicable regulatory requirements and internal procedures.

The successful candidate will be detail‑oriented, collaborative, and comfortable working in a fast‑paced, highly regulated environment where shipment accuracy, compliance, and timely execution are critical to patient supply and programme delivery.

This role is based in our Lexington, MA office and requires employees to be onsite five days per week.

(including, but not limited to)

• Execute and/or oversee domestic and international shipments of temperature‑controlled GMP pharmaceutical materials, including raw materials, drug substance, drug product, samples, finished goods, and other materials as required.
• Work closely with internal stakeholders and external partners, including contract manufacturing/development organisations, transportation providers, customs brokers, and contract warehouses, to ensure on‑time shipment execution and delivery.
• Generate and/or review required shipping documentation, including shipment request forms, notifications of incoming shipments, packing lists, commercial invoices, Shipper’s Letters of Instruction, FDA/USDA statements, end‑use letters, and other import/export documentation.
• Classify commodities using HTS/HS codes and maintain accurate product classification master data in alignment with approved classifications and internal procedures.
• Support compliance with applicable U.S. and global regulations, including FDA, CBP, TSA, USDA/APHIS, IATA, EU/UK customs, and other relevant import/export requirements.
• Coordinate with customs brokers and transportation providers to address customs holds, PGA flags, post‑entry corrections, documentation discrepancies, and other shipment exceptions.
• Maintain accurate import/export records and support record retention in line with regulatory requirements and internal policies, including appropriate storage of customs and shipment documentation.
• Maintain appropriate permits, licences, and trade compliance documentation required to facilitate compliant movement of Kiniksa materials and products.
• Schedule and monitor shipments with carriers, provide timely shipment status updates, resolve in‑transit issues, and obtain proof of delivery and temperature data as required.
• Document and support investigations of temperature excursions, shipment deviations, and logistics or compliance events in…