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.

Responsibilities (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 accordance with internal procedures and external partner requirements.
• Work with warehouse partners to support accurate inventory set-up, storage, reconciliation, and timely inventory reporting across external storage locations.
• Request transportation and storage quotes, support purchase order and accrual processes, review invoices, and work with logistics providers to resolve billing or service exceptions.
• Support logistics provider relationship management, including KPI tracking, business review preparation, broker performance monitoring, and continuous improvement activities.
• Follow and support development of SOPs, work instructions, training materials, and process improvements related to logistics, storage, and trade compliance.
• Support selection of appropriate shipping containers, temperature monitors, and transport solutions for temperature-controlled products, including transport validation or qualification activities as required.
• Participate in logistics assessments for new product introductions, internal and external audits, regulatory inspections, root cause analysis, CAPAs, and scaling activities as the organisation grows.

Standout Skills for Impact:

• Experience managing time- and temperature-sensitive shipments in a regulated pharmaceutical, biotechnology, or life sciences environment.
• Working knowledge of customs documentation, HTS/HS classification, incoterms, customs valuation, country of origin requirements, and import/export recordkeeping.
• Ability to communicate effectively with customs brokers, freight forwarders, transportation providers, government agencies, internal stakeholders, and external manufacturing/storage partners.
• Strong organizational skills, attention to detail, and ability to prioritize multiple shipments, documentation reviews, and compliance tasks in a fast-paced environment.
• Demonstrated problem-solving skills and sound judgement when resolving shipment delays, customs questions, documentation discrepancies, or temperature-controlled logistics issues.
• Experience with ERP systems, SAP, shipping systems, inventory management tools, or customs/broker platforms preferred.

Qualifications and Experience:

• Bachelor’s degree in Logistics, Supply Chain, Life Sciences, Business, or a related field.
• 1–3 years of international logistics and/or customs compliance experience in the biotechnology, pharmaceutical, or life sciences industry.
• Experience shipping temperature-controlled products, including controlled room temperature, 2–8°C, dry ice, and/or cryogenic shipments.
• Experience working with third-party logistics providers, customs brokers, transportation partners, contract manufacturers, and external warehouses.
• Working knowledge of import/export regulations and customs compliance requirements related to pharmaceutical products.
• Familiarity with HTS classification, incoterms, IATA requirements, FDA/CBP processes, and GDP/GMP expectations preferred.
• Industry certifications such as IATA Dangerous Goods, Customs Broker License, GDP/GMP training, or related trade compliance training preferred but not required.