Specialist, Logistics and Customs Compliance

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.

Additional information

Compensation decisions are based on objective criteria including role responsibilities, experience/qualifications, internal equity, geographic location, and external market benchmarks.

Pay Range $70,000—$90,000 USD

Kiniksa does not accept unsolicited resumes from staffing agencies or search firms. Any resumes submitted without a signed agreement will be considered property of Kiniksa, and no fees will be paid.