Specialist, Logistics and Customs Compliance

The posting, as Kiniksa Pharmaceuticals wrote it

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.

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, pos

[…]
oms/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.

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 is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, transgender status, age, genetics, national origin, protected veteran status, or disability status, or any other legally protected category. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

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.