Senior Specialist, Cell Therapy Trade Compliance

Senior Specialist, Cell Therapy Trade Compliance

Location: Gaithersburg, MD or Santa Monica, CA

Introduction to role:

In AstraZeneca's Cell Therapy division, we follow the science to explore and innovate. We are working toward treating, preventing, modifying, and even curing some of the world's most complex diseases. We have the potential to grow our pipeline and positively impact the lives of patients worldwide. Our commitment to making a difference is driven by our passion for science. Now, we are fusing data and technology with the latest scientific innovations to achieve the next wave of breakthroughs. This role is part of the Cell Therapy Supply Chain team, tasked with developing critical cell therapy trade compliance framework and processes to support ex-US patient enrollment across AstraZeneca clinical trials.

We are looking for a Sr. Specialist, Cell Therapy Trade Compliance to join our team. Reporting directly to the Director, Cell Therapy Patient Logistics, the Sr. Specialist will establish the cell therapy trade compliance framework used in cell therapy trials. This position ensures seamless compliance with global shipment requirements to optimize Clinical Logistics performance. The ideal candidate will have a strong background in biopharma trade compliance coupled with logistics to support ex-US operational readiness activities. This role requires collaboration with cross-functional teams to accomplish such objectives.

Accountabilities:

Key Responsibilities:

• Global Trade Compliance & Regulatory Oversight (Primary Focus)
  • Support documentation for import/export and chain of identity/chain of custody (CoI/CoC).
  • Ensure shipments comply with international trade regulations (GxP, GDP, GCP, GMP, IATA, DOT, Customs requirements, etc.).
  • Ensure accurate documentation (Customs invoice, customs letters/statements, import/export permits, shipping records).
  • Manage permits, licenses, approvals, FDA, EMA, Harmonized Tariff Schedules (HTS) codes, incoterms, customs valuation (VAT), country of origin rules, Export Control Classification Number (ECCN), free-trade zones/free-trade agreements.
  • Liaise with customs brokers, logistics service providers (LSPs), airline carriers, and government agencies to resolve compliance issues related to customs clearance delays.
  • Define and implement packaging and labeling requirements for apheresis material & IMP.
  • Communicate trade compliance risks, propose mitigations, and work with both operational and strategic-level cell therapy staff for resolution development.
  • Identify importer/exporter of record and buyer/seller for each country involved in the cell therapy portfolio.
  • Outline process improvements to strategic leadership.
  • Develop and maintain SOPs and business procedures for cell therapy trade compliance.
  • Develop educational materials, including checklists, work instructions, slide decks, training videos, and other resources for internal and external training related to cell therapy trade compliance.
  • Collaborate with Finance to assess valuation accurately for apheresis & IMP.
  • Support internal/external audits as needed.
  • Promote a culture of collaboration, cooperation, cross-functional inclusion, and execution excellence to foster a high-performing team.
  • Other responsibilities as needed.

Essential Skills/Experience:

• BS/BA or equivalent in Supply Chain, Life Sciences, Business with 5+ years of Cell Therapy Logistics/Clinical Supply Chain experience within the pharmaceutical or biotech industry.
• Certifications in trade compliance.
• Customs broker license preferred.
• Knowledgeable in import and exports from regions such as US, EU/UK, and APAC, including China, Japan, & Australia
• Strong experience with applications such as Cold Chain Logistics, 3PL management, Clinical and Commercial logistics, Cell & Gene Therapies.
• Proficiency in systems such as SAP/Oracle, Power BI/Tableau, Smartsheet, Cell orchestration platforms, and Intermediate/Advanced Excel (Pivot tables, macros).
• Stakeholder management – Comfortable working with finance, clinical, manufacturing, quality, trade compliance, and regulatory teams.
• Ability to communicate and build relationships with a broad spectrum of audiences at all organizational levels.
• Strong analytical skills to develop solutions to complex problems.
• Ability to work independently and collaboratively to achieve primary objectives.
• Serve as the primary contact on projects or business processes.
• Excellent interpersonal and collaboration skills.
• Outstanding organizational skills with the ability to multi-task and prioritize activities.
• Comfortable in