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 a fast-paced, dynamic, and fluid company environment, able to adjust workload based on changing priorities.

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

AstraZeneca offers an environment where you can break new ground and leave a lasting legacy. As part of our team, you'll have the opportunity to evolve supply chain processes, reimagine strategies, and contribute to sustainable lifecycle management. We are committed to doing things the right way, fostering a safe space for innovation and collaboration. Our diverse, multigenerational team connects science with business needs, driving manufacturing excellence and delivering life-changing medicines to patients.

Ready to make an impact? Apply now and join us in shaping the future of medicine!

The annual base pay for this position ranges from $85,012 to $127,518. Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience.  In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

Date Posted

22-Jul-2025

Closing Date

Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.