Senior Specialist, Cell Therapy Trade Compliance (FTZ)

Responsibilities

• Lead FTZ operations and compliance in accordance with 19 CFR Part 146, managing admissions, status elections, and annual reconciliations.
• Ensure compliant storage and movement of patient-specific materials and critical raw materials with high traceability and documentation accuracy.
• Maintain accurate FTZ inventory records, support cycle counts, and ensure audit-ready documentation and access controls.
• Coordinate import execution by reviewing documentation for HTS classification, valuation, and FDA/CBER requirements in partnership with customs brokers.
• Manage outbound FTZ shipment execution for intermediates and finished products to ensure timely and accurate customs processes.
• Partner cross-functionally with Manufacturing, Quality, and Supply Chain teams to align FTZ activities with manufacturing and patient schedules.
• Monitor KPIs such as inventory accuracy and entry accuracy to identify and implement continuous improvement opportunities.

Requirements

• Bachelor's degree in Supply Chain, International Business, Logistics, Life Sciences, or a related field.
• 5+ years of experience in customs brokerage, import/export operations, trade compliance, or global logistics.
• Hands-on experience with Free Trade Zone (FTZ) or bonded operations.
• Strong working knowledge of 19 CFR Part 146, HTS classification, and customs valuation.
• Experience working in a regulated environment (biopharma, advanced therapies, or temperature-controlled logistics preferred).
• Proficiency in Microsoft Excel and experience with inventory or logistics management systems.
• Strong written and verbal communication skills with the ability to work in a fast-paced, highly controlled environment.

Preferred Qualifications

• Experience supporting cell therapy, biologics, or other highly controlled healthcare logistics.
• Familiarity with GDP, GMP, and GxP documentation practices.
• Experience managing temperature-controlled, cryogenic, or time-sensitive material movements.

About the Company

AstraZeneca is a forward-thinking BioPharmaceutical company dedicated to delivering life-changing medicines. Our Cell Therapy division focuses on building highly coordinated, patient-centered supply chains to deliver complex, personalized therapies globally.