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Senior Specialist, Cell Therapy Trade Compliance (FTZ)

AstraZeneca

MD, Gaithersburg | US – Tarzana – CA, US$89k – $134konsite

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About this role

At  AstraZeneca Cell Therapy , we are building the capabilities required to deliver complex, personalized therapies through a highly coordinated, patient-centered, and globally scalable supply chain. In cell therapy, every movement matters. The reliable and compliant flow of patient materials, critical manufacturing inputs, intermediates, and finished product is essential to protecting product integrity, supporting manufacturing continuity, and helping therapies reach patients on time.  

The  Senior Specialist, Cell Therapy Trade Compliance – Free Trade Zone Operations   plays a critical role in that mission by leading Free Trade Zone (FTZ) operations  at AstraZeneca’s cell therapy manufacturing sites . This role helps ensure materials can move compliantly, predictably, and with full traceability through import/export and FTZ processes, while maintaining strong inventory control, audit readiness, and alignment to vein-to-vein timelines and manufacturing schedules.   This is an opportunity to work at the intersection of trade compliance, cell therapy logistics , and patient-centered operations, helping build the cross-border capabilities needed to support future growth and the next generation of personalized medicines.  

You will be responsible for the day-to-day operation of FTZ activities that support the compliant movement and control of materials across the cell therapy network. You will work closely with Manufacturing, Supply Chain, Logistics, Quality, brokers, and external partners to ensure high execution quality, strong documentation practices, and reliable support for time-critical operations.  

Key Responsibilities  

• Lead FTZ operations and compliance:   Manage FTZ execution in line with  19 CFR Part 146 (Foreign Trade Zones) , internal procedures, and site requirements, including admissions, status elections, zone-to-zone transfers, removals, exports, weekly entries, and annual reconciliation activities.    

• Support compliant material controls: Help ensure FTZ- compliant storage and movement of  patient-specific materials and critical raw materials with strong attention to traceability, segregation, documentation accuracy, and operational control.

• ​ Maintain Inventory, control and audit-ready records: Operate and maintain accurate FTZ inventory records within approved systems, support cycle counts and reconciliations, and ensure documentation is complete and compliance , and manage access controls .  

• Coordinate import execution and broker activities: Review and support import documentation and entry activities, including alignment to HTS classification, valuation, origin, and FDA/CBER import requirements , while partnering with customs brokers and internal stakeholders to resolve issues quickly and compliantly.  

• Support outbound FTZ shipment execution: Coordinate outbound movements from the FTZ for intermediates and finished product, ensuring documentation, customs processes, and shipment controls are completed accurately and on time.  

• Partner cross-functionally to support patient and manufacturing timelines: Work closely with  Manufacturing, Quality, Supply Chain to align FTZ activities with batch release and patient schedules .  

• Track performance and identify improvement opportunities: Monitor KPIs such as inventory accuracy, admission cycle time, entry accuracy, customs holds , and exception trends, and support root cause analysis and corrective actions that improve reliability, compliance, and operational efficiency.  

• Maintain procedures and support training: Help develop and maintain SOPs, work instructions, and role-based training materials for FTZ and import/export processes, while supporting knowledge sharing and consistent execution across the network.  

Essential Qualifications   • Bachelor’s degree in  Supply Chain, International Business, Logistics, Life Sciences , or a related field .  

• 5+ Years e xperience in  customs brokerage, import/export operations, trade compliance, or global logistics , including hands-on experience with  FTZ or bonded operations .  

• Strong working knowledge of  FTZ operations, customs documentation, broker coordination, and import/export execution .  

• Familiarity with  19 CFR Part 146 ,  HTS classification ,  customs valuation , and  FDA/CBER import requirements .  

• Experience working in a  regulated environment ; experience in  biopharma, advanced therapies, or temperature-controlled logistics  is preferred.  

• Experience maintaining accurate records, supporting audits or inspections, and working within controlled systems and documented procedures.  

• Attention to detail, ability to manage multiple priorities, and comfort working in a fast-paced and highly controlled operational environment.  

• Strong written and verbal communication skills, with the ability to work effectively across internal teams and external partners.  

• Proficiency in    Excel  and familiarity with  inventory systems, broker portals, or logistics/trade systems .    

Desirable Skills / Experience • Experience supporting  cell therapy, biologics, advanced therapies, or other highly controlled healthcare logistics  environments.  

• Familiarity with  GDP, GMP, GxP , and documentation practices relevant to regulated logistics and trade operations.  

• Experience supporting  temperature-controlled, cryogenic, or time-sensitive material movements .  

• Experience with operational reporting, KPI tracking, and continuous improvement activities.  

#CellTherapy The annual base pay for this position ranges from $89K to $134K. Our positions offer eligibility for various incentives—an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans. 

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