Senior Specialist, Cell Therapy Trade Compliance (FTZ)

AstraZeneca

California (MD)

On-site

USD 89,000 - 134,000

Full time

10 days ago

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Benefits offered by this job

Short-term incentive bonuses
Equity-based awards
Health, dental, and vision coverage
Paid time off

Job summary

AstraZeneca Cell Therapy is seeking a Senior Specialist to lead FTZ operations across its cell therapy network, ensuring compliant movement of materials with strong traceability and audit readiness. You will partner with Manufacturing, Quality, Supply Chain, and external brokers to keep timelines and compliance aligned.

Experience in FTZ or bonded operations, 19 CFR Part 146 familiarity, and knowledge of HTS classifications and FDA/CBER import requirements are essential.

Qualifications

  • Bachelor’s degree required in a related field and 5+ years in customs brokerage, import/export, or global logistics.
  • Hands-on FTZ or bonded operations experience with strong documentation practices.
  • Familiarity with HTS classification, FDA/CBER import requirements, and 19 CFR Part 146.
  • Experience in regulated environments such as biopharma or temperature-controlled logistics.

Responsibilities

  • Lead FTZ operations and compliance per 19 CFR Part 146 and site procedures.
  • Manage FTZ admissions, transfers, removals, exports, and annual reconciliations.
  • Ensure FTZ storage, traceability, and documentation accuracy for patient materials and raw materials.
  • Coordinate import documentation, entry activities, and broker interaction to resolve issues.
  • Oversee outbound FTZ shipments with accurate documentation and timing.
  • Align FTZ activities with batch release and patient schedules with cross-functional teams.
  • Monitor KPIs and drive root cause analysis for improvements in reliability and compliance.
  • Develop and maintain SOPs, work instructions, and role-based training for FTZ processes.

Skills

FTZ operations
customs documentation
broker coordination
import/export execution
Part 146 familiarity
regulated environment experience
records and audits
Excel familiarity
inventory systems

Education

Bachelor’s degree in Supply Chain, International Business, Logistics, Life Sciences, or related field

Tools

Excel
Broker portals

Job description

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) operationsat 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 tovein-to-vein timelinesand manufacturing schedules. This is an opportunity to work at the intersection oftrade 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 ofFTZ activitiesthat support the compliant movement and control of materials across the cell therapy network. You will work closely withManufacturing, Supply Chain, Logistics, Quality, brokers, and external partnersto 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 with19 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 ofpatient-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 toHTS 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 withManufacturing, 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 inSupply Chain, International Business, Logistics, Life Sciences, or a related field.
  • 5+ Years experience incustoms brokerage, import/export operations, trade compliance, or global logistics, including hands-on experience withFTZ or bonded operations.
  • Strong working knowledge ofFTZ operations, customs documentation, broker coordination, and import/export execution.
  • Familiarity with19 CFR Part 146,HTS classification,customs valuation, andFDA/CBER import requirements.
  • Experience working in aregulated environment; experience inbiopharma, advanced therapies, or temperature-controlled logisticsis 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 Exceland familiarity withinventory systems, broker portals, or logistics/trade systems.
Desirable Skills / Experience
  • Experience supportingcell therapy, biologics, advanced therapies, or other highly controlled healthcare logisticsenvironments.
  • Familiarity withGDP, GMP, GxP, and documentation practices relevant to regulated logistics and trade operations.
  • Experience supportingtemperature-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.

Date Posted

04-Oct-2026

Closing Date

19-Oct-2026

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.

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