Senior Specialist, Cell Therapy Trade Compliance (FTZ)

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 experience 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.