Lead FTZ operations and compliance: Manage FTZ execution in line with 19 CFR Part 146, internal procedures, and site requirements
Support compliant material controls: Help ensure FTZ-compliant storage and movement of patient-specific materials and critical raw materials
Maintain Inventory, control and audit-ready records: Operate and maintain accurate FTZ inventory records, support cycle counts and reconciliations
Coordinate import execution and broker activities: Review and support import documentation and entry activities
Support outbound FTZ shipment execution: Coordinate outbound movements from the FTZ for intermediates and finished products
Partner cross-functionally to support patient and manufacturing timelines: Work closely with Manufacturing, Quality, and Supply Chain
Track performance and identify improvement opportunities: Monitor KPIs and support root cause analysis and corrective actions
Maintain procedures and support training: Help develop and maintain SOPs, and role-based training materials for FTZ

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
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

Senior Specialist, Cell Therapy Trade Compliance – FTZ

Key skills