Senior Specialist, Cell Therapy Trade Compliance (FTZ)
$89,000–$134,000 year
On-siteGaithersburg, Maryland, United States
Job Summary
Manage Free Trade Zone (FTZ) operations and compliance for cell therapy manufacturing sites, overseeing admissions, zone-to-zone transfers, removals, exports, and weekly entries in accordance with 19 CFR Part 146. Maintain accurate inventory records, support cycle counts, and ensure documentation accuracy for patient-specific materials and critical raw materials while coordinating with brokers on import execution and outbound shipment controls. Partner cross-functionally with Manufacturing, Quality, and Supply Chain to align FTZ activities with batch release schedules and patient timelines, monitoring KPIs such as inventory accuracy and admission cycle time to drive operational efficiency.
Required 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
- 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 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
Desired Qualifications
- 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
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