職位描述
End-to-End Control Tower Job Description for Radioactive Products Tracking
Position Overview
The Control Tower for Radioactive Products ensures seamless, compliant, and safe end-to-end logistics operations for nuclear medicine products. This role focuses on real-time tracking, regulatory adherence, risk mitigation, and cold chain integrity for time-sensitive radioactive shipments. Responsibilities span from order initiation to final delivery, prioritizing safety protocols, regulatory compliance, and rapid escalation for critical incidents.
Core Responsibilities
? 1. End-to-End Shipment Monitoring o Track radioactive pharmaceuticals (e.g., radiopharmaceuticals, isotopes) across all logistics milestones: ? Production & Packaging: Validate compliance with radiation safety protocols (e.g., shielding, labeling).
? ? Customs Clearance: Manage specialized documentation (e.g., IAEA/NRC permits, transport licenses).
? ? Transportation: Monitor carrier adherence to radioactive material transport regulations (e.g., DOT/IATA/ADR guidelines).
? ? Last-Mile Delivery: Ensure timely handover to medical facilities, prioritizing short half-life products.
2. Cold Chain & Radiation Safety Compliance o Verify temperature-controlled logistics (2–8°C or -20°C) using IoT sensors and GPS-enabled devices.
o Monitor radiation exposure levels during transit and trigger alerts for deviations beyond permissible limits.
3. Regulatory & Documentation Management o Maintain records for radioactive material licenses, import/export permits, and emergency response plans.
o Ensure proper labeling (e.g., UN2910/Type A packaging, trefoil symbols) and documentation (e.g., transport index calculations).
4. Risk Management & Incident Response o Identify risks impacting delivery timelines (e.g., customs delays, equipment failures, radiation leaks).
o Activate emergency protocols for incidents (e.g., spillage, temperature excursions) and coordinate with safety officers.
o Collaborate with nuclear pharmacies, carriers, regulatory bodies (e.g., FDA, IAEA), and healthcare providers.
o Provide real-time updates to hospitals on shipment ETAs, especially for time-critical isotopes (e.g., Tc-99m).
o Input data into specialized TMS platforms (e.g., CGTM, Cryoport) for end-to-end visibility.
o Generate compliance reports for audits (e.g., radiation safety, cold chain integrity).
5. Stakeholder Coordination
6. System & Data Integration
Key Focus Areas
1. Radiation Safety & Compliance o Strict adherence to international/national regulations (e.g., IAEA SSR-6, 49 CFR §173).
o Proactive monitoring of transport equipment (e.g., lead containers, dry shippers) for integrity.
2. Cold Chain Integrity o Real-time tracking of temperature, humidity, and shock/vibration during transit.
o Validate backup power systems for temperature-controlled vehicles.
3. Timeliness & Product Viability o Prioritize shipments based on isotope half-life (e.g., F-18: ~110 minutes).
o Optimize routes to minimize transit time while complying with radiation exposure limits.
4. Incident Preparedness o Conduct drills for spill containment, radiation leak response, and product recalls.
o Maintain 24/7 escalation pathways for emergencies involving radioactive materials.
Qualifications
? Education: Degree in Nuclear Science, Logistics, or Regulatory Affairs preferred.
? Certifications: o Transport of Radioactive Materials (e.g., DOT/IATA certification).
o Radiation Safety Officer (RSO) training is a plus.
? Experience: o 3+ years in pharmaceutical logistics, preferably with radioactive/hazardous materials.
o Familiarity with cold chain management and IoT tracking tools (e.g., Logmore, Controlant).
? Technical Skills: o Proficiency in TMS platforms and radiation monitoring software (e.g., RadSafe).
o Knowledge of regulatory frameworks (e.g., IAEA, NRC, EU Directive 2013/59/Euratom).
? Soft Skills: Crisis management, attention to detail, cross-functional communication.
Performance Metrics (KPIs)
? On-Time Delivery Rate: ≥99% for short half-life isotopes (e.g., Tc-99m).
? Regulatory Compliance Rate: 100% adherence to radiation safety standards.
? Incident Response Time: ≤30 minutes for critical alerts (e.g., temperature breaches).
? Documentation Accuracy: Zero errors in transport permits or radiation exposure reports.
Note: This role requires balancing operational efficiency with safety-critical protocols to ensure life-saving nuclear medicines reach patients safely and on time.