Shipping and Receiving Specialist (RLT)

Breadth of Responsibilities

• Prepare and review all shipping documentation, including Bills of Lading (BOL), Dangerous Goods Declarations (DGD), air waybills, and radioactive labeling (e.g., UN2915), ensuring full regulatory compliance (DOT/IATA).
• Package and label Type A shipments, including proper application of radioactive labels, overpack markings, and all applicable labels in accordance with regulatory standards.
• Cookinate time-critical shipments, ensuring alignment with production, dosing schedules, and clinical site requirements.
• Communicate proactively with couriers and logistics providers to ensure proper handling, routing, and on-time delivery.
• Monitor and facilitate customs clearance and regulatory release (e.g., FDA) for international shipments, as needed.
• Schedule and coordinate transportation, including internal drivers and third-party logistics providers.
• Support cross-functional teams (CMC, TechOps) with packaging and shipping activities, including pre-clinical work, clinical doses, technical samples, and materials.
• Track shipments in real time and provide status updates, including proof of delivery and exception management.
• Ensure shipments meet required temperature control and packaging standards, when applicable.
• Maintain inventory of shipping materials, including Type A packaging, overpacks, labels, and temperature monitoring devices.
• Partner with Quality Assurance to receive incoming materials, including radioactive isotopes and GMP materials, to ensure timely material review and release, in accordance with established procedures.
• Order materials through the internal ordering system as needed to support operational and production requirements and ensure adequate stock levels are maintained to prevent supply disruptions.
• Accurately log and manage materials/inventory records, including receipts, usage and stock levels, to ensure full traceability and compliance with GMP and regulatory requirements.
• Perform routine inventory audits and cycle counts to ensure alignment between physical and system inventory.
• Analyze inventory and shipping data to identify trends, discrepancies, and process improvement opportunities.
• Support the routine maintenance of the manufacturing facility.
• Support production activities by participating in transferring materials into production suite as needed.
• Ensure compliance with all applicable procedures, SOPs, Radiation safety, Mariana Policies, QMS, and GMP guidelines during handling and shipping activities.

Requirements/Skills

• Minimum of 2 years of experience in shipping, receiving, or logistics operations.
• Associate degree or equivalent experience preferred.
• Experience in a pharmaceutical, biotech, or GMP-regulated environment preferred; radiopharmaceutical experience strongly preferred.
• Working knowledge of hazardous materials shipping regulations (DOT/IATA) required; radioactive material shipping experience (Class 7) is a plus.
• Experience handling time-sensitive or clinical shipments is highly desirable.
• Strong attention to detail and commitment to compliance and safety.
• Ability to manage multiple priorities in a fast-paced, deadline-driven environment.
• Strong communication and coordination skills across internal and external stakeholders.
• Commitment to maintain data integrity through strict adherence to standardized procedures and relevant compliance requirements.
• Team-oriented mindset with no job too big or too small.
• Physical requirements include ability to lift 25+ pounds.