Shipping and Receiving Specialist; RLT

Position: Shipping and Receiving Specialist (RLT)
Reporting:

Associate Director, Supply Chain and Logistics

Description:

We are seeking an experienced Shipping & Receiving Specialist (Radiopharmaceuticals) to join Mariana's Technical Operations organization, advancing personalized medicine and radiopharmaceuticals. This person is responsible for receiving, coordinating and executing the shipment of radiopharmaceutical materials in a highly regulated environment. This role ensures the safe, compliant, and timely movement of radioactive and non-radioactive materials to clinical sites, vendors, and internal stakeholders.

The ideal candidate will have experience in GMP and/or radiopharmaceutical logistics, with a strong understanding of time-sensitive shipments, regulatory requirements, and inventory control.

This is an on-site role and may require occasional after-hours support based on business needs and shipment schedules.

Illustrative 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.

* Coordinate 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, Tech Ops) 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.

* Identify and implement optimal storage and handling solutions for radioactive and non-radioactive materials.

* Analyze inventory and shipping data to identify trends, discrepancies, and process improvement opportunities.

* Participate in waste management, adhering to proper waste stream requirements and safety regulations.

* 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…