Shipping and Receiving Specialist (RLT)

Mariana Oncology•Watertown, MA

5d•Onsite

About The Position

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.

Requirements

Minimum of 2 years of experience in shipping, receiving, or logistics operations.
Working knowledge of hazardous materials shipping regulations (DOT/IATA) required.
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.

Nice To Haves

Associate degree or equivalent experience preferred.
Experience in a pharmaceutical, biotech, or GMP-regulated environment preferred.
Radiopharmaceutical experience strongly preferred.
Radioactive material shipping experience (Class 7) is a plus.
Experience handling time-sensitive or clinical shipments is highly desirable.

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, 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.
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.