GMP Shipping and Logistics Specialist

Job Description: GMP Shipping and Logistics Specialist

Overview
Shipping and Logistics Specialist is responsible for coordinating and executing all domestic and international shipping activities for small molecule drug substances and drug product samples between our vendors, including Good Manufacturing Practice (GMP) samples. This role ensures strict adherence to all applicable regulatory requirements (e.g., FDA, EMA, IATA, DOT), maintaining product integrity and a full chain of custody/identity, with a special focus on temperature-controlled shipments.

Responsibilities

• Coordinate and manage all inbound and outbound shipments, both domestically and internationally, ensuring timely and accurate delivery.
• Prepare and verify all required shipping documentation, including commercial invoices, customs documentation, and export declarations, to ensure international trade and customs compliance.
• Maintain records of all shipping conditions, temperature monitoring data, and any deviations to ensure audit readiness and compliance with GMP and GDP (Good Distribution Practice) guidelines.
• Manage the inventory and proper archival or disposal of samples and materials within the GMP warehouse, ensuring accuracy in the ERP/inventory management system.
• Develop and implement Standard Operating Procedures (SOPs) for handling, packaging, and transporting temperature-sensitive and hazardous materials.

Qualifications

• BS or BA in a relevant discipline; an Associate or Bachelor's degree in Supply Chain Management, Logistics, is a plus.
• Minimum of 5 years of experience in a shipping, warehousing, or distribution environment, within the pharmaceutical/biotech industry.
• Hands-on experience managing cold-chain logistics and shipping temperature-sensitive materials.
• Experience with Harmonized Tariff System (HTS) codes for materials
• Familiarity with domestic (DOT, FDA) and international (IATA, customs) shipping regulations, especially those pertaining to GMP/GDP compliance.