Logistics & Cold Chain Specialist II

RoslinCT US•Hopkinton, MA

9d•$65,000 - $98,000

About The Position

The Logistics & Cold Chain Specialist is responsible for executing and coordinating cryogenic logistics and supporting GMP warehousing and materials management operations, including inventory management, Fresh LP receiving, Cryogenic donor material receiving, product transfers, and finished product pack-out and shipments. This role ensures product integrity, traceability, chain of custody, chain of identity (COC/COI) and GMP/GDP compliance while independently resolving operational issues and supporting continuous improvement. The Specialist serves as a key resource for cross-functional teams and provides guidance to Associates on logistics, cold-chain, and cryogenic operations.

Requirements

A highly organized work style that ensures timely execution of tasks.
A mindset that ensures accurate results.
Proficiency in Microsoft Office Suite (Excel, Word, PowerPoint).
GMP Cold chain experience
Effective problem-solving capabilities.
Strong oral and written communication skills.
High school diploma or GED required.
5+ years of experience in GMP warehouse, logistics, materials management, supply chain operations or pharmaceutical/biotech operations.
Hands-on experience with cryogenic storage, material transfers, inventory management, and cold-chain operations; cell and gene therapy experience required.
Strong working knowledge of GMP/GDP, data integrity, chain of custody, and product traceability requirements.
Experience with GMP fresh and frozen donor material receipts, inventory reconciliation, finished-product pack-out, temperature-controlled shipping, and shipment documentation.
Experience supporting deviations, CAPAs, change controls, investigations, SOPs, and continuous improvement initiatives.
Proficiency with ERP, inventory management, warehouse management, or other electronic systems used to maintain controlled records.
Ability to independently identify, investigate, and resolve inventory, documentation, equipment, and operational issues.
Strong cross-functional collaboration skills with QA, QC, Manufacturing, Supply Chain, Facilities, and Logistics.
Highly organized, detail-oriented, and safety-focused with strong written and verbal communication skills.
Flexibility and willingness to adjust working hours or shifts to meet evolving business needs.

Nice To Haves

College degree in Life Sciences, Supply Chain, or related field a plus.
Preferred CMO experience.

Responsibilities

Manage cryogenic inventory, including inventory transactions, location tracking, container identification, reconciliation, and product status management.
Coordinate and execute cryogenic material and product transfers between storage locations, manufacturing areas, and controlled environments.
Lead and execute fresh patient/donor material receipts and perform COC/COI verifications for autologous products.
Lead and execute cryogenic donor material receipts and perform COC/COI verifications.
Lead and execute product pack-out and shipment activities, ensuring appropriate packaging, labeling, documentation, temperature control, and COC/COI.
Perform picklist for production staging that supports the production forecast.
Support inventory reconciliation and cycle-count activities, investigate discrepancies, and coordinate resolution with Supply Chain, QA, QC, Manufacturing, and Logistics.
Support GMP warehouse operations including receipt, inspection, identification, labeling, storage, picking, staging, and issuance of GMP materials and consumables as needed.
Review inventory, shipping, and logistics documentation for accuracy, completeness, and GMP/GDP compliance.
Support investigations, deviations, CAPAs, change controls, SOP revisions, and continuous improvement initiatives related to logistics and cold-chain operations.
Partners with Facilities and other teams to identify and resolve equipment, storage, and operational issues.
Serve as a knowledgeable resource for safe, compliant, and efficient cryogenic and cold-chain operations.