Transportation & Cold Chain Specialist – Bluebird Bio – Cambridge, MA, USA
Join bluebird bio’s enthusiastic and collaborative team by contributing to the overall success of our novel gene therapy approach. We are currently looking for a Transportation & Cold Chain Specialist to manage the daily activities related to transportation of our products. He/she is responsible for movement of products throughout the Supply Chain and will act as the liaison with both internal and external customers/vendors. In addition, the Transportation & Cold Chain Specialist is responsible for improving upon existing procedures/processes (SOP’s, work instructions) ensuring compliance with GDP, GMP and country specific requirements improving the overall quality and efficiency of the supply chain. The objective of the Transportation & Cold Chain Specialist is to ensure desired customer service levels are met and to ensure continuous product supply.
About the Role:
Supervise and control transportation related activities for bluebird bio ensuring continued conformance with GMP, IATA, DOT regulations
Daily cross functional interaction with Logistics Partners/Providers, Contract Manufacturing Organizations and bluebird bio’s functions as it relates to coordination of shipments and product availability; all to ensure timely and continuous product supply
Prepare and review shipping documentation and customs invoices for accuracy including valuation, commodity classification, and country of origin
Ensure all product flow meets international trade compliance requirements and that document controls are in place to support full trade compliance.
Ensure appropriate records retention to support global trade compliance requirements
Responsible for compliance and execution of all quality systems related Transportation & Cold Chain (i.e. deviations and CAPA’s)
Improve upon area related SOP’s and work instructions ensuring compliance with GDP’s, cGMP’s, and country specific regulations
Responsible for identifying local/global solutions for controlling movement of temperature sensitive material while in transit from Clinical sites to manufacturing sites through to final receipt at Clinical site
Direct Transportation/Logistics and Cold Chain vendors in day to day operations, supplier relations and invoicing
Support in training of Clinical Sites, CMO’s and bluebird bio’s partners on how to execute shipment of bluebird bio related products (including pack-out of shipping system activation of temperature monitoring devices etc.)
Support the maintenance of metrics on Cold Chain, transportation/Logistics operations
About You:
BS/MS degree in Supply Chain Management, Business or related field
3+ years of relevant Supply Chain Management/Logistics/Cold Chain Management experience, which includes 1+ years within the Biotech/Pharmaceutical Industry
Good working knowledge of trade and commerce regulations and practice as well as documentation requirements for both domestic and international transportation
Experience in a GMP environment desirable
Experience working with CMOs desirable
Proactive in approach to work, identifying potential issues well in advance and bringing them to the attention of appropriate personnel for resolution
Excellent MS Office and MS Project skills
Ability to work on multiple projects simultaneously
Effective analytical skills with demonstrated success in problem solving
Customs broker’s license highly preferred
Good communication, organizational, and customer service skills are a necessity
Working knowledge of current GMP/GCP regulations
Ability to work effectively in a collaborative team environment where results are achieved through influence and the incorporation of multiple points of view
Self-motivated, detailed oriented and energized in approach to work
Ability to work independently and thrive in a fast-paced environment
Excellent organizational skills, sufficient to multi-task in an extremely fast-paced environment with changing priorities.
Excellent communication skills and ability to influence across multiple functions.
Be ready to embrace the principles of the bluebird bio culture: b colorful, b cooperative, and b yourself
