Responsible for Cold Chain and Secondary Packaging strategy, including acting as the liaison with both internal and external customers/vendors, and improving upon existing procedures/processes (SOP’s, work instructions) to ensure compliance with GDP, GMP and country specific requirements and improve the overall quality and efficiency of the supply chain. Duties include the following: establish and build Packaging Strategy for all product needs; lead the qualification activities for all shipping systems utilized for the shipment of temperature controlled materials; manage the relationship with Cold Chain and Packaging vendors to assure fulfillment of bluebird bio product; support the regulatory filings related to Cold Chain and Packaging of bluebird bio products; 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; 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 and activation of temperature monitoring devices etc.); improve upon area related SOP’s and work instructions ensuring compliance with GDP’s, cGMP’s, and country specific regulations related to Cold Chain and Packaging; responsible for compliance and execution of all quality systems related Logistics & Cold Chain (i.e. deviations and CAPA’s); and support the maintenance of metrics on Cold Chain, transportation/Logistics operations.
Must have MS in packaging science or engineering, or a closely related field, and 5 years of experience with Packaging and/or Cold Chain Management within the Biotech/Pharmaceutical Industry and some experience with the following: U.S. and medical devise regulatory requirements; ASTM and ISTA; and managing the design and development of product/package. We will also accept a BS and 7 years of experience.