The Sr Logistics Specialist is responsible for supporting clinical studies by overseeing the execution and completion of distribution activities to ensure the efficient flow of IMP and information throughout the clinical supply chain. The responsibilities include representing Clinical Drug Supply with both internal stakeholders and distribution vendors for product order management and global distribution activities, driving budgetary performance, and completion of deviation and corrective action closure and reporting. Utilizing knowledge of departmental and industry best practices to support quality and performance metrics to ensure regulatory compliance and to meet drug supply timelines. Supporting the Logistics Management on projects as well as participating in supply chain projects as required.
1. Management of clinical finished goods distribution to US and international depot locations and clinical sites through study setup activities, representing Logistics in meetings, and oversight of distribution activities.
2. Monitoring of clinical order process/fulfillment as executed by 3rd party distributors. Raising order fulfillment issues to management and key customers and proposing mitigation strategies on a routine (daily/weekly) basis.
3. Works closely with Operations peers to avoid interruptions in supply and to ensure clinical products are available at clinical sites for uninterrupted patient dosing
4. Involved in distribution operations aspects of clinical trials, in relation to IXRS functionality, depot selection, courier selection, order management, and study closeout. Acting as a contact for internal customers (Clinical Operations, Clinical Planning, QA) and distribution vendors for all distribution related topics for the trial protocols.
5. Responsible for investigation of deviations and CAPA implementation in a timely compliant manner
6. Uses continuous improvement methodology to drive and quantify cost optimization while maintaining customer quality and service. Ensures and maintains distribution, transportation and warehouse budgetary goals to achieve the best cost and delivery possible.
7. Utilizes communications skills to develop effective working relationships with peers, management, and customers to maximize efficiencies across the organization.
Supply Chain, Global Operations
• 3-4 years’ experience in operations, 2+ years in cold-chain preferred
• Strong project management skills with the ability to manage multiple projects simultaneously
• Analytical and problem solving skills to review, compile, and present distribution data
• Working knowledge of GXP requirements, including experience in deviation investigation and CAPA implementation
• Familiarity with GXP requirements
• Strong interpersonal, verbal and written communication skills
• Experience in vendor interaction
• Knowledge of Oracle (or similar ERP systems), IXRS system setup and functionality, and proficiency with Microsoft applications
• Proven capability to work in a fast paced dynamic environment requiring multitasking
• Excellent organizational skills; detail-oriented
• BS/BA in Business, Chemistry, Biology, Supply Chain or related discipline
• MBA preferred
Biogen (NASDAQ: BIIB) is a global leader in the discovery, development and delivery of innovative therapies to improve the lives of...