Lead Logistics Specialist – Biogen – Cambridge, MA, USA
External Posting Title Lead Logistics Specialist Job Description The Lead Logistics Specialist is responsible for defining the distribution strategy of the Therapeutic Area to which they are assigned, as well as managing distribution activities, to ensure efficient flow of clinical IMP to support Biogen’s clinical studies. Ensures harmonious alignment of the strategies across Therapeutic Areas regarding process, people, and system utilization within CDS. The Lead Logistics Specialist manages distribution partners and represents Clinical Drug Supply (CDS) with Clinical Teams on shipment related matters to ensure timely delivery of IMP to clinical sites. Works globally within Logistics as well as cross functionally with peers to proactively implement process improvements to reduce risk and costs and allow for an efficient and robust supply-chain. The Lead Logistics Specialist provides guidance to the junior members of the Logistics team. Utilizes quality and performance metrics to ensure regulatory compliance and performs the completion of deviation and corrective actions to ensure quality IMP delivery. Leads Clinical Drug Supply group developmental initiatives along with local and global process harmonization in the achievement of company objectives. Personally coaches, and mentors other members within CDS and provides career development for direct reports, if applicable. For those with direct reports, manages the professional development and productivity of all staff members to ensure proper goal alignment, training, development, and project requirements are met.
Principal Accountabilities:
1) Understands study management activities across the Therapeutic Area to which they are assigned including issue resolution that aligns across all studies within a program. Defines the distribution strategy for as well as manages distribution partner (CMO) in drug supply aspects related to Biogen Idec’s studies, including quote/PO process, depot selection and setup, deviation resolution, and shipment prioritization. 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. 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. Investigates deviations and temperature excursions related to shipment activity and completes TrackWise deviations: Utilizes quality and performance metrics to ensure regulatory compliance and oversees the completion of deviation and corrective action closure and reporting to ensure quality IMP delivery. 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. 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. Represents Clinical Drug Supply (CDS) on SMT meetings and supports the clinical team in distribution related matters. Utilizes communications skills to develop effective working relationships with peers, executives and customers to maximize efficiencies across the organization.
2) Provides input into Interactive Response Technology (IRT) standardization, design, and development and participates in IXRS User Acceptance Testing related to IMP. Responsible for the setup and management of shipment activity in the IXRS system. Participates in IXRS User Acceptance Testing related to IMP. Provides ongoing processing of IXRS kit activations/expiry extensions, DNX parameter optimization/adjustment,and shipment processing. Supports direct reports as applicable.
3) Responsible for investigation of deviations and CAPA implementation in a timely and compliant manner. Understands the impact to of the deviation and resolution to the larger organization. Conducts focused risk assessments and drives process improvement through thoughtful CAPA development.
4) Define the distribution strategy of the bulk material for the Clinical Drug Supply organization. Proactively implement process improvement activities to build business efficiences and reduce costs. Oversee movement of bulk IMP between warehouses including coordination of activities, OPM transactions, review, and preparation of supporting documentation. Oversight of USDA permits and FDA holds for shipments coming into the United States.
- LI-POT1 Location Cambridge, MA, US Job Category Supply Chain, Global Operations Requisition Number 26553BR Qualifications
- Strong written and oral communication skills with excellent analytical skills
- Customer service and relationship management skills
- Prior experience managing clinical trial distribution
- Ability to multitask on a daily basis and maintain multiple projects in parallel
- Proven capability to work in a fast paced dynamic environment
- Must be very organized and detail-oriented
- 5+ years of Supply Chain, logistics, and distribution experience required. Minimum of 3-5 years of relevant working experience in the pharmaceutical and/ or biotech industries.
- 2+ years in cold-chain preferred
- Very good understanding of Oracle or similar ERP systems
- Strong Excel experience
- Good communicator
- Prior experience in a pharmaceutical environment, specifically within the supply chain Education Bachelor’s degree in Chemistry, Biology, Supply Chain or related discipline. Advanced degree a plus. 5+ years of Supply Chain (Global Logistics) with responsibility of logistics and distribution with third parties in management role. At least 3 – 5 years experience in the pharmaceutical and/ or biotech industries in cGMP and cGDP environment(s) required. Supervisory experience desired. About Biogen Biogen (NASDAQ: BIIB) is a biotechnology leader that discovers, develops and delivers innovative therapies to improve the lives of patients with neurodegenerative diseases, hematologic conditions and autoimmune diseases. Patients worldwide benefit every day from our medicines for multiple sclerosis (MS) and hemophilia.
