• Design and maintain all qualified shipping lanes, both domestic and international. • Select and manage specialty couriers for cell and gene therapies. • Define appropriate temperature profiles, packaging configurations, and routing guides for shipments. • Establish contingency lanes for countries or timelines considered high risk. • Coordinate bulk shipments between manufacturing, packaging, and depot locations. • Ensure proper transfer of custody and real-time visibility of shipments. • Reconcile shipment and receipt acknowledgements, addressing any discrepancies. • Monitor and track shipments to all Adverum facilities and partners to ensure smooth transit through the logistical path, including international shipping. • Prepare all supporting customs documents for international shipments. • Maintain collaborative relationships with third-party vendors to ensure all shipping activities are connected with operations and compliant with quality requirements. • Record, coordinate, and oversee sample transfers between storage facilities to maintain chain-of-custody audit trails. • Document and maintain inventory and organization of all applicable materials including devices, products, components, consumables, and chemicals. • Accurately pull and issue material to support Manufacturing, Quality, and R&D needs. • Support technical and impact assessments for out-of-specification (OOS) temperature or humidity conditions occurring during storage and shipment of materials. • Manage country-specific import and export documentation. • Coordinate with brokers for customs clearances. • Maintain Harmonized Tariff Schedule (HTS) codes, commercial invoices, and necessary permits. • Anticipate and mitigate customs delays for clinical materials. • Monitor shipments for temperature excursions using data loggers. • Lead investigations and coordinate quarantine and Quality Assurance (QA) notifications. • Document deviations and support impact assessments. • Implement corrective actions when necessary. • Oversee and ensure quality of couriers, freight forwarders, and brokers. • Track performance metrics of all vendors. • Review Statements of Work (SOW), rates, and service level agreements. • Serve as the escalation point for shipment delays, lost shipments, or routing errors. • Communicate with sites, depots, QA, and clinical teams during logistics events. • Develop Standard Operating Procedures (SOPs) and lane qualification documents. • Standardize shipping documentation across operations. • Maintain risk assessments for all shipping activities. • Lead lessons learned efforts from shipment deviations and customs issues. • Ensure logistics documentation is audit and inspection ready. • Maintain chain of custody records and shipment trackers/logs. • Ensure all activities comply with Adverum Biotechnology’s standards and all applicable regulatory requirements, including FDA, EU, USDA, DEA, and DOT as applicable. • Manage the shipping tracker to ensure it contains the most up-to-date information for internal and external stakeholders.