Manager, Clinical Logistics – Contract

Role Overview

• 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.

Requirements

• Bachelor’s degree required or equivalent combination of education and experience in the Biotech/Pharma industry.
• 5+ years in clinical logistics, GMP distribution or biologics shipping
• Knowledge of global trade compliance and customs processes.
• Must be highly organized, analytical, detail oriented and able to conduct work independently.
• Team oriented, creative, eager to take on responsibility
• Excellent written and verbal communication skills.
• Demonstrate ability to communicate with internal stakeholders and external collaborators.