Manager, Clinical Logistics (Contract)

Adverum Biotechnologies, Inc.•Redwood City, CA

11d

About The Position

Adverum Biotechnologies, Inc., a wholly owned subsidiary of Eli Lilly and Company is a mission-driven clinical-stage company that aims to establish gene therapy as a new standard of care for highly prevalent ocular diseases with the aspiration of developing functional cures to restore vision and prevent blindness. Leveraging the research capabilities of its proprietary intravitreal (IVT) platform, Adverum is developing durable, single-administration therapies designed to be delivered in physiciansâ offices to eliminate the need for frequent ocular injections to treat these diseases. By overcoming the challenges associated with current treatment paradigms for these debilitating ocular diseases, Adverum aspires to transform the standard of care, preserve vision, and create a profound societal impact around the globe. Adverum is looking for a Manager, Clinical Logistics (Contract) to join our team. The Manager, Clinical Logistics is responsible for overseeing the movement, visibility, and integrity of Adverum materials across manufacturing sites, packaging vendors, and depots. This position ensures that all materials are distributed in a compliant, temperature-controlled manner, maintaining chain of custody and aligning with manufacturing or study timelines, as well as country-specific export and import requirements. The manager serves as the operational owner for shipping lanes, couriers, depot interfaces, customs clearances, and excursion management to guarantee that products arrive on time, in proper condition, and are inspection ready. The Manager is accountable for the daily operations related to all shipments and receipts of Adverumâs cGMP materials, ensuring that every shipment complies with cGMP, GDP, and safety guidelines. Responsibilities include the receipt, storage, inventory management, and distribution of cGMP materials, samples, supplies, and equipment. Note to Recruiters and Agencies All recruiter and agency inquiries must go through Adverumâs internal Talent Acquisition team. Unsolicited resumes sent to Adverum will be considered property of Adverum. Agencies must be expressly engaged by Adverumâs Talent Acquisition team for any requisition. Direct contact with hiring managers by agencies will not be tolerated and may affect your ability to work with Adverum in the future.

Requirements

Bachelorâs 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.

Responsibilities

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 Biotechnologyâs 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.