Careers

Clinical Supply Chain Manager

About Aura:

At Aura Biosciences, we are developing a new class of therapies to target and destroy cancer cells selectively, while leaving surrounding tissue unharmed – an approach we call molecular surgery.  By safely eliminating cancer locally, we can treat early and transform the lives of people with a wide range of cancers that are poorly managed today.

Our lead program in ocular melanoma is designed to remove cancer cells in the back of the eye as a first-line therapy potentially long before the disease progresses and metastasizes to the liver, where it almost always is fatal. Development of a first-in-class treatment option to selectively destroy cancer cells would create the possibility of a cure in this and other cancers where the disease can be detected early.

Title:

Clinical Supply Chain Manager

Location:

Based in the Company’s North Cambridge office, with <20% travel required.

Summary:

The Clinical Supply Chain Manager will report to the Director Technical Program Lead CMC to support Aura’s clinical program. The Clinical Supply Chain Manager is responsible for overseeing packaging and labeling of Aura’s products and clinical supply planning.

Responsibilites:

Responsible for the management of the clinical supply chain function, including clinical logistics oversight, clinical supply packaging, labeling, distribution, and inventory of all GMP materials. Maintain an always current inventory of drug product in all locations (e.g., CMOs, labeling and packaging vendors, clinical sites).

  • Manage clinical demand planning.

  • Manage inventories for all raw materials and components controlled by Aura, including, but not limited to, Master/Working Cell Banks, plasmids, regulatory starting materials, drug substance intermediates, drug product (bright stock, labeled, packaged), cartons, etc.

  • Track and maintain inventory for Aura clinical and GMP supplies. Regularly monitor expiry and inventory levels across vendors. Coordinate regular cycle counts.

  • Analyze shipment temperature data to address temperature excursions during storage or when in transit.

  • Collaborate with Clinical Operations, applicable functional areas, CROs, and other as needed to evaluate and maintain up-to-date records and reporting for all clinical supply-related activities.

  • Develop and maintain information and reporting, in collaboration with QA, to ensure transparency of project / product, current expiry periods, and clinical supply inventory.

  • Target uninterrupted supplies throughout the duration of a clinical study program.[MDR1]

  • Prepares standard documents, such as work orders, purchase orders, material transfer requests or shipping documentation.

  • Develops and implements programs with suppliers and/or internal cross-functional team members to support continuous improvement.

  • Develop Interactive Response Technology (IRT) supply strategy and clinical labeling texts.

  • Manage relationships with packaging and labeling CMOs, track vendor performance. Manage contracts, expenses, and invoices.

  • Oversee investigation and root cause analysis on any supply disruptions or material quality issues. Communicate corrective actions.

  • Manage readiness for commercial supply chain development, including commercial packaging, 3PL identification and oversight, etc.

  • Ensure continuous commercial supply of Aura’s products through effective forecasting, planning, vendor management, etc.

Requirements:

  • Bachelor’s with 6+ years of work experience within a Clinical Supply Chain function in a biotech or pharmaceutical environment. APICS CSCP/CPIM certification is a plus.

  • Proficiency with clinical supply planning, forecasting, and inventory reconciliation

  • Experience with CMOs, CRO’s and Clinical Protocols/Labeling

  • Solid understanding of cGMPs, clinical operations and development process.

  • Strong knowledge of materials management, planning and controlled temperature shipping, and site production scheduling.

  • Experience managing contract manufacturing, contract packaging for commercial products and clinical supplies and labeling organizations (strongly preferred)

  • Aligned with Aura core values of collaboration, respect, innovation and teamwork.

 How we Work:

Aura is powered by a passion for bringing together diverse people, ideas and technologies behind common purpose: to create breakthroughs in diseases with significant unmet medical needs.  We constantly seek opportunities to broaden our impact and reach, using new platforms and technologies, and partnering to ensure that our drug development expertise reaches its full therapeutic potential.

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