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Manager, Supply Chain - Boston, United States - Aura Biosciences
Description
Job DescriptionJob Description Salary:
About Aura:
At Aura, our mission is to develop a new class of oncology targeted therapies that deliver meaningful therapeutic benefit to a range of cancer indications with high unmet need in which we believe we can establish a new standard of care.
We are driven by our passion and commitment to science and the patients battling cancer who are relying on us to pioneer these new therapies.
We are focusing the initial development of our VDC technology platform to treat tumors of high unmet need in ocular and urologic oncology.
AU-011, our first VDC candidate, is being developed for the first line treatment of primary choroidal melanoma, a rare disease with no drugs approved.
Beyond primary choroidal melanoma, we are developing AU-011 in additional ocular oncology indications, including choroidal metastases.Leveraging our VDCs' broad tumor targeting capabilities, we also plan to initiate a clinical program in non-muscle invasive bladder cancer, or NMIBC, our first non-ophthalmic solid tumor indication.
Position Summary:
Aura Biosciences is seeking a Manager of Supply Chain to play an important role in supporting end-to-end supply to enable Aura's clinical programs.
Reporting to the Head of Supply Chain, this person is responsible for supporting oversight of labeling, packaging, storage and distribution of Aura's products and supply planning.
The successful candidate will have a demonstrated track record of supporting clinical and/or commercial Supply Chain business processes across all GxP programs, optimizing the tracking, management of supplies, and studies with CMO partners.
This is an excellent opportunity for a highly motivated self-starter and creative problem solver who has a strong desire to make an important contribution to the development of novel therapies.
This is a position with the opportunity to innovate in an entrepreneurial and high growth organization.Responsibilities include but are not limited to:
Responsible for the managing clinical supplies, including, packaging, labeling, storage, distribution, and inventory of all GMP materials.
Maintain inventory and oversight of drug product and devices in all locations (e.g., CMOs, 3rd party vendors, depots and clinical sites).
Support demand planning andrecommend/implement
supply strategies and minimize supply risks.
Manage inventories of all raw materials, intermediates, devices, and components controlled by Aura.
Analyze shipment temperature data across the supply chain to resolve temperature excursions during storage and/or in transit.
Collaborate with QA, to develop, review and/or approve SOPs, batch records, specifications, GxP documents, label texts, deviations, change controls, expiry periods, and extensions.
Target uninterrupted supplies throughout the duration of a clinical study program.Support review and preparation of SOWs, invoices, purchase orders, material transfer requests and/or shipping documentation.
Partner with Clinical operations, CROs and CMOs to support supplies with Interactive Response Technology (IRT) and/or manual shipments, maintain up to date records for all supply related activities.
Partner with packaging and labeling CMOs, to review label texts, translations, proofs, planning, production and release of supplies globally. Develop and track metrics, KPIs and vendor performance.Oversee investigation and root cause analysis on any supply disruptions or material quality issues. Communicate corrective actions.
Support development and readiness for commercial supply chain, including commercial labeling, packaging, 3PL identification and oversight
Travel (approx. 20%) as needed to supply chain partners
Minimum Requirements:
Bachelor's degree with 5+ years of work experience within a Supply Chain function in a biotech or pharmaceutical environment.
Familiarity with demand and supply planning, forecasting, and inventory reconciliation.
Detail oriented and ability to interpret complex information via excellent written, presentation/oral communication, and customer service skills.
Experience working with CMOs, CRO's, third party partners
Solid understanding of cGMPs, quality, operations and development process.
Strong knowledge of management of cold chain, controlled temperature shipping, excursion handling and logistics.
Experience working with contract packaging, storage and shipping companies for clinical supplies and/or commercial products (strongly preferred).
Ability to work independently on routine and new assignments and under minimal supervision for complex assignments.
Aligned with Aura core values of collaboration, respect, innovation and teamwork.
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