- 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 and recommend/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
- 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.
-
Supply Chain Analyst
2 weeks ago
Wis-Pak Watertown, United States**ABOUT US** · Wis-Pak is a leading manufacturer and distributor of Pepsi-Cola, Mountain Dew, Bubbl'r, and other popular beverage brands. Headquartered in Watertown, Wisconsin, we have seven production facilities across the Midwest. We are a privately-owned business that cares ab ...
-
Supply Chain Manager
3 days ago
The Charles Stark Draper Laboratory Inc Cambridge, United StatesOverview: · **Equal Employment Opportunity** · Draper is committed to creating a diverse environment and is proud to be an affirmative action and equal opportunity employer. We understand the value of diversity and its impact on a high-performance culture. All qualified applicant ...
-
Supply Chain Manager
1 week ago
Nova Biomedical Waltham, United StatesNova Biomedical is hiring a **Supply Chain Manager** on-site in our **Waltham, MA **facility to oversee the day-to-day activities of the Purchasing department and coordinate the work of Supply Chain Specialists to ensure compliance with company policies, achieve best delivery tim ...
-
Supply Chain Manager
1 week ago
Vertex Pharmaceuticals Boston, United StatesJob Description · - Job Summary: · - Vertex has established a new research site in the Boston area where research, development, and clinical manufacturing for cell and genetic therapies will be primarily based. Cell and genetic therapies represent two rapidly emerging therapeutic ...
-
Supply Chain Logistics Specialist
1 day ago
Akebia Therapeutics Cambridge, United StatesNearly 37 million Americans are currently affected by Chronic Kidney Disease. 37 million. · At Akebia we take that number very seriously and every day we come to work, with the purpose of bettering the lives of each person impacted by kidney disease and the renal community that s ...
-
Supply Chain Specialist
1 week ago
VEIR Woburn, United States**WHY VEIR?** · Giving everyone in the world access to clean, reliable, affordable energy will require substantial expansion of global electricity transmission networks. VEIR is developing a new generation of High Temperature Superconductor (HTS)-based transmission lines, enablin ...
-
Manager, International Supply Chain Quality
1 week ago
Inspire Brands Boston, United StatesTo manage and maintain an international, industry-leading quality and food safety management systems throughout the Inspire Brands International supply chain, delivering quality (inclusive of food safety) and risk management, mitigation, and focused improvement. Ensuring the prot ...
-
Supply Chain Analyst Co-op
2 weeks ago
Chewy Boston, United States**Our Opportunity**: · The Chewy **Campus Recruiting Team** is seeking a motivated **Supply Chain** **Analyst Co-Op **to join our Supply Chain team in our Plantation, FL or Boston, MA office. · **Co-Op Timeframe**: June 3rd - December 6th, 2024 (must be available for the full dur ...
-
Supply Chain Planner
2 weeks ago
Prysmian Group Bridgewater, United StatesTeam Overview and Job Responsibilities · - Support Supply Chain Manager in all master scheduling, forecasting and procurement functions. Willingness to cross train within dept. · - Perform daily planning, scheduling across multiple value streams to optimize output with reduced ch ...
-
Supply Chain Specialist
2 weeks ago
SMC Ltd. Devens, United StatesSMC, Ltd. is a globally recognized premium supplier to the medical market with locations throughout the world. People committed to speed, technology, and exceptional performance are the cornerstone of our organization. Comprised of dedicated people and decades of manufacturing ex ...
-
Supply Chain Analyst
1 week ago
Cometeer Gloucester, United StatesThe Role · The Supply Chain Analyst will be responsible for supporting various aspects of Supply Chain, including but not limited to inventory management, strategic sourcing, and supplier management. This role is on-site preferred, remote considered. · We are seeking a highly m ...
-
Supply Chain Manager
1 week ago
Job Juncture Cambridge, United StatesJob Description · Job description: We are hiring a Supply Chain Manager to lead a team of Supplier Management and Small Business professionals and serve as the Supply Chain ERP implementation advisor for the department. · Reporting to the Director of Procurement & Property, the S ...
-
Supply Chain Coordinator
3 days ago
PepsiCo Haverhill, United StatesPepsiCo is a global food and beverage leader with a product portfolio including 22 brands that generate more than 1 billion in annual retail sales. Our Main businesses · - Quaker, Tropicana, Gatorade, Frito-Lay, and Pepsi Cola - make hundreds of enjoyable food and beverages that ...
-
Supply Chain Planner
1 day ago
ZDA, LLC Supply Chain Recruiting Cambridge, United StatesGrowing R&D Research Company seeking talented Supply Chain Buyer/Planner, that will be responsible for navigating complex supply chain support and business strategies with suppliers including ensuring right quality, and quantity is purchased for the companies needs. This role wil ...
-
Supply Chain Manager
2 weeks ago
Automata LLC Cambridge, United StatesLevel 4Salary band: $90,000 - $125,000 8% bonus (annual & discretionary & performance based)Working from Office Full-time - Newton, MA Automata is building a world-class company to disrupt the life science industry and empower scientists by making automation a reality for every l ...
-
Supply Chain Manager
2 weeks ago
Automata LLC Cambridge, United StatesLevel 4 · Salary band: $90,000 - $125,000 · 8% bonus (annual & discretionary & performance based) · Working from Office Full-time - Newton, MA · Automata is building a world-class company to disrupt the life science industry and empower scientists by making automation a reali ...
-
VP, Supply Chain
2 weeks ago
Vericel Corporation Cambridge, United StatesVericel Corporation, a leader in advanced therapies for the sports medicine and severe burn care markets, has an exciting opportunity for a top performing Supply Chain professional looking to join and contribute to a commercial stage company with an established portfolio of uniqu ...
-
VP, Supply Chain
2 weeks ago
Vericel® Corporation Cambridge, United StatesVericel Corporation, a leader in advanced therapies for the sports medicine and severe burn care markets, has an exciting opportunity for a top performing Supply Chain professional looking to join and contribute to a commercial stage company with an established portfolio of uniqu ...
-
Supply Chain Manager
2 weeks ago
Automata LLC Cambridge, United StatesLevel 4 · Salary band: $90,000 - $125,000 · 8% bonus (annual & discretionary & performance based) · Working from Office Full-time - Newton, MA · Automata is building a world-class company to disrupt the life science industry and empower scientists by making automation a reali ...
-
VP, Supply Chain
2 weeks ago
Vericel Corporation Cambridge, United StatesVericel Corporation, a leader in advanced therapies for the sports medicine and severe burn care markets, has an exciting opportunity for a top performing Supply Chain professional looking to join and contribute to a commercial stage company with an established portfolio of uniqu ...
Manager, Supply Chain - Brighton, United States - Aura Biosciences
Description
Job Description
Job DescriptionSalary: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:
Minimum Requirements:
