Contract - Clinical Supply Associate

Title:                   Contract - Clinical Supply Associate

Location:           Cambridge, MA

Reports to:        Supervisor, Clinical Supply

About Vedanta Biosciences:

Vedanta Biosciences is a late-stage biopharmaceutical company developing medicines for the treatment of gastrointestinal diseases. The company’s lead assets include potential first-in-class oral therapies, VE303, a Phase 3-ready candidate for recurrent C. difficile infection, and VE202, in a Phase 2 trial for ulcerative colitis. Vedanta’s pipeline has been built using the company’s industry-leading product engine for the development of therapies based on defined consortia of bacteria grown from pure clonal cell banks. The product engine, supported by foundational IP, includes one of the largest libraries of bacteria isolated from the human microbiome, vast clinical datasets, proprietary capabilities in consortium design, and end-to-end CGMP manufacturing capabilities at commercial launch scale.

The Role:

The Clinical Supply Associate will assist with the management of Drug Product packaging and distribution to support Vedanta’s clinical trial pipeline. 

Here’s What You’ll Do:

• Work closely with the Vedanta CMOs to oversee packaging documentation and production. Production management includes batch record review, drug tracking and storage management.
• Work with Clinical Operations to support trial protocols and clinical site drug needs.
• Monitor and update drug product forecasts.
• Track product usage and depot inventory levels.
• Assist with label management for clinical drug use.
• Manage the worldwide drug shipment from the CMO to clinical sites.
• Work cross-functionally with Clinical Operations, Quality, and CMOs to ensure an on-time delivery.
• Maintain accurate archives and documentation in electronic trial master files.

Requirements:

• BA or BS in a Business discipline, such as Supply Chain or Business Management
• 1-2 years prior experience with clinical trial supply preferred
• Experience with IRT and ERP systems
• Knowledge of CGMP and other relevant FDA and EU regulations
• Working knowledge of standard business software including MS Excel, Sharepoint, Powerpoint, and Project
• Highly motivated and organized
• Strong communication skills
• Able to work in a group setting as well as independently in a fast-paced environment
• Ability to work in a fast-paced setting and adjust to a changing environment