Contract - Clinical Supply Associate

Title:                   Contract - Clinical Supply Associate

Location:           Cambridge, MA

Reports to:        Supervisor, Clinical Supply

 

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

Why join Vedanta Biosciences:

Vedanta is pioneering the development of a new class of therapies that act by modulating the human microbiome. Modulation of the human microbiota holds enormous promise to treat a broad range of immune and infectious diseases in ways that are completely different to existing drug classes. Breakthrough discoveries of our scientific team in the field of mucosal immunology have led to the first rationally designed drug candidates in the microbiome field. Vedanta was founded by PureTech Health and a team of world-renowned experts in immunology and microbiology. 

We invite you to explore our site to learn more about our company and how our discovery platform enables identification of bacterial consortia with drug-like properties and their manufacture to GMP standards.

Our Vision:

We are harnessing the human microbiome to enable a new drug modality based on rationally defined bacterial consortia

Vedanta is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Vedanta will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Vedanta Biosciences requires all employees to be fully vaccinated against COVID-19 and newly hired employees must be fully vaccinated prior to their employment start date. Vedanta Biosciences will consider accommodations for individuals who are unable to be vaccinated against COVID-19 due to a qualifying medical condition or disability or a sincerely held religious objection.