Contract – Manufacturing Associate

Title:                   Manufacturing Associate

Location:           Cambridge, MA

Reports to:        Manager, Manufacturing

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, in a Phase 3 trial 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:

Vedanta is looking for a highly skilled biopharmaceutical Manufacturing Associate for their Cambridge, MA manufacturing site. The position will be a key element in establishing and operating Vedanta’s in-house GMP manufacturing capabilities. Applicants should be self-motivated, have strong communication skills, and be capable of working in a dynamic startup environment.

Occasional travel to Vedanta’s Acton, MA manufacturing facility may be required.

Here’s What You’ll Do:

• Manufacture Master Cell Banks, Drug Substance and Drug Product in a CGMP environment
• Prepare process solutions including media and buffer
• Request materials and supplies from Supply Chain/QC/QA to support manufacturing activities
• Maintain the in-suite consumable inventory
• Operate and maintain small-scale process equipment
• Author and revise SOPs

Requirements:

• BS in a Scientific Discipline or Engineering
• 2+ years of hands-on experience with CGMP manufacturing
• Direct experience with cell banking, cell culture, fermentation, cross-flow filtration, lyophilization, and/or capsule filling
• Ability to work in a fast-paced setting and adjust to a changing environment
• Excellent interpersonal and communication skills
• Ability to work in a team setting