Contract - Quality Control Specialist

Title:                   Contract - Quality Control Specialist

Location:           Cambridge, MA

Reports to:        Principal Quality Control Specialist

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:

This position directly supports Vedanta’s in-house cGMP manufacturing capabilities including programs in multiple phases of development.

This role will be lab-centered and focused on final product testing for release and stability. In addition to routine testing, this role will participate in the management of the Quality Control laboratory. Daily responsibilities will involve routine lab testing, inventory management, and data reporting.

The role will start as contract with expected opportunity to expand on responsibilities and grow with the company. There will be collaboration with Analytical Development and other departments, and opportunity to be involved in other aspects of quality control work.

A successful candidate for this role will have strong attention to detail, good organizational skills, able to troubleshoot challenges, drive continuous improvement, and be a quick learner. They will be able to exercise judgment within defined procedures and practices to determine appropriate action. Follow routine procedures, apply learned techniques, and contribute to analysis and investigation to solve problems. An ideal candidate will be a strong independent worker, able to self-organize and execute day-to-day work with minimal daily instruction.

Previous experience with hands-on laboratory testing in a microbiology laboratory, aseptic technique, qPCR, pipetting, working in an anaerobic chamber, and general USP microbiological and chemistry testing/data review preferred.

This role will require being on-site full-time in Cambridge.

Here’s What You’ll Do:

• Perform routine microbiology testing to support release and stability of Vedanta products
• Review test lab data, protocols, reports, and quality events (deviations, OOS etc.)
• Author, review, and revise SOPs, protocols, and reports
• Participate in continuous improvement projects to support the growth of the company
• Participate within the QC team to meet group and company goals

Requirements:

• BS in a scientific discipline
• Minimum 5+ years working in a GMP environment and/or Quality Control test lab
• Direct, hands on, experience with PCR/qPCR testing
• Direct experience with aseptic sampling and testing techniques
• Experience working in with anaerobic microorganisms
• Strong laboratory and organizational skills, attention to detail, flexibility, and the ability to work independently and within a team environment
• Experience working within QMS systems, deviation investigations, OOS, CAPAs and Change Controls (preferred, not required)
• Experience with QC continuous improvement projects; project management skills a plus
• Proficient in Outlook, MS Word, Excel, and lab-based data management systems
• Knowledge of FDA and EU compliance
• Knowledge of USP and ICH guidance