Contract - Principal Research Associate/scientist, Molecular Biology

Title:                   Contract - Principal Research Associate/Scientist, Molecular Biology

Location:           Cambridge, MA

Reports to:        Associate Director, Analytical Development

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:

We are seeking an experienced Molecular Biologist to join our Analytical Development (AD) team. This role will execute assay qualifications and support routine testing of multiple drug components for Vedanta's Live Biotherapeutic Products (LBPs). The selected candidate will lead the development and qualification of DNA-based assays, execute qualifications within a Quality Control (QC) environment, support investigations, and optimize assays through continuous improvement for their intended applications. We are looking for an independent, curious, and self-motivated individual with a strong scientific mindset, excited to work at the interface of Analytical Development and Quality Control, and committed to ensuring smooth assay qualification and GMP implementation.

The contract term begins now until June 2025, with the opportunity for conversion to a full-time position. The job title and level will align with the selected candidate’s experience and skills.

Here’s What You’ll Do:

• Lead the development of assay qualification and validation protocols and execute them to meet regulatory and compliance requirements.
• Author and revise Standard Operating Procedures (SOPs), protocols, and reports.
• Lead continuous improvement projects to optimize assays for their intended use.
• Handle GMP-grade drug substances and products for assay development, qualification, and method transfer.
• Collaborate with manufacturing, validation, quality control, and quality assurance teams.
• Adhere to cGMP documentation standards and USP/ICH guidelines.
• Support investigations into quality issues.

Requirements:

• MS/PhD in biology or a related field, including 3+ years of relevant experience.
• 3+ years of experience in DNA/RNA assay development or DNA sequencing.
• 1+ years of experience in microbiology with bacterial culturing is highly desirable.
• Experience in DNA extraction and qPCR techniques is required.
• Experience in assay qualification is a plus.
• Experience in Quality Control is a plus.
• Familiarity with cGMP documentation, ICH guidelines, and USP methods is desirable.
• Highly organized and detail-oriented. Must be a team player with the ability to execute independently within the context of activities such as assay qualifications and support of routine testing which require input and feedback from multiple functions across CMC.