Contract - QC Specialist I at Vedanta Biosciences

Cambridge, Massachusetts, United States

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Not SpecifiedCompensation

Entry Level & New Grad, Junior (1 to 2 years)Experience Level

Full TimeJob Type

UnknownVisa

Biopharmaceutical, MicrobiomeIndustries

Requirements

BS in a scientific discipline
Minimum 1+ years working in a GMP environment and/or QC test lab
Previous experience with environmental monitoring
Experience with aseptic sampling and testing technique
Strong organizational skills, attention to detail, flexibility, and the ability to work within a team environment
Proficient in Microsoft Outlook, Word, Excel, and lab-based data management systems
Experience working in a laboratory, with contract test organizations (CTOs), and with vendors
Knowledge of USP, EU, and ISO compliance
Experience working within QMS systems, ownership of deviation investigations, OOS, CAPAs and Change Controls (plus)

Responsibilities

Perform routine Environmental Monitoring (EM) and help support the EM program
Support in-house lab testing
Review test lab data, protocols, reports, and quality events (Deviations, Out of Specification (OOS) investigations, etc.)
Review and author standard operating protocols (SOP), Certificates of Analysis (CoA), and reports
Participate in continuous improvement projects to support the growth of the team and company
Participate within the Quality Control (QC) team to meet group and company goals
Help ensure activities occur in an efficient and cGMP compliant manner

Skills

cGMP

Environmental Monitoring

Personnel Monitoring

USP Chapters

Microbiological Testing

Chemistry Testing

Aseptic Technique

Data Review

QMS Software

Vedanta Biosciences

Develops microbiome-based therapies using bacteria

About Vedanta Biosciences

Vedanta Biosciences focuses on developing microbiome therapies using groups of beneficial bacteria known as bacterial consortia. These consortia can colonize the human intestine and have the potential to treat various diseases. The company utilizes a proprietary discovery platform to identify and assemble these bacteria into effective therapeutic teams. Unlike many competitors, Vedanta has achieved commercial-scale production of its drug candidates while adhering to strict FDA regulations for safety and quality. The goal of Vedanta Biosciences is to transform disease treatment by providing new options for patients through its innovative approach to drug discovery.

Cambridge, MassachusettsHeadquarters

2010Year Founded

$364.5MTotal Funding

LATE_VCCompany Stage

Biotechnology, HealthcareIndustries

51-200Employees

Risks

Competition from Seres Therapeutics with FDA-approved C. difficile treatment.

High production costs may impact profitability and market reach.

Regulatory challenges due to unclear FDA guidelines for microbiome therapies.

Differentiation

Vedanta uses defined bacterial consortia for consistent therapeutic outcomes.

First to achieve commercial-scale CGMP production of bacterial consortia drugs.

Proprietary platform identifies and assembles optimal bacterial consortia for therapies.

Upsides

Fast Track designation for VE303 accelerates regulatory approval process.

Phase 3 RESTORATiVE303 study positions Vedanta as a market leader for rCDI.

Recent $106.5M funding round strengthens financial position and growth potential.

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