Tbwa Chiat/Day Inc
Contract - Principal Research Associate/Scientist, Molecular Biology
Tbwa Chiat/Day Inc, Cambridge, Massachusetts, us, 02140
Contract - Principal Research Associate/Scientist, Molecular Biology
Cambridge, MATitle: Contract - Principal Research Associate/Scientist, Molecular BiologyLocation: Cambridge, MAReports to: Associate Director, Analytical DevelopmentAbout 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.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.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.Our Vision: Pioneering microbiome therapeutics by using Defined Bacterial Consortia to transform the lives of patients with serious diseases
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.
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Cambridge, MATitle: Contract - Principal Research Associate/Scientist, Molecular BiologyLocation: Cambridge, MAReports to: Associate Director, Analytical DevelopmentAbout 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.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.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.Our Vision: Pioneering microbiome therapeutics by using Defined Bacterial Consortia to transform the lives of patients with serious diseases
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.
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