Dianthus Therapeutics, Inc.
Biotechnology • Pharmaceuticals
Dianthus Therapeutics, Inc. is a clinical-stage biotechnology company focused on developing novel monoclonal antibodies to treat severe autoimmune and inflammatory diseases. The company leverages advanced antibody engineering technologies to create next-generation complement therapeutics with improved selectivity and potency. Its lead program, DNTH103, is a monoclonal antibody targeting the classical complement pathway for conditions such as generalized Myasthenia Gravis, Multifocal Motor Neuropathy, and Chronic Inflammatory Demyelinating Polyneuropathy. Based in New York City and Waltham, Massachusetts, Dianthus aims to deliver transformative medicinal therapies by addressing unmet needs in autoimmune treatment.
Senior Manager, Biologics Analytical Research and Development
November 13
Dianthus Therapeutics, Inc.
Biotechnology • Pharmaceuticals
Dianthus Therapeutics, Inc. is a clinical-stage biotechnology company focused on developing novel monoclonal antibodies to treat severe autoimmune and inflammatory diseases. The company leverages advanced antibody engineering technologies to create next-generation complement therapeutics with improved selectivity and potency. Its lead program, DNTH103, is a monoclonal antibody targeting the classical complement pathway for conditions such as generalized Myasthenia Gravis, Multifocal Motor Neuropathy, and Chronic Inflammatory Demyelinating Polyneuropathy. Based in New York City and Waltham, Massachusetts, Dianthus aims to deliver transformative medicinal therapies by addressing unmet needs in autoimmune treatment.
📋 Description
• Work collaboratively with the CMC organization to solve complex analytical problems. • Support activities related to clinical drug substance and drug product stability studies. • Provide technology development, strategic leadership, and technical expertise in methods development. • Collaborate cross-functionally to ensure timely and successful development of pipeline drug candidates. • Assist in monitoring contract laboratory stability testing, documentation, timely data review, and maintaining an up-to-date stability database.
🎯 Requirements
• BS in analytical chemistry/biochemistry or related field with 5+ years of relevant experience, advanced degree highly preferred. • Demonstrated experience in analysis of biologics, including Size Exclusion Chromatography (SEC), Ion Exchange Chromatography (IEX), Capillary Electrophoresis (CE-SDS, CEIEF) techniques, PCR, and cell-based potency assays and ELISA based assays. • Prior experience with analytical method development for fusion proteins/ bi-specific antibodies is a plus. • Experience with method validation, method transfer, analytical control strategy development, and execution in a GMP environment in support of biologics drug development programs. • Strong working knowledge of analytical methodologies, Critical Quality Attributes/QbD/DOE principles, and data analysis and statistics for setting specifications. • Ability to design and direct the development/qualification of release, characterization, and stability assays to support clinical drug substance / drug product testing and product/process development. • Working knowledge of LIMS, Veeva, SAS and/or JMP is a plus • Working knowledge of quality systems, GMP, FDA, ICH, and EMEA guidelines for stability, especially in biologics. • A strong team player with excellent oral and written communication skills; ability to work both independently for development of assays and cross-functionally for successful transfer of assays. Plan assay optimization and documentation to meet program deadlines. • Strong ability to deliver complex objectives under aggressive timelines in a rapidly changing environment.
🏖️ Benefits
• Remote work options
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