Associate Director/Director, Drug Product, CMC

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Dianthus Therapeutics, Inc.

WebsiteLinkedInAll Job Openings

1 - 10 employees

Founded 2017

🧬 Biotechnology

💊 Pharmaceuticals

💰 $100M Private Equity Round on 2022-04

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

• Lead the operational oversite of clinical external manufacturing (CMO) of Drug Product • Develop and execute robust, phase-appropriate aseptic strategies for monoclonal and bispecific antibody drug products • Experience managing CMOs and technology transfer of processes to external Contract Manufacturing Organizations • Ensure strict adherence to cGMP requirements and global health authority expectations regarding aseptic controls • Collaborate with formulation and device development teams to create stable, high-concentration liquid formulations • Execute risk assessments and define process control strategies using QbD principles • Troubleshoot manufacturing issues, analyze data, and implement process improvements • Lead deviation investigations, CAPAs, and change controls • Review CMC sections for regulatory submissions including INDs, IMPDs, and BLAs • Serve as a Subject Matter Expert during regulatory agency interactions • Manage vendor and CDMO relationships, ensuring alignment with project deliverables, budgets, and timelines

🎯 Requirements

• Bachelor of Science and 12 years or Master’s and 10+ years of experience in Chemical Engineering, Biochemistry, Pharmaceutics, or related scientific discipline • 10+ years’ experience in drug product CMC support. • Up to 5-10% of travel is required • Deep understanding of protein stability, prefilled syringe handling, isolator/RABS technologies, and sterile manufacturing. • Extensive knowledge of cGMP standards, ICH guidelines, and authoring BLAs for commercialization. • Proven track record as a people leader with strong cross-functional communication and strategic problem-solving abilities.

🏖️ Benefits

• remote work • collaborative culture • professional growth opportunities