CMC Project Manager

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October 2

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Dianthus Therapeutics, Inc.

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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.

2 - 10 employees

Founded 2017

🧬 Biotechnology

💊 Pharmaceuticals

💰 $100M Private Equity Round on 2022-04

📋 Description

• Support CMC and technical operations teams, to ensure that deliverables are completed on schedule, within scope and budget, and aligned with program goals. • Own sample management processes, including tracking, shipment, inventory control, and documentation in compliance with regulatory and quality requirements. • Coordinate cross-functional project teams, including analytical, process development, manufacturing, quality, regulatory, and supply chain functions to ensure alignment and progress. • Develop and maintain detailed project plans, timelines, dashboards, and status reports. • Facilitate effective communication between internal teams and external partners (vendors, CMOs, and CROs). • Work collaboratively with PMs across functions to identify process improvements, optimize resource planning, and risk mitigation strategies. • Proactively identify risks, issues, and dependencies, and escalate appropriately with mitigation recommendations. • Support the preparation of project documentation, including meeting agendas, minutes, and decision logs. • Track and report progress against milestones to senior management and program leadership.

🎯 Requirements

• Bachelor’s degree in scientific or engineering discipline. • Hands-on experience with sample management, including logistics, shipping, tracking systems, and compliance with GxP requirements. • Strong project management skills with the ability to manage multiple priorities in a dynamic start-up environment. • Excellent communication (verbal and written) and interpersonal skills; proven ability to engage with diverse stakeholders. • Proficiency in project management tools (e.g., MS Project, Smartsheet, or equivalent). • Strong problem-solving skills with a collaborative and solutions-oriented approach. • Highly motivated team player.

🏖️ Benefits

• Open to you working remotely