CMC Project Manager

CMC Project Manager

Dianthus Therapeutics is a publicly traded, clinical-stage biotechnology company dedicated to designing and delivering novel, best-in-class monoclonal antibodies with improved selectivity and potency. Based in New York City and Waltham, Mass., Dianthus is comprised of an experienced team of biotech and pharma executives who are leading the development of next-generation antibody complement therapeutics, aiming to deliver transformative medicines for people living with severe autoimmune and inflammatory diseases.

About the Role

As the CMC Project Manager you will be a critical team member to our technical operations group and will support the planning, execution, and oversight of key CMC activities across our pipeline.

Reporting to the Director, CMC Program Management, this position will own non-clinical sample management processes and additional workstreams, including coordinating Chemistry, Manufacturing, and Controls (CMC) operational planning, oversight of documentation timelines, risk management, and budget planning to support our development programs.

On a day-to-day basis you will follow up with internal stakeholders and communicate project updates to the team, maintain project timelines, develop templates to track deliverables, and facilitate meetings, including agendas, meeting minutes, and tracking action items. You must have experience in sample management, outstanding organizational and communication skills, and the ability to work collaboratively and engage effectively with cross-functional stakeholders and external partners.

This is an exciting opportunity to work with a collaborative, cross-functional team, building project management tools and processes supporting initiatives across our portfolio. We are building a culture of individuals who hold our core principles at the center of our operations, with the goal to elevate the care of our patients' lives. We are open to you working remotely.

Key Responsibilities

• 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.

Experience