About Us
We are developing potentially best-in-class therapies for patients living with severe autoimmune diseases. Our lead antibody, claseprubart (DNTH103), is purposefully engineered with extended half-life, improved potency, and high selectivity for only the active C1s complement protein that drives disease pathology – enabling less frequent and more convenient self-administered subcutaneous injections. Our second clinical candidate, DNTH212 is a first and potentially best in class, bifunctional inhibitor that targets clinically validated and complementary disease modifying mechanisms, Type 1 IFN suppression and B cell modulation – enabling potential for improved clinical outcomes and patient friendly convenient, self-administered subcutaneous injections. Our newest candidate, DNTH312, is an internally developed, investigational, first-in-class, next-generation bifunctional fusion protein combining claseprubart and TACI to target potent inhibition of aC1s and BAFF/APRIL. DNTH312 aims to be Phase 1 ready by year end 2027. To learn more, please visit www.dianthustx.com and follow us on LinkedIn .
About the Role
Dianthus Therapeutics is seeking an Associate Director or Director of Quality Assurance to join our growing CMC Quality team. In this role, you will provide quality oversight across the development, manufacturing, and regulatory approval of Dianthus products, with a direct impact on the investigational medicines we deliver to patients.
Reporting to the Executive Director, Quality Assurance, you will lead QA oversight of key external manufacturing (CROs) and testing partners (CTOs) across biologics and combination products. You will work closely with CMC Technical Operations, Manufacturing, Supply Chain, Regulatory Affairs, and other functions to solve complex quality challenges, support regulatory readiness, and ensure our clinical programs continue to move forward.
You will partner closely with CMC Technical Operations, Manufacturing, Supply Chain, Regulatory Affairs, and Project Management, working both independently and collaboratively to resolve issues and moving multiple complex programs forward in line with corporate goals and regulatory requirements.
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
CMC and Manufacturing Oversight
Provide QA oversight of CMO operations for cell banks, drug substance, and drug product/combination product, including review and approval of protocols, master batch records, starting material and finished product specifications, analytical test methods and raw data, stability reports, and method qualification/validation reports.
Ensure clinical manufacturing operations comply with cGMP requirements and Dianthus policies and procedures.
Disposition cell banks, drug substance, and finished drug product for clinical supply, including review of executed batch records and release and stability data.
Work with our external Qualified Person (QP) to ensure investigational product is suitable for release in EU.
Provide quality oversight of label and artwork review and approval.
Provide quality input to process development, technology transfer, comparability, and stability strategies, and approve key technical protocols and reports.
Quality Systems and Compliance
Serve as QA lead for deviations, investigations, OOS results, and change controls, including root-cause analysis and product impact assessment.
Lead or participate in risk assessments, including design and process FMEAs.
Partner with the Quality team to build, implement, and maintain phase-appropriate quality systems.
Monitor the evolving regulatory landscape and update policies, procedures, specifications, and other quality documents accordingly.
Act as the subject matter expert on CMC quality and compliance matters, providing guidance to teams across…