Associate Director/Director Drug Product, CMC

About the Company

Dianthus Therapeutics is developing potentially best in class therapies for patients living with severe autoimmune diseases. Their lead antibody and clinical candidates are engineered for improved potency and patient-friendly, self-administered subcutaneous injections.

Responsibilities

• Develop and execute phase-appropriate aseptic strategies for monoclonal and bispecific antibody drug products in vial and prefilled syringe formats


• Manage CMOs and technology transfer of processes to external CDMOs


• Develop manufacturing processes based on knowledge of vial/PFS Fillers, Isolators, RABS, and Sterilizers


• Ensure strict adherence to cGMP requirements and global health authority expectations (FDA, EMA)


• Collaborate with formulation and device development teams to create stable, high-concentration liquid formulations


• Execute risk assessments and...