Dianthus Therapeutics - Associate Director/Director Drug Product, CMC

• Develop and execute robust, phase-appropriate aseptic strategies for monoclonal and bispecific antibody drug products (liquid and lyophilized) in vial and prefilled syringe formats. • Experience managing CMOs and technology transfer of processes to external Contract Manufacturing Organizations (CDMOs). • Develop a robust manufacturing process based on sound knowledge of the functionality of vial/PFS Fillers, Isolators, RABS, Sterilizers and other ancillary equipment. • Ensure strict adherence to cGMP requirements and global health authority expectations (FDA, EMA) regarding aseptic controls. • Collaborate with formulation and device development teams to create stable, high-concentration liquid formulations that minimize protein aggregation. • Execute risk assessments (e.g., FMEA) and define process control strategies using QbD principles. • Troubleshoot manufacturing issues, analyze data, and implement process improvements through life cycle management of Drug Product. . • Lead deviation investigations, CAPAs (Corrective and Preventive Actions), and change controls. • Review CMC sections (Module 3) for regulatory submissions including INDs, IMPDs, and BLAs. • Serve as a Subject Matter Expert (SME) during regulatory agency interactions, audits, and pre-approval inspections (PAI) • Manage vendor and CDMO relationships, ensuring alignment with project deliverables, budgets, and timelines • Functional knowledge of analytical instruments is preferred but is not required.