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 define process control strategies using QbD principles
• Troubleshoot manufacturing issues and implement process improvements
• Lead deviation investigations, CAPAs, and change controls
• Review CMC sections (Module 3) for regulatory submissions including INDs, IMPDs, and BLAs
• Serve as a Subject Matter Expert during regulatory agency interactions, audits, and pre-approval inspections
• Manage vendor and CDMO relationships regarding deliverables, budgets, and timelines

Requirements

• Bachelor of Science with 12 years of experience or Master’s with 10+ years of experience in Chemical Engineering, Biochemistry, Pharmaceutics, or related disciplines
• 10+ years of experience in drug product CMC support
• Deep understanding of protein stability, prefilled syringe handling, isolator/RABS technologies, and sterile manufacturing
• Extensive knowledge of cGMP standards, ICH guidelines, and authoring BLAs
• Proven track record as a people leader
• Ability to travel up to 5-10%

Preferred Qualifications

• Functional knowledge of analytical instruments