Director, Biologics Formulation Development

About the Company

Dianthus Therapeutics is developing potentially best in class therapies for patients living with severe autoimmune diseases. Their lead candidates focus on extended half-life and improved potency to enable convenient self-administered subcutaneous injections.

Responsibilities

• Lead formulation development strategy for a new bispecific fusion protein from preclinical stage through clinical development
• Design and execute studies to assess protein stability, aggregation, degradation pathways, and viscosity
• Develop liquid and lyophilized formulations to support both IV and SC presentations
• Drive high-concentration formulation development for subcutaneous delivery, including syringeability and device compatibility
• Partner with Analytical Development, Drug Substance, Process Development, Quality, and Regulatory teams
• Collaborate with external CDMOs to ensure alignment between formulation strategy and manufacturability
• Provide technical leadership for drug product process development, fill-finish, and tech transfer
• Serve as the formulation subject matter expert during regulatory interactions and CMC filings

Requirements

• Ph.D. in Pharmaceutical Sciences, Chemistry, Chemical Engineering, Biochemistry, or related field with 10+ years of industry experience, or M.S. with 12+ years
• Deep expertise in formulation development for biologics (mAbs, bispecifics, or fusion proteins)
• Hands-on experience with protein stability assessment, excipient selection, and buffer optimization
• Experience developing formulations for high-concentration biologics for SC and IV delivery
• Experience working with external CDMOs and managing outsourced development activities
• Strong understanding of drug product manufacturing, fill-finish, and container closure systems
• Familiarity with regulatory expectations for biologics programs

Preferred Qualifications

• Prior experience supporting regulatory submissions and health authority interactions