Lead operational oversight of clinical external manufacturing (CMO) for drug product.
Transition monoclonal antibodies and biotherapeutics into scalable, robust processes from drug substance to drug product stage.
Partner with Quality, Supply Chain, External Manufacturing, and Regulatory CMC to manage technical risk.

Key Responsibilities:

Develop and execute phase-appropriate aseptic strategies for monoclonal and bispecific antibody drug products in vial and prefilled syringe formats.
Ensure strict adherence to cGMP requirements and global health authority expectations regarding aseptic controls.
Execute risk assessments (FMEA) and define process control strategies using QbD principles.

Experience:

Bachelor of Science and 12 years or Master's and 10+ years in Chemical Engineering, Biochemistry, or related scientific discipline.
10+ years in drug product CMC support, with deep understanding of protein stability and sterile manufacturing.
Proven track record as a people leader with strong cross-functional communication and strategic problem-solving abilities.

Dianthus Therapeutics

We develop potentially best-in-class therapies for patients with severe autoimmune diseases. Our lead antibody, claseprubart, is engineered for extended half-life and improved potency, and we are building a culture centered on core principles to elevate patient care.

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