Director, CMC - Precursor Development & Manufacturing

The Director, CMC – Precursor Development & Manufacturing is responsible for the development, optimization, manufacturing, and lifecycle management of precursor molecules and related reference standards used in the Company’s radiopharmaceutical products. This role provides technical leadership across synthetic chemistry, process development, analytical development, and GMP manufacturing of complex small molecules, including peptide-based and chelator-containing precursors.

The successful candidate will work closely with external contract development and manufacturing organizations (CDMOs) to build process understanding, support analytical method development and validation, and ensure alignment with global regulatory expectations (e.g., ICH, GMP). This work enables the timely delivery of high-quality drug substance and reference standards for clinical and commercial manufacturing. The Director also supports CDMO selection and shipping logistics for precursor materials.

The role also includes leading CMC regulatory writing and documentation to support regulatory submissions for precursors and related reference standards.