Associate Director, CMC - Analytical Development

Partnering closely with Process Development, MSAT, Quality, Regulatory Affairs, and External Manufacturing partners, the Associate Director, CMC - Analytical Development provides strategic and technical leadership for analytical activities supporting the development and commercialization of ²¹²Pb-based APIs and radiopharmaceutical products.

The role is responsible for establishing phase-appropriate analytical strategies, specifications, and control approaches that support GMP manufacturing, product release, stability programs, and regulatory submissions.

The successful candidate leads CMC regulatory authoring and documentation related to analytical development and validation, reference standards, and stability programs, supporting global regulatory submissions, lifecycle management activities, and responses to health authority inquiries. The role also drives continuous improvement initiatives to strengthen analytical capability, product and process understanding, and the advancement of the company's radiopharmaceutical portfolio.

Working in close collaboration with Technical Development, MSAT, Quality, Engineering, and Operations, this position provides leadership across analytical method development, qualification, validation, transfer, and laboratory readiness activities to ensure robust and reliable analytical support for clinical and commercial manufacturing.

In addition, the Associate Director provides analytical expertise to the Sr. Director of Precursor Development and Director of External Manufacturing to support CDMO activities, manufacturing investigations, and the implementation of effective analytical control strategies. The role helps ensure alignment between internal development programs and external manufacturing operations to maintain a reliable, scalable, and compliant supply network.