Director of Chemistry, Manufacturing and Controls

Thanks for your interest in Oklo! We are searching for a Director of Chemistry, Manufacturing and Controls (CMC) to join our team.

Position Description

Oklo Isotopes is building scalable U.S. radioisotope production capabilities in facilities dedicated to producing essential isotopes for healthcare, space, industry, research, and defense applications. Oklo’s isotope operations include the production and processing of medically and industrially important radioisotopes using advanced radiochemical processes, hot cells, gloveboxes, and specialized nuclear facilities.

We are seeking a Director of Chemistry, Manufacturing and Controls (CMC) to lead the radiochemistry and CMC organization supporting Oklo’s isotope production programs, initially focused on Lu-177 production and Am-241 and Ra-226 processing for medical, industrial, and other applications.

The Director will lead radiochemical process development and control, technology transfer, analytical strategy, process optimization, troubleshooting, validation support, and process lifecycle management, while building and managing a multidisciplinary radiochemistry team.

The successful candidate will develop rigorous, scalable processes from development through commissioning and routine manufacturing. The role requires deep radiochemistry and isotope-processing expertise, strong technical and team leadership, and experience in nuclear, radiological, quality, and cGMP environments.

The Director will collaborate across Manufacturing, Facility Operations, Quality, Regulatory, Radiation Safety, Engineering, and Supply Chain to establish safe, compliant, reliable, and scalable isotope production.

This is a on-site position located in Austin, Texas.

Specific

• •Lead the CMC and radiochemistry organization for isotope process development, implementation, technical support, and lifecycle management.
• •Lead Lu-177 production and Am-241 and Ra-226 processing, including dissolution, separation, purification, recovery, impurity control, characterization, and waste minimization.
• •Establish the technical basis for manufacturing processes, including process flows, material balances, critical parameters, operating ranges, specifications, and controls.
• •Lead development, scale-up, optimization, and implementation of radiochemical processes in hot cells, gloveboxes, and laboratory or remote systems.
• •Lead technology transfer and manufacturing readiness, including processes, equipment, analytics, procedures, training, and documentation.
• •Establish and maintain the cGMP technical framework, including process characterization, validation, continued verification, change control, deviations, investigations, and continuous improvement.
• •Own the analytical strategy for products, intermediates, impurities, waste streams, and process performance.
• •Serve as the senior technical authority for process troubleshooting and optimization, focused on yield, purity, recovery, reliability, cycle time, waste, dose, and capacity.
• •Support equipment design, commissioning, qualification, startup, and operational readiness with Manufacturing, Operations, Engineering, Quality, Radiation Safety, Regulatory, and Supply Chain.
• •Build, mentor, and manage the radiochemistry team; establish technical standards, procedures, training, and documentation; and promote safety, quality, rigor, and operational excellence.
• •Support regulatory activities, audits, inspections, and development of new isotope products, processes, technologies, and capabilities.