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 responsibilities may include:

• 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.

Minimum Qualifications:

• Masters in Radiochemistry, Chemistry, Chemical Engineering, Nuclear Engineering, or a closely related technical discipline.

• 10+ years of progressively responsible experience in radiochemistry, isotope production, radiochemical processing, nuclear chemical operations, pharmaceutical/radiopharmaceutical manufacturing, or a closely related field.

• Experience with cGMP manufacturing (US and EU requirements), particularly radiopharmaceuticals, medical isotopes, APIs, radioactive starting materials, or other regulated pharmaceutical manufacturing.

• Experience with CMC development, process characterization, technology transfer, process validation, continued process verification, and manufacturing science and technology (MS&T).

• Direct experience with Lu-177 production, lanthanide separations, target dissolution, radionuclide purification, or medical-isotope manufacturing.

• Demonstrated experience leading technical teams responsible for complex chemical, radiochemical, or manufacturing processes.

• Strong technical background in radiochemical separations, purification, radioactive-material handling, analytical chemistry, and process development.

• Demonstrated experience translating laboratory or development processes into reliable manufacturing operations.

• Experience with process development, scale-up, process optimization, technology transfer, troubleshooting, and technical lifecycle management.

• Experience working in highly regulated environments requiring disciplined procedures, documentation, configuration control, and quality systems.

• Demonstrated ability to lead complex technical investigations and make sound decisions using scientific and engineering data.

• Experience developing technical procedures, specifications, reports, process documentation, and training materials.

• Strong leadership, communication, technical writing, organizational, and problem-solving skills.

• Demonstrated ability to collaborate across Manufacturing, Operations, Engineering, Quality, Regulatory, Radiation Safety, and other multidisciplinary organizations.

• Experience with various regulatory regimes affecting isotope production and processing (FDA, NRC, DOE, etc.) regulatory frameworks relevant to radioactive-material and isotope manufacturing.

Bonus Qualifications:

• Passionate about unleashing beneficial isotopes and building domestic isotope-production capabilities.

• A strong technical leader who can maintain scientific rigor while moving programs rapidly toward manufacturing.

• Committed to nuclear safety culture, product quality, procedural compliance, and operational excellence.

• Capable of moving comfortably between detailed radiochemical problems and broader program and organizational decisions.

• Able to develop people and build a high-performing technical organization.

• Comfortable making decisions in technically complex environments where complete information may not always be available.

• Effective at translating scientific development into practical, repeatable manufacturing processes.

• Collaborative and able to work across Manufacturing, Facility Operations, Quality, Regulatory, Engineering, Radiation Safety, and Supply Chain.

• Comfortable in a fast-paced, highly iterative startup environment.

• Willing to challenge established approaches and develop novel solutions to difficult isotope-production problems.

• An excellent technical communicator capable of communicating complex chemistry and manufacturing issues clearly to technical and nontechnical audiences.

• Detail-oriented and disciplined about technical documentation, configuration control, quality, and follow-through.

• Able to balance near-term production needs with long-term process robustness and manufacturing scalability.

Who you are:

A startup person : You aren't driven by titles or hierarchy, and prefer efficiency to excess process. You don't need or expect to have a lot of guidance but you enjoy working in a fast-paced team. If you prefer the culture and feel of a large organization, that is great, but you likely won’t enjoy working with us! There is plenty of important work and plenty of good opportunities with organizations like that.

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