Director of Chemistry, Manufacturing and Controls
About the role
Director of Chemistry, Manufacturing and Controls (CMC) to lead radiochemistry and CMC organization for Oklo’s isotope production programs, initially focused on Lu-177 production and Am-241 and Ra-226 processing. On-site in Austin, TX.
Responsibilities
- 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.
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.
Skills
Benefits
- Salary: $170,000-$250,000
- flexible time off
- equity
- bonuses
- competitive pay
- 401(k)
- health insurance (with employer contribution)
- HSA
- FSA
- flexible work hours
- wellness credits
- other benefits

About Oklo
Emission free, always on power from advanced fission power plants.
About Oklo Inc.: Oklo Inc. (Oklo) is developing advanced fission power plants to provide emission-free, reliable, and affordable energy. Oklo received a Site Use Permit from the U.S Department of Energy, has performed successful prototypic fuel fabrication, was awarded fuel material from Idaho National Laboratory, developed the first advanced fission combined license application accepted and docketed by the U.S. Nuclear Regulatory Commission, and is developing advanced fuel recycling technologies in collaboration with the U.S. Department of Energy and national laboratories. Oklo has been featured in Time, Newsweek, Wall Street Journal, CNBC, Popular Mechanics, Wired, Architectural Digest, Hyperallergic, POWER Magazine, has been the subject of a Harvard Business School case, and is featured in the Oliver Stone documentary Nuclear, among other features.
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