Director, Isotope CMC & Radiochemistry

Oklo; Austin (TX); On-site; USD 240,000 - 360,000; Full time

Benefits offered by this job

Flexible time off

Equity

Bonuses

Competitive pay

401(k)

Health insurance (employer contrib.)

HSA

FSA

Flexible work hours

Wellness credits

Job summary

Oklo in Austin, Texas is seeking a Director of Chemistry, Manufacturing and Controls (CMC) to lead radiochemistry and CMC for isotope production programs, starting with Lu-177 and Am-241/Ra-226 processing. You will oversee process development, tech transfer, analytics strategy, validation, and lifecycle management in a regulated environment.

The role requires deep radiochemistry expertise, strong leadership, and experience in nuclear, radiological, quality, and cGMP settings, with collaboration

Qualifications

• Masters in Radiochemistry, Chemistry, Chemical Engineering, Nuclear Engineering, or a closely related technical discipline.
• 10+ years of radiochemistry, isotope production, radiochemical processing, nuclear chemical operations, pharmaceutical/radiopharmaceutical manufacturing, or related field.
• Experience with cGMP manufacturing (US and EU requirements), radiopharmaceuticals, medical isotopes, APIs, or radioactive starting materials.
• Experience with CMC development, process characterization, technology transfer, process validation, continued process verification, and MS&T.
• Direct experience with Lu-177 production, lanthanide separations, target dissolution, radionuclide purification, or medical-isotope manufacturing.
• Demonstrated experience leading technical teams for complex chemical/radiochemical/manufacturing processes.
• Strong radiochemical separations, purification, radioactive-material handling, analytical chemistry, and process development background.
• Experience translating lab/development processes to manufacturing operations.
• Experience with process development, scale-up, optimization, technology transfer, and troubleshooting.
• Experience in regulated environments with disciplined procedures, documentation, configuration control, and quality systems.

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 lab/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 cross-functional teams.
• Build, mentor, and manage the radiochemistry team; establish standards, procedures, training, and documentation; promote safety, quality, rigor, and excellence.
• Support regulatory activities, audits, inspections, and development of new isotope products, processes, technologies, and capabilities.

Skills

Leadership

Radiochemistry expertise

Analytical chemistry

Project management

Cross-functional collaboration

Education

Masters in Radiochemistry

Chemistry/Chemical Engineering/Nuclear Engineering

10+ years radiochemistry/radioisotope experience

cGMP manufacturing experience

CMC development/technology transfer

Lu-177 / radionuclide processing experience

Leadership of technical teams

Regulatory knowledge (FDA/NRC/DOE)

Technical documentation and procedures

Strong communication

Job description

Oklo in Austin, Texas is seeking a Director of Chemistry, Manufacturing and Controls (CMC) to lead radiochemistry and CMC for isotope production programs, starting with Lu-177 and Am-241/Ra-226 processing. You will oversee process development, tech transfer, analytics strategy, validation, and lifecycle management in a regulated environment.

The role requires deep radiochemistry expertise, strong leadership, and experience in nuclear, radiological, quality, and cGMP settings, with collaboration