Associate Director, Nuclear Engineering

Summary

We are looking for an Associate Director of Nuclear Engineering who will be responsible for technically designing, managing, and executing a plan for the supply of Th228 used for Pb212 generators to serve drug candidates in a network that can support clinical trials and can be ready for commercial deployment when it is decided by management. You will be an expert leader who is technically proficient in nuclear engineering development for radiopharmaceutical by building a Th228 purification and recycling process at scale. This is a great opportunity to leverage your deep understanding of the competitive landscape to participate and promote a dedicated vision for technical operations to execute a key pillar of the company’s strategy that supports and enhances the company’s long-term plan.

Responsibilities

• Develop an operational plan for developing Th228 process to transfer and manage an efficient manufacturing process of Th/Pb generator to our source holder CDMOs, including the identification and implementation of appropriate manufacturing processes, equipment, use and maintenance.
• Responsible for sourcing and contracting long term supply of isotope and execution of thorium loading processes
• Increase internal technical and operational capabilities to develop the platform including continuous monitoring, improvement and troubleshooting in the scope of process manufacturing of the Th for the generator, radiochemistry form to label any Pb212-candidate of the platform, in process control including QC and release time for both Th and Pb.
• Build the validation need to deliver robust evidence fulfilling to the DMF requirement of the generator and management life cycle of the dossier.
• Develop and execute the process of Th228 recycling including the dangerous good class 7 requirement.
• Manage the recycling of Th source holder to allow up to 99,99% of Th and minimum recovery of 90% decay corrected.
• Set up training, troubleshooting and iteration improvement to a commercial scale up process.
• Develop and maintain relationships with key suppliers and service providers to ensure the reliable and efficient supply of raw materials, equipment, and services.
• Identify and implement process improvements to increase efficiency, reduce costs, and enhance the safety and quality of the products and services provided by ARTBIO.
• Support the approval of the company’s manufacturing sites and their compliance with GMP, HSE and QA standards.
• Provide technical leadership and guidance to the team on nuclear physics, materials science and radiopharmaceuticals state of the art.

Qualifications & Experience

• PharmD, PhD in AlphaRadioChemistry, Radiopharmaceuticals, Chemistry or related field.
• Minimum of 6 years of experience in the radiopharmaceutical field, with a focus on manufacturing and process development.
• Demonstrated experience in developing alpharadiopharmaceutical at early stage.
• Strong technical knowledge and problem-solving skills in radiometal chemistry.
• Experience managing a team of engineers and nuclear scientists, with a track record of delivering projects on time, within budget, and to the required safety and quality standards.
• Strong technical knowledge and problem-solving skills in nuclear physics, materials science, isotopes separation techniques, Irradiation process, radioprotection and radioactive accuracy measurement with the ability to think strategically and communicate effectively with all stakeholders.
• Strong understanding of class 7 dangerous goods regulation to transport Isotopes.
• Program management experience.
• Familiarity with relevant radiopharmaceutical regulations (FDA, EMA), standards, and guidelines and with a GMP manufacturing environment and working with FDA and FDA cGMP regulations required.
• Written and verbal fluency in English.