Associate Director, Nuclear Engineering

Summary

This expert 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. The successful candidate will be an expert thinker who is also technically proficient in nuclear engineering development for radiopharmaceutical by building a Th228 purification and recycling process at scale. In addition, the nuclear Engineer must have a deep understanding of the competitive landscape and the ability to integrate learnings and failures from others to improve the manufacturing process and supply of Th228.

Responsibilities

• 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.
• Responsible for sourcing and contracting long term supply of isotope 
• Responsible for execution of thorium loading processes 
• 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.
• 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.
• Build operations, GMP, HSE, Business continuity and quality culture.
• Design new facilities if needed considering to internalize the critical processes.
• Develop and maintain relationships with key suppliers and service providers to ensure the reliable and efficient supply of raw materials, equipment, and services.
• Ensure compliance with all relevant regulations, standards, and guidelines, including those relating to quality, safety, and environmental impact for our CDMOs, internal R&D and own projects for the use of Th.
• 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.
• Communicate effectively with all stakeholders, including senior management, customers, suppliers, and regulators, to ensure that everyone is aligned on the strategic vision and objectives of the company.
• Stay abreast of technological advancements and market trends in the field of Th upstream processes and daughters mechanism and provide guidance to the senior management team on how ARTBIO can leverage these trends to enhance its competitive position.
• Provide technical leadership and guidance to the team on nuclear physics, materials science and radiopharmaceuticals state of the art.
• Support the company in fund raising.

Qualifications & Experience

• PharmD, PhD in Nuclear Engineering or related field.
• Minimum of 5 years of experience in the radiopharmaceutical/engineering development field, with a focus on manufacturing and process development of isotopes.
• Experience in manufacturing processes for radioactive materials
• Demonstrated experience in developing and operating complex radioactive separation and control technologies, ideally in the field of Isotopes manufacturing.
• 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.
• Excellent organizational and project management skills, with the ability to prioritize and multitask effectively.
• Familiarity with relevant regulations (FDA, EMA), radioactive standards reference (NIST), and guidelines, including those relating to quality, safety, and environmental impact.
• Excellent know-how on regulatory requirements related to drug development.
• Familiarity with current US and EU regulatory requirements for therapeutic products.
• Written and verbal fluency in English.