Senior Radiochemist, R&D Technical Development (Pb212 isotope)

The Senior Radiochemist, R&D Technical Development (Pb212 isotope) is responsible for executing and supporting AdvanCell’s Pb212 Radioisotope technical development activities, with a primary focus on process optimization, characterisation, scale-up activities and supporting preclinical and development supply of Pb212. The role contributes to developing and advancing the technical processes, product understanding, and scientific knowledge required to support AdvanCell’s pre-clinical programs and future clinical development. This includes planning and executing development and optimization studies, generating process and product knowledge, troubleshooting technical challenges, and supporting the development of robust and scalable processes. Working under the direction of the SVP, R&D Technical Development, the Senior Radiochemist provides strong hands-on radiochemistry expertise and takes a leading role in the execution and scientific interpretation of FDP development studies. The role works closely with Drug Discovery, CMC, MSAT, Manufacturing, Quality, QC, Engineering, and external technical partners to support program requirements and progression of FDP processes through development. The position is intentionally focused on R&D technical development and development-stage activities rather than routine GMP manufacturing execution or batch release. The Senior Radiochemist supports the generation and transfer of appropriate process and product knowledge to MSAT, Manufacturing, QC, and Quality as FDP processes mature. Key Responsibilities and Duties Generator & Pb-212 Process Development • Plan and execute radiochemistry development activities supporting AdvanCell's Pb-212 generator and radionuclide production technologies. • Develop, characterize, and optimize processes associated with generator operation, Pb-212 collection, recovery, purification, concentration, formulation, and transfer. • Investigate the impact of key process variables including source activity, collection time, eluent composition, flow rate, rinse conditions, process volumes, hold times, transfer conditions, and purification parameters. • Design and execute structured development, optimization, and characterization studies to improve process performance, robustness, reproducibility, and scalability. • Identify sources of process variability, yield loss, contamination, or performance degradation and develop practical, scientifically justified solutions. • Troubleshoot generator, purification, and Pb-212 production issues and provide technically supported recommendations. • Evaluate new reagents, materials, equipment, consumables, and technologies relevant to generator and Pb-212 process development. Pb-212 Purification & Characterization • Develop and optimize purification processes for Pb-212 generated from AdvanCell's radionuclide generator systems. • Characterize Pb-212 product quality throughout development, including radionuclidic purity, radiochemical behaviour, recovery, process yield, chemical purity, and other relevant quality attributes. • Investigate the impact of generator and purification conditions on Pb-212 quality and downstream suitability. • Develop process understanding around radionuclide breakthrough, impurities, adsorption, transfer losses, decay-related effects, and other factors affecting Pb-212 recovery and quality. • Support development of fit-for-purpose analytical and characterization approaches in collaboration with Analytical Development and QC. • Generate experimental evidence and scientific rationale to support specification development, process controls, and future manufacturing implementation. Generator Development & Scale-Up • Support development and optimization of generator operating processes from laboratory-scale development through clinically and commercially relevant configurations. • Execute studies assessing generator performance including emanation, collection efficiency, purification recovery, reproducibility, operating cycle, and output consistency. • Support characterization of generator performance across different source activities, configurations, operating conditions, and scales. • Contribute to the identification and characterization of critical and important process parameters and appropriate operating ranges. • Support development of robust and scalable generator and Pb-212 production processes suitable for subsequent transfer to MSAT and Manufacturing. • Generate the experimental data and process understanding required to support generator design and process-development decisions. Technical Transfer & Development Readiness • Prepare clear experimental records, development reports, protocols, and technical summaries. • Capture process knowledge, development history, and scientific rationale to enable effective knowledge transfer. • Support technology-transfer and scale-up activities with MSAT and Manufacturing. • Provide technical support during early implementation and troubleshooting of transferred processes. • Work with the Director to identify technical gaps requiring further development before transfer. Cross-Functional Collaboration • Work closely with FDP development colleagues to define testing requirements and interpret analytical results supporting overall drug product development. • Collaborate with Preclinical, Drug Discovery, CMC, MSAT, Manufacturing, Quality, and external partners as required. • Provide radiochemistry expertise during technical discussions and development planning. • Support externally performed radiochemistry or FDP-development activities where required. Team Support • Provide day-to-day technical guidance and scientific support to junior scientists and radiochemists. • Support planning and prioritization of experimental activities within the team. • Promote safe working practices, good scientific documentation, and high-quality experimental execution. • Contribute to a collaborative, scientifically rigorous, and practical R&D environment. Essential Skills, Qualifications, Industry and Educational Requirements • Degree in Radiochemistry, Chemistry, Pharmaceutical Sciences, Biochemistry, or a related discipline; PhD or equivalent advanced experience preferred. • 3+ years of relevant radiochemistry or radiopharmaceutical-development experience, with demonstrated ability to work independently in the laboratory. • Strong hands-on experience with radiolabelling and radiopharmaceutical process development. • Experience with therapeutic radionuclides and short-lived radiopharmaceuticals strongly preferred; experience with Pb-212 or other alpha-emitting radionuclides is highly desirable. • Experience with formulation, process optimization, troubleshooting, and experimental design. • Experience supporting preclinical radiopharmaceutical studies is desirable. • Good understanding of radiopharmaceutical analytical techniques sufficient to interpret and apply analytical data during process development. • Understanding of pharmaceutical development, GMP, and CMC principles appropriate to a development-stage role. • Strong experimental, problem-solving, documentation, and communication skills. • Ability to work effectively across multidisciplinary teams while maintaining ownership of hands-on technical activities.