Senior Radiochemist will apply extensive knowledge of radiochemistry in the manufacturing of clinical-grade radiopharmaceuticals to ensure the quality of clinical and investigational radiopharmaceuticals as specified by the standards stated in the USP Chapter <823> and 21 CFR 210, 211, 212. The individual will be familiar with equipment installation, maintenance, repair and technical support projects in
functional areas of the radiochemistry laboratory. The senior radiochemist will develop new approaches in the synthesis and labeling of novel radiopharmaceuticals for clinical use, and work with a multidisciplinary team in developing Chemistry, Manufacturing, and Control for investigational drug applications (IND) and New Drug Applications/Abbreviated New Drug Application (NDA/ANDA) submitted to the FDA. The
individual will collaborate actively and develop new investigations in these areas. The candidate will also report to the Associate Director and Directors of the PET Center and the Technical Manager of the PET Center for helping to manage and further develop standard operating procedures for the investigational Positron Emission Tomography (PET) drugs such that the facilities, equipment, and inventory control meet
the associated regulatory requirements. Key responsibilities: Lead the development of new procedures for the translation of new and/or novel radiotracers for investigational clinical use. Develop manual or automated radiosynthesis protocols for manufacturing clinical-grade radiopharmaceuticals Develop quality control methods for new or novel radiopharmaceuticals Plan and perform production and quality control
of radiopharmaceuticals according to current good manufacturing practices and aseptic technique Ensure that all manufacturing equipment are suitable and in working condition and all raw materials are qualified and within expiry before radiopharmaceutical production Ensure that radiopharmaceuticals used for clinical and research applica
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