QUALIFICATIONS

• KNOWLEDGE: Describe the technical or business knowledge required or desired to complete the job's primary responsibilities.

REQUIRED:

• Ph.D. degree or equivalent in radiochemistry or a related scientific field (e.g., chemistry) in addition to three years of relevant experience.
• Comprehensive understanding of radiochemistry with a focus on 18F/11C or radiometal radiolabeling strategies and troubleshooting.
• Sets up, operates, maintains, cleans, and calibrates automated and semi-automated radiopharmaceutical manufacturing and quality control equipment
• Extensive experience with radiotracer quality control techniques, including High Performance Liquid Chromatography (HPLC), Thin Layer Chromatography (TLC), gas chromatography (GC), Radioactivity Detectors, endotoxin, etc.
• Ability to follow established radiation safety procedures while developing and executing an approved radiochemistry production.
• In collaboration with staff, provides data to support Chemical Manufacturing and Control (CMC) documents as part of IND (Investigational New Drug) submissions to the FDA (Food and Drug Administration)
• General computer skills, experience with databases, cloud-based storage, and the ability to quickly learn/master various scientific computer programs (such as Chemstation, Tracerlab, Chromeleon etc.).
• Ability to work independently and/or as part of a cross-functional team.

DESIRED:

• Expert level knowledge and hands on experience with operating, optimizing, and troubleshooting automated radiosynthesis platforms (prefer GE FX N and/or FX C series of automated modules).
• Prior experience with cyclotron operation is preferred.
• Prior experience with USP <823> or <825> Radiopharmaceutical Drug Production.
• Supervisor experience, especially for training students for performing experiment.