Cyclotron Radiochemist (Quality Control)

Job title : Cyclotron Radiochemist (Quality Control)

Job Purpose

• The Cyclotron Radiochemist (Quality Control) will be responsible for ensuring the safety, efficacy, and quality of all radiopharmaceuticals produced at the hospital's cyclotron facility. This position is critical for supporting our advanced Positron Emission Tomography (PET) imaging services and advancing nuclear medicine by guaranteeing the reliable production of high-purity, clinically effective radiotracers.
• The role holder will lead all quality control (QC) operations, oversee the development and optimization of QC methods, and ensure strict compliance with international regulatory standards, including Good Manufacturing Practice (GMP).
• This position is central to patient safety, requiring expert technical knowledge, meticulous attention to detail, and a strong commitment to excellence. 

Key Accountabilities/Responsibilities
Quality Control & Assurance (Primary Focus):

• Lead and perform comprehensive quality control testing for all produced radiopharmaceuticals, including analyses for radiochemical purity (using HPLC, TLC), chemical purity, pH, radionuclidic identity (using gamma-ray spectrometry), and sterility. 
• Manage the QC laboratory, ensuring all equipment is calibrated, maintained, and qualified, and that all processes are compliant with GMP principles. 
• Maintain meticulous and complete documentation for all QC batches, ensuring full traceability and data integrity in compliance with international regulatory standards. 
• Develop, validate, and implement new QC standard operating procedures (SOPs) for novel radiotracers, ensuring they meet the stringent requirements for clinical use and investigational new drug (IND) applications. 

Radiopharmaceutical Production & Development Support:

• Support the routine synthesis, purification, and QC of a range of PET radiotracers using automated synthesis modules, stepping in to perform technical duties as needed. 
• Develop and optimize new radiochemistry methods and procedures to support clinical and research needs, collaborating with the production team. 
• Manage and coordinate the production schedule to efficiently meet clinical demand, working closely with the cyclotron and nuclear medicine teams. 

Radiation Safety & Regulatory Compliance:

• Ensure full compliance with all regulations set by international and local bodies for radiopharmaceutical production and laboratory safety. 
• Adhere to, and actively promote, strict radiation safety protocols for the handling, storage, and disposal of radioactive materials, participating in audits and inspections. 

Research & Innovation:

• Actively participate in research and development projects to innovate new radiotracers and improve existing synthesis and QC protocols. 
• Contribute to clinical trials by providing investigational radiopharmaceuticals and technical expertise on QC matters.
• Contribute to the scientific community by publishing findings in peer-reviewed journals and presenting at conferences.

Training & Collaboration:

• Train and mentor junior radiochemists and technologists on quality control procedures, synthesis techniques, and safety practices, fostering a culture of quality and compliance. 
• Collaborate effectively with cyclotron physicists, nuclear medicine physicians, and radiologists to ensure seamless workflow and high-quality patient care. 
• Provide expert technical advice to multidisciplinary teams on the selection, use, and quality control of appropriate radiopharmaceuticals.

Qualifications & Experience

• Master’s or PhD in Chemistry, Radiopharmaceutical Chemistry, Radiopharmacy, or a closely related field. 
• Formal training and certification in GMP and radiopharmacy is highly preferred. 
• Eligibility to act as a Qualified Person for radiopharmaceuticals is a distinct advantage. 
• 3 - 5 years of hands-on experience in a clinical or research radiopharmaceutical production environment, specifically with PET radiotracers. 
• Demonstrated, in-depth expertise in GMP-compliant quality control of radiopharmaceuticals. 
• Proven track record in method development, validation, and optimization of QC methods for novel radiopharmaceuticals. 
• Experience in a regulated laboratory environment, with expert knowledge of analytical techniques (HPLC, GC, TLC, gamma-ray spectrometry). 
• Experience in training or mentoring staff is desirable.