- The Cyclotron Radiopharmacist will be responsible for providing strategic leadership and technical oversight for all cyclotron and radiopharmacy operations, ensuring the safe, efficient, and regulatory-compliant production of high-quality radiopharmaceuticals.
- This role is pivotal in supporting advanced diagnostic imaging by guaranteeing the consistent availability of pure and effective radiotracers for nuclear medicine procedures.
- The role holder will manage production schedules, enforce stringent quality control measures, lead a team of radiopharmacy professionals, and uphold the highest standards of radiation safety and regulatory compliance, ultimately contributing to exceptional patient care and clinical outcomes.
Key Accountabilities/Responsibilities
Radiopharmaceutical Production & Operations Management:
- Manage and oversee the entire production process of radiopharmaceuticals, ensuring strict adherence to established synthesis protocols and safety standards.
- Optimize daily production schedules to efficiently meet clinical demand and implement sterile compounding techniques and aseptic conditions.
- Lead the planning and execution of cyclotron operations, including target preparation, irradiation, and target processing.
- Develop and implement departmental Standard Operating Procedures (SOPs) for all aspects of radiopharmaceutical production.
Quality Assurance & Regulatory Compliance
- Implement and monitor comprehensive quality control measures to ensure the safety, efficacy, purity, and potency of all radiopharmaceuticals.
- Develop and validate robust analytical methods for the testing and characterization of radiopharmaceutical batches.
- Ensure 100% compliance with all local and international regulations (e.g., NAFDAC, IAEA, pharmacopoeial standards) and prepare for regulatory inspections and audits.
- Investigate and resolve any out-of-specification (OOS) results or deviations and lead continuous quality improvement initiatives.
Equipment Management & Maintenance
- Oversee maintenance and calibration programs for the cyclotron and all associated radiopharmacy equipment (e.g., synthesis modules, dose calibrators, analytical instruments).
- Develop and implement robust preventative maintenance schedules to ensure optimal performance, reliability, and longevity of all critical equipment.
- Coordinate with external service providers for specialized equipment repairs, certifications, and compliance testing.
- Evaluate and recommend the acquisition of new radiopharmacy equipment and technologies.
Research, Innovation & Interdisciplinary Collaboration
- Actively participate in research initiatives to develop novel radiopharmaceuticals and explore new applications, collaborating on clinical trials.
- Stay updated on the latest scientific advancements in radiochemistry, nuclear medicine, and pharmaceutical sciences.
- Collaborate closely with nuclear medicine physicians, technologists, and other departments to optimize imaging protocols and patient care.
- Liaise with regulatory agencies, procurement teams, and senior management to ensure seamless operations and strategic alignment.
- Doctor of Pharmacy (Pharm.D.) or Master's/PhD in Radiopharmacy, Radiochemistry, Pharmaceutical Sciences, or a closely related field.
- Formal training and certification in Good Manufacturing Practice (GMP) , Good Radiopharmacy Practice (GRPP) , and radiation safety is highly preferred.
- Eligibility to act as a Qualified Person for radiopharmaceuticals is a distinct advantage.
- 5 - 7 years of progressive experience in a clinical or research radiopharmaceutical environment, with direct, hands-on experience in cyclotron operations and radiopharmaceutical production.
- Demonstrated, in-depth expertise in the GMP-compliant production and quality control of radiopharmaceuticals for PET imaging.
- Proven experience in leading teams, managing operational schedules, and developing SOPs within a regulated environment.
- Expert knowledge of analytical techniques (HPLC, TLC, gamma-ray spectrometry) and sterile compounding.
- Strong track record in regulatory compliance, audits, and meticulous documentation.
- Experience in research, development, and validation of novel radiopharmaceuticals is a distinct advantage.
- Excellent communication, leadership, and interpersonal skills.