Cyclotron Radio Pharmacist

Job title : Cyclotron Radio Pharmacist

Job Purpose

• 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.

Qualifications

• 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.