Radiochemist

Full-Time | 2-Year Contract

About the role

The South Australian Health and Medical Research Institute (SAHMRI) is South Australia's independent flagship health and medical research institute. SAHMRI is dedicated to delivering innovative, world-class research that improves health outcomes and transforms the quality of life of people locally, nationally and globally. We are seeking an experienced Radiochemist to join the Molecular Imaging and Therapy Research Unit (MITRU). This role offers a unique opportunity to work within a GMP-compliant radiopharmaceutical manufacturing facility responsible for the production and quality control testing of PET radiotracers used in clinical and research applications.

The successful candidate will undertake specialised radiochemistry activities involving the manufacture, testing, validation and release of radiopharmaceutical products in accordance with Good Manufacturing Practice (GMP), radiation safety requirements and British Pharmacopoeia standards.

Responsibilities

Key Responsibilities

• Conduct analytical and microbiological testing of radiopharmaceutical products in accordance with British Pharmacopoeia (BP) monographs and GMP requirements.
• Assess product quality using specialised analytical instrumentation and methods.
• Review test results and provide recommendations regarding batch approval or rejection to the Qualified Person/Authorised Person and management team.
• Perform qualification and verification of raw materials, reagents and suppliers.
• Conduct stability studies, investigations, validation activities and trend analysis to support continuous process improvement.
• Maintain accurate GMP-compliant records, laboratory documentation and quality reports.
• Calibrate, standardise and maintain laboratory equipment and testing systems.
• Prepare, review and update Standard Operating Procedures (SOPs), validation protocols and other GMP documentation.
• Support internal audits and regulatory compliance activities.

Production Functions

• Manufacture radiopharmaceutical products and PET radiotracers using aseptic techniques and validated GMP processes.
• Prepare synthesis modules, reagents and dispensing systems for routine F-18 radiotracer production.
• Perform routine production activities to meet clinical supply schedules and operational requirements.
• Operate and troubleshoot radiochemistry equipment and associated production systems.
• Prepare sterile components, consumables and production materials required for manufacturing activities.
• Package and dispatch radioactive materials in accordance with regulatory requirements.
• Assist with cyclotron operation and isotope production where appropriately trained.
• Conduct equipment calibration, qualification and preventative maintenance activities.
• Maintain detailed production records and manufacturing documentation in accordance with GMP requirements.
• Participate in validation studies, investigations, process improvements and technology enhancements.

General Responsibilities

• Promote and maintain compliance with Good Manufacturing Practice (GMP) principles.
• Contribute to continuous improvement initiatives across production and quality systems.
• Participate in training programs and maintain competency requirements.
• Expand technical knowledge in radiochemistry, radiopharmaceutical development and molecular imaging applications.
• Support research activities and contribute expertise toward future radiopharmaceutical development opportunities.

Requirements

• Bachelor’s Degree in Chemistry, Pharmacy or Biological Sciences and at least 12 months of relevant post-qualification experience.
• Experience in analytical methodology (chemical and microbiological), GMP, and an understanding of F-18 based synthesis.
• Essential understanding of and familiarity with tests that need to be carried out, and with the associated potential problems accompanying each of the analytical tests.
• Good understanding of pharmacopeia monographs.
• Previous training/study in laboratory operations and a working knowledge of radiation protection practices are required.
• Well versed with the preparation of production related documents.
• May need to operate the cyclotron, necessitating cross-training in both areas of production and QC testing.
• Working knowledge and regular training in radiation protection.

Special Requirements

• Some out of hours work may be required.
• DCSI Employment Screening and Police Checks may be required.

Pay

$75,000 - $85,000 per annum

Benefits

As a not-for-profit organisation, SAHMRI offers attractive salary packaging benefits of up to $15,900 per annum, allowing eligible employees to increase their take-home pay through tax-effective salary packaging arrangements.