Senior Scientist, Radiochemistry-Analytical

Summary

Join Telix Pharmaceuticals, a fast-growing radiopharmaceutical company, as we support the international rollout of our prostate cancer imaging agent and advance our late clinical-stage products. This role focuses on the development, validation, and technical transfer of analytical methods for our radiopharmaceutical assets. You will oversee the analytical method lifecycle, ensuring our products meet regulatory standards. The successful candidate will collaborate with global teams, develop new methods, generate SOPs, and support regulatory activities. This position requires experience in GMP analytical method development and validation, specifically with HPLC, TLC, or GC QC methods for radiopharmaceuticals. Telix offers a dynamic environment, competitive salaries, bonuses, equity incentives, generous vacation, wellness days, and support for learning and development.

Requirements

• Bachelor’s degree plus eight (8) years’ experience, or Master’s degree plus six (6) years’ experience or PhD plus five (5) years’ experience in Analytical Chemistry or Radiochemistry
• GMP analytical method development and validation experience using ICH Q2(R2) and Q14 is required
• Experience transferring HPLC, TLC, or GC QC methods for radiopharmaceuticals is required
• Strong written and verbal communication skills are required
• Experience with method development to support regulatory filings is required

Responsibilities

• Ensure that incoming method from external vendors, academic sites or Telix early-stage development group are fit for purpose and identify gaps/mitigations to address deficiencies
• Lead the development of new methods using external lab resources or analytical support from one of Telix global manufacturing sites
• Generate SOPs for test methods
• Work with other subject matter experts in the Radiochemistry and CMC teams to define and refine product specifications
• Define a strategy to ensure method robustness prior to Method Validation
• Review and approve validation protocols and reports
• Write Technical Transfer protocols and reports for moving methods to external vendors or within Telix
• Establish and maintain a life cycle management program for analytical methods
• Interface with key stakeholders, including external CMOs, to manage QC procedures for clinical and commercial stage radiopharmaceutical assets in compliance with all applicable GMP regulations
• Support regulatory activities like CMC data packages -for INDs, NDAs, and foreign equivalents, briefing books and responses to agency questions
• Ensure all documentation generated is consistent with Telix QMS and general principles of GMP
• Provide technical assistance, as required, during the development and Technical Transfer of methods (note: this will include some travel during the Technical Transfer stages)

Preferred Qualifications

Experience working with radioanalytical methods is preferred

Benefits

• Competitive salaries
• Annual performance-based bonuses
• An equity-based incentive program
• Generous vacation
• Paid wellness days
• Support for learning and development