Scientist II, Radiochemistry

Summary

Join Telix Pharmaceuticals, a fast-growing radiopharmaceutical company, as a Radiochemist. You will play a key role in supporting the international launch of a prostate cancer imaging agent and advancing our late-stage clinical products. This position involves managing radiochemistry development, ensuring manufacturing and QC procedures meet GMP regulations. You will collaborate with stakeholders, manage method transfers, and generate regulatory documentation. The ideal candidate possesses significant experience in GMP radiochemistry manufacturing and method development. Telix offers a supportive environment, competitive compensation, and various benefits.

Requirements

• Bachelor’s degree plus 5+ years’ experience, Master’s degree plus 3+ years experience, or PhD plus 2+ years experience in Chemistry or Radiochemistry
• GMP manufacturing radiochemistry experience
• Experience transferring HPLC, TLC, or GC QC methods for radiopharmaceuticals
• Strong written and verbal communication skills
• Experience with method/process development to support regulatory filings

Responsibilities

• Interface with key stakeholders, including external CMOs, to manage the development of manufacturing and QC procedures for clinical and commercial stage radiopharmaceutical assets in compliance with all applicable GMP regulations
• Manage the manufacturing and analytical method transfer process to new manufacturing facilities
• Manage the development and validation of manual or automated manufacturing procedures as required
• Manage the development and validation of non-compendial QC procedures as required
• Generate development, validation, method transfer, and various other types of protocols and reports to support regulatory filings for commercial drug products
• Support regulatory activities like CMC data packages -for INDs, NDAs, and foreign equivalents, briefing books and responses to agency questions
• Generate SOPs for manufacturing and QC procedures
• Provide technical support for manufacturing and QC procedures for all Telix Precision Medicine products as required
• Ensure all documentation generated is consistent with Telix QMS and general principles of GMP manufacturing

Preferred Qualifications

Experience working with fluorine and technetium radiochemistry

Benefits

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