Scientist II

Summary

Join Telix Pharmaceuticals, a dynamic and fast-growing radiopharmaceutical company, as a Scientist II, Radiochemistry to support the development of clinical-stage radiopharmaceutical assets. This role will focus on radiopharmaceuticals containing alpha-emitting radionuclides, managing manufacturing and QC procedures, and ensuring compliance with GMP regulations.

Requirements

• Bachelor’s degree plus five years experience, or Masters degree plus three years experience, or doctorate plus two years experience
• Practical radiochemistry experience is required
• Practical experience working with alpha-emitting radionuclides is required
• Experience developing HPLC, TLC, or GC QC methods for radiopharmaceuticals is required
• Experience working on GMP-compliant manufacturing is required
• Strong written and verbal communication skills are required

Responsibilities

• Provide subject-matter expertise on the radiochemistry of alpha-emitting radionuclides (e.g. 225Ac, 212Pb)
• Interface with key stakeholders, including external CMOs, to manage the development of manufacturing and QC procedures for clinical-stage radiopharmaceutical assets in compliance with all applicable GMP regulations
• 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
• Support regulatory filings via completion of CMC sections for INDs, NDAs, BLAs, and foreign equivalents
• Generate SOPs for manufacturing and QC procedures
• Support method transfers to external manufacturers
• Participate in the streamlining, optimization, and scale-up of manufacturing procedures in preparation for commercial supply
• Provide technical support for manufacturing and QC procedures for all Telix products as required
• Ensure all documentation generated is consistent with Telix QMS and general principles of GMP manufacturing

Preferred Qualifications

• Experience with conjugation and radiolabeling of biologics is preferred
• Experience of pharmaceutical development to support regulatory filings is preferred

Benefits

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