Senior Scientist, Radiochemistry

Role Summary

The Senior Scientist, Radiochemistry will support the development of clinical-stage radiopharmaceutical assets and manage manufacturing and QC procedures to meet requirements for clinical trials, regulatory submissions, and transition to commercial-scale manufacturing. The role will interface with external CMOs and cross-functional teams to advance Telix’s radiopharmaceutical portfolio.

Responsibilities

• 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.
• Demonstrate the ability to manage multiple CMOs with little oversight from management.
• 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.
• Author 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.

Qualifications

• Required: Practical radiochemistry experience.
• Required: Experience developing HPLC, TLC, or GC QC methods for radiopharmaceuticals.
• Required: Experience working in GMP-compliant manufacturing.
• Preferred: Experience with conjugation and radiolabeling of biologics.
• Preferred: Experience of method development to support regulatory filings.

Skills

• Strong written and verbal communication skills.

Education

• Degree requirements: Bachelor's degree plus 8+ years experience, or Master's degree plus 6+ years experience, or Doctorate plus 5+ years experience.