Telix Pharmaceuticals Limited

Director, Radiochemistry

Telix Pharmaceuticals Limited

full-time

Posted on:

Origin:  • 🇺🇸 United States

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Job Level

Lead

About the role

  • The Director, Radiochemistry leads the development, validation, and technical transfer of manufacturing and QC procedures for the company’s clinical-stage radiopharmaceutical assets.\n
  • This role sets the vision and strategy for the radiochemistry function, ensuring alignment with GMP requirements across multiple regions and readiness for commercialization.\n
  • The Director manages a team of radiochemists, oversees external partnerships with CMOs, and integrates radiochemistry activities within broader program timelines to support progression to commercial readiness.\n
  • Oversees development, validation, and optimization of manufacturing and QC processes for radiopharmaceuticals, ensuring GMP compliance across regions.\n
  • Ensures documentation aligns with the Quality Management System and regulatory requirements.\n
  • Partners with asset program managers, quality, regulatory, manufacturing, and supply chain teams to align project timelines and technical deliverables.\n
  • Contributes to regulatory submissions (CMC sections) for INDs, NDAs, BLAs, and international equivalents; supports scale-up for commercial supply.\n
  • Drives project management through established timelines; develops SOPs, protocols, and reports; drives continuous improvement in radiochemistry.

Requirements

  • PhD or Master’s degree in Radiochemistry, Chemistry, Pharmaceutical Sciences, Chemical Engineering, Nuclear Engineering, or related field\n
  • 12+ years of relevant experience in radiopharmaceuticals, radioisotope manufacture, or radiochemistry within the life sciences industry\n
  • 5+ years of leadership experience managing technical teams in a GMP environment, including direct management of scientists or engineers and cross-functional leadership\n
  • Demonstrated expertise in regulatory submissions (CMC sections) for investigational and commercial products (IND, NDA, BLA, or international equivalents)\n
  • Experience working with CMOs and managing external technical relationships\n
  • Familiarity with project management methodologies, technical problem solving, an cross-functional integration\n
  • Experience developing HPLC, TLC, or GC QC methods for radiopharmaceuticals is required.\n
  • Strong written and verbal communication skills are required.\n
  • Experience working with radiometals is preferred.\n
  • Experience with conjugation and radiolabeling of biologics is preferred.