Radiochemist

See Yourself at Telix

Telix is seeking applicants for a Radiochemist position to support the development of its clinical-stage radiopharmaceutical assets. The successful candidate will be responsible for managing the development required to ensure manufacturing and QC procedures meet the corporate requirements to support clinical trials, regulatory submissions, and transition to commercial-stage manufacturing. This is an ideal role for radiochemists with experience manufacturing under GMP regulations who are comfortable in a fast-paced environment and who are motivated to make vital contributions to the next generation of radiopharmaceutical drugs.

Key Accountabilities

• 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.

What You'll Bring to the Role

• 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.
• 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.
• Experience working with radiometals is preferred.
• Experience with conjugation and radiolabeling of biologics is preferred.
• Experience of method development to support regulatory filings is preferred.

Last updated on Oct 17, 2023