Scientist II

See Yourself at Telix

Telix is seeking applicants for a Radiochemist position to support the development of its commercial 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, and regulatory submissions. 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 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 filings via completion of CMC sections for INDs, NDAs, and foreign equivalents.
• Generate SOPs for manufacturing and QC procedures.
• 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.

Education and Experience

• Bachelor’s degree plus 5+ years’ experience, or Masters degree plus 3+ years’ experience required
• GMP level radiochemistry experience is required.
• Experience transferring 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 fluorine and iodine radiochemistry is preferred.
• Experience of method/process development to support regulatory filings is preferred.