Radiochemist - Talent Community

Radiochemist (Clinical-Stage Radiopharmaceuticals)

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 applicable GMP regulations.
- Manage the development and validation of manual or automated manufacturing procedures.
- Manage the development and validation of non-compendial QC procedures.
- Generate development, validation, method transfer, and other 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 streamlining, optimization, and scale-up of manufacturing procedures for commercial supply.
- Provide technical support for manufacturing and QC procedures as required.
- Ensure documentation aligns with Telix QMS and general GMP principles.

Education & Experience (required):
- Bachelor’s plus 5 years, or Master’s plus 3 years, or doctorate plus 2 years.
- Practical radiochemistry experience.
- Experience developing HPLC, TLC, or GC QC methods for radiopharmaceuticals.
- Experience working on GMP-compliant manufacturing.
- Strong written and verbal communication skills.

Skills (preferred):
- Experience working with radiometals.
- Experience with conjugation and radiolabeling of biologics.
- Experience of method development to support regulatory filings.

Application Instructions:
- Submit an application of interest; the team will contact you when there is an opening.