Senior Scientist, Radiochemistry
Telix Pharmaceuticals Limited
Full-time
Remote friendly (United States)
United States
Operations
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Role Summary
Senior Scientist, Radiochemistry. Support the development of clinical-stage radiopharmaceutical assets, ensuring manufacturing and QC procedures meet corporate requirements to support clinical trials, regulatory submissions, and transition to commercial-stage manufacturing.
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: Bachelor’s degree plus 8+ years experience, or Master’s degree plus 6+ years experience, or Doctorate plus 5+ years experience.
- Required: Practical radiochemistry experience.
- Required: Experience developing HPLC, TLC, or GC QC methods for radiopharmaceuticals.
- Required: Experience working in GMP-compliant manufacturing.
- Required: Strong written and verbal communication skills.
- Preferred: Experience with conjugation and radiolabeling of biologics.
- Preferred: Experience of method development to support regulatory filings.
Skills
- Radiochemistry
- GMP manufacturing
- CMC documentation
- Method development and validation
- QC method development
- Regulatory submissions support
- Technical communication
Education
- Bachelor’s degree with 8+ years experience, or Master’s degree with 6+ years, or Doctorate with 5+ years (as applicable).
Additional Requirements
- None specified.