Senior Scientist, Radiochemistry

Role Summary

Senior Scientist, Radiochemistry. Support the development of clinical-stage radiopharmaceutical assets, manage manufacturing and QC procedures to meet corporate requirements for clinical trials, regulatory submissions, and transition to commercial-scale 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

• Bachelor’s degree plus 8+ years experience, or Masters degree plus 6+ years experience, or doctorate plus 5+ years experience required.
• Practical radiochemistry experience is required.
• Experience developing HPLC, TLC, or GC QC methods for radiopharmaceuticals is required.
• Experience working in GMP-compliant manufacturing is required.
• Strong written and verbal communication skills.
• Experience with conjugation and radiolabeling of biologics is preferred.
• Experience of method development to support regulatory filings is preferred.

Skills

• Radiochemistry techniques
• GMP manufacturing and QC processes
• Method development and validation (HPLC/TLC/GC)
• CMC documentation for regulatory submissions
• Technical collaboration with CMOs and cross-functional teams

Education

• As listed in Qualifications (Bachelor’s, Master’s, or Doctorate in appropriate field)

Additional Requirements

• None beyond standard qualifications listed above.