Senior Scientist, Radiochemistry
Telix Pharmaceuticals (AMER)
•Hybrid
About The Position
The Sr Scientist, Radiochemist position will support the development of clinical-stage radiopharmaceutical assets. This role is 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.
Requirements
- Bachelor’s degree plus 8 years experience, or Masters degree plus 6 years experience, or doctorate plus 5 years experience.
- 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.
Nice To Haves
- Experience with conjugation and radiolabeling of biologics is preferred.
- Experience of method development to support regulatory filings is preferred.
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.
Benefits
- competitive salaries
- annual performance-based bonuses
- an equity-based incentive program
- generous vacation
- paid wellness days
- support for learning and development
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What This Job Offers
Job Type
Full-time
Career Level
Senior
