Senior Scientist, Radiochemistry
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Job Location:
Monthly Salary:
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
See Yourself at Telix
The Sr Scientist Radiochemisty 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.
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 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.
Education and Experience
- Bachelors 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.
Required Experience:
Senior IC
Key Skills
- Laboratory Experience
- Mammalian Cell Culture
- Biochemistry
- Assays
- Protein Purification
- Research Experience
- Next Generation Sequencing
- Research & Development
- cGMP
- Cell Culture
- Molecular Biology
- Flow Cytometry
About Company
Telix is a global, commercial-stage biopharmaceutical company focused on the development of diagnostic and therapeutic (‘theranostic’) products using targeted radiation.
