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 development and validation of manual or automated manufacturing procedures.
- Manage development and validation of non-compendial QC procedures.
- Generate development, validation, method transfer, and other protocols and reports.
- Support regulatory filings by completing 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 for all Telix products as required.
- Ensure all documentation aligns with Telix QMS and GMP principles.
Education & Experience (Required)
- Bachelorβs degree + 5 years, or Masters + 3 years, or doctorate + 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 developing methods to support regulatory filings.
Application Instructions
- Submit an application of interest; the team will contact you when an opening is available.