Overview
Telix Pharmaceuticals is a dynamic, fast-growing radiopharmaceutical company with offices in Australia (HQ), Belgium, Japan, Switzerland, and the United States. Our mission is to deliver on the promise of precision medicine through targeted radiation. At our core, we exist to create products that seek to improve the quality of life for people living with cancer and rare diseases. You will be supporting the international roll-out of our approved prostate cancer imaging agent and helping us to advance our portfolio of late clinical-stage products that address significant unmet need in oncology and rare diseases.
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
* 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.
At Telix, we believe everyone counts, we strive to be extraordinary, and we pursue our goals with determination and integrity. You will be part of an engaged and supportive group of colleagues who all have a shared purpose: to help people with cancer and rare diseases live longer, better quality lives. Being a Telix employee means being a part of a unique, global, interdisciplinary team working to deliver what's next in precision medicine. We have hybrid and remote employees located all around the world. We offer competitive salaries, annual performance-based bonuses, an equity-based incentive program, generous vacation, paid wellness days and support for learning and development.
Telix Pharmaceuticals is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, and other legally protected characteristics.
VIEW OUR RECRUITMENT PRIVACY POLICY HERE
Seniority level
* Mid-Senior level
Employment type
* Full-time
Job function
* Research, Analyst, and Information Technology
Industries
* Pharmaceutical Manufacturing
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