Senior Scientist, Radiochemistry
About the role
The Sr Scientist, Radiochemist position supports the development of clinical-stage radiopharmaceutical assets at Telix Pharmaceuticals. This role is responsible for managing the development of manufacturing and QC procedures to support clinical trials, regulatory submissions, and transition to commercial-stage 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.
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.
Qualifications
- 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
- Inclusive mindset: Demonstrates an understanding and appreciation for diversity and works to create an inclusive environment.
- Creativity and innovation: Willingness to think outside the box and come up with unique and creative solutions to challenges.
- Commitment to excellence: Takes pride in work and strives for excellence in everything done.
- Results-oriented: Driven to achieve goals and objectives, with a strong focus on delivering measurable results.
- Ethical behavior: Acts with integrity and demonstrates a commitment to ethical behavior in all interactions.
- Adaptability: Comfortable working in a dynamic environment, able to adjust to changing priorities, and willing to take on new challenges.
- Strong communication skills: Able to communicate effectively with colleagues and stakeholders at all levels, using clear and concise language.
- Collaboration: Works effectively as part of a team, actively sharing knowledge and expertise to achieve common goals.
- Resilience: Demonstrates the ability to bounce back from setbacks and persevere in the face of challenges.
- Continuous learning: Shows a commitment to ongoing learning and professional development, continually seeking out opportunities to expand knowledge and skills.
Benefits
- Competitive salaries.
- Annual performance-based bonuses.
- An equity-based incentive program.
- Generous vacation.
- Paid wellness days.
- Support for learning and development.
Pay
Telix Pharmaceuticals offers competitive salaries and an equity-based incentive program.
Schedule
Hybrid and remote work options are available.
Contact Information
To apply, please visit our careers page or email [email protected]
Equal Opportunity Employer
We are committed to providing an inclusive and respectful workplace for all employees. We are an equal opportunity employer and consider all qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, and other legally protected characteristics.