Scientist II, Radiochemistry

See Yourself at Telix

Telix is seeking applicants for a Radiochemist position to support the development of its Precision Medicine commercial and clinical stage radiopharmaceutical assets. The successful candidate will be responsible for managing the radiochemistry development required to ensure manufacturing and QC procedures meet the corporate requirements to support commercial launch and supply, clinical trials, and regulatory submissions. This is an ideal role for radiochemists with experience manufacturing under GMP regulations who are comfortable in a fast-paced environment and who are motivated to make vital contributions to the next generation of radiopharmaceutical drugs.

Key Accountabilities:

• Interface with key stakeholders, including external CMOs, to manage the development of manufacturing and QC procedures for clinical and commercial stage radiopharmaceutical assets in compliance with all applicable GMP regulations.
• Manage the manufacturing and analytical method transfer process to new manufacturing facilities.
• 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 to support regulatory filings for commercial drug products.
• Support regulatory activities like CMC data packages -for INDs, NDAs, and foreign equivalents, briefing books and responses to agency questions.
• Generate SOPs for manufacturing and QC procedures.
• Provide technical support for manufacturing and QC procedures for all Telix Precision Medicine 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 5+ years’ experience, Master’s degree plus 3+ years experience, or PhD plus 2+ years experience in Chemistry or Radiochemistry required
• GMP manufacturing radiochemistry experience is required.
• Experience transferring HPLC, TLC, or GC QC methods for radiopharmaceuticals is required.
• Strong written and verbal communication skills are required.
• Experience working with fluorine and technetium radiochemistry is preferred.
• Experience with method/process development to support regulatory filings is required.

Key Capabilities:

• Inclusive mindset: Demonstrate an understanding and appreciation for diversity, and actively work to create an inclusive environment where everyone feels valued and respected
• Creativity and innovation: Possess a willingness to think outside the box and come up with unique and creative solutions to challenges
• Commitment to excellence: Take pride in your work and consistently strive for excellence in everything you do
• Results-oriented: Driven to achieve goals and objectives, with a strong focus on delivering measurable results
• Ethical behavior: Act with integrity and demonstrate a commitment to ethical behavior in all interactions with colleagues and stakeholders
• 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: Work effectively as part of a team, actively sharing knowledge and expertise to achieve common goals
• Resilience: Demonstrate the ability to bounce back from setbacks and persevere in the face of challenges
• Continuous learning: Show a commitment to ongoing learning and professional development, continually seeking out opportunities to expand your knowledge and skills