Senior Scientist, Radiochemistry - Translational Medicine

See Yourself at Telix

Telix Pharmaceuticals is seeking a highly motivated and experienced Senior Scientist, Radiochemistry – New Product Translation to play a pivotal role in advancing our innovative radiopharmaceutical pipeline. This position will support the seamless development and technical transfer of new products from our Research and Innovation (R&I) team into first-in-human clinical trials. The successful candidate will be responsible for identifying and addressing any development gaps that must be resolved prior to initiating clinical studies. In addition, this role will lead the selection and execution of technical transfer activities to manufacturing sites responsible for producing clinical trial materials, including first-in-human and Phase 1 supplies. A key responsibility will also include authoring the Chemistry, Manufacturing, and Controls (CMC) sections of Phase 1 Investigational New Drug (IND) applications. This is an exceptional opportunity for a seasoned radiochemist with a strong background in translational science and experience working with remote manufacturing partners. The ideal candidate will thrive in a dynamic, cross-functional environment and be passionate about bringing cutting-edge therapies from bench to bedside.

Key Accountabilities:

• Ensure the readiness of projects originating from the Research & Innovation (R&I) group or early-stage in-licensed assets for translation into first-in-human or Phase 1 clinical trials.
• Conduct a comprehensive gap analysis on underdeveloped programs and lead efforts to close identified gaps.
• Manage the transition of processes and analytical methods from R&I to manufacturing sites supporting clinical studies.
• Develop and author Standard Operating Procedures (SOPs) for manufacturing processes and analytical test methods.
• Collaborate with Radiochemistry and CMC subject matter experts to define and optimize phase-appropriate product specifications.
• Prepare the Finished Product section of Module 3 for IND/IMPD regulatory submissions.
• Draft and execute technical transfer protocols and reports for internal and external method transfers.
• Ensure all documentation aligns with Telix’s Quality Management System (QMS) and adheres to Good Manufacturing Practice (GMP) standards.
• Provide on-site support during technical transfer activities at manufacturing partner facilities.
• Support Operations SMEs in conducting gap analyses and preparing for the transfer of processes and methods to manufacturing partners for Phase 2/3 clinical trials, as applicable.

Education and Experience:

• Bachelor’s degree plus seven years experience, or Masters degree or PhD plus five years’ experience in Radiochemistry.
• A post-doctoral fellowship or research associate experience in product translation is highly preferred.
• Experience transferring products from a research environment to clinical use.
• Strong written and verbal communication skills are required.
• Experience working with radioanalytical radiochemical production methods is required.
• Experience writing Module 3 for IND/IMPD 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