Sr. Scientist, Radiochemistry - Analytical

See Yourself at Telix

Telix is seeking applicants for an position to support the development, validation and Technical Transfer of analytical methods to support its Therapeutic and Precision Medicine commercial and clinical stage radiopharmaceutical assets. The successful candidate will be responsible for overseeing and managing the analytical method life cycle for HPLC, GC, Radio-TLC, Immunoreactivity or other non-microbiological quality control tests.  This includes development, validation and Technical Transfer required to ensure that Telix clinical and commercial products are tested appropriately and are aligned with regulatory standards. This is an ideal role for an analytical chemist who is comfortable working with remote teams on method development and qualification in a GMP environment and 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:

• Ensure that incoming method from external vendors, academic sites or Telix early-stage development group are fit for purpose and identify gaps/mitigations to address deficiencies
• Lead the development of new methods using external lab resources or analytical support from one of Telix global manufacturing sites
• Generate SOPs for test methods
• Work with other subject matter experts in the Radiochemistry and CMC teams to define and refine product specifications
• Define a strategy to ensure method robustness prior to Method Validation
• Review and approve validation protocols and reports
• Write Technical Transfer protocols and reports for moving methods to external vendors or within Telix
• Establish and maintain a life cycle management program for analytical methods
• Interface with key stakeholders, including external CMOs, to manage QC procedures for clinical and commercial stage radiopharmaceutical assets in compliance with all applicable GMP regulations.
• Support regulatory activities like CMC data packages -for INDs, NDAs, and foreign equivalents, briefing books and responses to agency questions.
• Ensure all documentation generated is consistent with Telix QMS and general principles of GMP.
• Provide technical assistance, as required, during the development and Technical Transfer of methods (note: this will include some travel during the Technical Transfer stages)

Education and Experience:

• Bachelor’s degree plus eight (8) years’ experience, or Master’s degree plus six (6) years’ experience or PhD plus five (5) years’ experience in Analytical Chemistry or Radiochemistry
• GMP analytical method development and validation experience using ICH Q2(R2) and Q14 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 radioanalytical methods is preferred
• Experience with method 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
• Attention to Detail: Have a strong attention to detail and be able to pick up errors before they become issues whilst also maintaining a helicopter view and be able to prioritise