Director, Radiochemistry

See Yourself at Telix

The Director, Radiochemistry leads the development, validation, and technical transfer of manufacturing and QC procedures for the company’s clinical-stage radiopharmaceutical assets. This role sets the vision and strategy for the radiochemistry function, ensuring alignment with corporate objectives, GMP requirements across multiple regions, and readiness for commercialization. The Director manages a team of radiochemists, oversees external partnerships with CMOs, and integrates radiochemistry activities within broader program timelines to support the advancement of clinical-stage programs into commercial readiness.

Key Accountabilities:

Department Leadership & Strategy

• • Set the departmental vision and goals for the radiochemistry development team, aligning with corporate objectives and clinical program milestones.
  • Lead, mentor, and develop a team of radiochemists, fostering a high-performance, compliance-focused culture.
  • Oversee a portfolio of development and validation activities across multiple clinical-stage assets.

Technical Development & GMP Compliance

• • Oversee the development, validation, and optimization of manufacturing and QC processes for radiopharmaceuticals, ensuring compliance with GMP standards across multiple regions.
  • Ensure all documentation aligns with the company’s Quality Management System and regulatory requirements.

External & Cross-Functional Stakeholder Management

• • Manage technical relationships with CMOs and external manufacturing partners to oversee development and method transfer.
  • Collaborate with asset program managers, quality, regulatory, manufacturing, and supply chain teams to align project timelines and technical deliverables

Regulatory & Commercial Readiness

• • Contribute to the preparation of CMC sections for regulatory submissions (INDs, NDAs, BLAs, and international equivalents).
  • Participate in the scale-up and optimization of manufacturing procedures to support readiness for commercial supply.

Project & Process Management

• • Employ project management tools to establish and track project timelines, ensuring on-time delivery of key milestones.
  • Support the creation of SOPs, protocols, reports, and project summaries to document development activities and outcomes.
  • Drive continuous improvement initiatives to streamline processes and enhance technical capabilities within the radiochemistry function.

Education and Experience:

• PhD or Master’s degree in Radiochemistry, Chemistry, Pharmaceutical Sciences, Chemical Engineering, Nuclear Engineering, or related field
• 12+ years of relevant experience in radiopharmaceuticals, radioisotope manufacture, or radiochemistry within the life sciences industry.
• 5+ years of leadership experience managing technical teams in a GMP environment, including direct management of scientists or engineers and cross-functional leadership.
• Demonstrated expertise in regulatory submissions (CMC sections) for investigational and commercial products (IND, NDA, BLA, or international equivalents)
• Experience working with CMOs and managing external technical relationships.
• Familiarity with project management methodologies, technical problem solving, an cross-functional integration.
• Experience developing HPLC, TLC, or GC QC methods for radiopharmaceuticals is required. 
• Strong written and verbal communication skills are required. 
• Experience working with radiometals is preferred. 
• Experience with conjugation and radiolabeling of biologics is preferred. 

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
• “Fist Time Right” mindset toward product development and technical transfer
• Accountable for on time and on budget project completion
• Quality mindset – programs are driving in compliance with FDA/ICH guidance on “Quality by Design”
• 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