Director, Radiochemistry

Summary

Join Telix Pharmaceuticals as the Director, Radiochemistry, leading the development, validation, and technical transfer of manufacturing and QC procedures for clinical-stage radiopharmaceutical assets. Set the vision and strategy for the radiochemistry function, ensuring alignment with corporate objectives and GMP requirements. Manage a team of radiochemists, oversee external partnerships with CMOs, and integrate radiochemistry activities within broader program timelines. Oversee development, validation, and optimization of manufacturing and QC processes for radiopharmaceuticals. Manage technical relationships with CMOs and external manufacturing partners. Contribute to regulatory submissions (CMC sections) and participate in scaling up manufacturing procedures. Employ project management tools and support the creation of SOPs, protocols, and reports. Drive continuous improvement initiatives. This role requires strong leadership, technical expertise, and collaboration skills.

Requirements

• 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

Responsibilities

• 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
• 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
• 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
• 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
• 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

Preferred Qualifications

• Experience working with radiometals is preferred
• Experience with conjugation and radiolabeling of biologics is preferred

Benefits

• Competitive salaries
• Annual performance-based bonuses
• An equity-based incentive program
• Generous vacation
• Paid wellness days
• Support for learning and development