Director, CMC – Radiopharmaceutical Process Development

About the role

The Director, Radiopharmaceutical Process Development partners closely with the Technical Development and Manufacturing Science & Technology (MSAT) teams to define and execute phase-appropriate CMC strategies supporting the development, optimization, and internal scale-up of manufacturing processes for the company's ²¹²Pb-based APIs and radiopharmaceutical products. The role provides technical leadership across process development, process characterization, scale-up, technology transfer, and manufacturing readiness, ensuring seamless transition from development to robust, scalable, and GMP-compliant manufacturing. The successful candidate leads CMC regulatory authoring and documentation for global submissions, lifecycle management of regulatory dossiers, and responses to health authority inquiries, while driving continuous improvement initiatives that strengthen process understanding, manufacturing robustness, and portfolio advancement.

Working closely with Technical Development, MSAT, Quality, Engineering, and Operations, this position provides leadership in equipment selection, facility readiness, operational start-up, and technology transfer to ensure successful integration of new processes into internal manufacturing operations and readiness for clinical and commercial supply. The Director also provides targeted technical support to the Director of External Manufacturing on CDMO-related activities, including technology transfer, process performance assessment, manufacturing investigations, and process optimization, helping ensure alignment between internal development programs and external manufacturing strategies to support a reliable, scalable, and compliant supply network.

Responsibilities

• Develop phase-appropriate CMC strategies and ensure generation of supporting data, technical documentation, and regulatory submission packages
• Partner closely with Technical Development and MSAT to align process development, optimization, and scale-up activities for ²¹²Pb-based API and radiopharmaceutical manufacturing processes
• Drive process characterization and lifecycle development studies to establish critical process parameters, critical quality attributes, and control strategies
• Establish phase-appropriate drug substance and drug product specifications based on process understanding, manufacturing performance data, and overall CMC strategy
• Ensure process development activities comply with GMP requirements and applicable radiopharmaceutical regulatory standards
• Provide technical leadership for regulatory interactions related to process design and control strategies
• Partner with Quality Assurance on investigations, change controls, and audit readiness activities
• Provide targeted technical support to External Manufacturing for CDMO-related activities
• Lead process investigation, troubleshoot manufacturing and development challenges, and drive continuous improvement initiatives
• Mentor, coach, and develop Radiopharmaceutical Process Development staff

Requirements

• Ph.D. in chemistry, engineering, pharmaceutical sciences, or a relevant discipline
• Minimum 4 years of experience in the radiopharmaceutical industry with a focus on CMC development, process development, and technical operations
• Advanced understanding of (radio)pharmaceutical manufacturing, process scale-up, and quality control methodologies
• Strong understanding of GMP requirements, radiopharmaceutical regulations, and industry standards across product development and commercialization
• Excellent communication, technical writing, and analytical problem-solving skills
• Demonstrated ability to build, mentor, and lead high-performing CMC teams
• Proven ability to manage multiple priorities, meet timelines, and perform effectively in a fast-paced environment
• Commitment to fostering a collaborative, inclusive, and diverse workplace culture

Qualifications

• Experience in GMP manufacture of radiopharmaceuticals
• Sound understanding of regulatory requirements and guidelines governing GMP manufacture of radiopharmaceuticals and quality control (e.g., cGMP, PIC/S, ICH)