Director, CMC – Radiopharmaceutical Process Development

Partnering closely with the Technical Development and Manufacturing Science & Technology (MSAT) teams, the Director, Radiopharmaceutical Process Development plays a central role in defining and executing phase-appropriate CMC strategies to support 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 a seamless transition from development to robust, scalable, and GMP-compliant manufacturing.

The successful candidate is responsible for leading CMC regulatory authoring and documentation to support global regulatory submissions, lifecycle management of regulatory dossiers, and responses to health authority inquiries. The role also drives continuous improvement initiatives that strengthen process understanding, manufacturing robustness, and advancement of the company's radiopharmaceutical portfolio.

Working in close collaboration with Technical Development, MSAT, Quality, Engineering, and Operations, this position provides leadership in equipment selection, facility readiness, operational start-up, and technology transfer activities to ensure successful integration of new processes into internal manufacturing operations and readiness for clinical and commercial supply.

In addition, the Director 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. The role helps ensure alignment between internal development programs and external manufacturing strategies to support a reliable, scalable, and compliant supply network.

Key Responsibilities and Duties

• Develop phase-appropriate CMC strategies and ensure generation of the 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.

Other Responsibilities

• Observe the Company’s workplace, health and safety, and regulatory policies and procedures.

• Engage and communicate with other AdvanCell business unit staff to ensure that activities are undertaking seamlessly and effectively.

• Adhere to the Company’s quality management system processes and policies.

• Other tasks as requested by the VP, CMC and Supply Chain

Essential Skills, Qualifications, Industry and Educational Requirements

• Ph.D. in chemistry, engineering, pharmaceutical sciences or a relevant discipline.

• Minimum 4 years of experience in 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.

Desirable Skills, Qualifications, Industry and Educational Requirements

• 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).