Director, MSAT Operations

Summary

The Director, MSAT Operations is responsible for all product and process transfer activities at the CDMO level (inbound, outbound, and within), including scale-up, industrialization, and other process adaptations. This role will collaborate with the technical transfer project teams at CDMO sites and serve as a liaison between internal ARTBIO and external CDMO functions (e.g., Generator and CMC Development, Supply Chain, Production Unit, Quality Control, HSE, etc.).

This role is critical in scaling complex generator use, radiolabeling, synthesis, and aseptic filling operations following acceptance from R&D, as well as CMC (i.e., process validation and initial batches). The Director, MSAT Operations will lead the transition to commercial readiness and global [JL1]expansion of the technology. This role will lead the technical and industrialization aspects of new production lines and/or site builds, ensuring facilities are designed and commissioned to meet the stringent requirements of radiopharmaceutical production, in line with radiation safety, containment, and regulatory compliance standards.

• Technology Transfer & GMP Industrialisation
• Lead the tech transfer of radiopharmaceutical processes after accepting (i.e., process validation and first batches) from R&D and/or external partners into GMP manufacturing, including isotopes, precursors, and final drug products manufacturing and QC characterization as needed.
• Develop and execute tech transfer plans covering process characterization, validation, and regulatory documentation, within timelines and budgets.
• Define a standard, optimized, reliable, and robust manufacturing process, from generator emanations through aseptic filling processes, in alignment with the CMC development, including process KPI monitoring and trending to ensure best process and product performance, including their use in APRs where relevant.
• Responsible for collecting the customer experience and triggering improvements needed from the operations and/or R&D teams.
• Support the supply chain of final drug products for GMP clinical phases.
• Collaborate with CMC, Quality Assurance, Regulatory Affairs, and Radiation Safety teams to ensure compliance with GMP and radiopharmaceutical-specific regulations (e.g., EU GMP Annex 3, FDA 21 CFR Part 212).
• Support regulatory submissions (e.g., NDS[JL1], CTA, NDA, MAA) with technical documentation and responses.
• Provides scientific and technical support for starting isotopes (with use of Alpha Direct™), Drug Substance, and Drug Product manufacturing
• Provide technical leadership and oversight for change control as required during technology transfer & process validation.
• Partner with internal and external stakeholders to communicate, elevate, and resolve technical transfer project issues.

• Site Build & Facility Fit
• Serve as technical lead for radiopharmaceutical facility builds or expansions, ensuring alignment with process needs and radiation safety requirements.
• Define URS and oversee design reviews, FAT/SAT, commissioning, and qualification of hot cells, shielded isolators, clean rooms, and automated synthesis modules.
• Ensure facility readiness for handling radioactive materials, including segregation, shielding, waste management, and environmental monitoring.
• Ensure a predictable and accurate cost per unit of the radiopharmaceutical products manufactured
• Partner with Engineering, Project Management, and external vendors to deliver compliant and efficient infrastructure.

• Leadership & Cross-Functional Collaboration
• Lead cross-functional project teams across global and local sites, ensuring clear communication and milestone delivery.
• Close collaboration with R&D Generator and CMC functions to expand from the initial development and regulatory approval to operations.
• Act as a technical liaison with external CDMOs, isotope suppliers, and regulatory agencies.
• Mentor junior staff and contribute to building radiopharmaceutical technical capabilities within the organization.

• Advanced degree (MSc/PhD) in Radiochemistry, Pharmaceutical Sciences, Chemical Engineering, or related field.
• 8+ years of experience in…