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.
Responsibilities
Technology Transfer & GMP IndustrialisationLead 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 AlphaDirect™), Drug Substance, and Drug Product manufacturingProvide technical leadership and oversight for change control as required during technology transfer & process validation.Partner with internal and external stakeholders to communicate, escalate, and resolve technical transfer project issues.Site Build & Facility FitServe 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, cleanrooms, 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 manufacturedPartner with Engineering, Project Management, and external vendors to deliver compliant and efficient infrastructure.Leadership & Cross-Functional CollaborationLead 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.
Qualifications & Experience
Advanced degree (MSc/PhD) in Radiochemistry, Pharmaceutical Sciences, Chemical Engineering, or related field.8+ years of experience in radiopharmaceutical manufacturing, tech transfer, and site build projects.Proven expertise in GMP production of PET/SPECT tracers, therapeutic radiopharmaceuticals, or similar modalities.Deep understanding of regulatory frameworks (FDA, EMA, ICH, radiation safety standards) and validation strategies.Experience with automated synthesis modules, hot cells, and aseptic processing is highly desirable.Strong leadership, project management, and stakeholder engagement skills.
Preferred Skills
Experience with CDMO tech transfers and global supply chains.Familiarity with radiopharmaceutical-specific digital tools and batch record systems.Radiation safety certification or training.Lean Six Sigma or similar operational excellence certification.Team player, able to work in autonomy, who can balance the needs of an entrepreneurial environment with the requirements of structured product developmentProven ability to efficiently work with and/or lead cross-functional teams in a and business functions in a matrix environment.Strong communication and presentation skills, strong project management skills, and scientific/technical writing, cultural difference understanding, and adjusting both from the country and business aspect (e.g., US, EU, China, CMO, internal operations).Ability to operate in a matrixed and global environmentFluent in English. Other languages considered a plus
About Us
Channeling Energy. Changing Lives. ARTBIO redefines cancer care by discovering and developing a new class of Alpha Radioligand Therapies (ARTs), powered by unique Pb-212 isotope technology and seamless supply. Our team works tirelessly to bring therapies that matter to patients who need them.
The unique ARTBIO approach selects the optimal alpha-precursor isotope (212Pb) and tumor-specific targets to create therapeutics with the potential for the highest efficacy and safety. The company's AlphaDirect™ technology, a first-of-its-kind 212Pb isolation method, enables a distributed manufacturing approach for the reliable production and delivery of ARTs. ARTBIO is advancing multiple pipeline programs, with lead program AB001 currently in first-in-human trials. The company is shaped by a long-standing scientific legacy with nearly a century of pioneering work in radiation therapy conducted at the University of Oslo and Norway’s Radium Hospital.
Cancer is relentless. So are we. We are driven by a desire to do better for cancer patients, lowering the burden of toleration and safety while at the same time raising the bar on clinical efficacy and duration. As an emerging, global biotech with locations in Boston, Basel, London, and Oslo, we take advantage of diverse scientific depth and insights, which makes ARTBIO a unique place to work.
EEO Statement
ARTBIO is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status. If you have a disability or special need that requires accommodation, please let us know.
Questions and Application Process
If interested, please apply and send your CV to
HR@artbio.com. All inquiries are treated confidentially.
ARTBIO does not accept unsolicited resumes from external agencies or recruiters. Submission of a resume without a prior written agreement does not create any express or implied contract between ARTBIO and the agency. ARTBIO will not pay any fees related to unsolicited resumes.
