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Associate Director, CMC Development

ARTBIO

Oslo Full-time Posted 30+ days ago
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SUMMARY The Associate Director, CMC Development provides scientific and cross-functional leadership for radiopharmaceutical development programs spanning discovery through First-in-Human readiness. The role integrates radiochemistry, analytical sciences and early CMC activities to advance multiple imaging and therapeutic radiopharmaceutical assets. Working closely with Discovery, CMC, Technical Operations, Quality, Regulatory Affairs, Clinical Development, and external CDMOs, the Principal Scientist drives technical strategy, manufacturing readiness, and cross-functional execution across the development portfolio. RESPONSIBILITIES Lead development of imaging and therapeutic radiopharmaceutical programs from discovery through clinical readiness. Define radiochemistry strategies, radiolabelling processes, formulation approaches, and analytical development plans. Drive technical decision-making based on scientific, analytical, and manufacturing data. Lead early CMC strategy across multiple development programs. Support preparation of CMC documentation for regulatory submissions (IND/IMPD). Support process scale-up, manufacturing readiness, troubleshooting, and clinical supply planning. Collaborate closely with TechOps and external manufacturing partners. CROSS-FUNCTIONAL LEADERSHIP Coordinate activities across Discovery, CMC, QA, Regulatory, TechOps, Clinical Development, and external collaborators. Identify technical and operational risks and develop mitigation strategies. Present scientific recommendations to senior leadership. PEOPLE LEADERSHIP Lead and mentor a multidisciplinary radiochemistry team. Build scientific capabilities, establish best practices, and promote operational excellence. Support recruitment, onboarding, and career development of scientists. QUALIFICATIONS & EXPERIENCE PhD in Radiochemistry, Chemistry, Pharmaceutical Sciences, Medicinal Chemistry, or a related scientific discipline. 10+ years of relevant experience in radiopharmaceutical development, biotechnology, the pharmaceutical industry, or academia. Strong expertise in radiochemistry, analytical development, and early CMC. Experience with GMP principles, clinical manufacturing readiness, and technology transfer. Experience working with external CDMOs and multidisciplinary project teams. Excellent communication, leadership, and project management skills. PREFERRED Experience with alpha therapeutic radiopharmaceuticals. Knowledge of GMP and radiopharmaceutical manufacturing environments. Experience supporting clinical-stage development programs. Experience working with CDMOs and technology transfer activities. Familiarity with regulatory expectations for radiopharmaceutical development. Experience with automated synthesis platforms and manufacturing equipment. PERSONAL ATTRIBUTES Proactive, detail-oriented, and eager to learn. Comfortable working in a fast-paced biotech environment. Team player who thrives on collaboration and cross-functional flexibility. Commitment to safety and continuous improvement. WHAT WE OFFER A unique chance to contribute to first-in-class cancer therapies. Exposure to both radiochemistry and CMC development in a dynamic biotech setting. Hands-on training and professional development opportunities. An international, collaborative, and supportive work culture. Competitive compensation and benefits. 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 [email protected]. 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.

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