Aktis Oncology, Inc. is a clinical-stage oncology company focused on expanding the breakthrough potential of targeted radiopharmaceuticals to large patient populations, including those not addressed by existing platform technologies. Aktis’ most-advanced program, AKY-1189, is a miniprotein radioconjugate targeting Nectin-4, with multi-indication potential across multiple tumor types, including locally advanced or metastatic urothelial cancer, breast cancer, non-small cell lung cancer, colorectal cancer, cervical cancer, and head and neck cancer. Aktis’ second pipeline program, AKY-2519, is a miniprotein radioconjugate targeting B7-H3 expressing tumors, including prostate, lung and other solid tumors. Aktis has a strategic collaboration with Eli Lilly and Company to leverage its miniprotein platform to develop novel radioconjugates outside of Aktis’ proprietary pipeline.

The Senior Scientist, Radiopharmaceutical Development is a key technical member of the Manufacturing Science & Technology (MSAT) organization responsible for advancing radiopharmaceutical products from mid/late-stage development through commercialization. This role develops, optimizes, validates, and transfers analytical methods and process controls that support Phase III clinical programs, process validation, regulatory submissions, and commercial manufacturing. The position provides technical leadership for internal manufacturing sites and contract organizations, supports investigations and root cause analyses, and authors reports, protocols, controlled GMP documents, and CMC content. The Senior Scientist collaborates across Radiopharmaceutical Development, Manufacturing, Quality, Regulatory, Supply Chain, and external partners to deliver robust, compliant, and commercially viable analytical and process solutions.

Role objective

Provide technical ownership for analytical methods, process controls, and technology transfer activities that enable late-stage clinical development, regulatory readiness, and reliable commercial manufacturing of radiopharmaceutical products.

Essential Functions

• Lead the development, optimization, qualification, validation, and lifecycle management of analytical methods and manufacturing process controls supporting radiopharmaceutical drug substances, drug products, precursors, excipients, and formulations.
• Design, plan, execute, and interpret scientific studies that advance analytical methods and manufacturing processes from late-stage development through commercial readiness.
• Develop control strategies and methods suitable for Phase III clinical manufacturing, process validation campaigns, regulatory submissions, and commercial production.
• Provide analytical and process technical support for process development, process optimization, manufacturing investigations, deviation assessments, root cause analyses, corrective and preventive actions, and continuous improvement initiatives.
• Independently manage multiple technical projects, establish experimental strategy, evaluate risks and opportunities, and deliver project objectives within established timelines.
• Lead technical transfers to internal laboratories, CDMOs, CMOs, CROs, and other external partners, including transfer planning, method readiness assessment, protocol authorship, acceptance criteria, execution support, discrepancy resolution, and final reporting.
• Serve as the radiopharmaceutical subject matter expert during technology transfer, manufacturing startup, engineering, qualification, and validation activities.
• Author and review technical reports, protocols, SOPs, regulatory documentation, change controls, deviations, investigations, and other controlled GMP documents.
• Contribute technical expertise to CMC development activities, including support for IND submissions, NDA submissions, health authority responses, and post-approval regulatory commitments.
• Collaborate effectively with cross-functional stakeholders, including Manufacturing, MSAT, Quality, Regulatory Affairs, Supply Chain, and external partners to achieve program objectives.
• Apply advanced scientific knowledge and sound judgment to solve complex technical problems, evaluate data, and recommend practical, science-based solutions.
• Maintain complete, accurate, and contemporaneous laboratory documentation in accordance with cGMP requirements, ALCOA+ principles, and company data integrity standards.
• Support the development, review, and continuous improvement of pharmaceutical batch records, manufacturing documentation, and associated control strategies.
• Ensure all activities are conducted in compliance with applicable regulations, company procedures, safety requirements, and quality management system expectations.
• Mentor junior scientists and laboratory personnel and may provide technical leadership for assigned development programs and project teams.
• Actively demonstrates Aktis values: Lead with Integrity, Succeed Together, Be Bold, and Own the Impact.

Typical Minimum Skills and Education

• Ph.D./M.S./B.S. Chemistry, Radiochemistry, Pharmaceutical Sciences, Physics, Chemical Engineering, or related physical science discipline with a deep understanding of the technical aspects of radiopharmaceutical development, and a fundamental awareness of the roles of other pharmaceutical functionalities (including Regulatory, Compliance, Quality and Supply Chain). 
• Requires a minimum of a Ph.D. degree and 4+ years relevant work experience or a M.S. degree and 6+ years relevant work experience or a B.S. degree and 10+ years relevant work experience.
• Minimum 1 year of experience in a GMP-regulated pharmaceutical environment; radiopharmaceutical experience is preferred.

Other Requirements

• Demonstrated expertise in analytical method & process development, optimization, qualification, validation, and technology transfer activities supporting pharmaceutical development and commercial manufacturing.
• Strong knowledge of pharmaceutical development, CMC principles, and regulatory expectations for late-stage clinical programs, process validation, and commercial products.
• Working knowledge of cGMP regulations and applicable pharmaceutical requirements, including 21 CFR Part 211, 21 CFR Part 212, data integrity principles, and pharmaceutical method lifecycle management.
• Experience supporting CDMOs, CMOs, CROs, and other external partners through technical transfer, qualification, validation, and GMP operations.
• Demonstrated ability to design, execute, and interpret complex scientific studies supporting development and commercialization programs.
• Expertise in analytical chemistry, radiochemistry, pharmaceutical sciences, or a related discipline; familiarity with alpha-emitting radiotherapeutics is a plus.
• Experience authoring technical reports, protocols, SOPs, GMP documents, CMC content, and regulatory submission documentation.
• Proven project leadership skills with the ability to manage multiple priorities and drive cross-functional outcomes.
• Excellent communication skills with the ability to convey complex scientific concepts to diverse audiences.
• Experience with batch record design and improvement, manufacturing documentation, and control strategy development is preferred.
• May provide technical leadership or direct supervision for targeted groups, functional areas, or assigned project teams.
• Travel, including international travel, is highly anticipated

Aktis Oncology is an Equal Opportunity Employer and does not discriminate on the basis of race, religion, color, sex, gender identity or expression, sexual orientation, age, disability, national origin, veteran status, or any other basis covered by appropriate law. Aktis Oncology is committed to promoting and maintaining a work environment in which all applicants, employees, and other individuals are treated with dignity and respect free from unlawful harassment, discrimination, or retaliation.