Senior Scientist, Radiopharmaceutical Development Manufacturing Science & Technology; MSAT), Boston, MA

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CMC:
Manufacturing Boston, MA, US

3 days ago Requisition

Salary Range: $ To $ Annually

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 mini protein radio conjugate 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 mini protein radio conjugate 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 mini protein platform to develop novel radio conjugates 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,…