Senior Scientist, RPD (MSAT)
About The Position
Aktis Oncology is a clinical-stage oncology company developing targeted radiopharmaceuticals. Its pipeline includes AKY-1189, a miniprotein radioconjugate targeting Nectin-4, and AKY-2519, targeting B7-H3-expressing tumors. The company also has a strategic collaboration with Eli Lilly and Company to develop radioconjugates outside Aktis’ proprietary pipeline. The Senior Scientist, Radiopharmaceutical Development is a key technical member of the Manufacturing Science & Technology (MSAT) organization. The role advances radiopharmaceutical products from mid- and late-stage development through commercialization by developing, optimizing, validating, and transferring analytical methods and process controls. The work supports Phase III clinical programs, process validation, regulatory submissions, and commercial manufacturing. The position provides technical leadership to internal manufacturing sites and external contract organizations, supports investigations and root cause analyses, and authors technical reports, protocols, controlled GMP documents, and CMC content. It collaborates with Radiopharmaceutical Development, Manufacturing, Quality, Regulatory, Supply Chain, and external partners to deliver robust, compliant, commercially viable analytical and process solutions. The role provides technical ownership of analytical methods, process controls, and technology transfer activities that enable late-stage clinical development, regulatory readiness, and reliable commercial manufacturing. It may also provide technical leadership or direct supervision for assigned groups, functional areas, or project teams. Travel, including international travel, is highly anticipated.
Requirements
- A Ph.D. with at least 4 years of relevant work experience, an M.S. with at least 6 years, or a B.S. with at least 10 years.
- At least 1 year of experience in a GMP-regulated pharmaceutical environment.
- Degree in Chemistry, Radiochemistry, Pharmaceutical Sciences, Physics, Chemical Engineering, or a related physical science discipline, with a deep understanding of radiopharmaceutical development and fundamental awareness of Regulatory, Compliance, Quality, and Supply Chain functions.
- Demonstrated expertise in analytical method and process development, optimization, qualification, validation, and technology transfer 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 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.
- 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.
- Experience authoring technical reports, protocols, SOPs, GMP documents, CMC content, and regulatory submission documentation.
- Project leadership skills and ability to manage multiple priorities and drive cross-functional outcomes.
- Excellent communication skills and ability to convey complex scientific concepts to diverse audiences.
- Travel, including international travel, is highly anticipated.
Nice To Haves
- Radiopharmaceutical experience.
- Familiarity with alpha-emitting radiotherapeutics.
- Experience with batch record design and improvement, manufacturing documentation, and control strategy development.
Responsibilities
- Lead development, optimization, qualification, validation, and lifecycle management of analytical methods and manufacturing process controls for radiopharmaceutical drug substances, drug products, precursors, excipients, and formulations.
- Design, plan, execute, and interpret scientific studies advancing analytical methods and manufacturing processes from late-stage development through commercial readiness.
- Develop control strategies and methods for Phase III clinical manufacturing, process validation campaigns, regulatory submissions, and commercial production.
- Provide analytical and process support for process development and optimization, manufacturing investigations, deviation assessments, root cause analyses, corrective and preventive actions, and continuous improvement.
- Manage multiple technical projects independently, establish experimental strategies, evaluate risks and opportunities, and deliver objectives on established timelines.
- Lead technical transfers to internal laboratories and 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, including support for IND and NDA submissions, health authority responses, and post-approval regulatory commitments.
- Collaborate with Manufacturing, MSAT, Quality, Regulatory Affairs, Supply Chain, and external partners to achieve program objectives.
- Apply scientific knowledge and judgment to solve complex technical problems, evaluate data, and recommend practical, science-based solutions.
- Maintain complete, accurate, contemporaneous laboratory documentation in accordance with cGMP, ALCOA+ principles, and company data integrity standards.
- Support development, review, and continuous improvement of pharmaceutical batch records, manufacturing documentation, and associated control strategies.
- Ensure activities comply with applicable regulations, company procedures, safety requirements, and quality management system expectations.
- Mentor junior scientists and laboratory personnel and provide technical leadership for assigned development programs and project teams.
- Demonstrate Aktis values: Lead with Integrity, Succeed Together, Be Bold, and Own the Impact.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
