Scientist, Radiopharmaceutical Analytical Development

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.

Aktis Oncology is seeking a highly motivated Scientist to support analytical method development for AKTIS Oncology’s proprietary radiopharmaceutical drug products. The candidate will lead method development, optimization, validation, and troubleshooting of HPLC methods focused on purity and impurity profiling, including RP-HPLC and SEC-HPLC techniques. This role is critical in ensuring product quality, regulatory compliance, and successful advancement of radiopharmaceutical programs from early development through clinical manufacturing. The position will collaborate closely with cross-functional team members to ensure timely delivery of robust QC protocols. The ideal candidate has hands-on experience in radio-analytical chemistry, chromatographic method development, and GMP , handle CRO/CDMO, analytical environments. This role will report to the Director of Analytical Development and requires full-time on-site presence.

Responsibilities

This role will drive several areas of strategic importance to Aktis:

• Develop and optimize RP-, IEX- and SEC-HPLC methods for chemical and radiochemical purity and impurity analysis
• Design stability-indicating analytical methods for radiopharmaceutical drug substances and drug products
• Perform method validation in compliance with ICH and GMP guidelines
• Troubleshoot complex chromatographic issues related to radiolabeled compounds, radiochemical impurities.
• Conduct radiochemical impurity profiling and forced degradation studies
• Support batch release testing and QC investigations
• Write and review analytical protocols, reports, SOPs, and validation documentation
• Collaborate with CMC, pre-clinical and process development, and manufacturing teams
• Maintain compliance with radiation safety and GMP laboratory standards
• Operate and maintain radio-HPLC systems, detectors, and analytical instruments
• Participate in regulatory submissions by preparing analytical sections
• Train junior staff and contribute to continuous process improvement

Qualifications

• PhD in Analytical Chemistry with 2 years relevant industry, Radiochemistry, Pharmaceutical Sciences, or related field OR MS with 4 years relevant industry experience OR BS with 6 years relevant industry experience
• Hands-on experience with RP-HPLC and SEC-HPLC method development in purity and impurity, method validation and transfer in support of drug product is essential.
• Stability study design and forced degradation expertise.
• Experience analyzing radiolabeled compounds, Experience with gamma detectors, UV, radio detector and mass-based detection
• Strong understanding of chemical purity and impurity analysis
• Familiarity with GMP analytical laboratories
• Experience with radioactive detectors and radio-HPLC systems (Agilent 1260 with Open lab CDS software)
• Knowledge of ICH method validation guidelines
• Project management and organizational skills, proven track record of setting priorities, and ability to work independently and as a team member.
• Strong desire to be part of a mission‐oriented company leading transformative change for patients.
• Proven demonstration of transparent communication and fostering open and diverse debate.
• Ability to work with agility and manage ambiguity.
• Personifies positive energy and exemplifies respect.

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.