Sr Manager, Global Radiopharmaceutical Manufacturing

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 Manager, Global Radiopharmaceutical Manufacturing, leads technology transfer and GMP manufacturing operations from development through clinical and commercial manufacturing. This role is accountable for transfer strategy, execution, compliance, and cross‑functional alignment across internal sites and external CDMO/CMO partners.

This role will report to the Senior Director of Global Radiopharmaceutical Manufacturing

RESPONSIBILITIES

• Serve as the primary operational and technical point of contact for contract manufacturing organizations (CMOs) producing radiopharmaceutical drug substance and drug product.
• Lead site selection, and management of manufacturing partners, ensuring alignment with program needs, timelines, and quality expectations.
• Oversee day‑to‑day CMO performance, including production planning, batch execution, deviation management, and timely delivery of clinical supplies.
• Ensure manufacturing processes are executed according to approved instructions, validated methods, and GMP requirements.
• Support technology transfer, scale‑up, and process optimization activities.
• Troubleshoot technical issues during manufacturing campaigns and drive root‑cause investigations and corrective actions.
• Partner with Analytical Development and Quality Control to ensure testing readiness, method transfer, and timely release of clinical materials.
• Ensure all external manufacturing activities comply with GMP, radiation safety regulations, and applicable global regulatory requirements.
• Support audits, inspections, and quality oversight activities at CMOs.
• Collaborate with Supply Chain to ensure isotope availability, material readiness, and on‑time delivery of clinical supplies to sites.
• Contribute to program planning, risk assessments, and scenario modeling for clinical supply strategies.
• Provide manufacturing input into regulatory submissions, including IND/IMPD updates and responses to health authority questions.

QUALIFICATIONS

• BS in chemistry or engineering or related field (advanced degree preferred).
• 3–5 years of experience in radiopharmaceutical manufacturing, process development, or technology transfer.
• Demonstrated experience leading internal and/or external tech transfers.
• Strong knowledge of GMP, validation, and regulatory expectations for radiopharmaceuticals.
• Proven project leadership and cross‑functional communication skills.
• High attention to detail and organizational skills to enable working in a fast-paced environment.

KNOWLEDGE, SKILLS, AND ABILITIES

• Experience with PET and/or therapeutic radiopharmaceuticals
• Familiarity with analytical methods and radiopharmaceutical manufacturing equipment
• Ability to interpret technical data and troubleshoot manufacturing issues
• Experience supporting audits and regulatory inspections
• Travel up to ~30–40%, as required
• Take on new challenges willingly and build a culture of rigor and data-driven decision making to bring novel therapies to the clinic
• Demonstrate high standards for scientific rigor, team behaviors, excellence and a culture of innovation that is fully aligned with company objectives
• Demonstrate tenacity and drive for enterprise benefit

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.