Senior Manager, Drug Substance Manufacturing

Aktis Oncology, Inc.; United States; On-site; USD 150,000 - 210,000; Full time

Job summary

Aktis Oncology, Inc. is seeking a Senior Manager, Drug Substance (DS) Manufacturing to lead day-to-day outsourced peptide/miniprotein production across our development portfolio.

You will supervise development, scale-up, technology transfer, GMP manufacturing, and analytical testing at external partners, while coordinating with QA, Supply Chain, and Finance to ensure on-time supply. This role requires strong technical judgment, partner management experience, and the ability to thrive in a

Qualifications

• Minimum 5 years of peptide/biologics process development or external manufacturing experience.
• Bachelor's degree or higher in chemistry, chemical engineering, biochemistry, pharmaceutical sciences, or related discipline.
• Experience with solid-phase peptide synthesis, analytical testing, and characterization is preferred.
• Experience managing CDMOs and coordinating multidisciplinary technical programs.
• Strong knowledge of cGMP regulations and validation principles.
• Excellent interpersonal and cross-functional collaboration skills.
• Ability to work independently in a fast-paced startup environment.

Responsibilities

• Manage day-to-day operations of external peptide/miniprotein manufacturing activities from development through clinical supply.
• Coordinate process development, scale-up, technology transfer, GMP manufacturing, and analytical testing at external partners.
• Review manufacturing documents, including protocols, batch records, campaign plans, and technical reports.
• Monitor stability studies, data availability, and report timelines; escalate upscale delays or unexpected results.
• Drive investigations, deviations, change controls, and corrective/preventive actions with Quality.
• Partner with Supply Chain and Operations to support material availability, manufacturing schedules, and demand planning.
• Manage CDMO contracts, statements of work, purchase orders, change orders, invoice tracking, and budget reconciliation.

Skills

External partner management

Project coordination

Analytical thinking

Communication skills

Independent worker

Education

Bachelor's degree or higher in chemistry/related field

Job description

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. 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 Aktis' proprietary pipeline.

The Senior Manager, Drug Substance (DS) Manufacturing, is responsible for the day-to-day planning, coordination, and oversight of outsourced manufacturing activities for peptide drug substance across Aktis’ development portfolio. This individual will report to the Associate Director, DS Manufacturing and be an integral part of the Chemistry, Manufacturing, and Controls (CMC) team contributing to the development of multiple portfolio programs. The ideal candidate combines strong technical judgment with external-partner management and thrives in a fast-paced, mission-driven environment.

ESSENTIAL DUTIES / RESPONSIBILITIES

• Manage day-to-day operations of external peptide/miniprotein manufacturing activities from development through clinical supply.
• Manage and coordinate process development, scale-up, technology transfer, GMP manufacturing, and analytical testing activities at external partners.
• Support review of manufacturing documents, including protocols, batch records, campaign plans, and technical reports.
• Monitor stability studies, including sample pulls, testing schedules, data availability, and report timelines, and upscale delays or unexpected results.
• Drive investigations, deviations, change controls, and corrective and preventive actions in partnership with Quality.
• Partner with Supply Chain and Operations to support material availability, manufacturing schedules, and demand planning.
• Manage CDMO contracts, statements of work, purchase orders, change orders, invoice tracking, and budget reconciliation in partnership with senior team members, Finance, and Procurement.

BACKGROUND AND QUALIFICATIONS

• Bachelor's degree or higher in chemistry, chemical engineering, biochemistry, pharmaceutical sciences, or related discipline
• 5+ years of experience in peptide, biologics, or small-molecule process development and/or external manufacturing within the biotechnology or pharmaceutical industry
• Direct experience with solid-phase peptide synthesis, analytical testing, and characterization is preferred
• Experience managing CDMOs and coordinating multidisciplinary technical programs
• Strong working knowledge of cGMP regulations and validation principles
• Strong analytical, problem-solving, and communication skills
• Excellent interpersonal skills and a collaborative approach with internal teams and external vendors
• Able to work independently with minimal supervision
• Self-starter who can prioritize and adapt in a fast-paced startup environment

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.