Senior Manager, Peptide Drug Substance Manufacturing

Aktis Oncology; United States; On-site; USD 120,000 - 160,000; Full time

Job summary

Aktis Oncology, Inc. is seeking a Senior Manager, DS Manufacturing to lead day-to-day outsourced peptide drug substance manufacturing for multiple programs.

You will coordinate development, scale-up, technology transfer, GMP production, and analytical testing with external partners, reporting to the Associate Director of DS Manufacturing within the CMC team. The role requires strong technical judgment, external-partner management, and the ability to thrive in a fast-paced startup environment

Qualifications

• Bachelor’s degree or higher in chemistry, chemical engineering, biochemistry, pharmaceutical sciences, or related discipline.
• 5+ years of peptide/biologics/small-molecule process development and/or external manufacturing experience in biotech/pharma.
• Experience with solid-phase peptide synthesis, analytical testing, and characterization preferred.
• Experience managing CDMOs and coordinating multidisciplinary programs.
• Strong knowledge of cGMP regulations and validation principles.

Responsibilities

• Oversee day-to-day external peptide/miniprotein manufacturing activities from development through clinical supply.
• Coordinate process development, scale-up, tech transfer, GMP manufacturing and analytical testing at external partners.
• Review manufacturing documents including protocols, batch records, and campaign plans.
• Monitor stability studies and coordinate data reporting; escalate delays or issues as needed.
• Lead investigations, deviations, CAPAs, and change controls with Quality.
• Collaborate with Supply Chain and Operations on material availability and schedules.
• Manage CDMO contracts, statements of work, POs, change orders, invoicing, and budget reconciliation.

Skills

CDMO management

External manufacturing oversight

GMP knowledge

Analytical skills

Communication

Education

Bachelor's degree in chemistry/biochemistry/pharma

Job description

Aktis Oncology, Inc. is seeking a Senior Manager, DS Manufacturing to lead day-to-day outsourced peptide drug substance manufacturing for multiple programs.

You will coordinate development, scale-up, technology transfer, GMP production, and analytical testing with external partners, reporting to the Associate Director of DS Manufacturing within the CMC team. The role requires strong technical judgment, external-partner management, and the ability to thrive in a fast-paced startup environment