What are the responsibilities and job description for the Director of External Manufacturing, CMC position at Aktis Oncology, Inc.?

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Director of External Manufacturing, CMC

13 days ago Requisition ID : 1023

Aktis Oncology is a biotechnology company pioneering the discovery and development of a new class of targeted alpha radiopharmaceuticals to treat a broad range of solid tumor cancers. Founded and incubated by MPM Capital, the company has developed proprietary platforms to generate tumor-targeting agents with ideal properties for alpha radiotherapy. Designed for high tumor penetration and long residence time, Aktis Oncology's molecules will quickly clear other areas of the body, thereby maximizing tumor elimination while minimizing the side effects of treatment. This approach would enable clinicians to visualize and verify target engagement prior to exposure to therapeutic radioisotopes.

We are seeking a dynamic and experienced Director of External Manufacturing to oversee and manage all aspects of external manufacturing operations of peptide conjugates to ensure timely delivery, quality compliance, and cost-effectiveness. The successful candidate will collaborate closely with internal teams and external partners to support the company's strategic objectives.

RESPONSIBILITIES

Develop and execute strategies for selecting, negotiating, and managing contract manufacturing organizations (CMOs) to align with company objectives
Build strong relationships with CMOs to ensure long-term partnerships and effective communication
Oversee day-to-day management of CMO relationships, including performance monitoring, production planning, and issue resolution
Support technology transfer and scale-up activities for new products
Ensure on-time delivery of products while maintaining high-quality standards and regulatory compliance
Partner with Quality Assurance to monitor CMO compliance with Good Manufacturing Practices (GMP) and regulatory requirements
Lead resolution of operational challenges, deviations, and supply disruptions
Monitor budgets and drive cost-effective solutions without compromising quality
Work closely with internal teams (R&D, Quality, Supply Chain, and Regulatory Affairs) to ensure seamless coordination and alignment of manufacturing activities
Stay updated on industry trends, technologies, and regulatory changes to drive innovation and continuous improvement

QUALIFICATIONS

Bachelor’s degree or higher in Chemistry, Biochemistry, Chemical Engineering, Pharmaceutical Sciences, or a related field

8 years of experience in pharmaceutical manufacturing, with at least 5 years in leadership role managing CMOs

Demonstrated understanding of manufacturing, testing, and controls, of solid-phase peptide manufacturing

Experience with the manufacturing of peptides and proteins

Demonstrated understanding of cGMP requirements and regulatory guidelines (e.g., FDA, EMA)

Proven experience in managing tech transfers, scale-up, and commercial manufacturing

Strong project management and problem-solving skills

Excellent interpersonal and communication abilities to collaborate with internal and external stakeholders

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

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Director of External Manufacturing, CMC

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