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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