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Director of External Manufacturing, CMC13 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 objectivesBuild strong relationships with CMOs to ensure long-term partnerships and effective communicationOversee day-to-day management of CMO relationships, including performance monitoring, production planning, and issue resolutionSupport technology transfer and scale-up activities for new productsEnsure on-time delivery of products while maintaining high-quality standards and regulatory compliancePartner with Quality Assurance to monitor CMO compliance with Good Manufacturing Practices (GMP) and regulatory requirementsLead resolution of operational challenges, deviations, and supply disruptionsMonitor budgets and drive cost-effective solutions without compromising qualityWork closely with internal teams (R&D, Quality, Supply Chain, and Regulatory Affairs) to ensure seamless coordination and alignment of manufacturing activitiesStay updated on industry trends, technologies, and regulatory changes to drive innovation and continuous improvementQUALIFICATIONS Bachelor's degree or higher in Chemistry, Biochemistry, Chemical Engineering, Pharmaceutical Sciences, or a related field8+ years of experience in pharmaceutical manufacturing, with at least 5 years in leadership role managing CMOsDemonstrated understanding of manufacturing, testing, and controls, of solid-phase peptide manufacturingExperience with the manufacturing of peptides and proteinsDemonstrated understanding of cGMP requirements and regulatory guidelines (e.g., FDA, EMA)Proven experience in managing tech transfers, scale-up, and commercial manufacturingStrong project management and problem-solving skillsExcellent interpersonal and communication abilities to collaborate with internal and external stakeholdersStrong desire to be part of a mission-oriented company leading transformative change for patientsProven demonstration of transparent communication and fostering open and diverse debateAbility to work with agility and manage ambiguityPersonifies positive energy and exemplifies respect
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