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Manager, External Manufacturing and Supply Operations

CytokineticsDublin, Dublin, Ireland
On-site Full-time

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Experience Level

Manager

Qualifications

Key Responsibilities:Develop and nurture strong, credible relationships with external CMOs and internal stakeholders. Provide hands-on technical oversight of manufacturing operations at CMOs, ensuring adherence to validated processes, regulatory standards, and internal guidelines. Lead the review and approval of batch records, verifying their accuracy, completeness, and compliance with cGMP and product specifications. Serve as the technical authority for batch disposition readiness, identifying and resolving issues affecting product quality or release timelines. Ensure timely execution of manufacturing and supply plans, proactively assessing risks and implementing mitigation strategies. Drive investigations and resolve deviations, OOS/OOT events, and product complaints, including leading or supporting root cause analysis (RCA) and CAPA development. Provide technical input and oversight for change controls, ensuring proper impact assessments and alignment with regulatory filings and process validations.

About the job

Cytokinetics is a pioneering biopharmaceutical company specializing in innovative cardiovascular treatments. Our focus is on the discovery, development, and commercialization of first-in-class muscle activators and next-in-class muscle inhibitors aimed at addressing severe diseases that compromise cardiac muscle performance. As a frontrunner in muscle biology, we are dedicated to creating small molecule drugs designed to enhance myocardial function and contractility.

Job Purpose

In the role of Manager, External Manufacturing and Supply Operations, you will oversee the comprehensive technical and operational aspects of external manufacturing and supply activities within a network of Contract Manufacturing Organizations (CMOs). This pivotal position within Manufacturing and External Supply Operations demands a solid technical foundation and the capacity to handle multiple priorities in a dynamic and fast-paced environment.

This position emphasizes the review and approval of batch records, process oversight, and informed technical decision-making, ensuring compliance with cGMP standards and alignment with global supply needs.

Your role will involve extensive collaboration with Quality Assurance, Technical Operations, Regulatory Affairs, and Supply Chain to ensure a robust, compliant, and dependable supply chain for both clinical and commercial products. You will report directly to the Director of External Supply Operations.

About Cytokinetics

Cytokinetics is dedicated to advancing the field of cardiovascular medicine through innovative research and the development of new treatments. Our commitment to understanding and enhancing muscle function drives our mission to improve the lives of patients facing debilitating conditions.

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