Director, Chemical Development

Responsibilities

• Provide technical leadership, mentorship, and people leadership for internal scientists, while building organizational capability within Chemical Development and effectively leading CDMO partners.
• Lead process R&D activities at CDMO partners and provide technical oversight for scale-up and tech transfer from the laboratory to the pilot plant and, as appropriate, to commercial manufacturing.
• Lead the technical evaluation and selection of CDMO partners by assessing process R&D and GMP manufacturing capabilities, participating in site visits, and influencing decisions that support program and portfolio needs.
• Review and approve cGMP documents, including batch records, change controls, deviations, specifications, validation master plans, and validation protocols/reports.
• Author technical sections of requests for proposal, review proposals, and partner with the Cytokinetics external supply team to support CDMO selection and contracting discussions.
• Partner with the Cytokinetics external supply team to coordinate production schedules at CDMO partners in support of non-clinical and clinical studies and formulation development activities.
• Partner with the Cytokinetics external supply team and CDMO partners to support sourcing and timely availability of custom raw materials for drug substance manufacturing.
• Lead the development of phase-appropriate drug substance control strategies, including identification of critical quality attributes (CQAs) and establishment of specifications for starting materials and intermediates to ensure consistent product quality.
• Drive development of safe, robust, scalable, and cost-effective manufacturing processes, including evaluation of process safety and scale-up risks to support clinical development and commercial readiness.
• Lead the design and execution of process characterization and fate/purge studies to establish critical process parameters and define process control strategies.
• Apply phase-appropriate Quality by Design (QbD) principles and risk assessment tools to process development, characterization, validation planning, and lifecycle management.
• Serve as the drug substance lead on cross-functional project teams and partner with functional leads in Analytical Development, Formulation Development, External Manufacturing, and Regulatory Affairs CMC to develop and execute aligned CMC strategies that support clinical and business objectives.
• Oversee preparation of technical development reports and contribute to authoring clinical regulatory filings (IND/IMPD) and global marketing applications (NDA/MAA), including responses to Health Authority inquiries.
• Support validation and commercial readiness activities, including process performance qualification, continued process verification, and ongoing lifecycle improvement, as appropriate.
• Drive cross-functional alignment and execution to ensure timely delivery of drug substance throughout the program lifecycle.
• Drive continuous improvement in drug substance development through scientific innovation, sound risk management, and adoption of best practices.
• Partner with Legal and Intellectual Property teams to support patent strategy and help identify, evaluate, and protect innovations related to synthetic routes, manufacturing processes, and other drug substance development activities.
• Contribute to external scientific visibility through publications, presentations, and participation in scientific conferences and industry forums, as appropriate.
• Represent Chemical Development in cross-functional governance and senior leadership discussions, clearly communicating development strateg

Benefits

Additional Information

Cytokinetics is a specialty cardiovascular biopharmaceutical company, building on its over 25 years of pioneering scientific innovations in muscle biology, and advancing a pipeline of potential new medicines for patients suffering from diseases of cardiac muscle dysfunction. We are seeking a highly skilled and motivated Director with expertise in small molecule process development and manufacturing to join our CMC team. In this role, you will lead the technical development strategy for small molecule drug substances from IND-enabling studies through late-stage development and commercial readiness for assigned programs . You will provide strategic and technical leadership across programs, including synthetic route design, process optimization, control strategy development, and scale-up and GMP manufacturing activities, during pre-commercial development , at external CDMO partners. You will serve as the drug substance lead on cross-functional CMC teams and drive comprehensive CMC development plans that support clinical development and long-range program objectives. This role is expected to influence strategic decisions, identify and mitigate technical and supply risks, and communicate effectively with senior leadership. It offers an exciting opportunity to contribute to the advancement of Cytokinetics' growing portfolio of novel therapeutics.

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