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.
• 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 strategy, key risks, mitigation plans, and tradeoffs.
• Contribute to functional excellence by advancing methodologies, evaluation criteria, and best practices for experimental design, data interpretation, and decision-making, while helping shape external development strategies and capabilities across the organization.
• Provide clear, timely communication to senior leadership within Global Supply Chain and Technical Operations on critical program developments and decisions.

Qualifications

• Ph.D. in chemistry with 12+ years of pharmaceutical/biotech industry experience in small molecule drug substance development; or M.S. with 15+ years of relevant experience.
• Strong expertise in synthetic organic chemistry and experience in process development, scale-up, and GMP manufacturing support for drug substances.
• Strong understanding of the solid-state properties of small molecules.
• Direct, hands-on experience leading CDMOs and ensuring high-quality execution and delivery.
• Well-versed with cGMP regulations and quality systems relevant to pharmaceutical development and manufacturing.
• Demonstrated ability to lead complex cross-functional initiatives, influence senior stakeholders, and represent the function effectively in high-level forums.
• Good understanding of analytical methods and associated ICH guidelines.
• Experience authoring CMC sections of regulatory filings.
• Thorough understanding of, and demonstrated experience across, all phases of drug development from initial process R&D through commercialization.
• Excellent problem-solving skills, attention to detail, and the ability to work both independently and collaboratively.
• Excellent written and verbal communication skills, with the ability to communicate effectively across technical, cross-functional, and senior leadership audiences.
• Strong interpersonal and organizational skills, with the ability to manage multiple priorities, complex projects, and cross-functional stakeholders effectively.
• Prior experience mentoring, developing, and managing scientists or matrix teams is preferred.
• Able to travel domestically and internationally.