Director, Chemical Development

Cytokineticsis 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 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.

• 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 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.
  

• 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.
• Ability to travel domestically and internationally.
  
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Pay Range:

Our employees come from different backgrounds and we celebrate those differences. We are looking for the best candidates for our open roles but do not expect applicants to meet every qualification in order to be considered. If you are excited about what you could accomplish at Cytokinetics and believe you can add value to our team we would love to hear from you.

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Our passion is anchored in robust scientific thinking grounded in integrity and critical thinking. We keep the patient front and center in all we do all actions and decisions are in service of the patient and their caregivers. We champion integrity ethics doing the right thing and being our best selves.

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Cytokinetics is an Equal Opportunity Employer