Director, Formulations

Requirements

• Advanced degree (Ph.D., M.S., or equivalent) in Pharmaceutical Sciences, Chemistry, Chemical Engineering, Materials Science, or a related discipline.
• Minimum of 10 years of industry experience in formulation and process development for oral dosage forms, including demonstrated experience in cGMP environments.
• Prior people leadership experience, including coaching, mentoring, performance management, and employee development, is preferred.
• Proven expertise in developing and advancing enabling formulations to improve solubility and bioavailability of poorly soluble compounds.
• Deep understanding of pharmaceutical sciences, with demonstrated hands-on experience in formulation development of new chemical entities and optimization of large-scale drug product manufacturing.
• Strong track record of cross-functional collaboration with CMC/Technical Operations, Quality Assurance, Regulatory Affairs, and related disciplines.
• Working knowledge of key analytical techniques, including HPLC, UV spectroscopy, dissolution testing, and solid-state characterization.
• Proficiency in authoring technical reports and CMC sections of regulatory submissions.
• Demonstrated ability to communicate effectively with senior leadership, with strong executive presence and the ability to represent the fun

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. As Director of Formulations at Cytokinetics, reporting to the Senior Director of Formulation Development and Pharmaceutical Engineering, you will provide strong technical and strategic leadership in the development of multiple early- and late-stage compounds. You will play a key role in advancing our drug development programs by leading efforts in formulation development, process optimization and scale-up, control strategy development, and development and GMP manufacturing activities at external CDMO partners. You will serve on cross-functional CMC teams and develop comprehensive CMC development plans that support clinical development. This position is integral to the advancement of Cytokinetics' growing portfolio of drug candidates. In addition to technical leadership responsibilities, this role may have people leadership responsibilities, including coaching, mentoring, performance management, talent development, and fostering a collaborative, high-performing team environment. Primary Responsibilities: Lead formulation and process development activities for early- and late-stage clinical candidates, ensuring alignment with overall development timelines and goals. Lead strategic planning for formulation development, identifying risks, proposing mitigation strategies, and enabling efficient progression to clinical and commercial stages. Accountable for formulation and process development activities and technical oversight of clinical drug product manufacturing at contract manufacturing organizations (CMOs), including management and approval of documentation, planning, scheduling, execution, and person-in-plant support (when required). Provide coaching, mentorship, and development support to team members as applicable, fostering scientific excellence, collaboration, and continuous learning. Support employee performance management activities, including goal setting, development planning, and ongoing feedback, when serving in a people leadership capacity. Develop and strengthen team capabilities by establishing methodologies, evaluation criteria, and best practices for experimental design, data interpretation, and decision-making. Apply sound formulation development principles to solve complex product development challenges and enable robust, scalable processes. Identify, evaluate, and implement innovative formulation technologies to enhance product performance and reduce development cycle time. Provide subject matter expertise to support global CMC regulatory strategies and cross-functional development plans. Author and review pharmaceutical development and manufacturing sections for clinical and commercial regulatory submissions. Design, execute, and analyze laboratory studies to advance scientific understanding of formulation development and address technical challenges. Prepare technical protocols, reports, and documentation, ensuring high-quality data analysis, interpretation, and communication of results. Contribute to external scientific visibility through publications, presentations, and participation in conferences. Partner with Legal/IP teams to support patent strategy and ensure appropriate protection of drug product innovations. Build and maintain strong cross-functional collaborations with Chemical Development, Analytical Development, Quality, Regulatory, DMPK, and other stakeholders to support integrated program success.

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