Director, Formulations

Cytokinetics, Inc.; United States; Hybrid; USD 232,110 - 270,795; Full time

Job summary

Cytokinetics, Inc. is looking for a proven leader to drive formulation and process development in their pipeline of cardiovascular medicines. This role requires extensive experience in developing oral dosage forms and ensuring compliance with cGMP standards.

The ideal candidate will have a Ph.D. or M.S. in Pharmaceutical Sciences and over 10 years of industry experience. You will be responsible for technical oversight, coaching team members, and collaborating with cross-functional teams.

The position offers a competitive pay range of $232,110 – $270,795 annually, reflecting the expertise and leadership needed in this critical role.

Qualifications

• Minimum of 10 years of industry experience in formulation and process development.
• Experience in cGMP environments is essential.
• Strong understanding of pharmaceutical sciences and optimization of drug product manufacturing.

Responsibilities

• Lead formulation and process development activities for clinical candidates.
• Accountable for technical oversight of clinical drug product manufacturing.
• Provide coaching and mentorship to team members.

Skills

Formulation development

Process development

Team leadership

Cross-functional collaboration

Regulatory submission expertise

Education

Ph.D. or M.S. in Pharmaceutical Sciences or related discipline

Tools

HPLC

UV spectroscopy

Dissolution testing

Job description

Cytokinetics is a specialty cardiovascular biopharmaceutical company, building on its 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.

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, 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.

Qualifications

• 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 function in high‑level forums.
• Strong leadership, coaching, and interpersonal skills with the ability to develop talent and foster collaborative working relationships.

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Pay Range: In the U.S., the hiring pay range for fully qualified candidates is $232,110 – $270,795 per year.

Cytokinetics is an Equal Opportunity Employer.