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.

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:

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.

Please review our General Data Protection Regulation (GDPR) policy PRIOR to applying.  

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.

Fraud Warning: How to Identify Impersonated Cytokinetics Job Postings and Offers

Recently, there have been fraudulent employment offers being sent to candidates on behalf of Cytokinetics. Please be advised that all legitimate offers from Cytokinetics will come directly from our official email domain (Cytokinetics.com) and will only be made after completing a formal interview process.

Here are some ways to check for authenticity:

• We do not conduct job interviews through non-standard text messaging applications

• We will never request personal information such as banking details until after an official offer has been accepted and verified

• We will never request that you purchase equipment or other items when interviewing or hiring

• If you are unsure about the authenticity of an offer, or if you receive any suspicious communication, please contact us directly at [email protected]

Please visit our website at: www.cytokinetics.com

Cytokinetics is an Equal Opportunity Employer