Scientist , Preformulation

Main Duties and Responsibilities

Serve as the preformulation representative on drug discovery and early development project teams, communicating strategy, risks, and data to cross-functional partners. Design and evaluate formulations for non-clinical PK, PK/PD, pharmacology, and toxicology studies, selecting vehicles and excipients that deliver the required exposure and stability. Lead preformulation assessment of new chemical entities (NCEs), including solubility, solid-state stability, particle size and morphology, bio-relevant dissolution, and polymorphism.

Conduct salt, co-crystal, and solid-form screening to support solid-form selection and de-risk downstream development. Apply solubility-enabling technologies, such as amorphous solid dispersions, lipid-based systems, nanosuspensions, and complexation, to poorly water-soluble compounds. Develop and qualify HPLC/UPLC methods supporting formulation characterization, stability assessment, and dose formulation analysis, including concentration and homogeneity verification for GLP toxicology studies. Plan and lead laboratory work in accordance with project timelines, and oversee formulation or analytical work placed with contract research organizations.

Contribute preformulation and formulation data to candidate selection decisions and to documentation supporting first-in-human studies. Author technical reports and correspondence to a standard suitable for internal review, CMC handoff, and regulatory filings. Monitor the scientific literature and proactively apply established and emerging approaches to project challenges. Effectively communicate and collaborate with CMC Formulation Development to enable robust and reliable advancement of compounds from preclinical to clinical phases of development.

M.S. or Ph.D. in Pharmaceutical Sciences, Chemistry, or a related discipline. M.S. with 7 or more years, or Ph.D. with 4 or more years, of relevant industry experience in preformulation and preclinical formulation development. Hands-on experience formulating poorly water-soluble compounds in a discovery research setting to maximize exposure in animal studies. Hands-on experience with HPLC/UPLC analysis and method development. Hands-on experience with dose verification and with solubility assays in simulated gastric fluid (SGF) and biorelevant media (FaSSIF and FeSSIF), performed in accordance with USP methods.

Strong technical knowledge of physicochemical and solid-state properties and their relationship to drug product design and performance. Practical experience selecting and developing solubility-enabling formulations. Practical experience with analytical method development across chromatographic techniques, with working familiarity with mass spectrometry. Ability to manage several projects concurrently, using initiative and creativity to meet agreed objectives and timelines. Excellent written and oral communication skills, including the ability to present technical results to research and CMC audiences.

Knowledge of biopharmaceutics and pharmacokinetic principles. Experience supporting GLP toxicology studies, including dose formulation analysis. Experience overseeing formulation or analytical work at contract research organizations. Demonstrated problem-solving ability and excellent practical laboratory skills. Strong collaboration and networking skills, with the ability to engage colleagues in new initiatives. Ability to deliver reliably under competing priorities and timelines.

Pay Range:
The expected salary range for this position based on the primary location of South San Francisco, CA is $135,000-$157,500. The base pay offered will take into account internal equity and may vary depending on the candidate's geographic region, job-related knowledge, skills, and experience among other factors.

Base salary is just one component of our competitive total compensation package, which includes

• equity in the form of stock options and/or restricted stock units
• comprehensive health, dental, vision, life and disability insurance coverage
• 401k retirement benefits with employer match
• learning and wellness stipends
• paid time off

Note that benefits are subject to change and may vary based on jurisdiction of employment.

Our employees come from different backgrounds, and we celebrate those differences.

Cytokinetics is an Equal Opportunity Employer

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