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Cytokinetics

Develops small-molecule therapies for muscle function

Scientist 1 - Preformulation

Bioprocess & BiomanufacturingConfirmed live in the last 24 hours
Full-timeSouth San Francisco, CA, USA$135k - $157.5kIn-person

About the Job

Requirements

  • A Master of Science with at least 7 years, or a Ph.D. with at least 4 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 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.

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.
  • Communicate and collaborate with CMC Formulation Development to enable robust and reliable advancement of compounds from preclinical to clinical phases of development.

Desired Qualifications

  • 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 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.

About the Company

Cytokinetics

Develops small-molecule therapies for muscle function

Cytokinetics develops and commercializes small molecule drugs aimed at improving muscle function for cardiovascular and neuromuscular diseases. Its products are designed to either enhance or adjust muscle contraction, with a pipeline that includes compounds like omecamtiv mecarbil, reldesemtiv, CK-274, AMG 594, and CK-601, currently in various stages of clinical trials. The company advances therapies through partnerships, licensing, and potential sales of approved medicines, and relies on extensive clinical testing to demonstrate effectiveness and safety. What sets Cytokinetics apart is its focused approach on muscle function modulators (activators and inhibitors) for both heart and skeletal muscle diseases, targeting conditions such as heart failure, hypertrophic cardiomyopathy, ALS, and SMA. Its goal is to bring medicines to patients to improve muscle performance and daily function, addressing unmet medical needs in these diseases.

Company size
501-1,000
Company stage
IPO
Headquarters
South San Francisco, CA
Founded
1998

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