Scientist I, Preformulation

Cytokinetics, Inc.; South San Francisco (CA); On-site; USD 135,000 - 158,000; Full time

Benefits offered by this job

Stock options

Health & dental insurance

401k retirement benefits

Wellness stipends

Job summary

Cytokinetics, Inc. is seeking a senior preformulation scientist to lead formulation efforts from discovery to preclinical stages in South San Francisco.

You will design and evaluate formulations for non-clinical studies, select vehicles and excipients, and support solid-form selection and downstream development. You will develop and qualify HPLC/UPLC methods, manage projects with CROs, and contribute to data packages for first-in-human filings while communicating results to cross-functional

Qualifications

• M.S. or Ph.D. in Pharmaceutical Sciences, Chemistry, or a related discipline.
• Hands-on experience formulating poorly water-soluble compounds to maximize exposure in animal studies.
• Hands-on experience with HPLC/UPLC analysis and method development.

Responsibilities

• Serve as the preformulation representative on cross-functional project teams and share strategy and data.
• Design and evaluate formulations for non-clinical PK, PK/PD, and toxicology studies.
• Lead preformulation assessment of NCEs including solubility, stability, and polymorphism; plan lab work.

Skills

Physicochemical knowledge

Solubility-enabling formulations

Analytical method development

Communication skills

Education

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

Tools

HPLC/UPLC

Mass spectrometry

Job description

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.

Education and Experience

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.

Required Skills

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.

Preferred Skills

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

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

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.

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.