Preformulation Scientist - Drug Formulation & PK Expert

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

Job summary

Cytokinetics is seeking a highly motivated Preformulation Pharmaceutical Scientist to join the Preclinical Research Sciences team in South San Francisco. You will lead preformulation assessments of small molecules, design formulations for non-clinical studies, and collaborate with biologists, chemists, and PK scientists to advance candidate drugs.

You will develop and qualify HPLC/UPLC methods, apply solubility-enhancing technologies, and contribute data to candidate selection and regulatory

Qualifications

• 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 SGF and FaSSIF/FeSSIF per USP methods.

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 for 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.
• Develop and qualify HPLC/UPLC methods supporting formulation characterization, stability assessment, and dose formulation analysis.
• Plan and lead laboratory work and oversee CROs.
• Contribute preformulation and formulation data to candidate selection decisions and to documentation for first-in-human studies.
• Author technical reports and correspondence for internal review, CMC handoff, and regulatory filings.
• Monitor the literature and apply established and emerging approaches to project challenges.
• Collaborate with CMC Formulation Development to advance compounds from preclinical to clinical.

Skills

Physicochemical properties

Solubility-enabling formulations

Analytical method development

Project management

Effective communication

Education

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

7+ years (MS) or 4+ years (PhD) in preformulation/formulation development

Tools

HPLC/UPLC analysis

Mass spectrometry

Job description

Cytokinetics is seeking a highly motivated Preformulation Pharmaceutical Scientist to join the Preclinical Research Sciences team in South San Francisco. You will lead preformulation assessments of small molecules, design formulations for non-clinical studies, and collaborate with biologists, chemists, and PK scientists to advance candidate drugs.

You will develop and qualify HPLC/UPLC methods, apply solubility-enhancing technologies, and contribute data to candidate selection and regulatory