Staff Scientist, Pharmaceutical Development

Responsibilities

• Develop early formulation strategies to deliver fit-for-purpose formulations supporting PK, PD, efficacy, and safety preclinical studies
• Design, manage, and execute early formulation screening studies including solubility assessments and excipient compatibility
• Implement formulation development workflows and best practices internally and with CDMOs/CROs
• Represent early formulation on cross-functional research teams and present data to stakeholders
• Author and review technical documents, including development reports and study protocols
• Manage multiple priorities in a fast-paced environment to ensure on-time supply of formulations

Requirements

• PhD with 6+ years, MS with 10+ years, or BS with 12+ years of industry experience in small molecule formulation development
• Proven success delivering formulation strategies for preclinical research studies
• Experience with multiple routes of administration including powders, solid dosage forms, solutions, suspensions, nanoparticles, and lipid-based systems
• Hands-on experience with analytical techniques such as UPLC/HPLC and solid-state characterization (DSC, DVS, PLM, XRPD)
• Working knowledge of industry standards and regulatory guidance (ICH, FDA, EMA, USP-NF)
• Ability to manage and collaborate with external partners and CDMOs/CROs
• Willingness to travel domestically and internationally up to 20%

About the Company

Septerna is a biotechnology company based in South San Francisco, CA, focused on developing life-changing medicines through its Native Complex Platform™ to target G protein-coupled receptors (GPCRs).