Scientist I, Drug Product Analytics

Responsibilities

• Execute routine and non-routine analysis of internal release, development, and stability samples using various analytical techniques.
• Support the execution, optimization, and continuous improvement of the internal multiplex immunoassay (MSD) assay suite.
• Design, execute, and interpret experiments to support non-GxP stability studies, including thermal, freeze/thaw, and agitation evaluations.
• Analyze and interpret complex assay data to identify trends or deviations and communicate findings to project teams.
• Contribute to method development, qualification, and technology transfer activities in collaboration with external laboratories and CMOs.
• Author and review technical documentation, including assay protocols, SOPs, reports, and study plans.
• Collaborate cross-functionally with Drug Product Development, Formulation, Analytical Development, and Quality teams.

Requirements

• PhD with 1-2 years of relevant industry experience, MS with 5+ years, or BS with 8+ years of relevant industry experience.
• Degree in Chemistry, Biochemistry, Biology, Pharmaceutical Sciences, or a related scientific discipline.
• Hands-on experience developing, optimizing, and executing ELISA or multiplex immunoassays (MSD preferred).
• Experience supporting analytical characterization of biologic or vaccine Drug Products.
• Experience supporting bioanalytical components of product release testing and stability studies.
• Proficiency in analyzing and visualizing assay data using tools such as Excel or Prism.
• Experience authoring technical documentation including SOPs, protocols, and reports.
• Strong organizational skills and the ability to manage multiple priorities in a fast-paced environment.

About the Company

Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases. We are driven by core values of rethinking convention, aiming high, leading with heart, and modeling excellence.