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 for 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

• MS degree in Chemistry, Biochemistry, or a related field with at least 5 years of relevant industry experience, OR a BS degree with at least 8 years of relevant industry experience.
• Minimum of 2 years of experience in an analytical development or quality control role.
• Hands-on experience with colorimetric assays.
• Hands-on experience with SEC-MALS.
• Hands-on experience with SDS-PAGE.
• Strong attention to detail, organizational skills, and meticulous record-keeping abilities.
• Ability to work independently and collaboratively in a fast-paced, lab-based 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 to tackle the most complex biologics in the industry.