Scientist I, Drug Product Analytics

Vaxcyte•San Carlos, CA

3d•$129,000 - $140,000•Onsite

About The Position

Vaxcyte is a clinical-stage vaccine innovation company focused on engineering high-fidelity vaccines to protect humankind from bacterial diseases. The Scientist I, Drug Product Analytics will drive the execution, optimization, and continuous improvement of Vaxcyte’s internal multiplex immunoassay (MSD) assay suite. This role involves designing, executing, and interpreting experiments for non-GxP stability studies, routine release, development, and stability samples using various analytical techniques. The position also includes developing and automating analytical assays, analyzing complex data, contributing to method development and technology transfer, and authoring technical documentation. This is a predominantly lab-based role requiring strong scientific judgment, independence, rigor in data analysis, and meticulous record keeping, supporting Vaxcyte’s PCV and VAX-A1 programs through cross-functional collaboration.

Requirements

PhD, MS or Bachelor’s degree in Chemistry, Biochemistry, Biology, Pharmaceutical Sciences, or a related scientific discipline.
PhD with 1-2 years relevant industry experience; MS with 5+ years relevant industry experience; BS with 8+ years of relevant industry experience.
Experience with design, qualification, and testing of critical assay reagents, such as antibodies, QC samples, calibrators, amongst others.
Experience analyzing and visualizing bioassay data using software tools such as Excel, Prism, JMP, or equivalent statistical/data analysis platforms.
Experience designing and supporting analytical characterization of biologic or vaccine Drug Products, ideally including materials in pre-filled syringes or vials.
Experience supporting bioanalytical components of product release testing and stability studies.
Experience authoring analytical technical documentation including method protocols, SOPs, reports, and study summaries, and maintaining well-documented electronic laboratory notebooks (ELN).
Strong organizational skills and the ability to manage multiple projects and shifting priorities in a dynamic development environment.
Strong analytical and problem-solving skills with the ability to think critically.
Strong interpersonal and communication skills, with the ability to effectively collaborate across teams and train or mentor junior analysts when needed.
Detail-oriented with a high level of scientific rigor and excellence in data integrity and record keeping.

Nice To Haves

Familiarity with automated liquid handling platforms will be considered an advantage.

Responsibilities

Drive the execution, optimization, and continuous improvement of Vaxcyte’s internal multiplex immunoassay (MSD) assay suite, including troubleshooting assay performance, improving robustness, and supporting assay lifecycle management.
Design, execute, and interpret experiments to support non-GxP stability studies including thermal, freeze/thaw, agitation, and container closure system evaluations for both Drug Substance and adjuvanted vaccine Drug Product materials.
Execute routine studies to support internal release, development, and stability samples using a variety of analytical techniques across Drug Product working groups, ensuring high-quality data generation and reporting.
Develop, automate, and iterate on analytical assays to support product characterization.
Analyze and interpret complex assay data, identify trends or deviations, and communicate findings to project teams to support development decisions.
Contribute to method development, qualification, and technology transfer activities, including collaboration with external analytical laboratories.
Author and review technical documentation including assay protocols, SOPs, reports, study plans, and technical summaries in support of development and analytical activities.
Support the Vaxcyte PCV and VAX-A1 programs through cross-functional collaboration with Drug Product Development, Formulation, Analytical Development, Quality, and external partners.