Scientist I, Drug Product Analytics

Essential Functions

• 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.

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

Reports to

Senior Scientist, Drug Product Analytics

Location

San Carlos, CA

Work Arrangement

Onsite (minimum of 4 days per week)

Pay

The compensation package will be competitive and includes comprehensive benefits and an equity component.

Salary Range: $129,000 – $140,000 (SF Bay Area)