Scientist I, Drug Product Analytics

**Join our Mission to Protect Humankind!**

Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, which have serious and costly health consequences when left unchecked. Working to eradicate or treat bacterial infections such as invasive pneumococcal disease, Group A Strep, and Shigella is just the beginning. Our path to success is clear and well-defined, and Vaxcyte is set up to go the distance.

WHAT we do is every bit as important as HOW we do it! Our work together is guided by four enduring core values:

• RETHINK CONVENTION: We bring creative and intellectual diversity to every facet of the work we do in order to innovate and re-innovate the way vaccines are delivered.
• AIM HIGH: We embody our collectively audacious goal to courageously make the most complex biologics ever attempted to protect humankind.
• LEAD WITH HEART: Everyone leads at Vaxcyte with a kindness-first, inclusive approach to collaboration and vigorous debate that advances our business objectives.
• MODEL EXCELLENCE: The magnitude of our challenge requires our shared commitment to demonstrating integrity, accountability, equality and clarity across communications and decision making.

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.
• Vaxcyte is seeking a flexible and collaborative scientist comfortable managing multiple priorities in a fast-paced development environment. This role is predominantly lab-based and requires strong scientific judgment, independence in experimental execution, rigor in data analysis, and meticulous record keeping.

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.