Scientist I (Contract), Drug Product Analytics at Vaxcyte

San Carlos, California, United States -

Full Time

Start Date

Immediate

Expiry Date

19 Aug, 26

Salary

68.0

Posted On

21 May, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Immunoassays, Multiplexed Immunoassay, MSD, ELISA, Biomolecule Characterization, Stability Studies, Method Development, Technical Documentation, Data Analysis, Drug Product Analytics, Biologics, Vaccine Development, SOP Authoring, ELN, Particle Characterization, Biochemical Analysis

Industry

Biotechnology Research

Description

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. Summary: Vaxcyte is looking for an energetic and talented individual to join our Drug Product Development team. The candidate must have knowledge of and practical experience in analyzing and characterizing biomolecules (proteins, polysaccharide conjugates, vaccines) using a variety of methods, especially immunoassays and multiplexed immunoassay formats. Experience in analyzing vaccine and adjuvant-containing formulations is a plus. In addition, Vaxcyte is looking for an experienced and flexible individual who would be comfortable working on multiple projects at once, with fluid prioritization to enable aggressive timelines. This position is for a lab-based scientific role and requires excellent scientific judgement, independence, rigor, and thorough record-keeping. Essential Functions: Execute routine and non-routine analysis of internal release, development, and stability samples using a variety of analytical techniques across Drug Product working groups, ensuring high-quality data generation and reporting. Support 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. 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 and manufacturing CMOs. 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 VAXA1 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. Hands-on experience developing, optimizing, and executing ELISA or multiplex immunoassays (MSD preferred) with demonstrated ability to troubleshoot assay performance and interpret assay data. Experience 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, including biochemical, biophysical, imaging, and compendial methods. Familiarity with plate-based assays (Lowry, BCA, etc.), multiplexed immunoassays (MSD), microscopy methods (brightfield, scanning electron microscopy), compendial methods (osmolality, pH, etc.), and particle characterization techniques (PSD, zeta potential). Experience analyzing and visualizing assay data using software tools such as Excel, Prism, or equivalent statistical/data analysis platforms. 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 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 Location: San Carlos, CA Work Arrangement: Onsite (minimum of 4 days per week). Expected Contract Length: 12months Hourly Range: $62/hr. - $68/hr. We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.

Responsibilities

Execute routine and non-routine analysis of drug product samples using various analytical techniques, specifically focusing on multiplex immunoassays. Support stability studies, method development, and the authoring of technical documentation to support vaccine programs.