Senior Associate Scientist (Contract), Drug Product Analytics

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.

Requirements

• BS degree in Chemistry, Biochemistry, or related field with minimum 5 years of relevant industry experience, or MS degree with minimum 3 years of relevant industry experience.
• At least 2 years of experience in an analytical development or quality control role.
• Prior experience running colorimetric assays is required.
• Prior experience with SEC-MALS is required.
• Prior experience with SDS-PAGE is required.
• Excellent attention to detail, organizational skills, and record-keeping abilities.
• Ability to work both independently and collaboratively in a fast-paced environment.
• Commitment to integrity, professionalism, and safety in all aspects of work.

Work Arrangement

Onsite (minimum of 4 days per week)

Pay

$56.00/hr. - $62.00/hr.