RA Capital

Summary:

The Development organization is comprised of four Process teams: Protein, Polysaccharide, Conjugate Drug Substance (Conjugation), and Drug Product. These Process Development teams are supported by Analytical Development and Formulation Development teams. Vaxcyte is seeking an Associate Engineer II with experience or strong foundational knowledge in vaccine or biologics process development and manufacturing to join the Polysaccharide Clinical Manufacturing/Process Development team.

The candidate will provide technical support for manufacturing activities in collaboration with CDMO partners, while also contributing to process development and process validation efforts. The position requires laboratory presence (>50%) and the ability to independently execute and document experiments, analyze data, and communicate results through technical reports and presentations. The successful candidate will collaborate cross-functionally and may interface with external CDMO partners to support manufacturing campaigns and process transfers.

Essential Functions:

• Provide remote manufacturing (MFG) oversight to support batch execution, ensuring adherence to process parameters and GMP requirements
• Participate in deviation investigations, root cause analysis, and implementation of corrective and preventive actions (CAPAs)
• Provide technical support for MFG and process development through data analysis, MFG document reviews, and supporting lab scale studies
• Perform in-process sample testing to support monitoring of MFG process performance and understanding
• Manage sample inventory, including tracking, storage, and organization of manufacturing samples
• Maintain accurate and timely documentation in electronic lab notebook (ELN) systems
• Analyze manufacturing and experimental data using statistical tools (e.g., JMP) and summarize findings in technical reports
• Collaborate with cross-functional teams including Process Development, Manufacturing, Analytical Development, and Quality
• Prepare and present technical data to internal stakeholders and support interactions with CDMO partners

Requirements:

• BS in Chemical Engineering, Biochemistry, or a related discipline, with minimum 2 years of relevant industry experience. MS without experience; or equivalent work experience.
• Experience or exposure to GMP manufacturing environments and process development activities
• Hands-on experience with in-process analytical techniques, including colorimetric and enzymatic assays
• Familiarity with upstream and downstream processing technologies, such as fermentation, UF/DF, depth filtration, and chromatography
• Experience supporting technology transfer, scale-up, or CDMO-based manufacturing is preferred
• Understanding of deviation investigations and root cause analysis methodologies
• Familiarity with statistical analysis tools (e.g., JMP) is preferred
• Experience using electronic lab notebook (ELN) systems is a plus
• Strong technical writing, data analysis, and communication skills