Associate Engineer II, Drug Product Process Development

Responsibilities

• Support the development, characterization, and qualification of robust Drug Product processes for late-stage clinical and commercial manufacturing.
• Execute bench- and pilot-scale process development studies, including compounding/mixing, sterile filtration, fill/finish, and container/closure evaluations.
• Perform in-process sample testing and analysis of DP intermediates and finished products to support process monitoring and release.
• Maintain accurate and timely data entry and documentation in Benchling (ELN) in accordance with Good Documentation Practices (GDP).
• Analyze experimental and manufacturing data using statistical tools to identify trends and summarize findings in technical reports.
• Perform routine laboratory upkeep, housekeeping, and regular inventory monitoring and reconciliation.

Requirements

• BS in Chemical Engineering, Biochemistry, or a related discipline with a minimum of 2 years of relevant industry experience (or an MS degree without prior experience).
• Working knowledge of Drug Product unit operations, such as compounding/mixing, sterile filtration, aseptic fill, and container/closure systems.
• Strong technical writing, data analysis, and communication skills.
• Ability to work independently and collaboratively in a fast-paced, cross-functional environment.

Preferred Qualifications

• Experience in early- or late-stage clinical fill/finish manufacturing under GMP regulations.
• Experience supporting technology transfer, scale-up/scale-down, or CDMO-based manufacturing activities.
• Familiarity with statistical analysis tools such as JMP or Minitab.
• Experience using electronic lab notebook (ELN) systems, specifically Benchling.

About the Company

Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases. We are driven by core values of rethinking convention, aiming high, leading with heart, and modeling excellence.