Associate Engineer II (Contract), Drug Product Process Development

Summary:

Vaxcyte is seeking an energetic and talented individual to join the Drug Product (DP) Process Development team within the broader Process Development organization. The primary responsibility of the incumbent will be to provide technical and engineering support across DP process development activities, spanning late-stage clinical supply, process characterization, tech transfer, and commercial readiness (PPQ) of Vaxcyte’s lead programs. The role requires close collaboration with internal cross-functional partners (Formulation, Analytical Development, MSAT, Quality) as well as external contract development and manufacturing organizations (CDMOs) supporting Vaxcyte’s fill/finish operations.

Due to the high number of Drug Substances (up to 31) within the DP and the aluminum-containing adjuvant system, this is arguably one of the most complex Drug Products in clinical and commercial development today, offering the right candidate an incredible opportunity to make a significant impact on the product, the company, and the industry. The successful candidate will be hands-on, detail-oriented, and comfortable operating in a fast-paced environment with fluid priorities. The role is predominantly lab- and office-based at Vaxcyte’s San Carlos headquarters, with opportunities to contribute to studies executed at both internal and external (CDMO) sites.

Essential Functions: 
•    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 using down-scaled models, including compounding/mixing, sterile filtration (filter selection and sizing), fill/finish, hold time, and container/closure evaluations. 
•    Perform in-process sample testing and analysis of DP intermediates and finished product to support process monitoring, process characterization, and release.
•    Maintain accurate and timely data entry and documentation in Benchling (ELN) in accordance with Good Documentation Practices (GDP), ensuring accuracy, completeness, and compliance with established standards and regulatory requirements.
•    Analyze experimental and manufacturing data using statistical tools (e.g., JMP), identify trends, and summarize findings in technical reports and presentations.
•    Perform routine lab upkeep and housekeeping to ensure laboratory cleanliness standards are met and conduct regular inventory monitoring and reconciliation.
•    Work within a team environment and provide support as necessary to further the team’s initiatives.

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 in, or exposure to, early- and/or late-stage clinical fill/finish manufacturing under GMP regulations preferred.
•    Working knowledge of Drug Product unit operations, such as compounding/mixing, sterile filtration, aseptic fill, and container/closure systems (vials, PFS, cartridges).
•    Experience supporting technology transfer, scale-up/scale-down, process characterization, or CDMO-based manufacturing activities is preferred.
•    Familiarity with statistical analysis tools (e.g., JMP, Minitab) is preferred.
•    Experience using electronic lab notebook (ELN) systems, preferably Benchling, is a plus.
•    Strong interpersonal and communication skills, both verbal and written, with the ability to work effectively with internal cross-functional teams.
•    Ability to work independently and collaboratively in a fast-paced, cross-functional environment, managing multiple priorities simultaneously.
•    Ability to execute, document, and interpret drug product process development and characterization experiments, adhering to scientifically sound practices.
•    Strong technical writing, data analysis, and communication skills.

Reports to: Engineer I, Drug Product Process Development

Location: San Carlos, CA

Expected Contract Length: 12 months

Hourly Range: 51/hr. – 56/hr.