Scientist II, Upstream Polysaccharide Process Development

Vaxcyte•San Carlos, CA

1d•Onsite

About The Position

Vaxcyte is a clinical-stage vaccine innovation company focused on engineering high-fidelity vaccines to protect humankind from bacterial diseases. The Development organization includes Process teams for Protein, Polysaccharide, Conjugate Drug Substance, and Drug Product, supported by Analytical Development and Formulation Development. Vaxcyte is seeking a Scientist II with expertise in microbial fermentation and upstream process development to join the Upstream Polysaccharide Process Development team. This role involves designing, executing, analyzing, and documenting experiments to develop, optimize, and characterize upstream processes for polysaccharide manufacturing using microorganisms. The ideal candidate will possess practical laboratory experience in microbial fermentation, apply scientific and engineering principles to experimental design and data interpretation, and be adept at process troubleshooting and technical decision-making. Significant hands-on laboratory work is expected, with a requirement to document procedures, results, conclusions, and recommendations. The successful candidate will lead project activities, mentor junior team members, collaborate with cross-functional teams, author technical documents, and communicate scientific findings to internal stakeholders.

Requirements

D in Chemical Engineering, Biochemical Engineering, Biotechnology, Microbiology, or a related discipline with 2-5 years of industry experience, or an MS with 7+ years, or a BS/BA with 10+ years of relevant pharmaceutical or biotechnology industry experience. Equivalent combinations of education and experience may be considered.
Experience independently designing, executing, analyzing, and documenting microbial fermentation and upstream process development studies.
Strong knowledge of microbial fermentation, process development, scale-up/scale-down, process optimization, and related analytical technologies.
Hands-on experience with fermenters, microbial media, and process analytical technologies.
Experience with bioreactor operations, automation systems (e.g., Ambr®250), and data analysis tools such as JMP.
Working knowledge of statistical analysis and Design of Experiments (DoE).
Working knowledge of GMP requirements and regulatory-supporting documentation.
Demonstrated ability to lead technical projects, troubleshoot process challenges, manage multiple priorities, and collaborate effectively in cross-functional teams.
Experience working with BSL-2 organisms.
Strong scientific writing, data presentation, and communication skills.
Ability to work independently and as part of a team in a fast-paced environment.

Nice To Haves

Experience with process characterization, technology transfer, manufacturing support, or raw material qualification is preferred.
Experience with cell banking, colony selection, and microbial strain characterization is a plus.
Experience with Streptococcus pneumoniae or Escherichia coli is a plus.

Responsibilities

Design, execute, analyze, and document upstream polysaccharide fermentation studies to support process development, optimization, characterization, scale-up, and vaccine production processes.
Develop and troubleshoot fermentation processes and operating parameters to improve product yield, quality, consistency, and robustness using appropriate statistical tools (e.g., DoE).
Perform microbiology, fermentation, and bioreactor operations, including equipment setup, operation, maintenance, troubleshooting, and automation script development for systems such as Ambr®250.
Coordinate and perform analytical testing, interpret experimental results, identify technical risks and process trends, and develop scientifically sound conclusions and recommendations.
Investigate unexpected or anomalous results, including variability in growth, yield, or polysaccharide quality attributes, through structured root-cause experimentation.
Support integration and interpretation of data across upstream, downstream, and analytical functions, in collaboration with Senior Scientist or function leads, to connect fermentation conditions to downstream performance and final product quality.
Identify and propose new experimental approaches, at-line or online monitoring, and multivariate data-analysis tools that increase the resolution with which the team can observe and interpret the process, with implementation led by Senior Scientist or above.
Support process characterization, raw material evaluations, technology transfer, manufacturing support, and technical investigations.
Author and review protocols, technical reports, SOPs, batch records, and development summaries; author regulatory-supporting documentation under the review and guidance of Senior Scientist.
Maintain accurate experimental records in laboratory notebooks and electronic laboratory notebook systems.
Lead assigned project activities, provide technical guidance to junior team members, and ensure timely execution of project deliverables.
Present scientific findings and collaborate effectively with internal stakeholders, cross-functional teams, and external partners to achieve project objectives.