Scientist II, Upstream Polysaccharide Process Development.

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 looking for a Scientist II with experience in microbial fermentation and upstream process development to join the Upstream Polysaccharide Process Development team. The candidate will be responsible for designing, executing, analyzing, and documenting experiments to develop, optimize, and characterize upstream processes for polysaccharide manufacturing using microorganisms. The successful candidate will have practical laboratory experience in microbial fermentation processes and the ability to apply scientific and engineering principles to experimental design, data interpretation, process troubleshooting, and technical decision-making. The role will require significant hands-on laboratory work, and this individual will be expected to document experimental procedures, results, conclusions, and recommendations in written and presentation formats. The successful candidate will lead assigned project activities, provide technical guidance to junior team members, collaborate with cross-functional teams, author technical documents, and communicate scientific results to internal stakeholders.

Essential Functions:

• 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.

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.
• 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.
• Experience with process characterization, technology transfer, manufacturing support, or raw material qualification is preferred.
• Working knowledge of statistical analysis and Design of Experiments (DoE).
• Experience with cell banking, colony selection, and microbial strain characterization is a plus.
• 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; experience with Streptococcus pneumoniae or Escherichia coli is a plus.
• Strong scientific writing, data presentation, and communication skills.
• Ability to work independently and as part of a team in a fast-paced environment.