Senior Engineer, Polysaccharide Downstream Process Development

Role Summary

Senior Engineer, Polysaccharide Downstream Process Development — San Carlos, CA. Vaxcyte is developing a multi-valent polysaccharide-based conjugate vaccine; the role focuses on downstream purification development, process characterization, and collaboration with the CMC team. This position requires >50% time in the lab, leadership on projects, and interaction with internal teams and external CMOs.

Responsibilities

• Design and execute experiments to further develop downstream processes including:
  • Continuous centrifugation and depth filtration development
  • TFF optimization and characterization
  • Chromatography screening, optimization, and characterization
  • Scaling studies
  • Development of scale-down model for unit operations
• Lead initiatives and tasks for downstream process characterization studies.
• Operate and maintain instrumentation for polysaccharide purification including automated TFF systems, Akta chromatography skids, automated filtration units and continuous centrifuges.
• Perform analysis and interpret results for polysaccharide and impurity assays (Anthrone, Lowry, SEC-MALS, HPAEC-PAD).
• Keep accurate and current records of development experiments and/or project related activities in laboratory notebooks or electronic notebook, prepare technical reports, summaries of testing, and detailed protocols.
• Present/communicate data to polysaccharide team as well as cross-functional teams.
• Research literature to identify novel methodologies and solve scientific problems which apply to the overall program.
• Review executed protocols and batch records and support tech transfer purification processes to external manufacturing groups.
• Writes, reviews, and approves R&D protocols, batch records, and reports in support of process development, and assay development.
• May have direct reports in the future. Works within a team environment and provides support as necessary to further the team‚Äôs initiatives.

Qualifications

• PhD in Bioprocess Engineering, Chemical Engineering, Biotechnology, or a related discipline, with a minimum of 5 years of industry experience or combination of industry and postdoctoral research; MS with a minimum of 10 years of industry experience; or BS with a minimum of 13 years of industry experience.
• Strong understanding of the principals of DOE (Design of Experiments); practical experience with DOE software; proficient in the design and interpretation of statistically modelled experiments.
• In-depth late-stage process characterization development experience (Risks assessments, CPP Identification, PAR, PC study report writing).
• Practical experience with and theoretical knowledge of traditional processing unit operations including TFF, depth filtration, continuous centrifugation, and chromatography.
• Demonstrated leadership on a project initiative and/or management of a team. Has successfully worked in a cross-functional team environment on multiple projects; ability to work effectively as a member of a team to deliver results.
• Proficient with engineering principles involved in scaling processes from lab to pilot scale as well as developing a scale-down model.
• Proficient with computer programs such as JMP, Microsoft Excel, Word, PowerPoint, Visio.
• Working knowledge of the requirements of GMPs.
• Experience working with CDMOs and ability to effectively communicate experimental design and results to a CDMO.
• Technical knowledge and experience using Tecan Fluent instrumentation and generating scripts for high throughput screening application is a plus
• Ability to travel internationally to a CMO as some international travel may be required.
• Strong interpersonal skills, with excellent written and verbal communication skills.
• Prior experience in polysaccharide development is a plus.

Education

• PhD/MS/BS in Bioprocess/ Chemical Engineering, Biotechnology, or related field with corresponding industry experience as detailed in Qualifications.

Additional Requirements

• Ability to travel internationally to a CMO as some international travel may be required.