Essential Functions:

• Develop and execute upon a high-level plan for validating the upstream commercial manufacturing process for the polysaccharide components of Vax-24.
•    Work with Process Development SMEs within the group and at CMO to complete risk assessments for critical process parameter identification.
•    Design process characterization studies to assess the criticality of parameters and manage a team to execute these studies.
•    Lead the authoring of PC reports and review PPQ protocols along with CMO counterparts.
•    Collaborate with CMOs to develop a validation plan for at-scale validation of the polysaccharide manufacturing process and drive the execution of that plan.
•    Work with internal stakeholders (e.g., Regulatory) to ensure that the Polysaccharide Upstream validation strategy fits within the program-wide strategy.
•    Collaborate with project management to maintain a detailed timeline for the activities that must be completed prior to a commercial PPQ campaign – communicate to team when activities are at risk of causing delays to timeline.
• Lead the development of the upstream processes for pipeline vaccine-based polysaccharides (transferred from the Research team).
•    Mature early-stage polysaccharide fermentation processes to be commercially ready.
•    Manage a group of scientists and engineers that develop upstream processes from early stage to late stage within a world class upstream laboratory.
•    Collaborate effectively with the downstream groups within polysaccharide development and manufacturing team.
•    Be an outstanding teammate and collaborate across groups both internal and external to Vaxcyte.
•    Represent upstream development at CMC meetings and with external partners.
•    Cultivate a cohesive, innovative, nimble and productive team environment.

Requirements:

• PhD in Chemical/Biochemical Engineering or similar, with 7+ years of industry experience; MS with 10+ years of industry experience; or BS with 15+ years of industry experience.
• In depth experience with upstream process characterization work. i.e. risk assessments, identification of pCPPs, PC reports etc.
• Strong understanding of design and interpretation of multi-variate development experiments (e.g. Design of Experiments) with practical experience using software required for these experiments.
• Excellent judgment when assessing risk – strong understanding of when to expend resources to reduce risk and when the level of risk is acceptable to move forward.
• Excellent background in fermentation development demonstrated through years of industrial experience.
•    Experience working with BSL2 organisms, Streptococcus pneumoniae and Escherichia coli a plus.
• Strong ability to motivate, mentor, and connect with junior team members.
• Strong sense of organization, preferably with experience managing timelines using a tool such as Microsoft Project.
• Ability to work across several teams to pull required information from SMEs and integrate it into centralized plan.
• Curiosity and drive to quickly come up to speed; creativity to solve challenging problems.
• Strong interpersonal skills, with excellent written and verbal communication skills.