Full-Time

Director – Upstream Polysaccharide Process Development

Posted on 3/22/2024

Vaxcyte

Vaxcyte

201-500 employees

Develops broad-spectrum bacterial infection vaccines

Biotechnology

Compensation Overview

$211,000 - $225,000Annually

+ Equity

Senior

San Carlos, CA, USA

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 including 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 is 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 a 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.
Responsibilities
  • 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.

Vaxcyte is centered on creating advanced vaccines such as VAX-24, a sophisticated 24-valent pneumococcal conjugate vaccine, by utilizing cutting-edge chemistry and the XpressCF™ cell-free protein synthesis platform. The company prioritizes developing high-fidelity, broad-spectrum vaccines to combat bacterial infections, continuously expanding its product pipeline with innovations like VAX-31 for various bacterial threats.

Company Stage

IPO

Total Funding

$2.3B

Headquarters

San Carlos, California

Founded

2013

Growth & Insights
Headcount

6 month growth

33%

1 year growth

69%

2 year growth

165%
INACTIVE