Full-Time

Sr. Manager

Early Phase Clinical Product

Confirmed live in the last 24 hours

Vaxcyte

Vaxcyte

201-500 employees

Develops vaccines for bacterial infections

Biotechnology
Healthcare

Compensation Overview

$176k - $190kAnnually

Expert

San Carlos, CA, USA

Hybrid position requiring in-office presence.

Category
QA & Testing
Quality Assurance
Requirements
  • Bachelor’s degree in Biochemistry, Chemistry, or a related field with 9+ years of relevant industry experience.
  • Thorough knowledge of applicable FDA, EU, and ICH regulatory guidelines and pharmacopeia for method qualification and validation in biologics and vaccines, along with proven expertise in applying these regulations to develop practical solutions and phase-appropriate analytical strategies.
  • Experience working with biochemistry, immunoassay, or microbiological assay techniques.
  • Excellent organizational and project management skills, with the ability to handle multiple projects under tight timelines.
  • Strong written and verbal communication skills, including the ability to work effectively in cross-functional teams.
  • Previous experience in validation and transfer of analytical assays is highly desired.
  • Ability to integrate and interpret interdisciplinary project information; with at least a high-level understanding of the drug/vaccine development process.
  • Ability to work globally with CMOs in different countries and continents.
  • Ability to work in a fast-paced, cross-functional environment and collaborate effectively with other team members.
  • Experience in IND, NDA, and BLA submission is preferred.
Responsibilities
  • Review validation and transfer protocols, data, and reports for analytical assays associated with the early-phase program. Collaborate with Quality Control to set appropriate validation/transfer acceptance criteria.
  • Act as the main contact within Vaxcyte QA and with external partners, fostering collaborations to support analytical requirements for Vaxcyte's materials. Work with internal stakeholders to understand methods performed onsite and at CMOs.
  • Review test methods, protocols, data, and CoAs from CMOs with technical and compliance expertise. Give compliance feedback to stakeholders who have developed the analytical methods.
  • Review and manage deviations, OOS/OOT results, and perform risk assessments related to drug product testing. Support vendor management for drug product testing vendors. Act as the Analytical QA representative in internal drug product discussions.
  • Accountable for execution and oversight of processes within the quality system as they apply to the early-phase program (deviations and investigations, change controls, and CAPAs).
  • Support regulatory submissions and responses to health authority questions during various clinical phase filings.
  • Work with others to identify opportunities for continuous improvement and implement/maintain solutions.
  • Provide strong teamwork in establishing a quality culture and shared accountability.

Vaxcyte develops vaccines aimed at preventing bacterial infections, focusing on diseases like invasive pneumococcal disease, Group A Strep, periodontitis, and Shigella. Their lead product, VAX-24, is a pneumococcal conjugate vaccine that targets 24 strains of the Streptococcus pneumoniae bacteria and has received Breakthrough Therapy designation from the FDA. Vaxcyte utilizes advanced chemistry and a proprietary cell-free protein synthesis platform, XpressCF™, to create vaccines that can effectively address the complex defenses of bacteria while stimulating an immune response. This method sets them apart from traditional cell-based vaccine production. The company's goal is to develop and commercialize broad-spectrum vaccines to improve global health outcomes, particularly for vulnerable populations.

Company Stage

IPO

Total Funding

$273.3M

Headquarters

Foster City, California

Founded

2013

Growth & Insights
Headcount

6 month growth

24%

1 year growth

63%

2 year growth

137%
Simplify Jobs

Simplify's Take

What believers are saying

  • Vaxcyte's VAX-24 has FDA Breakthrough Therapy designation, expediting its development.
  • Recent $1.5 billion public offering indicates strong investor confidence in Vaxcyte.
  • Growing demand for pneumococcal vaccines in emerging markets boosts Vaxcyte's market potential.

What critics are saying

  • Competition from Pfizer's Prevnar 20 could impact Vaxcyte's market share.
  • Reliance on XpressCF™ platform poses risks if technical challenges arise.
  • Emergence of new bacterial strains may reduce current vaccine effectiveness.

What makes Vaxcyte unique

  • Vaxcyte uses a proprietary cell-free protein synthesis platform, XpressCF™, for vaccine development.
  • Their lead product, VAX-24, targets 24 strains of Streptococcus pneumoniae.
  • Vaxcyte's vaccines aim to combat bacterial infections with broad-spectrum efficacy.

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