Full-Time

Manager – Quality Engineer

Posted on 8/1/2024

Vaxcyte

Vaxcyte

201-500 employees

Develops vaccines for bacterial infections

Biotechnology
Healthcare

Compensation Overview

$155k - $166kAnnually

+ Equity Component

Mid, Senior

San Carlos, CA, USA

Hybrid position.

Category
QA & Testing
Quality Assurance
Requirements
  • Bachelor’s degree in quality, mechanical or industrial engineering, Quality Management, or related field.
  • Minimum of 3-5 years of experience in quality engineering with a focus on packaging and labeling.
  • Strong knowledge of quality control principles, methodologies, and tools.
  • Familiarity with regulatory standards such as FDA, ISO, and GMP.
  • Excellent problem-solving and analytical skills.
  • Strong communication and interpersonal skills.
  • Ability to work effectively in a team environment and manage multiple projects simultaneously.
  • Proficiency in quality management software and Microsoft Office Suite.
  • Six Sigma or Lean Manufacturing certification.
  • Experience in the medical device or pharmaceutical industry.
  • Knowledge of statistical analysis software (e.g., Minitab).
Responsibilities
  • Develop, implement, and maintain quality procedures for packaging and labeling.
  • Conduct regular inspections and audits of packaging and labeling processes.
  • Ensure compliance with industry standards, regulatory requirements, and company policies.
  • Identify and analyze packaging and labeling process inefficiencies and implement corrective actions.
  • Lead continuous improvement initiatives to enhance product quality and operational efficiency.
  • Collaborate with production teams to resolve quality issues and implement best practices.
  • Maintain comprehensive documentation of quality processes, inspections, and audits.
  • Prepare detailed reports on quality metrics, trends, and corrective actions.
  • Ensure all packaging and labeling documentation complies with regulatory standards.
  • Stay updated on current regulations and standards related to packaging and labeling in the industry.
  • Ensure that all packaging and labeling activities comply with relevant regulations such as FDA, ISO, and other applicable standards.
  • Train and mentor production staff on quality standards and procedures.
  • Develop training materials and conduct regular training sessions on packaging and labeling quality.
  • Work closely with R&D, manufacturing, and regulatory teams to support new product development and launches.
  • Participate in design reviews and provide input on the packaging and labeling requirements.

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. Unlike traditional cell-based methods, their approach allows for the development of broad-spectrum vaccines. Vaxcyte's goal is to provide effective vaccines that can significantly reduce the impact of bacterial diseases on global health.

Company Stage

IPO

Total Funding

$273.3M

Headquarters

Foster City, California

Founded

2013

Growth & Insights
Headcount

6 month growth

2%

1 year growth

2%

2 year growth

0%
Simplify Jobs

Simplify's Take

What believers are saying

  • FDA Breakthrough Therapy designation for VAX-24 may accelerate its market entry.
  • Global pneumococcal vaccines market is projected to grow at a CAGR of 5.6% until 2030.
  • Recent $1.5 billion public offering strengthens Vaxcyte's financial position for future developments.

What critics are saying

  • Competition from mRNA technology developers like Moderna and BioNTech is intense.
  • Potential regulatory delays could impact Vaxcyte's clinical trial timelines.
  • Intellectual property disputes may arise over cell-free protein synthesis technology.

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 bacteria.
  • Vaxcyte focuses on broad-spectrum vaccines for bacterial infections, unlike traditional methods.

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Benefits

Company Equity

Stock Options

Remote Work Options

INACTIVE