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Full-Time

Sr. Manager

Process Validation MSAT Protein Sciences

Posted on 6/25/2024

Vaxcyte

Vaxcyte

201-500 employees

Develops vaccines for bacterial infections

Biotechnology
Healthcare

Compensation Overview

$180k - $187kAnnually

+ Equity

Senior

San Carlos, CA, USA

Requires onsite presence in San Carlos, California for hybrid work setup.

Category
Bioinformatics
Biology & Biotech
Requirements
  • Bachelor’s degree with at least five years of experience, OR a Master’s degree with more than three years of experience, OR a Ph.D. with 0-2 years of experience
  • Excellent written and verbal communication skills
  • Previous process validation experience within the pharmaceutical industry and strong knowledge of FDA and ICH guidelines
  • High proficiency in Word, Excel and demonstrated aptitude for computerized systems
  • High proficiency in validation technical writing
  • Ability to independently manage different projects and deadlines
  • Previous tech transfer experience
  • Experience with defending validation packages to boards of health/regulators
  • Background in problem-solving, negotiations, data integrity principles, and project management/support in a matrixed reporting environment
  • Prior experience in other areas of validation (including equipment validation)
  • Good understanding of risk management methodologies (e.g. FMEA) with a proven ability to apply to Bio-pharmaceutical operations
Responsibilities
  • Leading process validation activities
  • Generating protocols, evaluating data, and writing final reports
  • Process validation sampling oversight or coordination
  • Generating regulatory submission document subsections
  • Project management of overall and individual PV projects and activities
  • Authoring validation impact assessments for investigations
  • Authoring justifications for the assessment of change controls for process impact
  • Ability to manage multiple projects and activities of moderate complexity simultaneously
  • Liaising with various functions such as Development, Manufacturing, Supply Chain, QA, QC, and Regulatory Affairs
  • Supporting regulatory inspections through preparation, defense, and interaction with auditors

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 protect vulnerable populations from serious bacterial infections.

Company Stage

IPO

Total Funding

$2.3B

Headquarters

Foster City, California

Founded

2013

Growth & Insights
Headcount

6 month growth

27%

1 year growth

65%

2 year growth

126%
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Simplify's Take

What believers are saying

  • Significant investments from major financial entities like Vanguard and Mutual of America Capital Management indicate strong market confidence in Vaxcyte's potential.
  • The recent $816.5 million raised through stock and warrant sales provides substantial capital for advancing their vaccine pipeline.
  • The appointment of experienced board members like John Furey can provide strategic guidance and enhance corporate governance.

What critics are saying

  • The success of Vaxcyte heavily depends on the clinical and commercial success of its lead product, VAX-24, which is still subject to regulatory approval.
  • The competitive landscape in vaccine development is intense, with numerous established players potentially overshadowing Vaxcyte's market entry.

What makes Vaxcyte unique

  • Vaxcyte leverages its proprietary XpressCF™ cell-free protein synthesis platform, which allows for more efficient and versatile vaccine production compared to traditional cell-based methods.
  • Their focus on broad-spectrum vaccines, such as VAX-24 targeting 24 strains of Streptococcus pneumoniae, sets them apart in the vaccine development landscape.
  • The FDA Breakthrough Therapy designation for VAX-24 underscores the innovative potential and clinical significance of their lead product.

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