Associate Director, Biological Raw Material Validation Expert

1 day ago


San Carlos, California, United States Vaxcyte Full time
Unlock Your Potential as a Biological Raw Material Validation Expert

Vaxcyte is a pioneering vaccine innovation company dedicated to protecting humankind from the consequences of bacterial diseases. We're seeking an accomplished Associate Director to lead our Biological Raw Material Method Validation and QC team.

About the Role

This pivotal position will oversee method qualification/validation and all QC activities in a complex network of approximately 10 Contract Development and Manufacturing Organizations (CDMOs). You'll be responsible for ensuring the accuracy and compliance of biological raw material test methods, method qualification/validation protocols and reports.

Key Responsibilities
  • Lead method qualification/validation and oversee all QC activities in a complex network of CDMOs.
  • Collaborate with Analytical Development and interface with key stakeholders to determine when a biological raw material method is suitable for method qualification/validation.
  • Review and evaluate method development data, reports, and documents to be transferred to CMOs, provide technical and compliance feedback to internal and external stakeholders.
  • Collaborate with CDMOs to design an effective method qualification/validation plan, and lead method qualification/validation activities to ensure campaign readiness.
  • Review and approve biological raw material test methods, method qualification/validation protocols and reports, and responsible for the accuracy and compliance of these documents.
Requirements
  • PhD in Chemistry, Analytical Chemistry, or related field with 7+ years relevant industry experience; MS or BS with 12+ years of industry experience in Pharma/Biotech industry required.
  • Demonstrate sound decision-making skills and exhibit good judgment.
  • Successful track record of analytical method transfer, trouble shooting and validation.
  • Have solid understanding of principles of various analytical technology used for analysis of biological raw materials.
  • Result oriented; good judgment in directing attention and effort across competing priorities.
What We Offer

Vaxcyte offers a competitive compensation package, comprehensive benefits, and an equity component. The salary range is $190,000 - $197,000. We are an equal opportunity employer and welcome applications from diverse candidates.



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