Associate Director, Quality Control, Reference Standards

3 weeks ago


San Carlos, California, United States BioSpace, Inc. Full time
Job Summary

Vaxcyte seeks an experienced Associate Director to lead the Quality Control team in managing reference standards and critical reagents. The successful candidate will develop and implement policies, procedures, and strategies for global reference standard and critical reagent management systems.

Key Responsibilities
  • Develop and implement policies, procedures, and strategies for global reference standard and critical reagent management systems.
  • Lead the development of global business practices, policies, and standards for reference standards and critical reagents.
  • Author or oversee the authoring of technical protocols, qualification reports, requalification reports, and expiry extension reports for reference standards and critical reagents.
  • Oversee the monitoring of manufacturing schedules, request materials for reference samples and critical reagents, and coordinate support activities.
  • Establish and maintain the trending program for reference standards and critical reagents in collaboration with internal teams and external partners.
Requirements
  • Ph.D. with 8+ years of AD/QC experience or MS/BS with 12+ years of AD/QC experience, including 5+ years in reference standard management within the vaccine, biotech, or pharma industry.
  • Strong understanding of relevant cGMP, FDA, EU, and ICH regulatory guidance associated with release and characterization assays.
  • Strong knowledge of regulatory requirements and quality standards in the pharmaceutical industry.
  • Broad experience with biochemistry, immunoassay, biological, and microbiological assays.
  • Strong biostatistics background for evaluating comparability and qualification of reference standards.


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