Scientist II, Analytical Development Specialist

18 hours ago


San Mateo, California, United States Vaxcyte Inc Full time
Job Title: Scientist II, Analytical Development

Vaxcyte, Inc. is seeking a highly skilled Scientist II, Analytical Development to join our team. As a key member of our analytical development team, you will be responsible for developing and qualifying analytical methods for purity, content, and other quality attributes of biologic drug substances, carbohydrates, and vaccine targets.

Key Responsibilities:
  • Develop and qualify analytical methods for purity, content, and other quality attributes of biologic drug substances, carbohydrates, and vaccine targets
  • Conduct characterization studies to support formulation development and the establishment of appropriate manufacturing control strategies
  • Perform analytical method transfer to CROs/CMOs
  • Review and approve analytical method validation protocols and subsequent reports
  • Assist in the writing of protocols, SOPs and reports, and regulatory submissions as appropriate
Requirements:
  • PhD in Chemistry, Analytical Chemistry preferred, Organic / Biochemistry considered, with 3+ years relevant industry experience; MS or BS with 10+ years of industry experience; (Pharma / Biotech / Analytical Testing) required
  • Ideal candidate will have a strong theoretical understanding of various analytical chemistry methodology principles and successful track record of method development trouble shooting and validation
  • Extensive hands-on experience with modern analytical instrumentations commonly used in the analysis and characterization of biologics, carbohydrates, conjugates and small molecule drug candidates
  • Direct experience operating Agilent HPLC using OpenLab/Chemstation software and/or Waters UPLC and Empower software for data acquisition and analysis
  • Experience working in a regulated (GLP / GMP) environment
  • Solid understanding of relevant FDA, EU, and ICH regulatory guidelines and pharmacopeia as applicable to analytical method development and qualification/validation for small molecules, biologics and vaccines

Vaxcyte, Inc. is an equal opportunity employer and welcomes applications from diverse candidates. We offer a competitive compensation package, comprehensive benefits, and an equity component. If you are a motivated and experienced analytical development scientist looking for a new challenge, please submit your application.



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