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  RETHINK CONVENTION: We bring creative and intellectual diversity to every facet of the work we do in order to innovate and re-innovate the way vaccines are delivered.

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  AIM HIGH: We embody our collectively audacious goal to courageously make the most complex biologics ever attempted to protect humankind.

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  LEAD WITH HEART: Everyone leads at Vaxcyte with a kindness-first, inclusive approach to collaboration and vigorous debate that advances our business objectives.

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  MODEL EXCELLENCE: The magnitude of our challenge requires our shared commitment to demonstrating integrity, accountability, equality and clarity across communications and decision making.

Essential Functions:

• Act as subject matter expert for analytical methods (Immunoassays).
• Writing, review and approval of documents related to analytical testing to ensure compliance with applicable regulatory and industry standards. Review and approval of technical reports to support investigations and expiry/retest periods.
• Support the development and validation of analytical methods used for testing products. Ensure that methods are scientifically sound, reproducible, and suitable for their intended use.
• In partnership with the contract laboratories, support method validation and transfer activities between contract laboratories, ensuring the accuracy, reliability, and consistency of test methods and results across sites.
• Support implementation and maintenance of robust quality control systems that encompass sampling, testing, documentation, and release procedures for raw materials, intermediates, and finished products.
• Ensure that all testing activities are well-documented and comply with Good Documentation Practices (GDP).
• Review and approval of analytical data, test reports, and certificates of analysis (Co As) generated by contract laboratories to verify accuracy, completeness, and compliance with specifications for both release and stability testing.
• Support investigations and deviations, out-of-specification (OOS) results, laboratory incidents, and customer complaints related to contract laboratory testing, collaborating with contract laboratories and internal stakeholders to implement corrective and preventive actions (CAPAs).
• Support stability programs, regarding data analysis and trending. In partnership with the contract laboratories, ensure that stability data are timely available, accurate and reliable.
• Support the qualification and maintenance of reference standards.
• Support development and implementation of performance metrics to monitor the health and status of QC method performance; develop and implement improvement where indicated by the data.
• Contribute to the content of regulatory documents.

Requirements:

• Ph D in Microbiology/Chemistry/Biochemistry relevant science with 3+ years industry experience, or Master’s degree in in Microbiology/Chemistry/Biochemistry relevant science with 5+ years industry experience, Bachelor of Science with 10+ years of relevant experience in biotechnology/pharmaceutical industry
• Direct experience with analytical method development, qualification, validation and transfer. Experience with product characterization and analytical comparability is a plus.
• Comprehensive knowledge and experience with HPLC test methods.
• Comprehensive knowledge in c GMP.
• Ability to work independently.
• Excellent communication and relationship-building skills, with the ability to collaborate effectively with internal and external stakeholders.
• Strong analytical and problem-solving abilities, with a focus on data-driven decision-making and continuous improvement.
• Strong self-management, teamwork, interpersonal skills, and professionalism required.
• Relentless focus and passion around process improvements (efficiency and automation).