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Vaxcyte
Actively Hiring
Next-generation vaccine development company201-500 Employees

Jobs at Vaxcyte

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Operations

Lab Manager, Immunoassay Development

NewPosted 2 weeks ago

Lab Manager, Immunoassay Development

  • Support daily operations for the CMC Immunoassay, including laboratory scheduling, reagent and consumable readiness, sample coordination, equipment availability, laboratory organization, study logistics, inventory tracking, documentation, and issue escalation.
  • Support general laboratory management activities, including lab organization, space utilization...
Management

Senior Manager, Immunoassay Development

NewPosted 2 weeks ago

Senior Manager, Immunoassay Development

  • Manage daily immunoassay laboratory operations, including study scheduling, staff planning, assay execution oversight, sample and reagent readiness, instrument and workflow coordination, data review, documentation, issue escalation, and operational follow-through.
  • Lead, mentor, and manage scientists and research associates responsible for immunoassay develop...
Other

Senior Project Manager, Regulatory CMC

NewPosted 2 weeks ago

Senior Project Manager, Regulatory CMC

  • Project Management for the planning, coordination, and execution of regulatory CMC submissions, including Biologics License Applications (BLA), Prior Approval Supplements (PAS), and other regulatory filings, ensuring cross-functional CMC content is authored, reviewed, and delivered on schedule.
  • Partner with Regulatory and CMC subject matter experts to build and manage integrated submissio...
Engineering

Staff Engineer, Process Systems

NewPosted 3 weeks ago

Staff Engineer, Process Systems

  • Lead and manage all engineering activities for advanced biotechnological systems, including utilities, process equipment, automation systems, and facilities.
  • Work on significant and unique issues where analysis of situations or data requires an evaluation of intangible variables and may impact future concepts, products or technologies.
Management

Associate Director, QC (Analytical Technical Lead) Global Analytics

NewPosted 4 weeks ago

Associate Director, QC (Analytical Technical Lead) Global Analytics

  • Champion cross-functional analytical strategies between development, QC, regulatory, and manufacturing.
  • Pulls the analytical stages of each project through the product lifecycle ensuring commercial readiness to enable Quality by design from early stage and adapting on the project need per product phase.
Engineering

Sr. Director, Quality Assurance for Quality Control

NewPosted 1 month ago

Sr. Director, Quality Assurance for Quality Control

  • Lead quality oversight activities related to method validation, release and in-process testing for Drug Substance and Polysaccharide
  • Serve as the primary liaison within Vaxcyte QA and with outside collaborators, building partnerships that support analytical needs for relevant programs.
Other Engineering

Engineer II, Conjugation Development and Manufacturing

NewPosted 2 months ago

Engineer II, Conjugation Development and Manufacturing

  • Operation and maintenance of laboratory equipment, including chemical reactors, TFF systems, HPLCs, and plate readers.
  • Support the design and execution of development studies to optimize and characterize conjugation processes.
Management

Executive Director Quality Assurance, External Manufacturing

NewPosted 2 months ago

Executive Director Quality Assurance, External Manufacturing

  • Own quality performance across the external network, ensuring compliance, supply continuity, and effective management of quality risk, with escalation of critical risks to VP-level as appropriate.
  • Provide end-to-end QA leadership for externally executed GxP activities, including manufacturing and release of drug substance, drug product, components, and critical raw materials.
Other

Senior IT Systems Analyst, G&A

NewPosted 3 months ago

Senior IT Systems Analyst, G&A

  • Serve as an IT point of contact for G&A stakeholders; gather, analyze, and document business needs for processes and systems.
  • Document current-state and future-state processes; translate business needs into functional requirements, and system specifications.
Other Engineering

Senior Computer Systems Validation Engineer

NewPosted 4 months ago

Senior Computer Systems Validation Engineer

  • Hands-on lead full lifecycle Computer System Validation activities for cloud based GxP systems including databases, and applications.
  • Author, update, execute and maintain validation deliverables such as Validation Plans, User Requirements, Functional Specifications, Risk Assessments, Traceability Matrices, IQ, OQ, PQ protocols, and Summary Reports.