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Vaxcyte — San Carlos California
Join our Mission to Protect Humankind! Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, which have serious and costly health consequences when left unchecked. Working to eradicate or treat bacterial infections such as invasive pneumococcal disease, Group A Strep, and Shigella is just the beginning.
Our path to success is clear and well-defined, and Vaxcyte is set up to go the distance. WHAT we do is every bit as important as HOW we do it! Our work together is guided by four enduring core values: *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.
*AIM HIGH: We embody our collectively audacious goal to courageously make the most complex biologics ever attempted to protect humankind. *LEAD WITH HEART: Everyone leads at Vaxcyte with a kindness-first, inclusive approach to collaboration and vigorous debate that advances our business objectives. *MODEL EXCELLENCE: The magnitude of our challenge requires our shared commitment to demonstrating integrity, accountability, equality and clarity across communications and decision making.
Summary: The Analytical Technical Leader (ATL) is a key strategic role within a matrixed global vaccine organization, responsible for orchestrating analytical activities across diverse functions, teams, and geographic regions. This role ensures end-to-end alignment between Analytical Development, Process Development, Analytical and Manufacturing Science and Technology, Quality Control, Regulatory Affairs, Manufacturing, and external partners including CDMOs and CTOs. Without direct line management, the ATL will leverage their influence, technical expertise, and communication finesse to drive consistency, compliance, and innovation across the analytical landscape.
Essential Functions: Matrix Coordination & Strategy 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. Lead integration and harmonization of analytical workflows across sites and partner organizations.
Ensure alignment of analytical deliverables with broader program timelines, quality standards, relevant regulations and industry standards as well as regulatory milestones. Vaxcyte internal analytical contact for all functional stakeholders. Operational Oversight Accountable for the analytical readiness of the assigned project to meet execution timelines and delivery of the overall program.
Ensure the scalability, reliability, and regulatory compliance of analytical methods and lifecycle documentation. Develop and maintain analytical roadmaps and risk registers supporting critical quality attributes (CQAs). Conduit to the analytical steering committee providing updates on analytical stages, outstanding decision, potential risks and proposing mitigations using the ASC for escalation (if needed).
Communicates of analytical updates / decisions / risks within the project governance Provide support for audit readiness and regulatory submissions. Technical Leadership Serve as a thought partner and technical bridge across teams—enabling knowledge transfer and analytical capability building. Accountable for the analytical risk register ensuring risks are captured, assessed and tracks status of mitigations.
Accountable for the process-control-strategy and specifications. Review and approval of analytical documents related to the overall analytical strategy. Leadership & Influence Drive decision-making and consensus through strong communication, stakeholder management, and systems thinking.