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.
- Contribute to workforce planning, capability road-mapping, and organizational development for global analytical teams.
Requirements:- Bachelor degree in Analytical Chemistry, Pharmaceutical Sciences, or related field. 10+ years of experience in vaccine or biopharmaceutical industry with strong background in Quality Control or related analytical disciplines. Other combinations of education and/or experience may be considered.
- Proven success in matrixed environments with cross-functional coordination and strategic planning.
- Deep understanding of regulatory frameworks, data integrity, and method lifecycle requirements.
- Exceptional communication, negotiation, leadership and relationship-building
- Systems-thinking mindset and ability to identify leverage points in complex organizational structures.
- Experience with digital tools for data management, document review workflows, and collaborative project planning.
- Passion for mentoring, alignment building, and growing global technical communities
- Strong analytical and problem-solving abilities, with a focus on data-driven decision-making and continuous improvement.
- Level of Supervision: General Supervision
- The role will perform a variety of routine work within established policies and procedures. It is expected that the role receives rather high-level project information instead of detailed instructions on a weekly basis and general instructions on new projects and assignments.
Reports to: Senior Director, Quality Control
Location: San Carlos, CA
Work Arrangement (may be adjusted based on business needs, job responsibilities, or changes to company policy):
Hybrid
Compensation:The compensation package will be competitive and includes comprehensive benefits and an equity component.
Salary Range: $176,000 - $206,000 (SF Bay Area). Salary ranges for non-California locations may vary.
