Vaxcyte

Data Scientist

• 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.
• 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.
• 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.
• 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.

Associate Director, QC – Analytical Technical Lead, Global Analytics

QA Engineer

• 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.
• Represent QA at internal and external cross functional team meetings.
• Lead review and approval of internal and external GMP documentation for compliance, including specifications, Certificates of Analysis, validation reports, deviations, change controls, risk assessments, and CAPAs as they relate to polysaccharides and drug substance; apply technical and compliance expertise to critically evaluate reference standards, test methods, protocols, and raw data packages from CMOs and contract testing laboratories.
• Partner with QC, vendor management, and contract labs to set key performance indicators for monitoring vendor effectiveness.
• Drive resolution of quality performance issues with contract manufacturers and testing organizations.
• Review Quality Agreements and regulatory documentation as required.
• Lead quality investigations of testing deviations and OOS.
• Contribute to regulatory filings, respond to questions from health authorities, and ensure quality of documentation used in support of regulatory submissions.
• Take part in audit preparations and help ensure ongoing readiness.
• Develop, review, and update GMP-related internal policies and procedures as necessary.
• Champion a culture of quality excellence and continuous improvement by proactively identifying systemic gaps, driving implementation of sustainable solutions, and establishing performance standards that elevate GMP compliance across internal teams and external partners.

Senior Director, Quality Assurance

Director

• Provide strategic and scientific leadership for process validation (PPQ, CPV, lifecycle validation) across commercial programs.
• Lead and facilitate execution of validation strategies to support technology transfer, site readiness, and product launch.
• Ensure alignment of validation activities with regulatory expectations and lifecycle management plans.
• Develop and implement risk management frameworks, tools, and processes in collaboration with Quality.
• Lead cross-functional risk assessments to identify, evaluate, and mitigate operational, technical, and regulatory risks.
• Monitor and communicate risk trends and key risk indicators to stakeholders.
• Support commercial manufacturing operations by ensuring processes remain in a validated and controlled state.
• Contribute to lifecycle management activities, including process improvements and continued process verification.
• Collaborate with Regulatory, CMC, Quality, Supply Chain, Procurement, and Engineering to support commercialization and supply continuity.
• Partner with internal teams and external CMOs to ensure alignment on validation and risk strategies.
• Provide guidance for validation of processes, systems, facilities, and methods within the commercial organization.
• Support deviation investigations, ensuring timely resolution and sustained compliance.
• Contribute to authoring and reviewing regulatory filings and responses to health authorities.
• Effectively communicate the scientific and commercial rationale for validation and risk management strategies.
• Provide leadership for execution of process validation and comparability activities, ensuring data integrity and compliance.
• Provide guidance on raw material qualification strategies to ensure supply reliability.
• Support validation activities across internal and external manufacturing networks.
• Communicate process validation performance and risk insights to key stakeholders.
• Build strong working relationships and influence across a matrixed organization.
• Contribute as a key member of the Global MSAT organization to enable successful commercialization.

Associate Director, Process Validation

Manager

• The Senior Manager for Drug Substance (DS) Commercialization has the responsibility for launch readiness and commercial supply of the conjugate drug substance.
• This role focuses on technical launch planning and execution by bringing best-practices and coordinating cross-functional efforts for regulatory filings, facility readiness, and launch supplies.
• This role also provides leadership to ensure that the organization is equipped to effectively communicate the scientific and commercial rationale for conjugation processes to internal stakeholders, relevant CMOs, and to regulatory agencies.
• The incumbent will work with the organization to ensure on-time execution and appropriate planning for commercial lifecycle management.
• The role will also require the ability to interact effectively with people of diverse backgrounds and perspectives.

Senior Manager, Global Drug Substance Commercialization, Conjugation

Compliance

• Represent Regulatory Affairs in various internal cross-functional project teams, improvement initiatives and providing regulatory positions on various CMC related topics.
• Manage the collection, review, coordination, and preparation of documentation for regulatory CMC submissions, including maintaining comprehensive trackers for documentation requests and timelines.
• Manage preparation of responses to queries from regulatory authorities.
• Ensure conformance to commitments made with various regulatory agencies.
• Collaborate with cross-functional project teams and external business partners to develop regulatory strategies and identify regulatory risks.
• Manage coordination, preparation, and timely submission of regulatory documents and filings.
• Review and approve change controls related to proposed product/process changes and assess their impact against regulatory requirements.
• Cultivate productive working relationships with the Regulatory team and other departments.
• Coordinate responses to CMC-related queries from Health Authorities.

Senior Manager, Regulatory Affairs

• Serve as the CMC statistical lead for the VSWG, supporting specification-setting strategy for drug substance, drug product, intermediates, raw materials, release testing, stability testing, and in-process testing.
• Develop statistical strategies for specification and JOS using clinical experience, manufacturing experience, stability behavior, analytical variability, assay capability, and process capability.
• Design and execute statistical analyses such as confidence intervals, prediction intervals, tolerance intervals, regression, ANOVA, DOE, equivalence testing, trend analysis, control charts, and Cpk/process capability analyses.
• Provide statistical input to late-stage development, PPQ, BLA/MAA preparation, health authority responses, commercial readiness, and specification lifecycle management.
• Author and review statistical sections of specification and JOS documents, CMC technical reports, regulatory submission sections, and briefing materials.
• Assess analytical method performance and method lifecycle changes, including precision, transfer/bridging, comparability, and impact of analytical variability on specification decisions.
• Partner with Process Development, MSAT, Stability, QA, RA, Manufacturing, and external partners to align statistical rationale with CMC control strategy and regulatory expectations.
• Support PPQ, APR, and CPV activities by evaluating process consistency, state of control, trends, internal control limits, and capability relative to proposed or registered specifications.
• Translate complex statistical concepts into clear recommendations for cross-functional teams, senior leaders, and non-statistical stakeholders; support audits, inspections, and health authority interactions as needed.

Associate Director, QC – Analytical Technical Lead, Global Analytics

Senior Director, Quality Assurance

Associate Director, Process Validation

Senior Manager, Global Drug Substance Commercialization, Conjugation

Senior Manager, Regulatory Affairs

Associate Director, CMC Statistician