Vaxcyte

• 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. • Review and approve process equipment documentation, such as protocols, test plans, reports, and other deliverables, ensuring alignment with company standards and regulatory requirements. • Conduct comprehensive risk assessments and design strategies to validate and optimize critical process parameters in compliance with industry standards and regulatory guidelines. • Lead complex system and equipment inspections, including FATs (Factory Acceptance Tests), SATs (Site Acceptance Tests), and IQ/OQ/PQ (Installation Qualification/Operational Qualification/Performance Qualification), ensuring precision and compliance. • Lead engineering feasibility studies, conceptual & basic design activities for projects across a range of products and sites. • Direct and manage validation initiatives, ensuring compliance with cGMP, FDA, EMA, and other applicable regulatory agencies. • Oversee the review and approval of validation protocols, plans, and reports, ensuring their alignment with industry standards and ensuring robust and reliable processes. • Analyze complex validation data to identify critical trends, continuously improving the reliability, efficiency, and compliance of validated systems. • Create formal networks with key decision makers and serve as an external spokesperson for the organization with CDMO and supplier partners. • Oversees the activities of a project and teams involved in cross-functional engineering projects from conception through completion, balancing complex timelines, budget constraints, resource allocation, and quality standards. • Collaborate effectively with senior project managers, cross-functional teams, contractors, and external vendors to coordinate, prioritize, and execute engineering activities. • Provide strategic technical leadership and foster a culture of innovation, collaboration, and continuous improvement. • Ensure project deliverables are met within scope and timeline while maintaining focus on compliance, quality, and cost-effectiveness.

• Leads the preparation and review of CMC sections of global regulatory submissions, as well as the interactions and responses with regulatory agencies • Member of technical development teams which require experienced interpretation of applicable EMA/FDA/ICH/Global regulations to ensure CMC compliance • Defines CMC content (data and documentation) requirements for regulatory submissions and compiles/reviews this content for conformance with established requirements • Provides CMC regulatory guidance to cross-functional teams and key stakeholders • Manages regulatory assessment and guidance on product compliance topics including change controls, deviations, and GMP investigations throughout development • Leads projects with cross-functional teams and acts as the primary regulatory CMC contact for assigned products and projects • Represents company in Health Authority meetings and leads or supports CMC preparation activities for meetings with Health Authorities on CMC related matters • Stays abreast of current and evolving regulatory CMC requirements, applies this knowledge to assigned projects, and shares knowledge and experience with others to support their development • Participates in the design, development and implementation of department strategies, providing recommendations in area of expertise

• The Executive Director, Digital Enablement (DE) is a newly created role with a mandate to ensure that digital and AI capabilities give Vaxcyte better leverage across every launch function • Initially focused on the commercial launch of VAX-31 for the adult indication, this role will lead the build of the digital infrastructure, AI capabilities, and commercial technology roadmap from the ground up for Vaxcyte as a first-time launching company • The Executive Director, DE serves as an enabler across functions, designing systems and capabilities so that Marketing, Sales, Medical Affairs, Market Access, Commercial Operations (e.g. 3PL, Distribution, Customer Service, etc), Data and Analytics and any other commercial teams have less friction, better intelligence, and more leverage than the competition • The DE will work collaboratively with these partners to determine business needs and recommend/build system capabilities across the organization • This role sits within the Commercial organization and works in close partnership with the IT Commercial Lead (ITCL) in the IT function, who will own implementation, data security, and technical management • This role will own strategy through execution and ensure our launch functions are fully enabled • This role also supports the digital, data, and AI needs of Medical Affairs as one of several functions it enables, while respecting the independence of Medical Affairs in setting its own scientific strategy, content, and engagement priorities • All Medical Affairs enablement operates within the company’s compliance framework, preserving the separation of promotional and non-promotional activity and the independence of scientific engagement.

• Acquire and gather data from manufacturing nodes throughout the supply chain to enable regulatory filings, process monitoring, and continuous improvement. • Develop and oversee data management strategies to support operations, development, and regulatory submissions. • Own data verification for all commercial regulatory submissions. • Lead the integration of structured and unstructured data across departments (e.g., preclinical, clinical, regulatory, CMC). • Build systems and workflows to capture and retain organizational knowledge, including protocols, study results, lessons learned, and decision rationales. • Develop tools and processes that enable scientific teams to find, share, and reuse knowledge efficiently. • Champion a knowledge-sharing culture across scientific and operational functions. • Partner with regulatory, quality, R&D, IT and contract manufacturing teams to understand data and knowledge needs and align solutions. • Lead cross-functional initiatives focused on digital transformation, data harmonization, and collaboration tools. • Manage and mentor a team of data professionals, analysts, and knowledge specialists. • Ensure timely access to high-quality data for operational decision-making. • Partner with data science team to drive data visualization, reporting, and insights. • Support the use of AI/ML and automation for improved data analysis and knowledge extraction. • Ensure compliance with data protection and clinical trial regulations, including GDPR, HIPAA, and 21 CFR Part 11. • Identify and mitigate risks related to data security, access, and retention.

• 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.

• 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.

• 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.

• 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.

• The Senior Manager, Commercial MSAT for Polysaccharides will lead and facilitate launch readiness and commercial supply of the polysaccharides used in glycoconjugate vaccines. • 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 critical raw material manufacturing 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 Senior Manager will collaborate on overall program strategy, with primary responsibility and accountability for the polysaccharide drug substance intermediate.

• 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.