Vaxcyte

• 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.

• Serve as the technical expert for QC microbiological assays. • Support the authoring and review internal SOPs related to microbial Quality Control policies and procedures. • Responsible for quality event management related to microbiology QC and aseptic manufacturing operations. • Manage outsourced cGMP and characterization testing supporting lot release. • Collaborate with Analytical Development, Quality Control, and Product Development and interface with key stakeholders. • Apply technical and compliance expertise to the review of test methods and provide feedback. • Work with others to identify opportunities for continuous improvement and implement solutions. • Provide strong teamwork in establishing a quality culture and shared accountability.

Title: Director, Quality Assurance – Vendor Management Location: San Carlos, California, United States Job Description: 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 Director, Quality Assurance – Vendor Management is responsible for executing the global vendor quality strategy to ensure compliance, scalability, and inspection readiness across Vaxcyte’s GxP supplier network. This role provides leadership and oversight of vendor qualification, audit, supplier notifications, and performance management programs, ensuring alignment with corporate objectives and regulatory expectations. The Director will serve as a key quality leader, influencing cross-functional stakeholders and external partners, while driving continuous improvement, risk-based decision-making, and operational excellence across the vendor ecosystem. Essential Functions: - Strategic Leadership & Program Ownership - Own and define the global Vendor Management Quality Program, ensuring scalability to support clinical and commercial operations. - Provide end-to-end oversight of vendor qualification, auditing, monitoring, and lifecycle management programs. - Establish and drive risk-based frameworks for supplier selection, qualification, and oversight aligned with regulatory expectations. - Serve as the QA lead for external partnerships, including CMOs, CROs, and critical service providers. - Audit & Inspection Readiness - Oversee the global supplier audit program including preparation, scheduling, performance and audit closeout. - Ensure inspection readiness across the vendor network and support regulatory inspections as a QA subject matter expert. - Review and approve audit strategies, reports, and CAPA effectiveness, ensuring timely closure and systemic improvement. - Plan, schedule, and conduct supplier audits (on-site and remote) in support of supplier qualification and ongoing oversight programs. - Quality Systems & Governance - Provide strategic direction and oversight for Quality Agreements, working closely with the Associate Director, Quality Agreements, who leads day-to-day management and execution. - Establish and monitor vendor performance metrics and quality KPIs, reporting trends and risks to executive leadership. - Ensure robust processes for supplier change management, deviations, and CAPAs related to vendor activities. - Drive continuous improvement initiatives to enhance vendor quality systems, compliance, and efficiency. - Cross-Functional Leadership & Influence - Act as a strategic partner to Technical Operations, Clinical, Regulatory, and Supply Chain teams. - Provide expert guidance on risk management, vendor selection, and mitigation strategies. - Influence decision-making at the senior leadership level through data-driven insights and quality risk assessments. - Team Leadership & Development - Build, lead, and develop a high-performing Vendor Management QA team. - Foster a culture of quality excellence, accountability, and continuous improvement. - Mentor and develop talent, ensuring organizational capability scales with company growth. - External Engagement - Serve as the primary QA contact for key vendors and partners. - Represent Quality in executive-level vendor governance meetings. - Ensure external partners operate in alignment with Vaxcyte’s quality standards and expectations. Requirements: - BS/BA in a scientific discipline and minimum 12 years of relevant experience in GxP Quality within the biotech/pharmaceutical industry. Other combinations of education and/or experience may be considered. - Extensive experience in vendor management, supplier quality, and audit programs. - Deep knowledge of GMPs, FDA regulations, and ICH guidelines. - Demonstrated expertise in risk management principles and quality systems. - Experience supporting both clinical and commercial-stage products strongly preferred. - Proven ability to lead teams and influence cross-functional stakeholders at senior levels. - Strong track record of inspection readiness and regulatory interactions. - Excellent communication, leadership, and organizational skills. - ASQ certification (CQA, CQE) or auditor certification preferred. Reports to: Senior Director, Quality Assurance and Compliance Location: San Carlos, CA Work Arrangement: Hybrid (minimum of 2-3 days per week) Compensation: The compensation package will be competitive and includes comprehensive benefits and an equity component. Salary Range: $211,000 - $246,000 (SF Bay Area). Salary ranges for non-California locations may vary. Relocation: This role is not eligible for relocation assistance. #LI-JN1 We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status

Title: Associate Director, Regulatory CMC Location: San Carlos United States Job Description: 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: A hands-on role providing both strategic and operational activities. This role develops and executes multi-product global regulatory CMC strategies for investigational products and leads the preparation and filing of regulatory CMC submissions. Manages interactions with Health Authorities for CMC topics. Provides regulatory CMC guidance to various cross-functional teams and ensures all applicable global regulatory requirements are considered and incorporated into product development. Conducts routine regulatory surveillance and communicates new/changing regulations. Essential Functions: - 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 Requirements: Bachelor's Degree in a scientific discipline (e.g. Biology, Chemistry, Pharmacy, Regulatory Affairs for Drugs, Biologics or Medical Devices). Minimum 10 years of experience working in vaccine or biotech industry, or in a related field, or the equivalent combination of education and experience. Other combinations of education and/or experience may be considered. - Prior experience preparing/authoring CMC DS sections: - BLA highly preferred. - Post-approval supplements/variations highly preferred. - INDs/IMPDs. - Prior development or manufacturing experience is a plus. - Computer software skills (LIMS, SAP, TrackWise, Veeva will be used). - Ability to meet multiple deadlines across a variety of projects/programs, with a high degree of accuracy and efficiency. - Excellent interpersonal skills to communicate difficult concepts. - Strategic thinking and strong problem-solving skills - Collaborates and communicates in an open, clear, complete, timely, and consistent manner - Strong sense of planning and prioritization, and the ability to work with all levels of management - Advanced knowledge in regulatory (FDA, EMA, Health Canada and ICH) guidelines Reports to: Executive Director, CMC Regulatory Location: San Carlos, CA/Remote Compensation: The compensation package will be competitive and includes comprehensive benefits and an equity component. Salary Range: $180,000 - $210,500 (SF Bay Area). Salary ranges for non-California locations may vary. We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.

Role Description We are seeking a scientifically driven and communicative Senior Medical Science Liaison (Sr. MSL) to join our Medical Affairs team. This field-based role is critical in supporting the scientific exchange around our vaccine pipeline, engaging with healthcare professionals (HCPs), public health experts, and key opinion leaders (KOLs). The Sr. MSL will play a pivotal role in advancing vaccine education, supporting immunization strategies, and informing internal teams with real-world insights. - Advanced Stakeholder Management: Build and maintain peer-to-peer relationships with prominent physicians, researchers, key organizations, and high profile key opinion leaders (KOLs) at academic institutions and clinics. - Scientific Engagement: Conduct peer-to-peer discussions with prominent physicians, researchers, and other key opinion leaders (KOLs) regarding unmet medical need, vaccine efficacy, safety, and public health impact. - Medical Education: Present clinical data and disease prevention strategies at conferences, advisory boards, and educational forums. - Public Health Collaboration: Partner with local and national public health organizations to support immunization campaigns and address vaccine hesitancy. - Advisory boards and conferences: Participate in and help organize advisory board meetings with KOLs. Represent Vaxcyte at relevant medical conferences and scientific meetings, engaging in scientific exchange and gathering competitive intelligence. - Clinical Trial Support: Support in identification of clinical trial sites and provide scientific input on vaccine-related protocols and investigator-initiated studies. - Insight Collection: Gather field intelligence on emerging infectious disease trends, vaccination barriers, and unmet medical needs. - Cross-functional collaboration: Work closely with internal teams to update/align scientific messaging and contribute to strategic planning. - Compliance: Uphold ethical standards and regulatory guidelines in all field activities. Qualifications - Advanced degree (PharmD, PhD, MD, or equivalent) in life sciences, immunology, infectious diseases, or public health preferred. - At least 8 years relevant experience in a clinical, research, or industry-related medical role; experience in Medical Affairs preferred. - Deep understanding of immunization science, epidemiology, and vaccine development. - Exceptional communication, presentation, and interpersonal skills. - MSL positions are field-based and require significant travel, which can vary depending on the assigned territory. - Other combinations of education and/or experience may be considered. Requirements - Reports to: Senior Director, Medical Affairs - Location: Remote - United States Benefits - The compensation package will be competitive and includes comprehensive benefits and an equity component. - Salary Range: $204,000 - $238,000 Company Description 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. - Guided by four enduring core values: RETHINK CONVENTION, AIM HIGH, LEAD WITH HEART, and MODEL EXCELLENCE.

• Stakeholder Management: Build and maintain scientific relationships with key opinion leaders, clinicians, researchers, and public health stakeholders. • Scientific Engagement: Communicate epidemiological, clinical and real-world data regarding pneumococcal disease and Vaxcyte’s candidate vaccine. • Evidence Generation Support: Where relevant, support investigator-initiated studies and clinical trial recruitment in vaccine research. • Insight Collection and cross-functional collaboration: Gather and share field insights on pneumococcal disease landscape, vaccine data needs, and recommendation scenarios. • Education and Engagement: Represent the company at scientific meetings, conferences, and stakeholder events. • Compliance: Uphold ethical standards and regulatory guidelines in all field activities.