Accounting Summer Intern at Vaxcyte | San Carlos, CA

Vaxcyte, a clinical-stage vaccine company in San Carlos, California, develops vaccines targeting serious bacterial diseases such as invasive pneumococcal disease, Group A Strep, and Shigella. The team is committed to protecting people from bacterial infections and advancing vaccine technology. The company values creative thinking, ambitious goals, and a collaborative, inclusive culture. Integrity, accountability, and clear communication guide all decisions and actions at Vaxcyte. Role overview The Accounting Summer Intern position gives students the chance to apply academic knowledge to real-world accounting and finance projects. Interns will gain hands-on experience and develop practical skills that support future career growth. What you will do Assist with financial analysis and accounting tasks, such as variance analysis, manufacturing accounting, SOX compliance, and preparing financial statements. Research and benchmark finance and accounting tools, including AI-enabled solutions, to identify opportunities for process improvement, automation, and improved reporting. Help maintain and update financial documentation, including process flows, Standard Operating Procedures (SOPs), training materials, and internal controls documentation. Apply AI and advanced Excel tools to support data analysis, streamline reporting, and maintain accuracy in line with company policies and controls. This internship is based in San Carlos, CA.

Join Our Mission to Safeguard Humanity!Vaxcyte is a pioneering clinical-stage vaccine innovation firm focused on engineering high-fidelity vaccines aimed at protecting humanity from the severe and costly repercussions of bacterial diseases. Our commitment extends to eradicating or treating bacterial infections, including invasive pneumococcal disease, Group A Strep, and Shigella. Our roadmap to success is well-defined, and Vaxcyte is poised for long-term impact. Our Approach: What we do is as crucial as how we do it! Our collaborative efforts are guided by four enduring core values: *RETHINK CONVENTION: We embrace creative and intellectual diversity across all aspects of our work to innovate and transform vaccine delivery. *AIM HIGH: We embody an audacious goal to tackle the most intricate biologics ever conceived to protect humanity. *LEAD WITH HEART: Everyone at Vaxcyte leads with kindness, fostering an inclusive atmosphere conducive to collaboration and vigorous debate that furthers our business aspirations. *MODEL EXCELLENCE: The scale of our challenge demands a collective commitment to integrity, accountability, and clarity in our communications and decision-making processes.Role Summary:We are in search of a dynamic, proactive, and self-motivated Lab Manager to join our expanding Facilities and Lab Operations Team. This role is highly hands-on, overseeing the daily operations of Vaxcyte laboratories, including vendor management, lab supply inventory, equipment maintenance, and new equipment orders. As a pivotal point of contact for lab personnel, the Lab Manager will handle service requests, prioritize and assign tasks, provide training, and nurture a culture of safety and compliance. This role also involves supporting the design of lab space equipment layouts, collaborating with various departments to develop essential SOPs for training, maintenance, calibration, and repair. The Lab Manager will work closely with procurement and lab teams on CAPEX/OPEX budgeting and management of lab assets and service contracts, support installation in lab spaces, and oversee any qualification and validation activities. Additionally, this role will involve providing feedback on lab efficiency, operations, and policies and making recommendations for improvements.

About Vaxcyte Vaxcyte, Inc. is a biotechnology company based in San Carlos, California, focused on advancing vaccine development. Role Overview The Project Manager will oversee and execute projects that support Vaxcyte’s mission to develop new vaccine solutions. This role guides cross-functional teams, moving projects from initial concept through to completion. The Project Manager ensures each project aligns with company goals and strategic plans.

Join Our Mission to Protect Humankind!Vaxcyte is a pioneering clinical-stage vaccine innovation company dedicated to engineering high-fidelity vaccines aimed at safeguarding humanity from the devastating impacts of bacterial diseases. Our mission focuses on eradicating or effectively treating bacterial infections such as invasive pneumococcal disease, Group A Streptococcus, and Shigella. We are committed to a clear and defined path to success, ensuring Vaxcyte is prepared for the long haul. Our Approach: The impact of our work is equally as significant as the methodology we employ! Our collaborative efforts are driven by four fundamental core values: *RETHINK CONVENTION: We cultivate creative and intellectual diversity in all our endeavors to continuously innovate vaccine delivery methods. *AIM HIGH: We collectively strive to achieve audacious goals, tackling the most complex biologics for humanity's protection. *LEAD WITH HEART: At Vaxcyte, everyone contributes with a kindness-first, inclusive ethos that promotes collaboration and constructive debate, advancing our organizational objectives. *MODEL EXCELLENCE: The scale of our challenges demands a shared commitment to integrity, accountability, equality, and clarity in communication and decision-making.Position Summary:Vaxcyte is in search of an Associate Scientist II (contract) to bolster our research and development efforts for a groundbreaking bacterial polysaccharide conjugate vaccine. This role will play a crucial part in the setup, synthesis, purification, and analytical characterization of chemically modified polysaccharides and polysaccharide-protein conjugates.The ideal candidate should possess a robust understanding of conjugation process development, analytical chemistry principles, and significant hands-on laboratory experience. The successful individual will be expected to independently optimize and troubleshoot upstream and downstream conjugation processing procedures with minimal supervision. Contributions will extend to various related areas, including analytical development, stability studies, and process optimization initiatives. Responsibilities will also encompass record management, data presentation at team meetings, and collaborative authorship of laboratory protocols and development reports.

Join Our Mission to Protect Humankind!Vaxcyte is a pioneering clinical-stage vaccine innovation company dedicated to engineering high-fidelity vaccines designed to safeguard humanity from the severe health impacts of bacterial diseases. Our mission encompasses the eradication and treatment of bacterial infections such as invasive pneumococcal disease, Group A Strep, and Shigella. With a clear and well-defined path to success, Vaxcyte is committed to making a meaningful difference. Our Approach is as vital as our Results! Our collective work is driven by four core values: *Rethink Convention: We embrace creative and intellectual diversity to innovate and continually improve vaccine delivery. *Aim High: We strive to achieve audacious goals to develop the most complex biologics aimed at protecting humankind. *Lead with Heart: Everyone at Vaxcyte leads with kindness, fostering an inclusive environment that promotes collaboration and healthy debate to meet our business objectives. *Model Excellence: Our challenge demands a shared commitment to integrity, accountability, equality, and clarity in communication and decision-making.Position Summary:Vaxcyte is thrilled to offer an exciting opportunity for a dynamic and skilled individual to join our Analytical Development team. The Associate Scientist II, Analytical Development will be responsible for executing analytical testing and supporting method development activities for our biologics and vaccine development programs. This role will entail performing both routine and non-routine analytical assays utilizing modern analytical techniques and contributing to method optimization, troubleshooting, and continuous improvement initiatives under supervision. Candidates should possess demonstrated hands-on laboratory experience, strong technical execution, and the ability to work independently on routine tasks while supporting more complex development activities.Essential Functions:Analytical Testing & Data GenerationConduct routine and non-routine analytical testing using modern analytical methods (e.g., HPLC/UPLC, SEC, CE, UV-Vis, ELISA, electrophoresis, plate-based assays, and other biochemical or biophysical techniques).Prepare samples, reagents, standards, and controls for testing.

Join Our Mission to Safeguard Humanity!Vaxcyte is a pioneering clinical-stage vaccine company dedicated to developing high-fidelity vaccines aimed at combating the far-reaching impacts of bacterial diseases. Our mission is not only to eradicate but also to treat serious bacterial infections, including invasive pneumococcal disease, Group A Strep, and Shigella. Our roadmap to success is clear and meticulously defined, positioning Vaxcyte to make significant strides in global health. At Vaxcyte, what we do is just as important as how we do it! Our collaborative efforts are driven by four core values: *RETHINK CONVENTION: We embrace creativity and intellectual diversity in every aspect of our work to innovate and continuously improve vaccine delivery methods. *AIM HIGH: We embody an audacious ambition to develop the most complex biologics ever attempted for the protection of humanity. *LEAD WITH HEART: At Vaxcyte, everyone leads with kindness and inclusivity, fostering collaboration and spirited debate to advance our business objectives. *MODEL EXCELLENCE: The magnitude of our challenges calls for a collective commitment to integrity, accountability, equality, and clear communication in all decisions.Position Overview:We are on the lookout for a highly skilled Senior Software Engineer with robust full-stack expertise and a strong DevOps inclination. This role is critical in designing, developing, testing, and maintaining scalable web applications that underpin essential business operations.The ideal candidate will demonstrate a solid combination of frontend and backend development skills and a disciplined approach to automation, testing, CI/CD, and production reliability. This position requires technical leadership, architectural foresight, and the capability to promote engineering excellence throughout the software lifecycle.Key Responsibilities:Full-Stack Application DevelopmentDesign, architect, and implement scalable applications using Next.js and React.Create and manage backend services and GraphQL APIs, focusing on schema design and performance enhancement.Maintain high standards of code quality, security, performance, and maintainability.Engage in architectural design reviews and participate in technical decision-making processes.

Join Our Mission to Protect Humankind!At Vaxcyte, we are a pioneering clinical-stage vaccine innovation company dedicated to engineering high-fidelity vaccines aimed at safeguarding humanity from the serious health implications of bacterial diseases. Our efforts focus on eradicating or treating bacterial infections such as invasive pneumococcal disease, Group A Strep, and Shigella, marking the beginning of our ambitious journey. Our roadmap to success is clear and robust, positioning Vaxcyte for long-term achievements. Our Approach: The significance of WHAT we do is matched only by the importance of HOW we do it! Our collaborative efforts are anchored in four enduring core values: *Rethink Convention: We inject creative and intellectual diversity into every aspect of our work, continuously innovating the delivery of vaccines. *Aim High: We are driven by an audacious collective goal to create the most complex biologics ever developed to protect humankind. *Lead with Heart: Every team member at Vaxcyte leads with a kindness-first, inclusive approach that fosters collaboration and robust debate, propelling us towards our business objectives. *Model Excellence: The magnitude of our challenges demands our shared commitment to integrity, accountability, equality, and clarity in our communications and decision-making processes.We are always on the lookout for bright, dedicated, and innovative individuals who are passionate about making a difference. If you don’t find a suitable role on our Careers Page, we invite you to submit your resume to join our Talent Community for future opportunities. We encourage you to frequently check our Careers Page as we expand our team and add more opportunities.Vaxcyte is 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.

Join Our Mission to Safeguard Humanity!Vaxcyte is a pioneering clinical-stage vaccine innovation company dedicated to engineering high-fidelity vaccines that shield humanity from the severe and costly health impacts of bacterial diseases. Our mission focuses on eradicating or treating bacterial infections, including invasive pneumococcal disease, Group A Strep, and Shigella, marking just the beginning of our journey. With a clear and well-defined path to success, Vaxcyte is poised to make a lasting impact. Our Approach is as vital as Our Mission! Our collaborative efforts are anchored in four enduring core values: *RETHINK CONVENTION: We infuse creativity and intellectual diversity into every aspect of our work, continuously innovating how vaccines are delivered. *AIM HIGH: We embrace our ambitious goal to courageously tackle the most complex biologics aimed at protecting humanity. *LEAD WITH HEART: At Vaxcyte, everyone plays a leadership role with a kindness-first, inclusive approach that fosters collaboration and constructive debate to advance our business objectives. *MODEL EXCELLENCE: The magnitude of our challenge demands a shared commitment to integrity, accountability, equality, and clarity in communications and decision-making.Position Summary:Vaxcyte offers an exciting opportunity for a proactive and skilled individual to join our Analytical Development team as a Scientist II. In this role, you will execute analytical testing and contribute to the development of analytical methods for biologics and vaccine programs. You will perform both routine and complex analytical assays utilizing cutting-edge techniques, support method optimization and troubleshooting efforts, and engage in continuous improvement initiatives with moderate supervision while collaborating effectively with cross-functional teams. This position requires hands-on laboratory experience, strong technical execution, and problem-solving abilities, along with the capability to independently plan and execute assigned tasks, analyze and interpret data, and initiate or drive investigations as necessary. You will also author and maintain clear technical documentation, including method protocols, development summaries, and SOPs, while communicating experimental results and conclusions to internal stakeholders.

Join Our Mission to Safeguard Humanity!Vaxcyte, a pioneering clinical-stage vaccine innovation company, is dedicated to creating high-fidelity vaccines aimed at protecting humanity from the dire consequences of bacterial diseases. Our mission is to combat serious health threats posed by bacterial infections such as invasive pneumococcal disease, Group A Strep, and Shigella. Our path forward is clear and strategically defined, positioning Vaxcyte to achieve long-lasting success. Our Approach: At Vaxcyte, the WHAT we do is as significant as the HOW we do it! Our collaborative efforts are governed by four core values: *Rethink Convention: We foster creative and intellectual diversity to revolutionize vaccine delivery. *Aim High: We passionately pursue audacious goals to devise the most complex biologics for humanity's protection. *Lead with Heart: Every member leads with kindness and inclusivity, fostering collaboration and constructive debate to drive our business objectives. *Model Excellence: Our shared commitment to integrity, accountability, equality, and transparent communication is essential in overcoming challenges.Position Summary:This role presents an exciting opportunity to serve as a strategic financial partner to Vaxcyte’s R&D organization, focusing on clinical studies. You will support Clinical Operations and the Immunoassay and Non-Clinical teams by overseeing clinical trial and serology finances while adapting to broader R&D needs. This position requires close collaboration with Clinical Operations and Serology on planning, forecasting, accruals, financial reporting, and decision support across multiple development programs.Key Responsibilities:Provide strategic oversight for clinical outsourcing by collaborating with Clinical Operations, Clinical Development, Finance, and Legal to evaluate the best fit for Vaxcyte’s pipeline and outsourced scope of work.Oversee financial and commercial aspects of RFP processes, vendor selection, and budget management for the Clinical organization.Manage financial updates for clinical trials and support the annual planning process, including detailed analyses.

Join Our Mission to Safeguard Human Health!Vaxcyte is a pioneering clinical-stage vaccine innovation company dedicated to engineering high-fidelity vaccines that protect humanity from the severe and costly health consequences posed by bacterial diseases. Our commitment extends to eradicating or treating infections such as invasive pneumococcal disease, Group A Strep, and Shigella. Our roadmap to success is clear, and Vaxcyte is poised to make a lasting impact on global health. Our Approach: At Vaxcyte, we believe that what we do is just as crucial as how we do it. Our collaborative efforts are anchored in four core values: *Rethink Convention: We foster creativity and intellectual diversity in all aspects of our work, striving to innovate and continually improve vaccine delivery methods. *Aim High: We embody our ambitious goal of developing complex biologics that aim to protect humanity. *Lead with Heart: Our inclusive and kindness-first approach enhances collaboration and encourages vigorous debate to drive our business objectives forward. *Model Excellence: Our challenges necessitate a shared commitment to integrity, accountability, equality, and clear communication in all our decisions.Summary:Vaxcyte seeks a dynamic and skilled individual to join our analytical development team. The primary responsibilities will encompass method development, sample testing, data analysis, protocol and report authorization, and the oversight and coordination of analytical method transfers.Essential Functions:Independently conduct method development for a diverse array of analytical techniques utilized in raw material testing for quality control and characterization, supporting both pre-clinical and clinical projects.Facilitate method transfers to external contract testing laboratories; design and execute studies to troubleshoot QC testing, method qualification/validation, or any method-related issues as required.Conduct analytical testing, data analysis, and interpretation, presenting findings in various project and functional team meetings.Collaborate with cross-functional teams to meet project timelines and objectives.Maintain comprehensive and accurate records of laboratory activities.

Be Part of Our Mission to Safeguard Humanity!Vaxcyte is a pioneering clinical-stage vaccine innovation company dedicated to engineering high-fidelity vaccines aimed at protecting humanity from the severe and costly repercussions of bacterial diseases. Our mission goes beyond just addressing invasive pneumococcal disease, Group A Strep, and Shigella; we are committed to eradicating or treating bacterial infections through innovative solutions. With a clear and defined pathway to success, Vaxcyte is poised to make a significant impact in the field of vaccines. Our Work Ethos: What we achieve is equally matched by how we achieve it. Our collaborative efforts are underpinned by four enduring core values: *Rethink Convention: We embrace creative and intellectual diversity to innovate and continuously enhance vaccine delivery methods. *Aim High: We collectively strive to accomplish our ambitious goal of developing the most complex biologics to protect humankind. *Lead with Heart: At Vaxcyte, every individual leads with a kindness-first approach, fostering inclusive collaboration and constructive debate that propels our business objectives forward. *Model Excellence: Given the magnitude of our challenges, we commit to demonstrating integrity, accountability, equality, and clarity in our communications and decision-making processes.Position Summary:We are currently seeking a Scientist II in Conjugation Development. The selected candidate will primarily lead and execute experimental activities supporting our pneumococcal conjugate vaccine program, focusing on enhancing the understanding of the conjugation process. Concurrently, this role involves developing the conjugation process for Vaxcyte’s pipeline programs, contributing to process optimization, scalability, and readiness for future clinical manufacturing. Key responsibilities include the preparation, purification, and analytical characterization of chemically modified polysaccharides and polysaccharide-protein conjugates. The ideal candidate will have substantial laboratory experience and a robust understanding of analytical chemistry principles, with the ability to design, execute, and troubleshoot experiments independently. Additionally, contributions to analytical development and stability studies may be required. Responsibilities will also encompass record management and data presentation to the team.

Join Our Mission to Protect Humankind!Vaxcyte is an innovative clinical-stage vaccine company dedicated to engineering high-fidelity vaccines aimed at safeguarding humanity from the devastating impacts of bacterial diseases. Our mission involves not just the eradication but also the treatment of bacterial infections such as invasive pneumococcal disease, Group A Strep, and Shigella. We have a clear and ambitious roadmap to success, and Vaxcyte is poised to achieve remarkable milestones. What we do is equally important as how we do it! Our collaborative efforts are anchored by four enduring core values: *RETHINK CONVENTION: We foster creative and intellectual diversity in every aspect of our work, continually innovating how vaccines are delivered. *AIM HIGH: We embody our ambitious goal to courageously create the most complex biologics ever developed for the protection of humankind. *LEAD WITH HEART: At Vaxcyte, every individual leads with a kindness-first and inclusive approach to collaboration, encouraging healthy debate that advances our objectives. *MODEL EXCELLENCE: The scale of our challenges necessitates a shared commitment to integrity, accountability, equality, and clarity in communication and decision-making.Position Summary:Vaxcyte offers an exciting opportunity for a Senior Manager, Quality Control Data Analyst to join our Quality Control (QC) organization. This role will serve as a vital link between our technical QC Operations team and Business teams. The successful candidate will be responsible for the systematic collection, evaluation, interpretation, and visualization of complex datasets, transforming them into actionable insights that inform both technical and business decisions. Key responsibilities include generating reports, managing databases, and utilizing analytical tools to identify trends, initiate quality events when necessary, enhance operational efficiency, and support the formulation of acceptance criteria as well as strategic planning.Essential Functions:Collaborate closely with analytical sub-teams and other departments within Analytics, Process Development, Quality Assurance, Operations, and Regulatory functions.Ensure data integrity, accuracy, and reliability, ensuring datasets are evaluated promptly and conform to quality and regulatory standards, thereby securing a continuous supply of Vaxcyte’s innovative therapies.

Vaxcyte, Inc. seeks a Manager of Quality Management System (QMS) Vendor Management & Supplier Notifications to lead supplier-related quality activities. Based in San Carlos, California, this position plays a key role in maintaining and improving supplier compliance within Vaxcyte’s QMS, with a focus on timely and accurate handling of supplier notifications. Role overview This manager oversees the intake, triage, and coordination of supplier notifications using Veeva QMS. The role requires close collaboration across departments to evaluate risks, support change controls, and ensure that supplier compliance standards are met. Responsibilities also include participating in vendor qualification, supplier management, and assisting with audits when needed. Main responsibilities Supplier notification management: Manage the full process for supplier notifications in Veeva QMS, from intake and triage to prioritization and tracking. Conduct initial reviews of supplier notifications to determine necessary actions and assess potential impacts. Coordinate with cross-functional teams to ensure thorough impact assessments and follow-up steps are completed. Collaboration and compliance This position works with teams across the company to evaluate supplier-related risks and support ongoing supplier management. The manager may also contribute to internal and external audits as required.

Vaxcyte, Inc. seeks an IT Quality & Compliance Manager based in San Carlos, California. This role is central to upholding the integrity and compliance of the company’s IT systems. The manager leads efforts to maintain high quality standards throughout company operations. Key responsibilities Develop, implement, and monitor IT quality assurance processes Ensure IT practices follow both internal policies and external compliance requirements Collaborate with teams across the organization to support compliance initiatives Requirements Solid background in IT compliance frameworks Experience building and managing quality assurance processes for IT systems Strong ability to work with cross-functional groups to maintain compliance

POSITION SUMMARY: As a Histotechnologist I, you will be responsible for executing histological preparations essential for the Signatera Whole Exome/Genome Sequencing process. PRIMARY RESPONSIBILITIES: Conduct histological preparations for the tissue whole exome sequencing laboratory with precision and minimal errors. Your responsibilities may encompass a range of tasks including tissue preparation, slide staining, microdissection, and workflow support activities. After successful training and competency assessment, you may independently perform testing, as well as prepare reagents and equipment. Engage in validation processes. Qualify reagents as part of your duties. Monitor case management to ensure all cases meet departmental turnaround time (TAT) goals and address any sample processing issues. Actively contribute to Environmental Health & Safety initiatives, including safety audits. Participate in the development and revision of Standard Operating Procedures. Depending on your education and experience, you may take on a general supervisory role and conduct competency assessments. Possess a solid understanding of troubleshooting equipment and processes. Document all corrective actions when test systems deviate from established performance specifications, and escalate any protocol deviations to your supervisor. Provide oversight of laboratory personnel and daily operations, offering guidance to new team members.

Production Controller, Manufacturing OperationsSan Carlos, CA (on-site)About 1XAt 1X, we are pioneering the future of work by developing humanoid robots that collaborate with human workers to address labor shortages and foster a prosperous environment.The RoleAs a Production Controller, you will take the lead in orchestrating and overseeing production activities to ensure that our manufacturing schedules are achieved with maximum efficiency and punctuality. Your role will be vital in supervising workflows, assessing material availability, and ensuring smooth production floor operations. You will work in close collaboration with cross-functional teams to facilitate seamless operations, timely deliveries, and ongoing enhancements in our manufacturing processes.

Join Our Mission to Safeguard Humanity!At Vaxcyte, we are pioneering innovative vaccine solutions designed to protect humanity from the severe and costly impacts of bacterial diseases. Our commitment extends to addressing critical infections such as invasive pneumococcal disease, Group A Strep, and Shigella. With a clear and defined pathway ahead, Vaxcyte is poised for success in the fight against bacterial infections. Our Approach: We Value Both What We Do and How We Do It! Our collaborative efforts are driven by four core values: *RETHINK CONVENTION: We inject creativity and diverse intellect into every aspect of our work, continually innovating the vaccine delivery process. *AIM HIGH: We embrace ambitious goals, boldly tackling the complexities of biologics to safeguard human health. *LEAD WITH HEART: Vaxcyte fosters a culture of kindness and inclusivity, encouraging robust discussions that propel our objectives. *MODEL EXCELLENCE: Our challenges require a unified commitment to integrity, accountability, and clear communication.Position Overview:The Director of Device Development and Commercialization will oversee the VAX-31 drug product, an intricate biological entity consisting of 31 Drug Substances formulated as an adjuvanted suspension Drug Product. The role demands meticulous attention to the development of a pre-filled syringe (PFS) combination product for both clinical and commercial applications. We seek an enthusiastic and skilled professional to lead our Drug Product Development Team through essential development and regulatory milestones, ensuring our product's successful launch and distribution.The VAX-31DP presents unique challenges in production, handling, and testing due to its suspension system. The director will navigate these complexities by managing their team and collaborating within a matrix structure across the broader Drug Product and commercial organization. Furthermore, it is essential to comprehend, manage, and effectively communicate these challenges to regulatory bodies through compelling submissions. Experience in the vaccine sector, particularly with adjuvants, is highly desirable.

Be a Part of Our Mission to Safeguard Humanity!Vaxcyte is at the forefront of vaccine innovation, focusing on the development of high-fidelity vaccines aimed at protecting society from severe bacterial diseases that can lead to significant health challenges. Our commitment to combating bacterial infections, including invasive pneumococcal disease, Group A Streptococcus, and Shigella, positions us as leaders in the field. With a clear and defined path toward success, Vaxcyte is committed to making a lasting impact on global health. Our Approach: Values that Drive Us We believe that our mission is as important as our methodology. Our work is guided by four foundational values: *RETHINK CONVENTION: We embrace creativity and diverse perspectives to continuously innovate the delivery of vaccines. *AIM HIGH: Our ambitious goal is to develop the most complex biologics designed to protect humanity. *LEAD WITH HEART: Collaboration at Vaxcyte is rooted in kindness and inclusivity, fostering an environment where vigorous debate leads to meaningful outcomes. *MODEL EXCELLENCE: Meeting our challenges requires a collective commitment to integrity, accountability, and clarity in communication and decision-making.Position Summary:The Executive Director of Clinical Regulatory is a leadership role responsible for crafting and executing global regulatory strategies for clinical investigations and the commercialization of vaccines across both adult and pediatric populations. Working closely with Clinical Development and Safety teams, this position will provide regulatory oversight that supports the preparation of clinical development protocols, interpretation and summarization of clinical data, and the creation and management of clinical and pre-clinical regulatory documents. This role also entails liaising with regulatory authorities to secure commercial approval for innovative vaccine products.Candidates should possess extensive experience in developing and executing regulatory strategies for vaccines and preparing investigational and commercial regulatory submissions, such as IND/IMPD, BLA/MAA, and post-approval clinical and safety notifications. Strong communication skills are essential, particularly the ability to simplify complex regulatory issues and effectively convey potential options and opportunities.

Join Our Mission to Protect Humanity!Vaxcyte is at the forefront of clinical-stage vaccine innovation, developing high-fidelity vaccines aimed at safeguarding humanity from the dire consequences of bacterial diseases. Our mission tackles serious health challenges, including invasive pneumococcal disease, Group A Strep, and Shigella. As we strive to eradicate or treat these infections, our path to success is clearly defined, and Vaxcyte is poised for long-term achievement. Our Work Ethos: At Vaxcyte, the importance of WHAT we do is matched only by HOW we do it. Our collaborative efforts are guided by four enduring core values: *Rethink Convention: We embrace creative and intellectual diversity to innovate and continuously improve the delivery of vaccines. *Aim High: Our audacious goal is to develop the most complex biologics ever attempted for the protection of humankind. *Lead with Heart: Kindness and inclusivity shape our collaborative and vigorous discussions, advancing our business objectives. *Model Excellence: Our commitment to integrity, accountability, equality, and clarity is vital to overcoming the challenges we face.

Join Our Mission to Protect Humanity!Vaxcyte is a pioneering clinical-stage vaccine innovation company dedicated to engineering high-fidelity vaccines that aim to safeguard humanity from the severe health implications of bacterial diseases. We are committed to eradicating or effectively treating bacterial infections such as invasive pneumococcal disease, Group A Strep, and Shigella, with a clear and defined path toward success. Our Approach: What we do is just as vital as how we do it! Our collaborative efforts are anchored by four core values: *RETHINK CONVENTION: We infuse creativity and intellectual diversity into every aspect of our work to innovate and re-innovate vaccine delivery. *AIM HIGH: We embody our ambitious goal to courageously tackle the most complex biologics designed to protect mankind. *LEAD WITH HEART: At Vaxcyte, everyone leads with kindness and inclusiveness, fostering collaboration and spirited debate that drives our business objectives forward. *MODEL EXCELLENCE: The magnitude of our challenge necessitates our collective commitment to integrity, accountability, equality, and clarity in communications and decision-making.Position Overview:The Associate Director of Process Validation and Risk Management will spearhead and facilitate commercial process validation and risk management activities throughout Vaxcyte's comprehensive manufacturing processes. This role is pivotal in shaping technical strategies, executing plans, and coordinating across functions to ensure commercial readiness, regulatory compliance, and effective lifecycle management.The successful candidate will provide leadership to ensure our organization is adept at designing, executing, and communicating process validation and risk management strategies to internal stakeholders, external partners, and regulatory bodies.This position reports to the Senior Director of Process Validation within the Global MSAT organization and collaborates on the overarching validation strategy, with primary accountability for process validation execution and risk management frameworks supporting commercial manufacturing.