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

Summary:

Vaxcyte is seeking an Associate Scientist II (Contract), Conjugation Development, who will contribute to the development of a robust process for generating the company’s proprietary pneumococcal conjugate vaccine. This role will focus on the synthesis, purification, and analytical characterization of chemically modified polysaccharides and polysaccharide-protein conjugates. The successful candidate will apply a strong foundation in analytical chemistry and laboratory techniques to optimize and troubleshoot processes, while also supporting related areas such as analytical development and stability studies. This position requires strong organizational skills, clear communication, and the ability to work in a fast-paced, cross-functional environment.

Essential Functions:

• Perform and optimize multi-step syntheses of protein-polysaccharide conjugates.
• Purify polysaccharides and conjugates using methods including dialysis, size-exclusion chromatography, and tangential flow filtration (TFF).
• Analyze polysaccharides and conjugates using methods such as colorimetric assays, HPLC assays, SEC-MALS, and SDS-PAGE, and contribute to method bridging studies and qualification to ensure robustness and consistency.
• Maintain accurate, well-organized experimental records and support data verification and analysis to enable process optimization and reproducibility.
• Assist with troubleshooting of synthesis, purification, and analytical procedures.
• Track inventory of critical reagents and assist with ordering as needed.
• Support maintenance of assigned lab instruments, perform general lab duties, and contribute to training new team members.
• Present experimental results and progress updates at group meetings.
• Contribute to laboratory protocols, reports, and other documentation supporting process development.
• Collaborate effectively with team members and contribute to cross-functional activities.

Requirements: 

• BS degree in Chemistry, Biochemistry, or related field with minimum 2 years of industry experience, or MS degree with minimum 1 years of industry experience.
• Experience with laboratory-scale protein purification methods such as dialysis, diafiltration, and size-exclusion chromatography; experience with TFF is desirable.
• Working knowledge of analytical methods including colorimetric assays, HPLC, SEC, and SDS-PAGE.
• Hands-on experience with protein conjugation reactions or chemical modification of polysaccharides is desirable.
• Strong attention to detail, organizational skills, and record-keeping abilities.
• Effective communication skills, both verbal and written.
• Ability to work both independently and collaboratively in a fast-paced environment.
• Enthusiasm for learning new skills and applying them to challenges outside of current expertise.
• Commitment to integrity, professionalism, and safety in all aspects of work.

Summary:

Vaxcyte is seeking Senior Associate Scientist (Contract), Conjugation Development, who will support the development of a robust process for generating the company’s proprietary pneumococcal conjugate vaccine. This role will focus on analysis of vendor-supplied materials in a capacity similar to a Quality Control Lab, as well as supporting the Conjugation Development team as needed. This is lab-based, full-time position that requires strict adhesion to protocols and documentation standards. The ideal candidate has strong organizational skills, clear communication, a high level of attention to detail, and experience working in a QC environment.

Essential Functions:

• Conduct analyses of vendor-supplied samples using colorimetric assays, gel electrophoresis, and liquid chromatography while strictly adhering to established SOPs
• Support lab operations
• Track shipping details for vendor-supplied samples.
• Review analytical assay data for adherence to SOPs and accuracy.
• Maintain organized records of review status of notebook entries and analytical data.
• Contribute to reports, certificates, and other documentation supporting process development.
• Collaborate effectively with team members and contribute to cross-functional activities.

Requirements: 

• BS degree in Chemistry, Biochemistry, or related field with minimum 5 years of industry experience, or MS degree with minimum 3 years of industry experience.
• At least 2 years of experience in an analytical development or quality control role.
• Prior experience running colorimetric assays is required.
• Prior experience with HPLC is required.
• Prior experience with SDS-PAGE is required.
• Excellent attention to detail, organizational skills, and record-keeping abilities.
• Ability to work both independently and collaboratively in a fast-paced environment.
• Commitment to integrity, professionalism, and safety in all aspects of work.

Summary:

Vaxcyte is seeking an Associate Scientist II (Contract), Conjugation Development, who will contribute to the development of a robust process for generating the company’s proprietary pneumococcal conjugate vaccine. This role will focus on the synthesis, purification, and analytical characterization of chemically modified polysaccharides and polysaccharide-protein conjugates. The successful candidate will apply a strong foundation in analytical chemistry and laboratory techniques to optimize and troubleshoot processes, while also supporting related areas such as analytical development and stability studies. This position requires strong organizational skills, clear communication, and the ability to work in a fast-paced, cross-functional environment.

Essential Functions:

• Perform and optimize multi-step syntheses of protein-polysaccharide conjugates.
• Purify polysaccharides and conjugates using methods including dialysis, size-exclusion chromatography, and tangential flow filtration (TFF).
• Analyze polysaccharides and conjugates using methods such as colorimetric assays, HPLC assays, SEC-MALS, and SDS-PAGE, and contribute to method bridging studies and qualification to ensure robustness and consistency.
• Maintain accurate, well-organized experimental records and support data verification and analysis to enable process optimization and reproducibility.
• Assist with troubleshooting of synthesis, purification, and analytical procedures.
• Track inventory of critical reagents and assist with ordering as needed.
• Support maintenance of assigned lab instruments, perform general lab duties, and contribute to training new team members.
• Present experimental results and progress updates at group meetings.
• Contribute to laboratory protocols, reports, and other documentation supporting process development.
• Collaborate effectively with team members and contribute to cross-functional activities.

Requirements: 

• BS degree in Chemistry, Biochemistry, or related field with minimum 2 years of industry experience, or MS degree with minimum 1 years of industry experience.
• Experience with laboratory-scale protein purification methods such as dialysis, diafiltration, and size-exclusion chromatography; experience with TFF is desirable.
• Working knowledge of analytical methods including colorimetric assays, HPLC, SEC, and SDS-PAGE.
• Hands-on experience with protein conjugation reactions or chemical modification of polysaccharides is desirable.
• Strong attention to detail, organizational skills, and record-keeping abilities.
• Effective communication skills, both verbal and written.
• Ability to work both independently and collaboratively in a fast-paced environment.
• Enthusiasm for learning new skills and applying them to challenges outside of current expertise.
• Commitment to integrity, professionalism, and safety in all aspects of work.

Summary:

Vaxcyte is seeking an energetic and talented individual to join the Drug Product (DP) Process Development team within the broader Process Development organization. The primary responsibility of the incumbent will be to provide technical and engineering support across DP process development activities, spanning late-stage clinical supply, process characterization, tech transfer, and commercial readiness (PPQ) of Vaxcyte’s lead programs. The role requires close collaboration with internal cross-functional partners (Formulation, Analytical Development, MSAT, Quality) as well as external contract development and manufacturing organizations (CDMOs) supporting Vaxcyte’s fill/finish operations.

Due to the high number of Drug Substances (up to 31) within the DP and the aluminum-containing adjuvant system, this is arguably one of the most complex Drug Products in clinical and commercial development today, offering the right candidate an incredible opportunity to make a significant impact on the product, the company, and the industry. The successful candidate will be hands-on, detail-oriented, and comfortable operating in a fast-paced environment with fluid priorities. The role is predominantly lab- and office-based at Vaxcyte’s San Carlos headquarters, with opportunities to contribute to studies executed at both internal and external (CDMO) sites.

Essential Functions: 
•    Support the development, characterization, and qualification of robust Drug Product processes for late-stage clinical and commercial manufacturing.
•    Execute bench- and pilot-scale process development studies using down-scaled models, including compounding/mixing, sterile filtration (filter selection and sizing), fill/finish, hold time, and container/closure evaluations. 
•    Perform in-process sample testing and analysis of DP intermediates and finished product to support process monitoring, process characterization, and release.
•    Maintain accurate and timely data entry and documentation in Benchling (ELN) in accordance with Good Documentation Practices (GDP), ensuring accuracy, completeness, and compliance with established standards and regulatory requirements.
•    Analyze experimental and manufacturing data using statistical tools (e.g., JMP), identify trends, and summarize findings in technical reports and presentations.
•    Perform routine lab upkeep and housekeeping to ensure laboratory cleanliness standards are met and conduct regular inventory monitoring and reconciliation.
•    Work within a team environment and provide support as necessary to further the team’s initiatives.

Requirements: 
•    BS in Chemical Engineering, Biochemistry, or a related discipline, with minimum 2 years of relevant industry experience. MS without experience; or equivalent work experience.
•    Experience in, or exposure to, early- and/or late-stage clinical fill/finish manufacturing under GMP regulations preferred.
•    Working knowledge of Drug Product unit operations, such as compounding/mixing, sterile filtration, aseptic fill, and container/closure systems (vials, PFS, cartridges).
•    Experience supporting technology transfer, scale-up/scale-down, process characterization, or CDMO-based manufacturing activities is preferred.
•    Familiarity with statistical analysis tools (e.g., JMP, Minitab) is preferred.
•    Experience using electronic lab notebook (ELN) systems, preferably Benchling, is a plus.
•    Strong interpersonal and communication skills, both verbal and written, with the ability to work effectively with internal cross-functional teams.
•    Ability to work independently and collaboratively in a fast-paced, cross-functional environment, managing multiple priorities simultaneously.
•    Ability to execute, document, and interpret drug product process development and characterization experiments, adhering to scientifically sound practices.
•    Strong technical writing, data analysis, and communication skills.

Reports to: Engineer I, Drug Product Process Development

Location: San Carlos, CA

Expected Contract Length: 12 months

Hourly Range: 51/hr. – 56/hr. 

Summary:

The Veeva Configuration Specialist IT role serves as a techno-functional expert for Vaxcyte’s current and future Veeva applications and related technologies. Working closely with business and managed services partners, this role is responsible for implementing, managing, and maintaining Quality, Regulatory and Clinical Veeva Vault system configurations and other GxP and Non GxP enterprise applications. While technical in nature, this role drives business value by blending technology expertise with business process know-how. This is a hands-on role that reports to the Associate Director of Enterprise IT Systems at Vaxcyte’s San Carlos, California headquarters.

Essential Functions:

• Lead requirements gathering, impact assessments, analysis, design, and configuration activities.
• Customize and configure Veeva Vault applications to meet business requirements.
• Provide Veeva admin and operational support for issues impacting end-users, system unavailability, data integrity, and manage user account provisioning.
• Help develop and document business process flows.
• Create and maintain system-specific IT documentation such as configuration forms, business processes, operating procedures, templates and design standards.
• Establish and maintain close working relationships with cross functional business partners.
• Collaborate with stakeholders to understand current business processes and identify areas for improvement and optimization.
• Work with other IT teams to ensure seamless integration with other systems.
• Provide project management support for enhancement efforts.
• Follow GxP change management processes for system configuration changes and platform upgrades.
• Support periodic reviews and related compliance activities.
• Coordinate with managed services, business partners and assurance teams to implement planned releases and functional change requests.

Requirements: 

• Bachelor’s degree in computer science, information systems, or related field. Minimum 3 years of hands-on configuration experience with any Veeva Vault Platform systems and minimum 7 years of total IT Systems experience. Other combinations of education and/or experience may be considered.
• Strong understanding of Veeva application suites including Quality (QualityDocs, QMS, Vault Training), RIM and Clinical eTMF.
• Experience with validated GxP environments including implementation, documentation and change management is a must.
• Extensive experience as a business systems analyst for Enterprise IT systems.
• Veeva system administration certification is a plus.
• As is/to be process mapping and analysis.
• Solid problem-solving skills and ability to troubleshoot issues including root cause analysis.
• Excellent verbal and written communication skills, with the ability to effectively communicate complex technical concepts to non-technical stakeholders.
• Technical writing skills for updating SOPs, WIs, Knowledgebase articles and documenting business processes.

Summary:

The Manager, Quality Assurance, External Manufacturing is responsible for overseeing quality activities at contract manufacturing organizations (CMOs), ensuring compliance with cGMP standards, and driving performance through KPIs and continuous improvement initiatives. This role leads batch disposition, reviews critical GMP documentation, supports PPQ activities, and collaborates cross-functionally to resolve complex manufacturing and quality issues. The position requires strong expertise in pharmaceutical quality systems, regulatory requirements, and risk management, along with leadership, problem-solving, and communication skills to support both clinical and commercial operations.

Essential Functions:

• Provide Quality Assurance oversight of Contract Manufacturing Organizations (CMOs).
• Develop and report metrics and key performance indicators (KPIs) to evaluate CMO performance.
• Represent Quality Assurance at internal cross-functional meetings and Joint Project Team meetings.
• Lead polysaccharide batch disposition activities, including review of executed batch records, environmental monitoring data, and quality control results.
• Review and approve GMP documentation, including master batch records, deviations, risk assessments, change controls, and CAPAs.
• Drive resolution of quality performance issues in collaboration with contract manufacturers.
• Support Process Performance Qualification (PPQ) activities.
• Develop, implement, and maintain quality procedures, policies, and standards.
• Collaborate with key stakeholders to develop solutions to complex manufacturing and quality issues.
• Participate in compliance audits and regulatory inspections, as required.
• Promote a strong quality mindset and a culture of quality excellence across all activities.

Requirements: 

• Bachelor’s degree in chemistry, Biology, Pharmacy, Engineering, or a related scientific discipline.
• Minimum 5 years of experience in managing CMO quality, and quality systems management within the pharmaceutical, biotechnology, or life sciences industry. Other combinations of education and experience may be considered.
• Experience in batch record review, deviations and Out of Specification (OOS) investigations.
• Thorough knowledge of cGMP, ICH guidelines, FDA/EMA, Swiss medic regulations, and international pharmaceutical quality standards.
• Experience applying Quality Risk Management principles.
• Experience supporting both clinical and commercial products preferred.
• Strong leadership, management, and process improvement skills.
• Excellent organizational skills with strong attention to detail.
• In-depth understanding of biologics manufacturing operations.
• Proven ability to prioritize multiple assignments in a fast-paced, changing environment.
• Strong problem-solving abilities, including managing complex investigations and root cause analyses.
• Excellent written and verbal communication skills, with the ability to clearly present quality topics and risk-based decisions to cross-functional teams.

Summary:

Vaxcyte is seeking a Manager, QMS Vendor Management & Supplier Notifications to support the effective management of supplier-related quality activities within the Quality Management System (QMS). This role will be responsible for the intake, triage, and coordination of supplier notifications within Veeva QMS, ensuring timely impact assessments and appropriate follow-up actions. The individual will partner cross-functionally to assess risk, drive change controls, and maintain supplier compliance. This role will also contribute to vendor qualification activities, supplier management processes, and may support internal and external audit activities as needed.

Essential Functions:

• Supplier Notification Management
  • Manage the end-to-end lifecycle of supplier notifications within Veeva QMS, including intake, triage, prioritization, and tracking.
  • Perform initial assessments of supplier notifications to determine required actions and level of impact.
  • Assign and coordinate impact assessments with cross-functional stakeholders (e.g., Quality, Regulatory, Manufacturing, Supply Chain).
  • Ensure timely closure of supplier notifications in alignment with internal procedures and regulatory expectations.
  • Maintain visibility of notification status, risks, and trends, escalating issues as appropriate.
• Impact Assessments & Action Management
  • Facilitate and track impact assessments to evaluate potential effects on product quality, regulatory filings, and supply continuity.
  • Coordinate and manage follow-up actions, including change controls, supplier communications, and documentation updates.
  • Ensure actions are completed in a timely manner and in compliance with QMS requirements.
  • Support risk-based decision making and documentation aligned with GxP expectations.
• Vendor Management & Qualification
  • Support vendor qualification and requalification activities, including risk assessments and documentation review.
  • Maintain supplier records and ensure compliance with approved supplier lists and quality agreements.
  • Partner with cross-functional teams to ensure suppliers meet Vaxcyte quality and compliance standards.
  • Assist in maintaining supplier performance metrics and supporting supplier oversight activities.
• Audit Support
  • Participate in internal and external audits, including supplier audits, as needed.
  • Support audit preparation activities and contribute to responses and CAPA development for audit observations.
  • Assist in tracking and closure of audit-related actions.

Requirements: 

• BA or BS in a scientific or related field.
• Minimum of 5 years of experience in Quality Assurance, Supplier Quality, or Vendor Management within the biopharmaceutical, vaccine, or regulated industry. Other combinations of education and/or experience may be considered.
• Experience working within a Quality Management System (QMS), preferably Veeva QMS.
• Strong understanding of GxP regulations (GMP, GLP, GCP) and supplier quality requirements.
• Experience with supplier notifications, change control, and impact assessments preferred.
• Familiarity with vendor qualification and audit processes.
• Strong organizational and project management skills with the ability to manage multiple priorities.
• Excellent communication and cross-functional collaboration skills.
• Detail-oriented with strong problem-solving and risk assessment capabilities.
• ASQ certification (CQA, CQE) or auditor certification preferred.

Summary:

The Senior Director, Global Logistics & Distribution has overall responsibility for shipping and storage of all Vaxcyte CMC materials including finished goods, bulk product and samples. Scope includes material for Research, Development, Clinical and Commercial. This position will report to the Executive Director, Global Supply Chain.

Essential Functions:

STRATEGIC PLANNING:

• Develop and implement a global logistics and distribution strategy aligned with corporate objectives including network design, transportation optimization and warehousing operations

OPERATIONS MANAGEMENT:

• Ensure the efficient, timely, compliant and high-quality delivery of all materials in scope
• Ensure that pack-outs are robustly designed with the appropriate containers and associated components to maintain material at target temperature and facilitate efficient receipt
• Ensure robust shipping agreements are in place with CMOs and suppliers of criterial raw materials
• Oversight of all logistics related policies, guidelines, SOPs and Work Instructions
• Ensure sound inventory management practices are in place at all storage facilities
• Ensure inventory losses are minimized to lowest possible levels
• Establish and track Key Performance Indicators

COMPLIANCE / REGULATORY:

• Ensure compliance with international trade laws, import/export regulations, tariffs and customs requirements, including managing country of origin, customs valuation and documentation.
• Ensure all shipping and storage operations are compliant with Good Distribution Practices (GDP)
• Ensure that temperature excursions and other logistics related deviations occur at low frequency and are resolved in a compliant and timely manner with minimal material losses.
• Ensure external supply chain partners have an established CAPA program and monitor the same
• Ensure the successful design & execution of a Shipping Validation Program

VENDOR MANAGEMENT:

• Select and Manage relationships with logistics providers, transportation companies, freight forwarders, third-party logistics (3PL) partners, import /export brokers and other logistics service providers
• Select and manage relationships with passive and active cold chain packaging/container vendors

RISK MANGEMENT:

• Identify and mitigate risks within the logistics network to ensure product supply continuity

TEAM LEADERSHIP:

• Lead, mentor, and scale a high-performing global logistics team, fostering a culture of continuous improvement and professional development.

FINANCIAL OVERSIGHT:

• Manage the global logistics budget, conduct financial analyses to support decision-making, and ensure cost-effectiveness without compromising quality or service.
• Ensure tariff obligations are managed in a cost-effective manner.

TECHNOLOGY & AUTOMATION:

• Drive the adoption of advanced technologies and automation within logistics operations to enhance efficiency and resilience.
• Development and maintenance of IT systems to track shipping requests, actual shipments and temperature data.

CROSS FUNCTIONAL COLLABORATION:

• Interface with Vaxcyte Commercial, Quality, Finance, IT, Process Development, Regulatory, Legal MSAT, Supply Planning, Clinical Supply, Supplier Management, Project Management, Operations and other Functions
• Interface with Logistics staff at CMOs

Requirements: 

• BS in a science-related discipline is a definite plus.
• 12+ years’ experience working in the Life Sciences industry.
• 12+ years’ experience in International cGMP cold chain shipping
• Experience managing a pharmaceutical 3PL
• Fluent with all global shipping-related statutory and regulatory requirements.
• Understand the requirements, technologies, and processes of cold-chain supply management.
• Experience with pharma logistic service providers with knowledge of qualified active and passive containers.
• Experience with arranging international and domestic transportation.
• Experience authoring and using GxP documents such as SOP’s and work instructions.
• Relentless focus and passion around process improvements (efficiency and automation).
• Excellent communication, customer service, and relationship skills.
• Vaccine distribution experience highly valued.

Summary:

The Development organization is comprised of four Process teams: Protein, Polysaccharide, Conjugate Drug Substance (Conjugation), and Drug Product. These Process Development teams are supported by Analytical Development and Formulation Development teams. Vaxcyte is looking for a Senior Associate Scientist (contract) with experience in microbial fermentation and upstream processing to join the Upstream Polysaccharide Process Development team. The candidate will be responsible for collaboration on experimental design and execution of experiments to further develop and optimize upstream processes for polysaccharide manufacturing using microorganisms. The successful candidate will have practical laboratory experience related to microbial fermentation processes and eager to utilize and learn new laboratory skills. The role will require >50% time in the lab and this person will be able to independently detail experimental procedures/results in written and presentation formats. The successful candidate may interface closely with the cross-functional team, write detailed technical reports, present experimental results internally, and may potentially interface with external CMO partners.

Essential Functions:

• Support in study design, execute, and analyze experiments for upstream polysaccharide for bacterial fermentation (BSL2) and vaccine production processes.
• Execute experiments to develop the upstream process parameters (e.g., media, feed, pH, temperature, dissolved oxygen, agitation, etc.) and to enhance product yield, quality, and consistency.
• Perform microbiology related work including plating, colony selection, Gram staining and cell enumeration on microscope.
• Perform fermentation vessel assembly and script writing for process automation and execute fermentation experiment in shake-flask and lab scale bioreactors.
• Prepare media and buffer as needed for experiments.
• Operate and maintain instrumentation for bacterial fermentation and primary recovery (centrifugation, filtration, etc.) of bacterial polysaccharides utilizing aseptic techniques.
• Support analytical method execution including optical density, residual metabolites and polysaccharide concentration and other relevant analytical techniques.
• Assist in executing process development studies.
• Keep accurate and current records of research and/or project related activities in laboratory notebooks and Electronic Lab Notebook.
• Prepare and review protocol, technical reports, SOPs, and batch records.
• Present and communicate scientific data and results to internal stakeholders.
• Be an outstanding teammate and collaborate effectively with cross functional team members.
• and collaborate effectively with downstream, analytical, and manufacturing teams within Polysaccharide Development and Manufacturing team to ensure seamless technology transfer and process integration.

Requirements: 

• MSc in Chemical/Biochemical Engineering, Biotechnology, or similar degree with a minimum of 3 years of relevant industry experience, or BSc with a minimum of 5 years of relevant industry experience.
• Experience in handling microorganisms with proper aseptic techniques to perform upstream processing related work in flasks/bioreactors.
• Hands-on experience and theoretical understanding of key processing operations such as microbial culture, fermentation process, microbial media, and process optimization and relevant analytical technologies; experience with depth filtration, continuous centrifugation is a plus.
• Develop and optimize scripts for instrumentation, including Ambr® systems, to enhance efficiency and automate processes, leveraging programming languages such as Python or R is a plus.
• Experience with Design of Experiments (DoE) principles and DoE software.
• Process characterization experience is a plus.
• Cell banking expertise, colony selection and genetic analysis of recombinant strains is a plus.
• Proficiency with computer programs such as Microsoft Excel, Word, PowerPoint, Visio and JMP.
• Working knowledge of GMP requirements.
• Proven ability to succeed in a cross-functional team environment, effectively managing multiple projects and contributing to team outcomes.
• Strong interpersonal skills, with excellent written and verbal communication abilities.

Summary:

The Associate Director, Process Validation and Risk Management will lead and facilitate commercial process validation and risk management activities across Vaxcyte’s end-to-end manufacturing processes. This role focuses on technical strategy, execution, and cross-functional coordination to support commercial readiness, regulatory compliance, and lifecycle management.

The incumbent will provide leadership to ensure the organization is equipped to effectively design, execute, and communicate process validation and risk management strategies to internal stakeholders, external partners, and regulatory agencies.

This position will report to the Sr. Director of Process Validation within the Global MSAT organization and will collaborate on overall validation strategy, with primary responsibility for process validation execution and risk management frameworks supporting commercial manufacturing.

Essential Functions:

Process Validation Leadership

• 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.

Risk Management

• 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.

Commercialization & Lifecycle Support

• 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.

Cross-functional Interface

• 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.

Technical Oversight

• Provide guidance for validation of processes, systems, facilities, and methods within the commercial organization.
• Support deviation investigations, ensuring timely resolution and sustained compliance.

Regulatory

• 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.

Process Validation & Comparability

• Provide leadership for execution of process validation and comparability activities, ensuring data integrity and compliance.

Raw Material & Network Support

• Provide guidance on raw material qualification strategies to ensure supply reliability.
• Support validation activities across internal and external manufacturing networks.

Communication & Leadership

• 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.
• Travel - 10-30% domestic and international travel required.  

Requirements: 

• Degree(s) in Chemical or Biochemical Engineering, Chemistry, Biochemistry, or related discipline with a minimum of 9+ years of relevant experience for Ph.D., 11+ years for M.S./M.A., or 14+ years for B.S./B.A.
• Strong experience in biologics/vaccine manufacturing, including:
• Process validation (PPQ/CPV)
• MSAT, technical operations, or late-stage development
• Technology transfer and commercialization
• Experience in quality risk management (ICH Q9) and regulatory expectations
• Demonstrated leadership in matrixed or cross-functional team environments
• Ability to apply deep technical knowledge to develop strategies and drive execution
• Strong problem-solving, organizational, and strategic planning skills
• Excellent communication and stakeholder engagement skills
• Ability to analyze data and align stakeholders with organizational strategy
• Innovative and entrepreneurial mindset to drive continuous improvement
• An entrepreneurial and creative approach to developing new, innovative ideas that will stretch the organization and push the boundaries within the industry. 

Summary:

The Director for Drug Substance (DS) Commercialization of Critical Raw Materials will lead and facilitate launch readiness and commercial supply of critical raw materials for production of eCRM and associated components for glycoconjugate vaccines. In this role the incumbent will serve as the technical lead and SME on biologic raw material processes . This role focuses on technical launch planning and execution by bringing best-practices and coordinating cross-functional efforts for regulatory filings, facility readiness, launch supplies and post-launch process robustness initiatives.

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.

This position will be reporting into the Sr. Director for Global DS Commercialization, Protein. The Director will collaborate on overall program strategy, with primary responsibility and accountability for assigned critical raw material strategy, subject matter expertise and associated regulatory filings and supporting studies.

Global Manufacturing Science and Technology (GMSAT) is responsible for successfully and seamlessly transitioning the vaccine process from Process Development to Commercial, developing and executing technical launch and commercialization strategy, continuously improving process robustness through to end of lifecycle, and ensuring best possible patient outcomes while creating value for the enterprise. As part of the Technical Operations organization, GMSAT will lead the technical and process support for end-to-end commercial manufacturing, including Polysaccharides, Carrier Proteins, and Conjugation across all Drug Substances (DS). The range of activities will include technology transfer support, process characterization experiments in support of validation, process improvement, evaluation of novel process technologies, investigation of process related manufacturing issues, ensuring continuous improvement in process robustness throughout the product life cycle, etc. 

Essential Functions:

• DS Commercialization – Provide strategic and scientific leadership for critical raw materials with internal and external stakeholders and ensure successful execution of launch plans and post-launch commercial activities.
• Process robustness – Continuously improve process understanding and process robustness using staff and laboratory resources across the organization to monitor, trend, and optimize operations.
• Interface - Collaboration with cross-functional teams across the network, including Regulatory, Process Development, Quality, Supply Chain, Procurement, and DS Operations, to drive the successful development and commercial launch of critical raw materials for pipeline products.
• Tech-transfer new technologies - Ensure robust processes exist to support technical transfers and integration of new technologies.
• Support technical services - Support of our internal and external manufacturing network, including materials management and data analytics.
• Process validation and comparability - Provide leadership for the execution of process validation and process comparability activities. Effectively communicate the scientific and commercial rationale for raw material processes to the Manufacturing organization for commercialization
• Regulatory - Engage In technical reviewing and authoring of regulatory filings and responding to questions received from health authorities. Effectively communicate the scientific and commercial rationale for DS processes to the Boards of Health for regulatory submissions for commercialization.
• Communicate - Effectively and efficiently communicate process performance to key stakeholders (internal-facing and external-facing). Connect and build strong working relationships with others, demonstrating strong emotional intelligence and an ability to communicate clearly and persuasively.
• Leadership - Contribute as Strategy lead for assigned Critical Raw Materials and as member of the DS Commercial MSAT team, with an aim to ensure effective and efficient delivery of our life-enhancing therapies to our patients.
• Travel - 10-30% travel required.

Requirements: 

• Degree(s) in Organic Chemistry, Biochemistry, Chemical or Biochemical Engineering, or related discipline with a minimum of 10+ years of relevant experience for Ph.D., 12+ years for M.S./M.A., or 16+ years for B.S./B.A.
• Extensive experience in scale-up, technology transfer, and relevant manufacturing process technologies /unit operations, including fermentation, recovery and purification at commercial scale. Experience with cell free protein synthesis and associated critical raw materials desired.
• Experience in manufacturing equipment specification/qualification and commercial manufacturing in a GMP environment is preferred. Experience working with Contract Manufacturing Organizations is desired.
• Leadership experience in MSAT or Process Development in supervisory and/or matrixed team roles.
• Able to leverage deep technical knowledge in a collaborative manner to troubleshoot technical challenges, establish strategic plans, and achieve collective goals.
• Excellent organization, problem solving and strategic planning skills.
• Highly skilled in both verbal and written communication with the ability to interact effectively with people of diverse backgrounds and perspectives.
• Proactively recognizes needs and potential challenges, and directs activities to implement effective solutions.
• The ability to seek and analyze data from a variety of sources to support decisions and to align others with the organization's overall strategy.
• An entrepreneurial and creative approach to developing new, innovative ideas that will stretch the organization and push the boundaries within the industry.

Summary:

Vaxcyte is seeking a Director, Health Economics & Outcomes Research (HEOR) to establish and lead the company’s health economic strategy across the vaccine lifecycle, with initial focus on adult pneumococcal programs. This strategic leadership role will be responsible for developing and executing global health economic models to support payer value propositions, immunization policy engagement, reimbursement strategy, and external stakeholder communications.

This role will focus specifically on health economic modeling and payer value strategy. Observational real-world evidence and epidemiology studies will be led by the Epidemiology & Real-World Evidence function. The Director, HEOR will work in close collaboration with RWE and Epidemiology colleagues to ensure economic models are grounded in robust disease burden, vaccine effectiveness, and coverage assumptions.

As Vaxcyte advances toward commercialization, this role will partner closely with Market Access colleagues, who will lead pricing and contracting strategy. The Director, HEOR will provide the analytic foundation and economic evidence required to inform pricing strategy, payer engagement, and health technology assessment discussions.

Essential Functions:

Health Economic Strategy & Leadership

• Develop and lead Vaxcyte’s HEOR strategy across early development, launch planning, and lifecycle management.
• Define the economic evidence generation plan required to support payer access and policy recommendations.
• Ensure health economic considerations are incorporated early into development planning.

Health Economic Modeling

• Lead development of cost-effectiveness, budget impact, and population health models for adult and pediatric vaccine programs.
• Design and oversee decision-analytic models (e.g., Markov models, microsimulation models, dynamic transmission models as appropriate).
• Establish modeling assumptions grounded in epidemiologic, clinical, and real-world data.
• Ensure all models are scientifically rigorous, transparent, and defensible in policy and payer environments.

Value Communication & Policy Support

• Translate health economic findings into clear, compelling value narratives for internal leadership and external stakeholders.
• Support development of global value dossiers, AMCP dossiers, and materials for payer engagement.
• Contribute to peer-reviewed publications and scientific congress presentations.

Cross-Functional Partnership

• Partner closely with Epidemiology & RWE to integrate disease burden and vaccine effectiveness assumptions into economic models.
• Collaborate with Clinical Development, Regulatory, Medical Affairs, and Market Access teams to align value strategy.
• Support consistent, aligned value messaging across stakeholders.

Capability Building

• Establish best practices and governance processes for health economic modeling.
• Build and manage external modeling partnerships.
• Mentor future HEOR team members as the function expands.

Requirements: 

PhD in Health Economics, Health Services Research, Public Health, Epidemiology, or related quantitative field with 8+ years of relevant industry experience required OR Master’s degree (e.g., MPH, MSc, MBA) with 12+ years of relevant industry experience in health economic modeling.

• Demonstrated experience leading cost-effectiveness and budget impact models.
• Deep expertise in decision-analytic modeling methodologies.
• Experience supporting payer submissions or health technology assessments.
• Strong cross-functional leadership and communication skills.

Summary:

Vaxcyte is looking for an energetic and talented individual to join Vaxcyte’s Vaccine Product Development organization as a Stability Manager within the Quality Control Unit. The primary function of this level position is to manage the stability program for various projects in preclinical and clinical development. 

The position will be an integral part of the team implementing and maintaining cGMP Stability for all phases of clinical development. Primary responsibility will include managing stability studies for individual projects and stability data analysis. This individual will collaborate with QC members in a highly collaborative and cross-functional environment. The ideal candidate will apply strong stability experience, ensure compliant operations and documentation, foster open communication, and pursue data-driven approaches.

Essential Functions:

• Designs, coordinate, and execute stability studies for early and late-stage vaccine products according to regulatory guidelines and company protocols.
• Summarize vaccine stability results by applying analytical testing expertise to ensure scientific and technical excellence. Utilize statistical software like JMP to perform rigorous statistical analyses, ensuring robust interpretation of data and adherence to regulatory standards.
• This includes, but not limited to, creating, implementing, and managing stability databases, performing data trending and statistical analysis, study and testing forecasting and reporting of metrics, creation, revision and approval of SOP's, stability protocols and reports in accordance with current GMP, FDA, EU, Global and ICH guidelines and regulations.
• Produce impactful PowerPoint presentations to effectively communicate stability data to diverse project team members. Support the attainment of project milestones by facilitating stability monitoring and determining expiration dates for clinical and in-process materials.
• Authors, reviews, revises, and approves SOP's, stability protocols and reports, memo’s, regulatory and specification documents (as required).
• The Stability Manager will also assist with leading the functionality and maintenance of stability related processes and systems.
• Drives continuous improvement activities for the clinical stability programs.
• Ensures that the GMP stability program continuously aligns with FDA, ICH and other international agencies.
• Manages Quality Systems records for QC Stability- creates, assesses, reviews Deviations, Change Controls, CAPA's and other applicable stability-related investigations and events.
• Guide and work with others to identify opportunities for continuous improvement and implement/maintain solutions.
• Provide strong teamwork in establishing a quality culture and shared accountability. Ensure GMP compliance is built into the design and implementation of processes and systems, including tracking metrics to monitor and improve performance.

Requirements:

• MS or BS with minimum of 8 years of industry experience in Pharma / Biotech industry required. Other combinations of education and/or experience may be considered.
• Strong understanding of vaccine stability principles, including degradation pathways, accelerated stability testing, and shelf-life determination.
• Demonstrated proficiency and expertise in various analytical methodologies, particularly in the context of stability testing and assessment of biologics or vaccines.
• Solid understanding of relevant FDA, EU, and ICH regulatory guidelines and pharmacopeia as applicable to stability study design, expiry dating, and analytical method qualification/validation for biologics and vaccines.
• Solid understanding and hands-on experience of applying basic statistical tools for stability data trending and rate analysis to support retest period/ shelf-life proposals.
• Attention to detail and excellent skills in record keeping / documentation.
• Experience in IND, NDA and BLA submission is highly preferred.
• Experience working in a regulated (GLP / GMP) environment.
• Extensive technical writing experience.
• Strong interpersonal skills; ability to communicate effectively both verbally and in written formats.
• Solid understanding of product development activities in biotech/drug/vaccine development, including key interdependencies, and knowledge of proven development strategies and tactics.
• Ability to work globally with CMOs in different countries and continents.

Reports to: Director, Stability

Location: San Carlos, CA

Compensation:  The compensation package will be competitive and includes comprehensive benefits and an equity component.

Salary Range: $147,000 – $171,000 *(SF Bay Area). Salary ranges for non-California locations may vary. 

Summary:

Vaxcyte is looking for a Scientist-II, Conjugation Development. The candidate’s primary responsibility will be to lead and execute experimental activities that support company’s pneumococcal conjugate vaccine program with a focus on developing a deeper understanding of the conjugation process. In parallel, the candidate will work on conjugation process development for Vaxcyte’s pipeline programs contributing to process optimization, scalability, and technical readiness for future clinical manufacturing. Specifically, this will include preparation, purification, and analytical characterization of chemically modified polysaccharides and polysaccharide-protein conjugates. The ideal candidate will have significant laboratory experience and an excellent understanding of analytical chemistry principles. The successful candidate will be expected to design, execute, and troubleshoot experiments with minimal guidance. The candidate will also contribute when needed to a range of related areas such as analytical development and stability studies. Responsibilities will additionally include record management, data presentation at group meetings, authorship of laboratory protocols and development reports, communication with external organizations during tech transfer, and assumption of a leadership role in collaborative studies with other members of the conjugation group.

Essential Functions:

• Optimize and troubleshoot multi-step syntheses of protein-polysaccharide conjugates.
• Purify polysaccharides and conjugates using a variety of methods including dialysis, size-exclusion chromatography, and tangential flow filtration (TFF)
• Analyze polysaccharides and conjugates with a variety of analytical methods. Develop new laboratory workflows and analyses beyond established procedures when appropriate.
• Advise team members on experimental design, interpretation of results, and troubleshooting.
• Model and train team members on best practices for adherence to protocols and data management.
• Serve as a subject matter expert during tech transfer of conjugation processes to contract manufacturing organizations.
• Maintain highly organized records to enable optimization and assessment of reproducibility.
• Attend team meetings ready to provide updates on conjugation development progress.

Requirements: 

• PhD in chemistry, biochemistry, or related field with minimum 2 years of industry experience, or combination of industry and postdoctoral research; MS with minimum 7 years industry experience, or BS with minimum 10 years of experience industry.
• Strong biochemistry and organic chemistry knowledge base underpinning several years’ experience preparing bioconjugates.
• Proficiency with small- and large-scale techniques for purification of bioconjugates, including tangential flow filtration.
• Proficiency in a variety of techniques for bioconjugate analysis such as colorimetric assays, HPLC, and SEC-MALS.
• Sufficient knowledge of analytical principles to develop fit-for-purpose analytical methods as needed and provide cross-functional feedback on draft analytical methods.
• Experience with Design of Experiments is desirable.
• Experience with chemical modification of polysaccharides is desirable.
• Experience implementing and/or using electronic notebooks is desirable.
• Attention to detail and excellent organizational skills.
• Strong interpersonal skills; ability to communicate effectively both verbally and in written formats.
• Self-starter; ability to work in a fast-paced, cross-functional environment and collaborate effectively with other team members.
• Enthusiasm to learn the new skills and techniques necessary to tackle problems outside of current area of expertise.
• This is lab based role that requires an onsite presence. 

Summary:

Vaxcyte is seeking an accomplished Director, Immunoassay Development to establish and lead a dedicated analytical function focused on immunoassay development for complex conjugated vaccines. This role will build and manage a laboratory-based team responsible for developing, sustaining, and continuously improving potency- and antigenicity-based immunoassays to support CMC development from preclinical through BLA-stage programs and commercialization.

A key initial focus of this role will be stewardship of the VAX-31 MSD immunoassay platform, which has been developed and advanced to Phase 3 through extensive internal leadership spanning clinical serology, GLP studies, and immunoassay development. The successful candidate will work in close partnership with current immunoassay leadership to ensure comprehensive knowledge transfer, continuity of scientific and execution excellence, and the long-term robustness of the immunoassay strategy as accountability and responsibility intentionally transition into Analytical Development.

This is a hands-on scientific leadership role anchored in CMC execution, GMP readiness, and lifecycle management of immunoassays supporting vaccine development, lot release and stability testing and commercialization.

Essential Functions:

• Establish and lead a new Immunoassay Development function within Analytical Development, defining scope, strategy, and operating model aligned with CMC and program needs.
• For VAX-31, partner closely with current immunoassay leadership to learn and internalize the full development history, scientific rationale, and performance characteristics of the existing MSD-based immunoassay platform.
• Serve as scientific steward for the VAX-31 immunoassay, providing troubleshooting, root-cause analysis, and technical problem-solving support to Quality Control (QC) and Analytical Sciences and Technology (ASAT) teams.
• Support ASAT activities for VAX-31, including qualification, lifecycle management, and change control of critical immunoassay reagents.
• Develop and execute immunoassay strategies to support potency, antigenicity, identity, and trace-level impurity testing for conjugated vaccines across the pipeline.
• Lead the development and optimization of antigenicity- and potency-based immunoassays suitable for late-stage development and commercial use.
• Drive continuous improvement of existing immunoassays to enhance robustness, QC-friendliness, throughput, and long-term performance, even when methods are already deemed adequate.
• Build, mentor, and manage a team of laboratory scientists, fostering a cohesive, innovative, nimble, and high-performing team culture grounded in scientific rigor and accountability.
• Provide critical scientific judgment and problem-solving leadership when addressing complex, ambiguous, or conflicting technical challenges across programs.
• Manage immunoassay development activities across multiple projects, prioritizing resources, timelines, and deliverables in a fast-paced, matrixed environment; proactively escalate risks and issues to line management and project team as appropriate.
• Partner cross-functionally with Process Development, Manufacturing, Quality, Clinical Serology, and Regulatory teams to ensure alignment with overall CMC strategy and program timelines.
• Ensure immunoassay methods meet FDA, EMA, and ICH expectations for vaccines and biologics.
• Support regulatory submissions and health authority interactions through technical input, data review, and authorship of CMC documentation.
• Champion data integrity, scientific excellence, and continuous learning within the immunoassay organization.

Requirements: 

Ph.D. in Biochemistry, Immunology, Analytical Chemistry, Biological Sciences, or a related field (or equivalent experience) with a minimum of 10 years of experience. Other combinations of education and/or experience may be considered.

• Significant hands-on experience developing immunoassays within vaccine CMC, analytical development, or other regulated laboratory environments.
• Expert-level, hands-on experience with MSD (Meso Scale Discovery) or closely related immunoassay platforms, including method development, optimization, troubleshooting, and lifecycle support.
• Direct experience with conjugated vaccines, including polysaccharide–protein conjugates.
• Solid understanding of protein chemistry and conjugation chemistry, particularly as applied to biological drug and vaccine development.
• Demonstrated expertise in potency and antigenicity assays supporting vaccine release, stability, and comparability.
• Strong working knowledge of GMP and global regulatory expectations (FDA, EMA, ICH) for analytical methods supporting vaccines.
• Demonstrated ability to think critically and exercise sound scientific judgment when navigating complex, ambiguous, or conflicting technical and organizational challenges.
• Proven track record of scientific problem-solving, including data-driven decision-making and root-cause analysis.
• Strong written and verbal communication skills, with the ability to clearly and efficiently communicate technical concepts across interdisciplinary and cross-functional teams.
• Ability to operate effectively in a fast-paced, matrixed environment, manage multiple priorities, and meet aggressive timelines.
• Project and resource management experience, including planning and coordination of materials, staffing, timelines, and deliverables, with the ability to appropriately escalate issues and risks.

Preferred Qualifications:

• Experience supporting late-stage development and/or commercial vaccine programs.
• Direct interaction with global health authorities on analytical, potency, or immunoassay-related topics.
• Experience building or scaling analytical capabilities within a growing organization.
• Background in multivalent or highly complex vaccine programs.

Summary:

The Quality Control Operations function is an executive role within a matrixed global vaccine organization, responsible for the implementation of Vaxcyte analytical strategies at our CDMO’s and CRO’s. This role is the single point of contact for our CDMO’s and CRO’s to ensure they deliver the quality, accuracy, and compliance of testing and analytical services.  Working closely with the analytical technical lead and other functions within Analytics, Process Development, Analytical and Manufacturing Science and Technology, Quality Assurance, Manufacturing, and Regulatory Affairs, this role provides leadership and oversight for implementation of analytical strategies at the CDMO / external lab supporting analytical readiness and deliverables. The role is accountable that testing and release at our CDMO & CRO is performed in a timely and compliant manner to ensure secure and uninterrupted supply of Vaxcyte’s innovative therapies.

Essential Functions:

• Implement and maintain analytical strategies for process-related, release and stability testing for our programs at our CDMO/contract labs and ensure they are aligned with the CDMO's goals and objectives as well as comply with relevant regulations and industry standards.
• Implement, and maintain robust quality control systems that encompass sampling, testing, documentation, and release procedures.
• Ensure on-time performance for QC testing at our CDMO’s or contract laboratories related to raw materials, intermediates, and drug substance.
• Ensure that contracted QC laboratories are equipped with appropriate instrumentation and equipment, maintained according to regulatory requirements, and calibrated regularly to ensure accuracy and reliability of test results.
• In partnership with analytical technical lead and analytical science and technology as well as the contract laboratories, oversee method validation and transfer activities between contract laboratories.
• Assure that appropriate systems for data management, including secure storage, retrieval, and retention of QC data and documentation are in place. Ensure that all testing activities are well-documented and comply with Good Documentation Practices (GDP).
• Review and approval of analytical data, test reports, and certificates of analysis (CoAs) generated by contract laboratories to verify accuracy, completeness, and compliance with specifications for both release and stability testing.
• Lead and support investigations and deviations, out-of-specification (OOS), out-of-trend (OOT), out-of-expectation (OOE) results, laboratory incidents, and customer complaints related to contract laboratory testing, collaborating with contract laboratories and internal stakeholders to implement corrective and preventive actions (CAPAs).
• Provide technical support for product related regulatory documents and inspections by Health Authorities.
• Writing, review and approval of documents related to Quality Control to ensure compliance with applicable regulatory and industry standards.

Requirements: 

Bachelor of Science with 10+ years of relevant experience in the biotechnology/pharmaceutical industry specifically in Quality Control. Other combinations of education and/or experience may be considered.

• Experience in Pneumococcal vaccines is a plus.
• Excellent experience in managing CDMOs and/or contract laboratories.
• Comprehensive knowledge in cGMP and experience in multi-national regulations.
• Excellent communication, negotiation, and relationship-building skills, with the ability to collaborate effectively with internal and external stakeholders.
• Strong analytical and problem-solving abilities, with a focus on data-driven decision-making and continuous improvement.
• Strong teamwork and interpersonal skills.
• Relentless focus and passion around process improvements (efficiency and automation).
• Experience with digital tools for data management, document review workflows.
• 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.

Summary:

We are seeking a Vice President of Marketing to lead our marketing strategy as we prepare to become a U.S. commercial vaccine company within the next 18 months. This role is critical to shaping our U.S. launch, building the marketing foundation for a first commercial product, and positioning the company for future global expansion.

The ideal candidate brings deep vaccine marketing experience, a strong understanding of the U.S. immunization landscape, and a proven track record of leading pre-launch and launch activities in a highly regulated environment. This leader will balance strategic vision with hands-on execution, building capabilities, teams, and processes appropriate for a first commercial launch. This individual should have demonstrated experience driving commercial demand across target audiences—including healthcare providers, consumers/patients, payers, and public health stakeholders—with a particular emphasis on consumer engagement strategies that build disease awareness and motivate vaccination behavior.

Essential Functions:

U.S. Launch & Commercial Strategy

• Lead the development and execution of the U.S. marketing strategy for our initial vaccine launch, including disease awareness, brand positioning, and go-to-market planning.
• Develop differentiated value propositions grounded in clinical data, public health impact, and real-world evidence.
• Partner closely with the Chief Commercial Officer to align marketing strategy with overall commercial, sales, and market access plans.

Vaccine & Immunization Expertise

• Apply deep understanding of the U.S. vaccine ecosystem, including immunization schedules, CDC/ACIP considerations, public health stakeholders, and provider types.
• Design marketing strategies that address the unique dynamics of vaccine adoption, including site-of-care complexity, and public trust.
• Collaborate with Medical Affairs and Regulatory to ensure compliant, scientifically sound communications.
• Partner with Government Affairs and Policy teams to ensure marketing strategies account for evolving immunization policy, public funding mechanisms, and advocacy stakeholder dynamics.
• Collaborate with HEOR and Market Access to develop evidence-based value narratives and payer-facing materials that support formulary positioning and access.

Brand & Portfolio Marketing

• Establish the company’s commercial brand and narrative as we transition from a development-stage biotech to a commercial organization.
• Lead brand development, messaging, and omnichannel promotional strategy across HCP, payer, and patient audiences.
• Design and execute integrated omnichannel engagement strategies spanning personal promotion, digital channels, and non-personal promotion to optimize customer reach, frequency, and impact across the vaccine adoption journey.
• Develop digital-first engagement models for hard-to-reach HCP segments, including pharmacists and public health practitioners critical in vaccine delivery.
• Develop and execute consumer/patient engagement strategies—including disease awareness campaigns, direct-to-consumer (DTC) advertising, and health literacy initiatives—that drive vaccination demand at the population level.
• Build multi-audience demand generation strategies that create a pull-through effect across HCPs, consumers, payers, employers, and public health decision-makers to maximize vaccine adoption.
• Partner with Patient Advocacy organizations and community health stakeholders to inform patient-centric messaging and overcome barriers to vaccination, including vaccine hesitancy and health equity gaps.
• Develop lifecycle and indication expansion strategies to support future growth and pipeline advancement.

Market Insights & Analytics

• Lead market research, customer insights, and competitive intelligence to inform launch readiness and ongoing optimization.
• Define KPIs and performance metrics to measure marketing effectiveness and launch success.
• Leverage data analytics and AI-powered tools to enhance competitive intelligence, identify prescriber behavior patterns, and inform real-time marketing optimization decisions.

Team, Infrastructure & Capability Building

• Build and lead a high-performing marketing organization, scaling the team and capabilities over time.
• Establish agency partnerships and external vendors to support launch execution. Build and manage a high-performing agency roster with clear scopes of work, performance metrics, and governance structures that drive accountability and cost efficiency.
• Implement marketing processes, governance, and operating models consistent with U.S. commercial and regulatory requirements.
• Implement marketing operations infrastructure including project management systems, digital asset management (DAM), and content supply chain processes designed for scale and speed-to-market.
• Own the marketing budget, ensuring disciplined resource allocation across brand, digital, and promotional investments with clear ROI measurement and launch investment frameworks.

Future Global Expansion

• Design U.S. marketing strategies with future global scalability in mind.
• Partner cross-functionally to support early planning for potential international expansion, including global brand frameworks and knowledge transfer.

Digital Innovation & AI-Enabled Marketing

• Champion the integration of AI and emerging technologies into marketing workflows to improve quality, speed, cost efficiency, and decision-making across the marketing organization.
• Evaluate and deploy AI-powered tools for content creation, personalization, competitive intelligence, and customer engagement—ensuring all applications comply with regulatory and MLR requirements.
• Leverage generative AI to accelerate content development cycles, enable omnichannel personalization at scale, and streamline the Medical-Legal-Regulatory (MLR) review process.
• Establish an AI-informed marketing operations model that uses predictive analytics to optimize targeting, message sequencing, and media mix allocation.
• Identify opportunities to use AI and automation to reduce agency costs, accelerate time-to-market for promotional materials, and improve ROI across marketing investments.
• Partner with IT, Data Science, and Commercial Operations to build a connected, data-driven marketing ecosystem from the ground up.

Requirements: 

• Bachelor’s degree required; advanced degree (MBA, MS, PhD) preferred with 15+ years of progressive marketing experience in biotech or pharmaceuticals.
• Other combinations of education and/or experience may be considered
• Significant experience in vaccine marketing, including U.S. launch experience.
• Demonstrated success leading pre-launch and first-launch marketing efforts.

Preferred Qualifications:

• Experience building a marketing organization in a pre-commercial or first-launch biotech environment.
• Track record of leading omnichannel marketing strategies integrating digital, non-personal, and field-based promotion.
• Experience managing complex agency rosters and marketing vendor ecosystems across creative, media, digital, and analytics functions.
• Familiarity with AI/ML applications in marketing, including content generation, customer segmentation, predictive analytics, and campaign optimization.
• Demonstrated fluency in marketing analytics, including KPI frameworks, attribution modeling, and data-driven optimization.
• Experience with MLR processes and demonstrated ability to partner effectively with Medical and Legal/Regulatory in a compliant promotional environment.
• Strong executive presence with the ability to influence C-suite stakeholders and represent the marketing function on cross-functional leadership teams.
• Proven experience driving commercial demand generation across both HCP and consumer/patient audiences in a regulated healthcare environment, including DTC, disease education, or unbranded awareness campaigns.
• Public health marketing or disease awareness campaign experience preferred

Summary:

Vaxcyte is seeking a strategic and execution-focused Senior Manager, Supply Chain Planner to join our Supply Chain  Planning Team. This role is responsible for leading end-to-end supply planning across clinical and commercial programs, including demand and supply planning, capacity management, inventory strategy, and scenario analysis. The ideal candidate brings deep experience in biotech supply chains, strong systems and analytical capabilities, and a proven ability to translate complex data into actionable plans. This individual will play a critical role in driving cross-functional alignment, scaling planning processes and systems, and ensuring reliable supply to support Vaxcyte’s growth and commercialization objectives.

Essential Functions:

• Lead end-to-end supply planning processes, including demand, supply, capacity, and inventory planning, ensuring alignment with business objectives
• Develop integrated production and material plans using OMP Unison Planning System in collaboration with internal functions, CMOs, and suppliers
• Facilitate monthly demand and supply reviews within the S&OP process to align cross-functional stakeholders and enable informed decision-making
• Continuously improve planning processes, OMP Unison Planning system capabilities, and SOPs to enhance planning accuracy, efficiency, and scalability
• Build and maintain complex planning models, ensuring comprehensive system parameters and master data to support OMP and ERP integration
• Define and execute inventory strategies across raw materials, intermediates, and finished goods to balance service, cost, and expiry risk
• Lead scenario planning and “what-if” analyses to proactively identify risks and opportunities and implement mitigation strategies
• Monitor supply performance across CMOs to enable high-quality product delivery per plan
• Develop, track, and communicate KPIs to provide actionable insights and support data-driven decisions
• Cultivate strong cross-functional and external partnerships to enable effective planning, communication, and execution

Requirements: 

• B.S./B.A. required; advanced degree (MBA, MS, or equivalent) preferred
• 8+ years of progressive supply chain planning experience in biotechnology, pharmaceuticals, or a related regulated industry
• Deep expertise in end-to-end supply planning, including demand, supply, capacity planning, and inventory optimization
• Hands-on experience with advanced planning systems (APS), preferably OMP Unison Planning, including implementation and process design
• Drive exceptional accuracy, precision, and data integrity across all planning activities, with a clear understanding of the substantial financial impact of supply decisions
• Proven experience leading S&OP processes and driving cross-functional alignment
• Strong analytical and data modeling skills; advanced Excel required, experience with planning or visualization tools preferred
• Experience with external manufacturing networks in a GMP environment
• Demonstrated ability to lead scenario planning and risk mitigation to ensure continuity of supply
• Strong leadership and influencing skills, with the ability to align diverse stakeholders and drive execution
• Excellent communication and executive presentation skills
• Highly organized, with the ability to manage multiple priorities in a fast-paced, evolving environment
• Detail-oriented with a continuous improvement mindset and focus on operational excellence

Summary:

The Senior Computer Systems Validation (CSV) Engineer is responsible for leading validation activities for cloud based GxP systems to ensure they meet regulatory, quality, and operational requirements throughout the system lifecycle. The role focuses on traditional Computer System Validation with application of risk-based Computer Software Assurance (CSA) principles where appropriate.

The individual will work closely with IT and Quality teams to validate and maintain GxP systems across their lifecycle. Strong experience validating relational databases, cloud infrastructure, and integrated applications in regulated biotech or pharmaceutical environments is required.

This is a hands-on role requiring authoring and executing validation documents and protocols for GAMP 5 systems.

This is a hybrid role with minimum of 3 days a week onsite at San Carlos, CA location.

Essential Functions:

• Hands-on lead full lifecycle Computer System Validation activities for cloud based GxP systems including databases, and applications.
• Author, update, execute and maintain validation deliverables such as Validation Plans, User Requirements, Functional Specifications, Risk Assessments, Traceability Matrices, IQ, OQ, PQ protocols, and Summary Reports.
• Perform risk assessments to define validation scope, testing strategy, and documentation requirements in alignment with CSA principles.
• Define and execute validation strategies for data platforms and system components, ensuring systems meet defined functional, security, and data integrity requirements
• Assess and validate end to end data flows between upstream source systems and downstream applications to ensure accuracy, completeness, and traceability.
• Evaluate system changes for validation impact and ensure validated systems remain compliant through appropriate testing and documentation.
• Ensure validation activities align with automated build and deployment pipelines, confirming that system releases maintain validated state and appropriate validation evidence is generated.
• Support change control, deviation management, periodic review, and lifecycle management of validated systems.
• Participate in internal audits and regulatory inspections, providing validation documentation and rationale as required.
• Contribute to continuous improvement of validation procedures aligned with evolving CSA guidance and cloud delivery models.

Requirements: 

• Bachelor’s degree in Computer Science, Engineering, Life Sciences, or related field, or equivalent professional experience.
• Minimum 7 years of experience in Computer System Validation within biotech manufacturing and lab data systems. Other combinations of education and/or experience may be considered.
• Must have technical knowledge of IT infrastructure, software engineering, programming, databases and data integrations.
• Experience working in modern system environments utilizing CI/CD pipelines or automated release processes.
• Strong hands-on experience validating GAMP 5 systems for biotech manufacturing.
• Deep understanding of FDA 21 CFR Part 11, Part 210, Part 211, Annex 11, data integrity requirements, and risk-based validation methodologies.
• Strong technical writing skills and ability to create comprehensive validation documentation.
• Ability to communicate validation risks and requirements clearly to IT and Quality stakeholders.

Other combinations of education and/or experience may be considered.

Preferred Qualifications:

• Hands-on experience validating cloud based GxP systems, specifically Azure.
• Familiarity with infrastructure as code frameworks like GitHub, Terraform etc.
• Experience applying CSA principles to custom data applications in GxP cloud.
• Microsoft Azure or similar technical certifications.

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.

Summary:

We are seeking a highly experienced Senior Software Engineer with deep full-stack expertise and a strong DevOps orientation. This individual will play a key role in designing, building, testing, and operating scalable web applications that support critical business functions.

The ideal candidate combines strong frontend and backend development capabilities with a disciplined approach to automation, testing, CI/CD, and production reliability. This role requires technical leadership, architectural judgment, and the ability to drive engineering excellence across the software lifecycle.

Essential Functions:

Full-Stack Application Development

• Architect, design, and implement scalable applications using Next.js and React
• Develop and maintain backend services and GraphQL APIs, including schema design and performance optimization
• Ensure high standards for code quality, security, performance, and maintainability
• Participate in architectural design reviews and technical decision-making

Testing & Quality Engineering

• Lead implementation of comprehensive automated testing strategies, including:
• End-to-end UI testing (e.g., Playwright, Cypress)
• API and integration testing
• Unit and regression testing
• Establish and enforce best practices for test coverage and quality gates
• Improve system stability through proactive quality engineering practices

DevOps & Continuous Delivery

• Design, implement, and optimize CI/CD pipelines using GitHub Actions
• Automate build, test, and deployment workflows across environments
• Improve release reliability, deployment frequency, and rollback strategies
• Contribute to monitoring, logging, and observability improvements
• Support production systems and participate in incident resolution when needed

Technical Leadership

• Mentor engineers and provide guidance on architecture and best practices
• Contribute to engineering standards and documentation
• Drive continuous improvement in development processes and tooling
• Collaborate cross-functionally with Product, Design, and Infrastructure teams

Requirements: 

• Bachelor’s degree in Computer Science, Engineering, or related field (or equivalent experience)
• Minimum 5 years of professional software engineering experience and a minimum of 4 years of experience in modern frontend frameworks, including Next.js and React. Other combinations of education and/or experience may be considered.
• Strong experience designing and implementing GraphQL APIs
• Proven experience in full-stack system architecture and development
• Demonstrated experience implementing automated testing for UI and APIs
• Hands-on experience building and maintaining GitHub Actions CI/CD workflows
• Strong understanding of DevOps principles, continuous delivery, and production system reliability
• Experience working with scalable, production-grade applications
• Excellent communication skills and ability to lead technical initiatives

Preferred Qualifications

• Experience deploying and managing applications in Microsoft Azure
• Experience with Terraform or other Infrastructure-as-Code solutions
• Familiarity with containerization (Docker) and modern deployment patterns
• Experience with monitoring and observability platforms
• Familiarity with AI-assisted development tools such as ChatGPT, Claude, or similar platforms
• Experience integrating AI APIs or intelligent automation into applications
• Strong architectural and systems design capability
• Ownership mindset with accountability for outcomes
• Commitment to automation and operational excellence
• Ability to balance technical rigor with delivery timelines
• Continuous learner who leverages modern tools, including AI-assisted development
• Other combinations of education and/or experience may be considered.

Summary:

Vaxcyte is undergoing a major ERP transformation, moving to SAP S/4HANA to support its rapid growth and upcoming transition to Commercial Operations. The IT SAP Supply Chain Senior Business Systems Analyst (BSA) will play a critical role in bridging Supply Chain and IT, ensuring successful implementation, stabilization, and ongoing optimization of SAP S/4HANA Supply Chain capabilities. This position requires strong functional expertise in SAP Supply Chain functionalities, deep understanding of contract manufacturing processes, and experience in complex ERP implementation projects.

Essential Functions:

• Support the implementation and stabilization of SAP S/4HANA Supply Chain modules in a regulated environment.
• Collaborate with Supply Chain, Manufacturing, Quality, and IT teams to design future-state processes aligned with Vaxcyte's CDMO business model.
• Assist in data mapping, migration, cleansing, and validation during cutover and post-go-live activities.
• In-depth knowledge of SAP S/4HANA systems and integration techniques with third-party planning systems.
• Expertise with agile methodology, global deployments, and data migration planning.
• Experience working in GxP validated and SOX regulated systems.
• Configure and maintain SAP Supply Chain modules including Materials Management (MM), Master Data, Subcontracting & External Processing, Batch Management, and Forecast Consumption & Demand Planning.
• Assist with the integration points with FI (Financial Accounting) & CO (Controlling)
• Support end-to-end planning flows from demand through manufacturing and supply execution.
• Excellent verbal and written communication skills, with the ability to effectively communicate complex technical concepts to non-technical stakeholders.
• Work closely with Supply Chain stakeholders (Planning, Procurement, Finance) to capture requirements.
• Translate business needs into functional specifications for SAP configuration.
• Help develop and document business process flows.
• Support complex planning scenarios where capacity, lead times, and execution are controlled by external CDMO partners.
• Develop and execute test plans for SAP Supply Planning processes.
• Support User Acceptance Testing (UAT) and resolve issues promptly.
• Ensure validation readiness and maintain audit trail expectations in compliance with regulatory requirements.
• Training & Change Management
• Create training materials and deliver sessions for Supply Chain users.
• Provide ongoing support post go-live.
• Ensure compliance with GxP standards and Life Sciences industry requirements.

Requirements: 

• Minimum of 7 years of experience as a BSA with SAP Supply Chain modules.
• Bachelor's degree in Supply Chain, Operations, Information Systems, or related field
• Strong analytical and problem-solving skills, with the ability to independently diagnose and resolve SAP supply chain issues in complex CDMO-based manufacturing environments.
• Experience in identifying and managing project risks, with a proactive approach to mitigation.
• Familiarity with change management principles and techniques to facilitate smooth transitions and adoption of new systems.
• Hands-on experience with SAP S/4HANA Supply Chain (implementation or migration projects preferred) and Fiori applications.
• Proven experience supporting SAP-based contract manufacturing or CDMO operating models.
• Experience developing and mapping business process flows using Visio or similar tool.
• Strong understanding of Supply Chain processes and ERP implementation best practices.
• Excellent communication and stakeholder management skills.
• Solid experience managing SAP master data relevant to supply planning (materials, vendors, sourcing, BOMs).

• Other combinations of education and/or experience may be considered.

Summary:

Vaxcyte has an opportunity for a Project Manager to manage complex, cross‑functional initiatives focused on IT and Finance Systems implementations, ensuring smooth delivery across planning, requirements, system design, testing, deployment, training, and change management. This leader partners closely with finance teams, operations, IT, and vendors to deliver technology solutions that improve data integrity, operational efficiency, and strategic decision‑making. Reporting into the Associate Director of Project Management, the ideal candidate will bring experience managing cross-functional teams, a deep understanding of financial and system implementation workflows, and the ability to drive clarity, alignment, and execution across diverse stakeholder groups.

Essential Functions:

• Support day-to-day project management activities for ERP implementation, with a focus on Finance, Supply Chain, and Data/Analytics workstreams.
• Coordinate and manage recurring meetings, including scheduling, agenda preparation, and documentation of meeting minutes and action items
• Maintain and update key project management artifacts, including the project plan, RAIDD log (Risks, Assumptions, Issues, Dependencies, Decisions), and status tracking tools
• Prepare and update weekly and monthly project status reports and presentation materials for leadership and stakeholder updates
• Monitor progress across assigned workstreams, proactively identifying risks, issues, and dependencies, and escalating as appropriate
• Act as a communication liaison between workstream leads and program leadership to ensure alignment and timely information flow
• Participate in core team and cross-functional meetings, ensuring accurate roll-up of status, risks, and key decisions to program leadership

Requirements: 

• Bachelor’s degree in project management, information technology, or a related field. Master’s degree preferred. Other combinations of education and/or experience may be considered.
• Minimum 5 years of project management experience in IT system implementations, including work with finance applications. Other combinations of education and/or experience may be considered.
• Experience in biotechnology, pharmaceuticals, medical devices, or other regulated scientific environments preferred.
• Experience with change management frameworks.
• Familiarity with GxP validation practices and documentation.
• Proven success leading multiple projects in complex, multi‑stakeholder organizations.
• Experience working with supply chain, finance, and IT teams simultaneously.
• Strong understanding of financial processes (budgeting, GL, AP/AR, procurement, reporting) and laboratory workflows (sample lifecycle, instrument data, QA/QC, data integrity).
• Advanced proficiency in Smartsheet, including; Complex project plan development, Automation workflows, portfolio and executive‑level dashboards
• Demonstrated ability to build dashboards and reporting tools that summarize health, risks, KPIs, and resource status for leadership.
• High level of organization, analytical thinking, resourcefulness, and problem‑solving.
• Ability to thrive in dynamic, high‑growth environments with evolving priorities.
• Excellent verbal and written communication skills, with the ability to engage and influence stakeholders at all levels.

Summary:

The Associate Director, SEC Reporting & Technical Accounting will serve as a key contributor to the company’s external reporting and technical accounting function. Reporting to the Senior Director, Technical Accounting & SEC Reporting, this role will be highly hands-on, owning the preparation and execution of SEC filings and technical accounting analyses while also managing one direct report. 

This role is ideal for a technically strong accounting professional who enjoys operating in the details, partnering cross-functionally, and helping build processes in a growing public biotechnology company. 

Essential Functions:

SEC Reporting (Hands-On Execution) 

• Own the preparation of quarterly and annual SEC filings, including Forms 10-Q, 10-K, and 8-K 
• Prepare and/or review primary financial statements, footnotes, and related disclosures in accordance with U.S. GAAP and SEC requirements 
• Draft and support MD&A disclosures, with emphasis on R&D, G&A, stock-based compensation, and other pre-revenue biotech-specific areas 
• Coordinate the quarterly close-to-reporting process across Accounting, FP&A, Legal, and external auditors 
• Support earnings release tie-outs and disclosure controls 

Technical Accounting 

• Support technical accounting assessments and documentation for complex transactions, including: 
• Collaboration, licensing, and R&D-related arrangements 
• Equity and equity-linked financing transactions 
• Other complex and other non-routine transactions 
• Research new accounting standards and SEC guidance; assess applicability and implementation impact 
• Draft clear, well-supported technical accounting memos and communicate conclusions to stakeholders 
• Strong experience in ASC 842, including the identification, classification, and accounting of lease arrangements, as well as the preparation and review of related disclosures in compliance with U.S. GAAP

People Management 

• Manage and mentor one direct report, providing coaching, review, and development support 
• Review work products to ensure accuracy, quality, and adherence to timelines 
• Foster strong execution discipline and continuous improvement within the reporting function 

Process Improvement & Scaling 

• Help design and enhance scalable SEC reporting and technical accounting processes as the company grows 
• Partner with cross-functional teams to ensure accounting and reporting considerations are incorporated into business decisions 
• Support SOX and internal control documentation related to SEC reporting and technical accounting as applicable 

Requirements: 

Bachelor’s degree in Accounting or related field; CPA strongly preferred with a minimum 10 years of progressive accounting experience, including: Public accounting experience (Big 4 or national firm strongly preferred) and/or direct SEC reporting experience at a public company.  Other combinations of education and/or experience may be considered.

• Strong technical knowledge of U.S. GAAP and SEC reporting requirements
• Excellent written and verbal communication skills
• Highly detail-oriented with strong execution skills
• Comfortable operating in a fast-paced, evolving environment
• Strong ownership mindset with the ability to balance deadlines and quality
• Collaborative, proactive, and solutions-oriented 
• Ability to work onsite 3 days per week required; and more often based on business needs. 

Summary:

Vaxcyte’s IT team is seeking a motivated, forward-thinking Manager, IT Quality & Compliance to support executing and supporting IT Quality, Compliance, and Validation (CSV/CSA) activities across GxP systems. This role partners closely with the Director of IT Quality & Compliance to operationalize the IT QSC (Quality, Security, Compliance) strategy and ensure systems remain compliant, secure, and audit-ready. This is a hands-on role requiring expertise in IT system validation, auditing, vendor management, and compliance operations within a regulated GxP environment.

Essential Functions:

IT Validation & CSV/CSA Execution

• Execute Computer Software Assurance (CSA) and Computer System Validation (CSV) activities for GxP systems.
• Support validation lifecycle activities (planning, testing, documentation, release, and change management).
• Provide ITQA oversight for implementation of GxP systems.
• Support data migration validation (reconciliation, traceability, and verification).

Audit & Inspection Readiness

• Perform internal IT CSV audits to ensure regulatory and procedural compliance.
• Support and execute GxP vendor audits.
• Prepare audit documentation, evidence packages, and formal audit reports.
• Support regulatory inspections and inspection readiness activities.

Vendor Management & Oversight

• Conduct vendor qualification and periodic vendor audits.
• Support vendor risk assessments and compliance monitoring.
• Ensure vendors meet GxP, data integrity, and security requirements.

Periodic Reviews & Compliance Monitoring

• Perform periodic reviews of GxP systems to maintain validated state.
• Identify compliance gaps and drive remediation.
• Support continuous audit and compliance monitoring programs.

Investigations & CAPA Management

• Support IT investigations (deviations, incidents, compliance gaps).
• Author and manage CAPAs, ensuring timely closure and effectiveness.
• Partner cross-functionally to implement corrective and preventive actions.

Documentation & SOP Development

• Author and maintain IT and QA SOPs, policies, and work instructions.
• Ensure alignment with GxP and 21 CFR Part 11 requirements.
• Support continuous improvement of documentation and processes.

Data Integrity, Cybersecurity & Infrastructure Alignment

• Support implementation of data integrity controls (ALCOA+).
• Partner with IT Security to align compliance with cybersecurity controls (access, logging, monitoring).
• Ensure infrastructure supporting GxP systems is maintained in a secure and compliant state (patching, backup, recovery).
• Identify and escalate risks related to data integrity, cybersecurity, and infrastructure.

Training & Cross-Functional Collaboration

• Support IT Quality & Compliance training initiatives.
• Collaborate across IT, Security, Quality, and business teams.
• Promote a culture of compliance, quality, and audit readiness.

Requirements:

• Bachelor’s degree in IT, Quality, Life Sciences, or related field and minimum 5 years of experience in IT Quality, CSV/CSA, or compliance in a GxP environment. Other combinations of education and/or experience may be considered.
• Hands-on experience with:
  • IT system validation (CSV/CSA)
  • Internal and vendor audits
  • Periodic reviews of GxP systems
  • Vendor management and oversight
  • Data migration validation
• Experience supporting or working with laboratory (GxP lab) and manufacturing systems (e.g., MES, LIMS, lab instruments)
• Experience with Veeva, ERP systems, or regulated SaaS platforms
• Experience supporting or implementing GxP systems from a QA perspective
• Strong knowledge of GxP, 21 CFR Part 11, and data integrity principles
• Experience authoring SOPs, validation documentation, CAPAs, and investigations

Preferred:

• Experience in life sciences or biotech environments.
• Experience writing and presenting audit reports and familiarity with risk management frameworks.
• Exposure to QSC (Quality, Security, Compliance) integration and knowledge of data governance and data integrity practices.
• Working knowledge of cybersecurity (access control, data protection, incident response).
• Exposure to IT security and infrastructure controls (patching, system hardening).
• Experience using AI tools for research, analysis, and process optimization.

Summary:

This is an exciting opportunity to lead procurement support for clinical development programs, serving as a strategic business partner to the Clinical Operations Department, while maintaining the ability to flex across enterprise-wide procurement priorities as business needs evolve.

This role sits within the centralized Procurement function in Finance and serves as the primary procurement business partner to the Clinical organization. The Senior Manager, Indirect Procurement - Clinical will lead and support end-to-end procurement activities for clinical trials—from study start-up through closeout—while also flexing across other indirect spend categories to support broader enterprise needs. This role partners closely with Clinical Operations, Finance, and Legal to ensure timely, compliant, and cost-effective execution of vendor engagements.  Procurement owns activities including, but not limited to, the requisition to PO lifecycle, vendor selection support, contracting coordination, spend visibility/controls.

Essential Functions:

• Serve as the primary procurement business partner to Clinical stakeholders, providing guidance and influencing vendor strategy, budgeting, and procurement processes.
• Own and manage the end-to-end requisition-to-purchase order process, ensuring compliance with procurement policies and timely processing of purchasing requests.
• Lead the request for proposal process including bid comparison, bid review meetings, recommendation on selection and awarding the service.
• Provide procurement support across additional indirect spend categories (e.g., professional services, G&A, IT) as business needs evolve.
• Partner with Finance to support budgeting, forecasting, accruals, and spend tracking for clinical programs.
• Drive standardization and continuous improvement of procurement processes, templates, and workflows in partnership with Finance and Procurement leadership.
• Support contract negotiation activities in partnership with Clinical Operations and Legal, contributing procurement expertise to ensure appropriate terms, risk mitigation, and alignment with company policies, while ensuring purchase order readiness and alignment with procurement processes prior to contract execution.
• Manage multiple concurrent procurement activities across clinical programs and other categories in a fast-paced, evolving environment.

Requirements: 

Bachelor’s Degree in Business Administration or related field, with a minimum of 8+ years of procurement, sourcing, or vendor management experience, including experience supporting clinical trials or clinical services in a biopharmaceutical or CRO environment preferred. Other combinations of education and/or experience may be considered.

• Experience supporting Phase I–III clinical trials, including large, multi-site studies with significant patient enrollment.
• Must possess strong analytical ability, and solid business acumen including an understanding of business operations in a fast-paced environment.
• Ability to work independently, prioritize work, and handle simultaneous assignments under tight deadlines.
• Experience with procurement and financial systems (e.g., Netsuite, SAP, Coupa, Ariba, Oracle) preferred
• Advanced knowledge of Excel, PowerPoint and Word are required.
• Demonstrated ability to work collaboratively across organizations and utilize resources effectively.
• Excellent verbal and written communication skills.
• Ability to work in the HQ office 3-5 days a week

Summary:

Vaxcyte’s Summer Internship program offers students with an opportunity to gain valuable work experience that complements their college curriculum with relevant hands-on work that can shape their future career pathing and interests. 

As an Accounting Intern for Vaxcyte, you will work on a project as outlined below:

• Provide support for financial analysis and accounting activities, including variance analysis, manufacturing accounting, SOX compliance, and preparation of financial statements.
• Conduct research and benchmarking on finance and accounting tools, including AI-enabled solutions, to identify opportunities for process improvement, automation, and enhanced reporting.
• Assist with maintaining and updating financial documentation, including process flows, Standard Operating Procedures (SOPs), training materials, and internal controls documentation.
• Leverage AI an advanced Excel tools to improve data analysis, reporting efficiency, and accuracy while adhering to company policies and controls.

The Intern will learn and practice:

• Core accounting and finance processes in a regulated environment to enhance their skills and knowledge.
• Apply AI tools responsibly to improve efficiency and decision-making.
• Effective communication of financial insights to stakeholders across the organization.

Program Details:

The Internship will begin in June and will be around 10 weeks (8 hours per day) in duration at our San Carlos, California location.

Requirements: 

• Must be pursuing a Bachelor’s Degree (enrolled student with at least 1 year at university completed) with a focus on Accounting, Finance, Business Administration, or related field.
• Proficiency in Microsoft Office.
• Strong attention to detail and work quality.
• Demonstrates collaboration and teamwork.
• Enthusiastic-Shows curiosity and is eager to learn.
• Dedicated.

Summary:

The Development organization is comprised of four Process teams: Protein, Polysaccharide, Conjugate Drug Substance (Conjugation), and Drug Product. These Process Development teams are supported by Analytical Development and Formulation Development teams. Vaxcyte is seeking an Associate Engineer II with experience or strong foundational knowledge in vaccine or biologics process development and manufacturing to join the Polysaccharide Clinical Manufacturing/Process Development team.

The candidate will provide technical support for manufacturing activities in collaboration with CDMO partners, while also contributing to process development and process validation efforts. The position requires laboratory presence (>50%) and the ability to independently execute and document experiments, analyze data, and communicate results through technical reports and presentations. The successful candidate will collaborate cross-functionally and may interface with external CDMO partners to support manufacturing campaigns and process transfers.

Essential Functions:

• Provide remote manufacturing (MFG) oversight to support batch execution, ensuring adherence to process parameters and GMP requirements
• Participate in deviation investigations, root cause analysis, and implementation of corrective and preventive actions (CAPAs)
• Provide technical support for MFG and process development through data analysis, MFG document reviews, and supporting lab scale studies
• Perform in-process sample testing to support monitoring of MFG process performance and understanding
• Manage sample inventory, including tracking, storage, and organization of manufacturing samples
• Maintain accurate and timely documentation in electronic lab notebook (ELN) systems
• Analyze manufacturing and experimental data using statistical tools (e.g., JMP) and summarize findings in technical reports
• Collaborate with cross-functional teams including Process Development, Manufacturing, Analytical Development, and Quality
• Prepare and present technical data to internal stakeholders and support interactions with CDMO partners

Requirements: 

• BS in Chemical Engineering, Biochemistry, or a related discipline, with minimum 2 years of relevant industry experience. MS without experience; or equivalent work experience.
• Experience or exposure to GMP manufacturing environments and process development activities
• Hands-on experience with in-process analytical techniques, including colorimetric and enzymatic assays
• Familiarity with upstream and downstream processing technologies, such as fermentation, UF/DF, depth filtration, and chromatography
• Experience supporting technology transfer, scale-up, or CDMO-based manufacturing is preferred
• Understanding of deviation investigations and root cause analysis methodologies
• Familiarity with statistical analysis tools (e.g., JMP) is preferred
• Experience using electronic lab notebook (ELN) systems is a plus
• Strong technical writing, data analysis, and communication skills

Summary:

We are seeking a highly motivated and detail-oriented Senior Associate Scientist (Contract) to join our Polysaccharide team. Primary responsibility for the incumbent will be to support analytical testing and characterization of polysaccharide-based drug candidates. This individual will execute and optimize a variety of biochemical and chromatographic assays, contribute to method development initiatives, and ensure high-quality data generation in support of research and development programs.  

This role requires strong hands-on experience in HPLC-based techniques, biochemical assays, and analytical software platforms, along with a commitment to data integrity, documentation excellence, and cross-functional collaboration.

Essential Functions: 

Analytical Testing & Characterization

• Perform in-house assays for polysaccharide manufacturing, including in-process testing, process development and process characterization study sample analysis, including:
• HPLC-based assays (e.g., HPLC-RI, HPAEC-PAD, etc.)
• Spectrophotometric-based assays (e.g., UV/Vis, Lowry, PicoGreen, Anthrone, etc.)
• Enzyme- and/or Immuno assays (e.g., ELISA, MSD platforms)
• Nephelometry (e.g. Turbidity analysis)
• Metabolite Analysis (e.g. sugars)
• LC-MS-based assay
• Prepare samples, reagents, standards, and controls according to established protocols.
• Troubleshoot instrumentation and assay performance issues to ensure reliable data output.

Method Development & Optimization

• Assist in developing, qualifying, and optimizing analytical methods for sample preparation, testing, and characterization.
• Support method transfer, robustness evaluation, and documentation updates.
• Proactively recommend improvements to increase assay sensitivity, reproducibility, and throughput.

Data Analysis & Reporting

• Utilize data analysis software platforms such as Empower and Chromeleon for HPLC data acquisition and analysis, and SoftMax Pro for MSD and spectrophotometric assay data analysis.
• Analyze, interpret, and summarize experimental data clearly and concisely.
• Prepare technical summaries and present findings to cross-functional teams (e.g., R&D, CMC, Quality).

Compliance & Documentation

• Maintain meticulous laboratory notebooks and electronic records in compliance with internal SOPs and laboratory standards.
• Ensure data integrity and adherence to applicable regulatory guidelines (e.g., GLP/GMP where applicable).
• Participate in audits, documentation reviews, and quality initiatives as needed.

Collaboration & Continuous Learning

• Collaborate effectively with scientists across disciplines to support program milestones.
• Demonstrate eagerness to learn new analytical techniques and scientific concepts.
• Integrate best laboratory practices and contribute to a culture of operational excellence.

Requirements:

• MSc in Chemistry/Biochemistry, Biotechnology, or similar degree with a minimum of 3 years of relevant industry experience, or BSc with a minimum of 5 years of relevant industry experience.
• Hands-on experience with HPLC systems and carbohydrate or polysaccharide analysis.
• Experience with HPAEC-PAD is preferred.
• Experience with LC-MS/MS is a plus.
• Experience with Empower and/or Chromeleon software.
• Familiarity with biochemical assays (ELISA, colorimetric, fluorescence-based assays).
• Experience working with polysaccharides, biologics, or complex drug substances.
• Experience in in-process monitoring and testing for process-related impurities.
• Knowledge of regulatory expectations for analytical documentation.
• Experience supporting CMC, process development, or analytical development programs.
• Strong organizational skills and attention to detail.
• Excellent written and verbal communication skills.
• Strong analytical and problem-solving skills.
• High attention to data accuracy and reproducibility.
• Ability to manage multiple priorities in a fast-paced environment.
• Collaborative team player with proactive communication style.
• Continuous improvement mindset.

Reports to: Senior Scientist, Polysaccharide Analytical Development

Location: San Carlos, CA

Expected Contract Length:
12months

Hourly Range: $56.00/hr. - $62.00/hr.

Summary:

Vaxcyte is seeking an Associate Scientist II (contract), Research, to support the research and development of a novel bacterial polysaccharide conjugate vaccine. Specifically, this role will contribute to the setup, synthesis, purification, and analytical characterization of chemically modified polysaccharides and polysaccharide-protein conjugates. 

The ideal candidate will have an excellent understanding of conjugation process development, analytical chemistry principles, and substantial hands-on laboratory experience. The successful candidate will be expected to independently optimize and troubleshoot upstream and downstream conjugation processing procedures with minimal guidance. The candidate will also contribute across a range of related areas, including analytical development, stability studies, and process optimization initiatives. Responsibilities will also include record management, presenting data at group meetings, and contributing to the authorship of laboratory protocols and development reports.

Essential Functions:

• Set up, optimize, and troubleshoot multi-step syntheses of protein-polysaccharide conjugates using click-chemistry and other related chemistries.
• Purify polysaccharides and conjugates using a variety of methods, including dialysis, FPLC chromatography, and tangential flow filtration (TFF).

• Characterize protein/polysaccharide/conjugates using different analytical methods, including SDS-PAGE gel, Western blotting, ELISA, HPLC, SEC-MALS, colorimetric and dynamic binding assays, et al.
• Apply Design of Experiments (DoE) principles; design, execute, and interpret statistically modeled experiments using DoE software.
• Proactively contribute scientific ideas, experimental strategies, and process improvements.
• Independently review and summarize relevant scientific literature to inform experimental design.
• Maintain highly organized records and Benchling entries to enable optimization and assessment of reproducibility.
• Analyze, interpret, and clearly communicate experimental data, including identifying trends, anomalies, and recommending next steps.
• Execute established protocols with limited oversight, demonstrating strong technical proficiency.
• Support team in routine laboratory activities and instrument maintenance.

Requirements: 

• BS. in Chemistry, Biochemistry, or related field or a related discipline, with minimum 2 years of relevant industry experience. MS without experience; or equivalent work experience.
• Strong understanding of underlying scientific concepts, process development, and analytical assay principles.
• Extensive hands-on experience in purification methods such as diafiltration, depth filters, and TFF (required).
• Prior hands-on experience in the conjugation process development is highly desirable.
• Proficiency with common protein/polysaccharide/conjugates analytical techniques, including SDS-PAGE, Western blotting, ELISA, HPLC, and SEC-MALS, is required
• Proven track record of developing scalable processes suitable for the pharma/Biotech industry.
• Experience with vaccines, carbohydrates, or protein is a plus.
• Attention to detail and excellent organizational skills.
• Ability to contribute to the overall lab management, including organization of vendors, service contracts, and equipment maintenance.
• Demonstrated success working in a cross-functional team environment.
• Strong interpersonal skills, with excellent written and verbal communication skills.

Summary:

The Senior Manager for Drug Substance (DS) Commercialization has the responsibility for launch readiness and commercial supply of the conjugate drug substance. The conjugate product strategy will transition from the Process Development organization to Manufacturing Science and Technology (MSAT) during late-stage product development.  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 process to internal stakeholders, relevant CMOs, and to regulatory agencies. The incumbent will be highly skilled in written communication, especially in regard to authoring Health Authority submissions (IND/BLA). The role will also require the ability to interact effectively with people of diverse backgrounds and perspectives. The incumbent will also work with the organization to ensure on-time execution and appropriate planning for commercial lifecycle management.

This position will be reporting into the Director for Global DS Commercialization, Conjugation. The Sr. Manager will collaborate on overall program strategy, with primary responsibility and accountability for the drug substance strategy. 

Manufacturing Science and Technology (MSAT) is responsible for successfully and seamlessly transitioning the vaccine process from Process Development to Commercial, developing and executing technical launch and commercialization strategy, continuously improving process robustness through to end of lifecycle, and ensuring best possible patient outcomes while creating value for the enterprise. As part of the Commercial Manufacturing and Supply Chain organization, MSAT will lead the technical and process support for end-to-end commercial manufacturing, including Polysaccharides, Carrier Proteins, Conjugation across all Drug Substances (DS). The range of activities will include DS technology transfer support, process characterization experiments in support of validation, process improvement, evaluation of novel process technologies, and investigation of process related manufacturing issues, ensuring continuous improvement in process robustness throughout the product life cycle etc. 

Essential Functions:

• DS Commercialization – Provide strategic and scientific leadership for polysaccharide to protein conjugation with internal and external stakeholders and ensure successful execution of launch plans and post-launch commercial activities.
• Organization – Build a strong and highly-skilled team for the global network with special focus on manufacturing processes. Support resourcing recommendations on staffing requirements to meet organizational goals.
• Process robustness – Continuously improve process understanding and process robustness by putting systems in place to monitor, trend, and optimize operations.
• Interface - Collaboration with cross-functional teams across the network, including Regulatory, CMC, Quality, Supply Chain, Procurement, and Process Engineering, to drive the successful development and commercial launch of the conjugate drug substance. Provides technical representation into initial technology transfer, product launch, product lifecycle, to the end of life/product retirement and for defining/developing the next generation of production technologies.
• Tech-transfer new technologies - Ensure robust processes exist to support technical transfers and integration of new technologies.
• Support technical services - Support of our internal and external manufacturing network, including materials management and data analytics.
• Process validation and comparability - Provide support for the execution of process validation and process comparability activities.
• Regulatory - Engage In technical reviewing and authoring of regulatory filings and responding to questions received from health authorities. Effectively communicate the scientific and commercial rationale for DS processes to the Boards of Health for regulatory submissions for commercialization.
• Communicate - Effectively and efficiently communicate process performance to key stakeholders (internal-facing and external-facing). Connect and build strong working relationships with others, demonstrating strong emotional intelligence and an ability to communicate clearly and persuasively.
• Executing for Results - Set clear and challenging goals and take accountability for driving results. Comfortable with ambiguity and uncertainty; the ability to adapt nimbly and lead others through complex situations.
• Leadership - Contribute with the DS Commercialization lead and as member of the Global Manufacturing Operations, with an aim to ensure effective and efficient delivery of our life-enhancing therapies to our patients. Delegate effectively, celebrate diversity within the team, and manage team performance with a strong focus on colleague development.
• Travel - 10-30% travel required.

Requirements: 

• Degree(s) in Chemical or Biochemical Engineering, Chemistry, Biochemistry, or related discipline with a minimum of 5+ years of relevant experience for Ph.D., 8+ years for M.S./M.A., or 12+ years for B.S./B.A.
• Experience in development, tech transfer, scale-up or production of polysaccharide/protein conjugate vaccines
• Experience in MSAT or Process Development in supervisory and/or matrixed team roles.
• Able to leverage deep technical knowledge in a collaborative manner to achieve collective goals.
• Excellent organization, problem solving and strategic planning skills.
• Highly skilled in both verbal and written communication, especially in regards to authoring Health Authority submissions (IND/BLA) with the ability to interact effectively with people of diverse backgrounds and perspectives.
• Proactively recognizes needs and potential challenges, and independently identifies and implements effective steps and solutions.
• The ability to seek and analyze data from a variety of sources to support decisions and to align others with the organization's overall strategy.
• An entrepreneurial and creative approach to developing new, innovative ideas that will stretch the organization and push the boundaries within the industry.

Summary:

Vaxcyte is seeking a talented and experienced Engineer I/II, to join the Upstream Process Development group within the Protein Development and CMC team. This is an exciting opportunity to join an outstanding team pursuing bacterial fermentation development at Vaxcyte.

The successful candidate will have the following skills and qualities:

• Hands-on experience operating and maintaining bioreactors, including Ambr® 250, at laboratory scale.
• Experience with pilot scale fermentation and recovery equipment is a plus.
• Skillful in analyzing and presenting data for process improvements, troubleshooting, and optimization.
• An exceptional team player who works seamlessly with others, speaks up, and remains focused on achieving the best results to achieve company goals.
• Strong organizational and planning skills.

Essential Functions:

• Lead operational activities related to bioreactor set-up, monitoring, harvest, and maintenance.
• Develop, test, and implement recipe scripting for fed-batch fermentation feeding controls.
• Provide engineering support for design, implementation, and qualification of scale-down models.
• Author SOPs (standard operating procedure), process flow diagrams and batch records.
• Analyze and present fermentation data at internal project meetings. Participate in upstream database management and documentation in electronic notebooks.

Requirements: 

• BS in Chemical Engineering or a related discipline with 8+ years, MS with 4+ years, or PhD with 0-2 years of relevant Pharma/Biotech industry experience.
• Hands-on experience with fermentation and/or primary recovery unit operations.
  • Good understanding in fundamentals of bioreactor design, operation and controls.
  • Strong knowledge of aseptic techniques
  • Mechanical and technical knowledge of primary recovery unit operations such as homogenization, centrifugation, and depth filtration, is a plus
  • Understanding of fermentation scale up and development of scale down models
• Familiarity with DoE (Design of Experiments) principles and software.
• Familiarity with regulatory requirements of biotherapeutics. Late-stage process characterization experience is a plus.

Summary:

This is an exciting opportunity to serve as a strategic finance business partner to Vaxcyte’s R&D organization, with a focus on clinical studies. The role will support Clinical Operations and the Immunoassay and Non-Clinical teams, with responsibility for clinical trial and serology financial oversight, while flexing to support broader R&D as business needs evolve. This individual will partner closely with Clinical Operations and Serology on planning, forecasting, accruals, financial reporting, and decision support across multiple development programs.

Essential Functions:

• Lead and provide strategic oversight for clinical outsourcing, partnering with Clinical Operations, Clinical Development, Finance, and Legal to assess the best fit for Vaxcyte’s pipeline and outsourced scope of work.
• Lead the financial and commercial aspects of the RFP process, vendor selection, and budget management for the Clinical organization
• Manage clinical trials financial updates and support the annual planning process, including analysis of actuals versus forecast, risk and opportunity assessment, and clear reporting to Finance and business leadership
• Support contract and budget negotiations, bid evaluations, and vendor recommendations across a range of clinical service providers, including CROs, central laboratories, study supply vendors, oversight vendors, and patient recruitment partners
• Assist functional and department managers in the procurement process, including reviewing and validating invoices, supporting financial controls, and ensuring accurate visibility into vendor spend
• Partner with Clinical Operations, Clinical Development, Accounting, Procurement, Legal, and other stakeholders to align operational assumptions, vendor spend, timelines, and financial plans
• Manage the clinical accrual process, including review of applicable CRO and other clinical ancillary vendor contracts. Collaborate with key stakeholders to gather and analyze relevant information to ensure all accruals are complete, accurately computed, documented, and recorded
• Support program and project teams in identifying cost-saving opportunities, improving efficiencies, and optimizing the financial performance of clinical programs
• Implement new forecasting and analytics tools, enabling standardized metrics, scenario modeling, portfolio insights, greater transparency, and strategic decision support with an initial focus on clinical trials and serology
• Understand and maintain Sarbanes-Oxley (“SOX”) documentation and requirements for assigned area
• Lead other ad hoc analysis to support business partnering as needs evolve

Team Leadership

• This is an individual contributor role that requires collaboration with Procurement, Clinical Operations, and R&D leadership, as well as the ability to influence stakeholders without direct authority
• Demonstrate leadership through proactive problem-solving, strong business partnership, and a continuous improvement mindset across financial planning, forecasting, and decision support activities

Requirements: 

BA/BS in life sciences, technical, business, or a related field, advanced degree preferred with a minimum 12 years of progressive experience in biotech/pharma, including meaningful finance, FP&A, clinical outsourcing, CRO, or related business-partnering experience. Other combinations of education and/or experience may be considered

• Experience supporting Phase I-III clinical trials, including budgeting, forecasting, accruals, outsourcing, and vendor spend management, is required. Vaccines experience preferred
• Must possess strong analytical ability, a continuous learning mindset, and solid business acumen, including an understanding of business operations in a fast-paced environment
• Strong negotiations, financial modeling, forecasting, and scenario-analysis skills, with the ability to translate complex operational inputs into clear financial insights and actionable recommendations
• Prior experience with ERP systems, financial planning tools, BI/analytics platforms, and AI-enabled productivity tools preferred
• Knowledge of US GAAP, financial reporting, accounting controls, and analytics
• Strong relationship-building skills with internal and external stakeholders
• Exceptional project management skills, including the ability to prioritize, balance and manage multiple efforts with strong results/goal orientation
• Excellent organizational, multi-tasking, listening, facilitation, and communication skills
• Demonstrated ability to work collaboratively across organizations and utilize resources effectively
• Outstanding written, verbal, and presentation skills, with the ability to convey strategies and results to a diverse audience
• Ability to operate effectively in a dynamic, fast-paced environment and flex across functions as business needs evolve

Summary:

Vaxcyte has an exciting opportunity for an energetic and talented individual to join our Analytical Development team. The Scientist I, Analytical Development, is responsible for executing analytical testing and contributing to analytical method development activities for biologics/vaccine development programs. 

This role performs routine and non-routine analytical assays using modern analytical techniques, supports method optimization and troubleshooting efforts, and contributes to continuous improvement initiatives with moderate supervision while partnering effectively with cross-functional teams. The position requires demonstrated hands-on laboratory experience, strong technical execution, and problem-solving skills, with the ability to independently plan and execute assigned work, analyze and interpret data, and escalate and/or drive investigations as needed. This role authors and maintains clear technical documentation, including method protocols, method development summaries, and SOPs, and communicates experimental results and conclusions to internal stakeholders.

Essential Functions:

Method Development & Troubleshooting

• Contribute to method development, optimization, and qualification/validation readiness activities.
• Design and execute experiments to evaluate critical method parameters and define appropriate system suitability and control strategies.
• Troubleshoot assay and instrument performance issues using a structured approach; interpret data to identify likely root causes, implement corrective actions, and document outcomes and recommendations.
• Support and/or execute method transfer activities, including protocol preparation, training support, execution at receiving labs, and resolution of transfer issues.
• Author and revise analytical methods, SOPs, protocols, and technical reports; ensure clear documentation of experimental rationale, results, and conclusions for internal review and stakeholder communication.

Team Collaboration

• Partner effectively with cross-functional teams to define analytical plans, meet project timelines, and deliver high-quality outputs.
• Communicate experimental progress, data interpretation, and emerging risks clearly; propose mitigation plans and align next steps with stakeholders.
• Contribute to a compliant, safety-focused, and scientifically rigorous lab culture, model good documentation practices and data integrity expectations.

Analytical Testing & Data Generation

• Perform 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/biophysical techniques).
• Execute assays in accordance with approved methods, SOPs, and applicable quality standards (GLP/GMP as applicable); identify and troubleshoot common issues.
• Perform data processing and interpretation; summarize results, trends, and potential risks, and escalate complex findings for review and decision-making.
• Maintain accurate, timely documentation in laboratory notebooks or electronic systems; contribute to clear technical communications to project and cross-functional stakeholders.

Laboratory Operations & Instrumentation

• Coordinate routine instrument maintenance and service activities; interface with vendors as needed and support timely issue resolution.
• Ensure laboratory organization, cleanliness, and compliant material labeling/storage practices.
• Manage inventory of reagents, standards, and consumables; initiate procurement, track critical supplies, and support forecasting to avoid stockouts.

Safety & Compliance

• Follow all Environmental Health & Safety (EHS) policies and laboratory safety practices.
• Handle chemicals and biological materials safely and in compliance with regulatory requirements.
• Ensure proper waste disposal and adherence to hazardous material handling procedures.
• Support audit and inspection readiness activities where applicable.

Requirements: 

PhD, MS or Bachelor’s degree in Chemistry, Biochemistry, Biology, Pharmaceutical Sciences, or a related scientific discipline. PhD with 1-2 years; MS with 5+ years; BS with 8+ years of relevant industry experience in analytical development, QC, or related field. Other combinations of education and/or experience may be considered.

• Strong hands-on experience with multiple analytical techniques, such as UV-Vis, HPLC, CE, SDS-PAGE, icIEF, Liquid chromatography, Mass Spectrometry, enzyme kinetics, colorimetric and fluorescent plate-based assays, ELISA, Western Blot, and PCR.
• Experience independently driving method development or optimization activities preferred.
• Strong knowledge of analytical chemistry/biochemistry principles with demonstrated application to assay development and control strategies.
• Proven ability to independently troubleshoot non-routine assay and instrument issues using structured root-cause analysis and data-driven decision making.
• Proficient in analytical software, data processing workflows, and statistical tools.
• Strong scientific judgment and attention to detail consistently produces high-quality, inspection-ready documentation.
• Ability to independently plan and prioritize work, manage multiple projects, and meet timelines with minimal supervision.
• Clear and effective written and verbal communication; able to summarize complex data, present recommendations, and collaborate across functions.

Summary:

Vaxcyte is seeking a Senior Director, Launch Lead, VAX-31, to lead strategic planning and execution of the company’s first launch of VAX-31. This role will coordinate cross-functional activities from late-stage development through market entry, ensuring readiness across supply chain, regulatory, medical affairs, commercial operations, communications, and other functions. The position will partner with senior leadership to define launch strategies, manage timelines, mitigate risks, and drive alignment across internal and external stakeholders to deliver successful product introductions globally.

Essential Functions:

• Drive cross functional launch delivery of VAX-31 and oversee integrated launch plans.
• Ensure alignment with corporate objectives and market requirements.
• Develop and maintain comprehensive launch readiness frameworks, including working with supply chain, manufacturing scale-up, regulatory approvals, labelling, distribution, and commercial execution.
• Partner with Commercial, Medical Affairs, Regulatory, Quality, Manufacturing, Finance, Market Access, and Scientific Affairs teams to ensure seamless coordination and timely decision-making.
• Facilitate cross-functional launch meetings, track critical milestones, and proactively identify risks and contingency plans.
• Drive post-launch performance tracking and lessons learned to inform future launches.
• Champion best practices in pharmaceutical launch project management, including governance models, risk registers, and stakeholder engagement strategies.

Requirements: 

• BA/BS in life sciences, engineering, or business; advanced degree preferred.
• At least 15 years in pharmaceutical or biotechnology industry, with at least 5 years in launch related project management or product marketing/management; vaccine launch experience strongly preferred.
• Ensure adherence to project scope, budget, and schedule; ensure the alignment of the project to corporate strategic direction, resource allocation, and management decision-making.
• Facilitate team meetings, cross-functional communication, and decision-making; ensure alignment with internal and external stakeholders, program and project teams and functional area partners.
• Support continuous improvement efforts in Project Management practices at Vaxcyte.
• Proven track record of leading successful product launches in multiple markets. Expertise in cross-functional leadership, strategic planning, and risk management for complex launches.
• Strong understanding of regulatory pathways, supply chain logistics, and market access considerations.
• Thorough understanding of product development activities in biotech/drug/vaccine development, including key interdependencies, and knowledge of proven development strategies and tactics.
• Demonstrated strong organizational and strategic leadership skills.
• Demonstrated aptitude for successfully managing multiple projects, of varying complexity, within the specified guidelines, timeframes, and budgets.
• Self-starter with the ability to work independently, deal with ambiguity, and execute.
• Expert planning and tracking skills, well-organized, focused on results, capable of managing multiple projects with respect to priorities and self-management.
• Proven influence management and communication skills, at all levels of the organization.
• Expert knowledge of MS Word, Excel, PowerPoint, Visio, and Project.
• Excellent written and oral communication skills.
• Other combinations of education and/or experience may be considered.

Summary:

Vaxcyte is seeking a Manager, Quality Assurance, Compliance who is responsible for providing day-to-day operational oversight governance and strategic oversight of key Quality System processes, with a primary focus on leading Change Control governance and deviation/investigation oversight review board leadership. This role insures consistent, risk-based decision making, inspection readiness, and cross-functional accountability across quality systems. The Manager acts as an operational backbone a governance leader for cross-functional quality processes, proactively identifying systemic risks, ensuring procedural compliance, driving performance through KPIs, and presenting quality system health and trends through Management Review.

Essential Functions:

• Change Control Governance & Board Leadership
  • Lead and coordinate the Change Control Review Board (CCRB), including agenda development, facilitation, quorum confirmation, and documentation of decisions.
  • Perform pre-CCRB QA review of Change Requests to ensure completeness, clarity, and appropriate risk classification prior to board review.
  • Verify alignment of Change Requests with applicable SOPs, including confirmation of CCRB-required versus discretionary changes.
  • Provide QA authority on change classification, risk assessment, impact evaluation, and implementation strategy.
  • Own CCRB performance metrics, including cycle time, risk categorization trends, backlog, and recurring impact areas. Present trends and risk signals to senior leadership and during Management Review.
• Deviation and Investigation Governance
  • Lead or co-lead Deviation Review Boards to ensure consistent, risk-based decision making.
  • Ensure appropriate classification (minor, major, critical) and scientifically sound investigations.
  • Evaluate adequacy of root cause analyses (e.g., 5-Why, Fishbone).
  • Ensure linkage between deviations, CAPA, and change controls to prevent recurrence and address systemic risk.
• Quality Metrics and Management Review
  • Own development, maintenance, and reporting of Quality System KPIs related to Change Control, Deviations, Investigations, and CAPA.
  • Perform routine trend analysis and signal detection to identify emerging compliance risks.
  • Prepare and present Quality System performance data during Management Review.
• Inspection Readiness and Regulatory Support
  • Serve as Subject Matter Expert (SME) for Change Control and Deviation processes during regulatory inspections and audits.
  • Support preparation of audit responses and ensure timely and compliant closure of observations.
  • Maintain processes in a continuous state of inspection readiness.

Requirements: 

• Bachelor’s degree in Life Sciences or a related field.
• 5+ years of experience in Quality Assurance within the pharmaceutical, biotechnology, or medical device industry. Other combinations of education and/or experience may be considered.
• Experience leading cross-functional governance boards strongly preferred.
• Strong understanding of ICH Q10, risk management principles, and inspection expectations.
• Experience with electronic Quality Management Systems (eQMS) strongly preferred.
• In-depth knowledge of cGMP regulations.
• Excellent organizational skills, attention to detail, and ability to manage multiple priorities.
• Strong interpersonal and communication skills to work effectively across functions and with external partners.

Summary:

Vaxcyte is looking for an energetic and talented individual to join our Drug Product Development team. The candidate must have knowledge of and practical experience in analyzing and characterizing biomolecules (proteins, polysaccharide conjugates, vaccines) using a variety of methods, especially immunoassays and multiplexed immunoassay formats. Experience in analyzing vaccine and adjuvant-containing formulations is a plus.

In addition, Vaxcyte is looking for an experienced and flexible individual who would be comfortable working on multiple projects at once, with fluid prioritization to enable aggressive timelines. This position is for a lab-based scientific role and requires excellent scientific judgement, independence, rigor, and thorough record-keeping.

Essential Functions:

• Execute routine and non-routine analysis of internal release, development, and stability samples using a variety of analytical techniques across Drug Product working groups, ensuring high-quality data generation and reporting.
• Support the execution, optimization, and continuous improvement of Vaxcyte’s internal multiplex immunoassay (MSD) assay suite, including troubleshooting assay performance, improving robustness, and supporting assay lifecycle management.
• Design, execute, and interpret experiments to support non-GxP stability studies including thermal, freeze/thaw, agitation, and container closure system evaluations for both Drug Substance and adjuvanted vaccine Drug Product materials.
• Analyze and interpret complex assay data, identify trends or deviations, and communicate findings to project teams to support development decisions.
• Contribute to method development, qualification, and technology transfer activities, including collaboration with external analytical laboratories and manufacturing CMOs.
• Author and review technical documentation including assay protocols, SOPs, reports, study plans, and technical summaries in support of development and analytical activities.
• Support the Vaxcyte PCV and VAXA1 programs through cross-functional collaboration with Drug Product Development, Formulation, Analytical Development, Quality, and external partners.
• Vaxcyte is seeking a flexible and collaborative Scientist comfortable managing multiple priorities in a fast-paced development environment.
• This role is predominantly lab-based and requires strong scientific judgment, independence in experimental execution, rigor in data analysis, and meticulous record keeping.

Requirements: 

• MS degree in Chemistry, Biochemistry, or related field with minimum 5 years of relevant industry experience, or BS degree with minimum 8 years of relevant industry experience.
• At least 2 years of experience in an analytical development or quality control role.
• Prior experience running colorimetric assays is required.
• Prior experience with SEC-MALS is required.
• Prior experience with SDS-PAGE is required.
• Excellent attention to detail, organizational skills, and record-keeping abilities.
• Ability to work both independently and collaboratively in a fast-paced environment.
• Commitment to integrity, professionalism, and safety in all aspects of work.

Hourly Range: $62.00/hr. - $68.00/hr.

Summary:

Vaxcyte is undergoing a major ERP transformation, moving from NetSuite to SAP S/4HANA to support its rapid growth and upcoming transition to commercial operations. The Senior IT Business Systems Analyst (BSA), SAP Finance will play a critical role in bridging Finance and IT, ensuring a smooth transition and successful implementation of SAP S/4HANA Finance modules. This position requires strong functional expertise in SAP Finance, deep understanding of accounting processes, and experience in ERP migration projects. 

Essential Functions:

• Support the migration from NetSuite to SAP S/4HANA, ensuring data integrity and process continuity. 

• Collaborate with Finance and IT teams to design future-state processes aligned with Vaxcyte’s business needs.  

• Assist in data mapping, cleansing, and validation during migration. 

• In-depth knowledge of SAP systems, including SAP S/4HANA and integration techniques. 

• Configure and maintain SAP Finance modules including Financial Accounting (FI), Controlling (CO), Treasury & Cash Management, Financial Close & Reporting, and Procurement.  

• Work closely with Finance stakeholders (Accounting, FP&A, Procurement) to capture requirements. 

• Translate business needs into functional specifications for SAP configuration. 

• Help develop and document business process flows. 

• Develop and execute test plans for SAP Finance processes. 

• Support User Acceptance Testing (UAT) and resolve issues promptly. 

• Create training materials and deliver sessions for Finance users transitioning from NetSuite. 

• Provide ongoing support post go-live. 

• Ensure compliance with GAAP and biotech industry standards. 

Requirements: 

• Minimum 7 years of experience as a BSA with SAP Finance modules. Other combinations of education and/or experience may be considered. 

• Bachelor’s degree in Finance, Accounting, Information Systems, or related field. 

• Strong analytical and problem-solving skills, with the ability to identify issues and implement effective solutions. 

• Experience in identifying and managing project risks, with a proactive approach to mitigation. 

•  Familiarity with change management principles and techniques to facilitate smooth transitions and adoption of new systems. 

• Hands-on experience with SAP S/4HANA Finance (implementation or migration projects preferred) and Fiori applications.  

• Experience with Netsuite preferred. 

• Experience developing and mapping business process flows using Visio or similar tool 

• Strong understanding of financial processes and ERP migration best practices. 

• Excellent communication and stakeholder management skills. 

• SAP certification in FI/CO 

• Expertise with agile methodology, global deployments, and data migration planning. 

• Experience working in GxP validated and SOX regulated systems 

• Knowledge of integrated tools (e.g., BlackLine, Concur, Ariba) and reporting solutions. 

• Other combinations of education and/or experience may be considered. 

Summary:

Vaxcyte has an exciting opportunity for a Senior Manager, Quality Control Data Analyst to join our QC organization to act as a bridge between our technical QC Operations team and Business teams.  This individual will be responsible for the collection, evaluation, interpretation, and visualization of complex datasets to provide actionable insights that drive technical and business decisions. Key responsibilities include creating reports, maintaining databases, and using tools to identify trends, initiate quality events if needed, improve efficiency, and support definition of acceptance criteria as well as strategic planning.

Essential Functions:

• Work closely with the analytical sub teams and other functions within Analytics, Process Development, Quality Assurance, Operations, and Regulatory functions.
• Accountable for data integrity, accuracy, and reliability as well as that datasets are assessed in a timely manner and meet quality and regulatory standards to ensure secure and uninterrupted supply of Vaxcyte’s innovative therapies.
• Develop, implement, and maintain leading-edge analytics systems, taking complicated problems and building simple frameworks.
• Evaluate internal systems for efficiency, problems, and inaccuracies with regard to data collection and evaluation, and develop and maintain processes and SOPs for handling, evaluation, and visualization of complex data sets.
• Lead activities in QC Operations with regards the data warehousing and data mining programs underway (VaxData).
• Create and maintain rich interactive visualizations through data interpretation and analysis, with reporting components from multiple data sources.
• Define and implement data acquisition and integration logic, selecting an appropriate combination of methods and tools within the defined technology stack to ensure optimal scalability and performance of the solution.
• Develop and maintain databases by acquiring data from primary and secondary sources, and build scripts that will make our data evaluation process more flexible or scalable across datasets.
• Implement, and maintain robust quality control systems that encompass data mining, analysis, and visualization
• Follow prescribed systems for data management, including secure storage, retrieval, and retention of QC data and documentation are in place. Ensure that all testing activities are well-documented and comply with Good Documentation Practices (GDP).
• In partnership with the analytical subteams and analytical science and technology, oversee data collection, evaluation and visualization for in-process and release data in order to support monitoring the analytical control strategy and related acceptance criteria.
• Identify trends to initiate quality events and respective investigations through analysis of complex datasets.
• Review and approval of analytical data, test reports, and certificates of analysis (CoAs) generated by contract laboratories to verify accuracy, completeness, and compliance with specifications for both in-process and release testing.
• Act as point of contact with IT for QC operations.
• Support investigations and deviations, out-of-specification (OOS), out-of-trend (OOT), out-of-expectation (OOE) results, laboratory incidents, and customer complaints collaborating with internal stakeholders to implement corrective and preventive actions (CAPAs) as a data Subject Matter Expert.
• Writing, review and approval of documents related to Quality Control, Computer System Validation, and GAMP5 to ensure compliance with applicable regulatory and industry standards.
• Work directly with managers and users to gather requirements, provide status updates, and build relationships.

Requirements: 

Bachelor’s degree (or equivalent) in biology, biochemistry or other related science with 8+ years of experience in biotechnology/pharmaceutical industry and 3+ years of experience as data analyst in data science/statistics. Other combinations of education and/or experience may be considered.

• Proven analytics skills, including mining, evaluation, and visualization.
• Technical writing experience in relevant areas, including queries, reports, and presentations.
• Expert level knowledge of the standard MS suite of programs (Excel, Word, VBA, Teams, Access).
• Strong SQL, with aptitude for learning other analytics tools.
• Experience with database and model design and segmentation techniques.
• Practical experience in statistical analysis through the use of statistical packages SPSS, and SAS.
• Comprehensive knowledge in cGDP and experience in multi-national regulations.
• Strong analytical and problem-solving abilities, with a focus on data-driven decision-making and continuous improvement.
• Experience in Quality Control, especially late stage or commercial.
• Proven success in a collaborative, team-oriented environment.
• Relentless focus and passion around process improvements (efficiency and automation).

Summary:

Vaxcyte has an exciting opportunity for an energetic and talented individual to join our Analytical Development team. The Associate Scientist II, Analytical Development, is responsible for executing analytical testing and supporting method development activities for biologics/vaccine development programs. This role will perform routine and non-routine analytical assays using modern analytical techniques and will contribute to method optimization, troubleshooting, and continuous improvement initiatives under supervision. The position requires 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 Generation

• Perform 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 buffers according to established protocols.
• Execute assays in accordance with approved methods, SOPs, and applicable quality standards (GLP/GMP as applicable).
• Perform data processing and preliminary interpretation; summarize findings for review by senior scientists.
• Maintain accurate and timely documentation in laboratory notebooks or electronic systems.

Method Development & Troubleshooting (Under Supervision)

• Support method development, optimization, and qualification activities under the guidance of senior scientists.
• Assist in designing experiments to evaluate method parameters and robustness.
• Troubleshoot assay performance issues and instrument-related problems, proposing potential solutions for review.
• Participate in method transfer activities, including protocol execution and documentation.
• Contribute to drafting and revising analytical methods, SOPs, protocols, and technical reports.

Laboratory Operations & Instrumentation

• Coordinate instrument service activities and assist with vendor interactions as needed.
• Ensure laboratory organization, cleanliness, and proper material storage.
• Manage inventory of reagents, standards, and consumables; assist with procurement and restocking.

Safety & Compliance

• Follow all Environmental Health & Safety (EHS) policies and laboratory safety practices.
• Handle chemicals and biological materials safely and in compliance with regulatory requirements.
• Ensure proper waste disposal and adherence to hazardous material handling procedures.
• Support audit and inspection readiness activities where applicable.

Team Collaboration

• Collaborate with cross-functional teams to support project timelines and deliverables.
• Provide clear communication on experimental progress, risks, and results.
• Contribute to a positive, compliant, and scientifically rigorous laboratory culture.
• May assist in training junior staff or new team members on routine assays and lab practices.

Requirements: 

• Bachelor’s degree in Chemistry, Biochemistry, Biology, Pharmaceutical Sciences, or a related scientific discipline with 2+ years, or Master’s degree with 1+ years of relevant laboratory experience in analytical development, QC, or related field. Other combinations of education and/or experience may be considered.
• Hands-on experience with analytical techniques such as chromatography, electrophoresis, or immunoassays is required.
• Experience supporting method development or optimization activities preferred.
• Solid understanding of analytical chemistry or biochemistry principles.
• Experience with method troubleshooting and data interpretation.
• Familiarity with analytical software and data analysis tools.
• Strong attention to detail and organizational skills.
• Ability to work independently on routine assignments and manage multiple tasks.
• Effective written and verbal communication skills.
• Ability to work in a laboratory environment for extended periods.
• Ability to lift up to 25 lbs.
• Use of personal protective equipment (PPE) required.
• Contribute to a positive, inclusive, and safety-focused laboratory culture.

Summary:

Vaxcyte’s Legal team is seeking a motivated, forward-thinking AI Consultant to support the design, evaluation, and implementation of emerging AI solutions across Legal and Compliance functions. This project-based role is ideal for a student pursuing their MS or PhD with strong technical skills, curiosity about legal operations, and a passion for applying AI to real-world business problems. You will work closely with cross-functional teams to prototype, test, and deploy AI tools that drive efficiency, enhance compliance workflows, and expand the team’s ability to deliver strategic support to the business.

Essential Functions:

• Bot Development: Design and prototype an AI-powered chatbot to support Legal and Compliance functions (e.g., FAQs, SOP references, or workflow routing).
• Legal Dashboard Enhancements: Enhance the existing Legal Dashboard using Box AI and related integrations to improve automation, visibility, and user experience.
• Tool Evaluation: Research, evaluate, and recommend emerging AI tools and products; schedule and participate in demos; provide post-demo analysis and recommendations.
• Implementation Support: Assist with tool rollout, user onboarding, and training materials for Legal, Compliance, and other stakeholders.
• Continuous Exploration: Identify and scope new AI use cases within Legal and related functions, collaborating with IT and Operations as needed.
• AI Tool Integration: Support implementation and optimization of existing Legal AI tools such as Spellbook and CoCounsel to ensure full functionality and adoption across teams.
• System Connectivity: Collaborate with IT to integrate and connect AI tools and software applications, enabling seamless read-only and action-based access across platforms. 

Requirements: 

• Enrolled in an MS or PhD program pursuing a degree in Computer Science, Data Science, Engineering, AI or a related field. 
• Strong understanding of generative AI concepts (e.g., open-source small LLMs, MCPRAG and API integrations).
• Excellent communication and analytical skills.
• Ability to translate technical concepts into practical applications for non-technical teams.
• Experience using or configuring AI tools such as Box AI, Microsoft Copilot, ChatGPT Enterprise, or similar platforms is preferred.
• Prior exposure to automation tools or workflow design (e.g., Power Automate, Zapier, or custom bots) is preferred.
• Demonstrated project management or client-facing experience (internships count!) is preferred.