Summary:

The Director, Business Operations (Global QC) will lead the strategic design, implementation, and continuous optimization of global operational frameworks supporting Vaxcyte’s Quality Control (QC) and supporting Analytical interfaces. This role ensures that analytical inputs and QC operations are scalable, compliant, efficient, and aligned with corporate and regulatory expectations as the organization advances from development through commercial readiness.

The Director will serve as the central business operations leader for the Global Quality Control, partnering with leaders in Analytical Development, Analytical Science & Technology, Stability, Process Development, Manufacturing Science and Technology (MS&T), and Quality. This individual will drive governance, process standardization, infrastructure development, and cross-functional coordination to enable timely, compliant, and uninterrupted supply of Vaxcyte’s innovative vaccines.

Essential Functions:

Operational Excellence & Strategy
•    Lead the design and execution of operational strategies that translate Vaxcyte’s global vision into efficient, compliant, and scalable QC and analytical business operations.
•    Develop and maintain a global QC operations strategy, ensuring alignment with clinical and commercial objectives.
•    Implement continuous improvement frameworks (e.g., Plan-Do-Check-Act) to enhance efficiency, scalability, and compliance across analytical and QC processes.
•    Define and monitor key performance indicators (KPIs) that assess operational performance, quality, delivery timelines, and cost efficiency across the global analytics network.
•    Partner with cross-functional leaders to ensure analytical and QC infrastructure, systems, and processes are integrated into overall business objectives.
•    Lead initiatives that improve operational automation, data visibility, and process robustness.

Governance & Compliance
•    Establish and maintain robust governance frameworks for QC and analytical operations in alignment with global cGMP regulations and internal quality standards.
•    Define, visualize, and formalize QC business processes using RASCI principles, ensuring clear ownership and accountability across the analytical network.
•    Review and enhance the Quality Management System (QMS) infrastructure to close gaps, harmonize SOPs, and strengthen procedural consistency.
•    Ensure data integrity principles are embedded in all operational practices, compliant with Vaxcyte’s DI policies and global standards.
•    Support global inspection readiness and lead preparations for regulatory inspections, partner audits, and customer reviews.
•    Collaborate with Quality to ensure analytical operations and contract testing laboratories meet all compliance requirements.

Infrastructure & Systems Leadership
•    Oversee the development and validation of business systems, data management platforms, and documentation practices across global analytical and QC sites.
•    Ensure that contract and in-house laboratories maintain robust equipment qualification, calibration, and maintenance programs to support reliable analytical testing.
•    Lead network and site planning activities, including external partnerships and outsourcing strategies with CDMOs and CROs.
•    Develop business cases for laboratory expansion, outsourcing scenarios, and infrastructure investments to support strategic growth.

Capability Building & Team Leadership
•    Collaborate and mentor a global team of QC operations professionals to ensure scientific, technical, and operational excellence.
•    Drive training programs that enhance technical proficiency, compliance culture, and cross-functional understanding within the analytics organization.
•    Foster a culture of innovation, learning, and continuous improvement across the analytical network.
•    Collaborate closely with functional heads across Analytical Development, Analytical Science and Technology, Stability, and Manufacturing to harmonize operational practices.
•    Represent Global Analytics and QC Operations in governance bodies, steering committees, and cross-functional business forums.

Requirements: 

•    Bachelor’s or Master’s degree (or higher) in Biotechnology, Pharmaceutical Sciences, Engineering, or related field.
•    12+ years of progressive experience in Quality Control, Analytical Operations, or Technical Operations within a biotechnology or pharmaceutical company.
•    Demonstrated leadership in developing and managing operational systems in GMP-regulated environments.
•    Strong understanding of cGMP, global regulatory requirements, and analytical testing operations.
•    Proven ability to design and implement business processes, governance models, and performance management systems.
•    Experience with vendor management and collaboration with CDMOs/CROs on analytical testing and QC operations.
•    Exceptional communication, negotiation, and relationship-building skills with internal and external stakeholders.
•    Strong analytical, organizational, and problem-solving skills; adept at data-driven decision-making.
•    Demonstrated passion for process improvement, operational efficiency, and automation

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 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:

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.