Vaxcyte is a biotechnology company focused on developing novel vaccines to address infectious diseases.

vaxcyte

<div class="content-intro"><h3><strong>Join our Mission to Protect Humankind!</strong></h3>
<div>Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, which have serious and costly health consequences when left unchecked. Working to eradicate or treat bacterial infections such as invasive pneumococcal disease, Group A Strep, and Shigella is just the beginning. Our path to success is clear and well-defined, and Vaxcyte is set up to go the distance.&nbsp;</div>
<div>&nbsp;</div>
<div><strong>WHAT</strong>&nbsp;we do is every bit as important as&nbsp;<strong>HOW</strong>&nbsp;we do it!&nbsp;Our work together is guided by four enduring core values:</div>
<div>&nbsp;</div>
<div>*RETHINK CONVENTION: We bring creative and intellectual diversity to every facet of the work we do in order to innovate and re-innovate the way vaccines are delivered.</div>
<div>&nbsp;</div>
<div>*AIM HIGH: We embody our collectively audacious goal to courageously make the most complex biologics ever attempted to protect humankind.</div>
<div>&nbsp;</div>
<div>*LEAD WITH HEART: Everyone leads at Vaxcyte with a kindness-first, inclusive approach to collaboration and vigorous debate that advances our business objectives.</div>
<div>&nbsp;</div>
<div>*MODEL EXCELLENCE:&nbsp; The magnitude of our challenge requires our shared commitment to demonstrating integrity, accountability, equality and clarity across communications and decision making.</div></div><h3><strong>Summary:</strong></h3>
<p>Vaxcyte is seeking an accomplished Staff Scientist, Immunoassay Developmentto join the CMC Immunoassay group. This role will provide scientific and strategic leadership for the development, qualification, characterization, governance, and lifecycle management of critical reagents and reference materials that support immunoassays across Vaxcyte's vaccine pipeline.</p>
<p>The Staff Scientist will serve as a hands-on technical expert responsible for strengthening Vaxcyte’s immunoassay capability across the vaccine pipeline. This includes developing new fit-for-purpose immunoassays, evaluating innovative immunoassay platforms, advancing assay robustness, supporting method transfer and validation readiness, contributing to immunoassay control strategy, and providing senior-level scientific guidance to cross-functional teams.</p>
<p>This is not a primary people-management role. The Staff Scientist may mentor junior scientists and influence technical direction across programs, but the primary accountability is scientific depth, independent technical contribution, experimental strategy, complex data interpretation, and advancement of immunoassay capability.</p>
<h3>Essential Functions:</h3>
<ul>
<li>Serve as a senior technical expert and individual contributor for immunoassay development across Vaxcyte’s vaccine pipeline.</li>
<li>Lead and directly execute complex laboratory studies supporting immunoassay development, optimization, platform evaluation, qualification readiness, validation readiness, method transfer support, lifecycle management, and routine analytical testing.</li>
<li>Develop new fit-for-purpose immunoassays supporting potency, antigenicity, identity, impurity, characterization, comparability, release, stability, and lifecycle needs.</li>
<li>Provide scientific leadership for assay design, including assay format selection, sample preparation strategy, reagent strategy, plate or bead format selection, signal detection approach, system suitability, data analysis model, robustness assessment, and control strategy considerations.</li>
<li>Evaluate innovative and alternative immunoassay platforms and formats, including ELISA, MSD, multiplex assays, bead-based assays, automation-enabled workflows, and other ligand-binding technologies.</li>
<li>Design and execute studies to compare assay platforms and translate experimental findings into scientific recommendations for method selection, optimization, and long-term control strategy.</li>
<li>Independently troubleshoot immunoassay performance trends using structured, data-driven experimental approaches and clear documentation of observations, conclusions, and recommendations.</li>
<li>Interpret complex immunoassay data, including standard curves, sample interpolation, dilution response, parallelism, recovery, precision, specificity, assay controls, system suitability, robustness, comparability, and long-term method performance.</li>
<li>Contribute to immunoassay analytical control strategies, including critical reagent strategy, reference material strategy, sample preparation, assay controls, system suitability, bridging approaches, trending, robustness evaluation, and lifecycle monitoring.</li>
<li>Support routine testing within the CMC Immunoassay, including development-stage testing, characterization testing, platform evaluation studies, comparability support, reagent qualification, reference material qualification, and non-GMP or GMP-supporting analytical activities.</li>
<li>Provide senior-level technical guidance to scientists and research associates on experimental design, assay execution, data interpretation, troubleshooting, documentation, and good laboratory practices.</li>
<li>Support outsourced immunoassay activities with CROs, CDMOs, contract testing laboratories, reagent vendors, and technology partners by providing technical input, protocol review, data review, issue resolution, and deliverable assessment.</li>
<li>Author and review study protocols, technical reports, method development reports, platform evaluation summaries, validation-support documents, comparability packages, and regulatory-supporting documentation.</li>
<li>Represent Immunoassay Development as a technical subject matter expert in project teams, cross-functional technical discussions, vendor meetings, and internal scientific reviews.</li>
<li>Partner with Analytical Development, ASAT, QC, Process Development, Manufacturing, Quality, Clinical Serology, Regulatory, Program Management, and external partners to support CMC deliverables and program timelines.</li>
<li>Stay current with emerging immunoassay technologies, platform innovations, automation opportunities, and best practices that may strengthen Vaxcyte’s immunoassay capability.</li>
<li>Perform all work with strong commitment to scientific rigor, data integrity, documentation quality, laboratory safety, accountability, and continuous improvement.</li>
</ul>
<h3>Requirements:&nbsp;</h3>
<ul>
<li>PhD. in Biochemistry, Immunology, Analytical Chemistry, Biological Sciences, or a related discipline is preferred with a minimum of 8 years of relevant biopharmaceutical industry experience; or M.S. in a related discipline with a minimum of 13 years of relevant biopharmaceutical industry experience; or B.S. in a related discipline with a minimum of 16 years of relevant biopharmaceutical industry experience.</li>
<li>Significant hands-on, lab-based experience developing, optimizing, troubleshooting, transferring, lifecycle-supporting, and executing immunoassays in vaccine CMC, biologics analytical development, QC, ASAT, or other regulated analytical environments.</li>
<li>Demonstrated scientific depth in immunoassay method development, including assay format selection, reagent strategy, sample preparation, assay optimization, robustness assessment, qualification support, validation readiness, method transfer support, and lifecycle management.</li>
<li>Strong technical experience with ligand-binding immunoassay platforms such as ELISA, MSD, electrochemiluminescence-based assays, bead-based assays, multiplex assays, or other relevant immunoassay technologies.</li>
<li>Demonstrated ability to independently design experiments, interpret complex data, troubleshoot assay performance trends, and make sound scientific recommendations.</li>
<li>Experience evaluating innovative immunoassay platforms and translating platform learnings into fit-for-purpose analytical strategies.</li>
<li>Experience supporting potency, antigenicity, identity, impurity, characterization, comparability, release, stability, process development, method transfer, validation-support, routine testing, or regulatory-supporting assays.</li>
<li>Experience contributing to immunoassay control strategies, including critical reagents, reference materials, assay controls, system suitability, bridging, trending, and lifecycle monitoring.</li>
<li>Experience supporting outsourced immunoassay activities with CROs, CDMOs, contract testing laboratories, reagent vendors, or technology partners is desired.</li>
<li>Experience working in or supporting GMP-regulated analytical environments is desired.</li>
<li>Hands-on experience with MSD platforms is highly desirable.</li>
<li>Hands-on experience with multiplex or other multiplex immunoassay platforms is a plus.</li>
<li>Demonstrated ability to mentor junior scientists and influence technical direction without relying on formal people-management authority.</li>
<li>Strong written and verbal communication skills, with the ability to clearly communicate complex scientific concepts, data interpretation, technical risks, and recommendations.</li>
<li>Direct experience with conjugated vaccines, polysaccharide-protein conjugates, multivalent vaccines, or other complex biologics is strongly preferred.</li>
</ul>
<p><strong>Preferred Qualifications:</strong></p>
<ul>
<li>Experience supporting late-stage development, PPQ readiness, BLA preparation, commercial readiness, or lifecycle management of vaccine or biologics programs.</li>
<li>Experience contributing to regulatory submissions, health authority responses, technical reports, method development reports, or validation-support documentation.</li>
<li>Experience with automation, high-throughput immunoassay workflows, multiplex assay design, LIMS, ELN, and digital data analysis tools.</li>
<li>Experience helping build or scale analytical capabilities or technical platforms within a growing organization.</li>
</ul>
<div><strong>Reports to: </strong>Senior Director, Global Analytical Lead – Commercial Readiness and Analytical Strategy</div>
<div>&nbsp;</div>
<div><strong>Location: </strong>San Carlos, CA</div>
<div>&nbsp;</div>
<div><strong><span data-olk-copy-source="MessageBody">Work Arrangement (may be adjusted based on business needs, job responsibilities, or changes to company policy):&nbsp;</span></strong></div>
<div>Onsite (minimum of 4 days per week onsite)&nbsp;</div>
<div>&nbsp;</div>
<div><strong>Compensation:</strong></div>
<div>The compensation package will be competitive and includes comprehensive benefits and an equity component.</div>
<div>&nbsp;</div>
<div><strong>Salary Range: </strong>$209,000 - $244,000 (SF Bay Area).</div>
<div>&nbsp;</div><div class="content-conclusion"><p class="x_MsoNormal"><span class="x_spanwithbackgroundcolor"><strong><span data-olk-copy-source="MessageBody">Equal Opportunity</span></strong></span></p>
<p class="x_MsoNormal"><em>We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.</em></p>
<p class="x_elementtoproof"><strong>Recruitment Fraud Notice</strong></p>
<p class="x_elementtoproof"><em>Please be aware of fraud or scams from individuals, organizations and/or internet sites claiming to represent Vaxcyte in recruitment activities. Vaxcyte has an established recruitment process for all positions prior to issuing an offer for employment and we will never extend unsolicited employment offers or ask candidates to provide financial or sensitive personal information as part of the application process. All legitimate communication from Vaxcyte will come from an official @vaxcyte.com email address. Qualified and interested candidates should apply to current openings at&nbsp;</em><a href="https://vaxcyte.com/careers/" data-auth="NotApplicable" data-linkindex="4"><em>vaxcyte.com/careers</em></a><em>.</em></p>
<p>&nbsp;</p></div>

Staff Scientist, Immunoassay Development

<div class="content-intro"><h3><strong>Join our Mission to Protect Humankind!</strong></h3>
<div>Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, which have serious and costly health consequences when left unchecked. Working to eradicate or treat bacterial infections such as invasive pneumococcal disease, Group A Strep, and Shigella is just the beginning. Our path to success is clear and well-defined, and Vaxcyte is set up to go the distance.&nbsp;</div>
<div>&nbsp;</div>
<div><strong>WHAT</strong>&nbsp;we do is every bit as important as&nbsp;<strong>HOW</strong>&nbsp;we do it!&nbsp;Our work together is guided by four enduring core values:</div>
<div>&nbsp;</div>
<div>*RETHINK CONVENTION: We bring creative and intellectual diversity to every facet of the work we do in order to innovate and re-innovate the way vaccines are delivered.</div>
<div>&nbsp;</div>
<div>*AIM HIGH: We embody our collectively audacious goal to courageously make the most complex biologics ever attempted to protect humankind.</div>
<div>&nbsp;</div>
<div>*LEAD WITH HEART: Everyone leads at Vaxcyte with a kindness-first, inclusive approach to collaboration and vigorous debate that advances our business objectives.</div>
<div>&nbsp;</div>
<div>*MODEL EXCELLENCE:&nbsp; The magnitude of our challenge requires our shared commitment to demonstrating integrity, accountability, equality and clarity across communications and decision making.</div></div><h3></h3>
<h3><strong>Summary:</strong></h3>
<p>Vaxcyte is seeking an accomplished Associate Scientist II, Immunoassay Development to join the CMC Immunoassay group. This role will provide scientific and strategic leadership for the development, qualification, characterization, governance, and lifecycle management of critical reagents and reference materials that support immunoassays across Vaxcyte's vaccine pipeline.</p>
<p><br>The Associate Scientist will work closely with scientists, senior scientists, and laboratory leaders to execute immunoassays, support fit-for-purpose method development, assist with troubleshooting studies, and contribute to high-quality laboratory documentation and data integrity.</p>
<h3>Essential Functions:</h3>
<ul>
<li>Perform hands-on assay execution to support immunoassay development, optimization, platform evaluation, routine testing, method transfer support, and under direct supervision, validation readiness, and lifecycle activities.</li>
<li>Engage daily in laboratory operations, including reagent preparation, sample handling, plate or bead preparation, instrument operation, assay setup, data capture, documentation, and laboratory organization.</li>
<li>Execute immunoassays supporting potency, antigenicity, identity, impurity, characterization, comparability, release, stability, and development-stage analytical needs.</li>
<li>Support experiments using ELISA, MSD, bead-based assays, multiplex assays, electrochemiluminescence-based assays, or other ligand-binding assay formats.</li>
<li>Prepare reagents, buffers, samples, plates, beads, assay controls, reference materials, and other materials required for immunoassay testing.</li>
<li>Generate and summarize assay data, including standard curves, sample response, dilution response, recovery, precision, assay controls, and system suitability results.</li>
<li>Under direction of a Scientist or Sr. Scientist, support troubleshooting studies by executing experiments, documenting observations, organizing data, and communicating findings to scientists and project leads.</li>
<li>Support critical reagent and reference material activities, including aliquoting, labeling, inventory tracking, reagent screening, lot comparison, stability study support, and qualification-support testing.</li>
<li>Maintain accurate and timely laboratory documentation, including ELN entries, assay worksheets, reagent records, sample records, and data summaries.</li>
<li>Support laboratory readiness, including consumable tracking, instrument use coordination, sample tracking, safety compliance, and good laboratory practices.</li>
</ul>
<h3>Requirements:&nbsp;</h3>
<ul>
<li>BS. in Biochemistry, Immunology, Analytical Chemistry, Biological Sciences, or a related discipline with a minimum of 2 years of relevant biopharmaceutical industry laboratory experience; or M.S. in a related discipline with minimum 1 year of relevant biopharmaceutical industry laboratory experience.</li>
<li>Hands-on laboratory experience with immunoassays, ligand-binding assays, analytical testing, bioanalytical testing, or related biological assay workflows.</li>
<li>Experience with assay execution, reagent preparation, sample preparation, plate-based or bead-based assay setup, instrument operation, data analysis, assay controls, and documentation.</li>
<li>Familiarity with immunoassay platforms such as ELISA, MSD, electrochemiluminescence-based assays, bead-based assays, multiplex assays, or other ligand-binding assay technologies.</li>
<li>Ability to follow protocols, execute experiments carefully, document work accurately, and communicate observations clearly.</li>
<li>Strong attention to detail and commitment to laboratory safety, data integrity, documentation quality, and scientific excellence.</li>
<li>Ability to manage multiple laboratory tasks, samples, reagents, and timelines in a fast-paced environment.</li>
</ul>
<div><strong>Reports to: </strong>Director, Immunoassay Development</div>
<div>&nbsp;</div>
<div><strong>Location: </strong>San Carlos, CA</div>
<div>&nbsp;</div>
<div><strong><span data-olk-copy-source="MessageBody">Work Arrangement (may be adjusted based on business needs, job responsibilities, or changes to company policy):&nbsp;</span></strong></div>
<div>Onsite (minimum of 4 days per week onsite)&nbsp;</div>
<div>&nbsp;</div>
<div><strong>Compensation:</strong></div>
<div>The compensation package will be competitive and includes comprehensive benefits and an equity component.</div>
<div>&nbsp;</div>
<div><strong>Salary Range: </strong>$105,000 - $123,000 (SF Bay Area).</div>
<div>&nbsp;</div><div class="content-conclusion"><p class="x_MsoNormal"><span class="x_spanwithbackgroundcolor"><strong><span data-olk-copy-source="MessageBody">Equal Opportunity</span></strong></span></p>
<p class="x_MsoNormal"><em>We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.</em></p>
<p class="x_elementtoproof"><strong>Recruitment Fraud Notice</strong></p>
<p class="x_elementtoproof"><em>Please be aware of fraud or scams from individuals, organizations and/or internet sites claiming to represent Vaxcyte in recruitment activities. Vaxcyte has an established recruitment process for all positions prior to issuing an offer for employment and we will never extend unsolicited employment offers or ask candidates to provide financial or sensitive personal information as part of the application process. All legitimate communication from Vaxcyte will come from an official @vaxcyte.com email address. Qualified and interested candidates should apply to current openings at&nbsp;</em><a href="https://vaxcyte.com/careers/" data-auth="NotApplicable" data-linkindex="4"><em>vaxcyte.com/careers</em></a><em>.</em></p>
<p>&nbsp;</p></div>

Associate Scientist II, Immunoassay Development

<div class="content-intro"><h3><strong>Join our Mission to Protect Humankind!</strong></h3>
<div>Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, which have serious and costly health consequences when left unchecked. Working to eradicate or treat bacterial infections such as invasive pneumococcal disease, Group A Strep, and Shigella is just the beginning. Our path to success is clear and well-defined, and Vaxcyte is set up to go the distance.&nbsp;</div>
<div>&nbsp;</div>
<div><strong>WHAT</strong>&nbsp;we do is every bit as important as&nbsp;<strong>HOW</strong>&nbsp;we do it!&nbsp;Our work together is guided by four enduring core values:</div>
<div>&nbsp;</div>
<div>*RETHINK CONVENTION: We bring creative and intellectual diversity to every facet of the work we do in order to innovate and re-innovate the way vaccines are delivered.</div>
<div>&nbsp;</div>
<div>*AIM HIGH: We embody our collectively audacious goal to courageously make the most complex biologics ever attempted to protect humankind.</div>
<div>&nbsp;</div>
<div>*LEAD WITH HEART: Everyone leads at Vaxcyte with a kindness-first, inclusive approach to collaboration and vigorous debate that advances our business objectives.</div>
<div>&nbsp;</div>
<div>*MODEL EXCELLENCE:&nbsp; The magnitude of our challenge requires our shared commitment to demonstrating integrity, accountability, equality and clarity across communications and decision making.</div></div><h3><strong>Summary:</strong></h3>
<p>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 Scientist II with experience in microbial fermentation and upstream process development to join the Upstream Polysaccharide Process Development team. The candidate will be responsible for designing, executing, analyzing, and documenting experiments to develop, optimize, and characterize upstream processes for polysaccharide manufacturing using microorganisms. The successful candidate will have practical laboratory experience in microbial fermentation processes and the ability to apply scientific and engineering principles to experimental design, data interpretation, process troubleshooting, and technical decision-making. The role will require significant hands-on laboratory work, and this individual will be expected to document experimental procedures, results, conclusions, and recommendations in written and presentation formats. The successful candidate will lead assigned project activities, provide technical guidance to junior team members, collaborate with cross-functional teams, author technical documents, and communicate scientific results to internal stakeholders.</p>
<h3>Essential Functions:</h3>
<ul>
<li>Design, execute, analyze, and document upstream polysaccharide fermentation studies to support process development, optimization, characterization, scale-up, and vaccine production processes.</li>
<li>Develop and troubleshoot fermentation processes and operating parameters to improve product yield, quality, consistency, and robustness using appropriate statistical tools (e.g., DoE).</li>
<li>Perform microbiology, fermentation, and bioreactor operations, including equipment setup, operation, maintenance, troubleshooting, and automation script development for systems such as Ambr®250.</li>
<li>Coordinate and perform analytical testing, interpret experimental results, identify technical risks and process trends, and develop scientifically sound conclusions and recommendations.</li>
<li>Investigate unexpected or anomalous results, including variability in growth, yield, or polysaccharide quality attributes, through structured root-cause experimentation.</li>
<li>Support integration and interpretation of data across upstream, downstream, and analytical functions, in collaboration with Senior Scientist or function leads, to connect fermentation conditions to downstream performance and final product quality.</li>
<li>Identify and propose new experimental approaches, at-line or online monitoring, and multivariate data-analysis tools that increase the resolution with which the team can observe and interpret the process, with implementation led by Senior Scientist or above.</li>
<li>Support process characterization, raw material evaluations, technology transfer, manufacturing support, and technical investigations.</li>
<li>Author and review protocols, technical reports, SOPs, batch records, and development summaries; author regulatory-supporting documentation under the review and guidance of Senior Scientist.</li>
<li>Maintain accurate experimental records in laboratory notebooks and electronic laboratory notebook systems.</li>
<li>Lead assigned project activities, provide technical guidance to junior team members, and ensure timely execution of project deliverables.</li>
<li>Present scientific findings and collaborate effectively with internal stakeholders, cross-functional teams, and external partners to achieve project objectives.</li>
</ul>
<h3>Requirements:&nbsp;</h3>
<ul>
<li>D in Chemical Engineering, Biochemical Engineering, Biotechnology, Microbiology, or a related discipline with 2-5 years of industry experience, or an MS with 7+ years, or a BS/BA with 10+ years of relevant pharmaceutical or biotechnology industry experience. Equivalent combinations of education and experience may be considered. Experience independently designing, executing, analyzing, and documenting microbial fermentation and upstream process development studies.</li>
<li>Experience independently designing, executing, analyzing, and documenting microbial fermentation and upstream process development studies.</li>
<li>Strong knowledge of microbial fermentation, process development, scale-up/scale-down, process optimization, and related analytical technologies.</li>
<li>Hands-on experience with fermenters, microbial media, and process analytical technologies.</li>
<li>Experience with bioreactor operations, automation systems (e.g., Ambr®250), and data analysis tools such as JMP.</li>
<li>Experience with process characterization, technology transfer, manufacturing support, or raw material qualification is preferred.</li>
<li>Working knowledge of statistical analysis and Design of Experiments (DoE).</li>
<li>Experience with cell banking, colony selection, and microbial strain characterization is a plus.</li>
<li>Working knowledge of GMP requirements and regulatory-supporting documentation.</li>
<li>Demonstrated ability to lead technical projects, troubleshoot process challenges, manage multiple priorities, and collaborate effectively in cross-functional teams.</li>
<li>Experience working with BSL-2 organisms; experience with <em>Streptococcus pneumoniae</em> or <em>Escherichia coli</em> is a plus.</li>
<li>Strong scientific writing, data presentation, and communication skills.</li>
<li>Ability to work independently and as part of a team in a fast-paced environment.</li>
</ul>
<div><strong>Reports to: </strong>Senior Scientist, Upstream Polysaccharide Process Development&nbsp;</div>
<div>&nbsp;</div>
<div><strong>Location: </strong>San Carlos, CA</div>
<div>&nbsp;</div>
<div>
<div><strong><span data-olk-copy-source="MessageBody">Work Arrangement (may be adjusted based on business needs, job responsibilities, or changes to company policy):&nbsp;</span></strong></div>
<div>Onsite (minimum of 4 days per week onsite)&nbsp;</div>
</div>
<div>&nbsp;</div>
<div><strong>Compensation:</strong></div>
<div>The compensation package will be competitive and includes comprehensive benefits and an equity component.</div>
<div>&nbsp;</div>
<div><strong>Salary Range: </strong>$146,000 - $171,000</div>
<div>&nbsp;</div><div class="content-conclusion"><p class="x_MsoNormal"><span class="x_spanwithbackgroundcolor"><strong><span data-olk-copy-source="MessageBody">Equal Opportunity</span></strong></span></p>
<p class="x_MsoNormal"><em>We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.</em></p>
<p class="x_elementtoproof"><strong>Recruitment Fraud Notice</strong></p>
<p class="x_elementtoproof"><em>Please be aware of fraud or scams from individuals, organizations and/or internet sites claiming to represent Vaxcyte in recruitment activities. Vaxcyte has an established recruitment process for all positions prior to issuing an offer for employment and we will never extend unsolicited employment offers or ask candidates to provide financial or sensitive personal information as part of the application process. All legitimate communication from Vaxcyte will come from an official @vaxcyte.com email address. Qualified and interested candidates should apply to current openings at&nbsp;</em><a href="https://vaxcyte.com/careers/" data-auth="NotApplicable" data-linkindex="4"><em>vaxcyte.com/careers</em></a><em>.</em></p>
<p>&nbsp;</p></div>

Scientist II, Upstream Polysaccharide Process Development

<div class="content-intro"><h3><strong>Join our Mission to Protect Humankind!</strong></h3>
<div>Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, which have serious and costly health consequences when left unchecked. Working to eradicate or treat bacterial infections such as invasive pneumococcal disease, Group A Strep, and Shigella is just the beginning. Our path to success is clear and well-defined, and Vaxcyte is set up to go the distance.&nbsp;</div>
<div>&nbsp;</div>
<div><strong>WHAT</strong>&nbsp;we do is every bit as important as&nbsp;<strong>HOW</strong>&nbsp;we do it!&nbsp;Our work together is guided by four enduring core values:</div>
<div>&nbsp;</div>
<div>*RETHINK CONVENTION: We bring creative and intellectual diversity to every facet of the work we do in order to innovate and re-innovate the way vaccines are delivered.</div>
<div>&nbsp;</div>
<div>*AIM HIGH: We embody our collectively audacious goal to courageously make the most complex biologics ever attempted to protect humankind.</div>
<div>&nbsp;</div>
<div>*LEAD WITH HEART: Everyone leads at Vaxcyte with a kindness-first, inclusive approach to collaboration and vigorous debate that advances our business objectives.</div>
<div>&nbsp;</div>
<div>*MODEL EXCELLENCE:&nbsp; The magnitude of our challenge requires our shared commitment to demonstrating integrity, accountability, equality and clarity across communications and decision making.</div></div><p><strong>Summary:</strong></p>
<p>Vaxcyte has an exciting opportunity for an energetic and talented individual to join our Analytical Development team.&nbsp;The Senior Scientist, Analytical Development, is responsible for leading analytical method development activities for biologics/vaccine development programs. This role designs and drives method development, performs and oversees routine and non-routine analytical assays using modern analytical techniques, and leads method optimization, troubleshooting, and continuous improvement initiatives with minimal supervision, including mentoring and technical guidance to junior team members. The position requires demonstrated hands-on laboratory experience, deep technical expertise, and strong problem-solving skills, with the ability to independently plan and execute work, interpret complex data, and drive investigations to root cause and resolution. This role also authors, reviews, and maintains high-quality technical documentation, including method protocols, method development reports, qualification documentation, SOPs, and clear technical summaries that communicate experimental findings and conclusions to internal and external stakeholders.</p>
<p><strong>Essential Functions:</strong></p>
<p>Method Development &amp; Troubleshooting</p>
<ul>
<li>Provide technical leadership and strategic direction for method development, optimization and qualification/validation readiness.</li>
<li>Define development strategies and experimental roadmaps, identify critical method attributes, set robustness/qualification approaches, and drive alignment with program and regulatory expectations.</li>
<li>Lead complex troubleshooting and investigations across assays and instrumentation; establish root-cause and preventive controls, and mentor others in problem-solving.</li>
<li>Lead authorship and review of methods, SOPs, protocols, and technical reports; set documentation standards and ensure consistency and readiness for audits/inspections.</li>
</ul>
<p>Team Collaboration</p>
<ul>
<li>Serve as a cross-functional technical leader, aligning analytical strategy with program objectives and driving execution against key milestones and deliverables.</li>
<li>Proactively identify, communicate, and manage technical risks and resourcing constraints, influence decision-making with clear options, tradeoffs, and recommendations.</li>
<li>Champion a culture of scientific excellence, compliance, and continuous improvement; establish best practices and drive adoption across the team.</li>
<li>Lead capability building through mentoring, training programs, and coaching; develop team members’ technical depth, problem-solving, and communication skills.</li>
</ul>
<p>Laboratory Operations &amp; Instrumentation</p>
<ul>
<li>Promote efficient, compliant laboratory operations, including organization, cleanliness, and material control, aligned with applicable quality expectations.</li>
<li>Provide oversight and prioritization for instrument maintenance, qualification, and service activities; serve as a technical point of contact for Lab operation team and vendor interactions and complex instrument issues.</li>
<li>Ensure continuity of lab readiness by overseeing inventory strategy for reagents, standards, and consumables; support budgeting/forecasting and drive improvements to procurement and inventory processes.</li>
</ul>
<p>Analytical Testing &amp; Data Generation</p>
<ul>
<li>Lead 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).</li>
<li>Maintain accurate and timely documentation in laboratory notebooks or electronic systems.</li>
<li>Perform data processing and interpretation; draw conclusions, and clearly communicate outcomes, risks and recommendations to program and cross-functional stakeholders.</li>
</ul>
<p>Safety &amp; Compliance</p>
<ul>
<li>Follow all Environmental Health &amp; Safety (EHS) policies and laboratory safety practices.</li>
<li>Handle chemicals and biological materials safely and in compliance with regulatory requirements.</li>
<li>Ensure proper waste disposal and adherence to hazardous material handling procedures.</li>
<li>Support audit and inspection readiness activities where applicable.</li>
</ul>
<p><strong>Requirements:</strong></p>
<p>PhD, MS or Bachelor’s degree in Chemistry, Biochemistry, Biology, Pharmaceutical Sciences, or a related scientific discipline. &nbsp;PhD with 5+ years; MS with 8+ years; BS with 10+ years of relevant industry experience in analytical development, QC, or related field. Other combinations of education and/or experience may be considered.</p>
<ul>
<li>Extensive hands-on experience across a broad analytical technique, 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.</li>
<li>Experience leading method development or optimization activities preferred.</li>
<li>Deep expertise in analytical chemistry/biochemistry with broad understanding across platforms.</li>
<li>Recognized technical leader in troubleshooting complex, cross-cutting assay/instrument/system issues; drives investigations to root cause and establishes preventive controls.</li>
<li>Advanced capability in data analysis and interpretation, including method performance characterization, statistical evaluation, and automation/standardization of data workflows where appropriate.</li>
<li>Exemplary quality mindset and documentation rigor; authors/sets standards for methods, protocols, reports, and ensures audit/inspection readiness.</li>
<li>Demonstrated ability to lead multiple priorities and influence program direction; effectively resource-plans, remove blockers, and mentor others to deliver results.</li>
<li>Excellent communication skills: effectively communicate risk, options, and recommendations to stakeholders and leadership, and align cross-functional teams on path forward.</li>
<li>Ability to work in a laboratory environment for extended periods.</li>
<li>Ability to lift up to 25 lbs.</li>
<li>Use of personal protective equipment (PPE) required.</li>
<li>Contribute to a positive, inclusive, and safety-focused laboratory culture</li>
</ul>
<div><strong>Reports to: </strong>Associate Director, Analytical Development</div>
<div>&nbsp;</div>
<div><strong>Location: </strong>Onsite in San Carlos, CA</div>
<div>&nbsp;</div>
<div>
<div><strong><span data-olk-copy-source="MessageBody">Work Arrangement (may be adjusted based on business needs, job responsibilities, or changes to company policy):&nbsp;</span></strong></div>
<div>Onsite (minimum of 4 days per week onsite)</div>
</div>
<div>&nbsp;</div>
<div><strong>Compensation:</strong></div>
<div>The compensation package will be competitive and includes comprehensive benefits and an equity component.</div>
<div>&nbsp;</div>
<div><strong>Salary Range: </strong>$165,000 – $193,000 (SF Bay Area) Salary ranges for non-California locations may vary.</div>
<div>&nbsp;</div>
<div><strong>Relocation:&nbsp;</strong></div>
<div>This role is eligible for relocation assistance.&nbsp;</div><div class="content-conclusion"><p class="x_MsoNormal"><span class="x_spanwithbackgroundcolor"><strong><span data-olk-copy-source="MessageBody">Equal Opportunity</span></strong></span></p>
<p class="x_MsoNormal"><em>We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.</em></p>
<p class="x_elementtoproof"><strong>Recruitment Fraud Notice</strong></p>
<p class="x_elementtoproof"><em>Please be aware of fraud or scams from individuals, organizations and/or internet sites claiming to represent Vaxcyte in recruitment activities. Vaxcyte has an established recruitment process for all positions prior to issuing an offer for employment and we will never extend unsolicited employment offers or ask candidates to provide financial or sensitive personal information as part of the application process. All legitimate communication from Vaxcyte will come from an official @vaxcyte.com email address. Qualified and interested candidates should apply to current openings at&nbsp;</em><a href="https://vaxcyte.com/careers/" data-auth="NotApplicable" data-linkindex="4"><em>vaxcyte.com/careers</em></a><em>.</em></p>
<p>&nbsp;</p></div>

Senior Scientist, Analytical Development

<div class="content-intro"><h3><strong>Join our Mission to Protect Humankind!</strong></h3>
<div>Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, which have serious and costly health consequences when left unchecked. Working to eradicate or treat bacterial infections such as invasive pneumococcal disease, Group A Strep, and Shigella is just the beginning. Our path to success is clear and well-defined, and Vaxcyte is set up to go the distance.&nbsp;</div>
<div>&nbsp;</div>
<div><strong>WHAT</strong>&nbsp;we do is every bit as important as&nbsp;<strong>HOW</strong>&nbsp;we do it!&nbsp;Our work together is guided by four enduring core values:</div>
<div>&nbsp;</div>
<div>*RETHINK CONVENTION: We bring creative and intellectual diversity to every facet of the work we do in order to innovate and re-innovate the way vaccines are delivered.</div>
<div>&nbsp;</div>
<div>*AIM HIGH: We embody our collectively audacious goal to courageously make the most complex biologics ever attempted to protect humankind.</div>
<div>&nbsp;</div>
<div>*LEAD WITH HEART: Everyone leads at Vaxcyte with a kindness-first, inclusive approach to collaboration and vigorous debate that advances our business objectives.</div>
<div>&nbsp;</div>
<div>*MODEL EXCELLENCE:&nbsp; The magnitude of our challenge requires our shared commitment to demonstrating integrity, accountability, equality and clarity across communications and decision making.</div></div><p><strong>Summary:</strong></p>
<p>The Director for Drug Substance (DS) Commercialization of Conjugation will lead and facilitate launch readiness and commercial supply of glycoconjugate drug substances, including the polysaccharide activation, conjugation, and associated raw materials. 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.</p>
<p>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.</p>
<p>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, 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.&nbsp;</p>
<p><strong>Essential Functions:&nbsp;</strong></p>
<ul>
<li><strong>DS Commercialization – </strong>Provide strategic and scientific leadership for polysaccharide activation and conjugation processes with internal and external stakeholders and ensure successful execution of launch plans and post-launch commercial activities.</li>
<li><strong>Organization </strong>– Build a strong and highly-skilled team for the global network with special focus on conjugation manufacturing processes. Support resourcing recommendations on staffing requirements to meet organizational goals.</li>
<li><strong>Process robustness</strong> – Continuously improve process understanding and process robustness using staff and laboratory resources across the organization to monitor, trend, and optimize operations.</li>
<li><strong>Interface</strong> - 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 carrier proteins for pipeline products.</li>
<li><strong>Tech-transfer new technologies</strong> - Ensure robust processes exist to support technical transfers and integration of new technologies.</li>
<li><strong>Support</strong> <strong>technical services</strong> - Support of our internal and external manufacturing network, including materials management and data analytics.</li>
<li><strong>Process validation and comparability</strong> - Provide leadership for the execution of process validation and process comparability activities. Effectively communicate the scientific and commercial rationale for polysaccharide processes to the Manufacturing organization for commercialization</li>
<li><strong>Regulatory</strong> - 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 polysaccharide processes to the Boards of Health for regulatory submissions for commercialization.</li>
<li><strong>Communicate</strong> - 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.</li>
<li><strong>Leadership</strong> - Contribute as DS Commercialization lead for Conjugation and as member of the Global Manufacturing Operations organization, with an aim to ensure effective and efficient delivery of our life-enhancing therapies to our patients.</li>
<li><strong>Travel</strong> - 10-30% travel required.</li>
</ul>
<p><strong>Requirements:&nbsp;</strong></p>
<ul>
<li>Degree(s) in Chemical or Biochemical Engineering, Chemistry, Biochemistry, 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.</li>
<li>Extensive experience in conjugate production processes, including polysaccharide activation, conjugation to carrier proteins, and associated purification processes across multiple operational scales. Experience with glycoconjugate vaccines is highly preferred.</li>
<li>Leadership experience in MSAT or Process Development in supervisory and/or matrixed team roles.</li>
<li>Able to leverage deep technical knowledge in a collaborative manner to establish strategic plans and achieve collective goals.</li>
<li>Excellent organization, problem solving and strategic planning skills.</li>
<li>Highly skilled in both verbal and written communication with the ability to interact effectively with people of diverse backgrounds and perspectives.</li>
<li>Proactively recognizes needs and potential challenges, and directs activities to implement effective solutions.</li>
<li>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.</li>
<li>An entrepreneurial and creative approach to developing new, innovative ideas that will stretch the organization and push the boundaries within the industry.</li>
</ul>
<div>
<p><strong>Reports to: </strong>Sr.<strong> </strong>Director, Global Drug Substance Commercialization, Conjugation</p>
<p><strong>Work Arrangement (may be adjusted based on business needs, job responsibilities, or changes to company policy): </strong>Remote&nbsp;</p>
<p><strong>Location:</strong> Remote; prefer Raleigh, NC</p>
<p><strong>Compensation: </strong>The compensation package will be competitive and includes comprehensive benefits and an equity component.</p>
<p><strong>Salary Range:</strong> $210,000 - $245,000 Remote Salary Range</p>
</div><div class="content-conclusion"><p class="x_MsoNormal"><span class="x_spanwithbackgroundcolor"><strong><span data-olk-copy-source="MessageBody">Equal Opportunity</span></strong></span></p>
<p class="x_MsoNormal"><em>We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.</em></p>
<p class="x_elementtoproof"><strong>Recruitment Fraud Notice</strong></p>
<p class="x_elementtoproof"><em>Please be aware of fraud or scams from individuals, organizations and/or internet sites claiming to represent Vaxcyte in recruitment activities. Vaxcyte has an established recruitment process for all positions prior to issuing an offer for employment and we will never extend unsolicited employment offers or ask candidates to provide financial or sensitive personal information as part of the application process. All legitimate communication from Vaxcyte will come from an official @vaxcyte.com email address. Qualified and interested candidates should apply to current openings at&nbsp;</em><a href="https://vaxcyte.com/careers/" data-auth="NotApplicable" data-linkindex="4"><em>vaxcyte.com/careers</em></a><em>.</em></p>
<p>&nbsp;</p></div>

Director, Global Drug Substance Commercialization, Conjugation

<div class="content-intro"><h3><strong>Join our Mission to Protect Humankind!</strong></h3>
<div>Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, which have serious and costly health consequences when left unchecked. Working to eradicate or treat bacterial infections such as invasive pneumococcal disease, Group A Strep, and Shigella is just the beginning. Our path to success is clear and well-defined, and Vaxcyte is set up to go the distance.&nbsp;</div>
<div>&nbsp;</div>
<div><strong>WHAT</strong>&nbsp;we do is every bit as important as&nbsp;<strong>HOW</strong>&nbsp;we do it!&nbsp;Our work together is guided by four enduring core values:</div>
<div>&nbsp;</div>
<div>*RETHINK CONVENTION: We bring creative and intellectual diversity to every facet of the work we do in order to innovate and re-innovate the way vaccines are delivered.</div>
<div>&nbsp;</div>
<div>*AIM HIGH: We embody our collectively audacious goal to courageously make the most complex biologics ever attempted to protect humankind.</div>
<div>&nbsp;</div>
<div>*LEAD WITH HEART: Everyone leads at Vaxcyte with a kindness-first, inclusive approach to collaboration and vigorous debate that advances our business objectives.</div>
<div>&nbsp;</div>
<div>*MODEL EXCELLENCE:&nbsp; The magnitude of our challenge requires our shared commitment to demonstrating integrity, accountability, equality and clarity across communications and decision making.</div></div><h3><strong>Summary:</strong></h3>
<p>We are seeking a dedicated and experienced Senior Manager, Clinical Quality Assurance, to join our dynamic team. The ideal candidate will have a strong background in quality management within a clinical setting and a passion for maintaining the highest standards of clinical excellence. This role requires an individual who can work with teams to ensure compliance with regulatory requirements and achieve our mission of delivering high-quality healthcare solutions.</p>
<h3>Essential Functions:</h3>
<ul>
<li>Lead global investigations and support teams with CAPA preparation in compliance with applicable regulations/guidelines, customer requirements, Standard Operating Procedures (SOPs) and project specific guidelines/instructions.</li>
<li>Manage Quality Issues and serious breach investigations.</li>
<li>Review, approve Investigations, Root Cause Analysis (RCA), Corrective and Preventive Action (CAPA) and Effectiveness Check (EC) plans.</li>
<li>Track until closure quality events from Quality Issues, Audits, Inspections or during similar QA activities.</li>
<li>Manage/oversee quality event update in eQMS.</li>
<li>Plan, schedule, and conduct risk based and For Cause audits of clinical investigators sites, CROs, and other GCP vendors.</li>
<li>Support regulatory agency inspection readiness activities, including mock inspections, gap assessments, and inspection response coordination.</li>
<li>Evaluate policies and procedures for compliance with applicable regulations/guidelines and provide recommendations to management for continuous process improvements.</li>
<li>Support in QA initiatives/projects for quality, process improvements.</li>
<li>Promotes a quality mindset and quality excellence approach to all activities.</li>
<li>Understands and interprets regulatory agencies policies and guidance as it pertains to GCP requirements and assists in the implementation of compliant processes at Vaxcyte.</li>
</ul>
<h3>Requirements:&nbsp;</h3>
<ul>
<li>BA or BS in related field.</li>
<li>Minimum of 9 years of experience in Quality Assurance within the clinical or pharmaceutical industry. Other combinations of education and/or experience may be considered.</li>
<li>Knowledge of QMS system (Veeva preferred).</li>
<li>GCP QA Certification preferred (RQAP-GCP, or similar).</li>
<li>Experience across all phases of clinical development.</li>
<li>Knowledge of applicable FDA regulations and ICH guidelines.</li>
<li>Proficiency in QA tools and software (Veeva preferred).</li>
<li>Excellent communication and interpersonal skills, with the ability to work collaboratively with diverse teams.</li>
<li>Strong analytical and problem-solving skills, with a keen attention to detail.</li>
<li>Ability to travel up to 15%.</li>
</ul>
<div><strong>Reports to:&nbsp;</strong>Senior Director, Clinical Quality Assurance</div>
<div>&nbsp;</div>
<div><strong>Location:&nbsp;</strong>San Carlos, CA; Open to Remote</div>
<div>&nbsp;</div>
<div>
<div><strong><span data-olk-copy-source="MessageBody">Work Arrangement (may be adjusted based on business needs, job responsibilities, or changes to company policy):&nbsp;</span></strong></div>
<div>Hybrid (minimum of 3 days per week onsite) / Remote</div>
</div>
<div>&nbsp;</div>
<div><strong>Compensation:</strong></div>
<div>The compensation package will be competitive and includes comprehensive benefits and an equity component.</div>
<div>&nbsp;</div>
<div><strong>Salary Range: </strong>$163,000 – $191,000 (SF Bay Area). Salary ranges for non-California locations may vary.</div><div class="content-conclusion"><p class="x_MsoNormal"><span class="x_spanwithbackgroundcolor"><strong><span data-olk-copy-source="MessageBody">Equal Opportunity</span></strong></span></p>
<p class="x_MsoNormal"><em>We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.</em></p>
<p class="x_elementtoproof"><strong>Recruitment Fraud Notice</strong></p>
<p class="x_elementtoproof"><em>Please be aware of fraud or scams from individuals, organizations and/or internet sites claiming to represent Vaxcyte in recruitment activities. Vaxcyte has an established recruitment process for all positions prior to issuing an offer for employment and we will never extend unsolicited employment offers or ask candidates to provide financial or sensitive personal information as part of the application process. All legitimate communication from Vaxcyte will come from an official @vaxcyte.com email address. Qualified and interested candidates should apply to current openings at&nbsp;</em><a href="https://vaxcyte.com/careers/" data-auth="NotApplicable" data-linkindex="4"><em>vaxcyte.com/careers</em></a><em>.</em></p>
<p>&nbsp;</p></div>

Senior Manager, Clinical Quality Assurance

<div class="content-intro"><h3><strong>Join our Mission to Protect Humankind!</strong></h3>
<div>Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, which have serious and costly health consequences when left unchecked. Working to eradicate or treat bacterial infections such as invasive pneumococcal disease, Group A Strep, and Shigella is just the beginning. Our path to success is clear and well-defined, and Vaxcyte is set up to go the distance.&nbsp;</div>
<div>&nbsp;</div>
<div><strong>WHAT</strong>&nbsp;we do is every bit as important as&nbsp;<strong>HOW</strong>&nbsp;we do it!&nbsp;Our work together is guided by four enduring core values:</div>
<div>&nbsp;</div>
<div>*RETHINK CONVENTION: We bring creative and intellectual diversity to every facet of the work we do in order to innovate and re-innovate the way vaccines are delivered.</div>
<div>&nbsp;</div>
<div>*AIM HIGH: We embody our collectively audacious goal to courageously make the most complex biologics ever attempted to protect humankind.</div>
<div>&nbsp;</div>
<div>*LEAD WITH HEART: Everyone leads at Vaxcyte with a kindness-first, inclusive approach to collaboration and vigorous debate that advances our business objectives.</div>
<div>&nbsp;</div>
<div>*MODEL EXCELLENCE:&nbsp; The magnitude of our challenge requires our shared commitment to demonstrating integrity, accountability, equality and clarity across communications and decision making.</div></div><h3><strong>Summary:</strong></h3>
<p>Vaxcyte is looking for an energetic and talented individual to join the Manufacturing Science and Technology (MSAT) team in the role of Protein Intermediates Sr Bioprocess Engineer. The incumbent will support the microbial manufacturing operations from commercial readiness through PPQ and ongoing commercial production, onsite at contract manufacturing organizations (CMO), with the primary responsibility to provide technical and operational support of manufacturing operations that ensure robust and efficient manufacturing processes. This position will primarily be located in Visp, Switzerland, but will have responsibilities to oversee CMOs in Italy and Germany as well.&nbsp;</p>
<p>&nbsp;</p>
<p>This position will require the candidate to manage the highly complex microbial manufacturing processes for Vaxcyte’s vaccine portfolio. This is an exciting opportunity to join an outstanding team, with a mission to support late-stage clinical manufacture, launch, and commercial operations for the PCV franchise.&nbsp; The successful candidate will have the following skills and qualities:</p>
<ul>
<li>A skilled process engineer with expertise in:</li>
<li>microbial fermentation (cell expansion, fed-batch fermentation)</li>
<li>primary recovery (centrifugation, diverse filtrations, precipitation)</li>
<li>Purificatio<em>n (Ultrafiltration/Diafiltration and Chromatography)</em></li>
<li>An exceptional team player who works seamlessly with others, speaks up, and remains focused on achieving the best results to attain company goals.</li>
<li>The ability to analyze data and communicate conclusions, decisions and recommendations concisely to key stakeholders.</li>
<li>A strong sense of ownership and accountability; commitment to Vaxcyte’s mission of protecting humankind.</li>
</ul>
<h3>Essential Functions:</h3>
<ul>
<li>Work cross functionally with program management, process development, quality, facilities, regulatory, finance, logistics, clinical supply, and CMO / supplier management to ensure manufacture under GMP of different polysaccharide intermediates required for Vaxcyte’s vaccine portfolio.</li>
<li>Oversight of CMO service provider(s) to ensure delivery of commercial readiness, process validation, and commercial stage manufacturing campaigns.</li>
<li>Enable MSAT DS team participation in technology transfer, equipment/technology procurement and qualification, late-stage process characterization, process validation, and deviation and deficiency investigations and troubleshooting.</li>
<li>Lead all aspects of and engage in the planning, design, execution, and documentation of Polysaccharides manufacturing process Investigations and CAPAs.</li>
<li>Drive continuous improvement and change management in Polysaccharides manufacturing processes through technological innovation and application of first principles in process engineering.</li>
<li>Support the process to select new CMOs and suppliers.</li>
<li>Leverage literature, industry/regulatory guidance, and practical experience to perform work and influence CMC strategies.</li>
<li>Recommend and implement new technology that advances knowledge and productivity within the department. Drive continuous improvement.</li>
<li>Author and review technical reports, manufacturing documents, regulatory submissions, and publications.</li>
<li>Present at department, project team, and senior management meetings. May present externally at scientific conferences.</li>
<li>Support the CMOs during inspections of health authorities where necessary and ensure proper follow-up of any potential observation or recommendation.</li>
</ul>
<h3>Requirements:&nbsp;</h3>
<ul>
<li>PhD in Bio/Chemical Engineering or Microbiology/Chemistry/Biochemistry with 8+ years of relevant Pharma/Biotech industry experience, or Master’s degree in Bio/Chemical Engineering or Microbiology/Chemistry/ Biochemistry with 5+ years of relevant Pharma/Biotech industry experience.</li>
<li>Experience with Vaccine manufacturing operations preferred.</li>
<li>Strong experience in Drug Substance Manufacturing under GMP regulations required. Understanding of Quality systems. Experience in Drug Substance manufacturing equipment specification and qualification preferred.</li>
<li>Strong scientific or technological (process engineering) background and hands-on experience with bacterial fermentation, product recovery, and purification processes. Commercial manufacturing experience preferred.</li>
<li>Deep knowledge of protein-polysaccharide conjugation principles; <em>OR</em> In-depth understanding of bacterial fermentation principles, bioreactor systems and process analytics/control systems</li>
<li>Sound knowledge of
<ul>
<li>product recovery unit operations such as homogenization/microfluidization, centrifugation, and depth filtration</li>
<li>product purification unit operations such as chromatography, UF/DF TFF, and precipitation</li>
<li>process analytics/control systems</li>
</ul>
</li>
<li>Experience with cell-free upstream technology is a plus but not required.</li>
<li>Strong ability in troubleshooting equipment/technology and process. Adept at FMEA. Excellent analytic skills. Experience in Investigations and development and implementation of CAPAs preferred.</li>
<li>Experience with facility fit assessment, facility start-up, technology transfer, process validation, and scale-down studies implementing DOE desired.</li>
<li>Strong interpersonal and leadership skills. Ability to communicate effectively both verbally and in written formats. Experience with Cross-Functional teams and managing direct reports.</li>
<li>Proven technical leadership skills including strong project management skills.</li>
<li>Fluency in spoken and written English is mandatory.</li>
</ul>
<div><strong>Reports to:&nbsp;</strong>Associate Director, MSAT, Proteins</div>
<div>&nbsp;</div>
<div><strong>Location:&nbsp;</strong>Visp, Switzerland</div>
<div>&nbsp;</div>
<div>
<div><strong><span data-olk-copy-source="MessageBody">Work Arrangement (may be adjusted based on business needs, job responsibilities, or changes to company policy):&nbsp;</span></strong></div>
<div>Hybrid (minimum of 3 days per week onsite)</div>
<div>&nbsp;</div>
</div>
<div><strong>Compensation:</strong></div>
<div>The compensation package will be competitive and includes comprehensive benefits and an equity component.</div>
<div>&nbsp;</div>
<div>
<div><strong>Relocation:&nbsp;</strong></div>
<div>This role is not eligible for relocation assistance.&nbsp;</div>
</div><div class="content-conclusion"><p class="x_MsoNormal"><span class="x_spanwithbackgroundcolor"><strong><span data-olk-copy-source="MessageBody">Equal Opportunity</span></strong></span></p>
<p class="x_MsoNormal"><em>We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.</em></p>
<p class="x_elementtoproof"><strong>Recruitment Fraud Notice</strong></p>
<p class="x_elementtoproof"><em>Please be aware of fraud or scams from individuals, organizations and/or internet sites claiming to represent Vaxcyte in recruitment activities. Vaxcyte has an established recruitment process for all positions prior to issuing an offer for employment and we will never extend unsolicited employment offers or ask candidates to provide financial or sensitive personal information as part of the application process. All legitimate communication from Vaxcyte will come from an official @vaxcyte.com email address. Qualified and interested candidates should apply to current openings at&nbsp;</em><a href="https://vaxcyte.com/careers/" data-auth="NotApplicable" data-linkindex="4"><em>vaxcyte.com/careers</em></a><em>.</em></p>
<p>&nbsp;</p></div>

Senior Bioprocess Engineer II, MSAT, Proteins

<div class="content-intro"><h3><strong>Join our Mission to Protect Humankind!</strong></h3>
<div>Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, which have serious and costly health consequences when left unchecked. Working to eradicate or treat bacterial infections such as invasive pneumococcal disease, Group A Strep, and Shigella is just the beginning. Our path to success is clear and well-defined, and Vaxcyte is set up to go the distance.&nbsp;</div>
<div>&nbsp;</div>
<div><strong>WHAT</strong>&nbsp;we do is every bit as important as&nbsp;<strong>HOW</strong>&nbsp;we do it!&nbsp;Our work together is guided by four enduring core values:</div>
<div>&nbsp;</div>
<div>*RETHINK CONVENTION: We bring creative and intellectual diversity to every facet of the work we do in order to innovate and re-innovate the way vaccines are delivered.</div>
<div>&nbsp;</div>
<div>*AIM HIGH: We embody our collectively audacious goal to courageously make the most complex biologics ever attempted to protect humankind.</div>
<div>&nbsp;</div>
<div>*LEAD WITH HEART: Everyone leads at Vaxcyte with a kindness-first, inclusive approach to collaboration and vigorous debate that advances our business objectives.</div>
<div>&nbsp;</div>
<div>*MODEL EXCELLENCE:&nbsp; The magnitude of our challenge requires our shared commitment to demonstrating integrity, accountability, equality and clarity across communications and decision making.</div></div><h3><strong>Summary:</strong></h3>
<p>Vaxcyte is seeking a Commercial Project Manager to join the IT Project Management team and support commercial launch readiness. In partnership with the Commercial Launch Lead and cross-functional stakeholders, this role will own key project management deliverables, including the integrated launch schedule, critical path, meeting governance, risk log, dashboards, status reporting, and communications. The role will also coordinate across Commercial and functional workstreams to support resource planning, KPI tracking, process and tool adoption, launch issue resolution, and post-launch performance visibility.</p>
<h3>Essential Functions:</h3>
<p><strong>Launch Readiness &amp; Timeline Accountability</strong></p>
<ul>
<li>Manages the integrated launch schedule, keeping timelines, milestones, dependencies, and decisions current and aligned.</li>
<li>Manages the commercialization critical path, tracks priority milestones, and escalates timing or execution risks.</li>
<li>Establishes meeting governance, including cadence, agendas, decisions, action items, and follow-up.</li>
<li>Administers the commercialization risk log, tracking risks, owners, mitigation plans, status, and escalations.</li>
</ul>
<p><strong>Cross-Functional Coordination &amp; Communication</strong></p>
<ul>
<li>Coordinates across Commercial and functional workstreams to maintain alignment, visibility, and timely information flow.</li>
<li>Supports workstream owners by tracking deliverables, timelines, dependencies, and reviews without owning function-specific content or decisions.</li>
<li>Maintains dashboards, status reports, and communications that show readiness, risks, milestones, and dependencies.</li>
</ul>
<p><strong>Resource Management</strong></p>
<ul>
<li>Supports capacity planning, demand management, and resource allocation.</li>
<li>Identifies resource constraints and trade-offs to support leadership decisions.</li>
</ul>
<p><strong>Performance Metrics and Reporting</strong></p>
<ul>
<li>Develops and maintains selected project management KPIs.</li>
<li>Uses performance trends to inform improvements and leadership discussions.</li>
</ul>
<p><strong>Processes, Tools, and Dashboards</strong></p>
<ul>
<li>Maintains project management processes, tools, templates, and dashboards.</li>
<li>Drives consistent use of standards and tools across projects.</li>
<li>Improves visibility into project health, capacity, and outcomes.</li>
</ul>
<h3>Requirements:&nbsp;</h3>
<ul>
<li>MS, or BS degree in life sciences or biotechnology; advanced degree desired. Other combinations of education and/or experience may be considered.</li>
<li>8+ years of project management experience in the pharmaceutical, biotechnology, or vaccines industry, with demonstrated skill managing cross-functional timelines, dependencies, risks, governance, and communications.</li>
<li>Experience supporting commercial launch readiness in pharma or vaccines, including coordination across Commercial, Medical Affairs, Regulatory, Market Access, Trade and Distribution, Supply, IT, and related functions.</li>
<li>Experience enabling pharma commercial projects through digital tools, platforms, dashboards, and project management systems that improve visibility, coordination, and execution.</li>
<li>Experience with direct sales or field commercial models, including non-prescription or buy-and-bill channels; prescription-only experience is not sufficient.</li>
<li>Proven influence management and communication skills, at all levels of the organization</li>
<li>Experience with Enterprise Planning (ERP) software for resource planning</li>
<li>Working knowledge of MS Word, Excel, PowerPoint, Visio, and Project</li>
<li>Excellent written and oral communication skills</li>
<li>PMP Certification and/or Project Management training desired</li>
<li>All Vaxcyte employees require vaccination against COVID-19</li>
</ul>
<div><strong>Reports to: </strong>Senior Director IT Program Management</div>
<div>&nbsp;</div>
<div><strong>Location: </strong>Philadelphia, PA</div>
<div>&nbsp;</div>
<div>
<div><strong><span data-olk-copy-source="MessageBody">Work Arrangement (may be adjusted based on business needs, job responsibilities, or changes to company policy):&nbsp;</span></strong></div>
<div>Hybrid (minimum of 3 days per week onsite)</div>
</div>
<div>&nbsp;</div>
<div><strong>Compensation:</strong></div>
<div>The compensation package will be competitive and includes comprehensive benefits and an equity component.</div>
<div>&nbsp;</div>
<div><strong>Salary Range: </strong>$144,000 - $168,000 (SF Bay Area). Salary ranges for non-California locations may vary.</div>
<div>&nbsp;</div>
<div><strong>Relocation:&nbsp;</strong></div>
<div>This role is not eligible for relocation assistance.&nbsp;</div><div class="content-conclusion"><p class="x_MsoNormal"><span class="x_spanwithbackgroundcolor"><strong><span data-olk-copy-source="MessageBody">Equal Opportunity</span></strong></span></p>
<p class="x_MsoNormal"><em>We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.</em></p>
<p class="x_elementtoproof"><strong>Recruitment Fraud Notice</strong></p>
<p class="x_elementtoproof"><em>Please be aware of fraud or scams from individuals, organizations and/or internet sites claiming to represent Vaxcyte in recruitment activities. Vaxcyte has an established recruitment process for all positions prior to issuing an offer for employment and we will never extend unsolicited employment offers or ask candidates to provide financial or sensitive personal information as part of the application process. All legitimate communication from Vaxcyte will come from an official @vaxcyte.com email address. Qualified and interested candidates should apply to current openings at&nbsp;</em><a href="https://vaxcyte.com/careers/" data-auth="NotApplicable" data-linkindex="4"><em>vaxcyte.com/careers</em></a><em>.</em></p>
<p>&nbsp;</p></div>

Commercial Project Manager

<div class="content-intro"><h3><strong>Join our Mission to Protect Humankind!</strong></h3>
<div>Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, which have serious and costly health consequences when left unchecked. Working to eradicate or treat bacterial infections such as invasive pneumococcal disease, Group A Strep, and Shigella is just the beginning. Our path to success is clear and well-defined, and Vaxcyte is set up to go the distance.&nbsp;</div>
<div>&nbsp;</div>
<div><strong>WHAT</strong>&nbsp;we do is every bit as important as&nbsp;<strong>HOW</strong>&nbsp;we do it!&nbsp;Our work together is guided by four enduring core values:</div>
<div>&nbsp;</div>
<div>*RETHINK CONVENTION: We bring creative and intellectual diversity to every facet of the work we do in order to innovate and re-innovate the way vaccines are delivered.</div>
<div>&nbsp;</div>
<div>*AIM HIGH: We embody our collectively audacious goal to courageously make the most complex biologics ever attempted to protect humankind.</div>
<div>&nbsp;</div>
<div>*LEAD WITH HEART: Everyone leads at Vaxcyte with a kindness-first, inclusive approach to collaboration and vigorous debate that advances our business objectives.</div>
<div>&nbsp;</div>
<div>*MODEL EXCELLENCE:&nbsp; The magnitude of our challenge requires our shared commitment to demonstrating integrity, accountability, equality and clarity across communications and decision making.</div></div><h3><strong>Summary:</strong></h3>
<p>Vaxcyte has an exciting opportunity for an energetic and talented individual to join our Analytical Development team.&nbsp;The Scientist II, 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.</p>
<h3>Essential Functions:</h3>
<p>Method Development &amp; Troubleshooting</p>
<ul>
<li>Contribute to method development, optimization, and qualification/validation readiness activities.</li>
<li>Design and execute experiments to evaluate critical method parameters and define appropriate system suitability and control strategies.</li>
<li>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.</li>
<li>Support and/or execute method transfer activities, including protocol preparation, training support, execution at receiving labs, and resolution of transfer issues.</li>
<li>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.</li>
</ul>
<p>Team Collaboration</p>
<ul>
<li>Partner effectively with cross-functional teams to define analytical plans, meet project timelines, and deliver high-quality outputs.</li>
<li>Communicate experimental progress, data interpretation, and emerging risks clearly; propose mitigation plans and align next steps with stakeholders.</li>
<li>Contribute to a compliant, safety-focused, and scientifically rigorous lab culture, model good documentation practices and data integrity expectations.</li>
<li>Train and mentor junior staff/new team members on assays, workflows, and troubleshooting; provide day-to-day technical guidance and feedback.</li>
</ul>
<p>Analytical Testing &amp; Data Generation</p>
<ul>
<li>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).</li>
<li>Execute assays in accordance with approved methods, SOPs, and applicable quality standards (GLP/GMP as applicable); identify and troubleshoot common issues.</li>
<li>Perform data processing and interpretation; summarize results, trends, and potential risks, and escalate complex findings for review and decision-making.</li>
<li>Maintain accurate, timely documentation in laboratory notebooks or electronic systems; contribute to clear technical communications to project and cross-functional stakeholders.</li>
</ul>
<p>Laboratory Operations &amp; Instrumentation</p>
<ul>
<li>Coordinate routine instrument maintenance and service activities; interface with vendors as needed and support timely issue resolution.</li>
<li>Ensure laboratory organization, cleanliness, and compliant material labeling/storage practices.</li>
<li>Manage inventory of reagents, standards, and consumables; initiate procurement, track critical supplies, and support forecasting to avoid stockouts.</li>
</ul>
<p>Safety &amp; Compliance</p>
<ul>
<li>Follow all Environmental Health &amp; Safety (EHS) policies and laboratory safety practices.</li>
<li>Handle chemicals and biological materials safely and in compliance with regulatory requirements.</li>
<li>Ensure proper waste disposal and adherence to hazardous material handling procedures.</li>
<li>Support audit and inspection readiness activities where applicable.</li>
</ul>
<h3>Requirements:&nbsp;</h3>
<ul>
<li>PhD, MS or Bachelor’s degree in Chemistry, Biochemistry, Biology, Pharmaceutical Sciences, or a related scientific discipline. PhD with 2-5 years; MS with 7+ years; BS/BA with 10+ years of relevant industry experience in analytical development, QC, or related field. Other combinations of education and/or experience may be considered.</li>
<li>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.</li>
<li>Experience independently driving method development or optimization activities preferred.</li>
</ul>
<ul>
<li>Strong knowledge of analytical chemistry/biochemistry principles with demonstrated application to assay development and control strategies.</li>
<li>Proven ability to independently troubleshoot non-routine assay and instrument issues using structured root-cause analysis and data-driven decision making.</li>
<li>Proficient with analytical software, data processing workflows, and statistical tools.</li>
<li>Strong scientific judgment and attention to detail consistently produces high-quality, inspection-ready documentation.</li>
<li>Ability to independently plan and prioritize work, manage multiple projects, and meet timelines with minimal supervision.</li>
<li>Clear and effective written and verbal communication; able to summarize complex data, present recommendations, and collaborate across functions.</li>
<li>Ability to work in a laboratory environment for extended periods.</li>
<li>Ability to lift up to 25 lbs.</li>
<li>Use of personal protective equipment (PPE) required.</li>
<li>Contribute to a positive, inclusive, and safety-focused laboratory culture.</li>
</ul>
<div><strong>Reports to: </strong>Senior Scientist, Analytical Development</div>
<div>&nbsp;</div>
<div><strong>Location:&nbsp;</strong>San Carlos, CA</div>
<div>&nbsp;</div>
<div>
<div><strong><span data-olk-copy-source="MessageBody">Work Arrangement (may be adjusted based on business needs, job responsibilities, or changes to company policy):&nbsp;</span></strong></div>
<div>Onsite (minimum of 4 days per week onsite)</div>
</div>
<div>&nbsp;</div>
<div><strong>Expected Contract Length:&nbsp;</strong>12 Months</div>
<div>&nbsp;</div>
<div><strong>Hourly Range:&nbsp;</strong>$70 - $78</div>
<p>&nbsp;</p><div class="content-conclusion"><p class="x_MsoNormal"><span class="x_spanwithbackgroundcolor"><strong><span data-olk-copy-source="MessageBody">Equal Opportunity</span></strong></span></p>
<p class="x_MsoNormal"><em>We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.</em></p>
<p class="x_elementtoproof"><strong>Recruitment Fraud Notice</strong></p>
<p class="x_elementtoproof"><em>Please be aware of fraud or scams from individuals, organizations and/or internet sites claiming to represent Vaxcyte in recruitment activities. Vaxcyte has an established recruitment process for all positions prior to issuing an offer for employment and we will never extend unsolicited employment offers or ask candidates to provide financial or sensitive personal information as part of the application process. All legitimate communication from Vaxcyte will come from an official @vaxcyte.com email address. Qualified and interested candidates should apply to current openings at&nbsp;</em><a href="https://vaxcyte.com/careers/" data-auth="NotApplicable" data-linkindex="4"><em>vaxcyte.com/careers</em></a><em>.</em></p>
<p>&nbsp;</p></div>

Scientist II, Analytical Development (Contract)

<div class="content-intro"><h3><strong>Join our Mission to Protect Humankind!</strong></h3>
<div>Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, which have serious and costly health consequences when left unchecked. Working to eradicate or treat bacterial infections such as invasive pneumococcal disease, Group A Strep, and Shigella is just the beginning. Our path to success is clear and well-defined, and Vaxcyte is set up to go the distance.&nbsp;</div>
<div>&nbsp;</div>
<div><strong>WHAT</strong>&nbsp;we do is every bit as important as&nbsp;<strong>HOW</strong>&nbsp;we do it!&nbsp;Our work together is guided by four enduring core values:</div>
<div>&nbsp;</div>
<div>*RETHINK CONVENTION: We bring creative and intellectual diversity to every facet of the work we do in order to innovate and re-innovate the way vaccines are delivered.</div>
<div>&nbsp;</div>
<div>*AIM HIGH: We embody our collectively audacious goal to courageously make the most complex biologics ever attempted to protect humankind.</div>
<div>&nbsp;</div>
<div>*LEAD WITH HEART: Everyone leads at Vaxcyte with a kindness-first, inclusive approach to collaboration and vigorous debate that advances our business objectives.</div>
<div>&nbsp;</div>
<div>*MODEL EXCELLENCE:&nbsp; The magnitude of our challenge requires our shared commitment to demonstrating integrity, accountability, equality and clarity across communications and decision making.</div></div><h3><strong>Summary:</strong></h3>
<p>Vaxcyte is seeking a hands-on and detail-oriented Lab Compliance Manager to join our Global Analytical organization in San Carlos, CA. The Analytical Development (AD) laboratories within Global Analytical support Vaxcyte's CMC programs by performing method development, supporting method transfer, and executing various characterization testing activities that enable regulatory filings. This role will serve as the primary compliance partner for the AD laboratories, working collaboratively with Quality Assurance (QA), to operationalize established quality policies and procedures within the lab setting.</p>
<p>Additionally, along with ensure the AD labs are aligned with Vaxcyte Quality requirements, the individual will be key in supporting an ongoing effort to evaluate and enhance the AD laboratories to enable operation as a Phase I/II early clinical release and stability testing QC laboratory. This requires an individual with a solid understanding of laboratory GMP requirements who can help guide lab personnel through the transition from a non-GMP to a GMP-compliant operating environment. The Lab Compliance Manager will directly manage the Sample Management Specialist and will report to the Director of Infrastructure and Capabilities in Global Analytical.</p>
<h3>Essential Functions:</h3>
<ul>
<li>Directly manage the Sample Management Specialist, providing day-to-day oversight of sample receipt, logging, storage, distribution, and disposition activities to ensure compliance with approved SOPs, chain-of-custody requirements, and GDP standards.</li>
<li>Support the Sample Management process by stepping in and managing samples during times of high sample volume.</li>
<li>Partner with QA to translate established quality policies and procedures into AD laboratory-specific SOPs, work instructions, and forms; serve as the primary author of lab-level controlled documents with QA review and approval.</li>
<li>Support implementation of laboratory quality processes — including change control, deviation management, OOS/OOT investigations, and CAPA — in alignment with QA-approved frameworks and applicable regulatory expectations for Phase I/II programs.</li>
<li>Implement QA-defined data integrity requirements within the AD laboratory, ensuring all staff adhere to ALCOA+ principles across paper-based and electronic records, including systems such as Benchling and instrument data acquisition software.</li>
<li>Maintain method qualification records and lifecycle tracking documentation, including qualification status, method changes, and requalification needs, ensuring records are complete and inspection-ready.</li>
<li>Ensure equipment qualification activities (IQ, OQ, PQ) for AD laboratory instruments are in accordance with QA-approved protocols and maintain calibration and preventive maintenance schedules to ensure equipment remains in a qualified state. Additionally, partner with Facilities &amp; Engineering to oversee the AD equipment as a whole.</li>
<li>Ensure equipment logbooks and qualification records are maintained in a manner consistent with GDP requirements and inspection readiness expectations.</li>
<li>Partner with the Analytical Science and Technology (ASAT) group to ensure robust oversight is in place for the receipt, qualification, storage, traceability, and controlled disposal of reference standards and critical reagents used in AD laboratory testing.</li>
<li>Coordinate and deliver role-based laboratory training in alignment with QA-established training requirements, maintaining training records and qualification documentation for all AD laboratory personnel.</li>
<li>Ensure AD laboratory documentation, records, and daily practices are maintained in a state of inspection readiness; support QA during internal audits and regulatory inspections by serving as the lab-level point of contact for compliance-related questions.</li>
</ul>
<h3>Requirements:&nbsp;</h3>
<ul>
<li>Bachelor's degree in a life sciences discipline (Chemistry, Biochemistry, Biology, or related field), or equivalent combination of education and relevant work experience.</li>
<li>8+ years of experience in a compliance, quality, analytical, or laboratory role within the biopharmaceutical, vaccine, or related life sciences industry.</li>
<li>Working knowledge of GMP and/or GLP principles and their practical application in a laboratory setting, including familiarity with the distinction between GMP policy and lab-level operational procedures.</li>
<li>Experience authoring or contributing to controlled documents such as SOPs, work instructions, qualification protocols, or investigation reports in a regulated environment.</li>
<li>Familiarity with data integrity principles (ALCOA+) and Good Documentation Practices (GDP), with demonstrated ability to apply these in day-to-day laboratory operations.</li>
<li>Experience executing or supporting equipment qualification activities in a regulated analytical or QC laboratory environment.</li>
<li>Strong interpersonal and collaboration skills, with the ability to work effectively with QA, Analytical Development scientists, and cross-functional teams.</li>
<li>Effective written and verbal communication skills, with demonstrated ability to translate compliance requirements into clear, practical laboratory procedures.</li>
<li>Prior experience in a people management or mentorship capacity, or demonstrated readiness to take on direct management responsibilities.</li>
</ul>
<p></p>
<h3>Preferred:&nbsp;</h3>
<ul>
<li>Experience at a clinical-stage biopharmaceutical or vaccine company, ideally in a role interfacing with both QA and analytical laboratory functions.</li>
<li>Familiarity with FDA expectations for Phase I/II QC or analytical laboratory operations supporting early clinical biologics or vaccine programs.</li>
<li>Experience with electronic laboratory or quality systems such as Benchling, LIMS, or comparable platforms.</li>
<li>Exposure to 21 CFR Part 11 and electronic records/electronic signatures (ERES) compliance in a laboratory context.</li>
<li>Prior experience supporting internal audits or regulatory inspections.</li>
<li>Familiarity with ICH guidelines relevant to analytical methods and early clinical development (Q2, Q6, Q8, Q10).</li>
</ul>
<p></p>
<div><strong>Reports to:&nbsp;</strong>Director, Infrastructure &amp; Capabilities</div>
<div>&nbsp;</div>
<div><strong>Location:&nbsp;</strong>San Carlos, CA</div>
<div>&nbsp;</div>
<div>
<div><strong><span data-olk-copy-source="MessageBody">Work Arrangement (may be adjusted based on business needs, job responsibilities, or changes to company policy):&nbsp;</span></strong></div>
<div>Onsite (minimum of 5 days per week onsite)&nbsp;</div>
</div>
<div>&nbsp;</div>
<div><strong>Compensation:</strong></div>
<div>The compensation package will be competitive and includes comprehensive benefits and an equity component.</div>
<div>&nbsp;</div>
<div><strong>Salary Range: </strong>$153,000 - $178,000 (SF Bay Area). Salary ranges for non-California locations may vary.</div><div class="content-conclusion"><p class="x_MsoNormal"><span class="x_spanwithbackgroundcolor"><strong><span data-olk-copy-source="MessageBody">Equal Opportunity</span></strong></span></p>
<p class="x_MsoNormal"><em>We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.</em></p>
<p class="x_elementtoproof"><strong>Recruitment Fraud Notice</strong></p>
<p class="x_elementtoproof"><em>Please be aware of fraud or scams from individuals, organizations and/or internet sites claiming to represent Vaxcyte in recruitment activities. Vaxcyte has an established recruitment process for all positions prior to issuing an offer for employment and we will never extend unsolicited employment offers or ask candidates to provide financial or sensitive personal information as part of the application process. All legitimate communication from Vaxcyte will come from an official @vaxcyte.com email address. Qualified and interested candidates should apply to current openings at&nbsp;</em><a href="https://vaxcyte.com/careers/" data-auth="NotApplicable" data-linkindex="4"><em>vaxcyte.com/careers</em></a><em>.</em></p>
<p>&nbsp;</p></div>

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