Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to ... Excellent organizational and project management skills, with the ability to handle multiple ...
55 Vaxcyte Project Management Jobs Hiring Near You
Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to ... Excellent organizational and project management skills, with the ability to handle multiple ...
Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to ... Strong computer skills, project management skills, and a high attention to detail. * Experience ...
Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to ... Strong computer skills, project management skills, and a high attention to detail. * Experience ...
Stability Manager
San Carlos, CA · On-site
$134K - $162K/yr
Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to ... Primary responsibility will include managing stability studies for individual projects and ...
Stability Manager
San Carlos, CA · On-site
$134K - $162K/yr
Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to ... Primary responsibility will include managing stability studies for individual projects and ...
Senior Associate Scientist (Contract), Drug Product Analytics
San Carlos, CA · On-site
$56 - $62/hr
... on multiple projects at once, with fluid prioritization to enable aggressive timelines. This ... Vaxcyte is seeking a flexible and collaborative Scientist comfortable managing multiple priorities ...
Senior Associate Scientist (Contract), Drug Product Analytics
San Carlos, CA · On-site
$56 - $62/hr
... on multiple projects at once, with fluid prioritization to enable aggressive timelines. This ... Vaxcyte is seeking a flexible and collaborative Scientist comfortable managing multiple priorities ...
Associate Director of Data and Knowledge Management
San Carlos, CA · On-site
$183K - $214K/yr
Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to ... Strong project management and communication skills; able to work cross-functionally with scientific ...
Associate Director of Data and Knowledge Management
San Carlos, CA · On-site
$183K - $214K/yr
Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to ... Strong project management and communication skills; able to work cross-functionally with scientific ...
... navigate Vaxcyte's multiple projects and timelines. * Strong interpersonal skills; ability to ... Senior Manager, Drug Product Location: San Carlos, CA Work Arrangement: Onsite (minimum of 4 days ...
... navigate Vaxcyte's multiple projects and timelines. * Strong interpersonal skills; ability to ... Senior Manager, Drug Product Location: San Carlos, CA Work Arrangement: Onsite (minimum of 4 days ...
Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to ... Minimum 8 years of experience in IT project management, coordination, or change management roles.
Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to ... Minimum 8 years of experience in IT project management, coordination, or change management roles.
AI Implementation Consultant - Legal
San Carlos, CA · On-site
$40 - $50/hr
Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to ... Demonstrated project management or client-facing experience (internships count!) is preferred.
AI Implementation Consultant - Legal
San Carlos, CA · On-site
$40 - $50/hr
Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to ... Demonstrated project management or client-facing experience (internships count!) is preferred.
... to project teams to support development decisions. * Contribute to method development ... Vaxcyte is seeking a flexible and collaborative scientist comfortable managing multiple priorities ...
... to project teams to support development decisions. * Contribute to method development ... Vaxcyte is seeking a flexible and collaborative scientist comfortable managing multiple priorities ...
... on multiple projects at once, with fluid prioritization to enable aggressive timelines. This ... Vaxcyte is seeking a flexible and collaborative Scientist comfortable managing multiple priorities ...
... on multiple projects at once, with fluid prioritization to enable aggressive timelines. This ... Vaxcyte is seeking a flexible and collaborative Scientist comfortable managing multiple priorities ...
Sr. Director, Quality Assurance for Quality Control
OR · On-site +1
$229K - $268K/yr
Vaxcyte is looking for an energetic and talented individual to join our Quality Assurance team as a ... Excellent organizational and project management skills, with the ability to handle multiple ...
Sr. Director, Quality Assurance for Quality Control
OR · On-site +1
$229K - $268K/yr
Vaxcyte is looking for an energetic and talented individual to join our Quality Assurance team as a ... Excellent organizational and project management skills, with the ability to handle multiple ...
Sr. Manager, Regulatory Affairs
San Carlos, CA · On-site
$183K - $194K/yr
Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to ... Collaborate with cross-functional project teams and external business partners to develop ...
Sr. Manager, Regulatory Affairs
San Carlos, CA · On-site
$183K - $194K/yr
Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to ... Collaborate with cross-functional project teams and external business partners to develop ...
Associate Scientist II (Contract), Drug Product Analytics
San Carlos, CA · On-site
$51 - $56/hr
... navigate Vaxcyte's multiple projects and timelines. * Strong interpersonal skills; ability to ... Senior Manager, Drug Product Location: San Carlos, CA Work Arrangement: Onsite (minimum of 4 days ...
Associate Scientist II (Contract), Drug Product Analytics
San Carlos, CA · On-site
$51 - $56/hr
... navigate Vaxcyte's multiple projects and timelines. * Strong interpersonal skills; ability to ... Senior Manager, Drug Product Location: San Carlos, CA Work Arrangement: Onsite (minimum of 4 days ...
Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to ... data management, document review workflows, and collaborative project planning. * Passion for ...
Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to ... data management, document review workflows, and collaborative project planning. * Passion for ...
Vaxcyte is seeking a highly motivated and technically proficient Engineer II to join the ... Serve as a subject matter expert for conjugation related activities on project teams. * Contribute ...
Vaxcyte is seeking a highly motivated and technically proficient Engineer II to join the ... Serve as a subject matter expert for conjugation related activities on project teams. * Contribute ...
Senior Manager, Clinical Supply
San Carlos, CA · On-site
$158K - $185K/yr
Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to ... Develop detailed project plan for each packaging run. * Manage execution of packaging plan, and ...
Senior Manager, Clinical Supply
San Carlos, CA · On-site
$158K - $185K/yr
Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to ... Develop detailed project plan for each packaging run. * Manage execution of packaging plan, and ...
Senior IT Business Systems Analyst, SAP Finance
San Carlos, CA · On-site
$163K - $190K/yr
Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to ... Experience in identifying and managing project risks, with a proactive approach to mitigation.
Senior IT Business Systems Analyst, SAP Finance
San Carlos, CA · On-site
$163K - $190K/yr
Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to ... Experience in identifying and managing project risks, with a proactive approach to mitigation.
Scientist II, Upstream Development for Protein Development and Manufacturing
San Carlos, CA · On-site
$146K - $171K/yr
Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to ... project meetings. Participate in upstream database management and documentation in electronic ...
Scientist II, Upstream Development for Protein Development and Manufacturing
San Carlos, CA · On-site
$146K - $171K/yr
Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to ... project meetings. Participate in upstream database management and documentation in electronic ...
Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to ... Manage inventory of reagents, standards, and consumables; initiate procurement, track critical ...
Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to ... Manage inventory of reagents, standards, and consumables; initiate procurement, track critical ...
Corporate Affairs Associate
San Carlos, CA · On-site
... and for Vaxcyte's first potential product launch and additional key milestones. * Manage and ... Take on project-based assignments that build foundational skills in writing, coordination, and ...
Corporate Affairs Associate
San Carlos, CA · On-site
... and for Vaxcyte's first potential product launch and additional key milestones. * Manage and ... Take on project-based assignments that build foundational skills in writing, coordination, and ...
Vaxcyte Jobs Information
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Job description
Join our Mission to Protect Humankind!
Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, which have serious and costly health consequences when left unchecked. Working to eradicate or treat bacterial infections such as invasive pneumococcal disease, Group A Strep, and Shigella is just the beginning. Our path to success is clear and well-defined, and Vaxcyte is set up to go the distance.
WHAT we do is every bit as important as HOW we do it! Our work together is guided by four enduring core values:
*RETHINK CONVENTION: We bring creative and intellectual diversity to every facet of the work we do in order to innovate and re-innovate the way vaccines are delivered.
*AIM HIGH: We embody our collectively audacious goal to courageously make the most complex biologics ever attempted to protect humankind.
*LEAD WITH HEART: Everyone leads at Vaxcyte with a kindness-first, inclusive approach to collaboration and vigorous debate that advances our business objectives.
*MODEL EXCELLENCE: The magnitude of our challenge requires our shared commitment to demonstrating integrity, accountability, equality and clarity across communications and decision making.
Summary:
This role is pivotal in ensuring compliance with global regulatory guidelines and supporting our pipeline of high-fidelity vaccines. Vaxcyte is looking for an energetic and talented individual to join our Quality Assurance team as a Senior Director. This role carries dual accountability: providing direct QA support to the analytical operations based in Switzerland, while also managing the San Carlos-based QA team responsible for oversight of smaller-scale analytical activities. The Senior Director will be expected to operate effectively across both sites, navigating the distinct regulatory environments and operational cadences of each. The primary responsibility will be the QA oversight of QC activities associated with Vaxcyte's PCV Polysaccharides and Drug Substances. The Senior Director will work closely with internal teams (Process Development, MSAT, Quality Control, Regulatory, and Stability) and external partners (CDMOs and CTLs) to maintain the compliance of the analytical program.
Essential Functions:
Requirements:
Bachelor's degree in Biochemistry, Chemistry, or a related field with 15+ years of relevant industry experience. Other combinations of education and/or experience may be considered.
Reports to: Executive Director, Quality Assurance
Location: Raleigh, NC
Work Arrangement (may be adjusted based on business needs, job responsibilities, or changes to company policy): Remote
Compensation: The compensation package will be competitive and includes comprehensive benefits and an equity component.
Salary Range: $229,000 - $268,000 (North Carolina)
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.
Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, which have serious and costly health consequences when left unchecked. Working to eradicate or treat bacterial infections such as invasive pneumococcal disease, Group A Strep, and Shigella is just the beginning. Our path to success is clear and well-defined, and Vaxcyte is set up to go the distance.
WHAT we do is every bit as important as HOW we do it! Our work together is guided by four enduring core values:
*RETHINK CONVENTION: We bring creative and intellectual diversity to every facet of the work we do in order to innovate and re-innovate the way vaccines are delivered.
*AIM HIGH: We embody our collectively audacious goal to courageously make the most complex biologics ever attempted to protect humankind.
*LEAD WITH HEART: Everyone leads at Vaxcyte with a kindness-first, inclusive approach to collaboration and vigorous debate that advances our business objectives.
*MODEL EXCELLENCE: The magnitude of our challenge requires our shared commitment to demonstrating integrity, accountability, equality and clarity across communications and decision making.
Summary:
This role is pivotal in ensuring compliance with global regulatory guidelines and supporting our pipeline of high-fidelity vaccines. Vaxcyte is looking for an energetic and talented individual to join our Quality Assurance team as a Senior Director. This role carries dual accountability: providing direct QA support to the analytical operations based in Switzerland, while also managing the San Carlos-based QA team responsible for oversight of smaller-scale analytical activities. The Senior Director will be expected to operate effectively across both sites, navigating the distinct regulatory environments and operational cadences of each. The primary responsibility will be the QA oversight of QC activities associated with Vaxcyte's PCV Polysaccharides and Drug Substances. The Senior Director will work closely with internal teams (Process Development, MSAT, Quality Control, Regulatory, and Stability) and external partners (CDMOs and CTLs) to maintain the compliance of the analytical program.
Essential Functions:
- Lead quality oversight activities related to method validation, release and in-process testing for Drug Substance and Polysaccharide
- Serve as the primary liaison within Vaxcyte QA and with outside collaborators, building partnerships that support analytical needs for relevant programs.
- Represent QA at internal and external cross functional team meetings.
- Lead review and approval of internal and external GMP documentation for compliance, including specifications, Certificates of Analysis, validation reports, deviations, change controls, risk assessments, and CAPAs as they relate to polysaccharides and drug substance; apply technical and compliance expertise to critically evaluate reference standards, test methods, protocols, and raw data packages from CMOs and contract testing laboratories.
- Partner with QC, vendor management, and contract labs to set key performance indicators for monitoring vendor effectiveness.
- Drive resolution of quality performance issues with contract manufacturers and testing organizations
- Review Quality Agreements and regulatory documentation as required.
- Lead quality investigations of testing deviations and OOS.
- Contribute to regulatory filings, respond to questions from health authorities, and ensure quality of documentation used in support of regulatory submissions.
- Take part in audit preparations and help ensure ongoing readiness.
- Develop, review, and update GMP-related internal policies and procedures as necessary.
- Champion a culture of quality excellence and continuous improvement by proactively identifying systemic gaps, driving implementation of sustainable solutions, and establishing performance standards that elevate GMP compliance across internal teams and external partners.
Requirements:
Bachelor's degree in Biochemistry, Chemistry, or a related field with 15+ years of relevant industry experience. Other combinations of education and/or experience may be considered.
- Thorough knowledge of applicable FDA, EU, and ICH regulatory guidelines and pharmacopeia for method qualification and validation in biologics and vaccines, along with proven expertise in applying these regulations to develop practical solutions and phase-appropriate analytical strategies.
- Experience working with biochemistry, immunoassay, or microbiological assay techniques in a Quality Control environment.
- Excellent organizational and project management skills, with the ability to handle multiple projects under tight timelines.
- Excellent written and verbal communication skills, including the ability to work effectively in cross-functional teams.
- Previous experience in validation and transfer of analytical assays.
- Demonstrated ability to build and develop high-performing QA teams and influencing cross-functional and executive stakeholders in a fast-paced commercial-stage biotech company.
- Knowledge and experience in Risk Management principles.
- Knowledge in both clinical and commercial product desired.
- Ability to integrate and interpret interdisciplinary project information; with at least a high-level understanding of the drug/vaccine development process.
- Ability to work globally with CMOs in different countries and continents.
- Experience managing geographically distributed QA teams across multiple sites or countries, with the ability to build cohesive quality culture and consistent GMP standards across locations.
- Experience in BLA submission and commercial launch is highly desirable
Reports to: Executive Director, Quality Assurance
Location: Raleigh, NC
Work Arrangement (may be adjusted based on business needs, job responsibilities, or changes to company policy): Remote
Compensation: The compensation package will be competitive and includes comprehensive benefits and an equity component.
Salary Range: $229,000 - $268,000 (North Carolina)
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.
About Vaxcyte
Sourced by ZipRecruiter
Industry
Biotechnology research and development
Company size
51 - 200 Employees
Headquarters location
San Carlos, CA, US
Year founded
2013