All Vaxcyte employees require vaccination against COVID-19. * Other combinations of education and/or experience may be considered. Reports to: Vice President, Project Management Location: San Carlos ...
52 Vaxcyte Project Management Jobs Hiring Near You
All Vaxcyte employees require vaccination against COVID-19. * Other combinations of education and/or experience may be considered. Reports to: Vice President, Project Management Location: San Carlos ...
... Vaxcyte's products. The Staff Engineer, Process Systems will work closely with Process Development, MSAT, Supply Chain, Quality, Project Management, Business Development, and Regulatory functions, as ...
... Vaxcyte's products. The Staff Engineer, Process Systems will work closely with Process Development, MSAT, Supply Chain, Quality, Project Management, Business Development, and Regulatory functions, as ...
... Vaxcyte's products. The Staff Engineer, Process Systems will work closely with Process Development, MSAT, Supply Chain, Quality, Project Management, Business Development, and Regulatory functions, as ...
... Vaxcyte's products. The Staff Engineer, Process Systems will work closely with Process Development, MSAT, Supply Chain, Quality, Project Management, Business Development, and Regulatory functions, as ...
Strong computer skills, project management skills, and a high attention to detail. * Experience ... Vaxcyte has an established recruitment process for all positions prior to issuing an offer for ...
Strong computer skills, project management skills, and a high attention to detail. * Experience ... Vaxcyte has an established recruitment process for all positions prior to issuing an offer for ...
AI Implementation Consultant - Legal
San Carlos, CA · On-site
$40 - $50/hr
Demonstrated project management or client-facing experience (internships count!) is preferred ... Vaxcyte has an established recruitment process for all positions prior to issuing an offer for ...
AI Implementation Consultant - Legal
San Carlos, CA · On-site
$40 - $50/hr
Demonstrated project management or client-facing experience (internships count!) is preferred ... Vaxcyte has an established recruitment process for all positions prior to issuing an offer for ...
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 ...
All Vaxcyte employees require vaccination against COVID-19. * Other combinations of education and/or experience may be considered. Reports to: Vice President, Project Management Location: San Carlos ...
All Vaxcyte employees require vaccination against COVID-19. * Other combinations of education and/or experience may be considered. Reports to: Vice President, Project Management Location: San Carlos ...
Excellent organizational and project management skills, with the ability to handle multiple ... Vaxcyte has an established recruitment process for all positions prior to issuing an offer for ...
Excellent organizational and project management skills, with the ability to handle multiple ... Vaxcyte has an established recruitment process for all positions prior to issuing an offer for ...
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 ...
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 ...
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 ...
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.
... data management, document review workflows, and collaborative project planning. * Passion for ... Vaxcyte has an established recruitment process for all positions prior to issuing an offer for ...
... data management, document review workflows, and collaborative project planning. * Passion for ... Vaxcyte has an established recruitment process for all positions prior to issuing an offer for ...
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 ...
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 ...
Scientist II, Upstream Development for Protein Development and Manufacturing
San Carlos, CA · On-site
$146K - $171K/yr
... project meetings. Participate in upstream database management and documentation in electronic ... Vaxcyte has an established recruitment process for all positions prior to issuing an offer for ...
Scientist II, Upstream Development for Protein Development and Manufacturing
San Carlos, CA · On-site
$146K - $171K/yr
... project meetings. Participate in upstream database management and documentation in electronic ... Vaxcyte has an established recruitment process for all positions prior to issuing an offer for ...
Sr. Director, Quality Assurance for Quality Control
San Carlos, CA · 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
San Carlos, CA · 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 ...
... management of critical reagents and reference materials that support immunoassays across Vaxcyte ... with project objectives. * Support immunoassay analytical control strategy execution, including ...
... management of critical reagents and reference materials that support immunoassays across Vaxcyte ... with project objectives. * Support immunoassay analytical control strategy execution, including ...
Senior Manager, Microbiology Support for Global ASAT
San Carlos, CA · On-site
$166K - $194K/yr
Vaxcyte is looking for an energetic and talented individual to join our Analytical Science and ... Responsible for quality event management (deviations, investigations, change control) related to ...
Senior Manager, Microbiology Support for Global ASAT
San Carlos, CA · On-site
$166K - $194K/yr
Vaxcyte is looking for an energetic and talented individual to join our Analytical Science and ... Responsible for quality event management (deviations, investigations, change control) related to ...
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 ...
Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to ... Manage inventory of reagents, standards, and consumables; assist with procurement and restocking.
Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to ... Manage inventory of reagents, standards, and consumables; assist with procurement and restocking.
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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:
The Sr. Project Manager, Regulatory CMC will serve as a key contributor to the company's project management, regulatory and CMC functions. Reporting to the Vice President, Project Management, this role will be highly hands-on, owning the planning, coordination, and execution of regulatory CMC submissions - including BLAs and Prior Approval Supplements - while partnering closely with CMC subject matter experts and external manufacturing partners.
This role is ideal for a detail-oriented project management professional who enjoys building integrated timelines, driving cross-functional alignment, and helping streamline submission processes in a growing biotechnology company.
Essential Functions:
Reports to: Vice President, Project Management
Location: San Carlos, CA
Work Arrangement (may be adjusted based on business needs, job responsibilities, or changes to company policy):
Hybrid (3 days per week onsite)
Compensation:
The compensation package will be competitive and includes comprehensive benefits and an equity component.
Salary Range: $166,000 - $195,000 (SF Bay Area). Salary ranges for non-California locations may vary.
Equal Opportunity
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.
Recruitment Fraud Notice
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 vaxcyte.com/careers.
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:
The Sr. Project Manager, Regulatory CMC will serve as a key contributor to the company's project management, regulatory and CMC functions. Reporting to the Vice President, Project Management, this role will be highly hands-on, owning the planning, coordination, and execution of regulatory CMC submissions - including BLAs and Prior Approval Supplements - while partnering closely with CMC subject matter experts and external manufacturing partners.
This role is ideal for a detail-oriented project management professional who enjoys building integrated timelines, driving cross-functional alignment, and helping streamline submission processes in a growing biotechnology company.
Essential Functions:
- Project Management for the planning, coordination, and execution of regulatory CMC submissions, including Biologics License Applications (BLA), Prior Approval Supplements (PAS), and other regulatory filings, ensuring cross-functional CMC content is authored, reviewed, and delivered on schedule.
- Partner with Regulatory and CMC subject matter experts to build and manage integrated submission timelines, authoring and review cycles, and publishing schedules for BLA, PAS, and supplemental regulatory filings.
- Track health authority commitments and post-submission activities and coordinate cross-functional teams to ensure timely, high-quality responses.
- Develop detailed Reg CMC timelines, identify risks and mitigating actions and communicate/escalate accordingly to ensure clarity of deliverables and timing to achieve overall product/project plan and corporate goals/objectives.
- Lead Reg CMC cross-functional meetings, including scheduling and facilitating meetings, sending out agendas, writing and distributing meeting summaries, managing team documentation, and tracking goals and action items.
- Communicate with appropriate stakeholders to ensure project team and leadership are fully informed and knowledgeable of project activities, status, and potential risks.
- Contribute to program cross-functional working plans and timelines, help teams prioritize workstreams, proactively identify and mitigate risks, and ensure sufficient resourcing to achieve program goals.
- Build and manage trackers and dashboards to communicate real-time status of regulatory submissions and the interdependencies with campaign manufacturing and analytical readiness, release and downstream use.
- Manage regulatory submission authoring and review with external CMOs through development of Statements of Work (SOW) contracts. Manage execution of SOWs and track progress and completion of deliverables.
- Identify and implement processes/tools to continuously improve and streamline the workflow of Reg CMC project management and submission teams.
- BA or BS degree in life sciences, engineering, or business administration; advanced degree desired.
- PMP Certification and/or Project Management training desired.
- 8+ years of experience in the pharmaceutical or biotechnology industry with at least three years of relevant experience in a CMC organization and at least two years directly supporting regulatory submissions, including significant experience in a cross-functional team environment.
- Solid understanding of CMC manufacturing and analytical activities required in biotech/drug/vaccine development, including knowledge of cGMP regulations, FDA/ICH regulatory requirements, and eCTD structure (Module 3 CMC content). Direct experience supporting or leading regulatory filings, including BLA and Prior Approval Supplements (PAS), required.
- Prior experience as a liaison with external manufacturing organizations desired.
- Demonstrated experience preparing, coordinating, and submitting regulatory filings such as BLA and Prior Approval Supplements (PAS), including managing authoring timelines, cross-functional review cycles, and health authority responses.
- Familiarity with regulatory submission systems and publishing tools (e.g., Veeva Vault RIM/Submissions) a plus.
- Expert analytical skills for integrating and interpreting interdisciplinary project information.
- Strong planning and tracking skills, well-organized, focused on results, capable of managing multiple projects with respect to priorities and self-management.
- Demonstrated ability to manage complex projects independently and ability to manage changes in processes, strategy, and competitive landscape.
- Strong team management skills, including facilitation, conflict resolution, and team development.
- Proven influence management and communication skills, at all levels of the organization.
- Working knowledge of MS Word, Excel, PowerPoint, Visio, and Project.
- Working knowledge of Veeva and Smartsheet a plus.
- Excellent written and oral communication skills.
- All Vaxcyte employees require vaccination against COVID-19.
- Other combinations of education and/or experience may be considered.
Reports to: Vice President, Project Management
Location: San Carlos, CA
Work Arrangement (may be adjusted based on business needs, job responsibilities, or changes to company policy):
Hybrid (3 days per week onsite)
Compensation:
The compensation package will be competitive and includes comprehensive benefits and an equity component.
Salary Range: $166,000 - $195,000 (SF Bay Area). Salary ranges for non-California locations may vary.
Equal Opportunity
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.
Recruitment Fraud Notice
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 vaxcyte.com/careers.
About Vaxcyte
Sourced by ZipRecruiter
Industry
Biotechnology research and development
Company size
51 - 200 Employees
Headquarters location
San Carlos, CA, US
Year founded
2013