---
title: 'Senior Project Manager, Regulatory CMC at Vaxcyte'
canonical: 'https://feeny.ai/job/senior-project-manager-regulatory-cmc-vaxcyte-san-carlos-california-aa6p4rh4n0rp'
type: 'job'
last_seen: '2026-09-14'
---

# Senior Project Manager, Regulatory CMC at Vaxcyte

- **Company:** Vaxcyte
- **Location:** San Carlos California, United States
- **Posted:** 2026-08-03
- **Last confirmed live:** 2026-09-14
- **Apply:** https://boards.greenhouse.io/vaxcyte/jobs/5378107008?gh_jid=5378107008

## 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:

- 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.

Requirements:

- 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](https://vaxcyte.com/careers/).

## About Vaxcyte

## Company Overview
- **One-liner**: Vaxcyte is a clinical-stage biotechnology company re-engineering how vaccines are made to eliminate bacterial infections, using a cell-free protein synthesis platform to develop high-fidelity, broad-spectrum vaccines.
- **Entity Type**: Public (Ticker: PCVX)
- **Headquarters**: San Carlos, California, United States
- **Founded**: 2013 (as SutroVax; rebranded to Vaxcyte in 2020)
- **Founders**: Not publicly available (the company emerged from Sutro Biopharma’s spin-out)

## Core Business
- **Primary industry**: Biotechnology / Vaccines (Infectious Disease)
- **Target customers**: Global healthcare systems, public health organizations, and ultimately patients (B2B/Institutional); the company develops vaccines for both pediatric and adult populations.
- **Mission or purpose**: To protect humankind from the consequences of bacterial infections, eliminating diseases like invasive pneumococcal disease, Group A Strep, and Shigella.

## Products & Services
- **VAX-31 (31-valent PCV)**: A broad-spectrum pneumococcal conjugate vaccine candidate in Phase 3 for adults and Phase 2 for infants. Designed to cover over 95% of circulating IPD serotypes in U.S. adults 50+ and ~94% in infants. FDA Breakthrough Therapy designation granted.
- **VAX-24 (24-valent PCV)**: A pneumococcal conjugate vaccine candidate in Phase 2 for infants, designed to cover more serotypes than any infant PCV on the market today.
- **VAX-A1 (Group A Strep)**: A preclinical conjugate vaccine candidate for Group A Strep, a disease with no currently approved vaccine. Phase 1 first-in-human study (adults) underway in Australia.
- **VAX-GI (Shigella)**: A novel preclinical vaccine candidate targeting Shigella, a leading cause of diarrheal disease.
- **Platform Technology**: A proprietary cell-free protein synthesis platform that enables site-specific, carrier-sparing conjugation to produce precisely targeted vaccines with enhanced immunogenicity.

## Market Standing
- **Valuation/Market Cap**: ~$16.7 billion (as of early July 2026)
- **Key Metric**: Total funding raised (private) is not applicable; as a public company, key metrics include cash position (~$2.0 billion as of Q1 2026) and R&D investment. The company is pre-revenue.
- **Notable Investors/Partners**: Major institutional investors include Baker Bros. Advisors, Fidelity, and funds managed by BlackRock. Key partnership: exclusive license agreement with Sutro Biopharma for its cell-free protein synthesis platform.
- **Growth Signals**: 
  - Up to $1 billion commitment to expanding U.S. manufacturing with a new facility in North Carolina.
  - VAX-31 Phase 3 program (OPUS-1, OPUS-2, OPUS-3) topline data expected Q4 2026 – H1 2027.
  - Headcount growth: actively hiring across 100+ roles (Analytical, Commercial, Clinical, Conjugation, Quality, Regulatory).
  - Recognized as a Great Place to Work and Best Workplace in BioPharma (multiple years).

## Competitive Advantages
- **Broadest-spectrum PCV candidates**: VAX-31 is the broadest-spectrum pneumococcal conjugate vaccine in the clinic, targeting up to 31 serotypes.
- **Differentiated platform**: Cell-free protein synthesis allows for the creation of complex, high-fidelity vaccines that can overcome bacterial defense mechanisms (e.g., capsule-switching) that limit conventional cell-based vaccines.
- **Carrier-sparing technology**: Site-specific conjugation enables a higher valency (more serotypes) without compromising immunogenicity or tolerability.
- **Manufacturing scale**: Significant investment in U.S.-based production capacity provides a long-term supply chain advantage and aligns with "Investing in America" initiatives.

## Strategic Focus
- **Primary**: Advance VAX-31 and VAX-24 through late-stage clinical trials to secure regulatory approval and establish a new standard of care for pneumococcal disease.
- **Pipeline expansion**: Advance VAX-A1 (Group A Strep) and VAX-GI (Shigella) candidates through early clinical development.
- **Manufacturing**: Scale up internal manufacturing capabilities to support commercial launch and global supply.
- **Commercial readiness**: Building a commercial organization (e.g., hiring a VP of U.S. Market Access & Pricing, Senior Director of Product Launch) to prepare for potential VAX-31 launch.

## Why Work Here
- **Culture**: Described as a "kindness-first" mindset with a focus on audacious goals, collaboration, and mutual support. Recognized as a *Great Place to Work* and *Best Workplace in BioPharma* (Fortune).
- **Work Model**: Hybrid, Remote, and Onsite options available depending on role. San Carlos HQ offers a hybrid schedule.
- **Total Rewards**: 100% paid health, dental, and vision insurance; 401k matching; flexible PTO and holidays; paid parental and sick leave; equity awards (stock options & RSUs); Employee Stock Purchase Plan; lifestyle spending account; mental health and wellness resources.
- **Growth & Development**: Strong emphasis on learning culture, professional advancement through coaching, and career development programs.
- **Mission-driven**: Employees are directly contributing to creating vaccines that protect every child born and every adult at risk from bacterial infections globally.

## Sources
1. [vaxcyte.com](https://vaxcyte.com/)
2. [vaxcyte.com/careers](https://vaxcyte.com/careers/)
3. [vaxcyte.com/job-listings](https://vaxcyte.com/job-listings/)
4. [vaxcyte.com/culture](https://vaxcyte.com/culture/)
5. [vaxcyte.com/pipeline](https://vaxcyte.com/pipeline/)

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