Stability Manager

Vaxcyte, Inc; San Carlos (CA); Hybrid; USD 147,000 - 171,000; Full time

Benefits offered by this job

Comprehensive benefits

Equity component

Job summary

Vaxcyte, Inc. in the SF Bay Area is seeking a Stability Manager in the Quality Control Unit to lead the stability program for various vaccine development projects across preclinical and clinical stages.

You will design and manage stability studies, apply JMP for data analysis, maintain GMP-compliant documentation, generate clear reports, and collaborate across teams to ensure regulatory readiness and continuous improvement.

Qualifications

• Strong understanding of vaccine stability principles, including degradation pathways and shelf-life determination.
• Experience with stability study design, validation, and regulatory alignment (FDA/ICH).
• Experience applying basic statistics to stability data, trend analysis, and retest period proposals.
• Extensive technical writing, regulatory documentation, and GMP/GLP exposure.

Responsibilities

• Design, coordinate, and execute stability studies for vaccine products per regulatory guidelines.
• Summarize stability results using analytical methods and JMP analyses.
• Create, update, and manage stability databases and reports in GMP-compliant manner.
• Prepare presentations to communicate stability data to project teams and management.
• Lead continuous improvement and ensure alignment with FDA, ICH, and other agencies.

Skills

Vaccine stability principles

Analytical methodologies

Statistical analysis

Data trending

Regulatory guidelines

Cross-functional collaboration

Effective scientific communication

JMP software

Education

MS or BS in related field

Tools

JMP

Job description

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.

WHATwe do is every bit as important asHOWwe 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

Vaxcyte is looking for an energetic and talented individual to join Vaxcyte’s Vaccine Product Development organization as a Stability Manager within the Quality Control Unit. The primary function of this level position is to manage the stability program for various projects in preclinical and clinical development.

The position will be an integral part of the team implementing and maintaining cGMP Stability for all phases of clinical development. Primary responsibility will include managing stability studies for individual projects and stability data analysis. This individual will collaborate with QC members in a highly collaborative and cross-functional environment. The ideal candidate will apply strong stability experience, ensure compliant operations and documentation, foster open communication, and pursue data-driven approaches.

Essential Functions

• Designs, coordinate, and execute stability studies for early and late-stage vaccine products according to regulatory guidelines and company protocols.
• Summarize vaccine stability results by applying analytical testing expertise to ensure scientific and technical excellence. Utilize statistical software like JMP to perform rigorous statistical analyses, ensuring robust interpretation of data and adherence to regulatory standards.
• This includes, but not limited to, creating, implementing, and managing stability databases, performing data trending and statistical analysis, study and testing forecasting and reporting of metrics, creation, revision and approval of SOP's, stability protocols and reports in accordance with current GMP, FDA, EU, Global and ICH guidelines and regulations.
• Produce impactful PowerPoint presentations to effectively communicate stability data to diverse project team members. Support the attainment of project milestones by facilitating stability monitoring and determining expiration dates for clinical and in-process materials.
• Authors, reviews, revises, and approves SOP's, stability protocols and reports, memo’s, regulatory and specification documents (as required).
• The Stability Manager will also assist with leading the functionality and maintenance of stability related processes and systems.
• Drives continuous improvement activities for the clinical stability programs.
• Ensures that the GMP stability program continuously aligns with FDA, ICH and other international agencies.
• Manages Quality Systems records for QC Stability- creates, assesses, reviews Deviations, Change Controls, CAPA's and other applicable stability-related investigations and events.
• Guide and work with others to identify opportunities for continuous improvement and implement/maintain solutions.
• Provide strong teamwork in establishing a quality culture and shared accountability. Ensure GMP compliance is built into the design and implementation of processes and systems, including tracking metrics to monitor and improve performance.

Requirements

• MS or BS with minimum of 8 years of industry experience in Pharma / Biotech industry required.Other combinations of education and/or experience may be considered.
• Strong understanding of vaccine stability principles, including degradation pathways, accelerated stability testing, and shelf-life determination.
• Demonstrated proficiency and expertise in various analytical methodologies, particularly in the context of stability testing and assessment of biologics or vaccines.
• Solid understanding of relevant FDA, EU, and ICH regulatory guidelines and pharmacopeia as applicable to stability study design, expiry dating, and analytical method qualification/validation for biologics and vaccines.
• Solid understanding and hands-on experience of applying basic statistical tools for stability data trending and rate analysis to support retest period/ shelf-life proposals.
• Attention to detail and excellent skills in record keeping / documentation.
• Experience in IND, NDA and BLA submission is highly preferred.
• Experience working in a regulated (GLP / GMP) environment.
• Extensive technical writing experience.
• Strong interpersonal skills; ability to communicate effectively both verbally and in written formats.
• Solid understanding of product development activities in biotech/drug/vaccine development, including key interdependencies, and knowledge of proven development strategies and tactics.
• Ability to work globally with CMOs in different countries and continents.

Reports to

Director, Stability

Compensation

The compensation package will be competitive and includes comprehensive benefits and an equity component.

Salary Range

$147,000 – $171,000 *(SF Bay Area). Salary ranges for non-California locations may vary.

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.

Voluntary Self-Identification

For government reporting purposes, we ask candidates to respond to the below self-identification survey.Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiringprocess or thereafter. Any information that you do provide will be recorded and maintained in aconfidential file.

As set forth in Vaxcyte’s Equal Employment Opportunity policy,we do not discriminate on the basis of any protected group status under any applicable law.

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection.As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measurethe effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categoriesis as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.