Vaxcyte · 4 hours ago
Stability Manager
San Carlos, California, United States
Full-time
Onsite
Senior Level, Lead/Staff
$147K/yr - $171K/yr
8+ years expVaxcyte is a clinical-stage vaccine innovation company focused on developing high-fidelity vaccines to combat bacterial diseases. They are seeking a Stability Manager to oversee the stability program for various projects in preclinical and clinical development, ensuring compliance with regulatory standards and managing stability studies and data analysis.
BiopharmaBiotechnologyHealth Care
Responsibilities
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)
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
Qualification
Required
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 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
Preferred
Experience in IND, NDA and BLA submission is highly preferred
Benefits
Comprehensive benefits
An equity component
Company
Vaxcyte
Vaxcyte focuses on developing vaccines designed to prevent or treat some of the most common and deadly infectious diseases worldwide.
201-500 employees
H1B Sponsorship
Vaxcyte has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (14)
2024 (7)
2023 (5)
2022 (7)
2021 (2)
Funding
Current Stage
Public CompanyTotal Funding
$3.85BKey Investors
CARB-XTPG GrowthAbingworth
2024-09-04Post Ipo Equity· $1.5B
2024-01-30Post Ipo Equity· $862.5M
2023-04-19Post Ipo Equity· $500M
Leadership Team
Andrew Guggenhime
President & Chief Financial Officer
Jeff Fairman
Founder and Vice President, Research
Recent News
2025-12-09
Company data provided by crunchbase