Vaxcyte · 1 month ago
Senior Manager, Quality Control, Reference Standards
San Carlos, California, United States
Full-time
Onsite
Senior Level
$176K/yr - $205K/yr
5+ years expVaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from bacterial diseases. We are seeking a Sr. Manager for our Quality Control (QC) Reference Standards team to oversee the management and continuous supply of reference standards and critical reagents for testing and releasing clinical and commercial products.
BiopharmaBiotechnologyHealth Care
Responsibilities
Oversee the implementation and maintenance of the reference standards and critical reagent program, ensuring compliance with cGMP and ICH guidelines
Support the development of global business practices, policies, and standards for reference standards and critical reagents, including qualification, requalification, and inventory management
Collaborate in the authoring and review of technical protocols, qualification reports, requalification reports, and Certificates of Analysis (CoAs) related to reference standards. Ensure timely updates to SOPs and other relevant documentation
Manage supply chain logistics, including inventory and space planning, to ensure a continuous supply of qualified reference standards and critical reagents
Serve as a key point of contact within Vaxcyte QC and with external partners, fostering productive collaborations to support the company's vaccine programs
Provide technical guidance on assay qualification and validation to meet regulatory standards, and review test methods and release documentation for reference standards
Review and manage deviations, OOS/OOT results, and conduct risk assessments related to reference standards and critical reagents
Qualification
Required
Bachelor's, Master's, or Ph.D. in Biochemistry, Chemistry, or a related field
Ph.D. with 5+ years of relevant QC experience, or MS with 7+ years of experience, or BS with 9+ years of experience, including significant experience in reference standard management
Strong background in cGMP and ICH regulatory guidance associated with reference standards and critical reagents
Experience working with biochemistry, immunoassay, or microbiological assay techniques
Familiarity with statistical software (e.g., JMP) for data analysis, trending, and process optimization
Excellent organizational and project management skills, with the ability to handle multiple projects under tight timelines
Strong written and verbal communication skills, including the ability to work effectively in cross-functional teams
Preferred
Proficiency in LIMS and other laboratory data management systems
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