Vaccine Stability Manager - Equity Eligible

Vaxcyte; San Carlos (AZ); On-site; USD 147,000 - 171,000; Full time

Job summary

Vaxcyte is looking for an energetic and experienced Stability Manager within the Quality Control Unit. The primary responsibility is to manage the stability program for multiple vaccine projects in preclinical and clinical development, ensuring data integrity and regulatory compliance.

You will design and execute stability studies, perform data trending with JMP, generate reports and SOPs, and support IND/NDA/BLA submissions.

Qualifications

• MS or BS with minimum of 8 years of industry experience in Pharma/Biotech.
• Strong understanding of vaccine stability principles.
• Experience in GMP/GLP and regulatory guidelines (FDA/ICH).
• Experience with IND/NDA/BLA submissions preferred.
• Excellent documentation and technical writing skills.

Responsibilities

• Design, coordinate, and execute stability studies per guidelines.
• Summarize stability results with analytical testing and JMP analysis.
• Create and manage stability databases, data trending and reporting.
• Draft/revise SOPs, stability protocols and reports per GMP/ICH.
• Prepare presentations to communicate stability data to teams.
• Drive continuous improvement of clinical stability programs.
• Ensure GMP stability aligns with FDA/ICH and other agencies.
• Collaborate with global CMOs and cross-functional teams.

Skills

Stability testing

Statistical analysis

Regulatory compliance

Technical writing

Cross-functional collaboration

Communication

Education

MS or BS in Pharma/Biotech

Tools

JMP

Job description

Vaxcyte is looking for an energetic and experienced Stability Manager within the Quality Control Unit. The primary responsibility is to manage the stability program for multiple vaccine projects in preclinical and clinical development, ensuring data integrity and regulatory compliance.

You will design and execute stability studies, perform data trending with JMP, generate reports and SOPs, and support IND/NDA/BLA submissions.