Stability Manager

Responsibilities

• Design, coordinate, and execute stability studies for early and late-stage vaccine products in accordance with regulatory guidelines and company protocols.
• Summarize vaccine stability results using analytical testing expertise and statistical software like JMP to ensure robust data interpretation.
• Manage stability databases, perform data trending, and forecast testing requirements.
• Author, review, and approve SOPs, stability protocols, reports, and regulatory specification documents.
• Manage Quality Systems records for QC Stability, including Deviations, Change Controls, and CAPAs.
• Drive continuous improvement activities for clinical stability programs to ensure alignment with FDA, ICH, and other international agencies.
• Communicate stability data effectively to diverse project team members through impactful presentations.

Requirements

• MS or BS degree with a minimum of 8 years of industry experience in the Pharma or Biotech sector.
• Strong understanding of vaccine stability principles, including degradation pathways and shelf-life determination.
• Demonstrated expertise in analytical methodologies relevant to biologics or vaccines.
• Solid knowledge of FDA, EU, and ICH regulatory guidelines regarding stability study design and expiry dating.
• Hands-on experience applying statistical tools for stability data trending and rate analysis.
• Extensive technical writing experience and strong attention to detail in documentation.
• Experience working in a regulated GLP/GMP environment.
• Strong interpersonal and communication skills, with the ability to work effectively with global CMOs.

Preferred Qualifications

• Experience with IND, NDA, and BLA submissions.

About the Company

Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases. We are driven by core values of rethinking convention, aiming high, leading with heart, and modeling excellence.