Stability Manager

The role

The Stability Manager manages the stability program for various projects in preclinical and clinical development. This person implements and maintains cGMP Stability for all phases of clinical development and manages stability studies and data analysis.

What you will do

• Designs, coordinates, and executes stability studies for early and late-stage vaccine products.
• Summarizes vaccine stability results using analytical testing expertise.
• Utilizes statistical software like JMP to perform statistical analyses.
• Creates, implements, and manages stability databases.
• Performs data trending and statistical analysis.
• Performs study and testing forecasting and reporting of metrics.
• Creates, revises, and approves SOPs, stability protocols, and reports.
• Produces PowerPoint presentations to communicate stability data.
• Supports project milestones by facilitating stability monitoring and determining expiration dates.
• Manages Quality Systems records including Deviations, Change Controls, and CAPAs.

Required qualifications

• MS or BS with minimum of 8 years of industry experience in Pharma / Biotech industry
• Strong understanding of vaccine stability principles, including degradation pathways, accelerated stability testing, and shelf-life determination
• Demonstrated proficiency and expertise in various analytical methodologies for stability testing and assessment of biologics or vaccines
• Solid understanding of relevant FDA, EU, and ICH regulatory guidelines and pharmacopeia
• Solid understanding and hands-on experience of applying basic statistical tools for stability data trending and rate analysis
• 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
• Solid understanding of product development activities in biotech/drug/vaccine development
• Ability to work globally with CMOs in different countries and continents

Nice to have

• Experience in IND, NDA and BLA submission

Benefits

• Comprehensive benefits
• Equity component

About the company

Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from bacterial diseases.