An energetic and talented individual is sought to join the Vaccine Product Development organization as a Manager/Senior Manager of Stability within the Quality Control Unit. The primary focus of this role is to manage the stability program for various projects in preclinical and clinical development, reporting directly to the Director of Stability.

This position will be a key part of the team implementing and maintaining cGMP Stability for all clinical development phases. Responsibilities include managing stability studies for individual projects and conducting stability data analysis. This individual will collaborate closely with Quality Control members in a highly collaborative and cross-functional environment. The ideal candidate will bring extensive stability experience, ensure compliant operations and documentation, foster open communication, and pursue data-driven approaches.

Essential Functions

• Design, coordinate, and execute stability studies for early- and late-stage vaccine products according to regulatory guidelines and internal protocols.
• Summarize vaccine stability results using analytical expertise to maintain scientific and technical excellence. Use statistical software like JMP for rigorous statistical analyses, ensuring robust data interpretation and compliance with regulatory standards.
• Responsibilities include managing stability databases, performing data trending and analysis, forecasting study and testing metrics, and creating, revising, and approving SOPs, stability protocols, and reports in line with current GMP, FDA, EU, Global, and ICH guidelines.
• Prepare impactful PowerPoint presentations to communicate stability data to diverse project team members. Support project milestones by facilitating stability monitoring and setting expiration dates for clinical and in-process materials.
• Author, review, revise, and approve SOPs, stability protocols, reports, memos, regulatory, and specification documents as needed.
• Lead and maintain stability-related processes and systems, driving continuous improvement activities for clinical stability programs.
• Ensure the GMP stability program remains compliant with FDA, ICH, and other international regulations.
• Manage Quality Systems records for QC Stability, including creating and reviewing Deviations, Change Controls, CAPAs, and other relevant stability-related investigations and events.
• Work with others to identify continuous improvement opportunities and implement/maintain solutions.
• Foster a quality culture and shared accountability within the team, ensuring GMP compliance is embedded in process design and implementation, including tracking metrics to monitor and improve performance.

Requirements

• MS or BS with 5-10 years of experience in the Pharma/Biotech industry.
• Strong understanding of vaccine stability principles, including degradation pathways, accelerated stability testing, and shelf-life determination.
• Demonstrated expertise in analytical methodologies, particularly for stability testing and assessment of biologics or vaccines.
• Solid understanding of FDA, EU, and ICH regulatory guidelines and pharmacopeia related to stability study design, expiry dating, and analytical method validation for biologics and vaccines.
• Experience applying statistical tools for stability data trending and rate analysis to support retest period and shelf-life proposals.
• Excellent attention to detail, documentation, and technical writing skills.
• Experience with IND, NDA, and BLA submissions is highly preferred.
• Experience working in a regulated (GLP/GMP) environment.
• Strong interpersonal skills with effective verbal and written communication abilities.
• Knowledge of product development activities in biotech/drug/vaccine development, including understanding key interdependencies and proven development strategies.
• Ability to collaborate with CMOs internationally.

Reports to : Director of Stability

Location : San Carlos, CA

Compensation

The compensation package is competitive, with comprehensive benefits and an equity component.

Salary Range : $144,000 - $162,000 (SF Bay Area); salary ranges for other locations may vary.