Stability Manager

Essential Functions

• Designs, coordinates, and executes stability studies for early and late-stage vaccine products according to regulatory guidelines and company protocols.
• Summarizes vaccine stability results by applying analytical testing expertise to ensure scientific and technical excellence. Utilizes statistical software like JMP to perform rigorous statistical analyses, ensuring robust interpretation of data and adherence to regulatory standards.
• This includes, but not limited to, creating, implementing, and managing stability databases, performing data trending and statistical analysis, study and testing forecasting, and reporting of metrics, creation, revision, and approval of SOP's, stability protocols, and reports in accordance with current GMP, FDA, EU, Global, and ICH guidelines and regulations.
• Produces impactful PowerPoint presentations to effectively communicate stability data to diverse project team members. Supports the attainment of project milestones by facilitating stability monitoring and determining expiration dates for clinical and in-process materials.
• Authors, reviews, revises, and approves SOP's, stability protocols, and reports, memos, regulatory and specification documents (as required).
• The Stability Manager will also assist with leading the functionality and maintenance of stability related processes and systems.
• Drives continuous improvement activities for the clinical stability programs.
• Ensures that the GMP stability program continuously aligns with FDA, ICH, and other international agencies.
• Manages Quality Systems records for QC Stability - creates, assesses, reviews Deviations, Change Controls, CAPA's, and other applicable stability-related investigations and events.
• Guides and works with others to identify opportunities for continuous improvement and implements/maintains solutions.
• Provides strong teamwork in establishing a quality culture and shared accountability. Ensures GMP compliance is built into the design and implementation of processes and systems, including tracking metrics to monitor and improve performance.

Requirements

• MS or BS with minimum of 8 years of industry experience in Pharma / Biotech industry required. Other combinations of education and/or experience may be considered.
• Strong understanding of vaccine stability principles, including degradation pathways, accelerated stability testing, and shelf-life determination.
• Demonstrated proficiency and expertise in various analytical methodologies, particularly in the context of stability testing and assessment of biologics or vaccines.
• Solid understanding of relevant FDA, EU, and ICH regulatory guidelines and pharmacopeia as applicable to stability study design, expiry dating, and analytical method qualification/validation for biologics and vaccines.
• Solid understanding and hands-on experience of applying basic statistical tools for stability data trending and rate analysis to support retest period/shelf-life proposals.
• Attention to detail and excellent skills in record keeping/documentation.
• Experience in IND, NDA, and BLA submission is highly preferred.
• Experience working in a regulated (GLP / GMP) environment.
• Extensive technical writing experience.
• Strong interpersonal skills; ability to communicate effectively both verbally and in written formats.
• Solid understanding of product development activities in biotech/drug/vaccine development, including key interdependencies, and knowledge of proven development strategies and tactics.
• Ability to work globally with CMOs in different countries and continents.