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Purpose of Job
The Stability Manager is responsible for managing all aspects of the stability program across all projects and UK and Ireland sites, including initiating and managing stability studies, protocol development and maintenance, data monitoring, trending, and reporting.
Major Activities
- Designs, coordinates, and executes stability studies for clinical and commercial gene therapy products according to regulatory guidelines and company protocols.
- Generates stability reports 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.
- Authors, reviews, revises, and approves SOP's, stability protocols and reports, memo’s, regulatory and specification documents (as required).
- Assists with leading the functionality and maintenance of stability-related processes and systems.
- Drives continuous improvement activities for the 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 implement/maintain 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.
- Ensures that own work and that of the team complies with GMP, Data Integrity, and Good Documentation Practice (GDP) and is undertaken in accordance with applicable procedures.
- Ensures that own training and that of the team is undertaken in a timely and GMP-compliant manner before the task is undertaken.
- Ensures that any GMP documentation e.g. (but not limited to) Issues, CAPAs, Change Controls, BMRs & audit/inspection actions, within own area of responsibility, is closed timely and in a RFT state.
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Job Background
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- 5 years of relevant industry experience in Pharma / Biotech industry required.
- Strong understanding of gene therapy stability principles, including degradation pathways, accelerated stability testing, and shelf-life determination.
- Proven experience in managing staff.
- Demonstrated proficiency and expertise in various analytical methodologies, particularly in the context of stability testing and assessment of biologics or gene therapy.
- 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 gene therapy.
- 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.
- Strong interpersonal skills; ability to communicate effectively both verbally and in written formats.
- Solid understanding of product development activities in biotech/drug/gene therapy development, including key interdependencies, and knowledge of proven development strategies and tactics.
- To travel to other Meira sites when required.
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Jessica, London
Skills
Stability Study Design
Gene Therapy
GMP Compliance
Statistical Analysis
JMP Software
SOP Authoring
Quality Systems
Analytical Methodologies
Regulatory Reporting
Data Integrity
GDP
Staff Management
Biologics Assessment
ICH Guidelines
FDA Regulations
BLA Submission
Location