Stability Manager

Negotiable
  1. Permanent
Shannon, Republic of Ireland
  1. Quality Assurance, Quality Engineer
Posted: 03/06/2024
BBBH25493

Hobson Prior is seeking a Stability Manager for a role focused on managing stability programs across various projects. This role involves initiating and managing stability studies, developing protocols, monitoring data, and reporting trends. The successful candidate will also be responsible for creating and reviewing Quality Systems records for QC Stability.

Please note that to be considered for this role you must have the right to work in this location.

Key Responsibilities

  • Manage all aspects of the stability program for various projects.
  • Design, coordinate, and execute stability studies for clinical and commercial gene therapy products.
  • Generate stability reports by applying analytical testing expertise.
  • Use statistical software to perform rigorous statistical analyses, ensuring robust interpretation of data and adherence to regulatory standards.
  • Manage Quality Systems records for QC Stability- create, assess, review Deviations, Change Controls, CAPA's and other applicable stability-related investigations and events.

Requirements

  • Experience in the Pharma / Biotech industry.
  • 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.

Apply now

If you are interested in learning more or applying to this exciting opportunity then please click Apply and upload a copy of your CV. Alternatively for further details or to talk directly to a life sciences recruitment specialist directly please select Contact me at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.

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