Stability Scientist
Overview
A leading global organisation within the pharmaceutical and life sciences sector is seeking an experienced Stability Scientist to support stability activities across the full product lifecycle. This role focuses on generating and maintaining stability data to support regulatory submissions and shelf-life justification, working cross-functionally in a highly regulated, innovation-driven environment.
Responsibilities
- Act as SME for stability studies across development and commercial products
- Design and oversee stability strategies and protocols
- Author and review stability reports for regulatory submissions (IND, IMPD, NDA, MAA)
- Support regulatory queries related to stability data and product changes
- Coordinate stability activities across sites and external partners
- Manage stability impact of changes to registered products
- Ensure compliance with cGxP, ICH guidelines, and quality standards
- Perform statistical analysis and interpretation of stability data
Requirements
- Proven experience in stability studies and shelf-life determination within pharma
- Strong knowledge of GMP, ICH guidelines, and regulatory submissions (CTD)
- Experience supporting or contributing to regulatory filings
- Ability to work both strategically and hands-on
- Strong cross-functional collaboration skills
- MSc (or equivalent) in Chemistry, Chemical Engineering, Pharmacology, or similar
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