Job Description
Position Summary:
We are looking for a Stability Data Scientist to join our clients Global Development team. In this role, you'll manage studies and data to support new product registrations, including the design, planning, analysis, and reporting of stability studies. You'll also provide support for commercial product stability and act as a subject matter expert for at least one product in development.
Key Responsibilities:
- Collaborate with stakeholders across Development, QA, QC, Regulatory Affairs, and more to support ongoing stability trials.
- Design, implement, and manage exploratory studies for new product R&D.
- Author compliant stability protocols and reports.
- Act as a stability subject matter expert for assigned products.
- Analyse and interpret stability data and provide reports.
- Support commercial product stability activities and review associated documentation.
- Manage change controls and non-conformances, including CAPA investigations.
- Coordinate with external laboratories and suppliers as needed
- Lead project meetings related to stability and contribute to audit readiness.
- Recommend process improvements and contribute to cross-functional teams.
- Maintain compliance with GMP, health and safety standards, and internal procedures.
- Keep training records up to date and follow professional conduct standards. Minimum
Qualifications & Experience:
- BSc (Hons) in Biological Sciences, Chemistry, or related field.
- At least 2 years of relevant pharmaceutical industry experience.
Qualifications:
- Experience in R&D study design and reporting.
- Knowledge of biopharmaceutical stability studies.
- GMP environment experience.
- Familiarity with Minitab or similar statistical tools.
- Strong Excel skills and vendor management experience.
- Understanding of change management processes.
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