Stability Scientist (Pharmaceutical, Hybrid)

Job summary

This role involves significant scientific responsibilities in stability for late-stage and commercial pharmaceutical products, focusing on stability strategies, product quality, and regulatory compliance.

Qualifications

• Advanced scientific degree in Pharmacy, Biotechnology, Chemistry, or a related field.
• Extensive experience in stability within the pharmaceutical or biotech industry.
• Proven ability to interpret stability data and assess product impact, including handling temperature excursions.

Responsibilities

• Develop and manage stability strategies and studies, including planning, execution, and data analysis.
• Author Annual Stability Reports and regulatory documentation.
• Define and justify product shelf life, including evaluations of temperature excursions.
• Lead scientific assessments and risk evaluations related to product quality.
• Ensure compliance with cGMP and quality systems, including the preparation of key GMP documentation.

Skills

• Strong stakeholder collaboration and communication skills.
• High level of scientific ownership and accountability.
• Proficiency in English.

Tools

• Experience with stability equipment and LIMS/SampleManager.
• Familiarity with data integrity requirements in a regulated environment.

Education

• A scientific academic degree in a relevant field is required.