Stability Scientist (Biotechnology, Ballerup)

Job summary

The role involves planning and managing stability studies within a Quality Control (QC) laboratory to support product development and regulatory submissions. The position requires scientific expertise, collaboration across functions, and strong project management skills.

Qualifications

• Bachelor’s degree or higher.
• 2–5+ years of experience in stability studies in the pharmaceutical or biotechnology sector.
• In-depth knowledge of ICH stability guidelines and regulatory standards.
• Proven experience in writing stability protocols and reports.
• Strong project management capabilities with the ability to handle multiple priorities.
• Excellent analytical thinking and problem-solving abilities.
• Proficient written and verbal communication skills.

Responsibilities

• Plan and execute stability studies in the QC lab.
• Review stability protocols and support technicians during stability pulls.
• Manage storage planning and write Standard Operating Procedures (SOPs).
• Handle Corrective and Preventive Actions (CAPA), deviations, and change controls.
• Lead and oversee stability activities across various development programs.
• Develop timelines, track milestones, and ensure timely delivery of stability data.

Skills

• Strong analytical and problem-solving skills.
• Excellent communication and collaboration abilities.
• Project management skills to manage multiple tasks effectively.

Education

• Minimum of a Bachelor’s degree.

Tools

• Familiarity with stability study protocols and regulatory documentation.