Stability Scientist (Biotechnology, Ballerup)

Job summary

The role involves planning and managing stability studies in a Quality Control (QC) laboratory to support product development and regulatory submissions. The position is crucial in establishing a new QC Laboratory and requires scientific expertise, collaboration, and project management skills.

Qualifications

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

Responsibilities

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

Skills

• Strong analytical thinking and problem-solving skills
• Excellent communication and collaboration abilities
• Ability to work in a fast-paced, dynamic environment

Education

• Minimum of a Bachelor’s degree in a relevant field

Tools

• Familiarity with stability study protocols and regulatory documentation