ASSOCIATE PRINCIPAL SCIENTIST – QUALIFICATION SPECIALIST

Location: Edinburgh BioQuarter / Charles Darwin House, Penicuik

QUALIFICATIONS

• A Degree, Master or PhD in Life Sciences, or a related subject.

YOUR NEW ROLE

The Associate Principal Scientist – Qualification Specialist will be responsible for providing strategic and technical leadership in analytical method qualification for a diverse cell therapy portfolio. The position will oversee the design, execution, and interpretation of qualification studies to ensure methods are scientifically robust, phase-appropriate, and compliant with regulatory standards.
You’ll act as a Subject Matter Expert (SME) in molecular biology and cell-based analytical techniques, driving the development and implementation of robust qualification strategies that support GMP readiness and lifecycle management.

YOUR NEW ROLE

• Initiate and oversee change controls and risk assessments to support the introduction and lifecycle management of analytical methods in QC.
• Maintain regulatory and internal quality standards for analytical methods.
• Interpret complex datasets and communicate these findings effectively to technical and non-technical individuals.
• Author and critically review high-quality scientific and quality documentation, ensuring accuracy and compliance.
• Work closely with the Quality Assurance department to support audit readiness, resolve investigations and sustain global regulatory standards related to cell and gene therapy and sterile product manufacturing.
• Implement planning, risk mitigation and decision-support tools to drive program success and adaptability.
• Drive continuous improvement projects by promoting best practices and elevating standards in laboratory operations and documentation.