Analytical Development Scientist - Qualification Specialist

Analytical Development Scientist - Qualification Specialist

RoslinCT

Edinburgh, United Kingdom

Your new role

• An exciting opportunity for an Analytical Development Scientist – Qualification Specialist to join our team.
• Serve as a SME in molecular biology and cell-based analytical techniques, including flow cytometry, immunostaining and genetic analysis.
• Be a technical leader in the planning and hands-on execution of method development, transfer, suitability and qualification studies across multiple programs and platforms.
• Contribute to method transfer initiatives into QC.
• Design and conduct qualification studies within the QC laboratory.
• Develop and optimise product-specific analytical methods in close collaboration with clients, internal QC teams and cross-functional stakeholders.
• Apply scientific and technical knowledge to interpret, contextualise and present experimental data.
• Ensure analytical methods meet predefined requirements for intended use and are aligned with regulatory and internal quality standards.
• Critically review SOPs, study protocols, technical reports and other scientific and quality documents.
• Take ownership and review complex deviations, risk assessments, investigations and change controls relating to transfer of methods to GMP QC laboratories.
• Demonstrate working knowledge of global regulatory expectations in cell and gene therapy and sterile manufacturing to ensure practical compliance and operational excellence.

About you

• Proven expertise in analytical development and method qualification within a biotechnology or pharmaceutical environment, preferably supporting cell and gene therapy products.
• Extensive hands-on laboratory experience with cell culture and a wide range of analytical techniques, including molecular assays (RT-qPCR, digital PCR etc.), flow cytometry, cell imaging, immunoassays, and other cell-based functional assays.
• Detail-oriented and quality-driven, with a continuous improvement mindset and a strong commitment to right-first-time execution.
• Working knowledge of GMP regulations and practical experience operating in a QC laboratory setting, including familiarity with Good Documentation Practices, laboratory compliance standards and supporting method transfer and qualification activities.
• Exceptional attention to detail, ensuring data integrity, documentation accuracy and compliance with regulatory expectations.
• Excellent computer skills with experience in Microsoft Word and Excel.
• Collaborative team player, with the ability to work effectively across cross-functional teams.

Qualifications

• A degree, Master or PhD in a Life Science discipline

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