Analytical Development Scientist – Qualification Specialist

RoslinCT; City of Edinburgh; On-site; GBP 40,000 - 60,000; Full time

Job summary

RoslinCT, a global leader in cell and gene therapy, is seeking an Analytical Development Scientist – Qualification Specialist in Edinburgh. This role involves method development, compliance with quality standards, and requires extensive lab experience. We offer a competitive salary, generous leave, and a supportive work culture that prioritizes inclusivity and personal growth.

Benefits

31 days annual leave plus public holidays

Generous salary package

Competitive pension scheme

Private healthcare

Flexible benefits

Qualifications

• Proven expertise in analytical development and method qualification in biotechnology.
• Extensive hands-on experience with molecular assays and analytical techniques.
• Working knowledge of GMP regulations and QC laboratory standards.

Responsibilities

• Lead method development and qualification studies in a QC lab.
• Design and conduct qualification studies to ensure compliance.
• Review and interpret scientific and technical documents.

Skills

Flow Cytometry

Immunostaining

Genetic Analysis

Cell Culture

Molecular Assays

Detail-oriented

Quality-driven

Continuous Improvement

Attention to Detail

Collaborative

Tools

Microsoft Word

Microsoft Excel

Job description

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Analytical Development Scientist – Qualification Specialist, Edinburgh

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Client:

RoslinCT

Location:

Edinburgh, United Kingdom

Job Category:

Other

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EU work permit required:

Yes

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Job Reference:

e44201d6de41

Job Views:

5

Posted:

22.06.2025

Expiry Date:

06.08.2025

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Job Description:

RoslinCT is a global CDMO focused on Advanced Cell and Gene Therapies. It was established in 2006, built upon the ground-breaking cloning technology of Dolly the Sheep. RoslinCT is one of the first to produce clinical-grade human pluripotent stem cells and developed the first CRISPR-edited cell therapy product for a major inherited disorder, taking it from early development to commercialization.

Analytical Development Scientist – Qualification Specialist

Location: Edinburgh BioQuarter

Who are we?

We are RoslinCT, a world-leading cell and gene therapy contract development and manufacturing organisation creating cutting-edge therapies that change people’s lives.

Collaborative, dedicated and talented people are the backbone of our culture, working both autonomously and in driven teams to make life-changing products utilising ground-breaking science.

Find out more about what we do here!

• The opportunity to join a rapidly expanding company which is changing lives, giving you the skills and experience to develop your career.
• A generous salary package – we reward our people at the level they deserve.
• 31 days of annual leave, plus 4 public holidays which increases with tenure.
• A competitive company pension scheme to help you save for the future.
• Group Life Cover – you are automatically covered for three times your basic salary to give you and your family peace of mind.
• Private healthcare and access to mental health/wellbeing support as your health and wellbeing means a lot to us.
• Flexible benefits such as retail discounts and access to the Cycle2Work scheme.

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

Next Steps

If this sounds like you, then please hit ‘Apply’ now. We will ask you to upload your CV and complete a short application form detailing why you are interested and why we should hire you.

At RoslinCT, we’re all about inclusivity and creating a fair, welcoming workplace. Our goal is to make sure everyone knows they’re valued and encouraged to be themselves, whether they’re our employees, customers, or partners.

We take pride in being an equal opportunity employer. We treat all applicants fairly and don’t discriminate based on any protected characteristics. So, no matter who you are, we welcome your application with open arms.

If you’ve got any specific needs or concerns regarding accessibility during the recruitment process, don’t hesitate to reach out to us at [emailprotected] . We’re here to assist and make things as smooth as possible for you.