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.
Senior QC Analyst – Analytical
Location: Edinburgh BioQuarter, Little France
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 !
Why join us?
* 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
* We are looking for a Senior QC Analyst – Analytical to support the development and routine testing of cell and gene therapies for human application.
* Develop assays for the characterisation and safety testing of human embryonic stem cell lines and cell and gene therapies.
* Conduct routine QC testing to GMP standards.
* Review, update, and establish QC Standard Operating Procedures (SOPs).
* Train and certify personnel in analytical techniques.
* Ensure all processes undergo appropriate analytical sampling and review.
* Lead investigations into product contamination incidents.
* Compile and report analytical data to support product release.
* Stay up-to-date with regulatory requirements to ensure compliance.
* Enhance the Analytical Laboratory by identifying and implementing new technologies.
* Validate new analytical techniques and processes while training others.
* Oversee equipment validation, calibration, and servicing records.
* Generate trend and summary reports for management and lead review meetings.
* Support QC batch release by performing and coordinating required tests.
* Maintain a high standard of of laboratory organisation.
* Write, review, and approve SOPs and other GMP documentation (Incident Reports, Change Controls, Risk Assessments).
* Provide out-of-hours coverage for critical equipment alarms on a rotational basis.
* basis.
About you
The ideal candidate will have a strong background in analytical assay development, GMP compliance, and quality control processes. You will be proactive, detail-oriented, and capable of working in a fast-paced environment.
Essential skills & experience
* Proven experience working in a GMP Quality Control molecular biology/analytical laboratory within a commercial setting.
* Expertise in assay validation, stability testing, tissue culture, and QC product testing, ensuring compliance with GMP and ICH guidelines.
* Strong written communication skills, with the ability to draft accurate and clear technical documents.
* Excellent interpersonal skills and communication skills, with the ability to build strong working relationships.
* In-depth knowledge of UK regulations on cell therapy products and tissue donation.
* Proficiency in Microsoft Office applications.
* Strong organisational and multitasking skills, with the ability to manage priorities in a dynamic environment.
* A positive, self-aware approach, fostering a collaborative and supportive team environment.
* The ability to manage stakeholder and customer expectations effectively.
* Exceptional attention to detail, with a passion for continuous improvement.
Qualifications
* A degree in a life science subject or equivalent qualification and experience is required.
* A post graduate qualification is desirable.
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 jobs@roslinct.com. We’re here to assist and make things as smooth as possible for you.