RoslinCT

A leading cell and gene therapy organization in Edinburgh is seeking a Senior Quality Control Analyst in Microbiology. The role involves supporting sample flow, ensuring compliance with regulatory standards, and conducting environmental monitoring within GMP cleanroom environments. Candidates should have a degree in Microbiology, at least 4 years of experience in a GMP setting, and strong attention to detail. The organization values inclusivity and offers a competitive salary package along with several benefits.

Senior QC Analyst - Analytical 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 ! 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 An exciting opportunity for a Senior QC Analyst - Analytical to join our Quality team. You'll be responsible for working with the development team on analytical assays for testing human embryonic stem cell lines and cell & gene therapies for human application. Identify area of improvement and lead process improvement projects within the department. Perform assimilation, statistical analysis, and interpretation of complex, multi-format data sets. Author, revise, and implement QC SOPs in alignment with regulatory guidelines. Lead root cause investigations into contamination events and deviations. Compile and report on analytical data to facilitate product release. Develop and deliver trend analyses and periodic summary reports for senior management, including QPs, and chair formal review meetings to drive data-driven improvements. Execute GMP documentation workflows within QC, including Incident Reports, Change Controls and Risk Assessments. Coordinate and perform QC batch release testing of advanced cellular therapy product Oversee day-to-day laboratory operations, ensuring adherence to cGMP, maintenance of QC systems, and operational excellence. About you Prior experience working in a GMP Quality Control molecular biology / analytical laboratory, with commercial experience. Experience in assay validation, stability testing, tissue culture, QC product testing and writing procedures to meet GMP and ICH guidelines. Experience in a variety of laboratory activities, with specialist knowledge of Flow Cytometry. Working knowledge of UK laws and regulations for cell therapy products and tissue donation. Excellent verbal communication skills, with the ability to effectively manage and influence stakeholders' and customer expectations. Exceptional written communication skills, with a good standard of written English to support writing reports accurately and clearly. Good organisational and planning skills with the ability to multi-task in a fast-paced environment. Qualifications A degree in a life science, or relevant subject. A postgraduate qualification is desirable. 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 . We're here to assist and make things as smooth as possible for you.

MSAT Scientist 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 An exciting opportunity for a MSAT Scientist to join our team. You will be responsible for providing technical support to cell and gene therapy manufacturing processes including: Introduction of new process changes Identifying process improvements and their implementation Implementation of required process documentations to support manufacturing. Support with process monitoring and review process performance Identification, technical/quality assessment and introduction of new materials to manufacturing bill of materials. Providing support for on-floor process trouble shooting, escalation and resolution Quality investigations/out of specification investigations. Provisions of on the floor technical mentoring and guidance to Manufacturing personnel within the cleanroom Manufacturing suite. You will work directly with an MSAT Principal Scientist and collaborate with both internal teams and clients to deliver assigned technical projects/tasks ensuring project timelines are met according to internal and/or customer expectations. You will be an integral part of cross functional project teams including Process Development, Manufacturing, QC, QA, Supply Chain and Project Management to support on-going manufacturing. Write process change controls, validation protocols, risk assessments, batch records and other relevant documentation for both ongoing and new manufacturing processes. Develop new technical protocols, reports and any associated technical documentation to support process transfer and ongoing manufacturing projects. Provide specialist training to manufacturing staff supporting the introduction of new manufacturing processes, changes, and improvements. Support (as SME) technical investigations and out of specifications generating, reviewing, and approving technical reports to support timely close-out of QMS. Support critical process troubleshooting, manage any process escalation being on-call and on-site when required during out of hours and weekends for critical stages of manufacturing. About you Experience within GMP manufacturing and/or process technology transfer roles preferably in the Cell and Gene therapy industry. Hands on cGMP experience with cell culture (2D or 3D system) and other manufacturing process activities. Experience working to EU, MHRA and FDA regulations. Experience in writing technical documents such as process change controls, validation protocols, batch records and standard operating procedures. Excellent attention to detail, proven problem solver, self motivated and positive with a desire to develop technically in your area of expertise. Can do attitude with a determination to succeed and provide solution to complex problems. Contributes to identifying and completing continuous improvement activities to reduce costs, increase yield and productivity for the area. Good organisational and planning skills with the ability to plan whilst delivering results to deadline. Excellent oral and written communication skills; able to explain technical or complex concepts in a clear format to both technical and non technical audiences. Proven ability to learn and share knowledge with the rest of the manufacturing team and enable them to successfully perform new manufacturing processes. Qualifications A degree in a Life Science discipline or relevant equivalent experience.