MSAT Scientist Full Time

Location: Edinburgh BioQuarter, Little FranceWho 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 roleAn exciting opportunity for a MSAT Scientist to join our team.You will be responsible for providing technical support to both existing and new cell and gene therapy manufacturing processes within RoslinCT which includes:Process technology transfersProcess improvements and process change managementProcess trouble shooting and providing technical support and guidance to Manufacturing personnel within the cleanroom Manufacturing suiteQuality investigations/out of specification investigations.You will work directly with an MSAT Principal Scientist 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 Development Manufacturing, QC, QA, Supply Chain and Project Management that supports various manufacturing activities.Support review and onboarding of new processes and process changes.Participate in client discussions to support technical discussion on activities such as process trouble shooting, new process or process change onboarding, evaluation of new technologies etc.Monitor and trend manufacturing process outcomeProvide technical support and write quality investigations including process deviations, Out of Specification, out of trends.Provide technical support in writing and reviewing manufacturing master batch records and other required supporting manufacturing documentationWrite process change controls, validation protocols, risk assessments, batch records and other relevant documentation for both ongoing and new manufacturing processes.Develop new technical protocols, SOPs, and related technical documentation to support technology transfer and ongoing development of manufacturing projects.Complete GMP material assessments and finalize bills of materials.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 the troubleshooting of process excursions/out of trends as required.About youExperience within GMP manufacturing and/or process technology transfer roles preferably in the Cell and Gene therapy industry.Hands-on cGMP experience with cell culture and various process manufacturing activities. Experience in working with iPSCs or hESC lines is preferable.Experience in working with different cell culture platforms including closed system manufacturing process e.g., bioreactors, cell processors is preferable.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 their 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.QualificationsA degree in a Life Science discipline or relevant equivalent experience.