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 both existing and new cell and gene therapy manufacturing processes within RoslinCT which includes:

• Process technology transfers
• Process improvements and process change management
• Process trouble shooting and providing technical support and guidance to Manufacturing personnel within the cleanroom Manufacturing suite
• Quality 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 outcome
• Provide 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 documentation
• 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, 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 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 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.

Qualifications

• A degree in a Life Science discipline or relevant equivalent experience.