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:
o Introduction of new process changes
o Identifying process improvements and their implementation
o Implementation of required process documentations to support manufacturing.
o Support with process monitoring and review process performance
o Identification, technical/quality assessment and introduction of new materials to manufacturing bill of materials.
o Providing support for on-floor process trouble shooting, escalation and resolution
o Quality investigations/out of specification investigations.
o 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.
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