Job Description

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 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.