MSAT Scientist

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.