MSAT Scientist

Job Description

We are looking for a driven individual to join us in this brand new role of MSAT Scientist II/Senior MSAT Scientist (dependent on experience).RoslinCT is a world-leading contract manufacturing and development organisation specialising in the field of cell therapies, advanced therapeutic medicinal products and regenerative medicine across a range of therapeutic targets.As part of our continued growth, which includes the opening of our state-of-the-art BioCube facility, we are now recruiting across all of our teams including this MSAT Scientist role. This role is well suited to an individual with experience in cGMP cell culture within cell and gene therapy manufacturing looking to apply their knowledge to a fast-paced, growing organisation.The Role:You will be a key member of our Manufacturing team and hold responsibility for providing technical support to cell and gene therapy manufacturing process technology transfers, process improvements, process troubleshooting, quality investigations and on-the-floorguidance to Manufacturing personnel.Responsibilities:As a key member of a cutting-edge company your responsibilities will be varied but will include;

• The delivery of assigned technical projects and tasks ensuring that project timelines are met according to internal and customer needs.
• Supporting with the transfer of new processes into RoslinCTs GMP Manufacturing facilities working directly with clients and RoslinCTs Development team.
• Completion of process and facility gap assessments for new processes and generation of robust process transfer plans.
• Determination of process descriptions.
• Writing of process change controls, validation protocols, risk assessments, batch records and other relevant documentation for Manufacturing processes.
• Development of new technical protocols, SOPs and related technical documentation to support technology transfer and ongoing development of Manufacturing projects.
• Completion of GMP material assessments and finalisation of the bill of materials.
• Implementation of a process monitoring programme to identify and react to out of trends and shifts in Manufacturing process performance.
• Provision of cross-functional technical support to with Development, QC, QA and Supply Chain teams.
• Support of the evaluation and adoption of new cell therapy manufacturing technologies.
• Provision of specialist training to manufacturing staff on any new manufacturing processes/process changes.
• Support technical investigations and generate/approve technical reports to support close-out of deviations.
• Trouble-shooting of process excursions/failures as required.

Qualifications:The ideal candidate will hold a degree in a Life Science discipline.Skills and Experience:You will be able to demonstrate:

• Experience working with cGMP systems and FDA/EU regulations within biologics manufacturing, ideally within cell and gene therapy manufacturing.
• Hands-on cGMP experience with cell culture.
• Experience in writing technical documentation such as process change controls, validation protocols, batch records and SOPs.

Values:A key part of working at RoslinCT is being able to embody our company values, which are integral to the work we do here. As such, you should be able to demonstrate:

• Passion for customer satisfaction.
• Ability to support a one team approach.
• Great communication.
• Commitment to personal growth and development.
• Accountability for your work.

Location:We are based at Edinburgh BioQuarter, which acts as a hub for Scottish Life Science with close links to the University and the Royal Infirmary.

Keyskills :
Cell CultureGene TherapyGMPManufacturingCell Therapy