GMP Senior Scientist (Quality Control)

About the role

The post holder will support the Principal Investigators and senior team members as we work towards clinical batch manufacturing and continue to optimise our GMP manufacturing processes for retinal cell therapies. The post holder will undertake QC testing, and participate in protocol and assay development, facility and equipment maintenance, electronic record documentation and maintaining stocks. The work will include day-to-day operations and execution of QC testing, analysis and report writing, helping to ensure SOPs and schedules are followed by participating in development, validation and manufacturing processes, liaising with the production and technical teams, preparing documentation, identifying quality deviations, and reporting to Principal Investigator. While the role is predominantly focussed on QC, a willingness to additionally contribute to cell manufacturing and support ongoing pre-clinical R&D and research projects within the group is required.  

The post is suitable for a highly motivated individual who is competent in molecular, cellular and analytical techniques relevant to cellular QC assays. They will have working understanding of GLP and/or GMP QC processes and experience of QC development, validation of QC assays for in-process, stability and release testing, compiling laboratory reports and ensuring QC testing as per product specification file, reviewing electronic quality records for quality approval, batch certification and QP release. Excellent organisational skills, attention to detail and the ability to analyse, interpret, validate and report the results of routine investigations are essential.

This is a full-time position (35 hours per week), and you will be offered a fixed term contract for one year. This position requires full-time on-site work.

Essential criteria 

• Minimum level 4 qualification, plus work experience in relevant technical/scientific posts, in Biological and/or Engineering discipline related to life sciences OR considerable knowledge and skills gained through work experience, with GMP training and ATMP manufacturing experience for the release of cell therapy products as IMPs/INDs for clinical trials. 
• Strong background in analytical cellular and molecular techniques, aseptic handling, cellular and bioprocessing techniques  
• Trained in i) analytical assay development and qualification, analytical testing of cell therapy products and/or ii) QC or production experience in GMP 
• Good working knowledge of regulations and best practice governing cGMP compliance, in addition to approved QC procedures for use in GMP manufacturing and product release 
• Evidence of attention to detail and good record keeping including electronic and paper-based documentation 
• Clear and effective spoken and written communication skills, strong interpersonal skills dealing with internal and external stakeholders, ability to contribute to the team success such as training colleagues, providing scientific input during meetings, keeping a healthy working atmosphere in the lab and GMP facility. 
• Willingness and ability to work outside core hours, including evenings and weekends as required by manufacturing schedule, & understanding that research priorities can change and may require changes to planned work.

Desirable criteria

• Experience as Quality Control Technician or Scientist in a licensed GMP facility  
• Trained in relevant analytical cellular and molecular techniques for testing and release of cell therapy products 
• Hands on experience of working with human stem cell or neural cell cultures 
• Experience of flow cytometry, qPCR, ICC/IHC tissue/cell processing and image analysis   
• Good knowledge of the field of cell therapy, and expertise in translational research methodology with an organised and systematic approach to development and manufacturing 

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