Bio-assay Meth. Val. Scientist, Yorkshire
Are you looking for an exciting opportunity to join a global CRO who are supporting the world's best pharmaceutical organisation in the development of new medicines?
Our client are currently undergoing a significant expansion in their immunology department due to collaborations with new sponsors and exciting new projects. As a result they are searching for four highly skilled Bio-assay Method Validation Scientists to join them at their site in Yorkshire, initially on a 6 month contract basis, with the possibility of subsequent extensions.
There has been major investment made to the facilities on site. This is a fully GMP/ GLP/ GCP compliant facility providing a comprehensive portfolio of services including cell bank production and storage, cell bank and viral vector safety testing, viral clearance services, cell based bioassays, biodistribution studies, analysis of biofluids using immunochemistry based techniques and extensive protein chemistry support including cGMP batch release and stability testing.
This role will be part lab based and part office based, the main responsibilities of the role being:
To conduct analytical validation studies on a range of immunochemistry based assays while assisting with study supervision and supporting company clients.
Key responsibilities of the role include:
Conducting scientific reviews of client methods and SOPs to aid transfer of assays to the immunochemistry department
Regular validation of Immunochemistry Bio-assays to FDA and EMA standards
- Producing analytical procedures and documentation for developed methods
- Generating and maintaining study files for multiple studies, as required
Assisting with review of all study files post-analysis to ensure that all analytical work has been completed to regulatory standards and client requirements
Assisting with the delivery of studies: o Communicating with internal and external partners to ensure studies are progressed according to regulatory and client requirements o Direct interaction with clients via telephone, email and visits o Ensuring deadlines are met o Troubleshooting potential problems in a pro-active manner to avoid project delays o Analysing study data to aid in key decision making
Assisting with training and supervision of other analysts
- Working to strict GLP/GCP standards
To be considered for this position the successful candidate will have the following qualifications, skills and experience:
A scientific degree, or equivalent qualification, in a relevant discipline. A PhD would be highly beneficial.
Experience with routine use and maintenance of equipment appropriate for immunochemistry assays
Experience with validation of a range of Bio-assays
- Troubleshooting of equipment issues
- Experience with assay troubleshooting
- Understanding of regulatory requirements and working to GCP/GLP
- Proactive and able to meet tight deadlines
If successful, you will be joining a leading drug development services company working with some of the most renowned pharmaceutical organisations and most talented scientists in the world.
To apply for this Bio-Assay Method Validation position please contact Rob Walker (RWalker@ckscience.co.uk - 01246 457 724). Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.
CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference SH40043 in all correspondence.