Senior Bioassay Scientist, North Yorkshire

Placed: 04/12/17
Region: North Yorkshire
Category: Jobs


Content of the advertisement:

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 highly skilled Senior Bio-assay Method Development and Validation Scientists to join them at their site in North 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 development studies on Large Molecule Bio-analysis projects using Ligand Binding techniques and validate these studies to regulatory and client requirements. Supervising the analytical studies, communicating and supporting the company's clients, and ensuring that all staff receive appropriate training and support.

Key responsibilities of the role include:
· Routine Large Molecule Bioanalysis using Ligand Binding Assay techniques
· Drug Concentration analysis (PK) and detection of Anti-Drug Antibodies (ADA)
· Use of techniques such as ELISA, Gyros, MSD and Bio-marker analysis
· Developing new and existing assays according to regulatory and client requirements
· 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

· Study Supervision responsibilities: 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, or that clients are informed of any issues that may affect the project timelines o Troubleshooting potential problems in a pro-active manner to avoid project delays o Direct interaction with clients o Resource and cost management for personnel, equipment and lab supplies o Analysing study data to aid in key decision making
· External promotion of the company
· Day to day supervision of analysts and providing training and mentorship as required
· Training of other analysts, as required
· Working to strict GLP/GCP standards
· Demonstrate a flexible approach to laboratory work, possess excellent communication and time management skills and be able to maintain high standards of record keeping.

To be considered for this position the successful candidate will have the following qualifications, skills and experience:
· A degree (or equivalent) in a biological discipline. A PhD and post-doc experience would be highly beneficial
· Sound industry experience in the development of bio-assays, particularly Ligand Binding Assays
· Significant experience with techniques such as ELISA, MSD, Gyros and Bio-marker analysis
· Experience with assay troubleshooting
· 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
· Experienced with study supervision or management would be preferred

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.

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 SH40044 in all correspondence

Price / Salary: £35000 - £50000/annum