Bioanalytical Study Monitor
Georgia Bernard is recruiting for a Bioanalytical Study Monitor to join a leading drug discovery business at their facilities located in Slough on an initial six month contract.
Our client is in the business of improving the lives of patients around the globe with a particular focus on neurology and immunology based diseases.
This position will be based at our clients site in Slough.
As a Bioanalytical Study Monitor you will:
- Interact with bioanalytical project representatives to execute the bioanalytical strategy for a large molecule program, including method transfer/validation and bioanalysis (PK, ADA and BM) at key strategic vendors
- Oversee (neutralizing) immunogenicity method development and validation for different programs, at key strategic vendors
- Assure bioanalytical tasks are executed with good scientific quality, within the adequate quality system, and within the agreed upon timelines.
- Collaborate with multiple internal and external stakeholders
- Participate in clinical study design and documentation
- Participate in writing of the Immunogenicity Risk Assessment
- Participate in harmonization of bioanalytical testing and reporting processes
The successful applicant will have the following qualifications, skills and experience:
- Experience in the pharma or CRO industry supporting regulatory bioanalysis of large molecules
- Knowledge of a range of bioanalytical techniques, mainly (neutralizing) immunogenicity assays and ligand binding assays.
- Knowledge of the latest regulatory standards required for GXP studies including international guidance's published by regulatory agencies such as FDA, EMA
- Knowledge of diagnostic assay set up and validation is a plus
- Previous experience managing contract research organizations
- Experience with change management
For more information or to apply for this position, please contact Georgia Bernard at CK Group on 0191 384 8905 or email email@example.com. Alternatively, please click on the link below to apply online now. 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 47191 in all correspondence.