Role: Senior Scientist (Bioanalytical)
Salary: Attractive Salary+ Benefits
CPL Life Sciences is collaborating with a biotechnology company specialised in the development and commercialisation of new generation immunotherapies designed to treat a broad range of diseases, including cancer, infections and autoimmune diseases. They are currently working on their most advanced oncology therapeutic candidate which has demonstrated an overall survival benefit in a clinical trial.
Our client is currently looking for a passionate individual with a strong background in Immunology and experience in bioanalytical assay development and validation of protein macromolecules. The successful candidate will be required to demonstrate strong bioanalytical technical skills leading different projects communicating with different teams about results and future directions. Additionally, the successful candidate would be required to possess the knowledge of EU and USA regulations which is a vital factor within this role.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
- Interpreting data.
- Participating in clinical studies as a bioanalytical representative.
- Guiding bioanalytical projects with recommendations for next steps/future directions.
- Monitoring and reviewing the performance of CRO assays, sample analysis, PK and ADA results.
- Leading technical activities of assays ready for validation to the appropriate laboratory vendors.
- Overseeing method validation studies according to regulatory guidance and industry best practices.
- Coordinating and documenting sample collection and analysis according to established timelines.
- Designing and characterizing custom reagents, controls and biological matrices for use in bioanalytical assays.
- Designing of cell-based pharmacokinetics, immunogenicity and biomarker assays applicable for detection of target analytes in biological matrices.
- Strong background in immunology.
- BSc/MSc with 6-8 years Industrial experience or PhD with 3-5 years of relevant professional experience in immunology, biochemistry or related discipline.
- Experience with:
- Aseptic cell culture and cell-based assay development.
- Experience in GLP and/or clinical regulatory compliance.
- Bioanalytical assays for protein macromolecules with strong scientific and technical skills in method development and validation.
- Development and validation of quantitative immunoassays and immunogenicity assays for biologics (e.g. antibodies, proteins or peptides).
- EU and USA regulatory guidance and industry best practices for development and validation of bioanalytical methods for large molecule biologics.
If you are looking for an opportunity to enhance your experience, broaden your career horizons and change the future apply today.