We are looking for an experienced Senior Bioanalytical Scientist to oversee the execution of bioanalytical analysis outsourced to CROs for an established and exciting Biotech in London. Due to progression of a number of their therapeutic antibody programs, this role has been created to ensure successful delivery of PK, immunogenicity/ADA and biomarker assays to the clinic.
- Leading activities required to oversee the execution of analytical testing within method transfer and validation of a variety of bioanalytical methods.
- Methods are conducted under Good Laboratory/Clinical Practices (GLP/GCP) outsourced to CROs and include:
- Immunoassays (ELISA, MSD)
- Cell based assays (Cytotoxic, ADCC, CDC, nAbs)
- Flow cytometry
- Provide analytical project oversight by performing data review and trending analysis, evaluate assay quality, monitor performance and manage timelines.
- Recommend and implement processes and procedures to standardize, simplify and enhance quality and compliance of the bioanalytical operations.
- Manage critical assay reagents and materials related to GLP/GCP assays outsourced to CROs.
- Support continuous improvement in laboratory activities and contribute to general organisation of the laboratories
- Degree or above in a Biological Science (Biology, Immunology, Cell Biology etc)
- A thorough understanding of bioanalytical methods for preclinical and clinical development with a focus on immunogenicity, biomarkers and pharmacokinetics
- Several years industry experience working in a GLP/GCP regulated environment
- Prior experience and knowledge of bioanalytical assays used in the field of PK and ADA analysis, such as ELISA, MSD, ECLIA, LC-MS/MS, cell based assays etc
- Prior experiencing outsourcing to CROs is desirable