Job DescriptionBioanalytical Study Director - Biotech - London
We are looking for an experienced Bioanalytical Study Director 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