The Role
Reporting to the Director of Bioanalysis, we are seeking a highly motivated and skilled Large Molecule Bioanalytical Scientist who will work within a broader translational team and contribute to non-clinical and clinical development activities. The role will focus on aligning with internal stakeholders and external service providers to collaborate on effective bioassay delivery goals. You will be instrumental in designing, developing, and characterising assays in a timely fashion to support the pharmacokinetics, pharmacodynamics, and immunogenicity assessment of our novel antibody therapeutics. This is a hands-on, lab-based role.
Responsibilities
- Develop, optimize, and partially validate robust and phase-appropriate bioanalytical methods using suitable immunoassay technologies for quantifying antibody drugs, and biomarkers in various biological matrices (e.g., plasma/serum, urine, tissues).
- Ensure successful transfer of bioanalytical assays to external CROs.
- Conduct sample analysis for non-regulated study phases, as required, ensuring high-quality, reproducible data.
- Maintain detailed records of experiments, protocols, and results, and perform data analysis & interpretation, applying statistical methods to ensure data accuracy and reliability.
- Troubleshoot method and instrumentation issues effectively.
- Collaborate closely with early discovery and development teams.
- Communicate efficiently, interpret and summarise data for presentation to different audiences.
- Maintain assigned laboratory equipment and/or duties.
- Perform all work demonstrating due care and attention to all health and safety and COSHH regulations, and Human Tissue Act records where required.
Required Qualifications
Bachelor’s degree in Biochemistry, or a closely related field within biology or analytical sciences.
Required Experience:
- Demonstrable bioanalytical experience in a drug discovery and development context.
- Experience with development and validation of a variety of different assay formats.
- Proven hands-on experience with immunoassay techniques such as ELISA, MSD, Gyrolab.
- Good understanding of GxP and current FDA/EMA bioanalytical regulatory guidelines.
- Excellent organizational and communication (written and verbal) skills and a pro-active approach to problem-solving
- Ability to work independently and as part of a multi-disciplinary team.
Desirable Skills would be:
Experience of:
- LC-MS/MS
- LIMS and electronic lab notebooks (ELN).
- Method transfer and managing external CROs.
- Cell based assays
- PK/PD modelling
NOTE: This job description is not intended to be all inclusive. Employees may perform other related duties as negotiated to meet the ongoing needs of the organisation.
Note to recruitment agencies: we are not looking for assistance at this stage so please contact the HR department only at [email protected] if you think you can help in the future.
