Bioanalytical Scientist

Cambridgeshire - UK

Monthly Salary: Not Disclosed

Posted on: 11 hours ago

Vacancies: 1 Vacancy

Job Summary

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

Bachelors 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 if you think you can help in the future.

Required Experience:

Manager

The RoleReporting 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 st...