You will use your knowledge and experience to design, develop and validate fit-for-purpose assays to enable delivery of high-quality data to drive key project decisions, progress projects.
Work will also involve conducting experiments and data analysis to characterise PK, PD and ADA responses, and as required, manage the interaction with contract organisations.
Skills and Experience* Highly motivated individual who enjoys working collaboratively across functions* Ability to work independently and in a high-paced team environment, setting priorities for work from multiple projects to deliver objectives
* Organised with strong attention to detail * Clear written and verbal communications skills with the ability to clearly convey processes, results and key messages and able to build rapport, quickly and effectively* BSc/MSc or PhD with experience in bioanalysis either in industry, clinical laboratories and/or biomedical research* Extensive hands-on experience in the development, validation of quantitative immunoassays and immunogenicity assays, and performance of analysis using a range of technology platforms* In-depth knowledge of immunoassay with extensive experience of pharmacokinetic, immunogenicity (ADA) and biomarker analysis of large molecule biologics, additional experience with gene therapy and/or nucleic acid bioanalysis would be advantageous* Experience in transfer of validation-ready assays and oversee validation studies within GLP/GCLP compliant laboratories* Familiar with current regulatory guidelines and best practices for bioanalytical method development and validation for large molecule and/or gene therapies* Strong understanding of GLP and GCP principles, experience of working in a GxP regulatory laboratory would be advantageous * Contribution to reporting of data, protocols, SOPs, regulatory documents, and internal written reports
your application has been submitted