GLP Bioanalytical Scientist
The role will include but is not limited to:
- Lab based role focused on development, validation and application of bioanalytical methods either for PK, ADA or Biomarker analysis;
- Work closely with the project bioanalytical representatives to ensure effective knowledge transfer of bioanalytical methods to CRO partners;
- Collaboration with colleagues in Braine and Slough to ensure methods are appropriately validated to support GLP studies;
- Troubleshooting and resolving technical issues associated to ligand binding assays as they arise;
- Actively contribute to ensuring GLP and GCP quality systems are compliant with regulatory requirements and robust scientific practice;
- Actively promote transfer of scientific knowledge amongst peers and keep abreast of latest developments in regulatory bioanalysis including technologies and publications.
Education, Skills and experience:
- BSc./MSc. in Life Sciences (e.g. Biomedical Sciences, Medical technology, Immunology or similar);
- A minimum of 5 years’ experience working in the pharma or CRO industry supporting regulatory bioanalysis of NBE or biomarkers programs;
- Hands-on knowledge of a range of bioanalytical techniques and platforms including but not limited to ELISA, MSD and Gyros to support the analysis of Pharmacokinetic and Pharmacodynamics endpoints including Anti-Drug Antibodies and Biomarkers;
- Experience in autonomous method development and validation and transfer of novel methods for PK, ADA and Biomarker support;
- Ability to troubleshoot immunoanalytical methods to ensure methods are fit for purpose;
- Experience in working with a wide range of internal stakeholders including Non-Clinical Safety, DMPK, Translational Medicine, Clinical Pharmacology, Clinical operations and Quality Assurance colleagues;
- Well organized, capable of communicating clear instructions to partners and stakeholders alike;
- Good knowledge of the English language both written and spoken, working knowledge of French is a plus;
- Experience utilizing automation tools such as the Hamilton Starlet or other systems would be highly desired.
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