For one of our clients, we are looking for a Bioanalytical Research Associate/Scientist to join its Bioanalytical Sciences and Non Clinical Safety Department.
Reporting to the Head of the Bioanalytical Laboratory, this person will support key bioanalytical activities in development of our innovative biological entities.
? Responsible for development and validation of bioanalytical assays within the company and with outsourcing partners in the areas of PK, immunogenicity, biomarker and cell biology.
? Responsible for delivery of critical bioanalytical data in a timely manner; allocation of appropriate resources and budget.
? Liaise with internal and external stakeholders to place all bioanalytical endpoints in an appropriate biological context.
? Actively contribute to protect teams and drive the scientific discussion and rationale for bioanalytical endpoints. Responsible for setting and refining the strategy for bioanalytical endpoints within non-clinical and clinical studies.
? Provide the appropriate levels of assay validation to ensure that data quality is fit for the intended purpose.
? Supervise students / technicians in the Bioanalytical laboratory
? Responsible for troubleshooting technical issues and providing solutions, which may arise during the course of assay development, validation and/or sample analysis.
? Prepare and review appropriate bioanalytical plans, reports and supporting documentation.
? Deliver scientific presentations internally and at conferences; contribute to the preparation and review of manuscripts for publication in peer-reviewed journals.
? Promote strong scientific collaboration across the department and the company as a whole.
? Keep abreast of latest technologies and publications in the field of bioanalysis.
Skills and Competencies
? At least 5 years of experience in the pharma or CRO industry supporting bioanalysis of large molecules are required
? Very good knowledge of the regulatory framework (GCP for Bioanalytical Laboratories and Bioanalysis guidelines) is required
? Experience working with a wide range of internal stakeholders including Research Scientists, Non-Clinical Safety, Translational Medicine, Clinical Scientists, Clinical Operations and Quality Assurance colleagues is required
? Knowledge of a range of bioanalytical techniques including immunoassay, flow cytometry and quantitative PCR to support the analysis of pharmacokinetic, biomarker and immunogenicity endpoints is essential.
? Ability to represent the bioanalytical group in project teams, drive the scientific discussion and rationale for all bioanalytical endpoints.
? Ability to influence teams to ensure bioanalytical data generated is of the highest quality.
? Well organized, capable of communicating complex scientific information clearly and concisely.
? Fluency in English is required