Senior Scientist - Bioassay ValidationCK Group are recruiting for a Senior Bioassay Validation Scientist to join a growing biotechnology company on a permanent basis to be based in Oxford.
A great opportunity to take responsibility in a fast-paced environment, working within an interdisciplinary team to develop new cancer treatments.
The Role: The successful candidate will ensure successful conduct of development, qualification and validation of bioassays for sample analysis and management under regulatory guidelines, and to ensure execution, and data delivery of biomarker lab data for clinical trials.
Your responsibilities will include: Sample analysis management ensuring timely delivery of biomarker lab data.Ownership of quality records (Deviations, Change Controls and CAPAs).Work closely with the clinical operations teams to coordinate and integrate clinical sample management, handling, storage, shipment and data transfer agreements.
Work closely with operations teams to coordinate and integrate bioassays into clinical trial sample manuals.Provide guidance to lab scientists to ensure: accurate record keeping, report writing, assay qualification or validation.
Act as independent scientist reviewer and sign off lab book, verify calculations and approve technical SOPs.
Perform bioassay development and validation experiments, and patient sample analysis.Provide operational input into study related documentation and processes, and ensure collection, delivery and analysis of bio-samples in compliance with GCLP.Provide support with CRO management when required.
Your Background: Degree qualified (MSc/ PhD) with industry experience in bioassay validation, analysis, and clinical sample management in the industry setting.Up-to date GCLP certifications.Technical expertise and hands on sample management.Technical expertise and hands-on experience in bioassay development, qualification and validation requirements in a regulated environment in a CRO or Biotech setting.Practical knowledge and implementation of ICH guidelines such as Q14 and Q2(R2).Experience as independent scientist reviewer of validation reports and assays.Must be up to date with scientific and technical developments in translational/bioassay science.