My client, a global biopharmaceutical organisation, is looking for a QC Biologist to:
* Support activities in the areas of qualification of critical reagents (biomaterials) used in Bio-assays, such as ELISA coats, ELISA conjugates, reference toxins etc.
* To support analytical method validation / improvements and method transfers for Biology and Microbiology labs between sites.
Key Responsibilities and Duties:
* Expertise in Immunology techniques such as ELISA’s, haemagglutination tests, antigen mass assay is essential.
* Understanding of microbiology techniques is beneficial.
* Validation of biomaterials used in in-process and final product testing.
* Biology/Microbiology method validation / improvements and test transfer between labs/sites.
* Drive change management for introduction of new / improved methods and validation of new equipment.
* Be able to produce technical documents such as protocols, testing and execution plans and final reports.
* Ability to work on several projects simultaneously and be able to prioritise.
* Reporting and communication of results to stakeholders. Liaise with several departments - technical support groups, QA, Regulatory to drive project completion and deliver on milestones.
* The candidate will be required to report all laboratory activities in a clear, organised manner, in the form of reports, following the standard operating procedures.
* Good understanding and ability to perform efficient lab investigations arising from deviations or invalid/atypical results.
* The candidate should be able to provide training to staff on test methods and equipment usage.
* Additionally, the candidate may be required to support laboratory investigations, perform troubleshooting exercises and participate in proof of principle studies.
* Reporting and investigation of OOS and OOT results, determine root causes and implementing effective CAPA actions.
* Perform project related literature searches.
* Interact closely with fellow scientists and global/regional colleagues within own and other departments.
* Work in a multi-disciplinary and international team and environment.
The ideal candidate will hold a degree or equivalent in Biology or a related discipline and will have a good understanding and working knowledge of GMP quality systems. You will also have experience in Elisa and other immunological techniques with validation and method development experience