JO-2504-550701
NEW ROLE : Our client, an early-stage contract research organization requires a Senior In Vitro Bioassay Analyst to join their expanding team in Ballina. Reporting to the Biosafety & Cell Based Assay Supervisor.
Role:
- Leading the execution of routine cell-based potency assays
- Support technical transfer, qualification and validation of new cell-based assays
- Maintenance and propagation of antibiotic free cell cultures.
- Evaluation of mammalian cells / Generation and maintenance of mammalian cell banks.
- Establishment of Test Method SOPs and validation of methods
Core duties shall include:
- Maintenance and propagation of antibiotic free cell cultures.
- Competent in microscopic evaluation of mammalian cells (e.g. cell morphology, count and viability)
- Provide technical training to team as required.
- Receipt and processing of test samples in LIMS.
- Update current standard operating procedures.
- Assist in laboratory investigations where necessary.
- Responsible for reporting progress information to Management.
- Assist in internal, regulatory and client visits/audits and respond to findings.
- Complete understanding off all regulatory guidelines.
- Liaise with the Quality Department for the generation of all departmental quality documents including audit responses, facility replies and deviation reports.
- Generation of GMP compliant SOPs, Protocols and reports
- Generate risk assessments for laboratory and test items as required.
- Maintain Laboratory Data Integrity and compliance
