We are seeking an experienced Senior In Vitro Bioassay Analyst for one of our key clients
Biologics Division located in Co. Mayo, Ireland.
This role shall report to the Biosafety & Cell Based Assay Supervisor and the main duties &
responsibilities shall be to assist the Department Manager and/or the Scientist in the following:
• 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
Job Qualifications
• 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 complianc