Overview
We are seeking an experienced Senior In Vitro Bioassay Analyst for one of our key clients in the 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:
Responsibilities
* 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 of 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
#J-18808-Ljbffr