My client, a global CRO company in Mayo is currently recruiting for Senior In-Vitro Bioassay Analysts
· Mix of permanent and 1 year contract positions
· 4 day working week available after training period
· Benefits such as health insurance and pension
This role will work along with a Laboratory Supervisor and Junior analysts will be responsible for expanding the laboratory to GMP standards. The team will be responsible for the development and validation of new cell based potency assays (CBA) for clients, execution of routine validated CBAs and for day to day running of the laboratory. All new roles will be involved in both the culture of cells and in performing the end-point analysis e.g. . colorimetric assays, ELISA, PCR, Flow cytometry.
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:
Ø Leading the execution of routine cell based potency assays
Ø Support the technical transfer of new cell based assays
Ø Maintenance and propagation of antibiotic free cell cultures.
Ø Evaluation of mammalian cells / Generation and maintenance of mammalian cell banks.
Ø Establishment of Test Method SOPs and validation of methods
Core duties shall include:
Ø Maintenance and propagation of antibiotic free cell cultures.
Ø Competent in microscopic evaluation of mammalian cells and viral infections (e.g. CPE, Plaque assays, haemadsorption)
Ø Provide technical training to team as required.
Ø Receipt and processing of test samples in LIMS.
Ø Update current standard operating procedures.
Ø Assist in laboratory investigations where necessary.
Ø Responsible for reporting progress information to Management.
Ø Assist in internal, regulatory and client visits/audits and respond to findings.
Ø Complete understanding off all regulatory guidelines.
Ø Liaise with the Quality Department for the generation of all departmental quality documents including audit responses, facility replies and deviation reports.
Ø Generation of GMP compliant SOPs, Protocols and reports
Ø Generate risk assessments for laboratory and test items as required.
Ø Maintain Laboratory Data Integrity and compliance
The following are minimum requirements related to the Senior In-Vitro Bioassay Analyst position.
- MSc in a relevant science discipline (A minimum of 2 years relevant experience in Scientific Research preferably within a GMP regulated environment (EMEA/FDA) within the Pharmaceutical, Medical Device, CRO Industry).
- Experience of aseptic cell culture techniques mandatory.
- Experience in in-vitro bioassays/potency assays highly desirable.
- Knowledge of current EU/ HPRA/ FDA/ICH/USP/EP guidelines
If you are interested in applying for this role or discuss the position in more detail, please call aisling murray on 087 4671309 or reach me on [email protected]
