Senior In-vitro Analyst (Virology/Molecular)
We are seeking a Senior In-Vitro Bioassay Analyst for our Biosafety & Bioassay Department located in Ballina, Co. Mayo.
This role shall report to the Molecular and Virology Manager and the main duties & responsibilities shall be to assist the Department Manager and/or the Scientist in the following:
• Leading the execution of routine virology and molecular biology assays such as Adventitious viruses assay, viral titration assay (qPCR, TCID50, Fluorescent foci) and absolute titration assay (dPCR).
• Support technical transfer, qualification and validation of new virology or molecular based methods.
• Maintenance and propagation of antibiotic free cell cultures.
• Evaluation of mammalian cells / Generation and maintenance of mammalian cell banks and virus 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
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 and knowledge in virology/molecular biology highly desirable.
• Experience with TCID50/Fluorescent foci titration assays highly desirable.
• Knowledge of current EU/ HPRA/ FDA/ICH/USP/EP guidelines
• Ability to problem solve and work on own initiative.
• Must Exhibit exceptional teamwork skills
We are seeking a Senior In-Vitro Bioassay Analyst for our Biosafety & Bioassay Department located in Ballina, Co. Mayo.
This role shall report to the Molecular and Virology Manager and the main duties & responsibilities shall be to assist the Department Manager and/or the Scientist in the following:
• Leading the execution of routine virology and molecular biology assays such as Adventitious viruses assay, viral titration assay (qPCR, TCID50, Fluorescent foci) and absolute titration assay (dPCR).
• Support technical transfer, qualification and validation of new virology or molecular based methods.
• Maintenance and propagation of antibiotic free cell cultures.
• Evaluation of mammalian cells / Generation and maintenance of mammalian cell banks and virus 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
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 and knowledge in virology/molecular biology highly desirable.
• Experience with TCID50/Fluorescent foci titration assays highly desirable.
• Knowledge of current EU/ HPRA/ FDA/ICH/USP/EP guidelines
• Ability to problem solve and work on own initiative.
• Must Exhibit exceptional teamwork skills
