For 75 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on the health and well-being of people across the globe. Whether your background is in life sciences, finance, IT, sales or another area, your skills will play an important role in the work we perform. In return, we’ll help you build a career that you can feel passionate about.

JOB SUMMARY

We are seeking an experienced Senior Immunoassay Analyst for our Biologics Division located in Ballina, Co. Mayo, Ireland.

This role shall report to the Immunoassay Supervisor and the main duties & responsibilities shall be:

• Project Management of routine batch release testing in the Analytical Services Department (client correspondence, /weekly calls, management of subcontractors, ensuring samples are released within the required timelines i.e. scheduling of tests, review of basic data, liaising with QA, generation of CoA etc.)
• Generation of GMP compliant SOPs, Protocols and reports.
• Sourcing, purchasing and stocking consumables, standards and reagents required for testing.
• Receipt and processing of test samples in LIMS
• Carry out data calculations, basic statistics and trending. Provide additional information at the clients request as required.
• Assist in internal, regulatory and client visits/audits and respond to findings.
• Assist in the development and validation of different immunoassays (ELISA, Western Blot, ELISPot, etc.) and activity based assays.
• Safe and compliant disposal of all laboratory generated waste.

JOB QUALIFICATIONS

The following are minimum requirements related to the Senior Immunoassay Analyst position:

• A minimum of 3-5 years relevant experience in Scientific Research preferably within a GMP regulated environment (EMEA/FDA) within the Pharmaceutical, Medical Device, CRO Industry.
• Experience in project management essential.
• BSc/M.Sc. in a relevant science discipline
• Experience in analytical techniques/immunoassays desirable but not essential.

• Project Management of routine batch release testing in the Analytical Services Department (client correspondence, /weekly calls, management of subcontractors, ensuring samples are released within the required timelines i.e. scheduling of tests, review of basic data, liaising with QA, generation of CoA etc.)
• Generation of GMP compliant SOPs, Protocols and reports.
• Sourcing, purchasing and stocking consumables, standards and reagents required for testing.
• Receipt and processing of test samples in LIMS
• Carry out data calculations, basic statistics and trending. Provide additional information at the clients request as required.
• Assist in internal, regulatory and client visits/audits and respond to findings.
• Assist in the development and validation of different immunoassays (ELISA, Western Blot, ELISPot, etc.) and activity based assays.
• Safe and compliant disposal of all laboratory generated waste