Analytical Technology Specialist II
AbbVie
Westport, Ireland
The role centers on conducting Cell-Based Potency Assay (CBPA) testing, ad-hoc investigational & development testing.
In your new role, you will:
- QC Testing of commercial product via Cell Based Potency Assay and related ELISA methods;
- Routine lab duties including critical reagent qualifications, inventory management and equipment maintenance;
- Interdepartmental co-ordination - support product release, drive completion of defined projects etc.;
- Support and execute Method Transfer and Validation activities associated with key biological drug product projects;
- Assay performance monitoring and trending;
- Compiling and review of Laboratory documentation (e.g. SOPs, methods, validation documentation etc.);
- Perform lab duty tasks to maintain a high standard of housekeeping within the laboratory;
- Support regulatory inspections as required;
- Supporting Root Cause Analysis Investigations;
- Adhere to and support all EHS procedures and policies;
- Support and lead Laboratory projects to ensure timelines are met successfully.
Qualifications
To succeed in this role, you will have the following Education and Experience:
- Bachelors of Science, Master’s Degree or Ph.D in a Biological Science;
- Practical experience of mammalian cell culture and basic techniques (Passaging, freeze-down, drug treatments) is an advantage;
- Previous GMP experience is advantageous but not essential;
- Sound scientific/practical understanding of ELISA based methods;
- A clear understanding of working within a regulated environment;
- Excellent communication and presentations skills, both written and oral;
- Strong analytical skills with the ability to plan and schedule workloads.
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