We are hiring an Analytical Technology Specialist at our Westport site in Co. Mayo, Ireland.
Job Description
The role centers on conducting Cell-Based Potency Assay (CBPA) testing and ad-hoc investigational & development testing.
This is a 12 months fixed term contract opportunity to develop your career with an industry leader.
Key Responsibilities:
* QC Testing of commercial product via Cell Based Potody Assay and related ELISA methods
* Routine lab duties including critical reagent qualifications, inventory management and equipment maintenance
* Interdepartmental coordination - 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.