Are you an experience Micro Analyst with an interest in joining a hugely progressive modular cell therapy facility in Dublin?
Do you have 4+ years Micro experience working in a GMP environment?
Do you have strong microbiology testing experience including Sterility, endotoxin, mycoplasma and
Environmental Management? Are you an SME in any of these methods?
Would you like to be involved in the setup of a new lab?
If so this could be the opportunity for you!
The purpose of the role is to oversee the general running of the Microbiology laboratory, Environmental Management and the aseptic technique associated with the manufacture of the biological products.
You will also be responsible for the following:
- Oversee aseptic practices (gowning, monitoring, cleaning and related training).
- Perform microbiological testing as required to support operations.
- Perform environmental monitoring as required to support operations.
- Ensure that the Microbiology laboratory is set up and operates in compliance with current Good Laboratory Practice / Good Manufacturing Practice at all times.
- Develop and maintain excellent communication and collaboration between the Microbiology laboratory and operations.
- Training of microbiology analysts. Scheduling of microbiologist work via visual management
- Ensure that testing schedules are achieved and manage laboratory resources (instruments and personnel) to provide a comprehensive analytical service for testing of all samples.
- Oversee the environmental monitoring programme for the facility.
- Participate in the technical transfer / validation of microbiological testing procedures including Mycoplasma, Sterility testing and Endotoxin testing.
- Oversight of contract testing laboratories associated with microbiological testing
- Manage the investigation into any non-conformance, instrument malfunction, accident or other abnormal occurrence. Ensure that any Out of Specification (OOS) or Out of Trend (OOT) analytical results are managed as per SOP.
- Manage an effective laboratory documentation system. Prepare and review documents as required.
- Prepare for, and support, internal and external audits (e.g. HPRA, FDA, corporate, customer).
- Actively lead and support projects, quality initiatives and continuous improvement programmes within the Quality department and in other functional areas.
- Implement and maintain standards of safety to ensure a safe working laboratory. Ensure that the laboratory is kept clean, tidy and safe at all times.
- As required, act as designee for the Plant Microbiologist in their absence.
- Participate as required in global project teams relating to Microbiology and wider quality activities.
Morgan McKinley is acting as an Employment Agency in relation to this vacancy.
Please note that any references to salary or pay rates in this advertisement and in the salary refinement section are indicative only and should only be used as a guide.