- Responsible for oversight of the Microbiology laboratory supporting the manufacture of a biologic’s product.
- 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.
- Implement and maintain standards of GLP and analytical practice consistent with current regulatory expectations and Global standards
- The Senior Microbiology Analyst will 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 new 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.
- 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.
- The Senior Microbiology Analyst will have a BSc. in Microbiology or another relevant discipline.
- More than 4 years’ experience working in Microbiology in the pharmaceutical industry preferably in a Biologics company
- Experience of microbiology testing including Sterility, endotoxin, mycoplasma and Environmental Management
Following your application for this specific role, Sigmar may contact you regarding other positions that we feel you may be suitable for. If you do not wish to be contacted about other opportunities please let us know. For further information please refer to the Privacy Statement on our website.