- The Plant Microbiologist will be responsible for the overall management of the Microbiology laboratory supporting the manufacture of biologics product.
- Provide technical support for the qualification and validation of the manufacturing facility which includes Facility, Equipment, Environmental Monitoring program, Media Fills, Container Closure Integrity Validation, Process Validation and Continued Process Verification
- Establish and lead the Microbiology team supporting the technical transfer of product through to operation readiness: Method Transfer/Validation, Contamination control strategy, Aseptic training, Environmental Monitoring program, raw materials testing, product testing, in-processing testing, process validation and facility validation.
- Responsible for the Microbiology Laboratory Start-up activities which includes development of URSs, Risk Assessments, Protocols, Reports, SOPs, EOPs work instructions, procurement and qualification of equipment, software and utilities/facilities.
- People manager responsible for recruiting, managing, training, development and performance reviews from project phase into sustaining production.
- Responsible for the operation and inspection readiness of the Microbiology laboratory by ensuring the laboratory 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.
- Ensure that testing schedules are achieved and manage laboratory resources (instruments and personnel) to provide a comprehensive analytical service for testing of all samples.
- Manage the environmental monitoring to support the manufacturing of the Alofisel.
- The Plant Microbiologist will lead and participate in the technical transfer / validation of microbiological testing procedures including Mycoplasma, Sterility testing and Endotoxin testing.
- Manage 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.
- Generate, implement and control of Microbiology annual budget for consumables, capital and headcount.
- As required, act as designee for the QC Bioprocessing Laboratory Manager in their absence.
- Participate as required in global project teams relating to Microbiology and wider quality activities
- More than 7 years’ experience working in Microbiology in the pharmaceutical industry, preferably in a Biologics company
- Extensive experience of microbiology testing including Contamination Control. Sterility, endotoxin, mycoplasma and Environmental Management
- Thorough knowledge of GMP and current FDA & EMEA regulations
- Previous experience managing the performance of individual team members and the overall team
- Knowledge and experience of Lean Laboratories is preferable
- Previous experience in start-up projects for aseptic filling facility including the associated Microbiology laboratory is desirable
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