QC Micro Manager

Fastnet; Cork; On-site; EUR 90,000 - 120,000; Full time

Job summary

Fastnet seeks a QC Microbiology Manager to lead the microbiology laboratory team responsible for testing supporting release and monitoring of drug substance and drug product. The role coordinates QC, QA, Manufacturing, Facilities and Supply Chain to ensure testing and monitoring commitments align with the site plan and quality capacity.

The incumbent will demonstrate technical expertise in microbiology and aseptic operations, along with leadership abilities, initiative, energy and strong

Qualifications

• Familiarity with FDA and European regulatory requirements for microbiological control.
• Experience managing individual and team performance, including succession planning.
• Knowledge of lean laboratory principles and continuous improvement.

Responsibilities

• Lead QC Microbiology team to operate in compliance with current cGMP standards.
• Own site environmental monitoring and utilities monitoring programmes, including quarterly reporting and trending.
• Oversee investigations for out-of-specification and out-of-trend results, including root cause analysis.
• Own oversight for sterility testing on site related to the Drug Product Facility onsite.
• Support laboratory equipment lifecycle, service programmes and new equipment introductions for the microbiology laboratory, and support method and equipment validation activities.
• Author, review and approve procedures, protocols, specifications, reports and change controls relating to microbiological testing and contamination control.
• Support budget preparation and monitoring, including capital equipment needs, facility needs, staffing needs and contract service requirements.
• Identify and conduct personnel training for microbiology staff, prepare performance appraisals, and recruit and onboard team members.

Skills

Regulatory knowledge

People leadership

Lean lab principles

Continuous improvement

Aseptic processing

Job description

The QC Microbiology Manager reports to the Head of QC and is responsible for leading the QC Microbiology laboratory team. The team delivers the microbiological testing that underpins release and monitoring of drug substance and drug product, including anaerobic bioburden, environmental monitoring, water sampling, plate reading, growth promotion and associated trending and reporting.

It is expected that the incumbent will lead in a high-performing, team-based organisation, where colleagues are flexible, multi-skilled and empowered to make decisions. A high level of initiative, energy and motivation are key role requirements, alongside strong organisational and planning skills.

The incumbent must possess technical expertise in microbiology and aseptic operations, and demonstrate both technical and personnel leadership. The role provides co-ordination and alignment between QC, QA, Manufacturing, Facilities and Supply Chain so that microbiological testing and monitoring commitments are delivered in line with the site supply plan and quality capacity.

Key Responsibilities

• Lead the QC Microbiology team to operate in compliance with current cGMP standards at all times, ensuring samples are tested and results delivered within specified timelines.
• Own the site environmental monitoring and utilities (water and compressed gases) monitoring programmes, including routine execution, periodic review, quarterly reporting and trending.
• Provide oversight of out-of-specification, out-of-trend and excursion investigations, including microbial identification, root cause analysis and documentation of corrective actions.
• Own and provide oversight for sterility testing program on site related to the Drug Product Facility onsite.
• Support laboratory equipment lifecycle, service programmes and new equipment introductions for the microbiology laboratory, and support method and equipment validation activities.
• Author, review and approve procedures, protocols, specifications, reports and change controls relating to microbiological testing and contamination control.
• Support budget preparation and monitoring, including capital equipment needs, facility needs, staffing needs and contract service requirements.
• Identify and conduct personnel training for microbiology staff, prepare performance appraisals, and recruit and onboard team members.

Required Experience & Skills

• Understanding and familiarity with FDA and European regulatory requirements, guidelines and expectations for microbiological control, environmental monitoring and aseptic processing.
• Previous experience of managing the performance of individual team members and of the overall team, including development and succession planning.
• Knowledge and experience of lean laboratory principles and continuous improvement is preferable.