Senior QC Microbiology Leader

PSC Biotech® Corporation; Cork; On-site; EUR 90,000 - 120,000; Full time

Job summary

PSC Biotech is seeking a QC Microbiology Manager to lead the on-site microbiology laboratory team, ensuring adherence to cGMP and timely microbiological testing for drug substance and product.

The role requires strong leadership, regulatory awareness, and the ability to coordinate across QA, Manufacturing, Facilities, and Regulatory Affairs to support contamination control and quality objectives.

Qualifications

• Understanding FDA/European regulatory expectations for microbiological control, environmental monitoring and aseptic processing.
• Experience managing a microbiology team, including development and succession planning.
• Familiarity with lean laboratory principles and continuous improvement.

Responsibilities

• Lead QC Microbiology team to comply with current cGMP standards and deliver results on time.
• Own environmental monitoring and utilities monitoring programmes with periodic review and reporting.
• Oversee investigations for out-of-specification events, including root cause analysis and CAPA.
• Manage sterility testing program on site related to Drug Product Facility.
• Coordinate with QA, Manufacturing, Facilities and Regulatory Affairs; interface with external labs.

Skills

cGMP compliance

Microbiology

Environmental monitoring

Aseptic processing

Regulatory readiness

Leadership

Lean lab practices

Communication

Cross-functional collaboration

Job description

PSC Biotech is seeking a QC Microbiology Manager to lead the on-site microbiology laboratory team, ensuring adherence to cGMP and timely microbiological testing for drug substance and product.

The role requires strong leadership, regulatory awareness, and the ability to coordinate across QA, Manufacturing, Facilities, and Regulatory Affairs to support contamination control and quality objectives.