QC Microbiology Manager: Lead cGMP Lab & EM

BioMarin Pharmaceutical Inc.; Ireland; On-site; EUR 90,000 - 120,000; Full time

Job summary

BioMarin is seeking a QC Microbiology Manager to lead the Cork-based microbiology laboratory. You will oversee testing that underpins release and monitoring of drug substance and product, including environmental monitoring and sterility programs.

Reporting to the Head of QC, you will manage a high‑performing team, drive investigations, coordinate with QA, Manufacturing and Regulatory Affairs, and ensure inspection readiness across the site.

Qualifications

• Experience leading microbiology teams in cGMP environments.
• Knowledge of FDA and EU regulatory expectations for microbiology.
• Strong leadership and project management skills.
• Excellent written and verbal communication.

Responsibilities

• Lead QC Microbiology team to operate in compliance with current cGMP standards and deadlines.
• Own environmental monitoring and utilities monitoring programmes with quarterly reporting.
• Oversee investigations for out-of-spec, out-of-trend and excursions with root-cause analysis.
• Own sterility testing program on site related to the Drug Product Facility.
• Manage external microbial testing and relationships with labs and suppliers.
• Develop the team using operational excellence tools and Lean practices.
• Plan resource/capacity against manufacturing schedule and manage stock.
• Represent QC Microbiology during regulatory inspections and audits.

Skills

Regulatory Compliance

People Leadership

Lean Lab Principles

Microbiology Expertise

Job description

BioMarin is seeking a QC Microbiology Manager to lead the Cork-based microbiology laboratory. You will oversee testing that underpins release and monitoring of drug substance and product, including environmental monitoring and sterility programs.

Reporting to the Head of QC, you will manage a high‑performing team, drive investigations, coordinate with QA, Manufacturing and Regulatory Affairs, and ensure inspection readiness across the site.