QC Microbiology Lab Manager

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

Job summary

BioMarin in Cork, Ireland, is seeking a QC Microbiology Manager to lead the microbiology laboratory team at Shanbally. You will oversee environmental monitoring, sterility testing, and investigations to ensure compliance with regulatory standards and quality capacity.

We look for a strong people leader with deep microbiology expertise, knowledge of cGMP, and excellent communication skills to coordinate with QA, Manufacturing and Supply Chain in a fast-paced biopharmaceutical environment.

Qualifications

• FDA and EU regulatory requirements for microbiological control and environmental monitoring.
• Experience managing a microbiology team and succession planning.
• Lean laboratory principles and continuous improvement experience preferable.
• Excellent written and verbal communication with a customer focus.
• Self-motivated and able to work under pressure in a multi-product environment.

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.
• Manage external microbial testing and relationships with external testing labs and suppliers.
• Develop the team in areas of technical expertise, use of operational excellence tools and high-performance team behaviours, including standard work, 5S and lean laboratory practices.
• Support laboratory equipment lifecycle, service programmes and new equipment introductions for the microbiology laboratory, and support method and equipment validation activities.
• Plan resource and capacity for the microbiology team against the manufacturing schedule, and manage stock of media, consumables and reference cultures.
• Maintain the laboratory in an inspection-ready state and represent QC Microbiology during regulatory inspections, customer audits and internal audits.
• Author, review and approve procedures, protocols, specifications, reports and change controls relating to microbiological testing and contamination control.
• Interface with other BioMarin departments (Quality Assurance, Manufacturing, Facilities, Regulatory Affairs, Supply Chain) and with external contractors and contract laboratories as necessary.
• Participate as required in global project teams relating to QC Microbiology, contamination control strategy and wider quality activities.
• 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.
• As required, act as designee for the Director, QC in their absence.
• Other duties as assigned.

Skills

Regulatory knowledge

People management

Lean laboratory

Communication skills

Adaptable under pressure

Microbiology expertise

Job description

BioMarin in Cork, Ireland, is seeking a QC Microbiology Manager to lead the microbiology laboratory team at Shanbally. You will oversee environmental monitoring, sterility testing, and investigations to ensure compliance with regulatory standards and quality capacity.

We look for a strong people leader with deep microbiology expertise, knowledge of cGMP, and excellent communication skills to coordinate with QA, Manufacturing and Supply Chain in a fast-paced biopharmaceutical environment.