QC Microbiology Manager

LSC, Life Science Consultants; Cork; On-site; EUR 70,000 - 110,000; Full time

Job summary

LSC, Life Science Consultants in Cork, Ireland, seeks a QC Microbiology Manager to lead the on-site QC Microbiology team under cGMP guidelines. You will ensure timely sample testing and results delivery, while driving quality and regulatory adherence.

The role covers environmental monitoring, sterility testing oversight, OOS/OOT investigations, supplier management, and staff development, with a focus on lean lab practices and continuous improvement.

Qualifications

• Bachelor's degree in Science-related field.
• 5+ years of biopharmaceutical QC or GMP lab experience preferred.
• Experience with FDA/EU microbiology regulatory expectations preferred.
• Experience managing team performance and succession planning.

Responsibilities

• Lead the QC Microbiology team to operate in compliance with current cGMP standards and deliver results within timelines.
• Own environmental monitoring and utilities monitoring programmes, including quarterly reporting and trending.
• Oversee investigations for out-of-specification, out-of-trend and excursions, with root cause analysis and corrective actions.
• Oversee sterility testing program for Drug Product Facility on site.
• Manage external microbial testing and relationships with labs and suppliers.
• Develop the team in technical expertise and lean laboratory practices; support equipment lifecycle and validation activities.

Skills

Team leadership

cGMP knowledge

Regulatory compliance

Environmental monitoring

Education

Bachelor's degree in Science

Job description

LSC have a great contract opportunity for a QC Microbiology Manager to join a Cork based Biopharmaceutical company. The site manufactures low volume bulk API for Phase III clinical trials, initial product launch and long-term market support. The team on site grow, purify, formulate, and bulk fill mammalian cell culture derived APIs for medicines intended for human use.

If you have 5+ years of experience working in the pharmaceutical or biotechnology industry and are ready for your next challenge, this could be the perfect opportunity for you!

ABOUT THE PROJECT - 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.
• 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.

ABOUT YOU - ARE YOUR SKILLS A MATCH?

• Bachelor's degree in a Science-related field required
• 5+ years of biopharmaceutical QC experience, or related Quality Control/GMP laboratory experience within the pharmaceutical or medical device industry, is preferred.
• 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.

Note: Are you currently eligible to work in Ireland? As this is a contract opportunity you will need to hold a Stamp 1G/Stamp 4 visa to apply!