Job Title: Senior Lead Microbiology Analyst – QC Location: Limerick, Ireland
About the Role:
We are seeking an experienced Senior Lead Microbiology Analyst to join our cutting-edge biotech drug substance manufacturing facility in Limerick. This state-of-the-art facility incorporates advanced manufacturing technologies and data collection platforms, delivering improvements in safety, quality, and productivity. This is a unique opportunity to be part of a new technical team, supporting the startup of a greenfield site and ensuring successful cGMP operations.
Key Responsibilities:
QC Testing & Equipment Expertise:
Ensure a safety-first approach in all lab activities.Author and execute method verification protocols for microbiological test methods (bioburden, endotoxin).Serve as the Subject Matter Expert (SME) for microbiology lab test equipment.Provide support for microbiological studies, including data review and analysis.Compliance & Documentation:
Ensure all microbiological testing adheres to cGMP and complies with regulations and global standards.Lead investigations related to microbiology, including deviations and data integrity assessments.Maintain accurate records and author procedures, protocols, reports, and change controls as required.Ensure the laboratory is audit-ready at all times.Training & Process Improvement:
Develop training programs and lead training for new microbiology analysts in critical techniques (bioburden, endotoxin, environmental monitoring, etc.).Identify and implement process improvements within the lab to increase efficiency and compliance.Provide technical support and mentorship to lab analysts, fostering a culture of continuous improvement.Qualifications:
Bachelor's degree in Microbiology, Biology, or related field.Minimum of 6 years of experience in microbiology testing within the pharmaceutical or biotechnology industry.Proven expertise in QC microbiology techniques and a strong understanding of data integrity requirements.Demonstrated leadership and training ability, with a strong focus on team development.Excellent attention to detail, problem-solving skills, and the ability to manage multiple priorities.Familiarity with laboratory software (LIMS, electronic notebooks) and strong IT skills.Fluent in English with strong communication skills.What We Offer:
A dynamic and innovative work environment at the forefront of biotech manufacturing.Competitive salary and benefits.Opportunities for career growth and professional development.If you are a microbiology expert with a passion for quality and innovation, and you are looking to make a real impact, we want to hear from you. Apply today to be part of a high-performing team in a next-generation manufacturing facility!
#L1-DB4
#J-18808-Ljbffr
