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!
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