QC Microbiology Associate Scientist / Scientist

Overview

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. Regeneron is seeking a QC Microbiology Associate Scientist / Scientist to join our QC Tech Resources team. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

Location

Location: Raheen, Limerick

Responsibilities

• Validating methods and equipment related to sterility, bioburden, endotoxin testing, and microbial identifications.
• Writing technical documentation, including position papers, validation reports, and microbiological investigations.
• Culturing organisms, conducting research, and characterizing them for use in investigations and cleaning development.
• Reviewing new test procedures and assays for accuracy and compliance.
• Evaluating and acquiring new methodologies, techniques, and equipment as needed.
• Overseeing contract laboratory testing to ensure quality and compliance.
• Setting product specifications and alert/action levels for microbiological standards.
• Leading technical troubleshooting and problem investigations.
• Reviewing assay, process, and equipment validation reports, as well as other technical documents for correctness and regulatory compliance.
• Coaching junior team members on good microbiology lab practices and modern aseptic techniques.
• Supporting and participating in regulatory inspections to ensure compliance.
• Demonstrating investigational skills and working knowledge of microbiology assay development and validation.

Environment and Requirements

• You have a proven record to work independently or as part of a team.
• Possessing a strong background in pharmaceutical microbiology, GMP working experience in QC labs, and aseptic techniques.
• You possess strong trouble-shooting and problem solving skills.
• You have strong attention to detail & excellent written and oral skills.

Qualifications

• Assc QC Microbiology Scientist: Minimum 0-2 years of Experience
• QC Microbiology Scientist: Minimum 2 years of Experience
• BS/BA or equivalent experience in Microbiology or related field and 2+ years of validated experience, or equivalent combination of education and experience.

EEO and Benefits

Regeneron is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation or gender identity, national origin, disability, veteran status, or any other characteristic protected by applicable law. Regeneron offers a competitive and comprehensive total rewards package which may include bonuses, equity awards, retirement benefits, health and wellness programs, paid time off, and other benefits. For additional information about Regeneron benefits, please visit the company careers page.