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: 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 Qualifications

• You have a proven record to work independently or as part of a team.
• Strong background in pharmaceutical microbiology, GMP working experience in QC labs, and aseptic techniques.
• Strong trouble-shooting and problem solving skills.
• Strong attention to detail and excellent written and oral skills.
• Education: BS/BA or equivalent experience in Microbiology or related field and 2+ years of validated experience, or equivalent combination of education and experience.
• Experience levels:
  • Assoc QC Microbiology Scientist: Minimum 0-2 years of Experience
  • QC Microbiology Scientist: Minimum 2 years of Experience

Notes

Regeneron is an equal opportunity employer. We provide reasonable accommodation during the recruitment process where required. Salary ranges and benefits vary by country and role. Final offer determined based on country, role level, and experience. On-site requirements may apply in certain locations.