Quality Control Microbiology Scientist – Method Innovator

Regeneron Pharmaceuticals; Rensselaer (IN); On-site; USD 67,000 - 110,000; Full time

Job summary

Regeneron Pharmaceuticals is seeking a Quality Control Microbiology Scientist in Rensselaer, NY to support microbiology methods across cell-culture, manufacturing, and facilities. You will ensure cGMP compliance, lead validations, and drive improvements using rapid technologies.

The role emphasizes developing, validating, and troubleshooting microbiological test methods, data analysis, and cross-functional collaboration with manufacturing.

Qualifications

• BS/BA in Life sciences, microbiology or biology preferred.
• 3+ years of relevant experience in microbiology.
• Knowledge of microbiological test methods (Endotoxin, LAL, Bioburden, Sterility).
• Experience with BMRAM, Discoverant, Documentation Compliance, LIMS, MS Word and Excel.

Responsibilities

• Ensure QC microbiological compliance with cGMP standards.
• Conduct microbiological validations for raw materials, finished products, in-process controls, and buffers.
• Participate in cleaning and process validation activities involving microbiology.
• Investigate and review alert and action limits, microbiological product OOS results and DNFs, implementing corrective actions as needed.
• Develop, validate, and troubleshoot microbiological test methods, including rapid and alternative technologies.

Skills

Microbiology

QA/QC

Documentation

LIMS

Process validation

Education

BS/BA in Life sciences, microbiology or biology

Tools

BMRAM

Discoverant

Documentation Compliance

LIMS

Microsoft Word

Microsoft Excel

Process Compliance

Job description

Regeneron Pharmaceuticals is seeking a Quality Control Microbiology Scientist in Rensselaer, NY to support microbiology methods across cell-culture, manufacturing, and facilities. You will ensure cGMP compliance, lead validations, and drive improvements using rapid technologies.

The role emphasizes developing, validating, and troubleshooting microbiological test methods, data analysis, and cross-functional collaboration with manufacturing.