Quality Control Scientist (Microbiology)

Regeneron Pharmaceuticals • Rensselaer, IN

9d • $67,400 - $110,000 • Onsite

About The Position

Regeneron is seeking a Quality Control Microbiology Scientist specializing in microbiology test methods. The role provides microbiology support to cell-culture, manufacturing (drug substance and drug product), and facilities operations, while ensuring departmental compliance with regulatory guidelines and driving continuous improvements in microbiological methods.

The position is based in Rensselaer, New York, and is scheduled Monday through Friday, 8:00 a.m. to 4:30 p.m. The role level will be determined based on experience.

Requirements

• A BS/BA in life sciences, microbiology, or biology is preferred.
• At least 3 years of relevant experience.
• Previous experience working in a microbiology laboratory or pharmaceutical microbiology laboratory.
• Knowledge of microbiological test methods, including endotoxin, low endotoxin recovery, bioburden, and sterility, associated with drug substance, drug product, gene therapy, raw materials, utilities, and disinfectants.
• Experience with BMRAM, Discoverant, documentation compliance, LIMS, Microsoft Word, Microsoft Excel, and process compliance.

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.
• Lead data gathering, analysis, and reporting to support investigations and streamline processes.
• Lead and participate in validations, studies, and investigations at CMO/CLOs, applying advanced scientific expertise to resolve complex issues.
• Create, revise, and review microbiological documentation.
• Assist manufacturing personnel with microbiological root cause analysis and provide technical advice.
• Support maintenance of reference libraries for microbiological methods.
• Drive continuous improvement of microbiological methods by keeping current with industry trends, implementing updates in QC practices, and onboarding alternative and rapid technologies while serving as the SME for these innovations.
• Contribute to preparation and revision of technical proposals, amendments, reports, memoranda, and microbiological SOPs.
• Represent microbiology in cross-functional site meetings and provide technical advice to manufacturing personnel.
• Participate in transfer of methodologies to and from other test facilities.
• Assist in preparation for internal, customer, and regulatory inspections.
• Proactively identify and implement laboratory process improvements and lean initiatives, including integrating alternative and rapid technologies into QC practices.

Benefits

• Competitive and comprehensive total rewards package, which may include annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, medical, dental, vision, life and disability insurance, paid time off, and family support benefits.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level