Full Job Description
Regeneron is currently looking for a Quality Control Microbiology Scientist to join our team. This position will specialize in microbiology test methods; provide critical microbiology support to cell-culture, manufacturing (drug substance and drug product), and facilities. They will ensure departmental compliance to regulatory guidelines are maintained and drive continuous improvements for microbiological methods.
When & where:
• Monday-Friday, 8:00am-4:30pm
• Location: Rensselaer, New York, United States
Discover your role:
• 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 and apply advanced scientific expertise to resolve complex issues.
• Create, revise, and review microbiological documentation.
• Assist manufacturing personnel in the identification of microbiological root cause analysis and provide technical advice as needed.
• Support the maintenance of reference libraries for microbiological methods.
• Drive continuous improvement of microbiological methods by staying current with industry trends, implementing updates into QC practices, and onboarding alternative and rapid technologies while serving as the SME for these innovations.
• Contribute to the preparation and revision of technical proposals, amendments, reports, memoranda, and microbiological SOP.
• Represent microbiology in cross-functional site meetings and provide technical advice to manufacturing personnel.
• Participate in the transfer of methodologies to and from other test facilities.
• Assist in the preparation for internal, customer, and regulatory inspections.
• Proactively identify and implement laboratory process improvements and lean initiatives. Drive the integration of alternative and rapid technologies into QC practices.
This role requires:
• A BS/BA in Life sciences, microbiology or biology preferred, and 3+ years of relevant experience.
• Previous experience working in a microbiology lab or pharmaceutical microbiology lab.
• Knowledge of Microbiological Test Methods (Endotoxin, Low Endotoxin Recovery, Bioburden, Sterility etc.) associated with Drug Substance, Drug Product; Gene Therapy, Raw Materials, Utilities and Disinfectants
• Experience with BMRAM, Discoverant, Documentation Compliance, LIMS, Microsoft Word, Microsoft Excel, Process Compliance).
• Level will be determined based on experience.
Salary Range (annually)
$67,400.00 - $110,000.00
