Quality Control Scientist (Microbiology)

Regeneron is hiring a Quality Control Microbiology Scientist to specialize in microbiology test methods and provide microbiology support to cell-culture, manufacturing, and facilities. The role ensures regulatory compliance and drives continuous improvement of microbiological methods.

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 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

Preferred

• A BS/BA in Life sciences, microbiology or biology preferred
• Life Sciences
• Microbiology
• Biology

Benefits

• May include, depending on country and role: annual bonuses or other incentive plans
• May include, depending on country and role: equity awards
• May include, depending on country and role: pension or retirement benefits
• May include, depending on country and role: 401(k) company match
• May include, depending on country and role: health and wellness programs
• May include, depending on country and role: fitness centers
• May include, depending on country and role: insurance benefits (e.g. medical, dental, vision, life and disability)
• May include, depending on country and role: paid time off
• May include, depending on country and role: family support benefits

Company

• Develops and commercializes biopharmaceutical medicines for serious diseases
• Tarrytown, New York, USA
• http://www.regeneron.com/
• Founded in 1988
• 10001+ employees

Qualifications

• 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)
• A BS/BA in Life sciences, microbiology or biology preferred
• 3+ years of relevant experience.

Required skills

• BMRAM, Bioburden Testing, Discoverant, Endotoxin Testing, LIMS, Low Endotoxin Recovery, Microbiological Test Methods, Pharmaceutical Microbiology, Sterility Testing

Preferred skills

• A BS/BA in Life sciences, microbiology or biology preferred

Experience

• 3+ years