Quality Control Scientist (Microbiology)

Regeneron; City of Rensselaer (NY); Vor Ort; USD 90.000 - 130.000; Vollzeit

Zusammenfassung

Regeneron Pharmaceuticals, Inc. is seeking a Quality Control Microbiology Scientist to join our team in Rensselaer, NY.

The role specializes in microbiology test methods, providing critical support to cell-culture, manufacturing, and facilities to ensure regulatory compliance and drive improvements. Responsibilities include validating test methods, leading investigations, and supporting rapid technologies while maintaining documentation and cross-functional collaboration with manufacturing

Qualifikationen

• Bachelor's degree in life sciences or microbiology; 3+ years' relevant experience.
• Experience in pharmaceutical microbiology lab settings.
• Knowledge of microbiology test methods (Endotoxin, Bioburden, Sterility).
• Proficiency with LIMS and documentation compliance systems.
• Experience with rapid and alternative technologies is a plus.

Aufgaben

• Ensure QC microbiological compliance with cGMP standards.
• Contribute to validations, investigations and data reporting.
• Develop, validate, and troubleshoot microbiological test methods.
• Lead cross-functional activities and provide technical advice to manufacturing.

Kenntnisse

Microbiology lab

cGMP awareness

Data analysis

Documentation/compliance

Ausbildung

BS/BA in Life sciences or microbiology

Tools

LIMS

Discoverant

BMRAM

Microsoft Word

Microsoft Excel

Jobbeschreibung

Build our future together: 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.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits.

Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.

We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Please be advised that at Regeneron, we believe we do our