Quality Control Scientist (Microbiology)

Regeneron Pharmaceuticals, Inc (USA); City of Rensselaer (NY); On-site; USD 67,000 - 110,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc. in Rensselaer, NY is seeking a Quality Control Microbiology Scientist to support microbiology test methods across drug substance, drug product, and facilities. You will ensure cGMP compliance and drive method improvements.

The role requires a BS/BA in Life sciences and at least 3 years of microbiology experience in pharma, with knowledge of LIMS, Discoverant and related tools. Join a team delivering innovative therapies.

Qualifications

• BS/BA in Life sciences, microbiology or biology preferred.
• 3+ years of relevant microbiology experience.
• Experience in a pharmaceutical microbiology lab.

Responsibilities

• Ensure QC microbiological compliance with cGMP standards.
• Validate microbiological test methods for materials and products.
• Develop, validate, and troubleshoot microbiological test methods.
• Lead data gathering and reporting to support investigations.
• Represent microbiology in cross-functional site meetings.

Skills

Microbiology methods

cGMP awareness

Data analysis

Education

BS/BA Life sciences

Tools

LIMS

Discoverant

BMRAM

Process Compliance

Job description

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).

Salary Range (annually) $67,400.00 - $110,000.00

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.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurology, infectious diseases and rare diseases. Regeneron is also proud of award winning culture of innovation, being recognized as a Great Place to Work in 2021, Fast Company’s Best Workplace for Innovators in 2020, and Forbes JUST companies in 2020, among others.

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.