Quality Control Microbiology Analyst

Regeneron Pharmaceuticals, Inc (USA); City of Rensselaer (NY); On-site; USD 33,000 - 52,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc (USA) is seeking a QC Microbiology Analyst to perform microbiological assays and environmental monitoring for drug substance and product manufacturing. This role emphasizes routine environmental monitoring, utilities sampling, gowning, and aseptic qualifications, with strong cGMP adherence.

The candidate will contribute to SOPs, protocols, trend reports, and training while maintaining rigorous data review and technical writing.

Qualifications

• BS/BA in Microbiology or related field with 12-18+ months of experience.
• GMP experience in Microbiology related to drug substance or drug product preferred.
• Experience performing environmental monitoring and microbial testing.
• Ability to work in a fast-paced cGMP environment and follow SOPs.

Responsibilities

• Perform routine environmental monitoring for drug substance/product manufacturing areas.
• Conduct utilities sampling and testing, gowning and aseptic qualifications.
• Prepare SOPs, protocols, reports and trend analyses.
• Train employees and perform data peer review.
• Contribute to technical writing such as investigations and change controls.

Skills

Problem solving

Decision making

Communication

Education

BS/BA in Microbiology or related field

Tools

LIMS

Deviation Management Systems

Learning Management Systems

Microsoft Office Suite (Word, Excel, PowerPoint)

Job description

Regeneron successfully manufactures a range of biopharmaceuticals for patients worldwide. We are looking to fill a Quality Control (QC) Microbiology Analyst position. Our Microbiology Analysts perform microbiological assays related to clean room monitoring, utility monitoring, raw material, and product testing in accordance with Standard Operating Procedures (SOPs) and cGMP/FDA regulation. This position will be primarily responsible for performing routine environmental monitoring for drug substance/drug product manufacturing areas, utilities sampling and testing, gowning and aseptic qualifications, and raw materials, in process and finished product testing related to drug manufacturing. When & where: Sunday-Wednesday, 2nd shift 1:00pm - 11:30pm Location: Rensselaer, New York, United States.

Discover your role:

Environmental monitoring of controlled environments, personnel and clean utilities. Microbiological testing and analysis (bioburden testing, endotoxin content testing, plate enumeration, growth promotion, etc.) on a variety of sample types, related to environmental monitoring, utility, raw materials, and in-process and final product materials. Performing gowning and aseptic qualifications for personnel. Training of employees. Peer review of data. Technical writing assignments such as SOPs, protocols, reports, trend reports, risk assessments, laboratory investigations, change controls, etc. Have strong decision making and problem-solving skills. Develop and drive scientific and/or business-related improvement ideas. Have working knowledge of Microsoft Suite applications (Word, Excel, Powerpoint), Laboratory Information Management System (LIMS), Deviation Management Systems, and Learning Management Systems.

This role requires:

A BS/BA in Microbiology, Biology, or a related field, and a minimum of 12-18+ months of related experience. Prior GMP experience in Microbiology related to drug substance (bulk) or drug product (fill/finish) manufacturing is preferred. Level is determined based on experience and qualifications relevant to the role.

Gowning and Environment:

Full cleanroom attire (Examples may include: including laundered undergarments, gown, facemask, hairnet, safety glasses, safety shoes and booties, latex gloves and the use of sanitizing agents during gowning process including IPA) Ability to remove jewelry, make-up and nail adornments when wearing cleanroom attire.

Shift & Physical Requirements:

Ability to perform physical requirements for entirety of shift (up to 10 hours) in a clean room environment. Some physical requirements can include but not limited to: bending, climbing, crawling, kneeling, reaching, reaching overhead, sitting, squatting, walking, standing, driving, hand manipulation and ability to lift/push/pull up to 50lbs.

Does this sound like you?

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. 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.

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.

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. Salary Range (hourly) $24.76 - $38.70

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.