Quality Control Microbiology Analyst

Regeneron Pharmaceuticals, Inc.; City of Rensselaer (NY); On-site; USD 65,000 - 90,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc. is seeking a QC Microbiology Analyst in Rensselaer, NY. The role focuses on routine environmental monitoring, microbiological testing, gowning and aseptic qualifications, and related documentation in a GMP environment.

The position requires a BS/BA in Microbiology or related field and 12–18+ months of related experience. The role supports 2nd shift duties and adherence to SOPs and FDA regulations.

Qualifications

• BS/BA in Microbiology or related field required
• 1+ year of related experience in GMP microbiology preferred
• Experience with environmental monitoring and testing in pharma/biotech
• Strong documentation and data-review skills
• Familiarity with SOPs, protocols, reports, and investigations

Responsibilities

• Environmental monitoring of controlled environments, personnel and clean utilities.
• Microbiological testing and analysis on a variety of sample types.
• Gowning and aseptic qualifications for personnel.
• Training of employees.
• Peer review of data.
• Technical writing: SOPs, protocols, reports, trend reports, risk assessments, investigations, change controls.
• Develop and drive improvement ideas.
• Maintain proficiency with MS Office, LIMS, and related systems.

Skills

Environmental monitoring

Microbiology testing

Gowning & aseptic qualifications

Training of employees

Data review

Technical writing

SOPs

Education

BS/BA in Microbiology or related field

Tools

LIMS

Deviation Management Systems

Learning Management Systems

Microsoft Excel

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

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. 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.

Please be advised that at Regeneron, we believe we do our best work when we are together.