Quality Control Microbiology Analyst

Regeneron Pharmaceuticals, Inc.; United States; Presencial; USD 34.000 - 53.000; Jornada completa

Descripción de la vacante

Regeneron Pharmaceuticals, Inc. is seeking a QC Microbiology Analyst to perform routine environmental monitoring, microbiological testing, and related QC duties in support of drug substance and product manufacturing at our Rensselaer, New York site.

The role involves gowning and aseptic qualifications, data peer review, and technical writing for SOPs, protocols, and investigations, with emphasis on compliance with cGMP/FDA regulations and collaboration with cross-functional teams.

Formación

• BS/BA in Microbiology, Biology or related field; 12–18+ months of related experience.
• Prior GMP experience in Microbiology for drug substance or drug product manufacturing is preferred.

Responsabilidades

• Environmental monitoring of controlled environments, personnel and clean utilities.
• Microbiological testing and analysis (bioburden, endotoxin, plate enumeration, growth promotion).
• Gowning and aseptic qualifications for personnel.
• Training of employees.
• Peer review of data.
• Technical writing for SOPs, protocols, reports, trend reports, risk assessments, investigations, and change controls.

Conocimientos

Environmental monitoring

Microbiological testing

Gowning & aseptic qualification

Training of employees

Peer review of data

Technical writing

SOP compliance

LIMS familiarity

MS Office

Educación

BS/BA in Microbiology or related field

Herramientas

LIMS

Deviation Management Systems

Learning Management Systems (LMS)

Microsoft Office (Word, Excel, PowerPoint)

Descripción del empleo

Regeneron successfully manufactures a range of biopharmaceuticals for patients worldwide. We are lookingto fill aQuality 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. If you have any questions, please speak with your recruiter.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about on-site expectations for your role and location.

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