Quality Control Micro Analyst

Regeneron is currently looking to fill a Quality Control (QC) Microbiology Analyst position for a Wednesday to Saturday 1:00pm to 11:30pm shift. Regeneron successfully manufactures a range of biopharmaceuticals for patients worldwide, including our approved therapeutic proteins and those involved in clinical studies. 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.

As a QC Micro Analyst, a typical day might include the following:

• 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.

This role might be for you if:

• Enjoy working in a fast-paced environment and you have the innate ability to balance multiple priorities and/or prioritize and execute them.
• Can take on new and sometimes ambiguous challenges and learn quickly.
• Are able to work in a team environment and demonstrate respectful behavior at all times to promote and encourage a learning environment.
• 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.

To be considered for the QC Micro Analyst position you must be willing and able to work a Wednesday to Saturday 1:00pm to 11:30pm shift. For the various levels you must have the following:

• Associate QC Analyst: BS/BA in Life Sciences, or related field, or an equivalent combination of education and experience
• QC Analyst: BS/BA in Life Sciences, or related field, and a minimum of 12-18+ months of related experience; Or an equivalent combination of education and experience
• Sr. QC Analyst I: BS/BA in Life Sciences, or related field, and 4+ years of experience; Or an equivalent combination of education and experience
• Sr. QC Analyst II: BS/BA in Life Sciences, or related field, and 6+ years of experience; Or an equivalent combination of education and experience

Prior GMP experience in Microbiology related to drug substance (bulk) or drug product (fill/finish) manufacturing is preferred. Level is determined based on qualifications relevant to the role.

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels!

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, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.

For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions.  For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.

Please note that certain background checks will form part of the recruitment process.  Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.

Salary Range (hourly)