Regeneron is currently looking to for a Quality Control (QC) Microbiology Analyst position with a 2nd shift, Tuesday-Saturday, 2:00- 10:30pm schedule. 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 utilities sampling and testing, routine environmental monitoring, 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 you:
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.
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.
Shift Requirements: PhysicalAbility to perform physical requirements for entirety of shift (up to 10 hours):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 50lbsGowning and EnvironmentFull 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 jewerly, make-up and nail adornments when wearing cleanroom attireTo be considered for the QC Micro Analyst you must be willing and able to work Tuesday - Saturday, 2:00pm- 10:30pm. You must have a BS/BA in Life Sciences, or related field; or an equivalent combination of education and experience. For the various levels you must have the following:
Associate QC Micro Analyst: BS/BA in Life Sciences, or related field and 12+ months of related experience; or an equivalent combination of education and experience
QC Micro Analyst: BS/BA in Life Sciences, or related field and 12+ months of related experience; or an equivalent combination of education and experience
Sr. Micro QC Analyst I: BS/BA in Life Sciences, or related field, and 4+ 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 steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits including health and wellness programs, fitness centers and 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. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.Salary Range (hourly) $23.89 - $37.36
