Description

Regeneron is looking for a Quality Control Scientist (Microbiology) to focus on microbiological test methods. This includes, but not limited to, Endotoxin, Low Endotoxin Recovery, Bioburden, and Sterility. In this role you will also provide critical microbiology support to cell-culture, manufacturing (drug substance and drug product), and facilities.

A typical day in this position might include:

Perform Test Method validations, studies, and assisting on troubleshooting efforts (Investigations).
Ensure departmental compliance with regulatory guidelines are maintained. Drives continuous improvements for microbiological methods.
Participate in tasks associated with aseptic process simulations
Assist the team on activities associated with Change Control. This includes initiation, impact and implementation of the change; also, the initiation and closure of workflows and CAPAs
Assist with the writing of technical documents and studies to troubleshoot and support investigations.
Assist with the creation and update of SOPs
Gathers data for the analysis in support of investigations and business decision making.
Evaluate data entry, analysis, and reporting of microbiological data and support implementation of changes in order to identify streamlining opportunities.
Seeks and evaluates alternative solutions/work arounds while obtaining buy-in from the organization. Effective and out of the box problem solving. Assists in the translation of ambiguity into actional steps.

This job may be for you if:

You have knowledge in Microbiological Test Methods associated with Drug Substance, Drug Product; Gene Therapy, Raw Materials, Utilities and Disinfectants
You can drive continuous improvements for microbiological methods.
You have excellent written, verbal and interpersonal communication skills, with the

ability to effectively interact with all levels both within and outside the company.

You can handle multiple priorities with exceptional organizational and time management skills.
You have experience with BMRAM, Discoverant, Documentation Compliance, LIMS, Microsoft Word, Microsoft Excel, and Process Compliance.

To be considered for this position you must have a BS/BA in microbiology, or closely related field, and 2+ years working experience in a microbiology lab; preferably in the biotech industry.

Advanced degree preferred.
Level will be determined based on qualifications

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other countries’ specific benefits, please speak to your recruiter.
Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron’s roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron’s on-site policy and expectations for your role and your location.

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 (annually)

$67,400.00 - $110,000.00

Quality Control Scientist (Microbiology)

Description

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