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Regeneron is currently looking for a QC (Quality Control) Microbiology Laboratory Operations Specialist. Regeneron successfully manufactures a range of biopharmaceuticals for patients worldwide, including our approved therapeutic proteins and those involved in clinical studies. This role executes projects, monitors, and maintains compliance records and metrics, and provides inspection readiness support within QC. They’re responsible for assisting QC laboratories with investigations, deviations, method changes and document workflows.

As a QC Micro Lab Operations Specialist , a typical day might include the following:

+ Evaluates and implements new/updated techniques and procedures in the microbiology laboratory in terms of equipment, method comparison, software analysis, and data reporting to enhance microbiological testing and sampling efforts.

+ Ensures that laboratory tests and procedures are consistent with accrediting regulatory agencies standards and requirements.

+ Actively participate in cross-functional team meetings and communicate effectively and courteously with other team members to harmonize business operations.

+ Oversees activities such as: complex laboratory investigations, instrument trouble shooting, creation/revision of laboratory procedures and implementation of new software systems/instrumentation and equipment.

+ Ensures that all activities related to the investigation and resolutions of non-conformities are performed in a timely manner and in compliance with Regeneron procedures and regulatory requirements.

+ Performs procedural gap analysis, identifies continuous improvement and lessons learned opportunities and implements solutions.

+ Monitors and tracks department Key Performance Indicators (KPIs)

+ Serves as Subject Matter Expert (SME) for laboratory operations and personnel.

+ Executes and/or coordinates the completion of laboratory related protocols, both routine and atypical.

+ Facilitates inspection readiness activities and participates in audits and inspections.

+ May perform data review functions.

+ Executes Change Controls, CAPAs, and document workflows in electronic quality and document management systems.

This role might be for you if you:

+ Have advance Knowledge in Microbiological Test Methods (This includes, but is not limited to: Endotoxin, Low Endotoxin Recovery, Bioburden, Sterility) associated with Drug Substance, Drug Product; Gene Therapy, Raw Materials, Utilities and Disinfectants.

+ 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.

+ Assist in the development and support of strategies on how to achieve what needs to be done and develops metrics to measure the strategy.

+ Are able to work in a team environment and demonstrate respectful behavior at all times to promote and encourage a learning environment.

+ Can 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.

+ Ability to navigate and interpret regulatory guidance and compendia

To be considered for the Sr. QC Micro Operations Laboratory Specialist you must be willing and able to work Monday-Friday, 8am-4:30pm. You must have a BS/BA in a scientific field and 5+ years of related experience or equivalent combination of education and experience. You must possess a strong understanding of data integrity, ensuring the accuracy, security, and consistency of data throughout every stage of its lifecycle. Experience in a GMP pharmaceutical microbiology, setting is required. 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 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)

$77,600.00 - $126,800.00