Sr. Microbiology Scientist

Regeneron is currently looking for a QC (Quality Control) Microbiology Scientist to join our QC Technical Resources team. This position will specialize in microbiology test methods; provide critical microbiology support to cell-culture, manufacturing (drug substance and drug product), and facilities. They will ensure departmental compliance to regulatory guidelines are maintained and drive continuous improvements for microbiological methods.

A typical day as a QC Microbiology Scientist might include:

• Ensure QC microbiological compliance with cGMP standards.  
• Conduct microbiological validations for raw materials, finished products, in-process controls, and buffers.
• Participate in cleaning and process validation activities involving microbiology.
• Investigate and review alert and action limits, microbiological product OOS results and DNFs, implementing corrective actions as needed.  
• Develop, validate, and troubleshoot microbiological test methods, including rapid and alternative technologies.
• Lead data gathering, analysis and reporting to support investigations and streamline processes.
• Lead and participate in validations, studies, and investigations at CMO/CLOs and apply advanced scientific expertise to resolve complex issues.
• Create, revise, and review microbiological documentation.
• Assist manufacturing personnel in the identification of microbiological root cause analysis and provide technical advice as needed.
• Support the maintenance of reference libraries for microbiological methods.
• Participate in internal audits, technical discussions and problem-solving with external entities.
• Assist in the integration of technical updates into team procedures while maintaining regulatory compliance.
• Provide technical advice to manufacturing personnel and effectively communicate solutions with the organization.
• Drive continuous improvement of microbiological methods by staying current with industry trends, implementing updates into QC practices, and onboarding alternative and rapid technologies while serving as the SME for these innovations. 
• Contribute to the preparation and revision of technical proposals, amendments, reports, memoranda, and microbiological SOP.
• Represent microbiology in cross-functional site meetings and provide technical advice to manufacturing personnel.
• Participate in the transfer of methodologies to and from other test facilities. 
• Assist in the preparation for internal, customer, and regulatory inspections.
• Proactively identify and implement laboratory process improvements and lean initiatives. Drive the integration of alternative and rapid technologies into QC practices.

This role might be for you if you:

• Facilitate with organizational agility.
• Assist in the development and support of strategies on how to achieve what needs to be done and develops metrics to measure the strategy.
• Have knowledge of Microbiological Test Methods (Endotoxin, Low Endotoxin Recovery, Bioburden, Sterility etc.) associated with Drug Substance, Drug Product; Gene Therapy, Raw Materials, Utilities and Disinfectants
• Possesses excellent written, verbal and interpersonal communication skills and the ability to effectively interact with all levels both within and outside the company.
• Resolves and negotiates conflicts or problems with tact, diplomacy and composure.
• Able to prioritize multiple priorities with outstanding organizational and time management skills.
• Proficient in IOPS Systems (e.g. BMRAM, Discoverant, Documentation Compliance, LIMS, Microsoft Word, Microsoft Excel, Process Compliance).

To be considered for the QC Microbiology Scientist you must have a BS/BA in Life sciences, microbiology or biology is preferred, and 5+ years of relevant experience. Previous experience working in a microbiology lab or pharmaceutical microbiology lab is preferred.

Level will be determined based on experience.

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)

$78,700.00 - $128,700.00