Sr. Microbiology Scientist
Company: Regeneron Pharmaceuticals, Inc.
Location: Rensselaer
Posted on: March 13, 2026
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Job Description:
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 Regenerons roles are required to be performed
on-site. Please speak with your recruiter and hiring manager for
more information about Regenerons 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
Keywords: Regeneron Pharmaceuticals, Inc., New Britain , Sr. Microbiology Scientist, Science, Research & Development , Rensselaer, Connecticut