New · posted Oct 28
Regeneron · Biotechnology
Quality Control Scientist (Microbiology)
- Rensselaer, NY
- On-site
- Full-time
- Senior & Principal
The role
Build our future together
Regeneron is currently looking for a Quality Control Microbiology Scientist to join our 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.
What you need
This role requires
- A BS/BA in Life sciences, microbiology or biology preferred, and 3+ years of relevant experience.
- Previous experience working in a microbiology lab or pharmaceutical microbiology lab.
- 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
- Experience with BMRAM, Discoverant, Documentation Compliance, LIMS, Microsoft Word, Microsoft Excel, Process Compliance).
- Level will be determined based on experience.
Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.
Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on‑site. Please speak with your recruiter and hiring manager for more information about on‑site expectations for your role and location.
As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.
For jobs in Canada: this posting is for an existing position.
What you'll do
Discover your role
- 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.
- 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.
Pay and benefits
$67,400 – $110,000 a year
Employer provided$67,400.00 - $110,000.00
Annual bonuses
Equity awards
401(k) company match
Health and wellness programs
Medical, dental, vision, life and disability insurance
Paid time off
Where you'll work
Rensselaer, NYOn-siteOpen in Maps (opens in a new tab)
More jobs in Rensselaer, NYWorking conditions
When & where
- Monday–Friday, 8:00am–4:30pm
- Location: Rensselaer, New York, United States
Equal opportunity, accessibility and legal noticesRegeneron's statements, word for word
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. 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, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.
Job intelligence
The context around this role
Live data · October 28, 2026
Salary intelligence
How the pay compares
This role's midpoint is 7% below the US median for Quality Control roles at this level.
This roleEmployer provided
Senior & Principal roles in the US61 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $67,400 | — | $110,000 |
| All US (middle half) | $78,500 | $95,500 | $115,500 |
This role: Regeneron's own published range. Comparisons: the base pay employers published on open Quality Control roles at the same level on Regulatory Jobs, October 28, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Control
The general path across 341 open Quality Control roles on Regulatory Jobs, with the titles they carry most. Not Regeneron's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 26 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Lab testing and methods17
- GMP and compliance4
- Investigations and CAPA4
- Validation and qualification4
- Collaboration and leadership4
- Documentation and SOPs3
- Quality systems and risk3
- Data and digital systems1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
- FDA21 CFR Parts 210 and 211(official source, opens in a new tab)FDA current good manufacturing practice for finished pharmaceuticals
- FDAFDA OOS guidance(official source, opens in a new tab)Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production
- FDAFDA process validation guidance(official source, opens in a new tab)Process Validation: General Principles and Practices
- USPUSP compendial chapters(official source, opens in a new tab)Bioburden (USP <61>), endotoxin (USP <85>), TOC (USP <643>) and water testing
Company hiring pulse
Regeneron on Regulatory Jobs
- 88
- Open roles
- 77
- Distinct roles
- 10
- Locations
By discipline
- Quality60 68%
- Regulatory25 28%
- Compliance & Safety3 3%
By level
- Associate & Specialist41 47%
- Manager26 30%
- Senior & Principal13 15%
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Quality Control Scientist (Microbiology) at Regeneron
Open until filled. $67K–$110K a year, employer provided.