New · posted Nov 1
Regeneron · Biotechnology
Quality Control Scientist
- Rensselaer, NY
- On-site
- Full-time
- Senior & Principal
The role
Regeneron is looking for a Quality Control Scientist to support assay development, characterization, optimization, transfer, validation, and investigation in support of QC. This role will drive the automation of bioassays and ELISA-based methods to improve throughput, robustness, and data integrity.
What you need
This role requires
- BS/BA in Biochemistry, Biology, Chemistry, or a related field.
- 2+ years of relevant experience, preferably in the pharmaceutical or biotechnology industries.
- Hands-on experience with ELISA and/or bioassays; exposure to laboratory
Level will be determined based on qualifications and experience relevant to the role
- Associate Scientist: Requires BS/BA in Biochemistry, Chemistry, Biology or related field.
- Scientist: Requires BS/BA in Biochemistry, Chemistry, Biology or related field, and 2+ years of experience, preferably in the pharmaceutical or biotechnology industries.
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.
Preferred Qualificationsnice to have
- Hands-on experience automating bioassays and ELISA using platforms such as Hamilton, Tecan, Beckman Biomek, or Agilent Bravo, including method scripting, programming, and troubleshooting.
- Working knowledge of cGMP, ICH, FDA, and EMA requirements for analytical method validation and transfer.
- Familiarity with LIMS, ELN, and electronic data management systems.
What you'll do
Discover your role
- Develop, optimize, characterize, and validate QC assays, including bioassays and ELISA, in compliance with applicable regulatory guidelines (e.g., ICH Q2, USP, GMP).
- Design, implement, and qualify automated workflows for bioassays and ELISA using liquid handling platforms and plate-based instrumentation, including method migration from manual to automated formats.
- Review new test procedures and assays for scientific soundness, suitability, and compliance.
- Evaluate and introduce new methodologies, technologies, and automation solutions to improve assay performance, efficiency, and reliability.
- Lead and coordinate assay transfers from R&D to QC and to external business partners (e.g., CDMOs, contract labs), including protocol development, execution, and reporting.
- Establish and justify product specifications using development, stability, and manufacturing data.
- Provide technical support and guidance for release, stability, and in-process testing.
- Participate in technical troubleshooting, deviation, OOS/OOT, and root cause investigations, and help define corrective and preventive actions (CAPAs).
- Review analytical development reports, assay and process validation reports, and other technical documents for scientific accuracy and regulatory compliance.
- Apply statistical tools (e.g., parallel-line or four-parameter logistic analysis, design of experiments) to assay development, qualification, and data trending.
- Train, mentor, and support analysts, and contribute to the development of training programs.
- Maintain accurate, compliant documentation in line with GDP and data integrity principles (ALCOA+).
Pay and benefits
$67,400 – $110,000 a year
Employer provided$67,400.00 - $110,000.00
Annual bonuses or incentive plans
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 · November 1, 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 US63 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $67,400 | — | $110,000 |
| All US (middle half) | $79,500 | $95,000 | $111,250 |
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, November 1, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Control
The general path across 353 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 25 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Lab testing and methods13
- Validation and qualification6
- GMP and compliance4
- Documentation and SOPs3
- Data and digital systems3
- Investigations and CAPA2
- Collaboration and leadership2
- Clinical trial conduct1
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 data integrity guidance(official source, opens in a new tab)Data Integrity and Compliance With Drug CGMP: Questions and Answers
- 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
- ICHICH quality guidelines(official source, opens in a new tab)Q1 stability, Q2(R2) analytical validation, Q7, Q9 risk management, Q10 quality systems
- 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
- 163
- Open roles
- 140
- Distinct roles
- 11
- Locations
By discipline
- Clinical69 42%
- Quality67 41%
- Regulatory27 17%
By level
- Associate & Specialist53 33%
- Director49 30%
- Manager46 28%
More roles at Regeneron
- View role
Quality Control Data Reviewer
Rensselaer, NYAssociate & SpecialistBiotechnology$52K–$80K
- View role
Quality Control Analyst
Rensselaer, NYAssociate & SpecialistBiotechnology$52K–$80K
- View role
Quality Control Analyst
Rensselaer, NYAssociate & SpecialistBiotechnology$52K–$80K
- View role
Senior Quality Control Data Scientist
Rensselaer, NYSenior & PrincipalBiotechnology$79K–$129K
Similar Quality Control roles elsewhere
- View role
Sr. QC Technician
Thermo Fisher ScientificLebanon, TNSenior & PrincipalBiotechnologySalary not listed
- View role
Senior Associate Quality Control
AmgenWest Greenwich, RISenior & PrincipalBiotechnology$79K–$107K
- View role
Senior Scientist, Quality Control
Gilead SciencesFoster City, CASenior & PrincipalBiotechnology$158K–$204K
- View role
Senior Associate Scientist, External Quality Analytical Oversight
Gilead SciencesFoster City, CASenior & PrincipalBiotechnology$118K–$153K
Quality Control Scientist at Regeneron
Open until filled. $67K–$110K a year, employer provided.