Quality Control Scientist

Regeneron Pharmaceuticals, Inc (USA); City of Rensselaer (NY); On-site; USD 90,000 - 130,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc. in Rensselaer, NY is seeking a Quality Control Scientist to advance QC bioassays and ELISA methods. The role emphasizes automation, method validation, and regulatory compliance to improve throughput and data integrity.

You will design automated workflows, transfer assays from R&D to QC and with external partners, and provide technical support for release and stability testing. Strong data analysis and mentoring are expected.

Qualifications

• BS/BA in Biochemistry, Biology, or Chemistry; 2+ years of relevant experience.
• Hands-on experience with ELISA and/or bioassays.
• Exposure to automation and laboratory instrumentation.

Responsibilities

• Develop, optimize, characterize, and validate QC assays (bioassays/ELISA).
• Design, implement automated workflows using liquid handling platforms.
• Review new test procedures for scientific soundness and compliance.
• Lead assay transfers from R&D to QC and to external partners.
• Establish product specifications from development and manufacturing data.
• Provide technical support for release, stability, and in-process testing.
• Assist in troubleshooting, deviations, CAPAs and root-cause investigations.
• Review analytical development and validation reports for accuracy.
• Apply statistical analyses to assay development and trend data.
• Train and mentor analysts; contribute to training programs.
• Maintain compliant documentation per GDP and ALCOA+.

Skills

Bioassays

ELISA

Automation

Education

BS/BA in Biochemistry, Biology, or Chemistry

Tools

Hamilton

Tecan

Beckman Biomek

Agilent Bravo

Job description

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.

When & where: Monday-Friday, 8:00am–4:30pm Location: Rensselaer, New York, United States

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+).

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

Preferred Qualifications

• 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.

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.

Does this sound like you?

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.

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. Salary Range (annually) $67,400.00 - $110,000.00

Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases.

Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories.

Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurology, infectious diseases and rare diseases.

Regeneron is also proud of award winning culture of innovation, being recognized as a Great Place to Work in 2021, Fast Company's Best Workplace for Innovators in 2020, and Forbes JUST companies in 2020, among others.