Quality Control Scientist

Regeneron Pharmaceuticals, Inc.; City of Rensselaer (NY); On-site; USD 80,000 - 120,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc. in Rensselaer, NY is seeking a Quality Control Scientist to support QC assay development, characterization, optimization, transfer, validation, and investigation.

The role will drive automation of bioassays and ELISA-based methods to improve throughput, robustness, and data integrity. Responsibilities include developing and validating QC assays (bioassays/ELISA) per ICH Q2, GMP guidelines, and leading assay transfers to QC and external partners.

Qualifications

• Hands-on ELISA or bioassay experience required.
• Familiar with regulatory guidelines (ICH Q2, GMP) desirable.
• Bachelor’s degree in Biochemistry, Biology, or Chemistry or related field required.

Responsibilities

• Develop, optimize, validate QC assays (bioassays/ELISA) per regulatory guidelines.
• Design automated workflows for assays using liquid handling platforms.
• Lead assay transfers from R&D to QC and to external partners.
• Establish product specifications using development, stability, and manufacturing data.
• Provide technical support for release, stability, and in-process testing.
• Review analytics development, validation reports for accuracy and compliance.
• Apply statistical tools to assay development and data trending.
• Train and mentor analysts; contribute to training programs.

Skills

ELISA

Bioassays

Data analysis

Statistics tools

Education

BS/BA in Biochemistry, Biology, 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.

Monday-Friday, 8:00am-4:30pm

Location: Rensselaer, New York, United States

Role Responsibilities

• 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.

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.

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