Quality Control Scientist Full-time NEW

Quality Control Scientist

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.