Quality Control Scientist
About The Position
Regeneron is seeking a Quality Control Scientist to support assay development, characterization, optimization, transfer, validation, and investigation for QC. The role will drive automation of bioassays and ELISA-based methods to improve throughput, robustness, and data integrity. The position is based in Rensselaer, New York, and is scheduled Monday through Friday, 8:00 a.m. to 4:30 p.m. The role covers development and validation of QC assays, automated workflow design and qualification, review of testing procedures, adoption of new technologies, assay transfers, specification setting, technical support for testing, and participation in investigations. It also includes statistical analysis, technical document review, analyst training and mentorship, and maintenance of compliant documentation. The level—Associate Scientist or Scientist—will be determined based on relevant qualifications and experience. Regeneron describes its total rewards package as potentially including annual bonuses or other incentives, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits, paid time off, and family support benefits, depending on country and role. Many roles are required to be performed on-site; applicants should confirm expectations with the recruiter and hiring manager.
Requirements
- BS/BA in Biochemistry, Biology, Chemistry, or a related field.
- For the Scientist level, 2+ years of relevant experience, preferably in the pharmaceutical or biotechnology industries.
- Hands-on experience with ELISA and/or bioassays.
Nice To Haves
- 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.
Responsibilities
- Develop, optimize, characterize, and validate QC assays, including bioassays and ELISA, in compliance with applicable regulatory guidelines such as ICH Q2, USP, and GMP.
- Design, implement, and qualify automated workflows for bioassays and ELISA using liquid-handling platforms and plate-based instrumentation, including migration from manual to automated formats.
- Review new test procedures and assays for scientific soundness, suitability, and compliance.
- Evaluate and introduce 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, including CDMOs and contract labs; develop, execute, and report on transfer protocols.
- 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, including parallel-line or four-parameter logistic analysis and design of experiments, to assay development, qualification, and data trending.
- Train, mentor, and support analysts, and contribute to training program development.
- Maintain accurate, compliant documentation in line with GDP and ALCOA+ data-integrity principles.
Benefits
- Competitive and comprehensive total rewards package, which may include annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, medical, dental, vision, life and disability insurance, paid time off, and family support benefits, depending on country and role.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
