Quality Control Scientist

Regeneron is seeking a Quality Control Scientist to develop, characterize, optimize, validate, and transfer QC assays. The role also drives automation of bioassays and ELISA-based methods and supports testing, investigations, documentation, and analyst training.

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+)

Preferred

• preferably in the pharmaceutical or biotechnology industries
• 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
• Pharmaceutical industry experience
• Biotechnology industry experience
• Bioassay automation
• ELISA automation
• Hamilton platforms
• Tecan platforms
• Beckman Biomek platforms
• Agilent Bravo platforms
• Method scripting
• Programming
• cGMP knowledge
• ICH requirements
• FDA requirements
• EMA requirements
• Analytical method validation
• Method transfer
• LIMS
• ELN
• Electronic data management

Benefits

• Depending on country and role: annual bonuses or other incentive plans
• Depending on country and role: equity awards
• Depending on country and role: pension or retirement benefits
• Depending on country and role: 401(k) company match
• Depending on country and role: health and wellness programs
• Depending on country and role: fitness centers
• Depending on country and role: insurance benefits (e.g. medical, dental, vision, life and disability)
• Depending on country and role: paid time off
• Depending on country and role: family support benefits

Company

• Develops and commercializes biopharmaceutical medicines for serious diseases
• Tarrytown, New York, USA
• http://www.regeneron.com/
• Founded in 1988
• 10001+ employees

Qualifications

• BS/BA in Biochemistry, Biology, Chemistry, or a related field
• 2+ years of relevant experience
• Hands-on experience with ELISA and/or bioassays; exposure to laboratory
• Requires BS/BA in Biochemistry, Chemistry, Biology or related field
• Requires BS/BA in Biochemistry, Chemistry, Biology or related field, and 2+ years of experience
• Preferably in the pharmaceutical or biotechnology industries
• 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

Required skills

• Agilent Bravo, Analytical Method Validation and Transfer, Beckman Biomek, Bioassay and ELISA Automation, Bioassays, CGMP, ELISA, ELN, Hamilton Liquid Handling Platforms, ICH Requirements, LIMS, Tecan Liquid Handling Platforms

Preferred skills

• preferably in the pharmaceutical or biotechnology industries

Experience

• 2+ years