Quality Control Scientist

BioSpace; City of Rensselaer (NY); On-site; USD 67,000 - 110,000; Full time

Benefits offered by this job

Annual bonus plans

Equity awards

Pension benefits

401k match

Health & wellness

Fitness centers

Insurance benefits

Paid time off

Family support

Job summary

Regeneron is seeking a Quality Control Scientist to support assay development, characterization, optimization, transfer, validation, and investigation in QC. The role focuses on automating bioassays and ELISA-based methods to boost throughput, robustness, and data integrity.

The role requires BS/BA in relevant fields and 2+ years of experience, with hands-on ELISA/bioassay work and familiarity with regulatory guidelines, cGMP, and analytical method validation. Onsite at Rensselaer, NY.

Qualifications

• Hands-on ELISA and bioassay experience required.
• Experience designing/validating QC assays per ICH Q2, GMP.
• Familiarity with automated liquid handling platforms.

Responsibilities

• Develop, optimize, validate QC assays (bioassays/ELISA).
• Design automated workflows for assays and method migration to automation.
• Lead assay transfers from R&D to QC and external partners.
• Establish product specifications using development and manufacturing data.
• Provide support for release, stability, and in-process testing.

Skills

ELISA experience

Bioassays

Automation workflows

Data analysis

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.

When & Where

MondayFriday, 8:00am4:30pm

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.

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.

Benefits

• 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
• 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.

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 onsite.

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