Quality Control Scientist: Assay Dev & Validation

Regeneron Pharmaceuticals, Inc; City of Rensselaer (NY); On-site; USD 69,000 - 112,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc. is seeking a Quality Control Scientist in the Technical Resources Department.

You will perform assay development, validation, transfer, and investigations for QC, supporting release, stability, and in-process testing. The role requires a BS in Chemistry, Biochemistry, or Biology and at least 3 years of relevant experience; cell or gene therapy experience is strongly preferred; deep knowledge of HPLC‑based assays.

Qualifications

• BS in Chemistry, Biochemistry, Biology or related field with 3+ years of relevant experience.
• Experience with cell or gene therapy in a Biopharmaceutical environment is strongly preferred.
• In-depth knowledge of HPLC-based assays.

Responsibilities

• Performs assay development and validation for Quality Control.
• Reviews new test procedures and assays.
• Evaluates and introduces new methodologies and techniques when needed.
• Facilitates assay transfer from R&D to business partners.
• Organizes analytical assay transfer internally and externally.
• Sets product specifications.
• Participates in technical troubleshooting and problem investigations.
• Reviews analytical development reports and validation reports for technical correctness and regulatory compliance.
• Participates in training programs for analysts.

Skills

HPLC-based assays

Cell/gene therapy

Education

Bachelor's degree in Chemistry, Biochemistry or Biology

Job description

Regeneron Pharmaceuticals, Inc. is seeking a Quality Control Scientist in the Technical Resources Department.

You will perform assay development, validation, transfer, and investigations for QC, supporting release, stability, and in-process testing. The role requires a BS in Chemistry, Biochemistry, or Biology and at least 3 years of relevant experience; cell or gene therapy experience is strongly preferred; deep knowledge of HPLC‑based assays.