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Sr Quality Control Scientist

Regeneron
On-site
Rensselaer, NY
Operations

Role Summary

Senior Quality Control Scientist to join our Technical Resources Chemistry Group. You’ll mentor and supervise release, stability, in-process testing, and assay development to ensure technical excellence and regulatory compliance of QC chemistry processes.

Responsibilities

  • Leading assay development, validation, optimization, and transfer processes using advanced methodologies such as HPLC, UPLC, UV spectroscopy, and other techniques.
  • Reviewing and approving new test procedures and assays to ensure technical accuracy and compliance.
  • Facilitating seamless assay transfers from R&D to business partners and organizing analytical assay transfers both internally and externally.
  • Driving technical troubleshooting, problem investigation, and resolution for QC chemistry-related challenges.
  • Reviewing technical reports, protocols, and documents for regulatory compliance and scientific integrity.
  • Mentoring and training team members on systems, processes, and best practices to foster a collaborative and high-performing environment.

Qualifications

  • Required: Bachelor’s degree in Chemistry, Biochemistry, or a related field with 5+ years of experience in HPLC, UPLC, and UV spectroscopy.
  • Preferred: PhD in a relevant field.
  • Direct experience with AAV (adeno-associated virus) is highly desirable.

Skills

  • Expertise with HPLC-based assays, including UPLC and UV spectroscopy.
  • Strong communication—written and verbal—and ability to present complex scientific concepts clearly.
  • Ability to mentor, train, and supervise scientific staff in analytical methods and QA practices.

Education

  • Bachelor’s degree in Chemistry, Biochemistry, or related field (required).
  • PhD in a relevant field (preferred).
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