QC Method Specialist: Assay Dev & Transfers

Regeneron Pharmaceuticals, Inc; City of Rensselaer (NY); On-site; USD 62,000 - 92,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc in New York is seeking a Scientist to support method lifecycle management within Quality Control. The role applies scientific knowledge to perform and review assay characterization, optimization, transfer, validation, and investigation, acting as SME for release, stability, in-process testing, and assay development.

You will collaborate with Analytical Sciences to integrate methods into QC Commercial, monitor performance, coordinate transfers, drive process

Qualifications

• BS/BA in Chemistry, Biochemistry, Biology or related field, or equivalent combination of education and experience.
• BS/BA in Chemistry, Biochemistry, Biology or related field and 2+ years of experience or equivalent combination of education and experience.
• BS/BA in Chemistry, Biochemistry, Biology or related field and 5+ years of experience or equivalent combination of education and experience.

Responsibilities

• Collaborate with Analytical Sciences to integrate methods into QC Commercial, selecting suitable methods prior to process validation.
• Monitor and analyze daily method performance in the QC lab, coordinating with SMEs for problem resolution.
• Liaise with Regulatory Sciences and External Manufacturing to manage timelines for method validation and transfers.
• Monitor method updates, performance, and quality metrics across multiple sites.
• Coordinate post-transfer investigations and multi-site trending, escalating issues to management.
• Drive process improvements and support investigational analysis, coordinating assay qualifications and transfers.
• Develop and draft new test procedures and assays, authoring Analytical Development and Validation Reports.
• Participate in training programs for QC personnel to align with timelines and deliverables.

Education

BS/BA in Chemistry, Biochemistry, Biology or related field, or equivalent combination of education and experience

BS/BA in Chemistry, Biochemistry, Biology or related field and 2+ years of experience or equivalent combination of education and experience

BS/BA in Chemistry, Biochemistry, Biology or related field and 5+ years of experience or equivalent combination of education and experience

Job description

Regeneron Pharmaceuticals, Inc in New York is seeking a Scientist to support method lifecycle management within Quality Control. The role applies scientific knowledge to perform and review assay characterization, optimization, transfer, validation, and investigation, acting as SME for release, stability, in-process testing, and assay development.

You will collaborate with Analytical Sciences to integrate methods into QC Commercial, monitor performance, coordinate transfers, drive process