QC Method Lifecycle Scientist

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

Benefits offered by this job

Annual bonuses

Equity awards

Pension benefits

401(k)

Health & wellness

Fitness centers

Insurance benefits

Paid time off

Family support

Job summary

Regeneron Pharmaceuticals, Inc. seeks a specialist to support method lifecycle management within Quality Control (QC).

You will apply scientific knowledge to perform and review assay characterization, transfer, validation, and investigation, acting as a SME to guide release, stability, in-process testing, and assay development. You will collaborate with Analytical Sciences to integrate methods into QC, monitor performance across sites, and coordinate post-transfer investigations, ensuring timely

Qualifications

• Requires a BS/BA in Chemistry, Biochemistry, Biology or related field.
• 2+ years of experience for intermediate role or 5+ years for senior; equivalent education/experience accepted.
• Ability to collaborate across functions and coordinate multi-site activities.

Responsibilities

• Collaborate with Analytical Sciences to integrate methods into QC Commercial, evaluating and selecting suitable methods prior to process validation.
• Monitor and analyze daily method performance in the QC lab, coordinating with subject matter experts for problem resolution as needed.
• Liaise with Regulatory Sciences and External Manufacturing to manage timelines for method validation and transfers, communicating updates to management.
• Monitor method updates, performance, and quality metrics, ensuring consistent harmonization and performance evaluations across multiple sites.
• Coordinate post-transfer investigations and multi-site trending, escalating issues to management when necessary.
• Drive process improvements and support investigational analysis, performing and coordinating assay qualifications and transfers.
• Develop and draft new test procedures and assays, authoring technical documents like Analytical Development and Validation Reports.
• Participate in training programs for QC personnel, ensuring all activities align with project timelines and deliverables.

Education

BS/BA in Chemistry, Biochemistry, Biology or related field

BS/BA in Chemistry, Biochemistry, Biology with 2+ years experience

BS/BA in Chemistry, Biochemistry, Biology with 5+ years experience

Job description

Regeneron Pharmaceuticals, Inc. seeks a specialist to support method lifecycle management within Quality Control (QC).

You will apply scientific knowledge to perform and review assay characterization, transfer, validation, and investigation, acting as a SME to guide release, stability, in-process testing, and assay development. You will collaborate with Analytical Sciences to integrate methods into QC, monitor performance across sites, and coordinate post-transfer investigations, ensuring timely