Senior Scientist, Analytical Science & Tech (Hybrid-Remote)

Aurion Biotech, Inc.; Cambridge, Northern (MA, KY); Hybrid; USD 140,000 - 155,000; Full time

Job summary

Aurion Biotech, Inc. in Cambridge, MA is seeking a Senior Scientist, Analytical Science & Technology to lead method transfers and validations at external CDMOs.

You will author and review protocols, evaluate data, and ensure regulatory compliance for QC testing of cell therapy products. The role requires strong experience with cGMP, USP methods, and collaboration across QC, Analytical Development, CMC, and QA teams to drive successful transfer projects and validate analytical approaches in

Qualifications

• 5+ years in Quality Control or related function, with advanced degree.
• Experience with method validations and USP method verification in late-stage development.
• Hands-on knowledge of cGMP, pharmacopeial and regulatory guidelines.

Responsibilities

• Lead method transfers and validations at external CDMOs.
• Review analytical results and support deviations and investigations.
• Develop and implement monitoring tools for assay validity and data trends.
• Collaborate with CDMOs, Analytical Development, CMC and QA to ensure QC compliance.

Skills

Quality Control

Flow Cytometry

Regulatory compliance

Data analysis

Cross-functional collaboration

Education

Master's Degree

PhD

Bachelor's Degree

Tools

JMP

MS Office

Job description

Aurion Biotech, Inc. in Cambridge, MA is seeking a Senior Scientist, Analytical Science & Technology to lead method transfers and validations at external CDMOs.

You will author and review protocols, evaluate data, and ensure regulatory compliance for QC testing of cell therapy products. The role requires strong experience with cGMP, USP methods, and collaboration across QC, Analytical Development, CMC, and QA teams to drive successful transfer projects and validate analytical approaches in