Hybrid-Remote Senior Scientist, Analytical Transfer

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

Job summary

Aurion Biotech is seeking a Senior Scientist, Analytical Science & Technology in Cambridge, MA. The role leads method transfers and validations at external CDMOs, authoring and reviewing protocols and reports while troubleshooting methods and ensuring stability compliance.

You will collaborate with Analytical Development, CMC, and QA to maintain assay validity, monitor QC data, and investigate deviations in a fast-growing cell therapy company.

Qualifications

• 5+ years of experience in Quality Control or related function with a Master’s Degree (or a PhD with 2 years of relative QC experience).
• Or 8+ years of experience in Quality Control or related function with a Bachelor’s Degree.
• Experience with method validations and USP method verification in late-stage clinical development.
• Excellent working knowledge of cGMP requirements, pharmacopeial and relevant guidelines (EMA, FDA, ICH) as they relate to QC testing for cell therapy and method validations.
• Experience reviewing analytical test results and solving technical problems with a wide variety of cell-based QC assays.
• Must have hands-on experience with and a deep understanding of Flow Cytometry.
• Experience charting data and identifying trends; working with statistical analysis software (JMP highly preferred) is required.
• Ability to identify risks with method qualifications and validations and resolve challenges.

Responsibilities

• Support QC deliverables for cellular drug substance and drug product development in late-stage clinical development.
• Review outsourced GMP work and serve as Lead SME for method validations, assay control establishment, and method bridging/USP equivalency testing.
• Build tools to monitor assay validity and maintain them; periodically assess assay validity and investigate as needed.
• Interface with external stakeholders (CMOs or contract labs) and internal stakeholders including Analytical Development, CMC, and Quality Assurance.
• Independently resolve technical issues; collaborate to solve issues with broad scope and/or high complexity.
• Escalate challenges to management; develop technical proposals and implement solutions.
• Ensure compliance within QC by monitoring test methods, SOPs, and data to cGMPs and regulatory requirements.
• Provide technical support for deviations, laboratory investigations, and evaluate proposed analytical changes.
• Authoring and reviewing protocols, reviewing raw data and authoring reports.
• Maintain flexibility as phase-appropriate; perform other duties as assigned.

Skills

Quality Control

Flow Cytometry

Regulatory compliance

Statistical analysis

CDMO interface

Cross-functional collaboration

Data analysis

Education

Master's Degree (or PhD with 2 years QC experience)

Bachelor's Degree

Tools

JMP

MS Office

Job description

Aurion Biotech is seeking a Senior Scientist, Analytical Science & Technology in Cambridge, MA. The role leads method transfers and validations at external CDMOs, authoring and reviewing protocols and reports while troubleshooting methods and ensuring stability compliance.

You will collaborate with Analytical Development, CMC, and QA to maintain assay validity, monitor QC data, and investigate deviations in a fast-growing cell therapy company.