Senior Scientist, Analytical Method Transfer & QC

Socket.dev; Cambridge (MA); Hybrid; USD 140,000 - 155,000; Full time

Job summary

Aurion Biotech in Cambridge, MA is seeking a Senior Scientist, Analytical Science & Technology to lead method transfers and validations at external CDMOs, authoring protocols, reviewing data, and ensuring cGMP compliance. This role interfaces with Analytical Development, CMC, and Quality Assurance to resolve complex analytical challenges.

Your work will focus on building robust assays, maintaining QC readiness, and supporting regulatory-ready documentation while collaborating with internal and

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 associated 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 observed during studies. Working experience with statistical analysis software (JMP highly preferred) is required
• Ability to identify risks associated with method qualifications and validations with a proven track record of resolving challenges as they arise
• Demonstrated expertise in analytical method lifecycle management including test method approval, method verification, method validation, and method transfer

Responsibilities

• Support QC deliverables for cellular drug substance and drug product development in late-stage clinical development
• Review of 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 with internal and external teams to solve issues with broad scope and high complexity
• Escalate challenges to management; develop constructive technical proposals and implement solutions
• Ensure compliance within QC by monitoring test methods, SOPs, and QC analytical data to cGMPs, pharmacopeial, and regulatory requirements
• Provide technical support for deviations, laboratory investigations, and evaluate proposed analytical change requests
• Authoring and reviewing protocols, reviewing raw data and authoring reports
• Maintain flexibility as is phase appropriate
• Other duties as assigned

Job description

Aurion Biotech in Cambridge, MA is seeking a Senior Scientist, Analytical Science & Technology to lead method transfers and validations at external CDMOs, authoring protocols, reviewing data, and ensuring cGMP compliance. This role interfaces with Analytical Development, CMC, and Quality Assurance to resolve complex analytical challenges.

Your work will focus on building robust assays, maintaining QC readiness, and supporting regulatory-ready documentation while collaborating with internal and