Senior Scientist, Analytical Science – Technology

Aurion Biotech

. Lead all method transfers and validations at external CDMOs .

Posted 10/13/2026full-timeRemote • United StatesSenior💰 $140,000 - $155,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Quality Control processes, including method validations, assay control, and compliance with cGMP and regulatory requirements. Proven ability to collaborate with external and internal stakeholders while managing project deliverables and resolving technical challenges.

Highest-signal resume keywords

Quality Control ExperienceMethod ValidationsCGMP ComplianceFlow CytometryStatistical Analysis Software

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Method ValidationsAssay ControlAnalytical Method Lifecycle ManagementTest Method ApprovalMethod VerificationMethod TransferData ChartingTechnical Problem SolvingCompliance MonitoringRisk Identification

Soft Skills

Strong Communication SkillsCollaborationAdaptabilityIndependent WorkQuality Mindset

Tools & Technologies

JMPMS Office

Industry Keywords

CGMPPharmacopeial GuidelinesEMA GuidelinesFDA GuidelinesICH GuidelinesCell TherapyAnalytical TestingContract Development and Manufacturing OrganizationsQuality AssuranceLate-Stage Clinical Development

About the role

Key responsibilities & impact

Lead all method transfers and validations at external CDMOs
Author and review protocols, review raw data, and author reports
Support QC deliverables for cellular drug substance and drug product development in late-stage clinical development
Review outsourced GMP work
Serve as Lead SME for method validations, assay control establishment, and method bridging/USP equivalency testing
Build and maintain tools to monitor assay validity
Periodically assess assay validity and investigate as needed
Build collaborative relationships with external CMOs, contract labs, and internal Analytical Development, CMC, and Quality Assurance stakeholders
Independently investigate and resolve technical issues
Develop technical proposals and implement solutions
Escalate challenges to management
Monitor test methods, SOPs, and QC analytical data for compliance with cGMPs, pharmacopeial, and regulatory requirements
Provide technical support for deviations and laboratory investigations
Evaluate proposed analytical change requests
Maintain flexibility as is phase appropriate
Perform other duties as assigned

Requirements

What you’ll need

5+ years of experience in Quality Control or another related function with a Master’s Degree, or a PhD with 2 years of relative QC experience
8+ years of experience in Quality Control or another 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 EMA, FDA, and ICH guidelines 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
Hands-on experience with and deep understanding of Flow Cytometry
Experience charting data and identifying trends observed during studies
Working experience with statistical analysis software; JMP highly preferred
Ability to identify risks associated with method qualifications and validations, with a proven track record of resolving challenges
Demonstrated expertise in analytical method lifecycle management, including test method approval, method verification, method validation, and method transfer
Proven ability to interface with CDMOs
Ability to rapidly adapt to changing environments and circumstances while ensuring cGMP and regulatory requirements are met
Ability to collaborate cross-functionally at all organizational levels
Ability to manage assigned project deliverables
Strong written and verbal communication skills and ability to summarize scientific data clearly and persuasively
Quality mindset and ability to address compliance gaps
Advanced proficiency in MS Office products
Ability to work independently and with team members
Ability to travel up to 15%

Benefits

Comp & perks

Full health insurance for employees and their families
401(k) matching
EAP
FSA
Generous PTO
Paid parking
Subsidized commuter passes
In-office catered lunches
Team events
Community projects
Competitive compensation packages