Principal Research Associate, Analytical Development
Core
Serve as a critical bridge for analytical method development, transfer, and routine operations between Analytical Development and cross-functional partners (AST, QC, ATO, QA) to ensure robust methods for clinical-stage qualification and commercial validation.
Role type
Principal Research Associate (Analytical Development)
Builds
Analytical methods and assays for clinical and commercial stages
Domain
Biopharmaceuticals / Analytical Sciences
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work -> production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work -> research (method development & validation)
Required skills
HPLC, Absorption assays, Molecular Biology assays, analytical method transfer, GMP environment troubleshooting, root cause analysis, CQA frameworks, assay lifecycle management, complex data interpretation
Preferred skills
cross-functional collaboration with Quality/Manufacturing, continuous improvement, regulatory compliance (ICH Q2/Q14)
Technologies
HPLC, Absorption, Molecular Biology
Responsibilities
Liaise between Method Development, AST, ATO, and QC to align on method expectations; Represent Analytical Development in cross-functional forums; Ensure methods meet technical, operational, and regulatory requirements; Serve as subject matter expert for investigations and performance issues; Influence method development and optimization based on operational feedback; Collaborate on deviation investigations, CAPAs, and change controls; Analyze complex datasets to inform performance and comparability; Author and review technical documentation including protocols and lifecycle documents
Seniority
Principal, hands-on IC with strategic interface responsibilities
