Scientist, Analytical Development
Core
Lead the transfer and implementation of analytical methods from Analytical Development into Analytical Testing Operations (ATO) and Quality Control (QC) laboratories, ensuring methods are scientifically understood, reproducible, and robust.
Role type
Senior IC analytical method transfer lead
Builds
Transfer protocols, study designs, and operational procedures for analytical methods
Domain
Pharmaceutical development and manufacturing (biologics, vaccines, nucleic acids)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Analytical method development, method transfer execution, root-cause analysis, GMP compliance, risk assessment, technical writing, laboratory troubleshooting, regulatory knowledge (ICH Q2/Q14, USP <1224>)
Preferred skills
Hands-on chromatography/separation science, electrophoresis, spectroscopy, bioassays, mRNA/LNP/vaccine experience, cross-functional leadership
Technologies
Chromatography, electrophoresis, spectroscopy, bioassays, LIMS, analytical software
Responsibilities
Assess method readiness and design transfer strategies, execute transfers and troubleshoot technical barriers, lead root-cause investigations for method failures, author transfer protocols and regulatory documentation, build standardized transfer playbooks, monitor method performance trends.
Seniority
Senior, hands-on IC
