Scientist, Analytical Sciences and Technology
Core
Provide technical leadership and execution support for analytical method lifecycle management, including transfers, validations, troubleshooting, and investigations for commercial and late-stage development programs.
Role type
Senior Individual Contributor Scientist (Analytical Sciences)
Builds
Robust analytical performance, compliance, and inspection readiness for Quality Control laboratories, manufacturing operations, and external testing partners.
Domain
Biopharmaceuticals / Vaccines / mRNA technology
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Analytical method transfer and validation, GMP-regulated environment experience, technical documentation authoring, laboratory investigations (OOS/OOT), data trend analysis, cross-functional collaboration
Preferred skills
Risk-based validation strategies, chromatographic/spectroscopic techniques, regulatory filing support, CAPA management, external partner oversight
Technologies
Chromatography, Spectroscopy, GMP systems, LIMS (implied via data analysis)
Responsibilities
Lead analytical method transfers and validations, support troubleshooting of analytical issues, perform scientific data analysis for trend identification, author and review technical documents and SOPs, support regulatory submissions and inspections
Seniority
Senior, hands-on IC
