Specialist, Analytical Technical Operations
Core
Coordinate analytical testing schedules, manage stability studies for mRNA and LNP drug candidates, and support digital operations to enable product development decisions.
Role type
Specialist, Analytical Technical Operations (ATO)
Builds
Stability protocols, study deliverables, and data packages for novel mRNA and Lipid Nanoparticle (LNP) drug candidates
Domain
Biopharmaceuticals / Analytical Development / CMC Development
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
stability study management, analytical testing coordination, LIMS/ELN proficiency, data trend analysis, cross-functional project coordination, regulatory compliance documentation
Preferred skills
mRNA/LNP/biologics experience, CMC development knowledge, workflow automation, process improvement initiatives
Technologies
LabVantage, Benchling, LIMS, ELN
Responsibilities
Consolidate inputs from digital systems to create executable testing plans; compile and summarize analytical data for peer review; coordinate multiple program timelines for testing milestones; partner on forecasting and sample management; integrate laboratory and enterprise digital systems; maintain compliant documentation.
Seniority
Mid-level, hands-on specialist