TEMP - Senior Scientist, Bioanalytical Outsourcing
Core
Overseeing bioanalytical method development, validation, and sample analysis at contract research organizations (CROs) to support clinical development programs for small and large molecules.
Role type
Senior Scientist, Bioanalytical Outsourcing
Builds
Bioanalytical data and validated methods for clinical trials
Domain
Biopharmaceuticals / Clinical Pharmacology
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Bioanalytical method development, method validation, clinical sample analysis, regulatory compliance (ICH M10), project management, data review and discrepancy investigation, contract and work order management, stakeholder communication
Preferred skills
Troubleshooting experimental outcomes, data consolidation, laboratory equipment operation
Technologies
Laboratory equipment/tools
Responsibilities
Oversee bioanalytical method development, validation, and sample analysis at CROs; Establish contracts and work orders with R&D and legal teams; Manage sample transfer and tracking from clinical sites; Ensure CROs receive necessary supplies and information; Plan and track reagent preparation and analysis activities; Review validation plans and data for regulatory alignment; Facilitate meetings with CROs and manage accountability; Provide status updates to internal teams; Review data transfer protocols and support consolidation; Present data and recommendations to stakeholders
Seniority
Senior, hands-on IC
