Principal Investigator/Bioanalytical Lead Scientist I- (LC-MS)
Core
Lead scientific work and direct bioanalytical study teams to support drug development projects using LC-MS methods.
Role type
Senior IC bioanalytical lead scientist (LC-MS)
Builds
Bioanalytical data and reports for drug development clients
Domain
Life sciences / Bioanalysis / LC-MS
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
LC-MS, GLP compliance, bioanalytical method development, bioanalytical method validation, protocol development, data review, regulatory guideline knowledge, assay troubleshooting, scientific reporting, project management
Preferred skills
Watson/Nautilus/Analyst software, Root Cause Analysis, regulatory agency guideline expertise
Technologies
Watson, Nautilus, Analyst
Responsibilities
Lead and direct scientific work for external methods and projects; Serve as SD, RS, CS, LS, or PI for non-regulated, GLP-regulated, and GCP-regulated studies; Develop and review protocols and sample analysis plans; Approve validation methods and review sample analysis methods; Independently review and approve raw data; Ensure quality and integrity of studies; Evaluate data and tables for regulatory compliance; Review and approve reports for scientific accuracy; Lead efforts to troubleshoot and solve assay problems; Serve as scientific point of contact for clients; Provide technical and scientific guidance to clients and team members; Mentor other employees; Manage high volume study work for key clients
Seniority
Senior, hands-on IC
