Lead Scientist
Core
Develop, validate, and manage quantitative and immunogenicity assays for bioanalytical studies in compliance with regulatory guidance.
Role type
Senior IC Lead Scientist (Bioanalysis)
Builds
Validated analytical methods and assay data for clinical drug product programs
Domain
Healthcare / Bioanalytical Laboratory
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
quantitative bioanalysis, immunogenicity testing, HPLC, mass spectrometry, ligand binding assays, laboratory automation, sample preparation, GLP regulations, SOP development, data review, team supervision
Preferred skills
Doctorate degree, 6+ years experience, Masters degree, 8+ years experience, Bachelor's degree, 10+ years experience
Technologies
HPLC, mass spectrometry, ligand binding assays, laboratory automation, sample preparation, Microsoft Word, Excel, instrument-specific control and data acquisition software
Responsibilities
Develop and validate quantitative and/or immunogenicity assays; Design, perform, and evaluate method development and validation experiments; Manage Scientists and laboratory personnel; Evaluate, summarize, and present analytical results to management and clinical teams; Serve as a bioanalytical subject matter expert; Document laboratory activity and write/approve reports and SOPs; Troubleshoot analytical problems; Review data for scientific soundness and compliance.
Seniority
Senior, hands-on IC with supervisory responsibilities
