Senior Scientist II
Core
Lead biomarker and bioanalytical strategies for clinical programs, developing complex analytical methods and qualifying assays for regulated environments.
Role type
Senior Scientist II (Biomarker/Bioanalysis)
Builds
Biomarker assays and bioanalytical frameworks supporting drug development and Cell & Gene Therapy programs
Domain
Life Sciences / Bioanalytical Chemistry / Clinical Research
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
biomarker assay development, bioanalytical method validation, PCR/ddPCR, immunoassay platforms, GLP/GCLP compliance, technical mentoring, root cause analysis, assay troubleshooting, data integrity management
Preferred skills
biologics and Cell & Gene Therapy (CGT) program support, pharmacokinetics (PK) and pharmacodynamics (PD) assay development, viral shedding and immunogenicity (ADA) assay expertise, rare mutation detection, process improvement
Technologies
PCR, ddPCR, immunoassay platforms, bioanalytical instruments
Responsibilities
Lead biomarker strategies for clinical programs, execute and develop complex analytical methods, mentor junior staff in laboratory techniques, design fit-for-purpose assay qualification frameworks, resolve complex technical issues and troubleshoot assays, ensure compliance with regulatory standards (GLP/GCLP), support technology transfer activities
Seniority
Senior, hands-on IC with mentorship responsibilities