Senior Scientist II-Biomarker
Core
Lead biomarker and bioanalytical strategies for clinical programs, developing complex analytical methods, and ensuring compliant data generation for drug development.
Role type
Senior Scientist II, biomarker and bioanalytical lead
Builds
Regulated biomarker assays and bioanalytical frameworks for clinical programs
Domain
Life Sciences / Bioanalytical Chemistry / Drug Development
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
biomarker assay development, complex analytical method execution, troubleshooting, technical mentoring, regulatory compliance (GLP/GCLP), data quality management, root cause analysis, technology transfer, experimental design, SOP development
Preferred skills
biologics and Cell & Gene Therapy (CGT) program support, PK/PD/biodistribution/viral shedding/immunogenicity assay development, regulated biomarker bioanalysis (soluble proteins, gene expression, viral loading, rare mutations), advanced troubleshooting for assay instability and matrix effects, data integrity interpretation
Technologies
PCR, ddPCR, immunoassay platforms
Responsibilities
Lead biomarker and bioanalytical strategies for clinical programs; Execute and develop complex analytical methods and troubleshoot advanced technical challenges; Mentor junior and mid-level staff in laboratory techniques; Design and establish fit-for-purpose biomarker assay development frameworks; Monitor emerging trends in bioanalytical science and implement innovative tools; Ensure compliance with SOPs, GLP/GCLP, and regulatory standards; Contribute to technology transfer and process improvement projects
Seniority
Senior, hands-on IC with mentorship responsibilities
