(Associate) Principal Bioanalysis Scientist
Core
Leading clinical bioanalysis projects as principal investigator to generate quality-compliant PK, PD, ADA, NAb, and biomarker data for cell therapy projects and biotherapeutic development.
Role type
Associate Principal or Principal Bioanalysis Scientist
Builds
Bioanalytical assays and data for regulatory filing (NDA/BLA)
Domain
Biopharmaceuticals / Cell Therapy / Bioanalysis
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
LBA (ELISA, MSD) assay development and validation, ddPCR/qPCR (VCN, RCL) assay development and validation, multi-parameter flow cytometry (immunophenotyping, functional assays), GxP environment operations, bioanalytical method validation per ICH M10/FDA/EMA guidelines, regulatory dossier preparation (NDA/BLA), project management, mentorship
Preferred skills
Single-cell sequencing, bioinformatic QC, translational genomics, CRO bioanalytical oversight, NDA/BLA submission experience
Technologies
ELISA, MSD, ddPCR, qPCR, Flow Cytometry
Responsibilities
Lead clinical bioanalysis projects as principal investigator, manage in-house and outsourced bioanalytical studies, design and execute experiments for assay development and validation, review and approve sample analysis data and validation reports, mentor junior scientists, present results and prepare regulatory submission contributions, manage resources and timelines
Seniority
Senior, hands-on IC with mentorship responsibilities
