Principal Scientist - Bioanalytical Outsourcing
Core
Oversee bioanalysis of PK, immunogenicity, and biomarkers at external CROs, managing assay development, validation, and sample analysis for drug programs.
Role type
Principal Scientist, Bioanalytical Outsourcing
Builds
Bioanalytical data and validated assays for nonclinical and clinical drug programs
Domain
Pharmaceutical / Bioanalysis
Required skills
CRO management, assay validation/qualification, GLP/GCLP compliance, LBA, LC/MS, PCR-based methods, stakeholder communication, data quality review
Preferred skills
Novel drug candidates (gene therapies, CAR-T, ADCs, AOCs)
Technologies
LBA, LC/MS, PCR
Responsibilities
Provide scientific and operational oversight on bioanalytical activities at CROs; Obtain critical materials and documentation from CROs; Support CRO efforts in design, development, and implementation of analytical methods; Interface with CROs to ensure on-time delivery and contract compliance; Review sample analysis data to ensure quality and integrity.
Seniority
Principal, hands-on IC with strategic oversight