Senior Principal Scientist, Bioanalytical Outsourcing
Johnson & Johnson
Spring House, Pennsylvania, United States of America
Hybrid
Bioanalytical method development and validation
Glp and clinical trial bioanalysis
Cro management and oversight
This role is responsible for comprehensive oversight of all bioanalytical assays across assigned programs and analytical platforms at external partners, ensuring seamless execution from initiation through reporting
Job Summary
This role is responsible for comprehensive oversight of all bioanalytical assays across assigned programs and analytical platforms at external partners, ensuring seamless execution from initiation through reporting.
You will be responsible for ensuring that all contractual obligations with external partners are met, including closely monitoring deliverables, timelines, cost, and quality standards.
The position requires collaboration with internal partners to prepare Data Transfer Agreements and coordinate sample tracking/management processes, ensuring compliance with HGRAO guidelines for programs in China.
Matching Summary
This role is responsible for comprehensive oversight of all bioanalytical assays across assigned programs and analytical platforms at external partners, ensuring seamless execution from initiation through reporting.
Skills & Requirements
Must-have
bioanalytical method development and validation
GLP and clinical trial bioanalysis
CRO management and oversight
ligand binding and LC-MS/MS assays
drug quantitation and immunogenicity
Nice-to-have
patient-centric approach
collaborative multidisciplinary teams
regulatory compliance expertise
strong interpersonal communication
Key Requirements
PhD with 6+ years post-doctoral experience or Bachelor’s degree with 12+ years of experience
Knowledge of drug discovery to BLA/NDA
Experience managing clinical trials and GLP preclinical bioanalysis
Successful track record of problem solving and organization