Senior Principal Scientist, Bioanalytical Outsourcing

Johnson & Johnson Innovative Medicine

Spring House, Pennsylvania, United States of America
Hybrid
Bioanalytical method development and validation
Management of external bioanalytical cros
Glp and clinical-stage program support
This position 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 position 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 as outlined in contracts.
  • The role involves leading regular meetings with CRO labs to discuss bioanalysis progress, resources, reagent needs, issues, potential delays and communicating timelines and potential delays to J&J IM partners.

Matching Summary

This position 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
  • Management of external bioanalytical CROs
  • GLP and clinical-stage program support
  • Ligand binding assays and immunogenicity
  • LC-MS/MS assays for small and large molecules

Nice-to-have

  • Problem solving and organizational skills
  • Collaboration within multidisciplinary teams
  • Excellent interpersonal and communication skills
  • Detail-oriented record keeping

Key Requirements

  • PhD with 6+ years post-doctoral experience or Bachelor’s degree with 12+ years of working experience
  • Experience managing bioanalysis for clinical trials and GLP preclinical
  • Knowledge of drug development process
  • Ability to work under timelines
  • Travel up to 20% domestic and international

Work Rights

Not specified

Tailored Resume

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