Senior Scientist, Biologics Services

Senior Scientist, Biologics Services

Exton, PA (Research)

Position Summary

Scientific and regulatory expert responsible for large-molecule bioanalytical activities

Responsibilities

  • Act as the Principal Investigator or Responsible Scientists for the scientific conduct of immunochemistry projects methods development, validation and sample analysis Train staff on laboratory procedures, documentation and GLP compliance
  • Perform immunoassay techniques (ligand binding assays, ELISA, MSD, and/or RIA applicable to Pharmacokinetic and Immunogenicity studies) with proficiency Prepare and handle various cell lines, tissue culture media and other reagents for cell-based assays such as Neutralizing Antibody (NAb) assays with proficiency
  • Maintain interaction with external clients and industry professionals

Requirements

  • BS/MS or PhD in Immunology or equivalent, plus 10 years related experience CRO experience preferred Training in GLP regulations and ICH guidelines Experience working in a GLP environment

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