Principal Scientist - New Biological Entities (m/f/d)

  • BS (15+ years); MS (11+ years) or PhD (7+ years) in Chemistry, Biochemistry, or Biology, Ph.D. on protein analysis with mass spectrometry preferred
  • Previous work experience in a pharmaceutical laboratory setting
  • Experience with late-stage therapeutic protein characterization for BLA preferred
  • Experiences with regulatory document drafting preferred
  • Experience in analytical methodology, such as chromatography, KF, UV and compendial methods and bioanalytical techniques preferred (WCX, HIC, SEC, CGE, icIEF, particle imaging, ELISA and LC-MS)
  • Experienced in GMP laboratory systems (LIMS, CDS, ELN) preferred
  • Statistical knowledge and experience is preferred, e.g. capability analysis, gauge R&R and design of experiments (DOE) methodologies
  • Design and execute experiments for analytical characterization and assessment of development samples and clinical trial supplies (e.g. GMP compliant stability and release testing)
  • Support development of therapeutic proteins at various stages
  • Collect data for elucidation of structure and impurity / variant characterization of antibody-based drug materials
  • Author and/or review key regulatory documents, laboratory data, technical memos and reports
  • Advance science in characterization of novel biologics by generating original ideas for analytical technologies
  • Mentor junior staff on troubleshooting equipment and experimental problems
  • Propose ideas for continuous improvement activities and initiatives within work group
  • Understand and adhere to corporate standards regarding code of conduct, safety and GXP compliance

» Job description

AbbVie Inc.
Lake County, Illinois [USA]