Principal Research Scientist I

4 weeks ago


South San Francisco, California, United States AbbVie Full time
Job Summary

We are seeking a highly skilled and experienced Principal Research Scientist I to lead our QC Bioassay Lab and support the development and evaluation of newly discovered oncology and immunology drugs. The successful candidate will have a strong background in cell-based assays and/or target binding potency assays, with a minimum of 5 years of experience in a GMP regulated environment.

Key Responsibilities
  • Establish and lead the QC Bioassay Lab at the South San Francisco site, focusing on QC target-binding potency assays and cell-based functional potency assays.
  • Collaborate with cross-functional teams to enable the establishment of a new QC Bioassay lab, ensuring all elements are organized, maintained, and in compliance.
  • Ensure equipment, instruments, and software are appropriately qualified/validated.
  • Work closely with Bioassay Development scientists to enable rapid and efficient establishment of novel, complex potency assays in QC.
  • Plan, schedule, track, and document the QC activities of bioassay scientists for the release and stability testing of drug substance and drug product batches.
  • Monitor and track metrics for the QC Bioassay Lab.
  • Ensure QC activities are in conformance with AbbVie Quality System requirements and applicable regulatory and compendial requirements.
Requirements
  • Degree in biology, biochemistry, cell/molecular biology, or a related field with typically 14 years (BS), 12 years (MS), or 6 years (PhD) of relevant industry experience.
  • Experience with cell-based assays and/or target binding potency assays in a GMP QC organization performing release and stability testing.
  • Comprehensive knowledge of GMP analytical laboratory business, product quality, quality control lab operation, and regulatory quality requirements.
  • Experience in the use of LIMS and electronic notebook systems for GMP-regulated laboratories.
  • Ability to independently author technical reports and presentations.
About AbbVie

AbbVie is a global biopharmaceutical company that discovers and delivers innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We are committed to operating with integrity, driving innovation, transforming lives, serving our community, and embracing diversity and inclusion.



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