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Johnson & Johnson Innovative Medicine in Spring House, PA, seeks a Senior Principal Scientist, Bioanalysis, to lead bioanalytical assay development and validation, focusing on large‑molecule immunoassays and multiplex workflows.
You will design and oversee assay lifecycles, ensure GLP/GCLP compliance, support regulatory filings, transfer to CROs, and mentor a skilled team while evaluating new technologies.
Senior Principal Scientist, Bioanalysis, leading bioanalytical assay development and validation within Johnson & Johnson's Innovative Medicine division.
serve as development PK representative, design and troubleshoot immunoassays (LBA and LC-MS), oversee assay lifecycle including validation, reagent management, and stability programs; prepare scientific and regulatory documentation; ensure compliance with GLP/GCLP standards; support regulatory submissions and assay transfer to CROs; mentor staff; evaluate emerging technologies; communicate findings internally and externally.
Ph.D. in Biology, Immunology, Biochemistry, or Analytical Chemistry with 8+ years (or MS with 10+ years) in regulated bioanalysis; deep hands-on expertise in immunoassays for large molecules (MSD, Gyrolab, ELISA); proven experience with complex modalities (oligonucleotides, ADCs); familiarity with automation, GLP/GCLP, and regulatory guidelines (ICH M10); strong communication and matrix leadership skills.
experience in hybrid LBA-LC-MS, immunogenicity assays, regulatory filings, and staff training; knowledge of orthogonal bioanalytical methods.
biologics, complex modalities, regulated bioanalysis, GLP/GCLP, assay validation, assay transfer, regulatory support.
Spring House, PA.