Senior Principal Scientist, Bioanalysis

Role: Senior Principal Scientist, Bioanalysis, leading bioanalytical assay development and validation within Johnson & Johnson's Innovative Medicine division. Responsibilities: 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. Requirements: 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. Preferred: experience in hybrid LBA-LC-MS, immunogenicity assays, regulatory filings, and staff training; knowledge of orthogonal bioanalytical methods. HighValue: biologics, complex modalities, regulated bioanalysis, GLP/GCLP, assay validation, assay transfer, regulatory support. Location: Spring House, PA.