Principal Scientist, Analytical Development, Oligonucleotide & Small Molecule CMC

Role Lead and mentor the Oligonucleotide & Small Molecule CMC Analytical Development team, providing scientific leadership in analytical method development, testing, and characterization for biotherapeutics crossing the blood-brain barrier. Responsibilities oversee analytical activities for oligonucleotide and small-molecule programs, develop and validate analytical methods, establish laboratory capabilities, troubleshoot technical issues, and collaborate across discovery, process chemistry, quality, and regulatory teams. Manage external analytical work and author key regulatory documentation. Requirements Ph.D. in Chemistry, Pharmaceutical Sciences, or related discipline with 7+ years (Ph.D.) or 10+ years (M.S.) or 12+ years (B.S.) industry experience; at least 5 years of hands‑on analytical development supporting oligonucleotide and/or small‑molecule drug substances and products; expertise in chromatographic and mass spectrometry techniques; strong knowledge of oligonucleotide synthesis, purification, and impurity profiling; experience coordinating with CROs/CDMOs and regulatory submissions. HighValue biotherapeutics crossing the BBB, oligonucleotide and small‑molecule modalities, analytical development supporting clinical phases, regulatory documentation, GxP laboratory management. WorkSetup unspecified; likely on‑site or hybrid based on laboratory leadership role. #J-18808-Ljbffr Denali Therapeutics