Associate Director - Analytical Development (Oligonucleotide)

Role: Associate Director of Analytical Development focused on oligonucleotide therapeutics, providing scientific and strategic leadership across method development, characterization, qualification, validation, and lifecycle management. Responsibilities include defining analytical control strategies, ensuring regulatory compliance, authoring regulatory submissions (INDs, CTAs, BLAs, NDAs), overseeing internal and external analytical activities, and driving innovation in analytical technologies. Requirements: BS/MS with 6+ years or PhD with 2+ years in biopharma; strong expertise in chromatographic and mass spectrometry-based techniques; experience in oligonucleotide impurity profiling, stability, and specifications; prior management of technical teams. Preferred: Chemistry or Biochemistry degree, familiarity with regulatory standards (FDA, EMA, ICH, GMP), and external CRO/CDMO management experience. High-Value: Focus on oligonucleotide therapeutics, lifecycle management, regulatory documentation, and analytical technology innovation. Work setup: Based in Bridgewater, NJ, full-time onsite; travel approximately 10%.