Principal Scientist, CMC Analytical Development - Commercial Products

Role: Principal Scientist serving as Commercial Analytical Lifecycle Lead within Denali's large molecule analytical development team, focusing on biologics post-approval. Responsibilities: provide technical oversight for commercial manufacturing and QC activities, lead analytical method transfer for in-country testing, support global health authority interactions, and ensure compliance with industry standards. Collaborate with cross-functional teams across CMC, Quality, Regulatory, and external CMOs to support ongoing commercial supply and international registration processes. Requirements: PhD or MS with 10+ years (PhD) or 14+ years (MS) industry experience in analytical chemistry or related field; proven expertise in biologics analytical methods (e.g., HPLC, ELISA, mass spectrometry); experience supporting commercial biologics manufacturing, method validation, and regulatory submissions; strong communication skills; willingness to travel domestically and internationally. Preferred: experience with enzyme replacement or Fc-fusion biologics, expedited regulatory pathways, and managing multiple external testing sites. High-Value: biologics manufacturing post-approval, global health authority engagement, international registration, biologics analytical methods, regulatory compliance, biologics (e.g., AVLAYAH) in neurodegenerative diseases. Work setup: not specified, travel required.