Manager/Sr. Manager, Analytical Development

Role: Analytical development scientist and QC professional supporting clinical assets and regulatory submissions in biopharma. Responsibilities: manage analytical development, QC, and stability activities at contract manufacturing sites; author and review method transfer, validation, and stability protocols; support batch release and review of analytical data; contribute to regulatory filings (IND/IMPD/BLA/NDA); lead investigations of OOS/OOT deviations, manage change controls, and develop SOPs. Requirements: 10+ years of experience in Analytical Development or QC within pharma; proficiency in analytical techniques for biologics and small molecules; strong knowledge of cGMP, ICH, USP guidelines; experience with stability program management, data analysis (e.g., JMP), and enterprise QMS (Veeva, TrackWise, LIMS); effective communication skills. Preferred: experience with biopharma regulatory submissions and biologic modalities. High-Value: biologics, small molecules, stability programs, regulatory filings, contract manufacturing oversight, hybrid work with 5-15% travel. Location: hybrid role based in San Francisco.