Senior Manager Analytical Operations

Role: Analytical Development Scientist and Quality Control lead supporting clinical assets at a biopharma focused on rare diseases. Responsibilities: manage analytical development, QC, and stability activities at contract manufacturing sites; review and approve method transfer, validation, stability protocols, and technical reports; support regulatory filings (IND/IMPD/BLA/NDA/MAA); oversee reference standards, batch release, change controls, and investigations into deviations and out-of-specification results. Requirements: 10+ years in pharma/biotech analytical development or QC; proficiency in techniques supporting biologics and small molecules; strong knowledge of cGMP, ICH, USP guidelines; experience with regulatory document authoring and stability data analysis (e.g., JMP); familiarity with quality systems like Veeva Vault, TrackWise, LIMS; excellent communication skills and ability to prioritize under tight timelines. Preferred: biotech experience in early or late-stage development, biologics or small molecules, stability program management, international travel readiness. Work setup: remote/hybrid with occasional visits to San Francisco; travel approximately 5-15%.