Senior Manager, Analytical Quality Control

Responsibilities

• Provide QC oversight of analytical testing and stability studies performed at CDMOs
• Perform in-depth reviews of raw analytical data to ensure data integrity and compliance
• Establish and maintain processes for tracking and trending of CDMO testing
• Manage reference standards and reference materials including qualification and inventory tracking
• Author and review stability summary reports and scientific justifications for shelf-life
• Support development and maintenance of the quality system, including SOPs and work instructions
• Review analytical method validation protocols, change controls, deviations, and OOS/OOT investigations
• Author and verify data in CMC sections of regulatory documents (IMPD, IB, IND, NDA, etc.)
• Support the evaluation, selection, and management of CDMOs
• Collaborate cross-functionally with Analytical Development, Supply Chain, Quality, and Regulatory teams

Requirements

• BS, MS, or PhD in analytical chemistry or related field
• 10+ years experience with BS, 8+ years with MS, or 5+ years with PhD
• Experience in analytical quality control within the pharmaceutical industry
• Experience supporting programs through clinical development
• Proficiency in IR, UPLC/HPLC, KF, GC, dissolution, and microbial limit tests
• Knowledge of quality systems including SOPs, LIMS, cGMP, and Change Management
• Experience with ICH, FDA, MHRA, and EMA guidelines and USP-NF, Ph. Eur, BP, and JP compendia
• Experience managing external partners and CDMOs
• Ability to travel domestically and internationally up to 10%

About the Company

Septerna is a biotechnology company based in South San Francisco, CA on a mission to develop life-changing medicines for patients with the vision to become the industry-leading G protein-coupled receptor (GPCR)-focused drug discovery company.