Manager/Senior Manager, Stability

About the job Manager/Senior Manager, Stability We're looking for an Manager or Senior Manager, Stability to join the Analytical Development group. This position reports to the Director, Analytical Development. This is a newly created position due to company growth. ESSENTIAL JOB FUNCTIONS: • Manage all development and GMP stability studies for pipeline projects, including those for regulatory starting materials, intermediates, drug substances and drug products, and maintain the stability schedule for each study. • Propose appropriate stability study design per material and project needs, review and approve CMO-generated stability protocols, stability reports and associated raw data records within agreed time frame. • Enter all related stability and SOP documentation into EDMS and manage document control aspects for stability and related QC elements. • Coordinate with Quality Assurance to establish retesting and expiration periods and change controls for all specification documents for drug substance, drug product, and clinical trial materials as subject matter expert. • Coordinate with CMOs and provide technical input on stability-related investigations (OOE, OOS, etc.) to ensure each investigation is conducted and completed per applicable SOPs. • Perform stability trending analysis and keep CMC team updated on study status and issues. • Assign and document retest period or expiry date based on available stability data and applicable guidelines. • Assemble stability data tables, write the stability sections, and contribute to the reviews for regulatory submissions. • Contribute to setting specifications for drug substance and products, regulatory starting materials, intermediates, and raw materials. JOB REQUIREMENTS: • BS/MS degree in chemistry or pharmaceutics or equivalent. • 5+ years of relevant working experience in analytical development in pharmaceutical industry. • Good understanding of cGLP/cGMP principles and ICH guidelines. • Extensive analytical development background and hands on experiences with working knowledge of chemistry, analytical and pharmaceutical science. • Working knowledge of EDMS quality systems such as Veeva Vault. • Detail-oriented and ability to critically evaluate analytical data from a broad range of scientific disciplines. • Have both broad and in-depth knowledge as well as hands-on experience in modern analytical chemistry techniques. Outstanding problem-solving abilities. • Strong leadership, teamwork, organization, and collaboration skills. • Ability to thrive in a highly entrepreneurial, fast paced, and capital efficient environment. • Strong written and communication skills; and an ability to work effectively with a diverse team of co-workers in a dynamic environment.

Created: 2026-03-04