• The Stability Coordinator will be responsible for managing development stability studies including study execution and data management in alignment with regulatory guidance documents (CFR, ICH, etc.).
• In this role, the Stability Coordinator will interact with and support multiple cross-functional teams to meet stability needs for clinical programs in all stages of development.
• The Stability Coordinator will initiate stability studies for drug substance and drug product, maintain stability equipment, perform stability pulls, coordinate sample preparation/submission and testing, publish a monthly stability pull/testing status dashboard, follow through for on-schedule data delivery, receive, summarize and archive stability data, and manage stability inventory.
• The Stability Coordinator will interact with members of Drug Product and Combination Development, Analytical Development, Quality Control, Quality Assurance and outside test labs to create and manage the stability pull schedule based on the requirements of the protocols and industry guidance, and the needs of customers.
• The individual will be able to identify when an issue needs to be elevated and can manage the elevation appropriately.
• The Stability Coordinator will support generation and implementation of related quality systems (deviations, change controls, etc.) and assists in the development and maintenance of applicable standard operation procedures and related systems for congruent management and coordination of stability activities