Stability Program Coordinator

Job description

Job Description Stability Coordinator: At our company, we aspire to be the premier research-intensive biopharmaceutical company. We're at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We use the power of leading-edge science to save and improve lives around the world. Join our team and be part of a company that is making a difference. Responsibilities: - Draft, review, and maintain stability protocols and amendments in alignment with ICH guidelines, internal SOPs, and regulatory commitments. - Define study design parameters, storage conditions, timepoints, and analytical test plans. - Author stability study plans, change controls, and protocol deviations/justifications as required. - Ensure controlled document lifecycle management in the appropriate QMS. - Generate and manage stability pull schedules; execute and/or coordinate stability pulls at defined timepoints. - Oversee sample chain-of-custody, storage placement, and reconciliation, including management of chambers/incubators and alarms. - Coordinate timely sample handover to QC labs and track testing progress through completion. -...