The Stability Specialist 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 Specialist will interact with and support multiple cross-functional PDTS Teams to meet stability needs for clinical programs in all stages of development. The Stability Specialist 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 projection list, follow through for on-schedule data delivery, receive, summarize and archive stability data, and manage stability inventory. The Stability Specialist will create and manage the stability pull schedule based on the requirements of the protocols, Shire and industry guidance. The individual will be able to identify when an issue needs to be elevated and can manage the elevation appropriately. The Stability Specialist will assist in the development and maintenance of applicable standard operation procedures and related systems for congruent management and coordination of stability activities. Responsibilities
Support stability program activities by ensuring studies are initiated per timelines, stability pulls and test requirements are accurate and complete, and pull dashboards are prepared per schedule.
Initiate test requests, follow through with testing labs for on-schedule reporting of the test results, draft time point reports, and archive data.
Maintain an accurate inventory of stability samples.
Assist in developing/maintaining relevant procedures and systems.
Escalates unusual observations or incidents of non-compliance.
Seek out and perform process improvements. Education and Experience Requirements
- Minimum, BS or MS degree in chemistry, biology, biotechnology, or related field.
- 3-5 years of industry experience with quality functions: quality control, manufacturing, or project management.
- General knowledge of ICH guidelines for stability.
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At Shire, we help people with rare diseases and specialized conditions live their lives to the fullest.