Shire Stability Specialist in Lexington, Massachusetts

The Stability Specialist will be responsible for managing development and GMP 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. The Stability Specialist will collaborate with Quality and PDTS program owners to manage product related stability deviations, impact assessments, CAPAs, anomalous and OOS result investigations. The individual will be required to manage studies in LIMS as warranted.

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Equal Employment Opportunity

Shire is an Equal Opportunity Employer committed to a diverse workforce. Shire will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.

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Reasonable Accommodations

Shire is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.

Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.

Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.