at Incyte Corporation in Wilmington, Delaware, United States
Incyte is a biopharmaceutical company focused on the discovery, development, and commercialization of novel medicines to meet serious unmet medical needs in oncology and inflammation and autoimmunity. Incyte is committed to the rigorous pursuit of research and development excellence to improve the lives of patients, make a difference in health care, and build sustainable value.
The Company strives to discover and develop first-in-class and best-in-class medicines-advancing a diverse portfolio of large and small molecules.
Our Global Pharmaceutical Development group is looking for a motivated Stability Coordinator. This position is responsible for tracking stability of Incyte's small molecule drug substance and products.
Essential Functions of the Job (Key responsibilities)
Import approved stability study into LIMS and update as needed, archive study summaries in eDMS.
Serve as stability admin in LIMS.
Track and Maintain schedule of study pull dates and update weekly.
Report Internal stability tables.
Consolidate and archive CMO reports, raw data packages, investigations and deviations in eDMS.
Communicate status of ongoing stability studies with project leads.
Collaborate with project leads to enable DS retest date extensions and DP shelf-life extension as appropriate.
Qualifications (Minimal acceptable level of education, work experience, and competency)
Science Background (BS in chemistry or related scientific field).
Working knowledge of GxP ( at least 2 years experience).
Strong Administrative and Organizational Skills.
Critical attention to detail - Quality Control Mindset.
Cross functional collaboration with Subject Matter Experts and Quality Assurance.
Database and software savvy (LIMS, Veeva, SAP, Minitab).
Ability to balance several projects concurrently.
Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.
Incyte Corporation is committed to creating a diverse environment and is proud to be an equal opportunity employer.
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