Assoc Scientist Pharmaceutical Sci|ALX|US - New Haven, CT

Only for registered members New Haven, CT, United States

1 month ago

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Job Summary

The Stability Associate II is responsible for performing assigned tasks to support stability activities for client 's clinical phase candidates from development through Phase III and support Commercial Products.

Responsibilities

* Responsible for all aspects of on-site stability sample storage and sample management* Conduct Stability sample pulls at scheduled timepoints according to approved stability study plans* Deliver stability samples to labs and perform aliquots as needed, following Good Documentation Practices (GDPs) and Good Laboratory Practices (GLPs)* Perform data entry/review within paper-based and electronic systems* Point-of-contact between on-site testing labs and stability group* Author stability Protocols, Reports, SOPs and Quality documents as required* Work with internal stakeholders to provide testing requirements and obtain completed analytical test results* Track stability results generated internally and at external CMOs/ CLOs* Document stability results with a strong attention to detail; able to recognize trends outside of expected results and communicate to management as required*
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