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US: Senior Scientist,

Date: 05-Feb-2013
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Senior Scientist, Stability Technical Operations

* Responsible for developing, authoring and implementing stability protocols and reports for drug substance and drug product and reviewing stability-monitoring programs conducted by contract manufacturers; * Evaluate stability data and provide recommendations on project teams responsible for stability studies performed by collaborating partners; * Trend stability data to evaluate potential impact on product quality; * Analyze and report stability data as requested for management review and other internal and/or external requirements; * Provide recommendations based on experimental and/or statistical analyses that will be used in critical decisions about product stability and expiration dating; * Lead deviations, investigations, CAPAs and change controls associated with stability testing at contract manufacturer and partner locations; * Evaluate and utilize stability trending software; * Develop and improve Standard Operating Procedures necessary to perform routine and non-routine stability testing.

* Ph.D. or a B.S./M.S. in chemistry with 5+ years of relevant experience; * 2+ years of experience within the biotech or pharmaceutical industry related to stability programs; * Extensive knowledge of ICH stability guidelines and requirements for stability indicating methods; * Experience in stability protocol development, materials compatibility studies, sample management, interfacing with contract labs and promoting stability best practices; * Knowledge of statistical processes and applications required for the analysis of complex stability data; * Working knowledge in laboratory techniques, including high performance liquid chromatography, size exclusion chromatography, moisture analyses and dissolution testing; * Experience with oral dosage products, peptides, or related compounds will be considered an asset; * Ability to manage multiple and varied tasks, and prioritize workload; * Excellent written and verbal communication skills.

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