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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Thank you,
BioTech FYI Center
http://biotech.fyicenter.com/
