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  • Senior Scientist

    Company: Fougera

    Location: Melville, NY

    Date Posted: September 03, 2013

    Job Title: Sr. Scientist, Manufacturing Science & Technology (MS&T)Department: Manufacturing Science & Technology (MS&T) Reports To: Associate Director, Tech Services SUMMARY: Senior Scientist, MS&T will assist the Associate Director, MS&T in all aspects of MS&T including but limited to - timely resolution of discrepancy deviation investigations (DDI), long term back order (LTBO), laboratory investigation reports (LIR), annual product review (APR), material/site changes, process engineering studies, scale-up/process development, global remediation, and package engineering. Collaborate with multiple groups in a matrix environment including Analytical, Regulatory Affairs, Clinical, Project Management, Manufacturing, and Quality groups. Must know the FDA requirements for GMP, GLP, ANDA,...

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