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Steven Malecha

Chemistry - Knox College

Analytical Methods and CMC Strategy


Resolution of manufacturing issues, development of new therapeutic and device products, development of extractives and leachable assessment strategies, knowledgeable of quality system elements, including laboratory controls for data integrity and audit readiness.


Headed Over 30 years of R&D experience leading groups responsible for trace organic and metals analysis, compendia particle analysis, method development, computer system validation, metrology and stability testing.

Laboratory Quality systems experience, including preparation for FDA and MDSAP inspections.

Steven Malecha
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