James Parks
Director, Chemical and Process Engineering @Incyte
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WORK HISTORY
Director, Chemical and Process Engineering @Incyte
Perform technology transfer to contract manufacturing organizations (CMO) for production of our small molecule active pharmaceutical ingredients. Review CMO capabilities and equipment to ensure successful manufacturing campaigns. Work with both our internal process development group and CMO process development groups to ensure processes are suitable for scale up from laboratory and kilo lab to commercial production. Review documentation of CMO production campaigns including master batch records, executed batch records, and validation protocols to ensure compliance with FDA good manufacturing practices (GMP). Assist in preparation of various FDA submissions including new drug application (NDA).
EDUCATION
University of Delaware
BSChE, Chemical Engineering
SKILLS
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