Nicholas is an accomplished scientist and manager with over 18 years of experience in the pharmaceutical industry and proficient in all phases of pharmaceutical drug product development and manufacturing. Nicholas has extensive experience in managing and troubleshooting manufacturing products/processes from Phase 1 – Commercial, Solid oral dose and aseptic manufacturing. Nicholas is a technical expert in: spray drying, wet/dry granulation, compression, coating, continuous manufacturing, early phase formulations, microparticulate processing for parenteral injection, and aseptic fill/finish. Nicholas is quality focused with extensive knowledge of cGMP’s and compliance, including but not limited to; writing and reviewing: SOPs, batch records, IOQs, processing/cleaning validation, deviations, change controls, and technical GMP documentation. Nicholas has also been involved in designing labs and manufacturing suites with a focus on streamlining the drug product formulation and manufacturing process including assisting in the execution of one of the first continuous pharmaceutical commercial manufacturing rigs in North America.
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