Marlayna Chemin, MScPhm

Object of internship: Improvement of a method of analysis for a medical shampoo Development of a robust HPLC/UPLC method for the quality control of a glucocorticoid shampoo in response to regulatory requirements Developed an experimental plan to improve the reproducibility and specificity of the method for the identification and determination of the API and its related substances in a medicinal shampoo Performed pre - validation and drafted the protocol

Objective of internship: Biochemical and developmental characterization of cell wall mannan sugar complexes in wheat grain Developed an enzymatic fingerprint method to determine the biochemical structure of mannan polysaccharides (using alcohol extraction methods, immunodot assays, and GC and HPAEC-PAD analyses) Analyzed neutral and acidic sugar content (by GC and Skallar assays) of whole grain and wheat flour from various genotypes Determined, by permethylation, the presence of glycosidic bonds in purified extracts of parietal polysaccharides of wheat albumen

Wrote protocles, test procedures, and reports for the development and the manufacturing of orphan drugs, in accordance with the applicable pharmacopoeias, GLP, and GMP Provided assessment to ensure expectations were met regarding assigned change controls Participated in the drafting and preparation of documents for Regulatory Submission and commercialisation of products (NDA and ANDA) in collaboration with CMC Regulatory Affairs Officers, in accordance with Modules 2 and 3 of the ICH Establishment of an information management system (LIMs) in collaboration with the IT department of the laboratory Management of CAPA plans following regulatory audits (FDA, EMA)

Emission of quotes, negotiation of contracts and management of marketing and local communication Conduction of a water quality improvement project in collaboration with the Department of Environmental Protection