Must have experience with the following process development, validation, and qualification tasks associated with the cGMP; inwriting and aiding in the writing of SOPs for the project and performing related techniques according to established SOPs; independently conducting analysis and report studies; technical expertise in areas relevant to research projects, ordering and maintaining lab equipment, and vendor management; research activities involving all aspects of the research or protocol process investigation, technical, testing and validation of results, and report findings; qualifying, validating, and transferring analytical methods for testing biological drug substances and drug products with guidance from management; performing tissue culture and microbiological methods, and utilizing good aseptic techniques and lab practices to develop, process, and manufacture research and clinical grade cellular products under established SOPs; performing cellular, micro and molecular biology procedures Western blot, Northern blot, DNA and RNA, and PCR, Flow cytometry, Gene expression analysis, protein extraction, cell culture, immunocytochemistry, and staining; and conducting investigations regarding environmental monitoring EM action level excursions and outofspecification OOS results for quality control QC tests.
Categories: eb3
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