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Job description: ? Lead a team of scientists and associates to develop analytical assays and conduct assay validation and testing for therapeutic protein for various research and manufacturing stages. ? Define, implement, and manage the various quality control programs needed to ensure GMP/GLP and regulatory compliance. ? Establish SOPs and LIMS and ensure sample testing and testing reports completed in a timely manner to meet the demands of all projects. ? Manage and coordinate the activities of the department in support of biopharmaceuticals produced in the cGMP facility including: oversight of analytical (protein) and microbiological in-process, release and stability testing, the environmental monitoring and raw material programs; deviation investigation and guiding in potential CAPAs; draft and revise SOPs; staff training and development. ? Keep all required instrument and equipment calibrated, validated if needed, and maintained in good conditions. Requirement: ?Master degree in chemistry, biochemistry, molecular biology, analytical science or other related fields is required. ? A minimum of 10 years of working experience in pharmaceutical development environment with good track record in analytical development and quality control is required. Experiences in international pharmaceutical companies are preferred. ? Oversee all analytical laboratory procedures and related testing, data review, trending, interpretation and reporting of results. ? Oversee analytical (protein) and microbiological in-process, release and stability testing and the environmental monitoring and raw material programs. ? Coordinate cross-functional, intra-group and inter-group work assignments and address scheduling conflicts.