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.