Jobdescription This isan exciting opportunity to join and contribute to the buildup of a newbiologics manufacturing facility. This AQposition will lead AD function to support biologics method development and processdevelopment, method transfer and validation as well as trouble-shooting andmanufacturing investigation. This positionwill play an important role in developing the biologics site to be a top tier manufacturingfacility, Responsibilities l Build up AD department, recruiting and developing its team staff,and setting up lab operation systems. l Serve as subject matter expert (SME) and provide technical guidance,instructions and supervision to routine testing and methodology development. l Manage work and project plan according to timeline and functionalgoals and objectives l Develop group technical capability in analytical tests, andbiological assays in compliance with laboratory operation procedure andapplicable regulations. l Set up suitable laboratory operations practice and rules tocontinuously improve testing l Set up high throughput operations to enhance testingefficiency. l Communicate proactively to senior management with regard to projectplan, execution and completion. l Timely apprise senior management of major issue for awareness and discussionand understand the impact to larger organization l Innovate new ways of doing testing and create effectivecollaboration with process and manufacturing to make testing high effective andproductive l Develop key technical experts within the team and support personnelcareer growth. Provide coaching andmentoring to junior members and develop their technical and teamworkingcompetence Qualifications l Science or engineering undergraduate degree. Advanced degree (MS orPhD) is a highly desirable. l Strong expertise and experience in biologics analytical sciences,with over 10 years of industry experience in biopharmaceutical areas. Must haveprior experience of working with biologics (e.g. Ab). l Technical strength in protein analytical methodologies, such asHPLC/UPLC, CE, LC-MS, in-vitro bioassay and ELISA, automaticworkstation, spectrophotometry, endotoxin detection. l Prior experience of leading a team and managing group of people l Familiar with biologics development, manufacturing process, criticalcontrol points and Ab critical quality attributes (CQAs) l Collaboration, organization, and communication skills are criticalto this role l Fluent in English and Chinese
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