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无工作经验 -
招1人 -
02-09 发布
职位描述
Director/Senior Manager: Upstream Process DevelopmentLocation: ShanghaiPosition: Full TimeChimagen is seeking a highly experienced and motivated Director/Senior Manager of Upstream Process Development to lead the antibody process development group. The position will initially work primarily with third parties (e.g. CROs and CMOs). The candidate will have the exciting opportunity to lead the development of scalable cell culture processes for the production of multi-functional therapeutic antibodies. He/she will provide cross-functional support to quality control, analytical development, process analytics, and other functions. He/she will author and/or review protocols, technical reports, and regulatory submissions to support clinical development and licensure. Furthermore, this individual is expected to work independently on assigned tasks/projects, mentor scientists, and provide insight to improve processes, and communicate results to the CMC team. Essential ResponsibilitiesProvide technical leadership and guidance in the development of a scalable, robust, high yielding, and economically viable cell culture processes using miniature, bench-scale, and larger disposable bioreactors in the laboratory setting for the production of antibody and virus vectors Executes process monitoring and control strategies for robust process design and ensures scalability of unit operations during process development Designs scientifically rigorous experiments using statistical DoE where applicable and execution of experiments, analyzes and interprets data, to make process improvements, and further design next studies Provide technical oversight for outsourced process development and production with CROs and CMOs Establish and manage upstream process development laboratory, hire, supervise and train junior staff on procedures and processes in the lab Authors Standard Operating Procedures, technical reports, process descriptions, including data interpretation and procedures suitable for inclusion in pre-IND, IND or equivalent regulatory submission Supports the execution of start-up, commissioning, and maintenance of equipment and processes Collaborating closely with Downstream Process Development (DSP) groups to improve workflow efficiency and overall process yield. Participate in multi-disciplined project teams, and guide project and business strategies Reviews process descriptions and batch records during tech transfer Keeps current with advances in upstream processes for antibodies and viral vector production Education and ExperienceM.S. or Ph.D.(preferred) in chemical engineering, biochemistry or related fields 8+ years (M.S.) or 5+ years (Ph.D.) of experience in antibody upstream process development Demonstrated understanding of cGMP antibody process development and production Experience operating in early stage clinical to commercial environments, as well as contract development and manufacturing Hands-on experience with mammalian and/or insect cell culture, aseptic techniques, understanding of biochemical engineering concepts, and biochemical pathways Significant experience in developing and improving scalable fed-batch, transfection, and perfusion upstream processes in PD setting Familiar with Bioreactor Scale-up concepts and have a proven record for scaling-up processes to disposable/stainless bioreactors Ability to use Design of Experiments in JMP, Design Expert, or other for statistical experimental design, and data analysis Knowledge of statistical process control, QbD, and PAT concepts preferred Demonstrated scientific creativity, technical proficiency and knowledge of scientific concepts Excellent record keeping abilities to adequately document process development data Strong verbal and written communication skills and ability to communicate within the organization as well as externally Familiarity with cFDA guidance and quality systems preferredExperience in antibody production preferred Experience in a cGMP environment preferred Familiar with micro bioreactor system set-up, bioreactor controls, and using data historians Strong oral presentation and communication skills.Ability to communicate in English. 职能类别： 医药技术研发管理人员
联系方式
蔡伦路780号
公司信息
上海恩苜生物科技有限公司诚聘
