精英计划-GMFG – US&APACPDD-上海外高桥-制药生产-Manufacturing Management/Tech Expert/Clinical MFG Project Management-26届

as an integral component of our ethos and business strategy, and we aim to be an ESG leader in the biologics CRDMO sector. Our facilities use next-generation biomanufacturing technologies and clean-energy sources. We have also established an ESG committee led by our CEO to steer the comprehensive ESG strategy and its implementation, enhancing our commitment to sustainability. BioDev (Biologics Development) is the world's leading technology and capability platform for biologics CMC development and clinical manufacturing to expedite global biologics advancement. As of December 2024, our team in Shanghai, Wuxi, Suzhou, Hangzhou, Chengdu and US is composed by over 4,200 talents with near 400 experienced and outstanding scientists and senior managers and has become the biggest organization of biologics development in the world. The BioDev Clinical Manufacturing Department is consisted of multiple functions, including GMP cell banking (CB), GMP Drug Substance (DS) manufacturing, and Clinical Manufacturing Technical Support (CMTS), Clinical Manufacturing Production Management (CMPM) and Clinical Site Engineering & Maintenance Team (CSEM). Locations include Shanghai WaiGaoQiao, Shanghai FengXian and Suzhou, and Cranbury, NJ, US. We have state-of-art facilities, single-use equipment and technologies, automated filling lines and lab to support GMP productions. Biodev Clinical Manufacturing Elite program is designed to develop young talent to meet the fast-growing organization and business needs. In this program, you will receive customized individual development plan. Below are a few different training examples: •You will be receiving technical trainings and soft skills trainings from companies’ Subject Matter Experts (SMEs). •You will have a mentor to help customize your individual development plan. The mentors are graduated from the top schools and have plenty of industrial experiences. The mentor will also follow your growth and make adjustment as needed to help your growth. •You will also have area coach to help you enhance knowledge and guide you on day-to-day job. •You will receive 6-12 months of training in China (Suzhou, Shanghai), with opportunities to work in overseas bases such as the US Cranbury site. •You may have opportunities to work in different functions to obtain in depth knowledge to develop area of expertise. •You may receive tasks to work with cross-functional team to polish soft skills (communications/transversal leadership/negotiations, etc.) •You may be directly involved in the new drug development projects from domestic and foreign customers. •You may have opportunities to understand new drug projects from multiple dimensions such as production project management, production operations, auditing, and manufacturing technical support. In addition, there is also rotation job opportunities provided to the trainees. See below examples of the areas that can be rotated in: • GMP production (Drug Substance /Cell Banking) • Project Management • Clinical Manufacturing Technical Support • Manufacturing Operation • Manufacturing Compliance Job Responsibilities (assignment vary based on your background): • Perform daily duties focused on DS manufacturing process tech transfer, scale up and cGMP manufacturing operation. • Perform cGMP cell bank manufacturing activities. • Assist to establish DS/Cell Banking manufacturing operation system including but not limited to operation documentation/training system, project production schedule and follow up. • Trained to be function lead of DS/CB projects to coordinate with clients and internal departments to facilitate the success drug substance/product/cell banking manufacturing. • Perform experiments in the lab for GMP satellite runs or assist in experimental design to support complex deviation investigation or other studies to support GMP operations. • Author cGMP documents and presentations for internal and external reporting. • Draw process flow diagram and assisted in map out the process flow for different business processed to identify improvement opportunities. • Assist in data analysis and modeling to provide insights on manufacturing. • Assist in conducting client audit to prepare audit notes. • Assist to develop training programs for the DS/CB manufacturing team, and align with Site and Corp employee training and development policies. • Performs other duties as assigned.

• Recent undergraduate, master's, or doctoral graduates. • Majors in Biology, chemical engineering, pharmaceutical related fields • Strong critical and analytical thinking • Self-starter and be creative • Can adapt to fast speed working environment and handle pressure at work • Excellent interpersonal communication and presentation skills • Excellent written skills in English. Fluent in English as the primary language of communication. • Able to adapt to and embrace a multicultural environment. • Willing to follow arrangements to work at various sites in either China (Suzhou, Shanghai) or US. • Foreign nationals are welcome to apply