WuXi Biologics (stock code: 2269.HK) is a leading global Contract Research, Development and Manufacturing Organization (CRDMO) offering end-to-end solutions that enable partners to discover, develop and manufacture biologics – from concept to commercialization – for the benefit of patients worldwide. With over 12,000 skilled employees in China, the United States, Ireland, Germany and Singapore, WuXi Biologics leverages its technologies and expertise to provide customers with efficient and cost-effective biologics discovery, development and manufacturing solutions. As of December 31, 2024, WuXi Biologics is supporting 817 integrated client projects, including 21 in commercial manufacturing (excluding COVID CMO projects).WuXi Biologics views Environmental, Social, and Governance (ESG) responsibilities 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 engineers 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 with rich industrial experience to help customize your individual development plan.
You will receive regulatory training in company’s headquarter in China (Suzhou, Shanghai) to best comply to GMP requirement by USFDA, EMA, and other GMP authorities; and then to work in baes such as US Cranbury GMP manufacturing site.
You may receive tasks to work with cross-functional team to polish soft skills (communications/transversal leadership/negotiations, etc.)
You may actively participate in the new drug development projects for global customers.
You may develop expertise in production project management, production operations, auditing, and manufacturing technical support.
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.
Who you are:
Recent 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.