-The candidate will be the Subject Matter Expert of separation and characterization assays within Janssen R&D Biotherapeutics Development Shanghai lab and be responsible for the gap assessment, qualification, and transfer of separation and characterization assays to support Clinical Trial Application (CTA), Biologics License Application (BLA), and variation filings and product launches in China.
-The candidate will also be responsible for trouble shooting of separation assays during in-country testing throughout the product life cycle in China and Asia Pacific.
-The candidate will conduct monoclonal antibodies testing using HPLC and CE-based technologies and develop/optimize/qualify new analytical methods. The specific activities may include but not limited to authoring/reviewing technical documents (protocols, reports, SOPs, memos), hands-on execution of studies, reviewing notebooks, Ordering and maintaining reagents, consumables and instrument needed for the experiments, and guiding junior scientists.
-The individual will be required to stay compliant with JNJ company policies and related regulations such as GXP.
-The candidate will report toXian Janssen Commercial Quality GDP manager and routine management under Senior scientist of China Analytical Development. This position will be located in Zhangjiang, Shanghai, China.
Child care benefits
Short term disability