Job Responsibilities

Bioconjugation reactions and purification of antibody intermediates and conjugated drug substances. Perform downstream protein purification manufacturing operations for drug substances under the guidance of SOPs. This includes, but is not limited to, chromatography system operation, conjugation, low pH viral inactivation operation, nano filtration operation, ultrafiltration washing and filtration operation, and final bulk dispensing. Operate equipment and appliances following the guidance of SOPs and relevant documents. Prepare relevant documents, such as production batch records, SOPs, and validation reports. Communicate and resolve inconsistencies and/or anomalies in production operations. Monitor processes, including real-time review of process parameters, data, and trends. Ensure that the manufacturing operation of drug substances complies with quality and safety regulations. Complete other tasks assigned by superiors. Participate in shift production as required, ensuring compliance with SOP requirements.

Job Requirements

Bachelor's degree or above in Biological, Chemical, Pharmaceutical Engineering, or related fields; more than 2 years of experience in antibodies purification or conjugation is preferred. Possess rigorous scientific thinking and habits, with strong execution and planning abilities. Adapt to the GMP cleanroom environment, wearing dust-free clothing, masks, and goggles. Good communication and comprehension abilities. Obey leadership arrangements, demonstrate a hardworking spirit and a positive work attitude. Accept temporary work requirements, such as overtime on weekends or weekdays and other tasks.

Required Languages

English