Job Responsibilities

1、Participate in the development, optimization, and scale-up of cell culture processes, utilizing laboratory-scale bioreactor systems to establish and optimize cell culture workflows. Address key technical challenges.

2、Formulate technical design plans, monitor execution and strategic control, optimize processes, and conduct data analysis and report writing. Participate in drafting and improving standard operating procedures (SOPs) and safety protocols related to cell culture.

3、Assist in the daily management and operations of the laboratory, including routine maintenance, calibration, and validation of cell culture-related equipment.

4、Prepare technical documentation related to process development for Investigational New Drug (IND) and Biologics License Application (BLA) submissions.

Qualifications

1、 Education & Major:

Master’s degree or higher in Bioengineering, Cell Biology, Biotechnology, Fermentation Engineering, or a related field.

2、Work Experience:

l  Minimum 5 years of hands-on experience in mammalian cell culture process development, optimization, and scale-up production, with familiarity across laboratory, pilot, and commercial production scales.

l  Experience in pilot or production-scale cell culture process studies, proficient in bioreactor operation, maintenance, and process control. Ability to independently explore and optimize process parameters.

l  Familiarity with regulatory policies for project submissions and practical experience in IND/BLA application preparation and submission.

3、Competencies:

l  Ability to independently prepare project application materials and possess strong communication and coordination skills for regulatory submissions.

l  Knowledge of GMP regulations and quality system requirements in the biopharmaceutical industry. Prior experience in GMP-based cell culture production is preferred.

l  Strong sense of responsibility, initiative, and innovative mindset; meticulous and detail-oriented in work.

l  Proficiency in reading and writing technical literature in both Chinese and English, with effective communication skills.

l  Emphasis on teamwork and collaboration.