CMC Process Researcher

1. Responsible for the process development of new drugs in the clinical stage of the company;

2. Develop research plans for CMC, manage CDMO/CRO, and monitor the entire process and project execution of CMC development.

3. Responsible for connecting upstream research and development with downstream production, communicating and coordinating with relevant personnel in a timely manner, carrying out process technology transfer and SOP development, scaling up product scale, developing large-scale production process parameters, and quality standards;

4. According to the relevant regulations on drug registration, write and review IND/BLA pharmaceutical related materials.

1. Master's degree or above, majoring in biology, pharmacy, pharmaceutical engineering or related fields;

2. Has extensive experience in mammalian cell culture, including but not limited to T-Flask vial culture, cell factory culture, bioreactor culture (adherent cell culture and suspension cell culture experience), downstream purification of CMC experience (small-scale, pilot, and scale-up process development), and has participated in CGT products, human vaccine IND for mammalian cell production, and CMC research in clinical stages

4. Familiar with and involved in technology transfer;

5. Proficient in antibody production;

6. Familiar with the relevant regulations and policies for clinical application of cell gene therapy drugs, human vaccines, or extracellular vesicles;

7. Having a pioneering and innovative mindset, possessing the ability to think actively, identify problems, and solve them;